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{
"NCT_ID" : "NCT06979687",
"Brief_Title" : "Knotless Barbed Suture Closure of the Uterus at Caesarean Section",
"Official_title" : "Knotless Barbed Suture Closure of the Uterus at Caesarean Section",
"Conditions" : ["Caesarean Section", "Caesarean Section; Infection"],
"Interventions" : ["Procedure: knotless barbed suture closure of the hysterotomy at caesarean section", "Procedure: Standard 2 layer closure of caesarean hysterotomy using 910 polyglactin suture (SS)"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-11-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2025-02-11",
"Study_Completion_Date(Actual)" : "2025-02-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2025-05-13",
"First_Posted(Estimated)" : 2025-05-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2025-05-13",
"Last_Update_Posted(Estimated)" : 2025-05-20",
"Last_Verified" : 2025-01"
}
}}
|
#Study Description
Brief Summary
Caesarean section (CS) is an increasingly common mode of delivery. The way in which this operation is carried out is important as it affects millions of women each. In recent years use of a 'self-retaining' suture or thread for closure of the uterine closure has become a recognised approach with a proven safety record. These sutures are known as knotless barbed sutures (KBS) as the unidirectional barbs on the surface of the suture hold the suture in the tissue without the need for knots. These sutures can be used instead of the usual 'smooth' suture which requires knots at the angles. There are high-level level data that CS are quicker and on average need fewer additional stitches to control blood loss when KBS are used. There is additional evidence of a potential reduction in problems with healing of the uterus with KBS, it is thought that this might lead to a lower risk of problems in repeat CS as the chance of the placenta implanting into the scar might be lower. At present this evidence is based on ultrasound surveillance of scar appearance which is an indirect measure. The real risk difference will need to be explored with the examination of real world outcomes over the coming years.
There is currently no published data on KBS for uterine closure at caesarean from the UK. This cohort, although retrospective, is adequately controlled, shows excellent outcomes and signals a potential marked reduction in infectious morbidity. This potentially means a better patient experience as well as a large cost saving because of reduced re-admission rates. These data were collected as part of a service improvement project but the generalisable nature of our findings mean the finding are research and should be published.
Detailed Description
Caesarean section (CS) is one of the most commonly performed operations worldwide and the prevalence is increasing1. There are perioperative complications including neonatal morbidity and, on the maternal side, haemorrhage, infection and organ injury2. Furthermore, there are implications for future pregnancies, the risks of which rise with each successive caesarean3. Closure of the lower segment hysterotomy at CS is most commonly affected using a 2-layer approach employing braided absorbable sutures such as Vicryl (polyglactin 910)4. Closure is with a continuous suturing technique and the tension of the closure is maintained manually until the suture is secured with knots at the angles. Knotless barbed suture (KBS) closure of the caesarean hysterotomy remains a novel technique that is not yet widely employed. These sutures, first invented in 1964, were approved by the FDA in 2004 and were first used in a clinical trial in 20075. Barbed sutures anchor themselves within the tissue, as barbs on the suture resist backward movement through the tissue. They offer even tension over the length of the hysterotomy and are cut flush with the uterus without the need for anchoring knots.
A systematic review and meta-analysis of randomised control trials (n460) on KBS compared with 'smooth' sutures at elective CS found that operative times were lower and the need for additional haemostatic sutures was lower6. There was a trend towards lower blood loss and no difference in operative morbidity. Some trials, some of which are ongoing, have examined whether there is a difference in lower segment residual myometrial thickness (RMT) after KBS and whether there is a difference in the incidence of scar niche7. These outcomes, respectively, are offered as potential proxy measures for uterine rupture risk and praevia or PAS risk. The results of these trials, as per their proxy outcomes, have been encouraging. This trial offers the first data on KBS at CS in UK practise.
Methods:
This single-centre retrospective cohort study in a tertiary care hospital in Northern England including caesarean deliveries from November 2022 to October 2024 - a 24 month period. The cohorts are women who had a Medtronic's V-loc 180 absorbable device (KBS) and women who had 2 layer vicryl (polyglactin 910) uterine closure i.e. smooth suture (SS).
Data was collected prospectively using a Microsoft Excel™ spreadsheet by the lead clinician (HS) as part of a quality improvement project and data was cross-referenced with patient records using Clevermed badgernotes ™ maternity system data records. Baseline characteristics reported are: patient age at delivery, parity, number of previous caesarean sections, BMI at booking, additional intraoperative interventions, birth-weight, indication for, and category of, caesarean, mode of anaesthesia, grade of operator and whether a consultant was present if not the primary surgeon (Table 1). The pre-specified outcome was blood loss. The pre-specified secondary outcomes were operating time, infection rates, readmission, unplanned outpatient attendance, and other complications.
Women were grouped for comparison as follows: group 1, n290 elective CS undertaken using KBS (November 2022-December 2024); group 2 - n215 Elective caesareans undertaken on a number of consultant lists using SS (May-August 2024). Group 3 - n107 Emergency caesarean deliveries using KBS (January 2023-December 2024); Group 4 - n345 emergency caesarean deliveries using SS (May-August 2024). Group 5 - n397 comprises group 1 and group 3. Group 6 - n560 comprises group 2 and group 4. The plan for data analysis was pre-specified and published prior to analysis being undertaken.
We report baseline characteristics and outcomes as means (SDs), or numbers and percentages. Difference in outcome by cohort is reported as relative risk with 95% CI. Multivariate analysis was used to assess correlation for inclusion of variables in binary logistic regression for adjustment of risk. Variables felt relevant were included regardless of significance of correlation, as pre-specified - for the primary outcome, across all three comparisons, the following variables were pre-selected for inclusion in adjustment of risk: BMI, birthweight, mode of anaesthesia. For the secondary outcomes pre-specified variables for adjustment of risk across all three comparisons were as follows: for operating time; BMI, additional operative interventions, number of previous caesareans, for infection rates; BMI, category of caesarean and indication, for readmission; BMI and category of caesarean, for unplanned outpatient attendances as for readmission. There was no planed adjustment for the safety outcome of other complications. Unpaired t-tests, Chi square or Fisher's exact test were used to test significance for categorical and continuous outcomes. Analysis was carried out using IBM SPSS version 24. Alpha was taken as 0.05 for the primary outcome and 0.01 for the secondary outcomes.
#Intervention
- PROCEDURE : knotless barbed suture closure of the hysterotomy at caesarean section
- Use of Medtronic V-loc 180 suture (VL) for a 2 layer closure of the caesarean hysterotomy rather than the standard 2 layer closure using the 910 polyglactin suture (SS).
- PROCEDURE : Standard 2 layer closure of caesarean hysterotomy using 910 polyglactin suture (SS)
- Standard 2 layer closure using the 910 polyglactin suture (SS)
|
#Eligibility Criteria:
Inclusion Criteria:
* Women undergoing a caesarean section at the study hospital within the data collection period for that cohort - either with or without KBS depending on the cohort.
Exclusion Criteria:
* Not falling within the search criteria for a comparator group
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT06979687
| 230,354
|
{
"NCT_ID" : "NCT03316807",
"Brief_Title" : "Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults",
"Official_title" : "Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in HIV-infected Adults in China",
"Conditions" : ["Hepatitis B Vaccine"],
"Interventions" : ["Biological: 20 µg dose hepatitis B vaccine", "Biological: 60 µg dose hepatitis B vaccine"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-07",
"Study_Completion_Date(Actual)" : "2018-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-10-17",
"First_Submitted_that_Met_QC_Criteria" : 2020-12-20",
"First_Posted(Estimated)" : 2017-10-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-10-17",
"Last_Update_Posted(Estimated)" : 2022-03-11",
"Last_Verified" : 2021-12"
}
}}
|
#Study Description
Brief Summary
Uptake, adherence, and completion of vaccination among HIV-infected adults were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect HIV-infected adults from HBV infection. And the persistence of immunity induced by hepatitis B vaccination remains a challenge.
This is a randomized, open-label trial, conducted among HIV-infected adults with drug rehabilitation. This study will compare the immunogenicity, immune persistence, and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among HIV-infected adults.
Detailed Description
Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine group or 60µg recombinant hepatitis B vaccine group. The 20 µg group will receive three intramuscular injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6, respectively. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
#Intervention
- BIOLOGICAL : 60 µg dose hepatitis B vaccine
- three-dose, 60 µg per dose
- BIOLOGICAL : 20 µg dose hepatitis B vaccine
- three-dose, 20 µg per dose
|
#Eligibility Criteria:
Inclusion Criteria:
* HIV-infected
* Aged between 18 and 70 years
* Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
* Willing to adhere to the study protocol
Exclusion Criteria:
* Being pregnant
* Acute cytolysis in the last three months before enrollment
* Any vaccination before or during the month preceding enrollment
* Any Intolerance or allergy to any component of the vaccine
* Ongoing opportunistic infection
* Hematological disorder
* Cancer
* Unexplained fever the week before enrollment
* Immunosuppressive or immunomodulating treatment in the last six months
* Liver disease
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03316807
| 210,733
|
{
"NCT_ID" : "NCT00559182",
"Brief_Title" : "A Study of MK-8033 in Patients With Advanced Solid Tumors (MK-8033-001)",
"Official_title" : "A Phase I Dose Escalation Study of MK-8033 in Patients With Advanced Solid Tumors",
"Conditions" : ["Advanced Cancer"],
"Interventions" : ["Drug: Comparator: MK-8033 +/- omeprazole", "Drug: Comparator: MK-8033"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-12-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-06-10",
"Study_Completion_Date(Actual)" : "2010-07-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-11-14",
"First_Posted(Estimated)" : 2007-11-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-11-14",
"Last_Update_Posted(Estimated)" : 2022-07-26",
"Last_Verified" : 2022-07"
}
}}
|
#Study Description
Brief Summary
This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II Dose (RP2D), pharmacodynamic, and clinical activity of MK-8033.
Parts A and B of the study will determine the maximum tolerated dose (MTD) and RP2D. Part C of the study will be a single panel crossover study to determine the effect of omeprazole, a gastric pH modifier, on the pharmacokinetics of MK-8033.
#Intervention
- DRUG : Comparator: MK-8033
- MK-8033 will be administered as an oral formulation in sequentially rising dose levels starting at 50 mg and continuing at 100% dose increments until dose level 4 (800 mg total daily dose). Dose levels 5 to 11 will be escalated at \~40% dose increments until 3000mg (total daily dose). The daily dose of MK-8033 will be divided into two equal doses. MK-8033 will be administered in a first cycle of 14 days (continuous drug administration from Day 1 through Day 14), followed by a 1 week drug holiday (Cycle 1, Day 15 through Day 21). Subsequent cycles of MK-8033 will be administered for 14 days (Cycles 2 to 4) and 28 days (Cycle 5 and beyond).
Enrollment in Parts A and B has been completed.
- DRUG : Comparator: MK-8033 +/- omeprazole
- Part C will occur at only one of the investigational sites.
In Cycle 1, patients will be randomized to one of two treatment sequences, A/B or B/A, over two treatment periods. Treatment A: 770 mg MK-8033 twice daily with co-administration of 20 mg omeprazole once daily. Treatment B: 770 mg MK-8033 twice daily. After Cycle 1 is complete, patients may continue to receive MK-8033 until disease progression or unacceptable toxicity.
Enrollment for Part C has been suspended.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient must be at least 18 years, with adequate organ function, and an Eastern Cooperative Oncology Group (ECOG) performance of <2
* Patient must be willing to undergo pre-study and post-dose tumor biopsy and have tumor accessible for biopsy (Waived during Parts A and C)
Exclusion Criteria:
* Patient is currently using bisphosphonate therapy or has received this therapy in past 6 months
* Patient has had chemotherapy, radiotherapy, or biological therapy within 4 weeks of study participation
* Patient has history of cardiac disease
* Patient with a primary central nervous system tumor
* Patient has a known psychiatric or substance abuse disorder
* Patient is pregnant or breastfeeding, or expecting to conceive during the study
* Patient is known to be Human Immunodeficiency Virus (HIV) positive and the HIV infection is not well controlled
* Patient has received therapy with a Proton-Pump Inhibitor, Histamine2-Receptor antagonist or antacid within one week of study participation (Part B only)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00559182
| 7,757
|
{
"NCT_ID" : "NCT01237639",
"Brief_Title" : "Study of Red Blood Cell Transfusion Triggers in Patients Undergoing Hematopoietic Stem Cell Transplantation",
"Official_title" : "Transfusion of Red Cells in Hematopoietic Stem Cell Transplantation: The TRIST Study",
"Conditions" : ["Hematologic Malignancies"],
"Interventions" : ["Other: Red blood cell Transfusion"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-10",
"Study_Completion_Date(Actual)" : "2016-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-10-13",
"First_Posted(Estimated)" : 2010-11-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-11-08",
"Last_Update_Posted(Estimated)" : 2016-10-12",
"Last_Verified" : 2016-10"
}
}}
|
#Study Description
Brief Summary
Transfusion of red blood cells (RBCs) is important for the care of patients undergoing stem cell transplantation. Stem cell transplants are used to treat blood cancers and bone marrow disorders. This involves the use of high doses of chemotherapy and/or radiation to kill cancer cells; but this damages the marrow and blood system. Blood stem cells are transplanted by infusing into the recipient and blood counts recover over 2-3 weeks. Before bone marrow recovery, RBCs are needed to support the patient. Higher hemoglobin in these high risk patients may have benefits such as better energy and organ function. However, research in other areas of medicine suggests that a higher red cell count may be dangerous. Taken together, it is unclear whether having a lower or higher red cell count is better for patients having a blood stem cell transplant. The investigators plan to study this by randomly assigning patients having a transplant to be transfused with RBCs either at a higher or lower hemoglobin level. In this way, the investigators will be able to accurately find out if there are any benefits or harms in having a lower or higher red cell count during the recovery period after blood stem cell transplantation.
Detailed Description
1. Males or females aged 18 years or older who are undergoing either an autologous or allogeneic HSCT.
2. The indications for HSCT may include, but not limited to the following diseases :
1. Acute Leukemia, myeloid, lymphoid or biphenotypic in 1st, 2nd remission or in relapse
2. Chronic Myeloid Leukemia in chronic, accelerated or blast phase
3. Chronic Lymphocytic Leukemia
4. Myelodysplastic Syndrome
5. Myeloproliferative Disorder
6. Lymphoma
7. Myeloma
3. All study patients must provide consent at least 1 day prior to scheduled HSCT and provide written informed consent.
#Intervention
- OTHER : Red blood cell Transfusion
- Transfusion of Red blood cells to based on daily complete blood count
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients are aged 16 <= age <= 70 undergoing either an autologous or allogeneic HSCT for any hematologic malignancy
Exclusion Criteria:
* Pregnant or lactating at the time of enrollment
* Already received red cell transfusion after HSCT but prior to enrollment
* Unable/unwilling to provide informed consent.
* Patients receiving HSCT for non-malignancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01237639
| 82,231
|
{
"NCT_ID" : "NCT00215423",
"Brief_Title" : "Study in Patients With COPD",
"Conditions" : ["COPD", "Chronic Obstructive Pulmonary Disease"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2003-12",
"Study_Completion_Date(Actual)" : "2005-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-13",
"First_Posted(Estimated)" : 2005-09-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-14",
"Last_Update_Posted(Estimated)" : 2010-11-11",
"Last_Verified" : 2008-08"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to determine which dose of the investigational drug is the most safe and effective for the treatment of COPD compared to the control drug
#Intervention
- DRUG : Formoterol Fumarate
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of COPD
* History of cigarette smoking
Exclusion Criteria:
* Clinical diagnosis of asthma
* Significant pulmonary disease other than COPD
* Other significant major organ disease(s)
Sex :
ALL
Ages :
- Minimum Age : 5 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00215423
| 154,518
|
{
"NCT_ID" : "NCT05815121",
"Brief_Title" : "Use of Acupressing in Reproductive Medicine",
"Official_title" : "Interest of Acupressing in the Treatment of Preoperative Anxiety and Comfort of Patients Undergoing Oocyte Retrieval in Outpatient Surgery",
"Conditions" : ["Fertility Disorders", "Anxiety State"],
"Interventions" : ["Other: Control", "Other: Acupressing"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-02-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-03-11",
"Study_Completion_Date(Actual)" : "2023-03-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-02-08",
"First_Posted(Estimated)" : 2023-04-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-04-03",
"Last_Update_Posted(Estimated)" : 2025-04-03",
"Last_Verified" : 2025-04"
}
}}
|
#Study Description
Brief Summary
The objective of this preliminary study is therefore to assess the feasibility, safety and reduction of perioperative anxiety thanks to acupressing. In addition, patients undergoing oocyte retrieval often present postoperatively with nausea, abdominal pain and discomfort. Acupuncture could also help these patients.
Detailed Description
Infertility can lead to the realization of follicular puncture or oocytes in order to obtain an embryo for medically assisted procreation. It is a long treatment for the couples concerned and this intervention, relatively simple in young patients, is associated with a very high level of anxiety. According to studies, the incidence of preoperative anxiety ranges from 11% to 80% in adult patients. In patients undergoing outpatient surgery, anxiolytics are not administered before anesthesia in outpatient surgery, as this would risk altering their 'fitness for the street' and preventing their return home. Studies have shown a benefit of acupressing in the treatment of preoperative anxiety. This technique could therefore be an alternative to drug anxiety before surgery. Acupressing could also help these patients.
#Intervention
- OTHER : Acupressing
- Acupuncture with placement of 4 vaccaria seeds covered with stickers on the ears and 2 on the wrists.
- OTHER : Control
- with stickers only on the points, and the points should not be massaged.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients > 18 years
* Scheduled to undergo an oocyte retrieval in outpatient surgery
* Anxiety score >= 3 when they arrived in the outpatient unit
* Subject is willing and able to provide informed consent
* Covered by a national healthcare insurance
Non-Inclusion Criteria:
* Ear's pavilion infection
* Wrist infection
* Previous treatment with auriculotherapy or acupuncture
* With a planned intervention that does not allow the delay of 45 min delay (+/- 15 min) between the acupuncture treatment and the STAI assessment
* Being deprived of liberty or under guardianship
Exclusion criteria
* Patient having recourse to any treatment or method of anxiolysis the morning of the procedure, after having given her consent
* Patient wishing to withdraw from the study
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05815121
| 181,202
|
{
"NCT_ID" : "NCT04007211",
"Brief_Title" : "Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Applied to Postoperative Intrauterine",
"Official_title" : "A Randomized, Multi-center, Evaluator and Subject Blind, Active-controlled, Parallel, Medical Device Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Compared to Hyalobarrier Applied to Postoperative Intrauterine",
"Conditions" : ["Postoperative Adhesion of Uterus"],
"Interventions" : ["Device: Hyalobarrier", "Device: ABT13107"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-02-27",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-08-29",
"Study_Completion_Date(Actual)" : "2018-08-29},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-07-01",
"First_Posted(Estimated)" : 2019-07-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-07-01",
"Last_Update_Posted(Estimated)" : 2020-08-25",
"Last_Verified" : 2020-08"
}
}}
|
#Study Description
Brief Summary
This study is intended to evaluate the efficacy and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine.
#Intervention
- DEVICE : ABT13107
- Dose: 3mL, maximum 10mL
- DEVICE : Hyalobarrier
- Dose: 10mL
|
#Eligibility Criteria:
Inclusion Criteria:
* Female patients aged from 19 to 70
* Those who are scheduled for hysteroscopy to treat the following diseases: submucosal myomas, endometrial polyps, intrauterine adhesion etc.
Exclusion Criteria:
* Those who will apply other intrauterine device rather than investigational device during the study period.
Sex :
FEMALE
Ages :
- Minimum Age : 19 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04007211
| 228,586
|
{
"NCT_ID" : "NCT00097019",
"Brief_Title" : "A Study of Bevacizumab in Ovarian Cancer or Primary Peritoneal Cancer Where Doxil or Topotecan Therapy Has Failed",
"Official_title" : "A Multicenter, Single-Arm, Phase II Trial of Bevacizumab in Subjects With Platinum-Resistant Epithelial Carcinoma of the Ovary or Primary Peritoneal Carcinoma for Whom Subsequent Doxil or Topotecan Therapy Has Failed",
"Conditions" : ["Ovarian Cancer"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2006-05",
"Study_Completion_Date(Actual)" : "2006-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2004-11-17",
"First_Posted(Estimated)" : 2004-11-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2004-11-17",
"Last_Update_Posted(Estimated)" : 2017-05-16",
"Last_Verified" : 2017-05"
}
}}
|
#Study Description
Brief Summary
This is an open-label, single-arm, two-stage, multicenter Phase II study evaluating the efficacy and safety of bevacizumab in women with platinum resistant, advanced (Stage III or IV) EOC (epithelial ovarian cancer) or PPC (primary peritoneal cancer) that subsequently progressed either during treatment with Doxil or Hycamtin therapy or within 3 months of discontinuing treatment with Doxil or Hycamtin therapy.
#Intervention
- DRUG : bevacizumab
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Female, age >=18 years
* Advanced (Stage III or IV), histologically documented epithelial ovarian cancer or primary peritoneal cancer
* Platinum-resistant disease
* Platinum-resistant disease that subsequently progressed either during treatment with Doxil(R) or Hycamtin(R) therapy or within 3 months of discontinuing treatment with Doxil(R) or Hycamtin(R) therapy
* Received no more than three treatment regimens
* Measurable disease with at least one lesion that can be accurately measured in at least one dimension (longest dimension recorded) according to RECIST (with the exception that spiral CT scans of up to 8-mm slice thickness will be accepted)
* Recovered from prior cancer therapy (XRT, surgery, chemotherapy)
* ECOG performance status 0 or 1
* Life expectancy >12 weeks
* Use of an effective means of contraception (for women of childbearing potential)
Exclusion Criteria:
* Four or more treatment regimens
* Prior therapy with bevacizumab or other VEGF pathway-targeted therapy
* Current, recent (within 4 weeks of the first infusion of bevacizumab), or planned treatment with an experimental drug other than this Genentech-sponsored bevacizumab cancer study
* Screening clinical laboratory values: Granulocyte count <1500/uL; Platelet count <75,000/uL; Hemoglobin <8.5 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbopoeitin [Aranesp(R)] is permitted); Serum bilirubin >2.0 x upper limits of normal (ULN); Alkaline phosphatase, AST, and ALT >2.5 x ULN (AST, ALT >5 x ULN for subjects with liver metastasis); Serum creatinine >2.0; International normalized ratio (INR) >1.5 and activated partial thromboplastin time (aPTT) >1.5 x ULN (except for subjects receiving anticoagulation therapy); Urine protein/creatinine ratio >1.0 at screening
* Blood pressure >150/100 mmHg
* Unstable angina
* New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix B). Women who have received prior Doxil(R) therapy and have an ejection fraction <50% will be excluded from the study.
* History of myocardial infarction within 6 months prior to Day 0 (the day of the first bevacizumab infusion)
* History of stroke or transient ischemic attack within 6 months prior to Day 0
* Clinically significant peripheral vascular disease
* Evidence of bleeding diathesis or coagulopathy
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0; anticipation of need for major elective surgical procedure during the course of the study
* Minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to Day 0
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
* Serious, non-healing wound, ulcer, or bone fracture
* Presence of central nervous system or brain metastases
* History of other malignancies within 5 years of Day 0, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer
* Pregnant (positive pregnancy test) or lactating
* Inability to comply with study and follow-up procedures
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00097019
| 191,027
|
{
"NCT_ID" : "NCT03024606",
"Brief_Title" : "Smoking Cessation Intervention in Pregnant Women",
"Official_title" : "Smoking Cessation Following Text Message Intervention in Pregnant Women",
"Conditions" : ["Smoking Cessation"],
"Interventions" : ["Behavioral: text messages focused on smoking cessation and pregnancy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-06-14",
"Study_Completion_Date(Actual)" : "2017-06-14},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-01-13",
"First_Submitted_that_Met_QC_Criteria" : 2018-10-23",
"First_Posted(Estimated)" : 2017-01-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-01-16",
"Last_Update_Posted(Estimated)" : 2018-10-24",
"Last_Verified" : 2018-10"
}
}}
|
#Study Description
Brief Summary
The investigators propose an 18-month, randomized, open-label evaluation of the impact of texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients will be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years of age, are in the preparation stage of change and willing to set a quit date within 30 days and before 35 weeks gestation, and have a cellular phone that is capable of receiving text messages. Patients will be randomized to either the texting group or control group. A baseline carbon monoxide level will be obtained. The patient, regardless of group, will have the standard of care smoking cessation visit. If the pharmacist, physician, and patient deem that pharmacotherapy is appropriate, patient will receive nicotine replacement therapy patches or bupropion free of charge in 2-week intervals. Patients in the intervention group will receive text messages focused on smoking cessation and pregnancy. Patients will be seen on a bi-weekly schedule to obtain additional vouchers for patches or for bupropion, meet with the pharmacist, and complete a carbon monoxide exhalation test. These visits will be continued until the pharmacotherapy course is complete.
Detailed Description
Smoking during pregnancy has been shown to have detrimental effects on both the mother and the fetus. The perinatal period presents a critical opportunity to educate and support the mother as she attempts quit. Current studies suggest a median quit rate of only 4.9% in women receiving usual care (Cognitive Behavioral Therapy, CBT), but a number of studies have investigated new interventions in addition to usual care to help increase compliance with smoking cessation. Pharmacological aids such as nicotine replacement therapy (NRT) and bupropion are recommended as potential options by the American College of Obstetrics and Gynecology since they are considered safer than continued smoking during pregnancy. Studies thus far on smoking cessation with the help of electronic devices have demonstrated mixed results; however, the impact of texting in the pregnant population in combination with CBT and pharmacological therapy has yet to be assessed.
Smoking during pregnancy has been shown to have detrimental effects on both the mother and the fetus. Cigarettes contain over 3000 compounds many of which can cause risk to pregnancy. However, the nicotine and carbon monoxide components are of primary concern. Nicotine releases epinephrine, which results in a decrease in uterine blood flow and an increase in uterine resistance. There is also decreased production of fetal nitric oxide resulting in lower blood flow to the fetus and leading to decreased birth weight, length, and head circumference compared to non-smokers.
Studies have proven that exposure to tobacco can increase the risk for placental abruption, placental previa, preterm birth, antenatal death, sudden infant death syndromes, attention-deficit/hyperactivity disorder and asthma. Compared to children of non-smoking mothers, children of mothers who smoked during pregnancy had a higher BMI and increased odds for being overweight at 4-years of age; however, in the children whose mother quit smoking during pregnancy there was no increased risk of increased BMI or being overweight compared to the children of non-smoking mothers. According to the data from the 2009 Pregnancy Risk Assessment and Monitoring System (PRAMS) approximately 12.4% of pregnant women with live births reported smoking during the last three months of pregnancy (PRAMS). Of the 25% of women who smoked in the 3 months prior to pregnancy, 52% quit during pregnancy; of those, 44% relapsed within 6 months after delivery. The perinatal period presents a critical opportunity to educate and support the mother as she attempts quit.
Current studies evaluating rates of smoking cessation in pregnant women show less than ideal results. A primary analysis of 12 pooled trials found a median quit rate of 4.9% in women with usual care. This rate increased to 13.2% in patients that received tailored self-help intervention.12 To help increase compliance with cessation, studies have investigated new interventions as part of the usual care provided to pregnant patients that continue to smoke. One study looked at including a 15-minute video and provider prompting at baseline and one month. Although a higher percentage of patients in the intervention group had a higher 30-day abstinence rate at 2-months post baseline, the finding was not significant (26.1% vs 10.5%, p=0.12) although the study did not discuss if this was an appropriately powered sample size. Another study looking at the combination of smoking cessation education, physical activity counseling and supervised exercise found a 25% abstinence rate at 8-months gestation. The use of NRT has also been studied. One study found that CBT plus NRT verses CBT alone was effective at 7-weeks (24% vs 8%, p=0.02) and 38-weeks' gestation (18% vs 7%, p=0.04), unfortunately there was no benefit at 3-months post-partum (20% vs. 14%, p=0.55).
The use of pharmacological aids for smoking cessation is recommended as a potential option by the American College of Obstetrics and Gynecology. Currently, NRT products and bupropion are appropriate options during pregnancy and are the most utilized therapy for cessation during pregnancy. Although classified as pregnancy category-D medication, NRT patches are often used to assist the pregnant patient in smoking cessation when CBT is not successful. A review looking at 4-studies that examined pregnancy outcomes after NRT, found a significant decrease in the risk of preterm delivery and low-birth weight compared to active smokers. NRT is considered safer than continued smoking since it only provides nicotine whereas smoking provides nicotine plus over 3000 other chemicals. It has also improved cessation rates near the quit date compared to CBT in obstetric patients. Similarly, bupropion has improved cessation rates in non-obstetric patients and has not been associated with malformations or abnormal pregnancy outcomes.
The transtheoretical stages of change assessment is beneficial to help determine a patient's readiness to quit. Data has shown that the stages predict preparation for cessation and successful cessation. In the precontemplative stage, patients are not willing to consider smoking cessation. The contemplative stage is defined as patients considering smoking cessation but not ready to set a quit date. Preparation stage occurs when patient is ready to set a quit date within the next 30 days. In the action stage, patients have been smoke free for less than six months. Maintenance stage is cessation longer than 6 months. Relapse is when patients have starting smoking again after being in the action stage. In other obstetric smoking cessation literature, relapse has been defined as smoking more than 5 cigarettes or smoking more than 5 times since cessation.
Mobile technology is common place in today's society. According to the 2013 Nielsen report, 94% of all Americans 16 years of age or older use a cellular phone with more than half of those being smart phones. A total of 96% of phone owners have a data plan included. In 2012, the average monthly usage included 164.5 calls, 644.1 voice minutes, and 764.2 text messages. Ownership of cell phones and high tech devices extends to all socioeconomic classes, and the ease and affordability has made cell phone use common for all races and income brackets. When looking at text message specifically for race 79% of whites, 85% of Blacks and 87% of Hispanics report text messaging. When looking at household income 78% of those making \< 30K, 80% of those making between 30k-50k, and 88% of those making greater than 50k are active texters. African Americans are more likely than the general population to own smart phones (71% vs. 62%) and are 44% more likely than the broader market to create a social media profile. Over a monthly basis, African Americans also spend 24% more time on their phone , 12% more time on email, and 10% more time on the internet. Hispanics text the greatest of all ethnic groups at 943 text messages per month. Based on this data, it is apparent that mobile phone messaging is a potential convenient and cost-effective way to interact with patients of all races and income levels.
Results of current studies looking at smoking cessation with the help of computer or other electronic device are mixed. Several trials have looked at the use of text-messaging based smoking cessation programs. One randomized controlled pilot trial of 151 daily smokers interested in quitting found a non-clinically significant difference in cessation rates at 3 months between the intervention and control groups (11% versus 4%), this study was not powered to detect a statistical difference. A small pilot study evaluating Text2Quit, an automated, personalized, and interactive program that sends texts and emails over the course of 3 months, reported liking the program at 2 and 4 weeks after enrollment (91% and 82%, respectively) and 75% of participants reported reading most or all of the messages sent. Unfortunately, the majority of participants admitted to smoking at the 4-week visit. The txt2stop study was a trial of 5800 smokers that were randomized to receive text messages that were comprised of motivational and behaviour-change support versus the control group who received text messages unrelated to quitting. At 6-months abstinence was significantly increased in the intervention group versus the control group (10.7% vs. 4.9%; p\<0.0001).
#Intervention
- BEHAVIORAL : text messages focused on smoking cessation and pregnancy
- The impact of a text-message service on smoking cessation in medically underserved, obstetric patients when added to the usual care of pharmacist-driven CBT smoking cessation program and smoking cessation pharmacotherapy with either the nicotine replacement patch or bupropion.
|
#Eligibility Criteria:
Inclusion Criteria:
* Have a confirmed pregnancy,
* English speaking,
* 18 <= age <= 55 years,
* Are in the preparation stage of change and willing to set a quit date within 30 days and before 35 weeks gestation,
* Have a cellular phone that is capable of receiving text messages, and be willing to pay for any related fees for testing.
* Willing and able to commit to the visit schedule
Exclusion Criteria:
* Gestational > 35 yearsweeks at quit date
* If subjects are in the pre-contemplative or contemplative stages of change or have already received 30 minute pharmacy education targeted for the quit date in this pregnancy.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03024606
| 134,833
|
{
"NCT_ID" : "NCT00135889",
"Brief_Title" : "Continuous Femoral Nerve Block Following Total Knee Replacement",
"Official_title" : "Improving Postoperative Rehabilitation Following Total Knee Arthroplasty With Perineural Local Anesthetic Infusion",
"Conditions" : ["Pain"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-07",
"Study_Completion_Date(Actual)" : "2008-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-08-24",
"First_Posted(Estimated)" : 2005-08-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-08-24",
"Last_Update_Posted(Estimated)" : 2009-10-08",
"Last_Verified" : 2009-10"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to determine if putting local anesthetic-or numbing medication-through a tiny tube next to the nerves that go to the knee will improve pain control during physical therapy, and ultimately improve the results of surgery. It will also determine if patients having knee replacement surgery may receive the same or better pain control at home compared with staying in the hospital, and if this improves their experience following surgery.
Detailed Description
What procedures would be done as part of your normal clinical care (even if you did not participate in this research)?
You will have some monitors placed (such as a blood-pressure cuff) and be given some medicines through your intravenous (IV) line to make you very sleepy. The anesthesiologist will then place a nerve block so that much of your knee (not all) will be numb. At the same time, the anesthesiologist will place a tiny tube, called a catheter, near your nerves that will be used after the surgery is over. You will still go to sleep for the surgery, but you will be much more comfortable when you wake up because the numbing medicine will be working to take away much of the pain. If you are not part of this study, you would go from the recovery room to a room in the hospital for 3-5 days, and your catheter would be removed the morning following surgery. After your catheter was removed, you would depend on oral and IV opioids-or pain medicine-to control your surgical pain. You would go home with only oral opioids since IV opioids cannot be provided at home.
What procedures will be done only because you are participating in this research study?
From the recovery room you will go to the Clinical Research Center (CRC) which is a special part of the hospital where research is undertaken. During your stay at the CRC you will have the ability to push a button on a small infusion pump to give yourself more medicine through the tube to your nerves if you have pain. If this does not help enough, you will take pain pills to help. And if this does not help enough, you will be given opioids (strong pain medicine like morphine) into your IV. Each morning after surgery, the medicine in your little infusion pump will be replaced by either (1) more medicine, or (2) salt water, or 'normal saline'. The pharmacist will determine this randomly-like flipping a coin-and neither you nor the doctors/nurses caring for you will know which you have. This is to keep any of us from inadvertently/unconsciously affecting the results of the study. However, if you have pain that is not controlled with pain pills, you will be switched back to the regular medicine to improve your comfort until the following morning. You will undergo physical therapy and following this you will be checked to see if you are ready to go home. When you are ready to go home beginning on the third day after surgery, you may go home with the little infusion pump and the tube that goes to the nerves of your knee. One of the study physicians will call you each night to ensure that you are comfortable for the first 7 nights after your surgery, and you will be given the phone and pager numbers of a physician available for you to contact 24 hours/day, 7 days/week. When the medicine runs out or in the fourth evening following surgery, whichever comes first, your catheter will be removed. The pump is disposable, so it can be thrown away. A physician will call you the two nights after the catheter comes out to ensure that you are comfortable.
#Intervention
- DRUG : Femoral perineural infusion
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing unilateral, primary total knee arthropathy (TKA)
* 18 <= age <= 80 years
* Be able to understand the possible local anesthetic-related complications, study protocol, and care of the catheter and infusion pump system and are already planning on having a perineural catheter placed for postoperative analgesia
Exclusion Criteria:
* Any contraindication to femoral block/catheter
* Any comorbidity which results in moderate or severe functional limitation (American Society of Anesthesiologists [ASA] physical status >2)
* Baseline oxygen saturation < 96% on room air
* Known hepatic or renal insufficiency (creatinine level > 1.5 mg/dL)
* Allergy to study medications (other than nonsteroidal anti-inflammatory agents [NSAIDs] and acetaminophen)
* Inability to communicate with the authors
* Morbid obesity (body mass index [BMI]>40 kg/m2)
* History of opioid abuse or chronic regular opioid use (use within the 2 weeks prior to surgery and duration of use > 4 weeks)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00135889
| 44,750
|
{
"NCT_ID" : "NCT00248404",
"Brief_Title" : "NB1011 Administered by Continuous Infusion in Cancers That Overexpress Thymidylate Synthase (TS)",
"Official_title" : "A Phase I/II Study of NB1011 Administered Intravenously by Continuous Infusion in an Every Second Week Regimen With Open-label Continuation in Cancers That Overexpress the Enzyme Thymidylate Synthase",
"Conditions" : ["Tumors"],
"Location_Countries" : ["United States", "Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2007-12-12",
"Study_Completion_Date(Actual)" : "2007-12-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-11-03",
"First_Posted(Estimated)" : 2005-11-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-11-03",
"Last_Update_Posted(Estimated)" : 2022-05-16",
"Last_Verified" : 2022-05"
}
}}
|
#Study Description
Brief Summary
The purpose of this trial is to assess the tolerability and safety of NB1011 in the treatment of patients with cancers that overexpress TS, such as ovarian, gastrointestinal, colorectal, bladder, breast, and lung cancers.
#Intervention
- DRUG : NB1011
|
#Eligibility Criteria:
Inclusion Criteria:
* Advanced, recurrent, or metastatic solid tumors
* TS overexpression (> 4 by reverse transcription polymerase chain reaction [RT-PCR]) in archival and fresh samples
* Suitable for experimental monotherapy
* Measurable disease
Exclusion Criteria:
* Tumors that cannot be biopsied or with low level of TS expression
* Requirement for concomitant anticancer therapy
* Treatment with another investigational product within 30 days of study entry
* Pregnant or lactating women
* Active or uncontrolled serious bacterial, viral, fungal, or parasitic infection.
* HIV infection
* Clinically apparent meningeal or central nervous system (CNS) metastases or carcinomatous meningitis
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00248404
| 61,370
|
{
"NCT_ID" : "NCT04192734",
"Brief_Title" : "Retrospective Study of Ramucirumab and Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma",
"Official_title" : "A Retrospective Study for Evaluation of Real-world Efficacy and Safety of Ramucirumab Plus Paclitaxel in Patients With Locally-advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma",
"Conditions" : ["Gastric or Gastroesophageal Junction Adenocarcinoma"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-12-18",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-10-30",
"Study_Completion_Date(Actual)" : "2020-10-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-12-05",
"First_Posted(Estimated)" : 2019-12-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-12-09",
"Last_Update_Posted(Estimated)" : 2021-03-24",
"Last_Verified" : 2021-03"
}
}}
|
#Study Description
Brief Summary
This is a retrospective, multicenter, non-interventional study for the evaluation of real-world efficacy and safety of ramucirumab plus paclitaxel in gastric or gastroesophageal junction adenocarcinoma as part of the establishment of hospital medical record collection system to evaluate drug effectiveness by Health Insurance Review \& Assessment Service (HIRA). The medical records in approximately 1400 patients with locally-advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, who have received ramucirumab plus paclitaxel combination therapy will be collected.
Detailed Description
Ramucirumab plus paclitaxel combination therapy has shown a survival benefit in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. However, the real-world efficacy and safety of ramucirumab plus paclitaxel combination therapy in Korea have only been evaluated once outside of controlled clinical trials. Therefore, this large multicenter retrospective analysis was designed to evaluate the real-world efficacy and safety of ramucirumab plus paclitaxel under the Korea National Health Insurance System. The medical records in approximately 1400 patients with locally-advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, who have received ramucirumab plus paclitaxel combination therapy between May 2018 and December 2018 will be collected. Eligibility criteria included age ≥ 19 years, histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma, locally advanced unresectable or metastatic disease, and previous first-line systemic therapy including fluoropyrimidine and platinum. Efficacy was evaluated by overall survival, progression free survival, time to progression, objective response rate, disease control rate, and duration of response. Safety was evaluated by hematologic or non-non hematologic toxicities and adverse events of special interest with ramucirumab plus paclitaxel combination therapy.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >=19 years at the time of study registration
* Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
* Locally advanced unresectable or metastatic disease
* Patients who have received previous palliative first-line systemic therapy including fluoropyrimidine and platinum for advanced gastric or gastroesophageal junction adenocarcinoma
* Patients who have received ramucirumab plus paclitaxel combination therapy between May 2018 and December 2018 under the Korea National Health Insurance System
Exclusion Criteria:
* Patients who have received ramucirumab plus paclitaxel combination therapy outside of the Korea National Health Insurance System
* Patients who have received ramucirumab monotherapy
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04192734
| 106,136
|
{
"NCT_ID" : "NCT00737880",
"Brief_Title" : "Histidine-Tryptophane-Ketoglutarate (HTK) vs University of Wisconsin (UW) Perfusion in Clinical Pancreas Transplantation",
"Official_title" : "A Prospective Randomized Multicenter Trial Comparing Histidine-Tryptophane-Ketoglutarate (HTK) Versus University of Wisconsin (UW) Perfusion Solution in Clinical Pancreas Transplantation",
"Conditions" : ["Diabetes Mellitus", "Pancreas Transplantation"],
"Interventions" : ["Other: Organ perfusion during pancreas procurement"],
"Location_Countries" : ["Germany", "Austria", "Belgium"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2001-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2004-01",
"Study_Completion_Date(Actual)" : "2005-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-08-19",
"First_Posted(Estimated)" : 2008-08-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-08-19",
"Last_Update_Posted(Estimated)" : 2008-08-20",
"Last_Verified" : 2008-08"
}
}}
|
#Study Description
Brief Summary
Graft preservation in clinical pancreas transplantation is based on hypothermia achieved by topic cooling and cold in situ flushing using special perfusion solutions designed to attenuate the effects of ischemia/reperfusion and prolong cold ischemia tolerance.
For pancreas transplantation, University of Wisconsin (UW) solution is the most commonly used perfusate. However, over the last years, Histidine-Tryptophan-Ketoglutarate (HTK) solution has been increasingly used for abdominal organ procurement. Retrospective reports published so far have demonstrated the safety of both perfusion solutions.
However, to date, no prospective study comparing both perfusion solutions has been published. Aim of this study was to prospectively evaluate early pancreas graft function in clinical pancreas transplantation after organ perfusion with HTK vs. UW solution.
The study hypothesis is that HTK is not inferior to UW for organ perfusion during procurement in clinical pancreas transplantation.
#Intervention
- OTHER : Organ perfusion during pancreas procurement
- Usage of UW or HTK perfusion solution during in situ abdominal organ perfusion in multi-organ procurement
|
#Eligibility Criteria:
Inclusion Criteria:
* brain dead, heart beating organ donor
* donor age 10 - 50 years
* donor body mass index < 30kg/m2
* pancreas cold ischemia time < 20 hours
* written informed consent of the pancreas recipient
Exclusion Criteria:
* missing written consent
* pancreas retransplantation
* recipient participation in another study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00737880
| 47,643
|
{
"NCT_ID" : "NCT02313597",
"Brief_Title" : "Video-assisted Anal Fistula Treatment Versus Seton in the Management of High Peri Anal Fistula",
"Official_title" : "Outcomes in High Perianal Fistula Repair Using Video-assisted Anal Fistula Treatment Compared With Seton Use: a Randomized Controlled Trial",
"Conditions" : ["Post Operative Pain", "Recurrence"],
"Interventions" : ["Procedure: VAAFT", "Procedure: SETON"],
"Location_Countries" : ["Pakistan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-08-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-07-31",
"Study_Completion_Date(Actual)" : "2020-07-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-08-28",
"First_Submitted_that_Met_QC_Criteria" : 2021-01-07",
"First_Posted(Estimated)" : 2014-12-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-12-07",
"Last_Update_Posted(Estimated)" : 2021-03-11",
"Last_Verified" : 2021-02"
}
}}
|
#Study Description
Brief Summary
Anal fistula is the most common Peri anal disease. It's a disease with an incidence of 9 in 100,000. Anal fistula is classified on the basis of its location into high and low anal fistula, above or below dentate line respectively.
Multiple series have shown that the formation of a fistula tract following anorectal abscess occurs in 7-40% of cases. There are typically 8-10 anal crypt glands at the level of the dentate line in the anal canal arranged circumstantially. These glands afford a path for infecting organisms to reach the intramuscular spaces. The cryptoglandular hypothesis states that an infection begins in the anal canal glands and progresses into the muscular wall of the anal sphincters to cause an anorectal abscess.
According to internal opening many author proposed certain classification but the standardized in all of them is Park's classification, so this study categorized the patient through this classification. There are four types of fistula-in-ano in Park's Classification intersphincteric (between internal and external sphincters is 70%), transsphincteric (across external sphincters is 25%), suprasphincteric (over sphincters), and extrasphincteric(above and through levator ani).High anal fistula is considered to be difficult to treat because of its location.This study diagnosed the internal opening of high perianal with the help of endoluminal ultrasound and MRI.
Classic method of its treatment are fistulotomy, fistulectomy and Setone placement but these are associated with lots of complication like fecal incontinence,recurrence,pain.Therefore many method have been recently devised including Ligation of intersphincteric fistula tract (Lift), glue repair and flap advancement.Another recently introduced method for its treatment is Video-assisted anal fistula treatment (VAAFT) proposed by P. Meinero which has been associated with less complications.
#Intervention
- PROCEDURE : SETON
- In seton treatment, initially Hydrogen peroxide will be applied to the external opening with a 10-cc syringe, and the internal opening will be located by direct visualization of the anal canal via proctoscope. A probe will be inserted into the external opening and carefully maneuvered through the internal opening. Silk 1/0 suture will be then tied to the tip of the probe, which will be then squeezed out of the external opening. The suture will be then tied around the sphincter and through fistula tract. Later, the seton will be tightened at four-week intervals under local anesthesia until the suture cut through the sphincter.
- PROCEDURE : VAAFT
- Patients assigned to the VAAFT group will receive the following procedure. The external opening will be widened with a probe, and a fistulascope will be inserted to delineate the primary and secondary tracts and locate the internal opening. The internal opening will be then stitched with Vicryl™ (Polyglactin 910) 2-0 suture through the anal route with the help of a proctoscope. The tract of the fistula will be washed and debrided through the scope and cauterized. Finally, the external opening will be excised and will be sent for biopsy.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients of either gender with age ranging from 15 <= age <= 60.
* All patients with high anal fistula
Exclusion Criteria:
* Patients with suspected malignancy determined by the presence of a mass on digital rectal examination,
* History of previous perianal surgery,
* History of irritable bowel disease determined by medical record
* Uncontrolled diabetes
Sex :
ALL
Ages :
- Minimum Age : 15 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02313597
| 240,885
|
{
"NCT_ID" : "NCT03833375",
"Brief_Title" : "Shared Decision Making to Improve Goals-of-Care Decisions for Families of Severe Acute Brain Injury Patients",
"Official_title" : "Shared Decision Making to Improve Goals-of-Care Decisions for Families of Severe Acute Brain Injury Patients",
"Conditions" : ["Traumatic Brain Injury", "Ischemic Stroke", "Intracerebral Hemorrhage"],
"Interventions" : ["Other: Decision Aid"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-02-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-12-02",
"Study_Completion_Date(Actual)" : "2020-03-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-02-04",
"First_Posted(Estimated)" : 2019-02-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-02-05",
"Last_Update_Posted(Estimated)" : 2020-06-17",
"Last_Verified" : 2020-06"
}
}}
|
#Study Description
Brief Summary
Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and disability in adults in the U.S. Due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is the most common cause of death in SABI, but occurs at a highly variable rate (for example in Traumatic Brain Injury (TBI) 45-89%). Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. The investigators have developed a pilot DA for goals-of-care decisions for surrogates of SABI patients. This was developed through qualitative research using semi-structured interviews in surrogate decision makers of TBI patients and physicians. The investigators now propose to pilot-test a DA for surrogates of SABI patients in a feasibility trial.
Detailed Description
Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and disability in adults in the U.S, accounting for more than 200,000 of the acute brain injury-related deaths in the U.S. annually. Patients with SABI are critically ill and most commonly require mechanical ventilation and supportive medical care with artificial nutrition to ensure survival. However, due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is by far the most common cause of death in SABI but occurs at a highly variable rate (for example in TBI 45-90%) at different trauma centers. Shared decision making is a collaborative process that enhances patients' and surrogates' understanding about prognosis, encourages them to actively weigh the risks and benefits of a treatment, and to match them to patient preferences, thereby decreasing decisional conflict and improving decision quality and health related outcomes. Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. No DA currently exists for goals-of-care decisions in SABI. Such a patient- and family-centered DA has the potential to improve decision-making for SABI patients by ensuring proxies receive consistent, evidence-based prognostication while also addressing patients' preferences and values. The investigators have developed a pilot DA for goals of care decisions by surrogates of SABI patients using qualitative research using semi-structured interviews in surrogate decision makers of TBI patients and physicians, followed by an iterative feedback process with feedback by surrogates, physicians, and other stakeholders (ICU nurses). The investigators now propose to pilot-test a DA for surrogates of SABI patients in a feasibility trial.
#Intervention
- OTHER : Decision Aid
- Shared-decision making tool
|
#Eligibility Criteria:
Inclusion Criteria:
* >=18 years; no upper age limit
* Documented health care proxy or legal next of kin of admitted SABI patient with traumatic brain injury, intracerebral hemorrhage or acute ischemic stroke.
* >=3 days after insult ('stabilization period'); clinical team may ask study team to wait longer if clinically indicated
* SABI patient remains 'critically ill' after 3 days defined as: either intubated and mechanically ventilated, or unable to swallow, needing feeding tube beyond hospital discharge (even if not intubated)
* Surrogate is physically present in ICU to receive decision aid and participate in planned family meeting in person (not over phone)
Exclusion Criteria:
* Devastating SABI near death
* Patient will be extubated and pass swallow evaluation (as deemed by clinical team)
* Surrogate is non-English speaking and no interpreter available to translate decision aid (no available validated, translated decision aid version)
* Surrogate is illiterate
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03833375
| 162,212
|
{
"NCT_ID" : "NCT06246422",
"Brief_Title" : "Tranexamic Acid Instillation in Laparoscopic Cholecystectomy",
"Official_title" : "The Effect of Local Instillation of Tranexamic Acid on the Gallbladder Bed After Laparoscopic Cholecystectomy to Decrease Possible Bleeding: Randomized Controlled Study.",
"Conditions" : ["Postoperative Complications"],
"Interventions" : ["Drug: Normal saline", "Drug: Tranexamic Acid 500 MG"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-12-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-13",
"Study_Completion_Date(Actual)" : "2022-12-13},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-01-30",
"First_Posted(Estimated)" : 2024-02-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-01-30",
"Last_Update_Posted(Estimated)" : 2025-02-24",
"Last_Verified" : 2025-02"
}
}}
|
#Study Description
Brief Summary
Adult patients undergoing laparoscopic cholecystectomy are at high risk to develop postoperative bleeding especially in the presence of severe adhesions. Local instillation of the antifibrinolytic (tranexamic acid) at the gall bladder bed may decrease the risk of bleeding.
The aim of this study is to evaluate the role of topical administration of Tranexamic acid on gallbladder bed for prophylaxis against bleeding in cases of difficult dissection cases due to acute inflammation and dense adhesions.
Detailed Description
This prospective study will be conducted in 80 adult patients admitted to surgery department Tanta University, the study will be carried out over 6 months after obtaining ethical committee approval, an informed written consent will be included.
Any unexpected risk that will appear during the procedure will be announced to the participants and ethical committee at time and adequate measures will be taken.
Risk to the patients There is known risk to the patient except for rare possible allergy to the drug.
All participant surgeons are experienced and familiar with the field. There will be adequate supervision to maintain the privacy of patients and confidentiality.
There will be no conflict of interest nor conflict with religion, law or society standards.
End point of study This study will be terminated if there is any unexpected risk from the drug.
This is a prospective study performed on 80 patients suffering from symptomatic cholelithiasis and will undergo laparoscopic cholecystectomy, they will be divided into two groups randomly by slip method. And will be performed by experienced surgeons.
All patients were subjected to:
Detailed history including drug intake (anticoagulants or antiplatelets) and thorough clinical examination.
laboratory investigations complete blood count (CBC), C-reactive protein (CRP), fasting blood sugar, renal function tests, and abdominal ultrasonography done.
Operative procedure After applying general anaesthesia , standard 4 port laparoscopic cholecystectomy will be performed. Patients in group A (40 patients) will receive 500 mg of Tranexamic acid dissolved in 20 ml normal saline locally in the liver bed after completing the procedure, we will introduce a piece of gauze to keep the drug in place for about 3 minutes and then remove it and we will insert a drain and close it for one hour after finishing the operation, if there is easy going operation without any adhesions and very minimal risk for bleeding it will be excluded.
For group B (40 patients) they will also undergo the same procedure with routine care that there is no significant bleeding then instillation of 20 ml normal saline locally in the liver bed and introduce a piece of gauze to keep the drug in place for about 3 minutes and then remove it and drain will be inserted for difficult cases and also easy ones will be excluded.
Post operative care Heart rate and blood pressure will be checked every 6 hours after surgery. Drain output will be recorded drain fluid hematocrit and hemoglobin will be investigated after 6 hours and 24 hours, and all the patients will be followed up till discharged. Drain will be removed if less than 50 cc for 24 hours.
Hb level will be performed after 48 h and was compared with the preoperative levels.
Any possible morbidity and time for ambulation and hospital stay will be recorded.
#Intervention
- DRUG : Tranexamic Acid 500 MG
- Local instillation of 500 mg tranexamic acid in 20 ml normal saline in the gall bladder bed
- DRUG : Normal saline
- Local instillation of 20 ml normal saline in the gall bladder bed
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients aged 21 <= age <= 60 years that underwent laparoscopic cholecystectomy with intra-operative difficult dissection due to adhesions or acute inflammation.
Exclusion Criteria:
* Patients who will refuse participation in the study
* Patients with bleeding disorders, clotting abnormalities, or on anticoagulants therapy.
* Easy going operation that do not necessitate drain insertion.
* major bleeding that could necessitate surgical intervention to control.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT06246422
| 80,698
|
{
"NCT_ID" : "NCT02310672",
"Brief_Title" : "REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension",
"Official_title" : "A Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance Imaging",
"Conditions" : ["Pulmonary Arterial Hypertension"],
"Interventions" : ["Drug: Macitentan"],
"Location_Countries" : ["Germany", "Singapore", "United States", "Australia", "Italy", "United Kingdom", "France", "Hong Kong", "Malaysia", "Netherlands", "Russian Federation", "Israel"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-06-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-09-10",
"Study_Completion_Date(Actual)" : "2019-09-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-12-04",
"First_Submitted_that_Met_QC_Criteria" : 2020-09-03",
"First_Posted(Estimated)" : 2014-12-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-12-05",
"Last_Update_Posted(Estimated)" : 2025-03-30",
"Last_Verified" : 2025-03"
}
}}
|
#Study Description
Brief Summary
The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each patient can participate in no sub-study or in one sub-study. The sub-studies are: (1) metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the RHC); (3) Echo sub-study.
#Intervention
- DRUG : Macitentan
- All patients take open-label macitentan 10mg o.d.
- Other Names :
- ACT-064992
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent prior to any study-mandated procedure
* Symptomatic pulmonary arterial hypertension (PAH)
* World Health Organization (WHO) Functional Class (FC) I to III
* PAH etiology belonging to one of the following groups according to Nice classification:
* Idiopathic PAH
* Heritable PAH
* Drug- and toxin-induced PAH
* PAH associated with congenital heart diseases: only simple (atrial septal defect, ventricular septal defect, patent ductus arteriosus) congenital systemic to pulmonary shunts at least 2 year post surgical repair
* Hemodynamic diagnosis of PAH confirmed by right heart catheterization (RHC) during screening showing:
* mean pulmonary arterial pressure (mPAP) >= 25 mmHg and
* PCWP (pulmonary capillary wedge pressure) or left ventricular end diastolic pressure (LVEDP) <= 12 mmHg and pulmonary vascular resistance (PVR) >= 4 Wood Units (WU) (320 dyn.sec.cm-5) or
* 12 mmHg <= PCWP or LVEDP <= 15 mmHg and PVR >= 6WU (480 dyn.sec.cm-5)
* 6-minute walk distance (6MWD) >= 150 m during screening
* For patients treated with oral diuretics, treatment dose must have been stable at least 1 month prior to RHC during the screening period
* For patients treated with phosphodiesterase type-5 (PDE-5) inhibitors, treatment dose must have been stable at least 3 months prior to RHC during the screening period
* For patients treated with beta blockers, treatment dose must have been stable at least 1 month prior to the RHC during the screening period
* Men or women >=18 and < 65 years
* Women of childbearing potential (defined in protocol) must:
* Have a negative serum pregnancy test during screening and a negative urine pregnancy test on Day 1, and
* Agree to use reliable methods of contraception (defined in protocol) from screening up to 30 days after study treatment discontinuation, and
* Agree to perform monthly pregnancy tests up to 30 days after study treatment discontinuation
Exclusion Criteria:
* Body weight < 40 kg
* Body mass index (BMI) > 35kg/m2. For patients with 30kg/m2 < BMI < 35kg/m2, an eligibility form will be submitted to a Steering Committee member who will reserve the right to exclude the patient.
* Pregnancy, breastfeeding or intention to become pregnant during the study
* Recently started (< 8 weeks prior to informed consent signature) or planned cardio-pulmonary rehabilitation program
* Known concomitant life-threatening disease with a life expectancy < 12 months
* Any condition likely to affect protocol or treatment compliance
* Hospitalization for PAH within 3 months prior to informed consent signature
* Left atrial volume indexed for body surface area >= 43mL/m2 by echocardiography or cardiac MRI
* Valvular disease grade 2 or higher
* History of pulmonary embolism or deep vein thrombosis
* Documented moderate to severe chronic obstructive pulmonary disease
* Documented moderate to severe restrictive lung disease
* Historical evidence of significant coronary artery disease established by:
* History of myocardial infarction or
* More than 50% stenosis in a coronary artery (by percutaneous coronary intervention or angiography) or
* Elevation of the ST segment on electrocardiogram or
* History of coronary artery bypass grafting or
* Stable angina
* Diabetes mellitus
* Moderate to severe renal insufficiency (calculated creatinine clearance < 60 mL/min/1.73 m2)
* Cancer
* Systolic blood pressure < 90 mmHg
* Severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin > 3 × upper limit of the normal range (ULN) accompanied by an aspartate aminotransferase (AST) elevation > ULN at Screening.
* Hemoglobin < 100g/L
* AST and/or alanine aminotransferase (ALT) > 3× ULN
* Need for dialysis
* Responders to acute vasoreactivity test based on medical history
* Prior use of endothelin receptor antagonists (ERAs), stimulators of soluble guanylate cyclase or prostacyclin or prostacyclin analogues
* Treatment with strong inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 4 weeks prior to study treatment initiation (e.g., carbamazepine, rifampicin, rifabutin, phenytoin and St. John's Wort)
* Treatment with strong inhibitors of CYP3A4 within 4 weeks prior to study treatment initiation (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir)
* Treatment with another investigational drug (planned, or taken within the 3 months prior to study treatment initiation).
* Hypersensitivity to any ERA or any excipients of the formulation of macitentan (lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, polyvinyl alcohol, polysorbate, titanium dioxide, talc, xanthan gum, and lecithin soya)
* Claustrophobia
* Permanent cardiac pacemaker, automatic internal cardioverter
* Metallic implant (e.g., defibrillator, neurostimulator, hearing aid, permanent use of infusion device)
* Atrial fibrillation, multiple premature ventricular or atrial contractions, or any other condition that would interfere with proper cardiac gating during MRI.
* For patients enrolling in the metabolism sub-study only: glucose intolerance
* For patients enrolling in the biopsy sub-study only: PAH etiology belonging to Nice classification 1.4.4: PAH associated with congenital heart diseases
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT02310672
| 62,677
|
{
"NCT_ID" : "NCT00564083",
"Brief_Title" : "Randomized Controlled Trial Comparing Acellular Collagen Biomesh (Pelvisoft) to Polypropylene Mesh(Pelvitex) for Sacral Colpopexy",
"Conditions" : ["Uterine Prolapse"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "FACTORIAL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-03",
"Study_Completion_Date(Actual)" : "2010-06},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-11-26",
"First_Posted(Estimated)" : 2007-11-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-11-26",
"Last_Update_Posted(Estimated)" : 2011-03-22",
"Last_Verified" : 2007-11"
}
}}
|
#Study Description
Brief Summary
This research protocol is a randomized controlled trial. It is being done to compare and find out the relative differences between the materials, (Pelivisoft) 'natural organic mesh' to poly propylene mesh (Pelvitex) 'manmade mesh' after a surgery known as sacral colpopexy. This surgery involves supporting the prolapsed vaginal wall with a piece of material (known as a graft) attached to a ligament along your backbone (or sacrum). These materials are both FDA approved and widely used. The following objectives: anatomic outcomes, graft-related complications between the two materials, changes in pelvic organ prolapse-related quality of life, subjective changes in sexual function,changes in bowel function and the prolapse related pain present after sacral colpopexy will be evaluated.
The study visits are all under standard of care. Study questionnaires are unique to the study and will be completed at the enrollment in hospital, 2, 6,12 weeks, 6 months and one year visits The questionnaires are related to bowel function, bladder function, prolapse and sexual activity.
Permission will be requested to contact the patient again 5 years after surgery. Contact in the future will in no way obligate the patient to participate.
There may or may not be direct medical benefits to the participant. Decreased risk of erosion may be a possible benefit if placed in the organic 'natural' arm of the study. The information learned from this study may benefit other patients in the future
#Intervention
- PROCEDURE : sacral colpopexy
- This surgery involves supporting the prolapsed vaginal wall with a piece of material (known as a graft) attached to a ligament along your backbone (or sacrum)
|
#Eligibility Criteria:
Inclusion Criteria:
* Greater than 18 years
Exclusion Criteria:
* Prior sacral colpopexy or rectopexy
Contraindication to surgery based on co-existent medical condition
Desire for expectant management or pessary use
Pregnancy or the desire for pregnancy within 24 months of the sacral colpopexy procedure
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00564083
| 231,679
|
{
"NCT_ID" : "NCT01404455",
"Brief_Title" : "Effect of Wide Pulse Pressure on the Predictability of Stroke Volume Variation for Fluid Responsiveness in Patients Undergoing Off-pump Coronary Artery Bypass Graft",
"Conditions" : ["Stroke Volume Variation"],
"Interventions" : ["Other: HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SCREENING",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-08",
"Study_Completion_Date(Actual)" : "2011-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-04-01",
"First_Posted(Estimated)" : 2011-07-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-07-27",
"Last_Update_Posted(Estimated)" : 2012-01-18",
"Last_Verified" : 2012-01"
}
}}
|
#Study Description
Brief Summary
The investigators examined the predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure undergoing off-pump coronary artery bypass graft
#Intervention
- OTHER : HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading
- HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading during 15 minutes after induction of anesthesia
|
#Eligibility Criteria:
Inclusion Criteria:
* 1. Age >= 20
* 2. elective off-pump coronary artery bypass graft
Exclusion Criteria:
* 1. arrhythmia
* 2.EF <40%
* 3.valvular heart dz
* 4.pul HTN
* 5.PAOD
* 6.lung dz
* 7.NYHA IV
* 8.ESRD
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01404455
| 156,645
|
{
"NCT_ID" : "NCT01226576",
"Brief_Title" : "Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study",
"Official_title" : "Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study",
"Conditions" : ["Localized Low-Intermediate Risk Prostate Cancer"],
"Interventions" : ["Device: MRgFUS Treatment"],
"Location_Countries" : ["Singapore", "Italy", "United Kingdom", "Canada", "Israel"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-12",
"Study_Completion_Date(Actual)" : "2018-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-10-21",
"First_Posted(Estimated)" : 2010-10-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-10-21",
"Last_Update_Posted(Estimated)" : 2019-03-13",
"Last_Verified" : 2019-03"
}
}}
|
#Study Description
Brief Summary
The hypothesis of this feasibility study is that focal treatment with ExAblate MRgFUS has the potential to be a safe and effective non-invasive treatment for low to intermediate risk, organ-confined prostate cancer involving low incidence of morbidity. The study hypothesis will be tested by measuring treatment-related safety and initial effectiveness parameters in the ExAblate MRgFUS treated patients, as described above.
Based on the result of this study, InSightec will initiate a larger study in an effort to approve low risk, organ-confined prostate cancer as an indication for its ExAblate MRgFUS device.
Detailed Description
Objective of this feasibility trial is to assess safety and initial effectiveness of ExAblate MRgFUS in the treatment of low to intermediate risk, localized (organ confined) prostate cancer tumors.
ExAblate treatment will be implemented as a focal tumor-selective therapy, directed at pre-defined volume(s)/sector(s) in the prostate, (identified as cancerous by mapping biopsy with or without multi-parametric MRI), rather than a whole gland or hemi-ablation treatment.
Safety: evaluate incidence and severity of adverse events associated with ExAblate's MRgFUS focal treatment of low risk organ confined prostate cancer. The risk of ExAblate treatment-related incontinence and impotence will also be assessed in this study.
Effectiveness: determine the tumor control effect of ExAblate's MRgFUS focal treatment of low risk organ-confined prostate cancer (confirmed by TRUS-guided Transperineal Mapping Biopsy results).
#Intervention
- DEVICE : MRgFUS Treatment
- Local treatment of prostate cancer using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy
- Other Names :
- ExAblate 2100 Prostate system
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient of age between 50 <= age <= 75, inclusive.
* Biopsy confirmed adenocarcinoma of the prostate, performed up to 6 months prior to scheduled treatment.
* Patient with low-intermediate risk, early-stage organ-confined prostate cancer (cT1c and cT2a, N0, M0), diagnosed with TRUS guided transperineal biopsy (TPBx) and voluntarily chooses MRgFUS as the non-invasive treatment, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy.
* Patient with PSA less than or equal to 10 ng/mL
* Gleason score 6 or 7 (no 5 grades), based on TRUS guided Transperineal Mapping Biopsy, as defined in the protocol.
* Up to two (2) cancerous lesions may be identified in the prostate; each tumor is not more than 10 mm in maximal linear dimension; each tumor should comply with the maximal 7 Gleason score requirement.
* Positive TRUS-guided transperineal biopsy (TPBx) cores, detected in a maximum of four (4) sectors, (2 for each cancerous focus) out of 16 sectors (or out of 12 sectors in prostates with volume <20 cc)
* Low grade tumors may or may not be visible by multi-parametric MRI. Thus, in case of MRI-visible tumor, tumor should be in capsular contact of less than 5 mm, on axial images.
* No definite evidence of extracapsular extension or seminal invasion by MRI
* Patient eligible for epidural anesthesia, and general anesthesia (in case of complication, requiring intervention).
* Patient is willing and able to give consent and attend all study visits as defined in the protocol
* Prostate gland volume should be no greater than 70 cc, volumetrically measured.
Exclusion Criteria:
* ASA status > 2
* Contraindications to MRI 2.1. Claustrophobia 2.2. Implanted ferromagnetic materials or foreign objects 2.3. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist) 2.4. Known contraindication to utilization of MRI contrast agent
* Severely abnormal coagulation (INR>1.5)
* Patient with unstable cardiac status including:
4.1. Unstable angina pectoris on medication 4.2. Documented myocardial infarction within 40 days prior to enrolment 4.3. Congestive heart failure NYHA class IV 4.4. Unstable arrhythmia status, already on anti-arrhythmic drugs
* Severe hypertension (diastolic BP > 100 on medication)
* Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
* History of orchiectomy, PCa-specific chemotherapy, cryotherapy, Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy to the pelvis for prostate cancer or any other malignancy.
* Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
* Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs.)
* Any rectal pathology, anomaly or previous treatment, which can change acoustic properties of rectal wall or prevent safe probe insertion (e.g., fistula, stenosis, fibrosis).
* Any spinal pathology which can prevent safe administration of epidural anesthesia
* Identified calcification of 2 mm or more in largest diameter neighboring the rectal wall (in a distance of less than 5 mm) and interfering with the acoustic beam path.
* Lower limb musculo-skeletal fixed deformities.
* Prostate with multiple cystic lesions.
* Evidence for seminal vesicle/lymph node involvement of cancer.
* Subjects with distance of the less than 2mm margin between the tumor and the prostate capsule
* Bladder cancer
* Patient that had TURP procedure before
* Urethral stricture/bladder neck contracture
* Patient with baseline symptoms of incontinence defined as urine leak in any of the following circumstances:
20.1. Before the patient can get to the toilet 20.2. When coughing or sneezing 20.3. While being asleep 20.4. While being physically active/exercising 20.5. After finishing urinating and being dressed 20.6. Leaking for no obvious reason
* Patient with baseline impotence scoring 17 or below in the IIEF-5 (SHIM) questionnaire
* Active UTI
* Prostatitis NIH categories I, II and III
* Implant near (<1 cm) the prostate
* Interest in future fertility
* Current participation in another clinical investigation of a medical device or a drug or has participated in such a study within 30 days prior to study enrollment
Sex :
MALE
Ages :
- Minimum Age : 50 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01226576
| 49,624
|
{
"NCT_ID" : "NCT01818375",
"Brief_Title" : "Goal Directed Fluid Therapy and Postoperative Ileus",
"Official_title" : "Goal-directed Fluid Therapy and Postoperative Ileus After Elective Laparoscopic Colorectal Surgery Using an Enhanced Recovery Program: a Randomized Controlled Trial",
"Conditions" : ["Postoperative Ileus"],
"Interventions" : ["Procedure: Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided", "Other: Standard fluid therapy"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-08",
"Study_Completion_Date(Actual)" : "2015-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-03-21",
"First_Posted(Estimated)" : 2013-03-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-03-21",
"Last_Update_Posted(Estimated)" : 2015-10-05",
"Last_Verified" : 2015-10"
}
}}
|
#Study Description
Brief Summary
Despite Goal Directed Fluid Therapy (GDFT) has shown a reduction of hospitalization and overall complications in patients undergoing abdominal surgery, there is a need to address the effect of implementing GDFT on the incidence of specific surgical complications and in a context of en enhanced recovery program (ERP). Specifically, studies investigating the impact of GDFT on primary postoperative ileus (POI) in patients undergoing laparoscopic colorectal surgery and using an ERP are missing.
It is hypothesized that the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving Standard Fluid Therapy (SFT) after elective laparoscopic colorectal surgeries with an ERP program.
Detailed Description
Randomized Controlled Trial. Study population: elective laparoscopic colorectal resections with an Enhanced Recovery Program (ERP) Sample size: 128 patients (140 accounting for drops out)
Two arms:
GDFT: patients will receive GDFT esophageal doppler guided; SFT: patients will receive SFT based on standard anesthesia formula and international guidelines to calculate fluid requirements.
Study Hypothesis: the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving SFT after elective laparoscopic colorectal surgeries with an ERP program.
ERP: all patients will receive the same perioperative care according to the Enhanced Recovery After Surgery ERAS® program guidelines. Intravenous fluid will be stopped the first day after surgery. Patients will be allowed to have clear fluids the same day of surgery and diet, as tolerated, the first day after surgery.
#Intervention
- PROCEDURE : Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided
- Other Names :
- Esophageal doppler-Deltex Medical
- OTHER : Standard fluid therapy
- Other Names :
- Intravenous infusion as recommended by international guidelines and anesthesia text-books
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients undergoing elective laparoscopic colorectal resection with an Enhanced Recovery Program
Exclusion Criteria:
* Age <18 yr
* Emergency surgery
* Patients who do not understand, read or communicate in either French or English
* Patients who had undergone esophageal or gastric surgery
* Esophageal pathology (esophageal varices or cancer)
* Patients with coarctation of the aorta or aortic stenosis
* Chronic atrial fibrillation
* Preoperative bowel obstruction 8. Coagulopathies 9. Chronic use of opioids
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01818375
| 171,894
|
{
"NCT_ID" : "NCT00761033",
"Brief_Title" : "Music to Reduce Pain and Anxiety in the Pediatric Emergency Department",
"Official_title" : "Music to Reduce Pain and Anxiety in the Pediatric Emergency Department: a Randomized Controlled Trial of Children 3-6 Years Undergoing Intravenous Placement",
"Conditions" : ["Pain", "Distress"],
"Interventions" : ["Behavioral: music"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-10",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-09-25",
"First_Posted(Estimated)" : 2008-09-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-09-25",
"Last_Update_Posted(Estimated)" : 2016-12-08",
"Last_Verified" : 2016-12"
}
}}
|
#Study Description
Brief Summary
Many medical procedures aimed at helping children can cause them pain and distress. If children experience certain levels of pain or distress, it can have long lasting negative effects. The emergency department can be a particularly stressful place for children and their parents. There are also many procedures that children may have in the emergency department that can cause pain and distress. These include procedures such as needle pokes, stitches, or setting a broken bone. Two common methods of managing a child's pain in the emergency department are drugs and distraction. Drugs are not always practical and may come with unwanted side effects. Distraction is often used formally or informally and by parents or the health professionals. One form of distraction involves listening to music. This can lower the child's pain and distress by moving their attention from the painful stimulus, for example a needle poke, to a more pleasant sensation such as familiar children's songs. This study will test whether music is useful to help lower pain and distress for young children (ages 3 to 6 years) who are visiting an emergency department and need an intravenous line. Music is safe and pleasant for children. The results from this study could be important for many children receiving medical care.
#Intervention
- BEHAVIORAL : music
|
#Eligibility Criteria:
Inclusion Criteria:
* Children attending the pediatric ED between the ages of 3 and 6 years - Undergoing an IV placement
* Conscious
* Have sufficient knowledge of the English language to understand and follow instructions and complete the age-appropriate pain assessment
Exclusion Criteria:
* Children with hearing impairments, developmental disabilities, or sensory impairment to pain (e.g., spina bifida)
* Children will be excluded at the discretion of the attending staff (e.g., child in critical condition; requires urgent IV placement; or has altered level of consciousness).
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 6 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00761033
| 249,553
|
{
"NCT_ID" : "NCT00678535",
"Brief_Title" : "Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer",
"Official_title" : "Open-label, Randomized, Controlled, Multicenter Phase III Study Investigating Cetuximab in Combination With Capecitabine (Xeloda, X) and Cisplatin (P) Versus XP Alone as First-line Treatment for Subjects With Advanced Gastric Adenocarcinoma Including Adenocarcinoma of the Gastroesophageal Junction",
"Conditions" : ["Gastric Cancer"],
"Interventions" : ["Drug: Cisplatin", "Drug: Cetuximab", "Drug: Capecitabine"],
"Location_Countries" : ["Brazil", "Greece", "Italy", "Korea, Republic of", "France", "Austria", "Russian Federation", "Czech Republic", "Germany", "Bulgaria", "Belgium", "Portugal", "Israel", "Argentina", "Spain", "Australia", "Hungary", "United Kingdom", "Chile", "China", "Taiwan", "Poland", "Romania", "Hong Kong", "Japan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-03",
"Study_Completion_Date(Actual)" : "2013-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-05-13",
"First_Submitted_that_Met_QC_Criteria" : 2013-03-30",
"First_Posted(Estimated)" : 2008-05-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-05-14",
"Last_Update_Posted(Estimated)" : 2014-07-21",
"Last_Verified" : 2014-07"
}
}}
|
#Study Description
Brief Summary
The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) \[XP\] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS).
Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.
#Intervention
- DRUG : Cetuximab
- Single first dose of cetuximab 400 milligram per square meter (mg/m\^2) will be administered intravenously over 120 minutes followed by weekly intravenous infusion of cetuximab 250 mg/m\^2 over 60 minutes in each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.
- Other Names :
- Erbitux
- DRUG : Capecitabine
- Capecitabine 1000 mg/m\^2 will be administered orally twice daily from evening of Day 1 to morning of Day 15 for every 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.
- Other Names :
- Xeloda
- DRUG : Cisplatin
- Cisplatin 80 mg/m\^2 will be administered intravenously with infusion over 1 to 4 hours on Day 1 of each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
#Eligibility Criteria:
Inclusion Criteria:
* Written informed consent before any study-related activities are carried out
* Age greater than or equal to (>=) 18 years
* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Adenocarcinoma of the gastroesophageal junction [AEG] Types I-III according to Siewert classification)
* Archived tumor material sample for at least subsequent standardized Epidermal Growth Factor Receptor (EGFR) expression assessment
* Unresectable advanced (M0) or unresectable metastatic (M1) disease
* At least one radiographically documented measurable lesion in a previously non-irradiated area according to response evaluation criteria in solid tumors (RECIST). The primary tumor site is to be considered as a non-measurable lesion only
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 1
* Estimated life expectancy greater than (>) 12 weeks
* Medically accepted contraception (if the risk of conception exists)
* Glomerular filtration rate (GFR) >= 60 milliliter per minute (mL/min) The GFR is based on the Cockcroft-Gault formula for creatinine clearance
* Aspartate-aminotransferase (ASAT) less than or equal to (=<) 2.5 * upper limit of normal (ULN) and alanine-aminotransferase (ALAT) =< 2.5 *ULN
* Bilirubin =< 3 * ULN
* Absolute neutrophil count (ANC) >= 1.5 * 10^9 per liter
* Platelets >= 100 * 10^9 per liter
* Hemoglobin >=10 gram per deciliter (g/dL) (without transfusions)
* Sodium and potassium within normal limits or =< 10 percent above or below (supplementation permitted)
Exclusion Criteria:
* Prior chemotherapy, however, previous (neo-)adjuvant (radio-) chemotherapy allowed if finished > 1 year prior to start of study treatment and no more than 300 mg/m^2 cisplatin has been administered
* Prior treatment with an antibody or molecule targeting EGFR and/or Vascular Endothelial Growth Factor Receptor (VEGFR) related signaling pathways
* Brain metastasis and/or leptomeningeal disease (known or suspected)
* Radiotherapy (except localized radiotherapy for pain relief), major surgery or any investigational drug within 30 days before the start of study treatment
* Concurrent chronic systemic immune or hormone therapy not indicated in this study protocol (except for physiologic replacement)
* Clinically relevant coronary artery disease (New York Heart Association [NYHA] functional angina classification III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the 12 months before study Screening, or high risk of uncontrolled arrhythmia
* Active Hepatitis B or C
* Chronic diarrhea or short bowel syndrome
* Presence of any contra-indication to treatment with cetuximab, capecitabine and cisplatin including:
* Known hypersensitivity to capecitabine, fluorouracil, cisplatin, cetuximab or to any of the excipients of these drugs
* Known dihydropyrimidine dehydrogenase (DPD) deficiency
* Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Current treatment with sorivudine or chemically related analogues, such as brivudine
* Symptomatic peripheral neuropathy National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >= 2 and/or ototoxicity NCI CTCAE Grade >= 2, except if due to trauma or mechanical impairment due to tumor mass
* Pregnancy or lactation period
* Concurrent treatment with a non-permitted drug
* Treatment in another clinical study within 30 days prior to study screening
* Previous malignancy other than gastric cancer within 5 years prior to study screening, except for basal cell cancer of the skin or pre-invasive cancer of the cervix
* Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
* Legal incapacity or limited legal capacity
* Significant disease which, in the Investigator's opinion, would exclude the subject from the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00678535
| 83,166
|
{
"NCT_ID" : "NCT06767423",
"Brief_Title" : "Comparing the Effectiveness of Different Appointment Reminder Methods",
"Official_title" : "Comparative Effectiveness of Targeted Outreach With an Automated Caller for Increasing Appointment Completion: A Randomized Quality Improvement Initiative",
"Conditions" : ["Appointment Reminders"],
"Interventions" : ["Behavioral: Text Message + Automated Caller (Intervention)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2024-11-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-12-05",
"Study_Completion_Date(Actual)" : "2025-02-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-11-13",
"First_Posted(Estimated)" : 2025-01-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2025-01-05",
"Last_Update_Posted(Estimated)" : 2025-04-04",
"Last_Verified" : 2025-04"
}
}}
|
#Study Description
Brief Summary
Penn Medicine is continually trying to optimize operations and decrease number of patients who do not show up for their appointments. This has included new changes to text message reminders, implemented as usual care. At a baseline, less than 75% of scheduled outpatient appointments are actually completed. This results in longer wait times and decreased access for patients and operational inefficiencies. The goal of the project is to test whether supplementing standard text message appointment reminders with targeted outreach using an automated phone call to patients with increased risk of not showing up for their appointment (\>15% per Epic's Risk of Patient No-Show Model) reduces no show rate (the study's primary outcome) and increases patient appointment completion rate (% of appointments that were completed during scheduled appointment time, a secondary outcome). Participants will be randomized in a 1:1 ratio to receive either the standard text message or standard text message plus the automated caller. Eligible patients have already consented to receiving text message reminders from Penn Medicine and must have an in-person appointment scheduled during the study period. The Access Optimization Group at Penn will be monitoring the randomization and outcomes reporting of whether a patient confirmed, cancelled, or no showed at the scheduled appointment. All eligible outpatient appointments over a two week period will be included in this operational evaluation. The Access Optimization Group will then make a decision on which approach to implement as usual care based on the results of this operational evaluation.
#Intervention
- BEHAVIORAL : Text Message + Automated Caller (Intervention)
- Standard text message appointment reminders to English and Spanish-speaking patients. Text reminders will go out 3-weeks, 3 days, and 24 hours before the appointment. If patient has not confirmed their appointment after the 3-week and 3-day reminders they will receive an automated caller.
|
#Eligibility Criteria:
Inclusion Criteria:
* in-person appointments
* English or Spanish speakers
* 18 years or older
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT06767423
| 147,502
|
{
"NCT_ID" : "NCT06419790",
"Brief_Title" : "Effect of Electrode Belt Used for Lung Monitoring With EIT on Tidal Volume",
"Official_title" : "Effect of Electrode Belt Used for Lung Monitoring With Electrical Impedance Tomography on Tidal Volume of Healthy Volunteers",
"Conditions" : ["EIT Electrode Belt Stiffness", "Tidal Volume Changes"],
"Interventions" : ["Device: EIT electrode belt, spirometry"],
"Location_Countries" : ["Czechia"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-10-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-04-30",
"Study_Completion_Date(Actual)" : "2017-04-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-05-14",
"First_Posted(Estimated)" : 2024-05-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-05-14",
"Last_Update_Posted(Estimated)" : 2024-05-20",
"Last_Verified" : 2024-05"
}
}}
|
#Study Description
Brief Summary
Tidal volumes of ten spontaneously breathing healthy volunteers were measured using spirometer in two situations: wearing EIT electrode belt and without electrode belt. The changes of the tidal volumes were analysed in order to conclude whether the electrode belt has any impact on the volumes.
Detailed Description
Ten healthy, spontaneously breathing volunteers were in supine semi-sitting position and their tidal volume was measured for 15 min using spirometer Ergostick (Geratherm) twice: with electrode belt placed around the subjcest thorax in the level of 4th to 6th intercostal space in the parasternal line, and then without the electrode belt. The subjects were breathing for approx. 15 min sponatenously with deep, forced breathing in the last minute.
The stiff silicone electrode belt used for lung monitoring with electrical impedance tomography system PulmoVista 500 (Dräger Medical) is being placed tightly around the subjects chest in order to monitor distribution of the ventilation. The aim of the study is to analyse the differences in tidal volumes of the spontaneously breathing subject with and without the electrode belt.
Since the electrode belt is relatively stiff and the manufacturer recommends putting the belt on tightly, there is a possibility that it affects the breathing effort of the spontaneously breathing patients, which could possibly lead to lower tidal volumes.
#Intervention
- DEVICE : EIT electrode belt, spirometry
- Placing electrode belt for EIT monitoring and measuring tidal volume with spirometer
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy volunteers
Exclusion Criteria:
* morbid obesity
* Tiffeneau index lower than 80 %
* wounded skin in the electrode belt location
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06419790
| 128,277
|
{
"NCT_ID" : "NCT00210041",
"Brief_Title" : "Phase 2 Study of Association Gemcitabine-Cisplatin to Treat Penis Epidermoid Carcinoma",
"Official_title" : "Phase 2 Study for Treatment of Penis Epidermoid Carcinoma Loco-regionally Advanced or Metastatic by Association Gemcitabine-Cisplatin",
"Conditions" : ["Genital Neoplasms, Male"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2004-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-12",
"Study_Completion_Date(Actual)" : "2012-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-02",
"First_Posted(Estimated)" : 2005-09-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-13",
"Last_Update_Posted(Estimated)" : 2015-03-31",
"Last_Verified" : 2015-03"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether association Gemcitabine-Cisplatin is effective in the treatment of penis epidermoid carcinoma loco-regionally advanced or metastatic.
#Intervention
- DRUG : Gemcitabine
- Gemzar IV infusion 30 minutes Day 1/ Day 15 1250 mg/m²/j
- DRUG : Cisplatin
- Cisplatin 50 mg/m²/day 1 h IV infusion at Day 1 / Day 15
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* OMS <= 2
* Penis epidermoid carcinoma histologically proved. Tumor with ganglionic loco-regional injury inextirpable and/or metastatic (M1, all T , all N), at initial diagnostic or at relapse after first treatment with curative aim (surgery and / or radiotherapy)
* Disease measurable with RECIST criteria
* Absence of all former chemotherapy during 5 years between inclusion.
* If former radiotherapy, necessity to have appreciated targets outside the irradiation fields. If former radiotherapy, it must have been done more than 4 weeks before inclusion in the study.
* Biologicals values required : polynuclear neutrophils >= 1500/mm3, blood-platelets >= 100000/mm3, Hb >= 10 g/dl, Transaminases < 3N, TP >= 70%, total bilirubin < 1,5 N, creatinine in the blood <= 110 micromoles/l.
* Normal clearance of creatinine, according to Cockroft and Gault's formulae.
* Calcemia : normal or anomaly without clinical meaning.
* Well-informed written consent, signed by the patient.
Exclusion Criteria:
* Uncontrolled cerebral known metastasis
* All former chemotherapy administration during 5 years between inclusion
* Other cancer (except baso-cellular cancer of skin correctly treated, or cancerous disease considered with good prognosis and on remission until 5 years at least)
* Uncontrolled cardiac insufficiency or all other severe and uncontrolled pathology.
* Peripheric neuropathy >= grade 2 OMS
* Anormal audiogram
* Patient difficult to follow for geographical, psychological or family reasons.
* Persons protected by law.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00210041
| 98,729
|
{
"NCT_ID" : "NCT05478005",
"Brief_Title" : "Function and Pain Following Knee Replacement",
"Official_title" : "Comparison of Function and Pain Intensity in the Acute Stage Following Total Knee Replacement, Between Different Methods of Post-surgical Pain Relief",
"Conditions" : ["Knee Arthropathy", "Post Operative Pain", "Pain, Postoperative"],
"Interventions" : ["Procedure: Intra-articular block", "Procedure: Femoral nerve block"],
"Location_Countries" : ["Israel"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-11-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-07-21",
"Study_Completion_Date(Actual)" : "2023-07-21},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-07-04",
"First_Posted(Estimated)" : 2022-07-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-07-27",
"Last_Update_Posted(Estimated)" : 2023-10-23",
"Last_Verified" : 2023-10"
}
}}
|
#Study Description
Brief Summary
The goal of this interventional study is to compare pain management techniques (femoral nerve block, intra-articular block, none) in TKA patients. The main questions it aims to answer are:
* Are there differences in postoperative outcomes?
* Does preoperative quadriceps muscle strength predict early functional ability? Participants underwent TKA and assessments. Researchers compared pain management techniques to assess effects on postoperative outcomes and identified the importance of preoperative quadriceps muscle strength as a predictor of early functional ability. Further research is required to refine postoperative pain management strategies.
Detailed Description
Total knee arthroplasty (TKA) is a frequently undertaken elective orthopedic intervention for severe knee osteoarthritis, frequently yielding postoperative discomfort and complications. Peripheral nerve blocks, notably femoral nerve blocks, are commonly utilized for analgesia but may transiently impede motor nerve function, weakening the quadriceps muscle. Intra-articular blocks offer a potential alternative to mitigate motor impairment. However, there exists a dearth of information regarding the comparative effectiveness of these methods with respect to short-term functional outcomes in the immediate postoperative phase following TKA.
Objectives: This study assesses functional outcomes, pain, quadriceps strength after TKA with femoral nerve block, intra-articular block, and a control group. It identifies predictors of postoperative functional ability.
Methods: 54 patients undergoing TKA were evaluated, measuring pre-op quadriceps strength, and utilizing the Oxford Knee Score for functionality. Post-op, we evaluated mobility using the Timed Up \& Go, Elderly Mobility Scale, and Five Times Sit-to-Stand tests on POD 1 \& 3/4. Pain levels, hospitalization, surgical duration, complications, and falls were also recorded.
#Intervention
- PROCEDURE : Femoral nerve block
- Patients who receive a femoral nerve block during surgery, fill out a questionnaire and undergo a muscle strength test before surgery, undergo functional tests, a muscle strength test and are asked about pain intensity after surgery.
- PROCEDURE : Intra-articular block
- Patients who receive an intra-articular block at the time of surgery, fill out a questionnaire and undergo a muscle strength test before surgery, undergo functional tests, a muscle strength test and are asked about pain intensity after surgery.
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women, over the age of 18, electively assigned for primary knee replacement surgery.
* ASA score 1 <= age <= 3
Exclusion Criteria:
* Revision surgery
* Patients suffering from chronic pain syndrome or chronic opioid use.
* Patients with previous neurological deficits in the lower extremities.
* A cognitive state that does not allow signing of consent or understanding simple instructions.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05478005
| 238,363
|
{
"NCT_ID" : "NCT01178437",
"Brief_Title" : "Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy",
"Official_title" : "Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy - a Prospective Pilot Study Regarding Safety, Effectiveness and Clinical Performance",
"Conditions" : ["Epilepsy"],
"Location_Countries" : ["Germany"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-09",
"Study_Completion_Date(Actual)" : "2011-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-07-29",
"First_Posted(Estimated)" : 2010-08-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-08-09",
"Last_Update_Posted(Estimated)" : 2011-03-08",
"Last_Verified" : 2011-03"
}
}}
|
#Study Description
Brief Summary
The aim of the study is to prove the feasibility and safety of transcutaneous, electrical stimulation of the vagus nerve in patients with difficult-to-treat forms of epilepsy.
#Intervention
- DEVICE : T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve)
- daily, transcutaneous, electrical stimulation of the vagus nerve by the t-VNS device for a period of 9 months
- Other Names :
- T-VNS® Stimulator cM02
|
#Eligibility Criteria:
Inclusion Criteria:
* Written Informed Consent
* Patients of both gender, aged from 18 <= age <= 75 years
* Diagnosis of epilepsy according to the diagnosis criteria of the DSM IV/ ICD 10 (especially G 40.1 /G 40.2/ G 40.3)
* Insufficient response to at least one attempt of treatment in medical history with anticonvulsive medication, dosed sufficiently long and high
* Antiepileptic Drugs (AED) therapy must be stable at a level that promises long-term continuity for at least 10 before study start and has to be continued for at least 3 months during treatment phase
Exclusion Criteria:
* Absence of Informed Consent
* Pregnancy
* Psychiatric diseases, especially post-traumatic stress disorder, obsessive-compulsive disorders, schizophrenia, Borderline personality disorders (BPD), character disorders as well as major depressive disorders, anxiety disorders and eating disorders as comorbidity.
* Abuse of drugs and alcohol until 12 weeks before study start
* Cerebrovascular diseases
* Dementia
* Severe traumatic brain injury in medical history including invasive and non-invasive methods of therapy (tumor surgery, 'Gamma Knife Surgery')
* Indications of structural impairment of the basal ganglia or the brain stem
* active implants (e.g. cochlea implants, VNS, pacemaker)
* Severe neurological diseases (e.g. Morbus Parkinson, systemic neurologic diseases
* severe internistic diseases (e.g. arterial hypertension, respiratory failure)
* Bronchial asthma
* malignant diseases of any kind, within five years before study start
* Severe active infectious diseases (e.g. HIV, hepatitis)
* Bone diseases (e.g. Morbus Paget, recent fractures)
* Diseases of the ENT body system: Hearing loss of the left ear which is treated with a hearing instrument, all dermatologic and infectious diseases which affect the area around the pinna and the ear canal, severe malformation of the pinna
* Vagotomy
* Concurrent participation in other studies
* Other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01178437
| 200,763
|
{
"NCT_ID" : "NCT02289833",
"Brief_Title" : "A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor (HER)2 Immunohistochemistry (IHC)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)",
"Official_title" : "A Phase 2, Multicenter, Single-Arm Study of Trastuzumab Emtansine in Patients With HER2 IHC-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Received At Least One Prior Chemotherapy Regimen",
"Conditions" : ["Non-Small Cell Lung Cancer"],
"Interventions" : ["Drug: Trastuzumab Emtansine"],
"Location_Countries" : ["Germany", "Spain", "United States", "Switzerland", "Korea, Republic of", "Italy", "Poland"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-12-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-10-25",
"Study_Completion_Date(Actual)" : "2018-08-20},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-11-04",
"First_Submitted_that_Met_QC_Criteria" : 2017-10-24",
"First_Posted(Estimated)" : 2014-11-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-11-10",
"Last_Update_Posted(Estimated)" : 2019-08-07",
"Last_Verified" : 2019-07"
}
}}
|
#Study Description
Brief Summary
This is a Phase 2, multicenter study designed to evaluate the efficacy and safety of trastuzumab emtansine administered as a single-agent in participants with HER2-positive (HER2 IHC 2+ or HER2 IHC 3+) advanced or metastatic NSCLC. Participants will be treated with trastuzumab emtansine administered intravenously at a dose of 3.6 milligrams per kilogram (mg/kg) on Day 1 of 21-day cycles until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor, whichever occurs first.
#Intervention
- DRUG : Trastuzumab Emtansine
- Trastuzumab emtansine will be administered intravenously (IV) at a dose of 3.6 mg/kg on Day 1 of every 21-day cycle until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the sponsor, whichever occurs first.
- Other Names :
- Kadcyla, T-DM1
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically documented diagnosis of Stage IIIB not amenable to radical treatment or Stage IV NSCLC (pathological characterization must determine the non-squamous or squamous histological subtype as well as adenocarcinoma subtype classification)
* HER2 status of IHC 2+ or 3+ as determined by a Sponsor-designated central laboratory
* Prior treatment with at least one regimen of platinum-based (cisplatin or carboplatin) chemotherapy in the locally advanced or metastatic setting/recurrent NSCLC with documented disease progression by investigator assessment
* Participants with a known anaplastic lymphoma kinase (ALK) fusion oncogene (must be documented in the participant's chart) must have also experienced disease progression or intolerance with a first-line ALK Tyrosine Kinase Inhibitor (TKI) approved for the treatment of ALK fusion oncogene NSCLC (for example, crizotinib). Disease progression or intolerance must be documented
* Participants with a known mutation in the epidermal growth factor receptor (EGFR) gene (must be documented in the participant's chart) must have also experienced disease progression or intolerance with an EGFR TKI approved for the treatment of EGFR-mutant NSCLC (for example, gefitinib, erlotinib, afatinib). Disease progression or intolerance must be documented
* Measurable disease determined as per the RECIST v1.1
* Life expectancy of at least (>=) 12 weeks
* Adequate organ function
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Left ventricular ejection fraction (LVEF) >= 50 percent (%) by either echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan
* Use of highly effective contraception
Exclusion Criteria:
Cancer-Related Criteria:
* Any approved anti-cancer therapy less than or equal to (<=) 21 days (including chemotherapy or hormonal therapy) before the first study treatment; the following exceptions are allowed: (1) TKIs approved for the treatment of NSCLC must be discontinued greater than (>) 7 days prior to the first study treatment on D1C1 (The baseline computed tomography [CT] scan must be completed after discontinuation of TKIs); (2) Hormone-replacement therapy or oral contraceptives; (3) Anti-emetics, Granulocyte-colony stimulating factor (GCS-F), and prophylactic antibiotics according to local standards
* Investigational therapy participation in another clinical study with therapeutic intent <= 21 days before first study treatment
* Previous irradiation is permitted if >=14 days since the last fraction of radiotherapy have elapsed before the first study treatment on Day 1 as long as a sufficient number of target lesions remain to allow for measurable disease as per RECIST v1.1
* Participants who have untreated brain metastases or are symptomatic; participants with treated brain metastases must have discontinued corticosteroid therapy and not have any neurological symptoms
* History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any excipient of the product
* History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin > 500 milligram per meter-square (mg/m^2); Epirubicin > 900 mg/m^2; Mitoxantrone > 120 mg/m^2. If another anthracycline, or more than one anthracycline, has been used, the cumulative dose must not exceed the equivalent of 500 mg/m^2 doxorubicin
* Peripheral neuropathy of Grade >= 3 per the National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 (NCI CTCAE v. 4.0)
* History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those mentioned above
Cardiopulmonary Function Criteria:
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Severe dyspnea at rest due to complications of advanced malignancy or requiring current continuous oxygen therapy
* Clinical history of active hemoptysis
* Evidence of active pneumonitis during screening
* Current unstable ventricular arrhythmia requiring treatment
* History of symptomatic congestive heart failure (CHF) New York Heart Association (NYHA) classes II-IV
* History of myocardial infarction or unstable angina within 6 months of enrollment
* History of a decrease in LVEF to <50%
General Criteria:
* Current severe, uncontrolled systemic disease (for example, clinically significant cardiovascular, pulmonary, or metabolic disease)
* Major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of the need for major surgery during the course of study treatment
* Current pregnancy or lactation
* Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02289833
| 251,301
|
{
"NCT_ID" : "NCT02855970",
"Brief_Title" : "Validation of a French Quality of Life Questionnaire Adapted to Persons Who Have Suffered a Stroke",
"Official_title" : "Development and Validation of a French Quality Of Life Scale Specific to Patients Who Have Suffered a Stroke",
"Conditions" : ["Stroke"],
"Interventions" : ["Other: completion of a quality of life questionnaire"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-02-16",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-08-31",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-08-02",
"First_Posted(Estimated)" : 2016-08-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-08-03",
"Last_Update_Posted(Estimated)" : 2019-05-03",
"Last_Verified" : 2019-05"
}
}}
|
#Study Description
Brief Summary
The aim of this work is to develop and validate a scale adapted to French cultural characteristics. It will be based on the SS-QoL scale and be simple and quick to use in everyday practice. It is not simply a translation. This transcultural adaptation requires linguistic and psychometric validation, by studying its validity, its reliability and its sensitivity to change, as though it were a new instrument. The investigators will then develop a short version by reducing the items and conduct a psychometric validation.
The translation and validation of a short French version of the SS-QoL scale will generate a reliable and sensitive, easy-to-use tool suitable for use in everyday practice.
The final objective is to use this tool as a principal judgement criterion in future therapeutic trials and in patients of the Dijon Stroke Registry to bring to light prognostic factors that affect quality of life so as to provide better management of this disease.
#Intervention
- OTHER : completion of a quality of life questionnaire
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 years and older.
* Patients following a first stroke (ischemic or non-traumatic cerebral parenchyma haemorrhage) followed at a consultation at Dijon CHU and included in the Dijon Stroke Registry cohort.
* Patients who have provided oral informed consent.
* Patients with national health insurance cover
Exclusion Criteria:
* History of symptomatic stroke.
* Meningeal haemorrhage.
* Severe visual or hearing handicap making it difficult to complete the questionnaire.
* Global severe aphasia and mutism making communication with the patient impossible-.
* Unable to read or speak French.
* Dementia prior to the stroke.
* Psychiatric disorders and dependence on alcohol/drugs.
* Bedridden before the stroke.
* Other comorbidities considered severe by the clinician and not related to the stroke that could have significantly impaired quality of life before the stroke.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02855970
| 165,557
|
{
"NCT_ID" : "NCT01638455",
"Brief_Title" : "Pulse CO-Oximetry Noninvasive Monitoring and Laboratory Measurements of Subject Blood Samples",
"Official_title" : "Noninvasive Parameter Testing With Pulse CO-Oximetry and Measurement of Blood Constituents With In-Vitro Analyzers",
"Conditions" : ["Various Comorbidities"],
"Interventions" : ["Device: Noninvasive device"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-09-07",
"Study_Completion_Date(Actual)" : "2016-09-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-07-09",
"First_Posted(Estimated)" : 2012-07-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-07-10",
"Last_Update_Posted(Estimated)" : 2017-05-15",
"Last_Verified" : 2017-05"
}
}}
|
#Study Description
Brief Summary
Characterize Masimo noninvasive technology in spot check reading on subjects and make comparison to invasive blood sampling tested on reference analyzers.
Detailed Description
Noninvasive readings from subjects done according to manufacturer's directions of use compared to simultaneously derived blood samples measured on in vitro analyzers
#Intervention
- DEVICE : Noninvasive device
- Noninvasive device
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female of any age >= 3 kg.
* Subjects may include healthy volunteers, outpatient or inpatient populations
Exclusion Criteria:
* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, etc.
* Subjects deemed not suitable for study at the discretion of the investigator
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01638455
| 155,617
|
{
"NCT_ID" : "NCT03172078",
"Brief_Title" : "Sedation of Advanced Endoscopic Procedure",
"Official_title" : "Effects of Target-controlled Infusion and Bispectral Index Monitoring in Sedation of Advanced Endoscopic Procedure",
"Conditions" : ["Sedation"],
"Interventions" : ["Procedure: advanced endoscopic procedure"],
"Location_Countries" : ["Taiwan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-06-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-08-22",
"Study_Completion_Date(Actual)" : "2018-08-22},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-05-23",
"First_Posted(Estimated)" : 2017-06-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-05-28",
"Last_Update_Posted(Estimated)" : 2019-05-03",
"Last_Verified" : 2018-08"
}
}}
|
#Study Description
Brief Summary
To evaluate the impacts of target-control infusion (TCI) and bispectral index (BIS) monitoring during advanced endoscopic procedure.
Detailed Description
Anesthesia requirements for advanced endoscopic procedures are approaching those of specialized surgical interventions. Although many other sedative agents are used prior to and during endoscopy, none approach propofol in terms of desirable properties. The risk of propofol sedation for interventional procedures such as endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound (EUS), and therapeutic endoscopy are among the highest for any sedated endoscopic procedure. The reasons are many: the intensity of stimulation encountered during these procedures is similar to many minor surgeries; the airway management is complex and requires constant attention; the incidence of hypoxemia is high, and the time available for recognition and management is limited. In order to reap the benefits of advanced endoscopic procedures, anesthesiologists must rise to the challenge. This requires a dedicated anesthetic team practicing safe, efficient, and effective sedation techniques for advanced endoscopic procedures. Ongoing research into novel infusion methods can add safety to the existing sedation techniques and address some of the concerns related to sedative quality. This is a randomized controlled and prospective study. To evaluate the benefits when we use target-controlled infusion of propofol (TCI) with/without bispectral index monitoring in patients undergoing advanced endoscopic procedure. The primary outcome is the total amount of propofol. The secondary outcomes are patients' and endoscopists' satisfaction, sedative-related adverse events, recovery time.
#Intervention
- PROCEDURE : advanced endoscopic procedure
- The advanced endoscopic procedure include endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP), and other upper gastrointestinal endoscopy.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients undergo advanced endoscopic procedure
Exclusion Criteria:
* age less than 20 years, pregnant and lactating women, American Society of Anesthesiologists (ASA) class V, allergy to propofol, benzodiazepine, or opioid, and a requirement for general anesthesia
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03172078
| 255,395
|
{
"NCT_ID" : "NCT00414375",
"Brief_Title" : "Early Versus Delayed Operation for Perforated Appendicitis",
"Official_title" : "Early Versus Delayed Operation for Perforated Appendicitis With Abscess, a Pilot Study",
"Conditions" : ["Appendiceal Abscess"],
"Interventions" : ["Procedure: Drainage and Interval Appendectomy", "Procedure: Operation on Admission"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-02",
"Study_Completion_Date(Actual)" : "2009-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2006-12-19",
"First_Posted(Estimated)" : 2006-12-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2006-12-20",
"Last_Update_Posted(Estimated)" : 2009-03-03",
"Last_Verified" : 2009-03"
}
}}
|
#Study Description
Brief Summary
The objective of this study is to scientifically evaluate two different operative strategies for perforated appendicitis with abscess.
The hypothesis is that the increased difficulty of early operation is balanced by the immense patient investment with delayed operation.
Detailed Description
This will be a single institution, prospective, randomized clinical trial involving patients who present to the hospital with perforated appendicitis with abscess. This will be a pilot study.
Power calculations are not used for a pilot study. One group will undergo a primary laparoscopic appendectomy. The other group will receive intravenous antibiotics with drainage if possible and a laparoscopic appendectomy 10 weeks after initiation of treatment at presentation. All 7 general pediatric surgeons will be involved with the operations, who are all comfortable with these management arms. The surgeon will not induce a significant confounding variable into this study. The laparoscopic appendectomy is approached in the same manner by all members of our group. Those named on the form are qualified by the IRB to obtain consent and/or will be accountable for overseeing the study.
Both groups will have the same antibiotic regiment. All data will be analyzed on intention-to-treat basis.
#Intervention
- PROCEDURE : Operation on Admission
- Laparoscopic appendectomy on admission
- PROCEDURE : Drainage and Interval Appendectomy
- drainage with interval appendectomy
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with perforated appendicitis and an abdominal abscess diagnosed on CT scan.
* Children of any age will be included.
Exclusion Criteria:
* Patients with immune deficiency
* Another condition affecting surgical decision making or recovery (e.g. hemophilia, severe cardiac or respiratory co-morbidities).
* Acute sepsis or severe pain from perforation not allowing for delayed management.
Sex :
ALL
Ages :
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00414375
| 165,668
|
{
"NCT_ID" : "NCT02556047",
"Brief_Title" : "Evaluation of the Safety & Performance of 2 Intradermal Safety Devices",
"Official_title" : "A Clinical Investigation to Evaluate the Safety and Performance of Two Star Intradermal Safety Device (IDSD) Syringes in Healthy Adult Volunteers",
"Conditions" : ["Syringe"],
"Interventions" : ["Device: Star Intradermal Safety Device"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-10",
"Study_Completion_Date(Actual)" : "2015-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-09-17",
"First_Posted(Estimated)" : 2015-09-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-09-21",
"Last_Update_Posted(Estimated)" : 2015-10-14",
"Last_Verified" : 2015-10"
}
}}
|
#Study Description
Brief Summary
Several vaccinations are administered by the intradermal (ID) method where the vaccine is injected between layers of skin. The current technique required to do this can be difficult to learn and perform accurately, is slower to deliver than subcutaneous or intramuscular injections, and there is a risk that the injection will be given to too-deep skin layers or to underlying tissues, which might change the immune response. There is increasing interest in using ID administration for vaccines as it may be possible to achieve the same immune response with a smaller dose of vaccine. This could increase access to vaccines that are expensive or are only available in small quantities and therefore could have global health benefit for vaccine programs for diseases such as yellow fever and polio.
Because of the potential global-health benefits of being able to give ID injections of vaccines easily, quickly and with relatively little training or experience, several novel devices are currently being developed to allow easy ID administration. Star Syringe have developed two novel intradermal safety devices that differ only in the length of the needle used. The current study will assess how the two new devices perform, compared to the traditional Mantoux test, using injections of saline into the upper arm. Twenty volunteers (18-60 years, male and female) will be recruited and attend a screening visit (1), an injection visit (2a) and have a follow up telephone call (2b). At the injection visit they will receive 3 injections in each arm (Mantoux and 2 device injections) and measurements will be performed.
A subset of volunteers will be invited back to attend an additional visit (3a) which will be a repeat of visit 2 but with an ultrasound image taken of each injection site. There will be a follow up telephone call 24 hours later (3b).
Detailed Description
Volunteers will be asked to attend Surrey CRC for two visits with a follow up telephone call. A subset of volunteers will be aske to attend an additional visit and follow up call.
Visit 1 - Screening Visit (Day - 28 to -1) Visit 1 will take place up to 28 days prior to the injections being administered (Visit 2). At this visit consent will be taken and the following procedures performed: demography, medical history and concomitant medication, vital signs (blood pressure, heart rate, oral temperature), symptoms-directed physical examination including assessment of deltoid area, measurement of height and weight, blood sample taken for haematology and coagulation screen, completion of a medical health questionnaire. Inclusion/exclusion criteria will be assessed and volunteers that continue to be eligible will be invited back to attend Visit 2a.
Visit 2a - Injection (Day 0) At Visit 2a, continuing eligibility will be assessed and both adverse events and concomitant medication will be recorded. Vital signs will be measured and if the volunteer is still eligible then they will be randomised onto the study.
The volunteer will receive a total of 6 injections, 3 in each upper arm. In each arm there will be one Mantoux injection and 2 device injections (the same device or different). In total they will receive 2 Mantoux injections and 2 injections from each device. To maintain the blind of the study the volunteers will be asked to wear a blindfold during the injections. After each injection a number of measurements will be performed including assessing wheal size and wetness at the injection site as well as subjectively assessing pain. In addition the devices will be weighed before and after use.
Following the injections, vital signs will be recorded again and volunteers will be discharged and provided with a diary card to complete over the following 24 hours. They should record side effects and any medications taken, including over the counter medications as well as any skin reactions.
Visit 2b - Mandatory Follow Up telephone call (Day 1) The volunteer will be telephoned by a member of the study team 24 hours after the injection visit and both adverse events and concomitant medication will be recorded. Volunteers will be asked to return their diary cards to the CRC in the mail.
A subset of volunteers will be invited back to attend Visits 3a and 3b.
Visit 3a - Injection (Within days 7 to 28) At Visit 3a, continuing eligibility will be assessed and both adverse events and concomitant medication will be recorded. Vital signs will be measured and if the volunteer is still eligible then they will be randomised onto the study.
The volunteer will receive a total of 6 injections, 3 in each upper arm. In each arm there will be one Mantoux injection and 2 device injections (the same device or different). In total they will receive 2 Mantoux injections and 2 injections from each device. To maintain the blind of the study the volunteers will be asked to wear a blindfold during the injections. After each injection a number of measurements will be performed including assessing wheal size and wetness at the injection site as well as subjectively assessing pain. At this visit, ultrasound echography will be performed for each injection site. In addition the devices will be weighed before and after use.
Following the injections, vital signs will be recorded again and volunteers will be discharged and provided with a diary card to complete over the following 24 hours. They should record side effects and any medications taken, including over the counter medications as well as any skin reactions.
Visit 3b - Follow Up telephone call (24 h after Visit 3a) The volunteer will be telephoned by a member of the study team 24 hours after the injection visit and both adverse events and concomitant medication will be recorded. Volunteers will be asked to return their diary cards to the CRC in the mail.
#Intervention
- DEVICE : Star Intradermal Safety Device
- Star Intradermal Safety Device 1.2mm needle length, Star Intradermal Safety Device 1.5mm needle length, Mantoux technique by N\&S
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female volunteers aged 18 <= age <= 60 inclusive. Attempts will be made to achieve an equal gender ratio through appropriate screening procedures, but a failure to do so will not preclude analysis of the final data set.
* The volunteer is, in the opinion of the investigator, healthy on the basis of self-reported medical history, vital signs, a physical examination (including the skin overlying the deltoids of the upper arms), and the results of routine haematology and coagulation laboratory tests, with no active disease process that could interfere with the study endpoints.
* Body Mass Index >=18.5 and <29.5.
* The volunteer is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
* The volunteer has signed the ICF and is willing to comply with study procedures.
* Available for follow-up for the duration of the study.
Exclusion Criteria:
* 1. Clinically significant psychiatric, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological (particularly myasthenia gravis), immunological, or haematological disease or abnormality, as determined by the study physician, which might interfere with consenting or self-recording of safety events.
2. Presence of large or dark tattoos or other marking or abnormal variation in skin pigmentation in the area of the deltoids that would preclude measurement of six injection site wheals.
3. Acute, self-reported needle phobia. 4. Regular use of anti-coagulant medication, non-steroidal anti-inflammatory drugs, topical or oral steroids, anti-histamines and opiates for longer than six months.
5. Pregnant or lactating at any point during the study from screening to final follow up.
6. Any condition that, in the investigator's opinion, compromises the volunteers' ability to meet protocol requirements or to complete the study.
7. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
8. Dermatological and other conditions likely to cause excessive soreness, bleeding or pain at the site of injection or subsequent scarring; these might include hyperkeratosis and bleeding disorders.
9. Peripheral neuropathy, which might interfere with pain perception.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02556047
| 242,663
|
{
"NCT_ID" : "NCT00796172",
"Brief_Title" : "Evaluating the Effectiveness of a Computerized Medication Adherence System at Reducing Cardiovascular Disease Risk Factors",
"Official_title" : "Clinic-based Intervention to Improve Medication Adherence to Reduce Cardiovascular Disease Risks",
"Conditions" : ["Cardiovascular Diseases"],
"Interventions" : ["Behavioral: Usual Care", "Behavioral: Medication Adherence System (MAS)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-04",
"Study_Completion_Date(Actual)" : "2010-06},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-11-21",
"First_Posted(Estimated)" : 2008-11-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-11-21",
"Last_Update_Posted(Estimated)" : 2015-04-29",
"Last_Verified" : 2015-04"
}
}}
|
#Study Description
Brief Summary
High blood pressure and high cholesterol are both causes of cardiovascular disease (CVD), and it is important for people with these conditions to adhere to their medication regimens. This study will evaluate the effectiveness of a computerized program that provides individualized feedback to participants and their doctors for increasing medication adherence among people at risk of developing CVD.
Detailed Description
CVD is a disorder that affects the heart's ability to function normally. The most common cause of CVD is narrowing or blockage of the coronary arteries, which supply blood to the heart. There are many risk factors for CVD, including inflammation, high blood pressure, high cholesterol, and obesity. For people who take blood pressure and cholesterol lowering medications, adherence to their medication regimen is another important factor in reducing the risk of CVD. Currently, there are no programs available to assist patients with tracking their medication adherence, despite the fact that non-adherence is a major reason for elevated cholesterol and blood pressure levels. This study will evaluate a computerized medication adherence system (MAS) that provides individualized reports to participants and their doctors with information on identifying and overcoming barriers to medication adherence. The MAS will be evaluated in conjunction with counseling from participants' doctors. The purpose of this study is to evaluate the effectiveness of a computerized MAS plus counseling from doctors for increasing medication adherence and lowering blood pressure and cholesterol levels among people at risk of CVD.
This 1-year study will enroll people with high blood pressure or cholesterol levels who are at risk of CVD. At a baseline study visit, participants will undergo blood pressure measurements, a blood collection, and a medication review. Participants will be randomly assigned to either the MAS group or a usual care group. Participants in the MAS group will use the computerized MAS program and answer questions about their medication regimens. Reports will then be generated for both the participants and their doctors. Participants will meet with their doctors to review the reports and discuss their medications and CVD risks. Participants in the usual care group will receive written materials on CVD risk factors, and they will receive usual care from their doctors. At a 6-month visit, participants in the MAS group will undergo a medication review, blood pressure measurements, and interviews with study staff. They will also enter their medication information into the MAS and meet with their doctors to discuss the generated report. Participants in the usual care group will not take part in any study procedures at 6 months. At a 12-month visit, all participants will undergo blood pressure measurements, a blood collection, and a medication review. Participants in the MAS group will also complete questionnaires to assess the usefulness of the MAS computer program.
#Intervention
- BEHAVIORAL : Medication Adherence System (MAS)
- Participants will receive individualized reports from the MAS and counseling from their doctors. The counseling will focus on adherence to blood pressure and cholesterol management medications.
- BEHAVIORAL : Usual Care
- Participants will receive usual care from their doctors and written materials on CVD risk factors.
|
#Eligibility Criteria:
Inclusion Criteria:
* Prescribed one or more antihypertensive and/or lipid management medications
* Living independently
* Has a literacy level that will enable them to successfully navigate the MAS and read associated reports (i.e., approximately a sixth grade reading level)
Exclusion Criteria:
* Current substance use or abuse
* Recent (in the 6 months before study entry) heart attack, stroke, peripheral vascular disease, or other medical condition that limits a potential participant's ability to complete the necessary visits to the outpatient clinic site, to use the MAS, and to complete study assessments
* Residing in assisted living or a nursing home situation
* Medical condition for which survival is expected to be unlikely in the 1 year after study entry
* Unable to read or use a computer with a computer mouse
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00796172
| 75,296
|
{
"NCT_ID" : "NCT05890326",
"Brief_Title" : "Pain Neuroscience Education and Motor Imagery-based Exercise Protocol for Patients With Fibromyalgia",
"Official_title" : "Pain Neuroscience Education and Motor Imagery-based Exercise Protocol in Fibromyalgia",
"Conditions" : ["Fibromyalgia", "Pain", "Psychology Regression"],
"Interventions" : ["Behavioral: Motor imagery-based exercise protocol (MIEP)", "Behavioral: Pain neuroscience education (PNE)", "Behavioral: Combination Group"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-11-20",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-01-14",
"Study_Completion_Date(Actual)" : "2023-05-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-05-16",
"First_Posted(Estimated)" : 2023-06-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-05-25",
"Last_Update_Posted(Estimated)" : 2023-06-06",
"Last_Verified" : 2023-05"
}
}}
|
#Study Description
Brief Summary
The main aim of this study is to find out whether applying both pain neuroscience education (PNE) and motor imagery-based exercise protocol (MIEP) will primarily reduce the pain of fibromyalgia. These therapies could show an evidence of improvement in fibromyalgia patients. However, there are no studies evaluating their effectiveness in combination.
Secondary outcomes:
To assess motor imagery ability of PNE in fibromyalgia patients
To assess motor imagery ability of MIEP in fibromyalgia patients
To evaluate the motor imagery ability of PNE+MIEP combined in fibromyalgia patients
To evaluate pain beliefs of PNE in fibromyalgia patients
To assess the pain beliefs of MIEP in fibromyalgia patients
Combined PNE+MIEP to assess pain beliefs in fibromyalgia patients.
To assess fear of movement in fibromyalgia patients of PNE
To assess fear of movement in fibromyalgia patients of MIEP
Combined PNE+MIEP to assess fear of movement in patients with fibromyalgia
PNE to assess anxiety, depression, cognitive and mood in patients with fibromyalgia.
To assess anxiety, depression, cognitive and mood in patients with fibromyalgia MIEP
To evaluate anxiety, depression, cognitive and mood in patients with fibromyalgia together with PNE+MIEP
PNE to assess self-esteem and body awareness in fibromyalgia patients.
To assess self-esteem and body awareness in fibromyalgia patients of MIEP
Combined PNE+MIEP to assess self-esteem and body awareness in fibromyalgia patients.
#Intervention
- BEHAVIORAL : Pain neuroscience education (PNE)
- Pain neuroscience education (PNE) is a health education intervention that aims to provide up-to-date information on neuroscience developments in the field of chronic pain. All patients were trained once a week for 12 weeks, in groups of 3-4 people, for a maximum of 6 sessions and a minimum of 60 minutes. During the intervention, psychological factors such as self-efficacy, pain intervention/injury, coping with pain, catastrophic thoughts, emotional response to pain, anxiety, frustration/anger, fear of harm, concerns about pain, and fear of pain were examined. and discussed with patients. The sessions aimed to provide patients with a better understanding of their chronic pain by addressing the multifactorial aspects of chronic pain, sensitization and the plasticity of the brain, thus involving patients in treatment.
- BEHAVIORAL : Motor imagery-based exercise protocol (MIEP)
- All patients performed sessions of maximum 60 minutes in groups of 3-4 people twice a week for 12 weeks. This study protocol was developed in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The key standard was to practice simple and safe exercises that would encourage the patient to repeat the program at home. The exercises proposed in MIEP were selected according to the following principles: slowness, painlessness, arousing attention, easy to imagine. The main purpose of the motor imagery exercises was to bring the patient back to the state of 'feeling and self-perception' of the execution of the movement. More important than the 'quantity' of repetition was the painless 'quality' of movement. It was performed in 3 phases: relaxation (3 minutes), MI (8.5 minutes per image) and refocus (3 minutes), which included both kinesthetic imagery (KI) and visual imagery (VI).
- BEHAVIORAL : Combination Group
- Subjects received 6 sessions of Pain neuroscience education (PNE) and 12 weeks (2 times a week) of Motor imagery-based exercise protocol (MIEP).
|
#Eligibility Criteria:
Inclusion Criteria:
* Experiencing widespread chronic pain for more than 12 months
* Pain in at least 12 or more of 18 tender points with a pressure of 5 kg/cm2
* 18 <= age <= 60 old
* Not using pharmacological therapeutics
* Not having participated in any pain program.
* Not having participated in any physical exercise programs in the last twelve
Exclusion Criteria:
* Pregnancy
* Not being able to do a physical activity program
* Currently receiving treatment with any alternative medical methods (eg.hyperbaric).
* Cardiovascular, psychiatric, autoimmune, cancer, etc. children with secondary different disease
* Other causes of chronic pain
* Receiving any treatment support related to pain
* Mental disability status
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT05890326
| 21,828
|
{
"NCT_ID" : "NCT01793948",
"Brief_Title" : "Metformin Hydrochloride vs. Placebo in Overweight or Obese Patients at Elevated Risk for Breast Cancer",
"Official_title" : "A Double Blind Prospective Study of Metformin vs. Placebo in Overweight or Obese Post-menopausal Women at Elevated Risk for Breast Cancer",
"Conditions" : ["Breast Cancer", "Obesity"],
"Interventions" : ["Other: laboratory biomarker analysis", "Other: placebo", "Drug: metformin hydrochloride"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["EARLY_PHASE1"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-04-16",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-01-09",
"Study_Completion_Date(Actual)" : "2018-01-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-02-14",
"First_Posted(Estimated)" : 2013-02-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-02-14",
"Last_Update_Posted(Estimated)" : 2018-03-30",
"Last_Verified" : 2018-03"
}
}}
|
#Study Description
Brief Summary
This randomized clinical trial studies metformin hydrochloride in overweight or obese patients at elevated risk for breast cancer. Metformin hydrochloride may decrease the expression of early tumor makers in breast tissue of patients at increased risk for breast cancer
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the changes in the signal pathway profiling of breast tissue using reverse phase proteomics in tissue biopsy of overweight or obese women at elevated risk for breast cancer treated with metformin (metformin hydrochloride) (850mg orally twice a day) for 12 cycles.
SECONDARY OBJECTIVES:
I. To determine the effect of metformin on breast tissue density of overweight or obese women at elevated risk for breast cancer using qualitative mammographic fat density criteria.
II. To determine the effect of metformin on the insulin axis in serum of overweight or obese women at elevated risk for breast cancer treated with metformin (850mg orally twice a day) for 12 cycles.
III. To determine the toxicities associated with metformin.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive metformin hydrochloride by mouth once daily on days 1-30 in course 1 and twice daily on days 1-30 thereafter. Treatment repeats every 30 days for 12 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo by mouth once daily on days 1-30 in course 1 and twice daily on days 1-30 thereafter. Treatment repeats every 30 days for 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for up to 5 years.
#Intervention
- DRUG : metformin hydrochloride
- Given PO
- Other Names :
- Glucophage
- OTHER : placebo
- Given PO
- Other Names :
- PLCB
- OTHER : laboratory biomarker analysis
- Correlative studies
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must be post-menopausal women; post-menopausal women are defined as: (1) those >= 50 years who had not menstruated during the preceding 12 months or who had castrate follicle-stimulating hormone levels (> 40 IU/L), (2) those who had undergone a bilateral oophorectomy
* Patients must be at elevated risk for breast cancer based on strong family history or a history of breast biopsy documenting atypical hyperplasia anytime in the past; for this study strong family history is defined as having:
* 1 first-degree (parent, offspring, sibling) relative =< 50 years when diagnosed with breast cancer, or
* >= 2 first-degree relatives of any age when diagnosed with breast cancer, or
* >= 2 second-degree (aunts, uncles, grandparents, grandchildren, nieces, nephews, or half-siblings) maternal or paternal relatives diagnosed with breast cancer and at least 1 diagnosed at =< 50 years
* Patients must have a body mass index (BMI) >= 25.0 as calculated by the formula: weight in pounds / height squared x 703 = BMI; a BMI of:
* 18.5 <= age <= 24.9 is considered normal;
* 25.0 <= age <= 29.9 is considered overweight;
* 30.0+ is regarded as obese
* Patients must be willing to complete a bilateral mammogram at baseline with repeat exam after 12 cycles of protocol therapy; patients who have had a mammogram within 1 month prior to registration to protocol therapy will not need to repeat the exam
* Patients must be willing to provide a core tissue biopsy at baseline and with repeat tissue collection after 12 cycles of protocol therapy
* White blood cell (WBC) >= 3.0 x 109/L
* Granulocytes (polymorphs + bands) >= 1.5 x 109/L
* Platelets >= 100 x 109/L
* Hemoglobin >= 110 g/L
* Aspartate aminotransferase (AST) =< 1.8 X upper limit of normal (ULN)
* Alanine aminotransferase (ALT) =< 1.8 X ULN
* Alkaline phosphatase =< 2 X ULN
* Serum creatinine =< 115 umol/L (1.3mg/dL)
* Serum bilirubin =< institution ULN (except for subjects with Gilbert's Disease who are eligible despite elevated serum bilirubin level)
* 12 hour fasting glucose level < 7.0 mmol/L
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1 within 28 days of registration
* Life expectancy of >= 5 years
* Subjects must be accessible for treatment, adverse event tracking and follow-up as determined by the treating physician
* Subject consent and authorization for the release of health information must be obtained according to local institutional guidelines
Exclusion Criteria:
* No history of any malignancy except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for >= 5 years
* No known diabetes (type 1 or 2) or baseline fasting glucose >= 7.0 mmol/L
* No known hypersensitivity or intolerance to metformin
* No condition associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heart failure defined as New York Heart Association [NYHA] class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)
* No current treatment with metformin, sulfonylureas, thiazolidinediones or insulin for any reason
* No breastfeeding
* No concurrent or planned participation in randomized trials of weight loss or exercise interventions or trials targeting insulin, insulin-like growth factor 1 (IGF-1) or their receptors
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01793948
| 35,718
|
{
"NCT_ID" : "NCT06432257",
"Brief_Title" : "The Effect of the Application of Head Mounted Magnifying Glasses on Postoperative PTH Changes in Thyroid Surgery",
"Official_title" : "The Effect of the Application of Head Mounted Magnifying Glasses on Postoperative PTH Changes in Thyroid Surgery",
"Conditions" : ["Thyroid Cancer"],
"Interventions" : ["Device: head mounted magnifying glass assistance"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-12-31",
"Study_Completion_Date(Actual)" : "2024-05-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-05-22",
"First_Posted(Estimated)" : 2024-05-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-05-28",
"Last_Update_Posted(Estimated)" : 2024-05-29",
"Last_Verified" : 2024-05"
}
}}
|
#Study Description
Brief Summary
This study collected data on open thyroidectomy patients admitted to the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023 by reviewing medical records. This study was divided into an experimental group and a control group based on whether a head mounted magnifying glass was used, with the main calculation indicator being changes in PTH levels before and after surgery. This study investigated whether the application of head mounted magnifying glasses had an impact on preoperative and postoperative changes in PTH levels through inter group and self pre - and post control, in order to verify the practical effectiveness of head mounted magnifying glasses in thyroid surgery and provide reasonable suggestions for the selection of subsequent surgical treatment methods.
Detailed Description
In thyroid surgery, changes in postoperative parathyroid hormone (PTH) levels have a significant impact on the patient\'s recovery and long-term health status. Parathyroid hormone is responsible for regulating blood calcium levels, and its dysfunction can cause serious electrolyte imbalance and metabolic problems. In the process of thyroid surgery, especially in total thyroidectomy, protecting the function of the parathyroid gland is an important operation. The diameter of the parathyroid gland is small and similar to the morphology of lymph nodes, making it susceptible to damage during surgery. Although traditional magnification tools such as surgical microscopes have certain effects, their operation is complex and their adaptability to surgical scenes is limited.
In recent years, as an emerging magnifying tool, head mounted magnifying glasses have been increasingly used in thyroid surgery due to their portability, ease of operation, and providing a larger field of view. Wearing a head mounted magnifying glass can not only improve the clarity of vision during surgery, increase the recognition rate of parathyroid glands and nerves, but also reduce the risk of parathyroid injury by improving surgical accuracy, thereby more effectively maintaining the stability of postoperative PTH levels. In addition, the use of head mounted magnifying glasses can reduce surgical time, intraoperative uncertainty, and the risk of postoperative complications.
This study systematically evaluates the changes in PTH levels before and after surgery to verify the practical effectiveness of head mounted magnifying glasses in thyroid surgery, and further explores the effectiveness of parathyroid gland protection strategies, optimizing surgical techniques, and improving patient surgical safety and postoperative quality of life. In addition, the results of this study also have guiding significance for the innovation and improvement of surgical instruments, which may promote the development of related technologies and equipment, and thus promote their application in a wider range of surgical fields.
#Intervention
- DEVICE : head mounted magnifying glass assistance
- When performing thyroid surgery for patients in the experimental group, the surgeon uses a head mounted magnifying glass for assistance
|
#Eligibility Criteria:
Inclusion Criteria:
* All cases were the first to undergo open thyroidectomy surgery.
* All clinical data and research materials of the cases are complete.
* All cases underwent thyroid function examination before and after surgery.
* All cases in the experimental group were treated with a head mounted magnifying glass during surgery.
Exclusion Criteria:
* Except for cases of recurrence.
* Cases with incomplete clinical data and research materials are excluded.
* Cases that have not undergone thyroid function tests before and after surgery are excluded.
* Excluding cases of secondary surgery.
* Excluding cases in the experimental group who did not use a head mounted magnifying glass during surgery.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT06432257
| 25,555
|
{
"NCT_ID" : "NCT01684566",
"Brief_Title" : "A Comparative Investigation of Standard Of Care (SOC) and Episil® in Combination Versus SOC Alone on Oral Mucositis",
"Official_title" : "A Multicenter, Open-label, Parallel Group Investigation to Compare the Performance of Standard Of Care (SOC) and Episil® in Combination Versus SOC Alone on Oral Mucositis in Patients Receiving Conditioning Treatment for Hematopoietic Stem Cell Transplantation",
"Conditions" : ["Oral Mucositis"],
"Interventions" : ["Other: Oral hygiene procedures", "Device: episil(R)"],
"Location_Countries" : ["Germany", "Sweden", "Poland", "Israel"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-09",
"Study_Completion_Date(Actual)" : "2013-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-09-11",
"First_Submitted_that_Met_QC_Criteria" : 2016-02-17",
"First_Posted(Estimated)" : 2012-09-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-09-12",
"Last_Update_Posted(Estimated)" : 2016-03-14",
"Last_Verified" : 2015-11"
}
}}
|
#Study Description
Brief Summary
To compare the performance of standard of care (SOC) + episil® versus SOC alone on oral mucositis in patients receiving conditioning treatment for hematopoietic stem cell transplantation (HSCT). The primary variable will be the area under the curve (AUC) of oral mucositis scores defined by the World Health Organisation (WHO) oral toxicity scale assessed daily by the investigator over the 28-day study period.
Detailed Description
This was multicentre, open-label, randomised parallel-group study. Patients were randomised to one of two parallel treatment groups: episil® in combination with SOC or SOC alone.
The study was originally planned to be conducted in several sites in the following countries: Denmark, Israel, Poland, and Sweden. Following a country-specific Amendment on 20-Feb-2013 and a German Ethical Committee (EC) approval in 07-May-2013, Germany was added to the list of countries where the study would be conducted. No study sites were initiated in Denmark.
The study design was aimed to facilitate direct comparison of the performance of SOC + episil® versus SOC alone. The study was conducted in an open-label manner that is common in trials involving cancer patients, as this takes into the account the ethical issues involved in this indication and patient population. To reduce the likelihood of bias, assignment to study treatment was randomised.
SOC as control group is appropriate and widely used, especially in trials involving cancer patients. In this particular study, basic oral hygiene consisting of brushing, flossing, rinsing and moisturising was taken as the SOC used as control group.
.
#Intervention
- DEVICE : episil(R)
- episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
- OTHER : Oral hygiene procedures
- Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)
|
#Eligibility Criteria:
Inclusion Criteria:
* Is at least 18 years.
* Has a confirmed diagnosis for which he/she is scheduled for hematopoietic stem cell transplantation (HSCT) of either type of transplant (autologous or allogeneic).
* Is due to undergo treatment with myeloablative conditioning (radiation-based or non radiation based) before HSCT.
Exclusion Criteria:
* Will undergo reduced intensity conditioning before HSCT.
* Has got known allergy to any ingredient in the study product or to peanuts, peppermint oil, or soya.
* Is pregnant or breast feeding.
* Has any other concurrent medical condition that, in the opinion of the investigator, would increase the risk to the patient, compromise evaluation of the investigational device, or interfere with the conduct of the study.
* Has an unstable condition (eg, a psychiatric disorder, a recent history of substance abuse) or is otherwise thought to be unreliable or incapable of complying with the study requirements.
* Is undergoing treatment with parenteral opioids at enrolment.
* Uses treatments that promote mucosal healing (eg, palifermin).
* Uses electrolyte mouthwashes (eg, Caphosol®) or other topical oral treatments (eg, Tantum Verde® (benzydamine), Gelclair®, Fungicidin (nystatin)).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01684566
| 13,036
|
{
"NCT_ID" : "NCT05241730",
"Brief_Title" : "Glycaemic Index and Substrate Metabolism",
"Official_title" : "Influence of a Diet With Different Glycaemic Indices and Carbohydrate Content on Substrate Utilization, Energy Storage, and Performance-related Parameters in Endurance-trained Men",
"Conditions" : ["Substrate Metabolism During Exercise"],
"Interventions" : ["Other: High Glycaemic Index", "Other: Training intervention", "Other: LCHF", "Other: Low Glycaemic Index"],
"Location_Countries" : ["Austria"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-01-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-04-23",
"Study_Completion_Date(Actual)" : "2023-04-23},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-01-25",
"First_Posted(Estimated)" : 2022-02-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-02-04",
"Last_Update_Posted(Estimated)" : 2023-11-27",
"Last_Verified" : 2023-11"
}
}}
|
#Study Description
Brief Summary
Substrate metabolism during exercise can be influenced by various nutritional regimes. The effectiveness of the different nutritional regimes, which differ in their carbohydrate content, will be investigated not only by functional tests but also the measurement of the mechanistic processes in the muscle will be explored.
Magnetic resonance (MR), better known as magnetic resonance imaging (MRI), has been widely used in clinical practice as a non-invasive imaging technique. Importantly, in addition to producing anatomical images, an MR scanner also offers the possibility to measure the concentrations of a number of metabolic products. This is done through a technique known as magnetic resonance spectroscopy (MRS).
This research project asks the following questions:
* Can a diet containing carbohydrates with a low glycemic index achieve the same adaptations in basic endurance/fat metabolism as a high fat, low carbohydrate (ketogenic) diet?
* Does a high-fat, low-carbohydrate diet, compared with a high-carbohydrate diet, prevent improvements in performance in the submaximal and maximal range?
* What is the effect of diets with different carbohydrate content and variable glycemic index on endurance performance in a half marathon and a time trial?
* How do the diets with different carbohydrate content and variable glycaemic index affect the energy and glycogen stores in the muscles?
In active recreational athletes, the objectives are: (1) to investigate the effects of different diets with variable carbohydrate content and glycaemic index on substrate metabolism, (2) to determine the effects of the different diets on energy stores using multinuclear dynamic magnetic resonance spectroscopy, and (3) to measure the effects of the different diets on endurance performance.
#Intervention
- OTHER : Training intervention
- The training intervention will be a 10 week training plan for endurance runners. The plan consists of five sessions per week (three basic endurance sessions and two interval sessions)
- OTHER : High Glycaemic Index
- The subjects eat 55-60 E-% carbohydrates with ≥ 65 % from high glycaemic index carbohydrates per day, the other E-% are fats and proteins.
- OTHER : LCHF
- The subjects eat ≥ 65 E-% fats and a maximum of 50 g carbohydrates per day.
- OTHER : Low Glycaemic Index
- The subjects eat 55-60 E-% carbohydrates with ≥ 65 % from low glycaemic index carbohydrates per day, the other E-% are fats and proteins.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male gender
* Age between 18 and 40 years
* Recreational active in leisure time (2 <= age <= 3x/week physical activity)
* Motivation for performance testing and structured training plan
* Interest in different diets
* no acute or chronic illnesses
Exclusion Criteria:
* Contraindications to physical exercise according to ACSM (American College of Sports Medicine) guidelines
* Age <18 or >40 years
* Taking medication that could influence the measurements or that is prohibited in training and/or competition according to the WADA (World Anti-Doping Agency) Code
* Competitive athlete with own training plan
* Experience with intervention diets
MRI-specific exclusion criteria:
* Claustrophobia
* Cardiac pacemaker
* cochlear implant
* subcutaneous injection system
* Stents, metal implants, braces, piercings, tattoos
* Body weight of more than 180 kg or BMI of more than 37 kg/m2
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05241730
| 79,659
|
{
"NCT_ID" : "NCT03087409",
"Brief_Title" : "High-dose Chemotherapy With Hematopoietic Stem-cell Rescue for High-risk Breast Cancer: Long-term Follow-up",
"Official_title" : "High-dose Chemotherapy With Hematopoietic Stem-cell Rescue for High-risk Breast Cancer: Long-term Follow-up of a Randomized Phase III Study",
"Conditions" : ["Breast Cancer Female"],
"Location_Countries" : ["Netherlands"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-07-01",
"Study_Completion_Date(Actual)" : "2018-07-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-03-09",
"First_Posted(Estimated)" : 2017-03-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-03-16",
"Last_Update_Posted(Estimated)" : 2024-05-03",
"Last_Verified" : 2024-05"
}
}}
|
#Study Description
Brief Summary
Collection of follow-up data from the original trial patient cohort.
Detailed Description
Collection of follow-up data from the original trial patient cohort by means of structured patient file abstraction, a questionnaire to the general practitioner, and registry consultations.
|
#Eligibility Criteria:
Inclusion Criteria:
* Enrolment in the original trial.
Exclusion Criteria:
* None.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03087409
| 215,536
|
{
"NCT_ID" : "NCT02795637",
"Brief_Title" : "Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction",
"Official_title" : "Pharmacokinetics of Orally Administered Dasotraline in Subjects With Mild, Moderate, and Severe Hepatic Dysfunction",
"Conditions" : ["Attention Deficit Hyperactivity Disorder (ADHD)", "Binge-Eating Disorder Disorder"],
"Interventions" : ["Drug: dasotraline"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-11",
"Study_Completion_Date(Actual)" : "2016-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-05-23",
"First_Posted(Estimated)" : 2016-06-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-06-06",
"Last_Update_Posted(Estimated)" : 2016-12-02",
"Last_Verified" : 2016-12"
}
}}
|
#Study Description
Brief Summary
Study of the what the body does to the drug in subjects with mild, moderate, and sever liver dysfunction (not working properly)
Detailed Description
This is an open-label single-dose study. Approximately 40 total subjects will be enrolled. In each of the 3 hepatic impairment groups (mild hepatic dysfunction \[Child-Pugh score of 5 - 6\], moderate hepatic dysfunction \[Child-Pugh score of 7 - 9\], severe hepatic dysfunction \[Child Pugh score of 10 - 12\]) approximately 10 subjects will be enrolled in order to achieve 8 subjects completing the study in each group. In addition, approximately 8 12 healthy subjects with non-impaired hepatic function will be enrolled to match the subjects in the hepatic impairment groups. Subjects with non-impaired hepatic function may be matched to more than 1 hepatically impaired subject and may be matched to impaired subjects in different Child-Pugh categories; ie, mild, moderate, and/or severe. In order to obtain matched control subjects, after each subject with hepatic impairment has completed the study, a subject with non-impaired hepatic function will be sought; the already enrolled matched control subjects will be checked for a match prior to screening and enrollment of a new match. Each matched control subject will be selected to be demographically comparable to one or more hepatic dysfunction subjects in age (± 10 years), gender, and weight (± 20%). Subjects who do not complete the study may be replaced in order to achieve 8 subjects completing the study in each hepatic impairment group and appropriate healthy matched control subjects.
The study will consist of Screening (Days -28 to -2), Inpatient Period (Days 1 through 7), and Follow-up (Days 8 28). Screening assessments will be used to classify the degree of a subject's hepatic impairment. The degree of impairment will be assigned based on the Child-Pugh category for classification for severity of liver disease. Subjects will be admitted to the clinical site on the day prior to administration of study drug and remain inpatient until discharge on Day 7 (approximately 168 hours after treatment). Subjects may be discharged on Day 5, if in the investigator's opinion they can be relied upon to return for the Day 6 and 7 visits. The following safety assessments will be performed: physical examination; vital signs; clinical laboratory evaluations (hematology, prothrombin time, serum chemistry, and urinalysis); AE collection, ECGs, and C SSRS. Blood and urine samples will be collected for analyses of study drug concentrations and plasma protein binding. The blood sampling duration (648 hours postdose \[Day 28\]) was chosen to determine the terminal half-life of dasotraline, with the expectation that this time may be extended in hepatically impaired subjects compared to the control subjects. A blood sample for pharmacogenetics will be collected only from subjects who provide separate informed consent to collect this sample. The sample will be utilized for potential evaluation of genetic polymorphisms upon selected enzymatic pathway(s) responsible for the metabolism of dasotraline; this sample is optional for participation in the study.
Exclusion Criteria continued from Eligibility Section:
Any subject with hepatic impairment meeting any of the following criteria will be excluded:
1. Subject who does not tolerate venipuncture or has poor venous access that would cause difficulty for collecting blood samples.
2. Subject with a Child-Pugh classification score ≥ 13.
3. Subject with encephalopathy grade \> 1.
4. Subject experienced hepatic coma within the 12 months prior to screening.
5. Subject, who has any abnormal medical history, physical examination, ECG, or laboratory result which, in the opinion of the investigator and medical monitor, may affect the safety of the subject. Subjects with abnormal medical history that is stable may be enrolled.
6. Subject with clinically significant cardiovascular disease, including any of the following:
1. history of cardiac surgery or myocardial infarction within 6 months prior to screening;
2. unstable coronary artery disease;
3. congestive heart failure greater than New York Heart Association (NHYA) Functional Class 1;
4. cardiac arrhythmia or conduction disturbance resulting in atrioventricular block (AV) block, ventricular fibrillation or causing syncope, near syncope or other alterations of mental status;
5. severe mitral or aortic valvular disease;
6. moderately symptomatic peripheral vascular disorder;
7. uncontrolled hypertension (systolic blood pressure \> 200 mmHg and/or diastolic blood pressure \> 110 mmHg). However, subjects with stable mild hypertension who are controlled with the same medication over the 2 months prior to screening may be enrolled in the study.
8. any other cardiovascular condition which, in the opinion of the investigator or medical monitor, might interfere with the results or conduct of the study.
7. Subject has had hepatic transplant or has systemic lupus erythematosus or hepatic carcinoma, or is on the liver transplant list.
8. Subject has estimated creatinine clearance ≤ 60 mL/min according to the Cockcroft-Gault equation.
9. Subject with therapeutic paracentesis within 15 days prior to administration of study drug.
10. Subject has had an acute illness within 30 days prior to administration of study drug.
11. Subject who has had a febrile illness within 14 days prior to administration of study drug.
12. Subject has a disorder or history of a condition that may interfere with drug absorption, distribution, metabolism or excretion including clinically significant abnormality of the renal system, a history of malabsorption, or previous gastrointestinal surgery that could affect drug absorption or metabolism.
13. Subject has a presence or history of any medically diagnosed, clinically significant psychiatric disorder (including intellectual disability and substance-related disorders). Note: For subject with a history of substance-related disorder or alcohol related disorder as defined by DSM 5 criteria the condition must have been more than 1 year prior to screening.
14. Subject has an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over age 65 and females). 1 unit = 12 oz or 360 mL or beer; 5oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits.
15. Subject is unwilling to stop alcohol consumption for at least 48 hours prior to admission on Day -1 (as confirmed by breath or urine alcohol test) through Day 7.
16. Subject has had a portal systemic shunt including portal-systemic shunts (PSS) and transjugular I ntrahepatic portosystemic shunt (TIPS).
17. Subject has shown evidence of hepatorenal syndrome.
18. Subject has required treatment for gastrointestinal bleeding or encephalopathy within the 12 months prior to screening.
19. Subject has had significant blood loss (\> 500 mL) or donated blood, plasma, or other blood products within 30 days prior to administration of study drug.
20. Subject with known significant bleeding diathesis, which could preclude multiple venipunctures (for example, history of recent bleeding from esophageal varices, or platelet count less than 40,000/microliters or hemoglobin \< 10 g/dL).
21. Subject has exhibited evidence of acute viral hepatitis between the start of screening and study drug administration.
22. Subject answers 'yes' to 'Suicidal Ideation' Items 4 or 5 on the C SSRS. Subjects who have significant findings for suicidal ideation upon completion of the C SSRS must be referred to the investigator for follow-up evaluation.
23. Subject tests positive at screening for the HIV 1 or HIV 2 antibody.
24. Subject has a positive urine alcohol test.
25. Subject with albumin, potassium, magnesium and/or calcium outside the normal limits of the reference range may be included at the investigator's discretion.
26. Subject has used any drugs known or suspected to affect hepatic or renal clearance capacity within 30 days prior to administration of study drug.
27. Subject has taken any prescription or OTC medications, herbal tea, energy drinks, herbal products (eg, St John's Wort, milk thistle, etc) or supplement/supra-therapeutic doses of vitamins within 5 half lives or 14 days (whichever is longer) prior to administration of study drug or is anticipated to need any medication during the study, with the exception of those permitted by the protocol or approved by the investigator and medical monitor. Note: All drugs will be reviewed on a case-by-case basis by the medical monitor and are prohibited unless deemed acceptable by the investigator and medical monitor.
28. Subject who has previously received dasotraline.
29. Subject has history of intolerance to stimulants.
30. Subject has a history of allergic reaction or has a known or suspected sensitivity to any substance that is contained in the study drug formulation.
31. Subject has taken any investigational drug within 30 days or 5 half lives (whichever is longer) prior to administration of study drug.
32. Subject is currently a heavy user of nicotine, ie, smoking more than 20 cigarettes (eg, 1 pack) per day or equivalent (eg, e-vapor cigarette, pipe, cigar, chewing tobacco, nicotine patch or nicotine gum).
33. Subject cannot comply with the smoking restrictions of the study site during the confinement period or is unable or unwilling to refrain from smoking and tobacco use for 2 hours prior to study drug administration and 4 hours following administration.
34. Subject has a need for special dietary restrictions, unless the restrictions are approved by the investigator and medical monitor.
35. Subject with a history or suspicion of barbiturate, amphetamine, or narcotic abuse and/or positive screening result for any of these substances. Subjects who are currently receiving prescription narcotic pain relievers may be included at the investigator's and medical monitor's discretion.
36. Subject who received live vaccine(s) within 1 month prior to screening, or intends to during the study. Note: Influenza vaccine will be allowed, if administered \> 21 days prior to study drug administration.
#Intervention
- DRUG : dasotraline
- dasotraline 8mg capsule/day
- Other Names :
- SEP225289
|
#Eligibility Criteria:
Inclusion Criteria:
Subjects with non-impaired hepatic function must meet all of the following criteria:
* Male or nonpregnant, nonlactating female between 18 and 70 years.
* Subject must have a normal neurologic exam including tests for impending hepatic encephalopathy.
* Subject's weight is at least 50 kg.
* Subject's body mass index (BMI) is at least 18 kg/m2 but no more than 37 kg/m2
* Subject must be in general good health be demographically comparable to a least 1 subject with hepatic impairment who completed the study.
* Subject has a negative urine drug screen (UDS).
Subjects with hepatic impairment must meet all of the following criteria:
* Male or nonpregnant, nonlactating female between 18 and 70 years.
* Subject must have a normal neurologic exam including tests for impending hepatic encephalopathy. Note: Subjects with grade 0 or 1 hepatic encephalopathy will be considered for enrollment in the study.
* Subject's weight is at least 50 kg.
* Subject's BMI is at least 18 kg/m2 but no more than 37 kg/
* Subject has a negative UDS.
* Subject with stable, chronic medical conditions (eg, hypertension and hyperlipidemia) in addition to hepatic impairment that, in the opinion of the investigator, will not significantly alter the disposition of the study drug, will not place the subject at increased risk by participating in the study, and will not interfere with interpretation of the data may be permitted to enroll in the study after discussion and agreement between the investigator and medical monitor.
* Subject exhibits vital signs within the reference range for their age and level of hepatic impairment; subjects with vital signs outside the reference ranges may be eligible for the study if the investigator and medical monitor agree that the results are not clinically significant based on the age and hepatic impairment status of the subject, and will not impact study conduct.
* Subject with out-of-range laboratory results that are related to the subject's underlying condition are eligible; however, the results will need to be carefully reviewed by the investigator and medical monitor to determine if a subject is eligible for study participation. Out of range results could indicate a stable or unstable situation. If the subject is unstable (eg, rapidly changing liver tests, significantly worsened anemia compared to earlier labs, etc), then such subject would be excluded from study participation. Serum bilirubin, albumin, and prothrombin time will be assessed individually for a point score according to the Child-Pugh classification.
* Subject has a diagnosis of chronic hepatic impairment for at least 6 months and, in the opinion of the investigator, the severity of the subject's hepatic disease is stable, which is defined as having no clinically significant change in disease status within the 90 days prior to study drug administration, as documented by the subject's recent medical history. Copies of documentation of any clinical information used to make a previous diagnosis of hepatic dysfunction must be available. This may include abnormal liver function tests, clinical evidence of portal hypertension, a positive liver biopsy (eg, for cirrhotic disease, portal hypertension), and/or hepatic ultrasound.
* The total score of the Child Pugh classification must be 5 or 6 for subjects with mild hepatic dysfunction, and between 7 and 9, inclusive, for subjects with moderate dysfunction, and between 10 and 12, inclusive, for subjects with severe hepatic dysfunction.
* Subject receiving medication for underlying disease states or medical conditions related to hepatic dysfunction must be on a stable dose of medication and/or treatment regimen. Subjects who are receiving a fluctuating treatment regimen may be considered for inclusion if, in the opinion of the investigator, the underlying disease is under control; however these subjects must have medical monitor approval.
* Subject with a history of hepatic impairment due to hepatitis B is eligible provided there is no evidence of an active disease state, defined as a positive hepatitis B antigen test at screening.
* Subject with a history of alcohol abuse is eligible provided the urine alcohol test is negative.
* Subject with a history of type 2 diabetes mellitus is eligible provided that, in the investigator's opinion, he or she has stable diabetes.
Exclusion Criteria:
Any subject with non-impaired hepatic function meeting any of the following criteria will be excluded:
* Subject who does not tolerate venipuncture or has poor venous access that would cause difficulty for collecting blood samples.
* Subject has any clinically significant unstable medical abnormality, chronic disease, or history of clinically significant abnormality of the cardiovascular, respiratory, hepatic or renal systems.
* Subject has any clinically significant abnormal medical history, physical examination, ECG, or laboratory results.
* Subject has estimated creatinine clearance <= 60 mL/min according to the Cockcroft Gault equation.
* Subject has had an acute illness within 30 days prior to administration of study drug.
* Subject who, within 14 days prior to administration of study drug, has had a febrile illness.
* Subject has a disorder or history of a condition that may interfere with drug absorption, distribution, metabolism or excretion including clinically significant abnormality of the hepatic or renal system, a history of malabsorption, or previous gastrointestinal surgery that could affect drug absorption or metabolism.
* Subject has a presence or history of any medically diagnosed, clinically significant psychiatric disorder (including intellectual disability and substance-related disorders).
* Subject answers 'yes' to 'Suicidal Ideation' Items 4 or 5 on the C SSRS. Subjects who have significant findings for suicidal ideation upon completion of the C SSRS must be referred to the investigator for follow-up evaluation.
* Female subject who is pregnant, lactating, or within 6 months postpartum.
* Subject tests positive at screening for the hepatitis B surface antigen or hepatitis C antibody or human immunodeficiency virus (HIV 1 or HIV 2) antibody.
* Subject has a positive urine alcohol test.
* Subject has history of substance-related disorder or alcohol related disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria within 1 year prior to screening.
* Subject has an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over age 65 and females). 1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits.
* Subject is unwilling to stop alcohol consumption for at least 4 hours prior to admission on Day -1 (as confirmed by breath or urine alcohol test) through Day 7.
* Subject who has previously received dasotraline.
* Subject has history of intolerance to stimulants.
* Subject has history of allergic reaction or has a known or suspected sensitivity to any substance that is contained in the study drug formulation.
* Subject has had significant blood loss (> 500 mL) or donated blood, plasma, or other blood products within 30 days prior to administration of study drug.
* Subject has used any drugs known or suspected to affect hepatic or renal clearance capacity within 30 days prior to administration of study drug.
* Subject has taken any prescription or over-the-counter (OTC) medications, herbal tea, energy drinks, herbal products (eg, St John's Wort, milk thistle, etc) or supplement/supra-therapeutic doses of vitamins within 5 half lives or 14 days (whichever is longer) prior to administration of study drug or is anticipated to need any medication during the study, with the exception of those permitted by the protocol or approved by the investigator and medical monitor.
* Subject has taken any investigational drug within 30 days or 5 half lives (whichever is longer) prior to administration of study drug.
* Subject is currently a heavy user of nicotine, ie, smoking more than 20 cigarettes (eg, 1 pack) per day or equivalent (eg, e-vapor cigarette, pipe, cigar, chewing tobacco, nicotine patch or nicotine gum).
* Subject cannot comply with the smoking restrictions of the study site during the confinement period or is unable or unwilling to refrain from smoking and tobacco use for 2 hours prior to study drug administration and 4 hours following administration.
* Subject with history or suspicion of barbiturate, amphetamine, or narcotic abuse and/or positive screening results for any of these substances. Subjects who are currently receiving prescription narcotic pain relievers may be included at the investigator's and medical monitor's discretion.
* Subject who received anticoagulant therapy within 90 days prior to administration of study drug.
27 Subject who received live vaccine(s) within 1 month prior to screening, or intends to during the study. Note: Influenza vaccine will be allowed, if administered > 21 days prior to study drug administration.
* Subject has used a strong inhibitor or inducer of cytochrome P450 enzymes within 30 days prior to admission.
Please see additional eligibility criteria in the Study Description section, under Detailed Description
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02795637
| 197,812
|
{
"NCT_ID" : "NCT01282346",
"Brief_Title" : "SOLX Gold Shunt for Refractory Glaucoma",
"Official_title" : "Clinical Evaluation of the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Refractory Glaucoma",
"Conditions" : ["Glaucoma", "Glaucoma, Open Angle"],
"Interventions" : ["Device: SOLX Gold Shunt"],
"Location_Countries" : ["Brazil", "United States", "Venezuela", "Canada", "Israel"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-12",
"Study_Completion_Date(Actual)" : "2015-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-01-05",
"First_Posted(Estimated)" : 2011-01-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-01-22",
"Last_Update_Posted(Estimated)" : 2017-02-23",
"Last_Verified" : 2017-02"
}
}}
|
#Study Description
Brief Summary
To establish the clinical performance of the SOLX Gold Shunt for its ability to reduce intraocular pressure (IOP) in eyes with refractory glaucoma where medical and conventional surgical treatments have failed.
#Intervention
- DEVICE : SOLX Gold Shunt
- Single use implant
|
#Eligibility Criteria:
Inclusion Criteria:
* primary open-angle glaucoma
* age 21 or over
* refractory glaucoma, with IOP >= 24 mmHg on medications and failed prior incisional glaucoma surgery
* detectable visual field defect (negative MD score)
* written informed consent
* available for up to 24 months follow-up
Exclusion Criteria:
* either eye with VA worse than count fingers
* angle closure glaucoma episode within past 12 months
* uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular glaucoma
* diagnosis of pigmentary glaucoma or pseudoexfoliative glaucoma
* other significant ocular disease, except cataract
* active ocular infection
* expected ocular surgery in next 12 months
* no suitable quadrant for implant
* systemic corticosteroid therapy > 5 mg/day prednisone
* intolerance to gonioscopy or other eye exams
* mental impairment interfering with consent or compliance
* pregnancy
* known sensitivity to anticipated medications used at surgery
* significant co-morbid disease
* concurrent enrollment in another drug or device study
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01282346
| 69,183
|
{
"NCT_ID" : "NCT02755181",
"Brief_Title" : "fMRI in Impulsivity",
"Official_title" : "Assessment of Longitudinal Functional Magnetic Resonance Imaging (fMRI) as a Brain Measure for Impulsivity in a Borderline Personality Disorder (BPD) Model",
"Conditions" : ["Impulse Control Disorders", "Borderline Personality Disorder"],
"Interventions" : ["Behavioral: Experimental"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-07-22",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-05-30",
"Study_Completion_Date(Actual)" : "2018-05-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-04-08",
"First_Posted(Estimated)" : 2016-04-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-04-26",
"Last_Update_Posted(Estimated)" : 2018-08-29",
"Last_Verified" : 2018-08"
}
}}
|
#Study Description
Brief Summary
This study aims to use resting-state and task based functional Magnetic Resonance Imaging (fMRI) as a tool to evaluate trait characteristics of impulsivity in subjects with borderline personality disorder.
#Intervention
- BEHAVIORAL : Experimental
- with functional imaging and behavioural measurements at baseline and 4 weeks
|
#Eligibility Criteria:
Inclusion criteria:
* Healthy Controls: Volunteers (age 18 <= age <= 50 yrs) in generally good Psychiatric and non-Psychiatric medical health
* Borderline Personality Disorder subjects: Research volunteers (age 18 <= age <= 50 yrs) who meet DSM-5 criteria for Borderline Personality Disorder
Exclusion criteria:
All Participants:
* Current medications which affect the central nervous system or vascular activity, such as anti-depressants, anxiolytics, or blood-pressure medications
* Positive urine drug screen for cocaine, opioids, amphetamine, and benzodiazepines
* Positive breathalyzer test for alcohol
* History of clinically significant neurologic disorders or head trauma with loss of consciousness greater than 30 minutes
* Clinically significant non-psychiatric medical disorder requiring ongoing treatment.
* Unwillingness or inability to sign a written informed consent form
* Pregnancy as assessed by a urine test for ß-HCG at each visit
* Medical or physical contraindications for participation based on medical history interview, labs, and physical exam
* Metal fragments or other bodily metal (e.g., pacemaker, orthopedic prosthesis),claustrophobia, or any other condition that would put the subjects at risk for MRI scanning
In addition, Healthy Controls excluded, if:
* DSM-5 diagnoses of Personality Disorders (based on SCID-II)
* DSM-5 diagnoses based on the SCID-I (including the eating disorders module)
* History of arrest or incarceration
In addition, Borderline Personality Disorder Subjects excluded if:
* DSM-5 diagnoses
* DSM-5 Personality Disorder other than Cluster B Personality disorders
* Current psychoactive medications
* Further exclusion criteria apply
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02755181
| 69,480
|
{
"NCT_ID" : "NCT01018342",
"Brief_Title" : "Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg",
"Official_title" : "Single-Dose Food In Vivo Bioequivalence Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules (100 mg; Mylan) and Macrobid® Capsules (100 mg; Procter & Gamble) in Healthy Volunteers.",
"Conditions" : ["Healthy"],
"Interventions" : ["Drug: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg", "Drug: Macrobid® Capsules 100 mg"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2002-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2002-08",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-11-19",
"First_Posted(Estimated)" : 2009-11-23"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-11-19",
"Last_Update_Posted(Estimated)" : 2024-04-23",
"Last_Verified" : 2024-04"
}
}}
|
#Study Description
Brief Summary
The objective of this study was to investigate the bioequivalence of Mylan nitrofurantoin monohydrate/macrocrystals capsules to Procter \& Gamble Macrobid® capsules following a single, oral 100 mg (1 x 100 mg) dose under fed conditions.
#Intervention
- DRUG : Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
- DRUG : Macrobid® Capsules 100 mg
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy, adult subjects, 18 years and older
* able to swallow medication
Exclusion Criteria:
* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01018342
| 167,685
|
{
"NCT_ID" : "NCT05096936",
"Brief_Title" : "Pilates Method and/or Photobiomodulation in Women With Stress Urinary Incontinence",
"Official_title" : "Pilates Method and/or Photobiomodulation Therapy Combined to Static Magnetic Field in Women With Stress Urinary Incontinence: What is Better?",
"Conditions" : ["Laser Therapy", "Urinary Incontinence,Stress", "Pilates Method"],
"Interventions" : ["Other: Pilates", "Other: Photobiomodulation"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-10-14",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-12-30",
"Study_Completion_Date(Actual)" : "2023-01-19},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-10-14",
"First_Posted(Estimated)" : 2021-10-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-10-14",
"Last_Update_Posted(Estimated)" : 2023-05-11",
"Last_Verified" : 2023-05"
}
}}
|
#Study Description
Brief Summary
The present study is a clinical intervention applied to patients with urinary incontinence, with the intention of verifying the effects of the Pilates method associated or not with photobiomodulation with static magnetic field. The sample will consist of women with stress urinary incontinence from Bento Gonçalves attended at the school clinic of Faculdade Cenecista de Bento Gonçalves.
#Intervention
- OTHER : Pilates
- The solo Pilates method will be applied twice a week for 12 weeks using the following exercises:
20 Breaths, Double leg stretch, Single leg stretch, Leg circles, Hip lift on ball, Abdominal tightening on ball, Alternating two supports, Side bend, Side kick - side kick, Side kicks, Shell and Swan and Neck pull stretches; in the tenth session, we evolved some exercises: The saw, Swan dive, Book close series, Hip lift on the ball and Front pulls; in the eighteenth session we changed again some exercises for: Leg pull back, Rolling like a Ball, Swimming, Roll over and Leg pull front.
- Other Names :
- Pilates exercise, Pilates Methods
- OTHER : Photobiomodulation
- Applications of FBM or placebo (MR4 ACTIVet PRO Laser Shower Portable, MRM, USA) will last for 115s and will deliver 60 J at each point. The mode of application, with the patient supine on a stretcher, with the grouping probe held stationary in contact with the skin, at a 90-degree angle, in the pubic mound and in the perineum region.
|
#Eligibility Criteria:
Inclusion Criteria:
* Women between 30 and 60 years;
* Present a clinical diagnosis of SUI;
* The patient must be available at pre-scheduled times for a period of 12 weeks, with full participation;
* The participant must agree with the methodology proposed by the project and, if so, must sign the TCLE as legal proof of their participation.
Exclusion Criteria:
* Patients with urge urinary incontinence;
* Constant flow urinary incontinence and stress urinary incontinence during the gestational period (because these are possible transitory cases due to pregnancy);
* Women who have difficulty in understanding;
* Patients who have more than one absence per month during the interventions.
Sex :
FEMALE
Ages :
- Minimum Age : 30 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT05096936
| 132,575
|
{
"NCT_ID" : "NCT05143866",
"Brief_Title" : "A Pilot Study of Evidence-based Guided Self-help for the Treatment of Binge Eating",
"Official_title" : "Closing the Treatment Gap: A Pilot Study of Evidence-based Guided Self-Help for the Treatment of Binge Eating and Related Disordered Eating",
"Conditions" : ["Binge-Eating Disorder", "Binge Eating"],
"Interventions" : ["Behavioral: Cognitive behavioral therapy guided self help (CBTgsh)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-02-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-09-30",
"Study_Completion_Date(Actual)" : "2024-09-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-11-16",
"First_Posted(Estimated)" : 2021-12-03"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-11-20",
"Last_Update_Posted(Estimated)" : 2024-12-18",
"Last_Verified" : 2024-12"
}
}}
|
#Study Description
Brief Summary
The purpose of the present pilot study is to evaluate the feasibility, acceptability and likely effectiveness of an evidence-based guided self-help intervention for binge eating and related disordered over-eating in those unable to access clinician provided treatments. If feasible, acceptable and likely to be effective, such interventions could be made available more widely as an early intervention to those in need. Such interventions have the potential to improve quality of life by removing or ameliorating symptoms that impair psychological and social functioning. Eligible participants will receive the guided self-help intervention - an evidence-based self help program in the form of a self-help book plus telephone support and encouragement to follow the program provided by specially trained help-line volunteers. Support completing the self-help program will be provided over a period of 4 months and participants will be followed up for a year after completion of the intervention. Participants will be asked to complete brief online assessments before starting the program, at the end of 4 months when they complete the program and at 6 month and 12 month follow up.
#Intervention
- BEHAVIORAL : Cognitive behavioral therapy guided self help (CBTgsh)
- Based on evidence based cognitive behavioral treatment for eating disorders. Self-help version described in self-help book. Participant follows self-help program with encouragement and support of a non specialist guide
|
#Eligibility Criteria:
Inclusion Criteria:
* Participant contacted National Eating Disorder Association (NEDA) with binge eating problems or disordered overeating
* Completed NEDA screen and study screen
* Age 18 and over
* Able to speak, understand and read English
* Consenting to guided self-help and completing study assessments
Exclusion Criteria:
* Currently receiving treatment for an eating disorder
* Self-reported weight body mass index (BMI) <20
* Reported self-induced vomiting, laxative or diuretic use (purging)
* Reports suicidal ideation
* Breast feeding or pregnant
* Receiving treatment for co-existing psychiatric condition (e.g., bipolar disorder, psychotic illness, drug or alcohol dependence
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05143866
| 12,791
|
{
"NCT_ID" : "NCT05346692",
"Brief_Title" : "Digital Meditation for Postoperative Pain Control After Abdominal Surgery for Cancer",
"Official_title" : "A Prospective, Double-Arm Pilot Study to Investigate the Safety, Feasibility and Acceptability of a Digital Mindfulness Intervention Following Open Abdominal Surgery for Cancer",
"Conditions" : ["Hematopoietic and Lymphoid System Neoplasm", "Malignant Solid Neoplasm"],
"Interventions" : ["Other: Text Message-Based Navigation Intervention", "Other: Interview", "Other: Survey Administration"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["EARLY_PHASE1"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-03-28",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-07-12",
"Study_Completion_Date(Actual)" : "2023-07-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-03-28",
"First_Posted(Estimated)" : 2022-04-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-04-21",
"Last_Update_Posted(Estimated)" : 2025-01-14",
"Last_Verified" : 2025-01"
}
}}
|
#Study Description
Brief Summary
This phase I trial tests a digital meditation for postoperative pain control after abdominal surgery for cancer. Mindfulness interventions such as guided meditation may improve pain control and decrease stress. Including a brief mindfulness intervention administered via test messages as part of postoperative care may improve pain severity, decrease opioid use, and improve patient responses to non-surgical treatments.
Detailed Description
PRIMARY OBJECTIVES:
I. To investigate and define anticipated and unanticipated adverse events (AEs) related to a daily virtual mindfulness intervention delivered via short message service (SMS) text messaging and to test its safety in the postoperative period amongst patients with cancer.
II. To determine the feasibility and acceptability of a novel, brief mindfulness intervention delivered via SMS text messaging in the postoperative period amongst patients undergoing surgery for cancer.
III. To determine the feasibility and acceptability of an artificial intelligence platform to deliver and receive SMS text messages for the purpose of delivering pain assessment tools and collecting and storing pain-specific and patient reported outcomes.
OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients complete pain survey via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.
ARM II: Patients complete mindfulness intervention via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.
#Intervention
- OTHER : Survey Administration
- Complete Survey
- OTHER : Interview
- Complete Interview
- OTHER : Text Message-Based Navigation Intervention
- Complete mindfulness intervention
- Other Names :
- Automated Text Message-Based Navigation, Text Message-Based Navigation
- OTHER : Interview
- Complete interview
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients >= 18 years
* Open abdominal surgery for cancer
* Ownership of smartphone (iOS or Android operating systems) with SMS texting capabilities
* Ability to read
* Ability to understand the purposes and risk of the study and willingly give standard written informed consent for treatment established by each participating institution.
Exclusion Criteria:
* Patients with contraindications to abdominal surgery and/or general anesthesia
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05346692
| 77,110
|
{
"NCT_ID" : "NCT00991809",
"Brief_Title" : "Study on the Development of Opioid Induced Hyperalgesia (OIH) After Exposure to Alfentanil",
"Official_title" : "A Pilot Study of Prolonged, Intermittent Exposure to Alfentanil on Opioid-Induced Hyperalgesia in Healthy Volunteers",
"Conditions" : ["Hyperalgesia"],
"Interventions" : ["Drug: Diphenhydramine", "Drug: Alfentanil"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-05",
"Study_Completion_Date(Actual)" : "2010-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-10-07",
"First_Submitted_that_Met_QC_Criteria" : 2013-08-09",
"First_Posted(Estimated)" : 2009-10-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-10-07",
"Last_Update_Posted(Estimated)" : 2017-10-06",
"Last_Verified" : 2017-09"
}
}}
|
#Study Description
Brief Summary
The purpose of this study was to follow a person's response to experimental pain after multiple consecutive exposures to alfentanil or diphenhydramine to see if the person can tolerate the pain more, less, or the same at the end of the study.
Detailed Description
This project investigates the phenomenon of opioid-induced hyperalgesia (OIH). Opioid analgesics, in addition to their therapeutic anti-nociceptive effects, under some conditions produce pro-nociceptive effects. This phenomenon of pain or pain sensitivity being increased by prior opioid administration is called opioid-induced hyperalgesia. It is thought to be relevant both to pain management complications and to complications of opioid dependence and its treatment. This study investigated the time-course of opioid-induced hyperalgesia development in healthy normal volunteers (N=12 completers), using a series of acute alfentanil administrations (15 mg/kg mg intramuscular (IM) per day) spaced at 3-4 day intervals, with testing for pain tolerance using the cold pressor test (CPT), and mechanical quantitative sensory testing (MQST) each administered repeatedly over time within each testing day. The goal was to determine the time course of OIH development following acute opioid administration, and to assess whether this changes over repeated acute opioid administrations.
#Intervention
- DRUG : Alfentanil
- 15 mcg/kg IM
- DRUG : Diphenhydramine
- 25 mg IM
- Other Names :
- Benadryl
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 55
* No active medical conditions
* BMI between 20 <= age <= 30
* Able and willing to perform/tolerate pain procedures
* Able to communicate in English
Exclusion Criteria:
* Lifetime substance use disorder, except for alcohol abuse/dependence in remission
* Use of opiates in last 3 months
* Ongoing marijuana use
* Acute or chronic pain
* Neurologic or psychiatric condition known to influence cold pressor testing (peripheral neuropathy, major depression, or schizophrenia)
* Current use of prescribed or over the counter pain medications
* Previous adverse reaction to opiate medications or diphenhydramine
* Use of tobacco or caffeine on study days
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00991809
| 211,094
|
{
"NCT_ID" : "NCT05687812",
"Brief_Title" : "Effects of Cephalaria Syriaca Flour-added Bread on Glucose Metabolism and Appetite Parameters in Individuals With Obesity, Diabetes, and Healthy Controls.",
"Official_title" : "Effects of Cephalaria Syriaca Flour-added Bread on Glucose Metabolism and Appetite Parameters in Individuals With Obesity, Diabetes, and Healthy Controls.",
"Conditions" : ["Nutrition, Healthy"],
"Interventions" : ["Dietary Supplement: Cephalaria Syriaca flour-added bread"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-31",
"Study_Completion_Date(Actual)" : "2022-12-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-01-08",
"First_Posted(Estimated)" : 2023-01-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-01-08",
"Last_Update_Posted(Estimated)" : 2023-01-19",
"Last_Verified" : 2023-01"
}
}}
|
#Study Description
Brief Summary
Cephalaria Syriaca is a common weed in Anatolia and grows wild in wheat fields, with high fat, protein, and dietary fiber content. This study it is aimed to evaluate the effects of lowering the glycemic index of white bread consumed in large quantities in Turkey by adding Cephalaria Syriaca, on healthy, obese, and diabetic individuals.
Detailed Description
Nutrition is essential in the treatment and management of diabetes and obesity, and other accompanying diseases. Consumption of low glycemic index (GI) foods is the primary approach in medical nutrition therapy to ensure glycemic control and long-term satiety. The glycemic index is the rate at which foods raise blood sugar. The GI is determined by comparing the area of increase in blood glucose within 2 hours after consumption and absorption of a test food containing 100 g of digestible carbohydrates to the area of increase in glucose generated by the reference food containing the same amount of carbohydrates (primarily white bread). The GI value of the food taken as a reference is 100, and the reference ranges of foods are ≤55 low, 56-69 moderate, and ≥70 high GI. Annual bread consumption is much higher than the world average in Turkey and is about 400 g/day. It has been determined that 66% of the energy consumed per capita is provided from cereals, 56% of this energy is met from bread, and 50% of the protein in the daily diet is completed from bread.
It has been reported that the GI of white bread is 87 in our country and 70 in other countries. Reducing the GI value of a large amount of food consumed will be a positive step for obesity and diabetes management.
Cephalaria syriaca, common in Anatolia and growing wild in wheat fields, has high oil (\~20%), protein (15.5%), dietary fiber (25.5%), and polyphenol content and is an annual weed rich in vitamins and minerals. It is known that the flour obtained from Cephalaria Syricia seed strengthens even the flours with low core quality. For this reason, it is used especially in rural areas to increase dough and bread quality. It is known that dietary fiber, fat, and protein contents in foods lower the GI value. Therefore, Cephalaria Syricia flour added to bread flour is expected to reduce the GI value of bread. A study conducted in 2020 showed that the GI value of regular white bread with 5% Cephalaria Syricia flour added decreased by 17%. Although there are in-vitro studies on the effects of Cephalaria Syricia in the literature, no clinical studies with published results have been found. From this point of view, this study is planned to investigate the effects of 0.2% Cephalaria Syricia flour added to bread (market name: İstanbul Halk Ekmek, Akdeniz Bread) on blood glucose and related hormones levels of individuals with diabetes and obesity and healthy volunteers.
#Intervention
- DIETARY_SUPPLEMENT : Cephalaria Syriaca flour-added bread
- 100g of test bread (consisting of 0.2% Cephalaria Syriaca flour bread) containing 50g of carbohydrates (KH).
|
#Eligibility Criteria:
Inclusion Criteria:
Healthy group (n=20):
* 18 <= age <= 65 years, non-obese and non-diabetic healthy individuals
* OGTT is normal
* Body Mass Index (BMI)= 18.5 <= age <= 24.9 kg/m2
Diabetic group (n=20):
* Individuals aged between 18 <= age <= 65 years with Type 2 Diabetes
* Using only metformin
* BMI= 18.5 <= age <= 29.9 kg/m2
Obese group (n=20):
* 18 <= age <= 65 years, non-diabetic and obese individuals;
* BMI >= 30 kg/m2
Exclusion Criteria:
Individuals with
* Smoking
* Use Alcohol
* Pregnant
* Breastfeeding
* Those with chronic diseases (CKD, COPD, Malignancy,..)
* Using food supplements
* Using DPP-4 inhibitors and GLP-1release analog in the treatment of DM
* Professional athlete or excessive physical activity
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05687812
| 116,754
|
{
"NCT_ID" : "NCT02891655",
"Brief_Title" : "KERatoconus and Metalloproteinases InvesTigation",
"Conditions" : ["Keratoconus"],
"Interventions" : ["Other: immuno-histo-chemical analysis"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-12-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-06-26",
"Study_Completion_Date(Actual)" : "2020-11-26},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-08-25",
"First_Posted(Estimated)" : 2016-09-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-09-01",
"Last_Update_Posted(Estimated)" : 2020-12-10",
"Last_Verified" : 2020-12"
}
}}
|
#Study Description
Brief Summary
Corneal stromal thinning observed in keratoconic eyes could result from an increased synthesis of MMP at the level of the anterior stroma and the corneal epithelium induced by an overexpression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) and Galectin-3 by epithelial cells. A differential expression of EMMPRIN, Galectin-3 and metalloproteinases (MMP) may be observed between the apex of the keratoconus and the peripheral cornea. Highlighting the implication of EMMPRIN and Galectin-3 could lead to the development of specific inhibitors to slow or to stop keratoconus evolution.
#Intervention
- OTHER : immuno-histo-chemical analysis
- in vitro immuno-histo-chemical analysis of corneal epithelium
|
#Eligibility Criteria:
Inclusion Criteria:
* > 18 yearsyears old
* Patient with keratoconus undergoing corneal collagen cross-linking (epithelium-off methods)
* Patient with keratoconus undergoing his first corneal graft for optical indication (control)
Exclusion Criteria:
* Patient with keratoconus undergoing corneal graft for tectonic indication
* Patient undergoing corneal refractive surgery (refractive photokeratectomy) with a normal topography, a normal slit lamp examination and no previous ophthalmic condition (control)
* pregnant or breast feeding patient
* patient under judiciary protection
* patient opposition to participate in the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02891655
| 156,224
|
{
"NCT_ID" : "NCT00117390",
"Brief_Title" : "Evaluation of the Optimal Technique for Determination of Renal Function of Critically Ill Patients",
"Official_title" : "Evaluation of the Optimal Technique for Determination of the Renal Function of Critically Ill Patients",
"Conditions" : ["Renal Function", "Critical Illness"],
"Location_Countries" : ["Belgium"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2004-06",
"Study_Completion_Date(Actual)" : "2006-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-06-30",
"First_Posted(Estimated)" : 2005-07-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-06-30",
"Last_Update_Posted(Estimated)" : 2007-12-28",
"Last_Verified" : 2007-12"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the optimal technique for determination of the renal function of critically ill patients.
#Intervention
- PROCEDURE : Measurement of inulin clearance
|
#Eligibility Criteria:
Inclusion Criteria:
* Over 18 years
* Intensive care patient
* Given informed consent
* Arterial infusion
* A bladder catheter
Exclusion Criteria:
* Diurese < 400 mL/d
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00117390
| 184,534
|
{
"NCT_ID" : "NCT01348269",
"Brief_Title" : "Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome",
"Official_title" : "A Prospective, Bi-centric,Randomized, Primary Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome",
"Conditions" : ["Bone Marrow Edema"],
"Interventions" : ["Drug: Aclasta", "Drug: Placebo"],
"Location_Countries" : ["Germany"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-08-26",
"Study_Completion_Date(Actual)" : "2015-08-26},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-05-02",
"First_Submitted_that_Met_QC_Criteria" : 2024-08-09",
"First_Posted(Estimated)" : 2011-05-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-05-04",
"Last_Update_Posted(Estimated)" : 2024-08-13",
"Last_Verified" : 2024-08"
}
}}
|
#Study Description
Brief Summary
The primary aim is to test the reduction of bone marrow edema syndrome after a singular intravenous treatment with Zoledronic Acid within 6 weeks compared to placebo. The volume of the edema is defined as biometric data measured by the use of MRT before and six weeks after treatment. The hypothesis has to be checked whether Zoledronic Acid is efficient in the treatment of painful bone marrow edema. A statistically significant reduction of the edema in the MRT is considered as evidence for efficacy.
#Intervention
- DRUG : Aclasta
- 1 x intravenous non-current drip (infusion)
- DRUG : Placebo
- NaCl Solution
|
#Eligibility Criteria:
Inclusion Criteria:
* Men: age over >= 18 years or women: age over >= 18 years with finished reproductivity according to the following definition:
* >= 12 month persistent natural (spontaneous) amenorrhoea (women aged <50: additionally: FSH >40MIE/ml and estrogen deficiency of <30pg/ml or a negative estrogen test)
* status post hysterectomy and / or bilateral oophorectomy
* finished reproduction planning
* secure diagnosis of bone marrow edema using MRT
* current osteologic basic laboratory values (<= 4 weeks before V2) according to DVO criteria
* presence of an personally signed informed consent for the participation in the study
Exclusion Criteria:
* - subchondral bone loss or already occurred cartilage damage due to the bone marrow edema
* reactive bone marrow edema with advanced arthrotic changes in the adjacent joint (grade III and IV according to Kellgren and Lawrence)
* patients with edematous changes in bone marrow due to the diagnosis of M. Sudeck / algodystrophy / Complex Regional Pain Syndrome (CRPS)
* patients with known hypo- and hyperparathyroidism, osteogenesis imperfecta, osteomalacia, M. Paget or another systemic skeletal diseases, except osteoporosis
* patients with bone necrosis in the painful skeletal region
* patients with infectious process at the affected bone or the adjacent joint and adjacent soft parts, respectively
* patients with diagnosed or assumed rheumatoid arthritis, Lupus erythematodes, collagenosis or vasculitides
* patients with advanced renal insufficiency (GFR according to Cockcroft
/ Gault <= 40 ml/min/KO)
* patients with malignant diseases with osseous manifestation in anamnesis/history
* status post malignant basic/primary disease with large dosed chemotherapy
* current or massive dose therapy completed before less than 6 weeks (>7.5mg prednisolon equivalent) with glucocorticoids
* patients with a malignant tumor disease within the past 5 years, independent from the affected organ system and independent from the implemented treatment, the presence of a relapse or metastatic invasion, except basal cell carcinoma and squamous-cell carcinoma of the skin Current treatment due to uveitis
* vague/ambiguous hyper- or hypocalcemia, hyper- or hypophosphatemia
* etiological vague/ambiguous AP-increase
* symptomatic renal calculus or nephrocalcinosis within 2 years before V2
* recent fracture within the last 3 months independent of the localisation
* non consolidated fractures
* previous treatment with i.v. bisphosphonates within the last 12 months
* previous treatment with oral bisphosphonates within the last 12 months and longer than 3 months
* pre-treatment with prostacyclin analogs (Ilomedin® / Iloprost®) within the past 6 months
* Current treatment due to inflammatory diseases of the jaw area as well as planned tooth extractions or tooth extractions less than 6 months ago or oral surgery implant treatment
* pregnancy or nursing period
* patients immediately involved in the conduction of the trial and relatives
* patients with current proceedings related to the bone marrow edema
* patients for which the participation in the study carries an increased risk under consideration of the health condition due to the assessment of the investigator
* participation in another clinical trial within 30 days before study start or during the trial
* participation of patient who might be dependent on the investigator, also the spouse, parents or children
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01348269
| 112,686
|
{
"NCT_ID" : "NCT03255941",
"Brief_Title" : "Clinical Study of Depo Provera Comparing Lay Health Workers and Clinically-trained Health Workers",
"Official_title" : "'A Randomized Controlled Trial of Safety and Effectiveness of Depo Provera Intramuscular and Subcutaneous Administration Comparing Lay Lady Health Workers With Clinically-trained Family Welfare Workers in Pakistan",
"Conditions" : ["Contraception"],
"Interventions" : ["Drug: Sayana Press", "Drug: DMPA"],
"Location_Countries" : ["Pakistan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["EARLY_PHASE1"],
"Primary_Purpose" : "HEALTH_SERVICES_RESEARCH",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-03-19",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-07-15",
"Study_Completion_Date(Actual)" : "2018-07-23},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-07-19",
"First_Submitted_that_Met_QC_Criteria" : 2021-03-18",
"First_Posted(Estimated)" : 2017-08-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-08-17",
"Last_Update_Posted(Estimated)" : 2021-04-13",
"Last_Verified" : 2021-03"
}
}}
|
#Study Description
Brief Summary
This is a randomized controlled trial comparing lay Lady Health Workers (Lay Health Workers) with Family Welfare Workers (Clinically- trained Health Workers) on quantitative measures of safety and effectiveness of Depo Provera and Sayana Press provision in a clinic setting. This comparative trial will test the non-inferiority hypothesis that Lady Health Workers are just as competent as clinically-trained Family Welfare Workers in screening and counseling first-time injectable users. These first time users will also be randomly assigned to receive intramuscular or subcutaneous injections of DMPA.
Detailed Description
FHI 360 and Jhpiego in collaboration with USAID, Aga Khan University (AKU) and the Government of Sindh province propose a randomized controlled trial (RCT) to provide evidence that could change current policies in Pakistan that forbid initiation of DMPA by Lady Health Workers (LHWs). Positive findings on the safety and effectiveness of LHW-initiation of DMPA may also prompt the WHO to consider modifying the recommendation for targeted M\&E for lay health worker provision of intramuscular injectable contraceptives. The trial will compare the screening and counseling of (LHWs)-the main lay health worker cadre--with that of Family Welfare Workers (FWWs) who are clinically-trained. The Government of Sindh province also expressed interest in introducing Pfizer's subcutaneous form of Depo Provera, Sayana Press® (SP) in Pakistan, which could simplify administration of injectable contraceptives. As such, an SP arm will be included in the trial, which will be facilitated by relevant training of LHWs and FWWs by Jhpiego and stocks provided by a special USAID procurement, since the registration process for SP in Pakistan is ongoing. A successful RCT demonstrating the non-inferiority of LHWs vis á vis FWWs on first-dose initiation of Depo Provera IM (DMPA IM) and (SP) would facilitate efforts to expand CBA2I in Pakistan, and in turn improve access to family planning services for a potentially large number of underserved women.
#Intervention
- DRUG : DMPA
- The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.
- DRUG : Sayana Press
- The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press
|
#Eligibility Criteria:
Inclusion Criteria:
* Women who voluntarily accept DMPA
Exclusion Criteria:
* Women unable to provide informed consent
* Women with contraindications to DMPA
* Women who are pregnant
Sex :
FEMALE
Ages :
- Minimum Age : 15 Years
- Maximum Age : 49 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03255941
| 98,851
|
{
"NCT_ID" : "NCT03998995",
"Brief_Title" : "Virtual Reality Distraction From Procedural Pain in Children",
"Official_title" : "Virtual Reality Distraction From Procedural Pain in Children",
"Conditions" : ["Exostosis of Elbow", "Upper Extremity Fracture", "Burn; Arm", "Burn Scald"],
"Interventions" : ["Device: Immersive Virtual Reality"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "DEVICE_FEASIBILITY",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-12-13",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-04-30",
"Study_Completion_Date(Actual)" : "2019-04-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-06-25",
"First_Posted(Estimated)" : 2019-06-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-06-25",
"Last_Update_Posted(Estimated)" : 2019-06-26",
"Last_Verified" : 2019-06"
}
}}
|
#Study Description
Brief Summary
This study explored the feasibility, acceptability and perceived the effectiveness of an Immersive Virtual Reality (IVR) 'game' in the rehabilitation of children with upper limb injuries. The objectives of the clinical trial were:
* To qualitatively assess the perceptions of child and parent regarding the acceptability of the game and equipment, and their perceptions of its effectiveness in reducing pain and discomfort and facilitating movement, compared to usual physical therapy experiences.
* To qualitatively assess physical therapy practitioners' perceptions of the effectiveness, usability, feasibility, and acceptability of VR in their clinical setting with this client group.
Hypothesis:
1. IVR rehabilitation game as an intervention will be acceptable to child patients and their parents.
2. IVR rehabilitation game experience will show less procedural pain, discomfort, and difficulties to movement, compared to usual physical therapy experiences.
3. IVR rehabilitation game will demonstrate any perceived disadvantages as a therapeutic intervention, compared with usual rehabilitation care.
4. IVR rehabilitation game will demonstrate usability in the clinical setting during the rehabilitation of a small sample of children with varying ULIs.
Detailed Description
Children with upper limb and hand injuries often have to undergo repetitive therapeutic exercises to regain or maximise function and movement which can be painful, uncomfortable and tedious, reducing compliance and limiting the movement and function achieved. There is a growing body of literature demonstrating the effectiveness of VR in reducing pain (e.g. in burns). Its effectiveness in rehabilitation, especially in children, is a promising but under-researched area. This study was focus on an under-researched target group in relation to IVR interventions, children undergoing physical therapies to enhance or optimise the upper limb and hand movement.
PARTICIPANT RECRUITMENT AND INFORMED CONSENT 10 children were recruited, plus one parent from each, and members of the clinical team of physiotherapists involved in their care. If considered suitable for the research, participants were introduced to the study and recruited via clinical staff responsible for their care. Staff was asked to provide information sheets to those who show interest in participation, including separate sheets for both child and parent.
If, having discussed the study with their child and other family members, parents were happy for their child to participate, and the child also wishes to participate, parents were asked to let a member of their clinical team know and arrangements were made for the date and time when the research will be take place.
Focus group: clinical staff involved in physical therapy for children where the VR intervention has been trialed was invited verbally, by letter or email to participate in a focus group after the trial is complete, and provided with an information sheet.
Having expressed an interest in hearing more about the study, based on a simple verbal explanation provided by staff, potential parents and children were provided with full, printed information (age-appropriate for children) about the study to read and consider in their own time. The information included a statement that participation is not obligatory and reassurance that refusal to participate will not affect their care, also explain that having decided to participate, the parent and child will be free to change their mind before, during or immediately after the study (prior to data analysis), without giving a reason. Advice was provided regarding how to withdraw their consent. Details regarding confidentiality, anonymity, data access, storage, and retention also were provided. It was suggested that the person retain the Information sheet for future reference and in order to make contact with the research team. Parents/children who, having read the information sheet and discussed the study together, wish to participate was asked to let the clinical staff know. Clinical staff contacted IP and made arrangements for him to visit the Unit on one of the child's appointment dates, to conduct the research. Shortly prior to using the VR for the trial on the day and before written consent was taken, the child was offered a 5-10 minute exposure to activities in the VR game (e.g. archery activity, rock climbing activity), to familiarise themselves, check there are no problems, and avoid unnecessary distractions and confusion during the procedure itself. If there were any problems or the child becomes unhappy about participation at this stage, they were reassured that they don't have to participate if they prefer not to and can also withdraw at any point during trial themselves if they wish. They were reminded verbally at this stage that deciding the study is not for them would have no consequences whatever for their future treatment.
If the child and their parent, having read the Information Sheet, expressed a wish to participate, tried out the equipment, and asked any questions they have, wish to go ahead, the parent was asked to sign a consent form and the child was asked to complete an assent form. This was done in the presence of a clinician on the research team, ahead of the intervention being implemented. Copies was be retained by the team, given to participants, with one copy kept in the child's medical notes.
DATA COLLECTION AND ANALYSIS A short interview was conducted with each child and their parent (together) after each trial and was audio recorded. These interviews took place in a quiet, private location near to where the physiotherapy and trial have taken place.
Focus groups with staff took place after all children's trials, in a quiet and private environment and at a time convenient for participants. Interviews and focus groups were guided by pre-written schedules and audio-recorded.
Thematic analysis was applied to all the resulting qualitative data, resulting from interviews with each child and parent, and focus group with therapeutic staff. This involved a process of careful reading, coding and comparison in order to identify important patterns in the data, focused on answering the aims of the study. Themes were generated based upon the analysis process, which were discussed and refined within the research team.
DATA HANDLING AND RECORD KEEPING On consenting to participate, participants were given a code (e.g. 01C, 01P for child01, parent01), by which they were identified for the duration of the study and in reports. A file linking participant identity to codes was created, password, and stored securely within a study file on a SHU password protected computer, as well consent forms. The lead investigator, IP, collect all data. He was audio record interviews and the focus group. Password protected digital recorders was used during interviews/focus groups to ensure data safety whilst on the ward and in transit back to the office. Recordings were saved as audio files on University-based password protected computers, then deleted. Audio files were used to create transcripts in the form of word documents, and both were securely stored in password protected computer files held by research team members. No one from outside the research team will have access to any information by which participant identity and data can be linked. The SHU and MRC Guidelines for research with human participants were followed in all aspects of the research, including data confidentiality. No one from the research team (who is not also a member of participants' clinical team) will require access to participants' medical records. Clinicians in the research team may make use of medical records - and their knowledge of their patients - in deciding whether to introduce the parent/child to the research study.
Consent forms are kept in locked cabinets in the locked office of the SHU-based project manager, SL. The cabinets themselves are kept locked (by key) at all times and only the key-holder will be able to access office and cupboards. Data collected for the study will be treated with the utmost care, retained within the research team, password protected/encrypted, and no one outside the team will have access. Personal information is securely stored within the SHU-based password protected computer files and separately from anonymised raw data. Files are password protected and encrypted for transfer.
Anonymised transcriptions made from the audio files and these are also saved as password protected files, identified by participant code. In reports, quotes from individuals will be only identified by participant code.
Throughout, data are stored securely and a study file maintained by SL. If the team is disbanded prior to this time, data will be stored at Sheffield Hallam University's research archive, SHURDA. Data will be collected and retained in accordance with the Data Protection Act 1998. All source documents will be retained for a period of 10 years following the end of the trial.
SAFETY ASSESSMENTS The Oculus Rift Virtual Reality headset was used with a laptop computer and all equipment was safety tested by the university before it used on participants. Appropriate health and safety measures were taken throughout the sessions, with each session limited to 15 minutes, with breaks in-between. Playing virtual reality games can sometimes cause disorientation, dizziness or nausea in some people, for example, those with severe motion sickness. However, in the most recent versions of this technology, and in our own recent trials of similar games, adverse reactions have been rare. Virtual rock climbing can also create anxiety in some children, especially if they suffer from vertigo. To check they were happy with the experience of VR before their sessions start, children were provided with a short 'test' session in the headset before parent and child agree to continue. Once the trial is underway, we asked the participating children to let us know straight away if they begin to feel uncomfortable or unwell.
The study was monitored and audited in accordance with the Monitoring Standard Operating Procedures of the Directorate of Research \& Innovation at Sheffield Children's NHS Foundation Trust. All study related documents will be made available on request for monitoring and audits by the Sponsor, the Health Research Authority and the relevant Research Ethics Committee.
ETHICAL CONSIDERATIONS The study has been reviewed and approved by Sheffield Hallam University Research Ethics Committee, NHS Research Ethics Committee, and the Research and Development Dept. at Sheffield Children's Hospitals. The study was conducted in compliance with a Research Ethics Committee favourable opinion, Health Research Authority approval and Confirmation of Capacity \& Capability at all participating sites.
The study was conducted in accordance with the International Conference for Harmonisation of Good Clinical Practice (ICH GCP), and the Research Governance Framework for Health and Social Care (2nd Edition).
#Intervention
- DEVICE : Immersive Virtual Reality
- An Oculus Rift VR Headset and a set of Oculus Touch Controllers was used as interactivity device. Two scenarios of IVR rehabilitation game were offered to the patients: 1) Archery based on behind-the-neck overhead press, using a quiver on the user back to encourage bending their arm and firing the arrow to help with stretching exercises and 2) Climbing based on an overhead arm raise exercise.
Each child will took part in a single IVR trial during their rehabilitation care with the physiotherapist, supported by IP, the games expert/researcher. Timing of participation was approximately 15 minutes of trial with each scenario of game. A short interview was conducted with each child and their parent (together) after each trial, and a focus group was conducted with the clinical staff.
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged 7 <= age <= 16
* Upper limb or hand injuries, for which they are receiving rehabilitative care
* Able to speak and understand English
Exclusion Criteria:
* Injuries to the face or head that could hinder the correct positioning of the headset or pose an infection risk
* A learning impairment that could hinder the understanding of the task
* A history of severe motion sickness or vertigo.
* Mental health problems, such as anxiety.
Eligibility for parents:
* Having a child taking part in the study
* Being available on the day of treatment for interview
* Able to speak and understand English.
Eligibility for staff:
* Having a patient trialing VR during physiotherapy during which they were present as practitioner
* Being able to speak and understand English
* Being available on the day of the focus group
Sex :
ALL
Ages :
- Minimum Age : 7 Years
- Maximum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT03998995
| 153,232
|
{
"NCT_ID" : "NCT05790018",
"Brief_Title" : "Effect of Pregnant Pıllow on Sleep and Comfort",
"Official_title" : "Effect of Pregnant Pıllow Used In the Last Trımester on Sleep and Comfort: Randomızed Controlled Study",
"Conditions" : ["Pregnancy Related", "Sleep", "Comfort"],
"Interventions" : ["Device: PREGNANT PILLOW"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-05-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-12-30",
"Study_Completion_Date(Actual)" : "2024-05-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-03-01",
"First_Posted(Estimated)" : 2023-03-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-03-28",
"Last_Update_Posted(Estimated)" : 2025-02-17",
"Last_Verified" : 2025-02"
}
}}
|
#Study Description
Brief Summary
One of the most special life events of the fertile period is pregnancy. Pregnancy causes many physiological, metabolic, mental and social changes. These changes may adversely affect the sleep quality and comfort levels of pregnant women. Sleep is one of the basic life activities. Comfort is the state of being physiologically, mentally and socially comfortable. The woman who completes her pregnancy comfortably has a high self-confidence and quality of life. On the other hand, it is known that stress, anxiety and depression are experienced more and pregnancy and birth complications increase. For this reason, it is important to determine the comfort levels of pregnant women and to know the factors affecting them. It should not be forgotten that sleep quality in the prenatal period may be effective on the comfort levels of individuals. Evaluation of sleep quality and comfort levels of pregnant women is a routine part of prenatal care. Various interventions can be used to improve the sleep quality of pregnant women. The use of a pregnant pillow in the prenatal period is one of these applications. By providing support and relaxation to 5 different parts of the body simultaneously, the pregnancy pillow helps to increase the sleep quality of expectant mothers during pregnancy and to reduce the neck, abdomen, waist, back and leg pains they experience. It is known that sleep problems are experienced especially in primaries and third trimesters. For this reason, using the pregnant pillow in the third trimester, when sleep problems increase and comfort is adversely affected, may help improve the sleep quality and comfort level of pregnant women. With this planned study, it was aimed to examine the effect of the pregnant pillow used in the last trimester on sleep and comfort.
This research will be carried out with pregnant women who applied to Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital NST and polyclinic unit between 01 March and 31 August 2023. The data of the study will be collected by using Personal Information Form, Information Form on Sleep in Pregnancy, Prenatal Comfort Scale and Pitsburg Sleep Quality Scale.
Detailed Description
To research Over 18 years of age Volunteer to participate in the research, Primiparous, 29-30. during pregnancy, Fluent in Turkish, At least primary school graduate, It is planned to include pregnant women who do not have sleep problems, visual/mental and diagnosed psychiatric problems and do not use medication.
Persons who do not meet these criteria and do not volunteer to participate in the study will not be included in the study.
Data Collection The pregnant women included in the study will be randomly assigned to the groups and homogeneity will be ensured in the distribution of the groups. 'Random Allocation Software Program' will be used in the randomization of pregnant women into groups and a randomization list for the study will be created. If the pregnant woman leaves the study for any reason during the study, the first pregnant woman who meets the research criteria will be assigned to the other group in the randomization list.
Midwifery Initiative Midwifery Attempts Made to the Control Group The researcher will apply the questionnaires and scales in the pre-test to the pregnant woman included in the control group, and no other intervention will be applied. 37-38 to the pregnant women in the control group. The final test will be done weekly.
Midwifery Attempts Made to the Experimental Group First of all, questionnaire forms and scales will be applied to the pregnant women included in the experimental group in the pre-test (at 29-30 weeks). Then the pregnant pillow will be given and necessary explanations will be given about its use. Second follow-up 33-34. It will be done at the gestational week and the scales will be repeated. The final test is 37-38. It will be done at the gestational week (before birth) and the research will be completed.
#Intervention
- DEVICE : PREGNANT PILLOW
- First of all, questionnaire forms and scales will be applied to the pregnant women included in the experimental group in the pre-test (at 29-30 weeks). Then the pregnant pillow will be given and necessary explanations will be given about its use. Second follow-up 33-34. It will be done at the gestational week and the scales will be repeated. The final test is 37-38. It will be done at the gestational week (before birth) and the research will be completed.
|
#Eligibility Criteria:
Inclusion Criteria:
* Volunteer to participate the study
* Primiparous
* 29 <= age <= 30. during pregnancy
Exclusion Criteria:
* Sleeping problems
* Vision/mental diagnosed psychiatric problems
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05790018
| 137,773
|
{
"NCT_ID" : "NCT01366924",
"Brief_Title" : "Essential Amino Acids Supplementation and Muscle Protein Synthesis",
"Official_title" : "The Effect of Amino Acid Supplementation on Skeletal Muscle Protein Turnover Following Endurance Exercise",
"Conditions" : ["Muscle Loss", "Muscle Anabolism"],
"Interventions" : ["Dietary Supplement: Essential Amino Acids", "Other: Endurance exercise"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-07",
"Study_Completion_Date(Actual)" : "2010-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-06-01",
"First_Posted(Estimated)" : 2011-06-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-06-02",
"Last_Update_Posted(Estimated)" : 2017-07-21",
"Last_Verified" : 2011-06"
}
}}
|
#Study Description
Brief Summary
The modern warfighter faces numerous physiological challenges including sleep deprivation, sustained intense physical activity, and caloric restriction, the combined effects of which may result in the loss of lean body mass and decreased physical performance. Dietary interventions may help preserve lean body mass and facilitate recovery from periods of intense physical demand. For example, dietary strategies that increase amino acid availability have been shown to stimulate protein synthesis in skeletal muscle following resistance exercise. Because military tasks also incorporate endurance exercise components, studies regarding the effects of increasing dietary amino acids following endurance exercise are warranted. The objectives of this study are to characterize the effect of endurance exercise on protein synthesis and breakdown as well as the ability of an essential amino acid supplement to influence skeletal muscle protein metabolism and its cellular and molecular regulation following endurance exercise.
#Intervention
- DIETARY_SUPPLEMENT : Essential Amino Acids
- 10 Gram Essential Amino Acid solutions with different leucine contents consumed during two identical endurance exercise trials
- OTHER : Endurance exercise
- 60 minute endurance exercise session
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 18 - 35 years
* Weight stable
* Recreationally active with VO2max of 40 - 50 ml/kg/min
* Refrain from taking any NSAIDS or any aspirin-containing medications
* Supervisor approval if a federal employee
Exclusion Criteria:
* Disease or medication that affects macronutrient metabolism and/or the ability to participate in strenuous exercise
* Allergies to foods or medications (including, but not limited to, lidocaine or phenylalanine) to be utilized in the study
* Abnormal PT/PTT test or problems with blood clotting
* Present condition of alcoholism or other substance abuse that compromises exercise capacity
* Musculoskeletal injuries that compromise the ability to exercise
* Pregnancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01366924
| 94,046
|
{
"NCT_ID" : "NCT04413630",
"Brief_Title" : "Workshops for Toddlers With Speech and Language Developmental Delay",
"Official_title" : "Therapeutic Effects of Family-centered Workshops for Toddlers With Speech and Language Developmental Delay",
"Conditions" : ["Developmental Delay"],
"Interventions" : ["Other: family workshop"],
"Location_Countries" : ["Taiwan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "HEALTH_SERVICES_RESEARCH",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-12-31",
"Study_Completion_Date(Actual)" : "2018-12-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-05-29",
"First_Posted(Estimated)" : 2020-06-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-06-02",
"Last_Update_Posted(Estimated)" : 2020-06-04",
"Last_Verified" : 2020-05"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to identify the therapeutic effects of family workshops on speech and language developmentally delayed children and their family
Detailed Description
The family workshop with 5 courses, 6 families in one course, a 2-hour session per week, for 6 weeks.
Effects:
1. Investigate the therapeutic effects of the workshop for the toddlers with developmental delay
2. Investigate the therapeutic effects of the workshop for the parents of toddlers with developmental delay
#Intervention
- OTHER : family workshop
- The family workshop with 5 courses, with 6 families in one course The intervention of one course; 2 hours per session, one time per week, for a total of 6 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 to 36 months old children with speech and language developmental delay with or without delay in gross motor, fine motor, cognition, and emotional or social function
the availability of toddlers and their parents to attend one 2-hour session of the workshop per week for 6 weeks
Exclusion Criteria:
* Less than 18 months old or older than 36 months old
Sex :
ALL
Ages :
- Minimum Age : 18 Months
- Maximum Age : 36 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04413630
| 30,157
|
{
"NCT_ID" : "NCT01789554",
"Brief_Title" : "The Use of Mobile Phones in Out of Hospital Cardiac Arrest to Increase Bystander CPR",
"Official_title" : "The Response to Urgent Mobile Message for Bystander Activation (RUMBA) Trial - The Use of Mobile Phone Positioning for Dispatch of Bystanders to Out of Hospital Cardiac Arrest.",
"Conditions" : ["Out-of-Hospital Cardiac Arrest", "Death, Sudden, Cardiac", "Heart Diseases", "Ventricular Fibrillation"],
"Interventions" : ["Other: MLS dispatch for bystander CPR"],
"Location_Countries" : ["Sweden"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "HEALTH_SERVICES_RESEARCH",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-12",
"Study_Completion_Date(Actual)" : "2013-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-02-06",
"First_Posted(Estimated)" : 2013-02-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-02-08",
"Last_Update_Posted(Estimated)" : 2014-09-11",
"Last_Verified" : 2014-09"
}
}}
|
#Study Description
Brief Summary
Death from cardiac disease is one of the most common causes of death in the western world. The majority of these deaths takes place outside hospital as sudden cardiac death. However, with immediate (within minutes) actions such as cardiopulmonary resuscitation (CPR) and defibrillation many lives would be saved. CPR is a key factor to increase survival from Out of Hospital Cardiac Arrest (OHCA). CPR buys time by supporting the brain with some circulation in waiting for a defibrillator that can restart the heart. In Sweden about 2,5 million people are trained in CPR. However, only about half of all OHCA victims will get CPR in waiting for ambulance arrival.
The aims of the Response to Urgent Mobile message for Bystander Activation (RUMBA) trial is to try a new way of logistics to increase bystander CPR by recruiting lay volunteers to nearby OHCAs via their mobile phones.
Hypothesis: By dispatching lay volunteers to nearby OHCAs with mobile phone technology bystander CPR may increase from 50% to 62,5 %
Detailed Description
Survival from out-of-hospital cardiac arrest (OHCA) is generally low, about 5-10%, with the exception of a few controlled settings (casinos, airports and some cities). The poor prognosis of OHCA is mainly explained by long time intervals between cardiac arrest, cardiopulmonary resuscitation (CPR) and defibrillation. To increase bystander actions and to decrease time to defibrillation substantial resources have been put into CPR educational campaigns and in recent years into the spread of automated external defibrillators (AEDs) in public venues. Still, the vast majority of the public with CPR training will never use their skills in real life. Mobile phone technology offers the possibility to locate single mobile phone users at any given moment. If designated lay responders immediately can be identified and recruited to the scene of nearby suspected OHCAs bystander CPR, CPR quality and finally survival might be increased.
Mobile phone positioning and dispatching of lay responders:
Tailored mobile phone services that use MPS to locate selected mobile phone users can be developed for different purposes. A computer-based application for mobile phone positioning and dispatch of lay responders is developed for the purpose of this study and is referred to as the Mobile Lifesaver Service (MLS). All participants connected to the MLS are called Mobile Responders (MRs). The MLS acts as an interface between the emergency medical service (EMS) data system and the MPS. The MLS handles the localisation and dispatching of MRs based on the data present in the EMS data system. The location of all incoming calls to all dispatch centres in Sweden is determined automatically.
When the dispatcher receives an emergency call from a witness of a suspected OHCA the dispatcher activates the MLS in parallel with standard EMS. When the MLS is activated it uses the MPS to compare the current geographical position of all MRs connected to the MLS with the position of the incoming emergency call of the suspected cardiac arrest. If one or more MRs is present within a radius of 500 m (optional) from the suspected arrest the MRs receives a cardiac arrest alert with a computer generated phone call and a text message (i.e. SMS = short message system) with information about the place of the suspected cardiac arrest. A map for finding the way to the suspected OHCA is also sent. Additional information can, if needed, be sent to the MRs.
For further details see 'Mobile phone technology identifies and recruits trained citizens to perform CPR on out-of-hospital cardiac arrest victims prior to ambulance arrival.' Ringh M, Fredman D, Nordberg P, Stark T, Hollenberg J. Resuscitation. 2011 Dec;82(12):1514-8.
Data from earlier non randomized pilot studies in urban Stockholm has shown that CPR was performed by MLS dispatched lifesavers prior to ambulance, firefighters and police in about 20 % of all cases of true OHCAs.
The hypothesis is that bystander CPR in Stockholm County can be increased from 50 % to 62,5% if the MLS is used. An estimated number of 6000 MR needed is based on earlier pilot studies.
The current proportion of bystander CPR is derived from OHCA registry data but is uncertain.
A safety and efficacy analyze will be made at approximately 200 true OHCA cases.
A ethical and safety board and log for adverse events will be set up.
#Intervention
- OTHER : MLS dispatch for bystander CPR
|
#Eligibility Criteria:
Inclusion Criteria:
* All suspected OHCAs in Stockholm County
* All EMS treated out of hospital cardiac arrest in Stockholm County were the mobile positioning system is triggered
Exclusion Criteria:
* Traumatic OHCA
* Children under 8 years
* Suicide
* Intoxications
* Obvious signs of death
* Do not resuscitate orders (DNR)
Sex :
ALL
Ages :
- Minimum Age : 8 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01789554
| 275,787
|
{
"NCT_ID" : "NCT00426803",
"Brief_Title" : "Recombinant Factor VIIa in Acute Intracerebral Haemorrhage",
"Official_title" : "Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Parallel Groups, Study to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (NovoSeven®) in Acute Intracerebral Haemorrhage",
"Conditions" : ["Acquired Bleeding Disorder", "Intracerebral Haemorrhage"],
"Location_Countries" : ["Germany", "Sweden", "Singapore", "Spain", "Australia", "Switzerland", "Italy", "United Kingdom", "Canada", "Netherlands", "Belgium", "Norway", "Finland", "Austria", "Denmark"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2002-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2004-06",
"Study_Completion_Date(Actual)" : "2004-06},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-01-24",
"First_Posted(Estimated)" : 2007-01-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-01-24",
"Last_Update_Posted(Estimated)" : 2017-01-18",
"Last_Verified" : 2017-01"
}
}}
|
#Study Description
Brief Summary
This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute intracerebral bleeding.
#Intervention
- DRUG : activated recombinant human factor VII
|
#Eligibility Criteria:
Inclusion Criteria:
* Spontaneous intracranial haemorrhage (ICH) within 3 hours after first symptom
Exclusion Criteria:
* Patients with secondary ICH
* Pre-existing disability
* Haemophilia
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00426803
| 187,673
|
{
"NCT_ID" : "NCT05253274",
"Brief_Title" : "The Effect of Virtual Reality Glasses Applied During Emergency Surgical Intervention",
"Official_title" : "The Effect of Virtual Reality Glasses Applied During Emergency Surgical Intervention With Local Anesthesia on Patients Anxiety",
"Conditions" : ["Anxiety"],
"Interventions" : ["Device: Virtual Reality Glasses"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-02-20",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-02-20",
"Study_Completion_Date(Actual)" : "2022-03-24},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-02-06",
"First_Posted(Estimated)" : 2022-02-23"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-02-21",
"Last_Update_Posted(Estimated)" : 2022-04-07",
"Last_Verified" : 2022-04"
}
}}
|
#Study Description
Brief Summary
This randomized controlled trial evaluates the effect of virtual reality glasses applied during emergency surgical intervention with local anesthesia on patients anxiety. This study hypothesizes that virtual reality glasses reduces anxiety.
Detailed Description
The sample of this study consisted of 138 patients in the experimental (n=69) and control groups (n=69). Virtual Reality (VR) application will be applied to the experimental group during the emergency surgical intervention under local anesthesia. Anxiety level will be assessed with the Spielberger State Anxiety Scale and measured by physiological responses of anxiety such as systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR) and peripheral oxygen saturation (SpO2) before and after VR application. In the control group, no application will be made except for standard care only.
#Intervention
- DEVICE : Virtual Reality Glasses
- In addition to the routine practice of the emergency service, the virtual reality (VR) group will watch a video with VR glasses during the emergency surgical intervention under local anesthesia. Before the emergency surgery, the patients will be asked to wear a VR glasses compatible with mobile phones with android operating system and a headset that minimizes sound loss. Patients will be shown their preferred 3D licensed video software with relaxing music in the background. VR glasses will be put on the patients before starting the emergency surgical procedure under local anesthesia and applied until the procedure was completed. Patients will be asked to refill the The State Anxiety Inventory at the end of the emergency surgical intervention. At the same time, blood pressure, heart rate, respiratory rate, SpO2 values will be monitored on a portable monitor.
|
#Eligibility Criteria:
Inclusion Criteria:
* Emergency surgical intervention with local anesthesia,
* Between the ages of 18 <= age <= 65,
* Conscious, oriented and cooperative,
* Able to read and understand Turkish,
* Agree to participate in the study
* Does not have physical problems that will prevent the application of virtual reality glasses,
* No previous experience with virtual reality glasses,
* Not diagnosed with anxiety,
* Does not use drugs for anxiety,
* Does not use alcohol and/or drugs,
* No mental illness
* Patients who signed the Informed Consent Form/Written Consent Form
Exclusion Criteria:
* No emergency surgical intervention with local anesthesia,
* Those under the age of 18, over the age of 65,
* Unconscious, oriented and uncooperative,
* Can't read and understand Turkish,
* Those who do not agree to participate in the study,
* Having a physical problem that will prevent the application of virtual reality glasses,
* Diagnosed with anxiety,
* Using drugs for anxiety (anxiolytic, antidepressant, antipsychotic, etc.),
* Using alcohol and/or drugs,
* Having a mental disorder,
* Patients who did not sign the Informed Consent Form/Written Consent Form
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05253274
| 6,841
|
{
"NCT_ID" : "NCT04774185",
"Brief_Title" : "Hearing Aid Transmitter Performance Study - SRF-366",
"Official_title" : "Hearing Aid Transmitter Performance Study - SRF-366",
"Conditions" : ["Hearing Loss"],
"Interventions" : ["Device: New hearing aid loudspeaker", "Device: Standard hearing aid loudspeaker"],
"Location_Countries" : ["Australia"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-04-26",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-04-25",
"Study_Completion_Date(Actual)" : "2022-04-25},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-02-25",
"First_Posted(Estimated)" : 2021-03-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-02-26",
"Last_Update_Posted(Estimated)" : 2023-03-28",
"Last_Verified" : 2021-04"
}
}}
|
#Study Description
Brief Summary
Sonova Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Sonova Hearing Systems undergo a final quality control in terms of clinical trials. This is a confirmatory study, investigating benefits of a modified hearing aid loudspeaker. This will be a clinical investigation which will be conducted mono centric at National Acoustic Laboratories a well known institution with exceptional experience (Australia).
Detailed Description
In this study a comparison with two Phonak Receiver in Canal (RIC) devices is done. The experimental device with a modified hearing aid loudspeaker concept and the active comparator with the existing technology will be compared regarding speech intelligibility, listening effort and sound quality in speech in noise, quiet situations for people with mild to moderate hearing losses.
#Intervention
- DEVICE : New hearing aid loudspeaker
- The new hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.
- DEVICE : Standard hearing aid loudspeaker
- The standard hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss)
* Good written and spoken English language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Willingness to wear Receiver in Canal hearing aids
* Informed Consent as documented by signature
* Normal cognitive abilities
Exclusion Criteria:
* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Sydney (AUS)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Known psychological problems
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04774185
| 206,977
|
{
"NCT_ID" : "NCT05492071",
"Brief_Title" : "Impact of Regional Vibration Application and Flow Mediated Dilation on Brachial Artery Hemodynamics",
"Official_title" : "Vibration Mediated Dilation and Flow Mediated Dilation in Human Circulatory System",
"Conditions" : ["Vasodilation", "Diabetes Mellitus, Type 2"],
"Interventions" : ["Device: Local Vibration Application Following Flow Mediated Dilation", "Other: Flow mediated dilation"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-08-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-09-10",
"Study_Completion_Date(Actual)" : "2022-09-20},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-08-04",
"First_Posted(Estimated)" : 2022-08-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-08-05",
"Last_Update_Posted(Estimated)" : 2023-03-01",
"Last_Verified" : 2023-02"
}
}}
|
#Study Description
Brief Summary
Application of vibration has been previously shown to affect tissue perfusion and utilized in different branches of medicine. Little is known about the acute impact of vibration application on peripheral artery hemodynamics. In this study, investigators intend to assess:
1. vibration induced hemodynamic changes in brachial artery in non-diabetic patients and compare the characteristics of these alterations with flow mediated dilation mediated changes in same cohort.
2. compare the characteristics of vibration mediated hemodynamic alterations in diabetic and non-diabetic subgroups.
Detailed Description
Background and Rationale:
Vibration application has been previously shown to affect tissue perfusion and utilized in different branches of medicine. However, previous studies have mainly focused on the impact of vibration on skin perfusion or vibration with active muscle contractions, therefore couldn't truly demonstrate acute impact of local vibration application on peripheral arteries. In addition to that, as a population that is prone to develop vascular problems, it is not known whether diabetic patients have comparable response to vibration application with non-diabetic population.
Objectives:
In this study, investigators aim to demonstrate and compare hemodynamic alterations in brachial artery with paired measurements pre- and post- vibration application and compare the characteristics of these changes with those of flow-mediated dilation in a non-diabetic cohort. Additionally, differences and similarities in vascular hemodynamic response to vibration in diabetic and non-diabetic subgroups are intended to be elucidated.
Methods:
Flow mediated dilatation and vibration will be applied after the participants will abstain from alcohol, caffeine and nicotine for 24 hours. Flow mediated dilatation (FMD) will be induced via 5 min cuff inflation below left elbow at supra-systolic pressures (50mmHg above pre-application systolic pressure). Vibration will be applied with a commercially available vibration plate to forearm at 20 hz and 3 mm of vertical amplitude for 5 minutes, 30 minutes after termination of FMD. Left Brachial artery flow will be measured with pulsed Doppler and diameter will be measured via 2D ultrasonographic imaging at 0th, 2nd, 4th, 6th, 8th minutes.Throughout the entire application and measurement periods, patients will be continuously monitored with electrocardiogram.
#Intervention
- DEVICE : Local Vibration Application Following Flow Mediated Dilation
- Flow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure). Vibration is applied with a commercially available vibration plate to forearm at 20 hz and 3 mm of vertical amplitude for 5 minutes, 30 minutes after termination of FMD.
- OTHER : Flow mediated dilation
- Flow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure).
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 - 80
* Sinus Rhythm in ECG
* Ejection Fraction > %35
* Informed Consent
Exclusion Criteria:
* Unstabile angina
* Certain or suspected subclavian artery or brachial artery atherosclerotic disease (assessed with USG)
* Heart failure ( New York Heart Association III - IV)
* Atrial fibrillation or frequent extrasystoles in ECG.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05492071
| 221,193
|
{
"NCT_ID" : "NCT02282228",
"Brief_Title" : "Detecting Chronic Subdural Hematoma With Microwave Technology",
"Official_title" : "Detecting Chronic Subdural Hematoma With Microwave Technology - An Open Study Evaluating the Sensitivity and Specificity of a Microwave-based Device, Medfield Strokefinder MD100, to Detect Chronic Subdural Hematoma",
"Conditions" : ["Chronic Subdural Hematoma", "Healthy Volunteers"],
"Location_Countries" : ["Sweden"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-01",
"Study_Completion_Date(Actual)" : "2016-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-10-22",
"First_Posted(Estimated)" : 2014-11-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-11-03",
"Last_Update_Posted(Estimated)" : 2018-08-23",
"Last_Verified" : 2018-08"
}
}}
|
#Study Description
Brief Summary
An open study evaluating the sensitivity and specificity of a microwave-based device, Medfield Strokefinder MD100, to detect chronic subdural hematoma, by comparing measurements on patients recruited for surgery of chronic subdural hematoma to an age- and gender-matched group of healthy volunteers.
Detailed Description
This open study will enroll patients admitted for surgery of chronic subdural hematoma at the Department of Neurosurgery at Sahlgrenska University Hospital and compare them to measurements of healthy volunteers. Patients will be asked to participate in the study, as early as possible after admission. After physical examination, checking the inclusion/exclusion criteria, and after informed consent has been acquired, the microwave-based measurement will be performed. The diagnostic procedure is estimated to take 30 min whereof total subject measurement time will be less than five minutes. Healthy volunteers will be recruited in parallel and the same procedure as for the patients will be followed.
Safety will be followed throughout the study, and a safety follow-up will be performed 12 hours after the microwave-based investigation is finalized.
To avoid measurement bias all measurements, for both patients and healthy volunteers, will be performed by the same operator.
#Intervention
- DEVICE : Medfield Strokefinder MD100
- Measurement with Medfield Strokefinder MD100.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient admitted for surgery of chronic subdural hematoma.
* A CT scan of the patient has been performed, within the latest 96 hours.
* The patient should be able to have a normal conversation and understand the information about the study, corresponding to Glasgow Coma Scale (Verbal Response) of 5.
* Patient/healthy volunteer should be >= 18 years.
* The patient/healthy volunteer has signed a written informed consent.
Exclusion Criteria:
* Females who are pregnant or breast feeding women.
* Patient/healthy volunteer has a shunt or other foreign object implanted in the brain.
* Patient/healthy volunteer participating in any other clinical study that could interfere with the result in the ongoing study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02282228
| 236,392
|
{
"NCT_ID" : "NCT03566225",
"Brief_Title" : "Pioglitazone Versus Metformin as First Treatment in Infertile Women With Polycystic Ovary Syndrome",
"Official_title" : "Combined Pioglitazone and Clomophene Citrate Versus Combined Metformin and Clomiphene Citrate as First Treatment in Infertile Women With Polycystic Ovary Syndrome",
"Conditions" : ["Pioglitazone"],
"Interventions" : ["Drug: Metformin", "Drug: Clomiphene Citrate", "Drug: Pioglitazone"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["EARLY_PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-01-30",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-02-28",
"Study_Completion_Date(Actual)" : "2021-03-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-05-26",
"First_Posted(Estimated)" : 2018-06-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-06-20",
"Last_Update_Posted(Estimated)" : 2021-06-02",
"Last_Verified" : 2021-05"
}
}}
|
#Study Description
Brief Summary
Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment
1. metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B.
2. pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A.
3. Induction of ovulation by clomiphene citate 50 mg tablets to all participants
Detailed Description
Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment
1. metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B.
2. pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A.
3. Induction of ovulation by clomiphene citate 50 mg tablets once or twice dialy 12hours apart starting from the 3rd day of menstrual cycle and continue for five days during treatment with insulin sensitizing agents to group A and B.
Participants with oligomenorrhea will recieve two tablets of noreththisterone 5 mg tab every 12 hours for 5 days to allow for withdrawal bleeding before start ovulation induction
#Intervention
- DRUG : Pioglitazone
- Insulin sensitizing agents
- Other Names :
- Glustazon
- DRUG : Metformin
- Insulin sensitizing agent
- Other Names :
- Cidophage
- DRUG : Clomiphene Citrate
- Induction drug
- Other Names :
- Clomid
|
#Eligibility Criteria:
Inclusion Criteria:
* women age 20_35
* BMI 18_29.9
* Women with PCOS(diagnosed by using Rotterdam criteria
* Infertility is cause for seeking tfeatment
Exclusion Criteria:
* Causes of infertility other than PCOS.
* patient refusal.
* Contraindication of any of the drugs used in the study
* Cause of oligo/anovulation other than PCOS
* Current or previous (within the last six month) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetics, antiobesity drugs or other hormonal drugs.
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03566225
| 30,773
|
{
"NCT_ID" : "NCT03465865",
"Brief_Title" : "Visual Acuity and Optical Coherence Tomography One Year After ILM-flap Transposition",
"Official_title" : "Visual Acuity and Optical Coherence Tomography One Year After ILM-flap Transposition for Surgical Repair of Macular Holes",
"Conditions" : ["Macular Hole"],
"Interventions" : ["Device: optical coherence tomography"],
"Location_Countries" : ["Austria"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-09-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-12-31",
"Study_Completion_Date(Actual)" : "2024-12-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-03-08",
"First_Posted(Estimated)" : 2018-03-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-03-08",
"Last_Update_Posted(Estimated)" : 2025-02-13",
"Last_Verified" : 2025-02"
}
}}
|
#Study Description
Brief Summary
ILM-flap (internal limiting Membrane-flap) transposition is a new surgical option in repair of macular holes, therefore one year outcomes are needed to better evaluate that method.
Detailed Description
Patients that have been scheduled for vitrectomy with ILM-flap transposition, a new surgical option in repair of macular holes, are invited to a follow-up one year after surgery, including optical coherence tomography and visual acuity testing.
#Intervention
- DEVICE : optical coherence tomography
- optical coherence tomography enables diagosis of macular structures and therefore provides information on macular hole closure.
- Other Names :
- visual acuity test
|
#Eligibility Criteria:
Inclusion Criteria:
* history of ILM-flap transposition
Exclusion Criteria:
* none
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03465865
| 13,098
|
{
"NCT_ID" : "NCT00051558",
"Brief_Title" : "Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis",
"Official_title" : "Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis",
"Conditions" : ["Osteoporosis"],
"Interventions" : ["Drug: Teriparatide", "Drug: Placebo", "Drug: Alendronate Sodium"],
"Location_Countries" : ["Puerto Rico", "United States", "Belgium", "Norway", "Austria", "Denmark"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2002-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2006-07",
"Study_Completion_Date(Actual)" : "2008-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2003-01-13",
"First_Submitted_that_Met_QC_Criteria" : 2009-01-14",
"First_Posted(Estimated)" : 2003-01-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2003-01-13",
"Last_Update_Posted(Estimated)" : 2009-03-12",
"Last_Verified" : 2009-02"
}
}}
|
#Study Description
Brief Summary
Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called 'glucocorticoid-induced osteoporosis.' This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.
#Intervention
- DRUG : Teriparatide
- 20 micrograms/day, injection, 36 months
- Other Names :
- LY333334, Forteo, Forsteo
- DRUG : Alendronate Sodium
- 10 mg/day, oral, 36 months
- DRUG : Placebo
- Oral placebo, daily, 36 months
- DRUG : Placebo
- Injection placebo, daily, 36 months
|
#Eligibility Criteria:
Inclusion Criteria:
* Men or women age >= 21 years
* Taking on average 5.0 mg/day prednisone or equivalent for at least 3 months prior to screening
Exclusion Criteria:
* Taking bisphosphonates within past 6 months
* More than 30 micrograms/day of estradiol or equivalent in past 3 months
* History of alcoholism or drug abuse in past year
* Pregnant women or nursing mothers
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00051558
| 88,776
|
{
"NCT_ID" : "NCT04938063",
"Brief_Title" : "Association Between Functional Impairment and Parenting Stress Among Children Diagnosed with Diplegic Cerebral Palsy",
"Official_title" : "Association Between Functional Impairment and Parenting Stress Among Children Diagnosed with Diplegic Cerebral Palsy",
"Conditions" : ["Cerebral Palsy", "Parent-Child Relations"],
"Interventions" : ["Other: Assessing the correlation between Functional Impairment and Parenting Stress"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-05-30",
"Study_Completion_Date(Actual)" : "2021-06-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-06-18",
"First_Posted(Estimated)" : 2021-06-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-06-18",
"Last_Update_Posted(Estimated)" : 2024-11-22",
"Last_Verified" : 2024-11"
}
}}
|
#Study Description
Brief Summary
1. To find out the relation between the severity of ADL limitation in diplegic CP children and the level of parents' stress.
2. To detect the correlation between the PS level to the different domains of ADL limitation.
3. To determine the substantial factors that underlying the parents' stress of those diplegic CP children.
Detailed Description
The health and well-being of children are intimately related to their parents' physical, emotional and social health in addition to child-rearing practices. The way parents of CP children deal with their stress may adversely affect their parenting ability, which in turn leads to difficulties for the child, which may lead to more parenting stress. The extent to which parents of CP children adjust and the resources to meet the needs of their children is of primary concern to professionals working in children's healthcare.
To support parents, it is important to determine the level of independence of diplegic CP children in their daily lives. This is necessary to identify predictors of their stress, which may be a mentally debilitating factor in their lives. In return, it may support us as physiotherapists to make more informed decisions about treatment planning, as well as facilitate conversations with parents around identifying sources of stress and developing healthy coping strategies that lead to a better quality of life for their children. Finally, this will have a direct positive impact on the children's abilities
#Intervention
- OTHER : Assessing the correlation between Functional Impairment and Parenting Stress
- Association Between Functional Impairment and Parenting Stress Among Children Diagnosed With Diplegic Cerebral Palsy
|
#Eligibility Criteria:
Inclusion Criteria:
* Diplegic CP children.
* Their age ranges from 18 months to five years old.
* All levels of GMFCS will be included.
* Both sexes will be included.
* All children were medically and clinically stable.
* Parents must be able to write and read.
Exclusion Criteria:
* Diplegic CP children, who might have one or more of the following:
* History of chronic cardiac or chest disease.
* Any behavioral disorders.
* Current hospitalization for urgent medical reasons.
* Significant visual or auditory impairment.
* Previous history of Botox injection within last six months.
Sex :
ALL
Ages :
- Minimum Age : 18 Months
- Maximum Age : 5 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04938063
| 82,573
|
{
"NCT_ID" : "NCT02896543",
"Brief_Title" : "The Relationship of Change of Dendritic Cells Fractalkine and P-selectin Patients With Acute Myocardial Infarction",
"Official_title" : "The Relationship of Change of Dendritic Cells Fractalkine and P-selectin in Patients With Acute Myocardial Infarction",
"Conditions" : ["Acute Myocardial Infarction"],
"Interventions" : ["Other: measurement"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-01",
"Study_Completion_Date(Actual)" : "2017-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-07-06",
"First_Posted(Estimated)" : 2016-09-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-09-06",
"Last_Update_Posted(Estimated)" : 2017-08-01",
"Last_Verified" : 2017-07"
}
}}
|
#Study Description
Brief Summary
This study evaluates the relationship of change of dendritic cells fractalkine and P-selectin in patients with acute myocardial infarction.
Detailed Description
Dendritic cells (DCs) are the most potent antigen-presenting cells, with the unique ability to initiate a primary immune response to certain antigens by activation of 'naive' T cells, and are actively related to the process of atherosclerosis. Two DC subsets, myeloid DCs (mDCs) and plasmacytoid DCs (pDCs), were identified in humans. In our previous study, the investigators found that change of dendritic cells and fractalkine in patients with acute myocardial infarction. At the same time, the level of P-selectin increased. In addition, the interaction of dendritic cells and P-selectin promotes the progress of atherosclerosis. In this study, the investigators want to see whether the balance between mDCs and pDCs is altered in patients with acute myocardial infarction. sP-selectin is one of the members of the family of proteins, mediate leukocyte adhesion and rolling in vascular endothelial, studies have shown that in patients with unstable angina and acute myocardial infarction in serum sP-selectin protein increased significantly, showed that sP-selectin associated with the activity of coronary heart disease, causing plaque instability.However, there is few relevant studies about the relationship of dendritic cells and P-selectin in patients with acute myocardial infarction. This study valuates the relationship of dendritic cells and P-selectin in patients with acute myocardial infarction
#Intervention
- OTHER : measurement
- Blood is obtained into ethylene diamine tetraacetic acid（EDTA） tubes from all subjects via antecubital vein puncture to measure the number of dendritic cells(DCs) and the concentration of sP-selectin. The number of dendritic cells(DCs) and the concentration of sP-selectin are measured in all patients with STEMI at 0 and 5-7 days after admission. The number of dendritic cells(DCs) and the only once in control group after admission.
|
#Eligibility Criteria:
Inclusion Criteria:
* diagnosed as STEMI.
* with left ventricular ejection fraction（LVEF）>=45%
* written informed consents are obtained.
* admitted within 24 hours after chest pain attacked.
Exclusion Criteria:
* Obvious blood system diseases.
* Combination with other organs function failure: severe liver dysfunction, severe renal insufficiency,severe heart failure (NYHA class 3 and 4), acute or chronic infectious diseases, disease of immune system, asthma, malignant tumor, other advanced disease, etc.
* Pregnant women and planned pregnancy women.
* With drug allergy or contraindications.
* refusal to sign the informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02896543
| 128,186
|
{
"NCT_ID" : "NCT02092844",
"Brief_Title" : "Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause",
"Official_title" : "Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause",
"Conditions" : ["Menopause", "Insomnia", "Hot Flashes"],
"Interventions" : ["Behavioral: CBT for Menopausal Insomnia (CBTMI)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-09",
"Study_Completion_Date(Actual)" : "2016-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-01-31",
"First_Posted(Estimated)" : 2014-03-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-03-18",
"Last_Update_Posted(Estimated)" : 2017-05-12",
"Last_Verified" : 2016-10"
}
}}
|
#Study Description
Brief Summary
The primary aim of the current study is to evaluate the effectiveness of a Cognitive Behavioral Therapy intervention in the treatment of menopause-associated insomnia and nocturnal hot flashes.
Detailed Description
This study aims to develop and evaluate a primary care-based intervention for insomnia and nocturnal hot flashes (nHF) in peri- and postmenopausal women. Menopause-associated insomnia is associated with adverse consequences including reduced quality of life, increased health care utilization, and risk for psychiatric disorders and medical conditions. The poor benefit/risk ratio of estrogen and progesterone replacement therapy and concerns about long-term effects of sedative hypnotics has left women desperate for new approaches to resolve menopause-related health problems, including poor sleep. The proposed intervention aims to develop and evaluate a much-needed safe treatment of menopause-associated insomnia that combines and enhances cognitive behavioral therapies for insomnia and hot flashes. To maximize the public health impact, improve access, and reduce treatment barriers (stigma and transportation issues), we propose to evaluate the efficacy and effectiveness of the intervention delivered by nurses in gynecology clinics, where women receive routine care. Primary outcomes, for which the study is optimally designed and sufficiently powered, are subjectively- and objectively-measured sleep and nHF.
The Aims of this research are to:
1. To explore feasibility, acceptability (willingness to be randomized and dropout rates) of CBTMI, and indications of efficacy/effectiveness of CBTMI in a randomized, placebo-controlled, pilot study.
2. To explore the effects of CBTMI on the number and duration of arousals/awakenings that follow nHFs. If effective, the intervention has the potential to improve the quality of life in peri- and postmenopausal women and reduce the significant costs to society.
#Intervention
- BEHAVIORAL : CBT for Menopausal Insomnia (CBTMI)
- Cognitive Behavioral Therapy for Menopausal Insomnia (CBTMI) includes education about sleep, sleep restriction, stimulus control, cognitive restructuring of sleep interfering thoughts, and relapse prevention; while also addressing women's beliefs about and reactions to hot flashes.
|
#Eligibility Criteria:
Inclusion Criteria:
* Women in menopausal transition (defined by standardized criteria as variable cycle length seven days different from their normal cycle or >2 skipped cycles and an interval of amenorrhea of 2 <= age <= 12 months) or postmenopausal (defined as >12 months since last menstrual period).
* Meet Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for insomnia assessed by Duke Structured Interview for Sleep Disorders.
* Score >14 on the Insomnia Severity Index (ISI) or >8 on the Pittsburgh Sleep Quality Index (PSQI).
* Have at least one nocturnal hot flash/night sweat on 3 or more nights a week (based on 2 weeks of daily hot flash diaries).
Exclusion Criteria:
* Chemotherapy/radiation-induced menopause.
* Presence of any unstable medical disorder assessed by medical tracking form.
* Traumatic brain injury or cognitive impairment defined by a score < 25 on Mini Mental Status Exam.
* Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in past 3 years).
* Presence of psychotic disorder, substance abuse or dependence, or bipolar disorder, assessed by MINI International Neuropsychiatric Inventory (to increase generalizability other psychiatric comorbidities will not be excluded).
* Recent initiation/change in existing treatments that may impact sleep or nocturnal hot flashes (recency is defined by: < 4 weeks for antidepressant, < 16 weeks for any psychotherapy, and <8 weeks for estrogen, progestin, or androgen).
* As needed use of hypnotic, over-the-counter, or herbal supplements known to affect sleep or hot flashes.
* The following comorbid sleep disorders based on structured diagnostic interview: narcolepsy, circadian rhythm disorder, restless less syndrome, periodic leg movement disorder (PLMD), obstructive sleep apnea (OSA), or positive screening PLMD (PLMI > 15) or OSA (AHI > 15) on polysomnography (PSG) following screening visit.
Sex :
FEMALE
Ages :
- Minimum Age : 40 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02092844
| 71,768
|
{
"NCT_ID" : "NCT04065646",
"Brief_Title" : "Nutrition Education and e-Texting to Increase Access to Fresh Produce",
"Official_title" : "Nutrition Ed, Access and Texting (NEAT): Combining the Hartford Mobile Market With e-Marketing",
"Conditions" : ["Healthy Eating"],
"Interventions" : ["Other: Mobile"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-10-23",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-09-30",
"Study_Completion_Date(Actual)" : "2016-09-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-08-02",
"First_Posted(Estimated)" : 2019-08-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-08-21",
"Last_Update_Posted(Estimated)" : 2019-08-22",
"Last_Verified" : 2019-08"
}
}}
|
#Study Description
Brief Summary
The proposed project, Nutrition Ed, Access and Texting (NEAT): Combining the Hartford Mobile Market with e-Marketing , uses an e-technology social marketing strategy to promote use of a recently launched mobile produce market among SNAP-Ed recipients. This study will potentially increase fresh produce access and intake by combining an innovative food system change (produce mobile market) with existing SNAP-Ed nutrition education curriculum and the use of e-marketing technology.
Detailed Description
The proposed project, Nutrition Ed, Access and Texting (NEAT): Combining the Hartford Mobile Market with e-Marketing uses an e-technology social marketing strategy to promote use of a recently launched mobile produce market among SNAP-Ed recipients. This study will potentially increase fresh produce access and intake by combining an innovative food system change (produce mobile market) with existing SNAP-Ed nutrition education curriculum and the use of e-marketing technology. Thus, the study combines key elements that have been deemed necessary for increasing produce intake among low income communities. The goal of the NEAT study is to assess the impact of a texting-based social marketing campaign on SNAP-Ed participants' access to and purchase of fresh produce on a recently launched mobile produce market, and their subsequent produce intake. Objectives include: 1) Compare the impact of nutrition education alone to nutrition education plus promotional text messaging on purchase of fruits and vegetables; 2) Compare the impact of nutrition education alone to nutrition education plus promotional text messaging on consumption of fruits and vegetables; and 3) Assess the effectiveness of coupon distribution on coupon redemption at a mobile produce market. The NEAT design will be a randomized controlled trial using a pre-post assessment comparing change in behavior. Both intervention and control groups will receive SNAP-Ed education as currently delivered by the Hispanic Health Council. The intervention group will receive additional promotional text messaging related to use of the mobile market. The control group will receive text messaging about free activities taking place at the Hartford Public Library and other community locations. Participants will be interviewed via phone at baseline, then randomized to intervention and control groups, and re-interviewed again 6 weeks after they start receiving the text messages, which it will be 2 weeks after the one-month texting period ends.
#Intervention
- OTHER : Mobile
|
#Eligibility Criteria:
Inclusion Criteria:
* SNAP eligible participants with children under 5 years living at home.
* Living in Hartford, CT.
* Having a cell phone with unlimited smart phone data plans.
Exclusion Criteria:
* Not living in Hartford Less than 18 years
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04065646
| 116,273
|
{
"NCT_ID" : "NCT01431183",
"Brief_Title" : "Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions",
"Official_title" : "Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions",
"Conditions" : ["Seasonal Influenza Vaccination"],
"Interventions" : ["Behavioral: Mailed influenza vaccination reminder notice"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "HEALTH_SERVICES_RESEARCH",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-02",
"Study_Completion_Date(Actual)" : "2010-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-09-06",
"First_Posted(Estimated)" : 2011-09-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-09-07",
"Last_Update_Posted(Estimated)" : 2011-09-09",
"Last_Verified" : 2011-09"
}
}}
|
#Study Description
Brief Summary
The objective of this study was to assess the feasibility and effectiveness of using a statewide immunization information system (IIS) to send seasonal influenza vaccine reminders from Local Health Departments (LHDs), targeting children with high-risk conditions.
#Intervention
- BEHAVIORAL : Mailed influenza vaccination reminder notice
- Influenza vaccination reminder sent by postal mail
|
#Eligibility Criteria:
Inclusion Criteria:
* children, 24 <= age <= 60 months
* current or previous enrollment in Medicaid (Michigan)
* presence of at least 1 chronic condition, as indicated by the Michigan Care Improvement Registry (MCIR)
* resident of Kalamazoo, Ottawa, or Kent counties (Michigan)
Exclusion Criteria:
* receipt of influenza prior to notification date
* ineligible for reminder/recall notification in the Michigan Care Improvement Registry (MCIR)
Sex :
ALL
Ages :
- Minimum Age : 24 Months
- Maximum Age : 60 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT01431183
| 261,572
|
{
"NCT_ID" : "NCT00549861",
"Brief_Title" : "Characterization of Irreversible Myocardial Injury in Cardiomyopathies by Contrast-enhanced CMR",
"Official_title" : "Characterization of Irreversible Myocardial Injury in Dilated Forms of Cardiomyopathies by Gadobutrol (Gadovist®)-Enhanced Cardiovascular Magnetic Resonance Imaging",
"Conditions" : ["Cardiomyopathy, Dilated", "Cardiomyopathies, Secondary"],
"Interventions" : ["Procedure: Cardiac Magnetic Resonance study"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-08",
"Study_Completion_Date(Actual)" : "2008-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-10-24",
"First_Posted(Estimated)" : 2007-10-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-10-25",
"Last_Update_Posted(Estimated)" : 2011-10-04",
"Last_Verified" : 2011-10"
}
}}
|
#Study Description
Brief Summary
Different studies have shown that fibrosis of the heart increases the risk for a sudden death from e.g. arrhythmias. Magnetic Resonance Imaging (CMR) can easily identify even small areas of fibrosis in the heart muscle after contrast agent application (Gadolinium). With the development of faster scanners and new contrast agents, the detection of small fibrotic areas may even be improved.
In this study, we will apply dedicated T1- and T2-weighted CMR sequences before and after administration of Gadolinium-based contrast (Gadobutrol, Gadovist(r)), the study parameters will be full cardiac function, areas of edema, areas of inflammation and areas of fibrosis.
We hypothesize, that we can detect fibrotic areas in the myocardium using Gadobutrol (Gadovist (r)) better than with the commonly used Gadolinium-DTPA contrast agents. We also hypothesize, that fibrosis of the myocardium is correlated to prognosis of the patients.
Detailed Description
Dilated forms of cardiomyopathies present with left ventricular enlargement and reduced ejection fraction. Myocardial fibrosis as assessed by gradient echo sequences after contrast application ('late enhancement') has been proven to be of outstanding value for the detection of small irreversibly injured lesions and has been used to accurately characterize scarred tissue in infarcts (Kim et al, Circulation 1999), myocarditis (Mahrholdt et al., Circulation 2004), and hypertrophic cardiomyopathy (Moon et al., J Am Coll Cardiol 2004). Whereas fibrosis pattern have been described for non-ischemic cardiomyopathies (Mahrholdt et al., Eur Heart J 2005), little is known about the specific regional distribution of fibrous tissue within the group of dilated forms. McCrohon et al. have described a mid-mural and a patchy pattern in patients with global LV dysfunction and no evidence of relevant coronary artery disease (McCrohon et al., Circulation 2003). This study however, did not include right ventricular cardiomyopathy patients and patients with isolated non-compaction as two important dilated forms of cardiomyopathy.
Justification/relevance/purpose
The presence of fibrosis in dilated forms of cardiomyopathy may be predictive of progression of left ventricular dysfunction over time, as it may represent irreversible damage.
Gadobutrol will be used as the only contrast agent in this study; the significantly higher relaxivity as compared to other contrast agents will potentially allow the visualization of small, focal areas of irreversible injury in the myocardium, thus increasing sensitivity of the method to identify even localized fibrotic areas.
Objective, hypothesis
We attempt to define disease-specific patterns of extent and spatial distribution of irreversible tissue injury within the group of dilated forms of cardiomyopathies.
We hypothesize that in patients with dilated cardiomyopathies certain patterns of late enhancement can be identified, which are useful for a more specific phenotyping.
We also hypothesize that the use of Gadobutrol (Gadovist®) as the only contrast agent identifies small areas of irreversible tissue injury better than standard contrast agents and may be beneficial for diagnosing small fibrotic changes.
#Intervention
- PROCEDURE : Cardiac Magnetic Resonance study
- Cardiac MRI study
|
#Eligibility Criteria:
Inclusion Criteria:
* Known cardiomyopathy (DCM, HCM, ARVC or LVNC)
* Clinical indication for contrast-enhanced Cardiac Magnetic Resonance study
* Ability to give informed consent
Exclusion Criteria:
* Any contraindication for a Magnetic Resonance Study including implanted devices, claustrophobia etc.
* Allergic reaction to Gadolinium-based contrast agents
* Known adverse reaction to Gadovist®
* Inability to give informed consent
* Known long-QT syndrome or other known conduction abnormalities
* Pregnancy or breast-feeding
* Any exclusion criteria for the administration of Gadovist® as stated in the product monograph for Warning and Precautions, e.g. Hx of allergic dispositions, or bronchial asthma; sickle cell anemia or hemoglobinopathies; renal insufficiency, with hypokalemia; convulsive states
* Conditions and concomitant medication which may prolong the QTc interval, e.g. long-QT syndrome, patients with hypokalemia, receiving Class I1 (e.g. quinidine, procainamide) or class III (amiodarone, sotalol) known antiarrhythmogenic drugs, or other medication that are known to prolong QT interval (such as cisapride, erythromycin, antipsychotic and antidepressants) - since there is a lack of clinical experience and potential risks with the concomitant use of these medication with the MRI contrast
* Patients with severe renal impairment (GFR <30mL/min)
* Patients with previous reaction to MRI and / or CT contrast media
* Patients with acute renal dysfunction due to hepato-renal syndrome or patients in the perioperative liver transplantation period
* Patients with end-stage renal disease (GFR <15mL/min/1.73m2)
* Unstable patients, e.g. from CCU / ICU
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00549861
| 234,036
|
{
"NCT_ID" : "NCT03024190",
"Brief_Title" : "Kinesiotaping Combined With Therapeutic Exercise in Upper Extremity Spasticity and Function in Subacute Stroke Patients",
"Official_title" : "The Clinical Effect and Sonographic Findings of Kinesiotaping Combined With Therapeutic Exercise in Upper Extremity Spasticity and Function in Subacute Stroke Patients",
"Conditions" : ["Stroke", "Upper Extremity Spasticity"],
"Interventions" : ["Other: stretching exercise", "Other: OT rehabilitation program", "Other: Kinesiotaping"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-07",
"Study_Completion_Date(Actual)" : "2018-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-12-27",
"First_Posted(Estimated)" : 2017-01-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-01-13",
"Last_Update_Posted(Estimated)" : 2018-09-24",
"Last_Verified" : 2016-12"
}
}}
|
#Study Description
Brief Summary
Poststroke spasticity (PSS) is one of the common complications in stroke patients who had a brain injury leading to limbs weakness and impaired coordination between agonist and antagonist contraction. PSS leads some physical impairments and functional deficits. The clinical managements for PSS are stretching and range of motion (ROM) exercises, antispasticity splint, neuromuscular electrical stimulation, oral medications, local injection with phenol or botulism, or surgery. Recently, some investigators tried to use Kinesiotaping (KT) for spasticity management or postural control. They found some benefits in walking ability and upper extremity function facilitation after stroke.
40 subacute stroke patients with hemiplegia would be enrolled in this study. These 40 patients will be randomly divided into the experimental and control groups. In experimental group (n=20), the patients will perform combined KT and 15- min stretching exercise for upper extremity twice daily and regular rehabilitation program for 3 weeks. In the control group (n=20), the patients will perform 15- min stretching exercise for upper extremity twice daily and regular rehabilitation program for 3 weeks. Before intervention, immediately and 2 week post intervention, all patients will receive associated physical examinations, hand function evaluations, and sonography.
Detailed Description
In this study, 40 subacute stroke patients (duration is 3\~6 months after stroke) with hemiplegia would be enrolled. Each stroke patient is diagnosed by a neurologist according to the history, physical examination, and brain imaging evaluation. These 40 patients would be randomly divided into a experimental or a control group. All patients in the control and experimental groups will both receive regular rehabilitation therapy including occupational therapy (OT) 3 times per week and one hour for one session OT intervention. Additionally, 15- min stretching exercise for upper extremity twice daily will be performed for 3 weeks in this study. KT intervention in the experimental group: The technique of KT for spastic wrist and fingers in stroke patient will be performed from the proximal interphalangeal joints of all fingers acted on the extensor carpal and digital muscle groups, with an anchor at the proximal one-third forearm. The KT will be applied for 5 days one week for 3 weeks.
In this study, all patients in the control and experimental groups will receive the following evaluations before intervention, immediately post intervention, and 2-week after intervention: Physical examinations (modified shworth scale and Tardieu scale), Hand function evaluation (Fugl-Meyer Assessment for upper extremity, box and block test, and Minnesota Manual Dexterity Test), and Musculoskeletal sonography (sonoelastography and shear wave velocity). SPSS software will be used to record and analysis the collecting data. Investigators will analyze and compare the findings of physical examinations, upper extremity function assessments, and musculoskeletal sonography within and between the experimental and control groups before and after interventions.
#Intervention
- OTHER : Kinesiotaping
- The technique of Kinesiotaping for spastic wrists and fingers in stroke patients is performed from the proximal interphalangeal joints of all fingers acted on the extensor carpal and digital muscle groups, with an anchor at the proximal one-third forearm.
- OTHER : stretching exercise
- 15- min stretching exercise for upper extremity twice daily
- OTHER : OT rehabilitation program
- regular rehabilitation program for 3 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* stroke with hemiplegia (duration is 3~6 months after stroke).
* The upper extremity function of participated patients could perform hand grasp and release movements.
Exclusion Criteria:
* age is younger than >= 18 years than 80 years
* previous history of upper extremity tendon or neuromuscular injury
* any other systemic neuromuscular disease
* cognition or language impairment leading to communication difficulty
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03024190
| 173,536
|
{
"NCT_ID" : "NCT01059604",
"Brief_Title" : "Sumatriptan and Naratriptan Pregnancy Registry",
"Official_title" : "The Sumatriptan and Naratriptan Pregnancy Registry",
"Conditions" : ["Migraine Disorders"],
"Interventions" : ["Drug: Sumatriptan", "Drug: Naratriptan", "Drug: Sumatriptan-naproxen combination"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2001-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-04",
"Study_Completion_Date(Actual)" : "2013-04},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-01-28",
"First_Posted(Estimated)" : 2010-02-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-01-29",
"Last_Update_Posted(Estimated)" : 2014-11-02",
"Last_Verified" : 2014-10"
}
}}
|
#Study Description
Brief Summary
Anti-migraine drugs, including triptans, are not indicated for use in pregnancy. However, the peak prevalence of migraine is in women of childbearing age. This, coupled with the sporadic nature of migraine attacks and high rates of unplanned pregnancies, makes unintentional exposure to anti-migraine medications during pregnancy likely. Prior to an anti-migraine medication being marketed there are few data available on drug safety in pregnancy: data from animal models may not translate directly to humans and pregnant women are routinely excluded from clinical trials. The Sumatriptan Pregnancy Registry was established by GlaxoSmithKline (GSK) in 1996 to monitor the safety of sumatriptan during pregnancy. It was combined with the Naratriptan Pregnancy Registry in 2001 and data collection on the sumatriptan-naproxen combination (Treximet) began in 2008.
Detailed Description
The Sumatriptan, Naratriptan and Treximet Pregnancy Registry aims to assess whether there is a substantial increase in the risk of major congenital malformations (MCMs) following in utero exposure to those anti-migraine medications. Exposure during the first trimester is of primary interest as this represents the period of organogenesis.
The Registry is a primarily prospective enrolment and follow-up study. Patients exposed to sumatriptan, naratriptan, or the sumatriptan-naproxen combination during pregnancy, are enrolled, on a voluntary basis, by their healthcare provider. Enrolment is encouraged early in pregnancy and if possible prior to any prenatal testing. The healthcare provider provides initial information concerning patient demographics; details of the pregnancy including the estimated delivery date and results of any prenatal testing; and the timing, dosage, route of delivery (e.g. oral, subcutaneous, intranasal) of drug exposure in pregnancy. The registry accepts exposure reports from anywhere in the world. Within the United States (US) the healthcare provider can contact the registry using a toll free number. Outside of the US enrolments are made through the GlaxoSmithKline local operating company.
Close to the estimated date of delivery the healthcare provider is contacted by the Registry to provide follow up information concerning the pregnancy outcome (live or still birth, spontaneous or induced abortion), the presence or absence of a MCM, and the history of headache and exposure to sumatriptan, naratriptan or the sumatriptan-naproxen combination during pregnancy. Up to six attempts are made to contact the healthcare provider to obtain pregnancy outcome information. After six attempts, the record is closed as lost to follow up.
Pregnancy outcomes are classified as outcomes with MCMs, outcomes without MCMs and spontaneous abortions. The outcomes with and without MCMs are further classified as live births, stillbirths/fetal deaths and induced abortions. Spontaneous abortions are reported separately due to potential for inconsistent identification of malformations in that situation.
It is beyond the scope of the Registry to consistently access pediatric evaluations and medical records. For this reason the main outcome is restricted to major congenital malformations that are external and recognizable in the delivery room or shortly after birth. To provide consistency, reported congenital malformations are classified as major or minor according to criteria used by the Centers for Disease Control and Prevention (CDC)'s Metropolitan Atlanta Congenital Defects Program (MACDP). All malformation reports are reviewed and classified by a paediatrician from the CDC and further information is requested as necessary.
Analyses are restricted to prospectively enrolled pregnancies (enrolment prior to knowledge of the birth outcome). Retrospectively enrolled pregnancies are reviewed for patterns of malformation types, but are not included in formal analyses as retrospective reporting can be biased towards more unusual and severe outcomes and are less likely to be representative of the general population experience.
The proportion of infants with MCMs among prospectively reported exposures is calculated as: the total number of outcomes with major birth defects (number of outcomes with major birth defects + the number of live births without defects).
All spontaneous pregnancy losses, as well as induced abortions and fetal deaths without reported defects, are excluded from the denominator due to the potential for inconsistent identification of malformations in those situations. The 95% confidence intervals (CIs) for risk estimates are calculated using exact methods based on the binomial distribution.
Analyses are stratified according to trimester of exposure (with the second trimester starting at week 14 and the third trimester at week 28 of gestation) for each anti-migraine of interest. If an individual is exposed to multiple drugs of interest during pregnancy, the exposure is included in analyses for each drug of interest.
The registry does not have an internal comparator group, but descriptive comparisons are made with MCM rates from general population studies in the literature.
Prospective reports are also reviewed to detect any unusual patterns of malformation types that may warrant further investigation.
The data from the Sumatriptan, Naratriptan and Treximet Pregnancy Registry are reviewed, and conclusions developed, by an independent scientific advisory committee. A semi-annual interim report summarizing aggregate data is provided to disseminate information on a regular basis.
#Intervention
- DRUG : Sumatriptan
- Sumatriptan
- DRUG : Naratriptan
- Naratriptan
- DRUG : Sumatriptan-naproxen combination
- Sumatriptan-naproxen combination
|
#Eligibility Criteria:
Inclusion Criteria:
* Women exposed in utero to sumatriptan, naratriptan or the sumatriptanp-naproxen combination during pregnancy. Exposure can occur at any time during pregnancy, though exposure in the first trimester is of primary interest.
* Pregnancies exposed to sumatriptan, naratriptan or the sumatriptan-naproxen combination and reported before the outcome of the pregnancy is known (prospective reporting). Ideally exposed pregnancies are registered prior to prenatal testing, but only those pregnancies enrolled after prenatal testing has diagnosed a congenital malforamtion are excluded.
* Retrospectively reported exposures (i.e. exposures registered once the pregnancy outcome is known) are included in the registry, but are considered descriptively and are not included in risk analyses.
Exclusion Criteria:
* Retrospectively reported exposures (i.e. exposures registered once the pregnancy outcome is known) are included in the registry, but are reviewed separately and descriptively. These are not included in risk analyses.
* Patient reported exposures and outcomes that are not verified by a healthcare provider.
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01059604
| 114,247
|
{
"NCT_ID" : "NCT00677079",
"Brief_Title" : "Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer",
"Official_title" : "A Phase 2, Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer",
"Conditions" : ["Primary Peritoneal Cancer", "Advanced Epithelial Ovarian Cancer"],
"Interventions" : ["Drug: Iniparib"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-12",
"Study_Completion_Date(Actual)" : "2008-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-05-09",
"First_Posted(Estimated)" : 2008-05-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-05-12",
"Last_Update_Posted(Estimated)" : 2013-10-01",
"Last_Verified" : 2013-09"
}
}}
|
#Study Description
Brief Summary
The goal of this study was to determine the efficacy of iniparib (BSI-201/SAR240550) in patients with breast cancer gene-associated (BRCA) ovarian cancer.
Up to 35 patients were to be treated using a Simon 2-stage optimal design, i.e. twelve were to be treated in a first stage, then if 2/12 patients responded to treatment as defined by Response Evaluation Criteria in Solid Tumor (RECIST), 23 additional patients were be treated in the second stage.
Detailed Description
Participants were treated for at least one 8-week cycle, with additional cycles as long as they had stable or responding disease (per RECIST criteria) and wished to remain on study.
Participants had a final follow-up visit within 4 weeks following the last dose of iniparib, after which time they were contacted by study staff every 3 months for the first year and every 6 months thereafter to assess disease status and survival.
#Intervention
- DRUG : Iniparib
- Body weight adjusted dose
1 hour intravenous infusion
- Other Names :
- BSI-201, SAR240550
|
#Eligibility Criteria:
Inclusion Criteria:
* Female, age >= 18 years;
* Histologically or cytologically confirmed advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (stage III or IV);
* At least one previous regimen with platinum/taxane combination therapy and no curative options as determined by their physician (no limit on the number of prior therapies);
* Confirmed BRCA1 or BRCA2 status;
* One or more measurable lesions, at least 10mm in longest diameter by spiral computed tomography (CT) scan or 20mm in longest diameter when measured with conventional techniques (palpation, plain x-ray, CT or magnetic resonance imaging (MRI));
* Karnofsky performance status >=70%;
* Estimated life expectancy of at least 16 weeks.
Exclusion Criteria:
* Normal clinical laboratory values;
* Any anti-cancer therapy within 21 days prior to study start;
* Any other malignancy within 3 years of study start, except adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, or basal or squamous cell skin cancer;
* Active viral infection including HIV/AIDS, Hepatitis B or Hepatitis C infection;
* Active central nervous system or brain metastases;
* History of seizures or current treatment with anti-epileptic medication;
* Persistent grade 2 or greater toxicities from prior therapy, excluding alopecia.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00677079
| 184,995
|
{
"NCT_ID" : "NCT02003846",
"Brief_Title" : "Comparing Bubble and Ventilator Nasal CPAP in Preterm Infants",
"Official_title" : "Comparing the Effects of Bubble Nasal CPAP Versus Ventilator Nasal CPAP in Preterm Infants",
"Conditions" : ["Respiratory Distress Syndrome"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-10",
"Study_Completion_Date(Actual)" : "2014-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-11-19",
"First_Posted(Estimated)" : 2013-12-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-12-02",
"Last_Update_Posted(Estimated)" : 2015-06-30",
"Last_Verified" : 2015-06"
}
}}
|
#Study Description
Brief Summary
There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal intensive care units (NICU) use an underwater bubbling system and others use a ventilator to generate the pressure. There is no right or wrong way to generate the pressure and both methods are approved and accepted.
The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on each for a defined time period and reviewing the infant's vital signs. The investigators expect that the pressure generated by bubble CPAP will be better and lead to improved vital signs.
Detailed Description
There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal intensive care units (NICU) use an underwater bubbling system and others use a ventilator to generate the pressure. There is no right or wrong way to generate the pressure and both methods are approved and accepted.
The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on each for a defined time period and reviewing the infant's vital signs. The investigators expect that the pressure generated by bubble CPAP will be better and lead to improved vital signs.
|
#Eligibility Criteria:
Inclusion Criteria:
* Neonates between 26 <= age <= 32 weeks gestational age who have been on Nasal CPAP for at least 48hrs on fraction of inspired oxygen (FiO2) of < or = 0.3. Parental consent will be obtained prior to enrollment.
Exclusion Criteria:
* Infants with severe congenital anomalies, such as airway or chest wall deformities, pulmonary hypoplasia, congenital heart disease, neurologic abnormalities including severe intraventricular hemorrhage (IVH) and need for surgery eg. for necrotizing enterocolitis will be excluded from the study. Any infants with genetic/chromosomal abnormalities will be excluded.
Sex :
ALL
Ages :
- Minimum Age : 2 Days
- Maximum Age : 3 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02003846
| 115,759
|
{
"NCT_ID" : "NCT04628949",
"Brief_Title" : "A Single-Use Duodenoscope in a Real-World Setting",
"Official_title" : "A Single-Use Duodenoscope in a Real-World Setting",
"Conditions" : ["Endoscopic Retrograde Cholangiopancreatography (ERCP)"],
"Interventions" : ["Device: aScope™ Duodeno endoscope and aBox™ Duodeno"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-01-25",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-01-27",
"Study_Completion_Date(Actual)" : "2022-02-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-11-05",
"First_Posted(Estimated)" : 2020-11-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-11-09",
"Last_Update_Posted(Estimated)" : 2022-08-01",
"Last_Verified" : 2022-07"
}
}}
|
#Study Description
Brief Summary
This study will assess how the aScope™ Duodeno endoscope performs in procedures that treat problems of the bile and pancreatic ducts.
Detailed Description
This is a prospective, non-randomized, single-arm post-market observational clinical study that will assess the single-use Ambu® aScope™ Duodeno for non-emergent, standard of care (SOC) ERCP procedures.
#Intervention
- DEVICE : aScope™ Duodeno endoscope and aBox™ Duodeno
- The aScope™ Duodeno endoscope is a sterile single-use disposable duodenoscope indicated for endoscopic retrograde cholangiopancreatography (ERCP) procedures.The aScope™ Duodeno endoscope is designed to be used with aBox Duodeno, endoscopic accessories and other ancillary equipment for ERCP procedures.
The aBox Duodeno is the console that is necessary for processing the endoscope camera´s video image, regarding the remote switches and output video and recorder data. The aBox Duodeno is designed to be used with the aScope™ Duodeno endoscope.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject is >= 18 years.
* Subject is indicated and scheduled for an elective, non-emergent ERCP.
* Subject is willing and able to give informed consent and HIPAA authorization.
Exclusion Criteria:
* Subject has altered pancreaticobiliary anatomy including:
1. Billroth II
2. Roux-en-Y gastric bypass
3. Loop gastric bypass
4. Post-Whipple
5. Roux-en-Y hepaticojejunostomy
* Subject requires an emergency ERCP (emergent decompression procedure within 6 <= age <= 12 hours of presentation to prevent life-threatening sequelae).
* Subject has any of the following severe co-morbid conditions
1. Morbid obesity (BMI >= 40)
2. Unstable cardiopulmonary conditions
3. Severe and uncorrectable coagulopathy
4. Severe and uncorrectable thrombocytopenia
* Subject has clinically significant esophageal, pyloric or duodenal strictures.
* Subject has been previously been treated under this investigational plan.
* Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
* Subject is actively taking an anticoagulant or antiplatelet agent other than aspirin.
* Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not allow the subject to be a good study candidate.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04628949
| 138,993
|
{
"NCT_ID" : "NCT01983618",
"Brief_Title" : "Impact of Interscalene Nerve Block on Cerebral Perfusion During Surgery in the Beachchair Position",
"Official_title" : "Impact of Interscalene Nerve Block on Cerebral Perfusion During Surgery in the Beachchair Position Under General Anesthesia",
"Conditions" : ["Cerebral Ischemia"],
"Interventions" : ["Procedure: Interscalene nerve block and catheter", "Procedure: Interscalene catheter"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-02",
"Study_Completion_Date(Actual)" : "2015-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-11-07",
"First_Posted(Estimated)" : 2013-11-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-11-13",
"Last_Update_Posted(Estimated)" : 2015-10-16",
"Last_Verified" : 2015-10"
}
}}
|
#Study Description
Brief Summary
Beachchair position is used by many orthopaedic surgeons for shoulder surgery. Most patients undergoing surgery in this position have no complications. However, reported cases of postoperative neurological deficits have highlighted the risk of cerebral and spinal cord ischemia. The etiology of such complications remains unclear. The most plausible explanation for these events would be intraoperative hypotension followed by cerebral hypoperfusion.
General anesthesia is commonly used for shoulder surgery in conjunction with interscalene brachial plexus blockade. During the block, local anesthetic's spread is frequently observed leading to a block of sympathetic fibres. Since all nerves located in the head and neck area go through the stellate ganglion, its block will cause a sympathetic denervation and a decrease of the peripheral vascular resistance, thus increasing the circulation in cerebral blood vessels. In normal situations, there is a vasoconstriction of the cerebral blood vessels in response to a sympathetic stimulation and a vasodilation if sympathetic fibres are blocked.
Transcranial Doppler (TCD) is a non-invasive examination that provides a reliable evaluation of intracranial blood flow in real-time. It can help to detect sudden changes in perfusion and identify potential embolic events. Some studies using TCD have shown an increased ipsilateral cerebral blood flow (CBF) secondary to a reduced vascular tone associated with a stellate ganglion block. Others have shown a reduction of contralateral CBF that could theoretically increase the risk of ischemia in the affected area.
This study will assess the role of interscalene nerve blockade in the protection of cerebral ischemia and preservation of cerebral autoregulation. This study will also aim to identify changes in contralateral CBF.
The investigators hypothesize that:
1. Interscalene nerve block will increase CBF
2. Interscalene nerve block will not decrease contralateral CBF
3. Cerebral autoregulation will be preserved under general anesthesia in conjunction with an interscalene nerve block in this setting.
Detailed Description
Prior to surgery, each patient will undergo a baseline bilateral TCD examination in supine position. If the Doppler's results are satisfactory, the patient will then be randomized and proceed to the next step. In case of inadequate results, the patient's participation to the study will be terminated.
The interscalene nerve block and the insertion of the interscalene catheter will be performed according to randomization. In the interscalene nerve block and catheter group, the attending anaesthesiologist will assess the success of the block and record the presence or absence of Horner's syndrome. The transcranial Doppler operator will be blinded to these observations. Following the insertion of the interscalene catheter, the patient will undergo a second bilateral TCD in supine position before induction of anesthesia.
The anesthetic technique and monitoring will be standardized. After the induction of anesthesia, a bilateral TCD will be performed with the patient in supine position. Another examination will be performed under general anesthesia immediately after and 30 minutes following the installation of the patient in the beachchair position. A last TCD will be performed after a reduction of end-tidal carbon dioxide at 30 mm Hg.
For each examination, the arterial blood pressure must be stabilized for at least 5 minutes before the Doppler can be initiated. Arterial blood pressure will be measured during each examination. Type, duration of surgery and beachchair position will be recorded. Vasopressor therapy will be noted. Body temperature, end-tidal carbon dioxide and minimum alveolar concentration of desflurane will be collected during each examination performed under general anesthesia.
#Intervention
- PROCEDURE : Interscalene nerve block and catheter
- PROCEDURE : Interscalene catheter
|
#Eligibility Criteria:
Inclusion Criteria:
* Scheduled for shoulder surgery in the sitting position
* Surgery of the shoulder and clavicular area, eligible to an interscalene nerve block
* American Society of Anesthesiologists (ASA) physical status 1 <= age <= 3
Exclusion Criteria:
* Carotid artery stenosis
* History of stroke or other significant central nervous system lesion
* Inadequate temporal window to perform transcranial Doppler
* Contraindication to interscalene nerve block
* Patient refusal
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01983618
| 137,654
|
{
"NCT_ID" : "NCT02802059",
"Brief_Title" : "E. Coli Nissle 1917 - Suspension for Infection Prophylaxis",
"Official_title" : "E. Coli Nissle 1917 - Suspension for Infection Prophylaxis",
"Conditions" : ["Infections"],
"Interventions" : ["Drug: Placebo", "Drug: EcN-Suspension"],
"Location_Countries" : ["Germany", "Poland"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-10-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-10-12",
"Study_Completion_Date(Actual)" : "2020-10-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-01-18",
"First_Posted(Estimated)" : 2016-06-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-06-13",
"Last_Update_Posted(Estimated)" : 2020-10-27",
"Last_Verified" : 2020-09"
}
}}
|
#Study Description
Brief Summary
This study evaluates the long term effects of E. coli strain Nissle 1917 (EcN-Suspension) probiotic bacteria administration on the number of both, bacterial and viral infections during the first 24 months of infant's life. Half of study participants will receive EcN-Suspension, while the other half will receive placebo. In an additional non-clinical explorative evaluation will furthermore be investigated whether the early intestinal colonization with E.coli strain Nissle 1917 affects the establishment of the intestinal microbiota.
Detailed Description
In the course of the present trial the participants will be observed during the first 24 months of life, starting right after birth.
All newborns meeting all inclusion criteria and non-fulfilling any exclusion criteria will be included into the trial. Each participant of this clinical trial will be randomly allocated to one of the two trial arms, by using the method of randomly permuted blocks.
The newborns will be primarily treated during the first three weeks of life and re-treated after 6 and 12 months according to trial interventional plan.
Data on the efficacy and safety will be recorded during control visits after first month, 6, 12, 18 and 24 months.
A follow-up examination of study participants will be performed two years after the end of the participation in the present trial (i.e. at an age of 48 months), during which each child will be examined for its normal physical and cognitive development (covered by the U8 standardized examination). In addition data on allergic/atopic complaints or symptoms will be recorded.
In an additional non-clinical explorative evaluation, it will furthermore be investigated whether the early intestinal colonization with E.coli strain Nissle 1917 affects the establishment of the intestinal microbiota. Therefore stool samples of study participants will be collected at an age of 24 and 48 months. The microbial composition of these samples will be characterized and compared between the two trial arms (EcN vs. placebo).
#Intervention
- DRUG : EcN-Suspension
- Initial administration not later than 120h after birth. 14 ampoules a 1 ml are administered within a time of 3 weeks (1 ampoule per day within first week and 1 ampoule every second day within the following two weeks).
Subsequent re-administration after 6 and 12 months. 10 ampoules a 1 ml are administered within 10 days (1 ampoule per day).
- Other Names :
- E. coli strain Nissle 1917 bacteria
- DRUG : Placebo
- Initial administration not later than 120h after birth. 14 ampoules a 1 ml are administered within a time of 3 weeks (1 ampoule per day within first week and 1 ampoule every second day within the following two weeks).
Subsequent re-administration after 6 and 12 months. 10 ampoules a 1 ml are administered within 10 days (1 ampoule per day).
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent form by the parents
* Age at inclusion: max. 120 hours after birth
* Functionally mature infant
* Gestational age more than 35th week of development
* Mother's intention to breastfeed the participant
* Readiness of the mother to administer no probiotics additionally to the trial medication
Exclusion Criteria:
* Non-fulfilment of the at least one inclusion criteria
* Lack of propensity/compliance of mother
* 5 min APGAR SCORE less than 5
* 10 min APGAR SCORE less than 8
* pH of umbilical cord blood less than 7 (Determination not obligatory, if APGAR SCORES do not indicate that the child may have suffered from a perinatal asphyxia)
* Any perinatal infection required antibiotic treatment
* Birth weight less than 2000 g
* TORCH-infection of the mother
* HIV-infection of the mother
* Any severe medical condition of mother or newborn which in the opinion of the investigator may have a critical impact on the conduct of the study.
Sex :
ALL
Ages :
- Maximum Age : 120 Hours
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02802059
| 172,285
|
{
"NCT_ID" : "NCT02245919",
"Brief_Title" : "Chronic Low Back Pain Rehabilitation in Primary Care: a Pilot Study",
"Official_title" : "A Primary Care Biopsychosocial Intervention (Back on Track) for Patients With Chronic Low Back Pain in Which Psychosocial Factors Moderately Influence Daily Life Functioning: a Pilot Study",
"Conditions" : ["Chronic Low Back Pain"],
"Interventions" : ["Other: Back on Track intervention"],
"Location_Countries" : ["Netherlands"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-11",
"Study_Completion_Date(Actual)" : "2017-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-09-16",
"First_Posted(Estimated)" : 2014-09-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-09-18",
"Last_Update_Posted(Estimated)" : 2018-02-05",
"Last_Verified" : 2017-11"
}
}}
|
#Study Description
Brief Summary
Up to now, only little research has been performed in tailoring treatment of patients with chronic low back pain (CLBP). It would be interesting to evaluate a biopsychosocial intervention in patients with a moderate to high level of disability and in whom the contributing role of psychosocial factors to this disability is mild to moderate (WPN3-). Nowadays, these patients receive cognitive behavioral-based treatments in multidisciplinary rehabilitation settings but might also benefit from treatments based on these multidisciplinary rehabilitation treatment principles when provided by specifically trained primary care physical therapists. Therefore, the aims of this pilot-study are to evaluate the feasibility of a specifically for primary care physiotherapist developed biopsychosocial intervention ('Back on Track' intervention) in WPN3- classified patients, and to evaluate whether this 'Back on Track' intervention results in a significant improvement in functional disability in this subgroup of patients.
#Intervention
- OTHER : Back on Track intervention
- A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.
|
#Eligibility Criteria:
Inclusion Criteria:
* Chronic low back pain; defined as pain between scapulae and gluteal region, whether or not with radiation towards one or both legs, present for at least three months.
* Presence of contributing social and psychological factors, however not complex (WPN3-classification).
* Age between 18 and 65 year
* Sufficient knowledge of the Dutch language
* Acceptance towards the biopsychosocial approach instead of biomedical approach
Exclusion Criteria:
* Chronic low back pain attributable to e.g. infection, tumour, osteoporosis, fracture, structural deformation, inflammatory process, radicular syndrome or cauda equina syndrome
* Pregnancy
* Any suspicion of an (underlying) psychiatric disease, for which psychiatric treatment is better suited, according to the expert opinion of the consultant in rehabilitation medicine.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02245919
| 98,798
|
{
"NCT_ID" : "NCT06238193",
"Brief_Title" : "Molecular Characteristics of Early-onset Compared With Late-onset Colorectal Cancer",
"Official_title" : "Molecular Characteristics of Early-onset Compared With Late-onset Colorectal Cancer",
"Conditions" : ["Colorectal Cancer", "Microsatellite Instability"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-31",
"Study_Completion_Date(Actual)" : "2024-01-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-01-22",
"First_Posted(Estimated)" : 2024-02-02"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-02-01",
"Last_Update_Posted(Estimated)" : 2024-02-02",
"Last_Verified" : 2024-02"
}
}}
|
#Study Description
Brief Summary
The distribution rate of microsatellite instability-high (MSI-H) was significantly higher in early-onset colorectal cancer, and early-onset colorectal cancer has a specific mutational profile and relatively high programmed cell death ligand 1(PD-L1) expression, which may be used to guide personalized treatment to better control the disease.
Detailed Description
The prognosis of early-onset colorectal cancer (EOCRC) is worse than that of late-onset colorectal cancer (LOCRC), and the incidence has gradually increased in recent years, so it is necessary to study the pathogenesis and explore the target of early-onset colorectal cancer patients. In this study, investigators aimed to explore the specific molecular pathologic map of EOCRC by comparing LOCRC. This study enrolled 11,344 patients with colorectal cancer treated at the Colorectal Center of the First Affiliated Hospital of Nanjing Medical University from 2003 to 2022, of whom 578 were EOCRC and 10,766 were LOCRC. The tumor-related mutation status and tumor mutation burden (TMB) of patients were detected by next-generation sequencing technology. PD-L1 expression was detected by immunohistochemistry. The microsatellite instability was detected by polymerase chain reaction (PCR) coupled with capillary electrophoresis (2B3D NCI Panel) in all patients. Among the 11,344 patients, 180 patients with EOCRC and 90 patients with LOCRC patients underwent NGS investigation. Compared with LOCRC, EOCRC patients generally presented a later TNM stage, lower tumor differentiation, and poorer histological type. In LOCRC with MSI-H stupe, TNM stage is earlier than whom with MSI-L/MSS. In addition, the frequency of MSI-H was significantly higher in EOCRC (10.2%) than LOCRC (2.2%). The frequency of 7-mutation panel (ARID1A, FANCI, CASP8, DGFRA, DPYD, TSHR, and PRKCI) were relatively higher in LOCRC. In EOCRC group, the TNM stage of MSI-H subtype patients was earlier while harbored with worse tissue differentiation and higher proportion of mucinous adenocarcinoma. Besides, among the EOCRC patients, FBXW7, FAT1, ATM, ARID1A and KMT2B mutation frequencies were significantly increased in patients with MSI-H type. Comparing with MSI-H patients of LOCRC, the EOCRC patients with MSI-H presented a higher mutation frequencies of FGFBR2, PBRM1, RNF43, LRP1B, FBXW7, ATM and ARID1A. In addition, EOCRC patients were identified with higher tumor mutation burden, especially in the MSI-H type. PD-L1 expression calculated by tumor proportion score (TPS) was also elevated in EOCRC and correlated with MSI status.
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 18 <= age <= 75 years;
* Histologically proven colon or rectal adenocarcinoma.
Exclusion Criteria:
* Patients > 80 years;
* Recurrent colorectal cancer;
* Multiple primary tumors.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT06238193
| 219,579
|
{
"NCT_ID" : "NCT00571831",
"Brief_Title" : "The Effect of a Blue Light Filtering IOL",
"Official_title" : "The Effect of a Blue Light Filtering Intraocular Lens on Blood Retinal Barrier After Cataract Surgery",
"Conditions" : ["to Compare the Effect of Two Types of IOLs", "on the Incidence of Cystoid Macular Edema", "After Cataract Surgery"],
"Interventions" : ["Procedure: intraocular lens implantation"],
"Location_Countries" : ["Japan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-02",
"Study_Completion_Date(Actual)" : "2005-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-12-11",
"First_Posted(Estimated)" : 2007-12-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-12-11",
"Last_Update_Posted(Estimated)" : 2007-12-12",
"Last_Verified" : 2007-12"
}
}}
|
#Study Description
Brief Summary
To compare the effect on blood retinal barrier disruption 3 and 12 months after implantation of either a blue light filtering intraocular lens(blue-filtering IOL) or an ultraviolet light filtering intraocular lens(UV-filtering IOL).
Detailed Description
The following parameters were measured for evaluation of blood retinal barrier disruption.
* the incidence of macular leakage by fluorescence angiography (FA)
* the mean fluorescein concentration in the vitreous by fluorophotometry (VFP)
* the thickness of the macula by optical coherence tomography (OCT)
Results
* the incidence fo macular leakage decreased significantly from 24%(3 months) to 5% (12 months) in the blue-filtering IOL group (P\<0.05), and was significantly lower compared with the UV-filtering IOL group at 12 months.
* the VFP significantly decreased in both group from 3 to 12 months.
* the OCT decreased from 175 (3 months) to 166 um (12 months) in the blue- filtering IOL group.
#Intervention
- PROCEDURE : intraocular lens implantation
- Intraocular lens implantation
- Other Names :
- a blue-filtering IOL (ENV-13, Menicon Co.Ltd, Japan), an UV-filtering IOL (ES-13, Menicon Co.Ltd, Japan)
|
#Eligibility Criteria:
Inclusion Criteria:
* cataract patients
* All eligible for intraocular lens implantation
Exclusion Criteria:
* Patients had undergone an intraocular operation
* Patients had hypertensive retinopathy
* Patients had diabetic retinopathy
* Patients had ange-related macular degeneration
* no observable fundus
* The cataract operation was more than 30 minutes in duration
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00571831
| 11,765
|
{
"NCT_ID" : "NCT05057390",
"Brief_Title" : "HMF Preterm Case Studies",
"Official_title" : "Evaluating the Tolerance, Compliance, Acceptability and Safety of a New Human Milk Fortifier (NHMF) in Preterm Infants: a Case Study Series",
"Conditions" : ["Preterm Infants"],
"Interventions" : ["Dietary Supplement: New Human Milk Fortifier (NHMF)"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-12-16",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-12-31",
"Study_Completion_Date(Actual)" : "2021-12-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-09-06",
"First_Posted(Estimated)" : 2021-09-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-09-15",
"Last_Update_Posted(Estimated)" : 2022-02-17",
"Last_Verified" : 2022-02"
}
}}
|
#Study Description
Brief Summary
Nutritional requirements in preterm infants can be elevated, as a result of complex clinical circumstances including infections, immaturity of the gastrointestinal tract and invasive treatments, such as surgery which can place a greater metabolic demand on the body. Furthermore, these circumstances can impact an infant's ability to meet nutritional requirements and achieve optimum growth through normal feeding alone. Most preterm infants may need specialist care by the neonatal team during hospital admission and post-discharge, which includes enteral nutritional support.
Human Milk Fortifier (HMF) have become a component of the routine clinical care of preterm infants on neonatal units. There is published evidence to support this practice as being safe and effective. A multitude of trials have demonstrated improvements in weight, length and head circumference following interventions using HMF, compared to non-supplemented cohorts, and benefits have been observed at long term follow up.
Whilst HMF is used routinely in neonatal units, there is little clinical evidence for using them beyond discharge in the community, although this is widely accepted in practice. Nutricia have developed a new HMF (NHMF) that can be provided for use in the community.
This series of case-studies will evaluate the tolerance, compliance, acceptability and safety of the NHMF, in 15 preterm infants. Each case study will last at least 28 days, including at least 7 days in the community setting. The case studies will be conducted across multiple specialist neonatal centres in the UK, to meet the UK ACBS requirements.
#Intervention
- DIETARY_SUPPLEMENT : New Human Milk Fortifier (NHMF)
- The case study product will be added to human milk during the hospitalization and will continue after discharge for at least 1 week (7 days), to obtain community data. NHMF prescription will be specified on an individual basis by the investigating Dietitian responsible for the infant's nutritional management. The intervention period will end when the infant does not require NHMF (according to local neonatal guidelines and/or clinical indication).
The case study product will be labelled specifically for the case study and will be available in a powder format.
Full preparation, storage and safety instructions will be given to the parent/caregiver by the investigating Dietitian before commencing the case study product to ensure its correct and safe use.
|
#Eligibility Criteria:
Inclusion Criteria:
* Preterm infants fed own mother's milk (or donor human milk) requiring HMF (as decided by the investigator)
* Born before 37 weeks completed gestational age and >1 dropped centile since birth requiring HMF (as decided by the investigator)
* Tolerating adequate volume of enteral nutrition
* Expected to require HMF after discharge (minimum 4.0g NHMF per day at discharge)
* Written or electronic informed consent from parent/caregiver
Exclusion Criteria:
* Anticipated short term use of HMF leading to discontinuation of HMF after hospital discharge
* Presence of any relevant proven or suspected chromosomal anomaly or genetic syndrome, any gastrointestinal malformation/compromise, including Necrotising enterocolitis (NEC) (defined as Bell's stage two or higher), metabolic disorder, or congenital central nervous system malformation that may impact tolerance of enteral feeding
* Failure to establish enteral nutrition and requiring full parenteral nutrition
* Participation in other studies within 1 month prior to the entry of this study
* Known allergy to any of the study product ingredients, including cow's milk, fish and egg
* Concern or issues around the breast milk supply from mother of preterm infant at enrolment
* Investigator concerns around willingness/ability of the parent/caregiver to comply with protocol requirements and/or handle and store NHMF appropriately
Sex :
ALL
Ages :
- Maximum Age : 37 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05057390
| 128,319
|
{
"NCT_ID" : "NCT04689711",
"Brief_Title" : "Prognostic Models for COVID-19 Care",
"Official_title" : "Generalizable Prognostic Models for Patient-Centered Decisions in COVID-19",
"Conditions" : ["Covid19"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-12-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-08-31",
"Study_Completion_Date(Actual)" : "2021-08-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-11-20",
"First_Posted(Estimated)" : 2020-12-30"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-12-28",
"Last_Update_Posted(Estimated)" : 2022-01-20",
"Last_Verified" : 2022-01"
}
}}
|
#Study Description
Brief Summary
Approximately 20% of patients hospitalized with COVID-19 require intensive care and possibly invasive mechanical ventilation (MV). Patient preferences with COVID-19 for MV may be different, because intubation for these patients is often prolonged (for several weeks), is administered in settings characterized by social isolation and is associated with very high average mortality rates. Supporting patients facing this decision requires providing an accurate forecast of their likely outcomes based on their individual characteristics.
The investigators therefore aim to:
1. Develop 3 CPMs in each of 2 hospital systems (i.e., 6 distinct models) to predict:
i) the need for MV in patients hospitalized with COVID-19; ii) mortality in patients receiving MV; iii) length of stay in the ICU.
2. Evaluate the geographic and temporal transportability of these models and examine updating approaches.
1. To evaluate geographic transportability, the investigators will apply the evaluation and updating framework developed (in the parent PCORI grant) to assess CPM validity and generalizability across the different datasets.
2. To evaluate temporal transportability, the investigators will examine both the main effect of calendar time and also examine calendar time as an effect modifier.
3. Engage stakeholders to facilitate best use of these CPMs in the care of patients with COVID-19.
Detailed Description
There has been a proliferation of COVID-19 clinical prediction models (CPMs) reported in the literature across health systems, but the validity and potential generalizability of these models to other settings is unknown. Generally, most hospitals (and systems) do not have a sufficient number of cases (and outcomes) to develop models fit to their local population, and predictor variables are not uniformly and reliably obtained across systems. Therefore, pooling and harmonizing data resources and assessing generalizability across different sites is urgently needed to create tools that may help support decision making across settings. In addition, since best practices are rapidly evolving over time (e.g., proning, minimizing paralytics, lung-protective volumes, remdesivir, dexamethasone or other treatments), updating and recalibrating these CPMs is crucially important.
In the current PCORI Methods project, the investigators developed a CPM evaluation and updating framework including both conventional and novel performance measures. The investigators will use this framework to evaluate COVID-19 prognostic models in the largest cohort of COVID-19 patients examined to date, spanning 2 datasets from very different settings. As the COVID-19 pandemic affects different regions, with subsequent waves expected, identifying the most accurate, robust and generalizable prognostic tools is needed to guide patient-centered decision making across diverse populations and settings.
|
#Eligibility Criteria:
Inclusion Criteria:
* COVID-19 patient survivor
* Family member/caregiver of patient hospitalized for COVID-19
* Physician with experience caring for COVID-19 patients
* Other provider (pastoral care, nursing, respiratory therapy) with experience caring for COVID-19 patients
Exclusion Criteria:
* Not proficient in reading or speaking English
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04689711
| 236,350
|
{
"NCT_ID" : "NCT06053424",
"Brief_Title" : "Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease",
"Official_title" : "A Phase 1b Open Label Positron Emission Tomography Study to Assess Changes in Abdominal [11C]AZ14132516 Uptake Following Administration of Single Doses of AZD7798 to Healthy Participants and Patients With Crohn's Disease",
"Conditions" : ["Crohn's Disease"],
"Interventions" : ["Drug: [11C]AZ14132516", "Drug: AZD7798"],
"Location_Countries" : ["Sweden"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SEQUENTIAL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-09-25",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-10-08",
"Study_Completion_Date(Actual)" : "2024-10-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-08-30",
"First_Posted(Estimated)" : 2023-09-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-09-22",
"Last_Update_Posted(Estimated)" : 2024-11-21",
"Last_Verified" : 2024-11"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to measure the changes in small bowel uptake of radioligand \[11C\]AZ14132516 after IV administration of a single dose of AZD7798 in healthy participants and participants with Crohn's disease.
Study details include:
* The study duration will be variable (adaptive design).
* There will be 5 in-person study visits: 1 screening visit, 1 visit for the baseline PET examination, 1 residential (24h) visit for AZD7798 administration and 2 visits for repeated PET examinations. There will be a final follow-up virtual visit (telephone call).
#Intervention
- DRUG : AZD7798
- Solution
- DRUG : [11C]AZ14132516
- Radioligand
|
#Eligibility Criteria:
Inclusion Criteria:
HEALTHY PARTICIPANTS:
* Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
* Able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures.
* Participant must be >= 20 <= age <= 65 of age inclusive, at the time of signing the informed consent.
Type of Participant and Disease Characteristics
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory parameters, and cardiac monitoring before first administration of investigational product.
Weight
* Body weight within 50.0 to 100.0 kg and body mass index within the range 18.0 to 30.0 kg/m2 (inclusive).
* Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
(b) Male participants:
- Non-sterilised male participants who are sexually active with a female partner of childbearing potential must use a condom with spermicide during the study period and for at least 7 days following last radioligand administration and 4 months following last dose of AZD7798, whichever is longer.
- It is strongly recommended that female partners of male participants also use at least one highly effective method of contraception throughout this period.
- Male participants must refrain from fathering a child or donating sperm during the study period and for at least 7 days following last radioligand administration and 4 months following last dose of AZD7798, whichever is longer.
(c) Female participants: (i) Women of non-child bearing potential are defined as meeting one of the following criteria at screening:
- Postmenopausal defined as amenorrhoea for at least 12 months following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range.
- Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation.
(ii) WOCBP (ie, not meeting criteria above) must have a negative pregnancy test at screening and before PET examination.
(iii) If sexually active with a non-sterilised male partner, WOCBP must use at least one highly effective method of birth control during the study period and for at least 7 days following last radioligand administration and 4 months following last dose of AZD7798, whichever is longer.
(iv) It is strongly recommended that non-sterilised male partners of WOCBP participants use a male condom plus spermicide during the study period.
(v) WOCBP participants must not breastfeed and must not donate or retrieve ova for their own use during the study period and for at least 7 days following last radioligand administration and 4 months following last dose of AZD7798, whichever is longer (d) Highly effective methods of birth control (i) Methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:
* Combined (oestrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal)
* Progesterone-only contraception associated with inhibition of ovulation (oral, injectable or implantable)
* Intrauterine device or hormone-releasing system
* Bilateral tubal occlusion
* Vasectomised partner (only acceptable if the partner is the sole sexual partner of the participant and the vasectomised partner has received medical assessment of surgical success)
* Sexual abstinence as defined by refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. It is only acceptable if the preferred and usual lifestyle of the participant.
PARTICIPANTS WITH CROHN'S DISEASE
<!-- -->
* As for Healthy Participants (IC#1) procedures.
* Participant must be >= 20 <= age <= 65 of age inclusive, at the time of signing the informed consent.
* Participants with confirmed Crohn's disease with small bowel involvement per study gastroenterologist (diagnosed via combination of clinical findings and at least one of endoscopy and/or histology and/or imaging) with diagnosis made at least 3 months prior to screening.
* Body weight within 50.0 to 100.0 kg and body mass index within the range 18.0 to 30.0 kg/m2 (inclusive).
* As for Healthy Participants (IC#6).
Exclusion Criteria:
HEALTHY PARTICIPANTS:
* Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, haematological disease, hepatic disease, renal disease, gastrointestinal disease, or other major disease.
* History of cancer with the following exceptions
(a) Solid malignancy with curative therapy completed at least 5 years prior to screening (b) Basal cell carcinoma or localised squamous cell carcinoma of the skin or in-situ carcinoma of the cervix, provided that curative therapy was completed at least 12 months prior to screening
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to biologic therapies.
* Participants with unstable hypertension (as judged by the Investigator) or symptomatic hypotension, history of pre-syncope or syncope due to orthostatic hypotension and/or induced by change of posture (orthostatic hypotension defined as 25 mmHg decrease in systolic and/or 15 mmHg).
* Significant abnormalities on clinical examination, including neurological and physical examination, vital signs and ECG.
* Chemistry, haematology, or urine analysis results that may interfere with the study or present a safety risk to the participant.
* Leukocyte, lymphocyte or neutrophil counts below the LLN. A re-test is allowed during screening in cases of mild leukopenia clinically suspected to be transient.
* Abnormal vital signs, after 10 minutes of supine rest as judged by the investigator. As a guide, any readings outside the following should be considered in the evaluation:
1. systolic BP >= 150 mmHg
2. diastolic BP >= 90 mmHg
3. heart rate <= 35 bpm or >= 100 bpm The inclusion of participants meeting the above criteria may be decided on a case-by case basis by the Principal Investigator.
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. This may include participants with any of the following:
(a) PR (PQ) interval prolongation of clinical significance as judged by the Investigator (b) Intermittent second or third-degree AV block (AV block II Mobitz type 1, Wenchebach, while asleep or in deep rest is not disqualifying) (c) Incomplete, full, or intermittent bundle branch block (QRS <= 110 ms with normal QRS and T wave morphology is acceptable if there is no evidence of left ventricular hypertrophy) (d) Abnormal T wave morphology (e) Prolonged QTcF >= 470 ms or shortened QTcF <= 340 ms or a family history of long QT syndrome The inclusion of participants meeting the above criteria may be decided on a case-by case basis by the Principal Investigator.
* Positive hepatitis B, hepatitis C or HIV serology as defined by:
(a) HBsAg or anti-HBc Ab positivity (b) Anti-HCV Ab positivity (c) Anti-HIV Ab positivity Prior/Concomitant Therapy
* Participants must abstain from taking prescription or non-prescription drugs (including vitamins, recreational drugs, and dietary or herbal supplements) within 7 days or 5 halflives (whichever is longer) before the start of study intervention until completion of the follow-up visit, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
* Current drug abuse or dependence or positive screen for drugs of abuse at screening visit.
* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
* Suffers from claustrophobia that limits the ability to undergo the scanning procedure.
* Positive SARS-CoV-2 rapid antigen test at screening.
* Any other reason that, in the study PI opinion, prohibits the inclusion of the participants into the study.
* Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
* Live or attenuated vaccine within 4 weeks of Screening and until the end of the follow-up period and until 12 weeks after the end of the follow-up period (1 year for BCG vaccination).
* An active infection, or history of serious infection within the preceding 28 days.
* Use of antibiotics within 28 days prior to the first administration of IMP, unless, in the opinion of the investigator, the medication will not interfere with the study.
* History of symptomatic herpes simplex (excluding cold sores) or herpes zoster infection within 3 months prior to screening.
* Positive or indeterminate tuberculosis (TB) QuantiFERON test.
* Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days/5 half-lives, whichever is longer, of the first administration of IMP in this study. The period of exclusion begins 30 days/5 half-lives, whichever is longer, after the final dose.
* Participation in a PET imaging research study within last year.
PARTICIPANTS WITH CROHN'S DISEASE
* Current diagnosis of ulcerative colitis, indeterminate colitis, inflammatory bowel disease unclassified, infectious colitis, or ischaemic colitis.
* History of CMV colitis within 12 months prior to screening.
* Complications of Crohn's Disease including short bowel syndrome, strictures/stenoses with symptomatic obstruction or pre-stenotic dilation, or other conditions where surgery may be anticipated during the study period.
* Planned bowel or perianal surgery for Crohn's disease prior to end of study follow up visit.
* Recent bowel resection surgery within 6 months of screening.
* Participants with undrained fistula or abscess, including active perianal disease.
* Positive C. difficile toxin test during screening.
* Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, haematological disease, hepatic disease, renal disease, gastrointestinal disease, or other major diseases other than active Crohn's disease.
* History of cancer with the following exceptions (a) Solid malignancy with curative therapy completed at least 5 years prior to screening (b) Basal cell carcinoma or localised squamous cell carcinoma of the skin or in-situ carcinoma of the cervix, provided that curative therapy was completed at least 12 months prior to screening
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to biologic therapies.
* Participants with unstable hypertension (as judged by the Investigator) or symptomatic hypotension, history of pre-syncope or syncope due to orthostatic hypotension and/or induced by change of posture (orthostatic hypotension defined as 25 mmHg decrease in systolic and/or 15 mmHg).
* Significant abnormalities on clinical examination, including neurological and physical examination, vital signs and ECG other than signs of Crohn's disease.
* Chemistry, haematology, or urine analysis results that may interfere with the study or present a safety risk to the participant.
* Abnormal vital signs, after 10 minutes of supine rest as judged by the investigator. As a guide, any readings outside the following should be considered in the evaluation:
(a) systolic blood pressure (BP) >= 150 mmHg (b) diastolic BP >= 90 mmHg (c) heart rate <= 35 bpm or >=100 bpm The inclusion of participants meeting the above criteria may be decided on a case-by case basis by the Principal Investigator.
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. This may include participants with any of the following:
1. PR (PQ) interval prolongation of clinical significance as judged by the Investigator
2. Intermittent second or third-degree AV block (AV block II Mobitz type 1, Wenchebach, while asleep or in deep rest is not disqualifying)
3. Incomplete, full, or intermittent bundle branch block (QRS <= 110 ms with normal QRS and T wave morphology is acceptable if there is no evidence of left ventricular hypertrophy)
4. Abnormal T wave morphology
5. Prolonged QTcF >= 470 ms or shortened QTcF <= 340 ms or a family history of long QT syndrome.
The inclusion of participants meeting the above criteria may be decided on a case-by case basis by the Principal Investigator.
* Positive hepatitis B, hepatitis C or HIV serology as defined by:
1. HBsAg or anti-HBc Ab positivity
2. Anti-HCV Ab positivity and HCV RNA positivity
3. Anti-HIV Ab positivity Prior/Concomitant Therapy
* Treatment with an anti-TNF biologic within 8 weeks of first dose and throughout the study period, unless therapeutic drug monitoring is performed and drug concentrations are undetectable.
* Treatment with any biologic, other than an anti-TNF (including vedolizumab and ustekinumab) within 12 weeks prior to first dose and throughout the study period, unless therapeutic drug monitoring is performed and drug concentrations are undetectable.
* Treatment with rituximab within 12 months prior to first dose and throughout the study period.
* Treatment with Sphingosine-1-phosphate receptor modulators within 12 weeks prior to first dose and throughout the study period.
* Treatment with Janus Kinase inhibitors within 2 weeks prior to first dose and throughout the study period
* Treatment with apheresis (eg, Adacolumn, Cellsorba) within 2 weeks prior to first dose and throughout the study period.
* Treatment with corticosteroids at a total daily dose of greater than 20 mg prednisone or equivalent.
* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
* Suffers from claustrophobia that limits the ability to undergo the scanning procedure.
* Positive SARS-CoV-2 rapid antigen test at screening.
* Any other reason that, in the study PI opinion, prohibits the inclusion of the participants into the study.
* Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
* Live or attenuated vaccine within 4 weeks of Screening and until 12 weeks after the end of the follow-up period (1 year for Bacillus Calmette-Guerin vaccination).
* An active infection, or history of serious infection within the preceding 28 days.
* History of symptomatic herpes simplex (excluding cold sores) or herpes zoster infection within 3 months prior to screening.
* Positive or indeterminate TB QuantiFERON test performed within 1 year of screening (without known interval exposure to TB) or during screening period unless evidence of completion of full treatment course for latent TB with no clinical symptoms or signs indicative of re-activation.
* Chest x-ray with signs of malignancy or latent or active TB infection performed within 1 year of screening (without known interval exposure to TB) or during screening period.
* Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days/5 half-lives, whichever is longer, of the first administration of IMP in this study. The period of exclusion begins 30 days/5 half-lives, whichever is longer, after the final dose.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06053424
| 105,710
|
{
"NCT_ID" : "NCT01123343",
"Brief_Title" : "Clinical Evaluation of TrueVision System: LRI and Capsulorhexis Templates",
"Official_title" : "CLINICAL EVALUATION OF THE TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY: LRI AND CAPSULORHEXIS TEMPLATES",
"Conditions" : ["Subjects Undergoing Cataract Surgery and Insertion of IOL"],
"Interventions" : ["Device: TrueVision 3D Visualization and Guidance System for MicroSurgery"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-06",
"Study_Completion_Date(Actual)" : "2010-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-05-12",
"First_Posted(Estimated)" : 2010-05-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-05-12",
"Last_Update_Posted(Estimated)" : 2015-06-29",
"Last_Verified" : 2015-06"
}
}}
|
#Study Description
Brief Summary
To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery. Device images, safety results and surgeon questionnaire will demonstrate that the TrueVision system provides clear images to assist surgeons during LRI or capsulorhexis procedures.
#Intervention
- DEVICE : TrueVision 3D Visualization and Guidance System for MicroSurgery
- Adjunct imaging tool (to the microscope oculars) that provides onscreen video guidance for alignment, orientation, and sizing during eye surgery, based on a surgeon's defined nomogram
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy eye with no previous ocular surgery
* Natural lens for which phacoemulsification extraction and posterior IOL implantation is planned
* Clear intraocular media other than cataract
* Potential visual acuity 20/30 or better
* Able to comply with preop and postop examination procedures
* Signed and dated informed consent
Exclusion Criteria:
* Keratometric astigmatism > 2.5 diopters
* Corneal pathology potentially affecting topography including corneal degeneration
* Irregular astigmatism
* Macular degeneration or any other macular disease which reduces potential acuity
* Previous corneal surgery (including LASIK, radial keratotomy, penetrating keratoplasty, etc)
* Use of systemic or ocular medications that affects vision
* Acute or chronic systemic or ocular disease or illness that would increase risk or confound study results
* Use of Flomax or any other medication which negatively impacts surgical outcomes
* History of ocular trauma or ocular surgery
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01123343
| 145,509
|
{
"NCT_ID" : "NCT01129687",
"Brief_Title" : "Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy",
"Official_title" : "Multicenter Prospective Analysis of Treatment Outcome in Patients With Large Acoustic Neuromas",
"Conditions" : ["Neuroma, Acoustic"],
"Interventions" : ["Procedure: Stereotactic radiation therapy", "Procedure: Microsurgery"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-05-08",
"Study_Completion_Date(Actual)" : "2022-05-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-03-10",
"First_Posted(Estimated)" : 2010-05-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-05-24",
"Last_Update_Posted(Estimated)" : 2022-05-10",
"Last_Verified" : 2022-05"
}
}}
|
#Study Description
Brief Summary
The investigators study is to investigate safety and efficacy of performing a planned incomplete removal of large acoustic neuroma tumors to decrease surgical morbidity and yet avoid tumor recurrence by post-operative radiation therapy.
Detailed Description
The current standard treatment of a large tumor of the balance nerve (acoustic neuroma or vestibular schwannoma) is surgical resection. Complete removal of such tumor is associated with significant risks of hearing loss and facial paralysis whereas incomplete removal of the tumor is associated with significant risks of regrowth. Stereotactic radiation is a well accepted therapy aiming at stopping the growth of smaller acoustic neuromas before their sizes become large enough to cause problems. The purpose of our study is to determine whether the combination of subtotal resection followed by stereotactic radiation of the remnant can control large acoustic neuromas without the significant risks associated with complete resection.
#Intervention
- PROCEDURE : Microsurgery
- Patient would under to total, near-total, or subtotal resection of tumor
- PROCEDURE : Stereotactic radiation therapy
- Patient who has sign of growth of tumor remnant would undergo this treatment
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients with acoustic neuromas the widest diameter of 2.5 cm or larger at the cerebellopontine angle are eligible for this trial.
* Patients that are deemed good surgical candidates based on age, general health, genetic predispositions, and hearing in contralateral side would be included as the subjects of this trial.
* Although we would include patients with neurofibromatosis II in this trial, considering their genetic predisposition for recurrence, we would analyze their outcome as a separate group.
Exclusion Criteria:
* Patients who have received any form of treatment of their acoustic neuromas prior to enrollment in the study including surgery or radiation therapy.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01129687
| 230,195
|
{
"NCT_ID" : "NCT00490347",
"Brief_Title" : "VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial",
"Official_title" : "Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Feasibility Trial",
"Conditions" : ["End-Stage Heart Failure", "Cardiomyopathies"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-07",
"Study_Completion_Date(Actual)" : "2007-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-06-20",
"First_Posted(Estimated)" : 2007-06-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-06-21",
"Last_Update_Posted(Estimated)" : 2008-01-17",
"Last_Verified" : 2008-01"
}
}}
|
#Study Description
Brief Summary
The purpose of this trial is to determine the safety and feasibility of the VentrAssist LVAD in providing circulatory support for patients who require an LVAD as a bridge to cardiac transplantation.
#Intervention
- DEVICE : VentrAssist Left Ventricular Assist Device
|
#Eligibility Criteria:
Inclusion Criteria (The following are general criteria; more specific criteria are included in the study protocol):
* Approved and listed for cardiac transplantation.
* Patient for whom LVAD implantation is planned as a clinically indicated bridge to cardiac transplantation.
Exclusion Criteria(The following are general criteria; more specific criteria are included in the study protocol):
* Presence of heart conditions that would contraindicate LVAD implantation by adversely affecting patient survival or LVAD function.
* Primary coagulopathy or platelet disorder; contraindication to anticoagulant or anti-platelet agents.
* Presence of any mechanical circulatory support other than intra-aortic balloon pump.
* Therapy with an investigational intervention at the time of screening.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00490347
| 242,888
|
{
"NCT_ID" : "NCT05222347",
"Brief_Title" : "Immunomodulatory and Preventive Effects of Olive Leaf Tea Against COVID-19",
"Official_title" : "Evaluation of the Immunomodulatory and Preventive Effects of Olive Leaf Tea Against COVID-19",
"Conditions" : ["Immunomodulation"],
"Interventions" : ["Dietary Supplement: Olive Leaf Tea"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-09-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-03-04",
"Study_Completion_Date(Actual)" : "2021-09-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-02-01",
"First_Posted(Estimated)" : 2022-02-03"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-02-01",
"Last_Update_Posted(Estimated)" : 2022-02-03",
"Last_Verified" : 2022-02"
}
}}
|
#Study Description
Brief Summary
During the Coronavirus Disease-2019 (COVID-19) pandemic, in addition to the current measures, boosting the immune system seems to be one of preventive measures that can be taken against COVID-19 infection. Various natural agents have been recommended to boost the immune system. The aim of this study was to investigate the possible immunomodulatory and preventive effects of Olive Leaf Tea (OLT) drinking with regards to COVID-19 infection. The study was conducted among 249 workers in a tractor factory where OLT was served. Of the 249 workers, 168 of them were OLT drinkers and 81 were not OLT drinkers. Drinking at least one cup of OLT per day for a minimum of one month was the inclusion criteria used in the study. The workers with a history of infection or vaccination of COVID-19 were excluded. Lymphocyte subsets, IL2, INF-gamma, specific IgM, and IgG levels were analyzed in all the study subjects. The results showed higher values of CD3-/CD16/56 (NK) cells, CD3+/CD16/56 (NKT) cells, total NK (NK+NKT) cells, and serum IFN-gamma and IL-2 levels in OLT drinkers as compared to the nondrinkers. These immune changes are indicative of immune defense mechanisms. Although all the OLT drinkers and non-drinkers reported no history of COVID-19, specific COVID-19 IgG levels were found positive in 60% of OLT drinkers and 38% OLT non-drinkers. There were significant negative correlations between age and NK cells, number of cigarettes smoked and NK cells, number of cigarettes smoked and TNK; and there were positive correlations between OLT drinking frequency and TNF-alpha, IL-2 and IFN-gamma. Also, serum creatinine levels in OLT non-drinkers were found significantly higher than in the OLT drinkers. In conclusion, drinking OLT may contribute fighting against COVID-19 by boosting the innate immune system.
Detailed Description
Coronavirus Disease-2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It emerged out of China in late 2019 and rapidly led to a pandemic in early 2020. As the mutations of the virus continue to increase, the pandemic has become difficult to control and no specific treatment has been proven to be effective.
According to the European Centre for Disease Prevention and Control (ECDC), until a safe and effective vaccine is available, non-pharmaceutical tools are accepted as the most effective public health interventions against COVID-19. World Health Organization (WHO) states that in addition to public health and social measures, it is also beneficial for individuals to maintain a balanced diet, stay well hydrated, exercise regularly and sleep well.
It is now clear that there is a close interaction between the COVID-19 and the immune system of an individual resulting in diverse clinical manifestations of the disease. While some patients present severe complications, some individuals remain asymptomatic. Weakened immunity is responsible for most COVID-19 deaths, therefore, elderly people with chronic diseases are considered at high risk from COVID-19.
As soon as SARS-CoV-2 binds to angiotensin converting enzyme 2 (ACE2) receptors and releases viral RNA for replication, both the innate and adaptive immune responses are triggered. Natural killer (NK) cells are innate effector lymphocytes that play a critical role in the first line of defense against tumor cells and viral infections. They are essential in the early immune response against viral infections, mainly through the clearance of virus-infected cells. Human NK cells, CD3-CD56+ NK, represent an average of 15% of peripheral blood and they can be subdivided based on the relative expression of the surface markers CD16 and CD56. Additionally, in chronic viral infections, CD56-CD16+ NK cells are expanded and seems to represent an exhausted/anergic subset of NK cells. Through several mechanisms, NK cells provide exocytosis of perforin and granzyme causing lysis of the infected cell, Fas ligand-mediated induction of apoptosis, and antibody-dependent cellular cytotoxicity (ADCC), while having an essential role as immunomodulatory cells that bridge the innate and adaptive immune responses. Natural killer T cells (NKT) are cells that express a semi-invariant T cell receptor (TCR). Crucial cytokines for the cytotoxic activity of NK and NKT cells are IL-2 and INF-gamma, and these cytokines enhance the killing properties and proliferation of these cells. Both IL-2 and IFN-gamma secretions are induced in a healthy young individual while this effect decreases in the elderly.
Immune system boosting nutrition may play a role to lower the risk of infections by inhibiting virus replication, promoting virus clearance, inducing tissue repair, and triggering a prolonged adaptive immune response against viruses. Besides, certain medicinal plants are known for their antiviral bioactivities and immune boosting capacity. Some herbs have immunomodulatory potential and can be applied as a preventive medicine to combat COVID-19. Olive-leaf tea (OLT) is widely used in the traditional medicine in the Mediterranean region. Due to the high concentration of phenolic compounds, of which most abundant is oleuropein, interest in olive leaf has increased recently. The components of the olive leaves are known for their immune-modulatory, anti-inflammatory, antioxidant, hypoglycemic, antihypertensive, antimicrobial, and anti-atherosclerotic effects. Although its antiviral mechanism of action is not fully known, many studies have been conducted on the antiviral effects of olive leaf extract . However, studies on the protective or immune system strengthening effect of olive leaf extract against viral diseases are limited. There is only one available in vitro study that shows olive leaf extract alters the immune response by increasing the number of CD8 + and NK cells and IFN-gamma. The aim of this study is to investigate the possible immunomodulatory and preventive effects of OLT against COVID-19.
#Intervention
- DIETARY_SUPPLEMENT : Olive Leaf Tea
- Olive-leaf tea (OLT) is widely used in the traditional medicine in the Mediterranean region. Due to the high concentration of phenolic compounds, of which most abundant is oleuropein, interest in olive leaf has increased recently \[22, 23\]. The components of the olive leaves are known for their immune-modulatory, anti-inflammatory, antioxidant, hypoglycemic, antihypertensive, antimicrobial, and anti-atherosclerotic effects \[24, 25\]. Although its antiviral mechanism of action is not fully known, many studies have been conducted on the antiviral effects of olive leaf extract .
|
#Eligibility Criteria:
Inclusion Criteria:
* Health male subjects aged between 20 <= age <= 60
Exclusion Criteria:
*Those who drank less than three cups of OLT a day were excluded from the study.
Sex :
MALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05222347
| 262,943
|
{
"NCT_ID" : "NCT02690168",
"Brief_Title" : "Testing Glial Pathways to HAAF in Human Subjects Using Carbon 13 Magnetic Resonance Spectroscopy",
"Conditions" : ["Diabetes Complications", "Hypoglycemia"],
"Interventions" : ["Behavioral: Fasting"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-03-27",
"Study_Completion_Date(Actual)" : "2017-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-01-27",
"First_Submitted_that_Met_QC_Criteria" : 2021-06-28",
"First_Posted(Estimated)" : 2016-02-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-02-18",
"Last_Update_Posted(Estimated)" : 2021-07-19",
"Last_Verified" : 2021-06"
}
}}
|
#Study Description
Brief Summary
Hypoglycemia-associated autonomic failure (HAAF), a condition commonly developed in diabetic patients, which causes them to have severely low blood sugar levels. This condition makes clinical management of blood sugar in diabetic patients very challenging. This research seeks to better understand how diabetic patients develop HAAF, and what can be done to prevent it.
Detailed Description
Following the detection of severe hypoglycemia by the central nervous system (CNS), a series of physiological countermeasures are triggered which return serum glucose to euglycemic levels. This vital homeostatic response frequently becomes dysfunctional in both type 1 and type 2 diabetics, leaving them particularly vulnerable to life threatening bouts of hypoglycemia. This dysfunction, often termed hypoglycemia-associated autonomic failure (HAAF), is thought to be caused by maladaptive changes in the CNS. Currently, progress towards rectifying this HAAF is severely hindered by a lack of knowledge regarding the exact nature of these maladaptive changes and the antecedent events which cause them. Previous work by the PI, as well as others, has identified altered glial metabolism as a potential biological substrate driving HAAF. The alterations in glial metabolism associated with HAAF are strikingly similar to those induced by prolonged dietary restriction in rodents. This raises the intriguing possibility that HAAF may be driven by glial adaptations, normally induced only by prolonged starvation, which are triggered in diabetic individuals by treatment-induced exposure to severe hypoglycemia. The primary goal of our pilot project is to conduct a prospective observational study in humans to test the hypothesis that prolonged fasting will induce changes in glial metabolism similar to those previously measured in individuals with HAAF. The investigators will accomplish this goal via the following specific aims: Aim 1: Using a prospective observational study design in humans, test whether a 72 hour fast will induce acute alterations in glial metabolism, Aim 2: Determine if changes in plasma glucose and leptin levels following prolonged fasting are correlated with changes in glial adaptation. The investigators will utilize innovative 13C magnetic resonance spectroscopy to measure alterations in glial metabolism and substrate preference following acute dietary restriction in healthy young individuals. By demonstrating that metabolic adaptations of glial cells induced by prolonged fasting are similar to those previously associated with HAAF, the investigators can provide key insights into the precursors that may lead to the development of HAAF in diabetic individuals.
#Intervention
- BEHAVIORAL : Fasting
- 72 hour fasting
|
#Eligibility Criteria:
Inclusion Criteria:
* Male
* BMI 20.0 <= age <= 24.9 kg/m2
* 18 <= age <= 40 years
* Willing to reside at Pennington Biomedical for 4 days
Exclusion Criteria:
* Type 1 diabetes mellitus
* Type 2 diabetes mellitus
* Fasting glucose >= 110 mg/dL (determined at screening visit)
* Hyperketonuria >15 mg/dL, (determined at screening visit)
* Contraindication to MRI
* History of or current eating disorder
* History of obsessive compulsive disorder
* Current use of any medication (excluding over-the-counter pain medication)
* Contraindication to prolonged fasting
* Consume >10 alcoholic drinks/week
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02690168
| 120,319
|
{
"NCT_ID" : "NCT05099081",
"Brief_Title" : "Effectiveness of Diode Laser and Sclerotherapy in Treatment of Oral Pyogenic Granuloma",
"Official_title" : "Effectiveness of Diode Laser Versus Sclerotherapy in the Treatment of Oral Pyogenic Granuloma: a Randomized-controlled Clinical Trial",
"Conditions" : ["Pyogenic Granuloma of Gingiva"],
"Interventions" : ["Procedure: intra-lesional injection of ethanolamine oleate", "Procedure: diode laser application"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-12-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-09-01",
"Study_Completion_Date(Actual)" : "2021-09-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-09-09",
"First_Posted(Estimated)" : 2021-10-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-10-18",
"Last_Update_Posted(Estimated)" : 2021-10-29",
"Last_Verified" : 2021-09"
}
}}
|
#Study Description
Brief Summary
To clinically assess the effectiveness of diode laser versus sclerotherapy in the treatment of oral pyogenic granuloma.
A randomized-controlled clinical trial conducted on 20 patients with oral pyogenic granuloma. Patients were assigned into two groups. Group I treated by diode laser1; group II treated by injection of ethanolamine oleate2 as sclerosing agent. All patients were clinically assessed for pain, bleeding during surgery and healing quality; 1st week, 2nd week and 4th week. The patients were followed up after 3 months from the end of treatment.
Detailed Description
Background: Pyogenic granuloma (PG) is one of the most common reactive hyperplasia that causes soft tissue enlargement. It affects skin and oral mucosa. The traditional treatment for oral PG is conservative surgical excision with cold blade together with the removal of causative irritant or source of trauma. Bleeding susceptibility, healing quality and pain represent common complications following surgical excision of pyogenic granuloma. Sclerosing agents are widely used in the treatment of pyogenic granuloma as it is a conservative non painful procedure. The use of lasers in dentistry have grown in the last 4 decades. It has proved its efficacy in the treatment of pyogenic granuloma.
Study objective: Study will be conducted to evaluate healing quality of using diode laser versus sclerotherapy (Ethanolamine oleate) in the treatment of oral pyogenic granuloma.
Materials and Method: This randomized controlled clinical trial will include 20 patients with pyogenic granuloma, divided equally into two groups. Group-I (test group) will be managed by application of diode laser. Group- II (control group) will be managed by injection of ethanolamine oleate as sclerosing agent on weekly injection visits. Patients of both groups will be evaluated intraoperatively for bleeding severity and postoperatively in terms of pain at the 2nd and 7th day and healing quality.
Results: Results will be tabulated and statistically analysed.
#Intervention
- PROCEDURE : diode laser application
- Local anesthesia will be applied Lesion will be excised with diode laser (Medency, Italy) continuous wave mode 980 nm wave length with an output power 3 W in contact mode
- PROCEDURE : intra-lesional injection of ethanolamine oleate
- Local anesthesia will be applied Injection of ethanolamine oleate (sclerosing gent) with concentration 5% diluted in distilled water to form 2.5% ethanolamine oleate According to lesion size range from 1.5 to 3 ml of solution will be injected slowly into lesion using gauge needle until leaked from lesion.
Lesion will be compressed for 5 minutes. Lesion will be observed once a week after injection until it becomes necrotic and falls off spontaneously.
Repeated injection may be needed.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients of both genders diagnosed clinically and confirmed histologically with oral pyogenic granuloma.
* Size of the lesion not less than 5mm.
* Patients included in the study will be having gingival pyogenic granuloma as it is the most common site for its occurrence.
* Patient age ranges from 19 <= age <= 50 old.
Exclusion Criteria:
* Patients with uncontrolled diabetes.
* Immuno-compromised patients.
* Patients with renal disease.
* Patients having coagulation disorders.
* Patients having allergic reaction to any of the sclerosing drug constituents.
* Pregnant and lactating women.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05099081
| 117,168
|
{
"NCT_ID" : "NCT01640990",
"Brief_Title" : "A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intravenous Infusion of GW328267X in Healthy Volunteers",
"Official_title" : "A Single-centre, Escalating Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Slow Intravenous Infusion of GW328267X in Healthy Volunteers",
"Conditions" : ["Lung Injury, Acute"],
"Interventions" : ["Drug: GW328267X (total dose of 12mcg)", "Drug: GW328267X (total dose of 40mcg)", "Drug: Saline"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "OTHER",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-11-22",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-12-09",
"Study_Completion_Date(Actual)" : "2011-12-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-07-12",
"First_Posted(Estimated)" : 2012-07-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-07-12",
"Last_Update_Posted(Estimated)" : 2017-06-12",
"Last_Verified" : 2017-06"
}
}}
|
#Study Description
Brief Summary
This study is a single dose evaluation using an open label dose escalating design. Cohort1 will consist of 3 healthy male volunteers. Each volunteer will receive a slow IV infusion over 6 hours consisting of saline for 30 minutes (run in period), 8 mcg/h GW328267X for 1.5 hours (total dose of 12mcg) and 10 mcg/h GW328267X for 4 hours (total dose of 40 mcg). Subjects will have continuous cardiac monitoring throughout the dosing period and up to 2 hours after cessation of the intravenous infusion. PK measurements and measurement of erythropoietin and platelet activation will also be done. Samples for PK will be taken at 30 minute intervals during the infusion of GW328267X up to and including 1 hour after cessation of the intravenous infusion. Samples for erythropoietin and platelet aggregation will be done.
Cohort 2 is optional and may be carried out in the event that the dose of GW328267X given in Cohort 1 is both well tolerated and subjects do not meet the stopping criteria. The decision to proceed to Cohort 2 and the dose level will be made by the GSK Study Team and the Investigator based on safety, tolerability and preliminary PK/PD data obtained in Cohort 1. It is planned that the maximum total dose given to any subject will not exceed 150mcg. Cohort 2 will consist of 3 healthy male volunteers and the study procedures for this additional Cohort will be the same as that described for Cohort 1.
#Intervention
- DRUG : Saline
- 30mins run-in period
- DRUG : GW328267X (total dose of 12mcg)
- 8 mcg/h for 1.5 hours (total dose of 12mcg)
- DRUG : GW328267X (total dose of 40mcg)
- 10 mcg/h for 4 hours (total dose of 40 mcg)
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Male, between 18 and 45 years inclusive, at the time of signing the informed consent.
* Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until the follow up visit.
* Body weight >= 50 kg and BMI within the range 18.5 - 29.9 kg/m2 (inclusive).
* Heart rate within the range 50 - 85 bpm (inclusive) and blood pressure range between 115/60 - 140/90 mmHg (inclusive) at Screening and Day 1.
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Single QTcF < 450 msec.
* 24-hour Holter monitoring at screening within normal limits.
* Peripheral veins suitable for venous blood sampling and cannulation
Exclusion Criteria:
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* A positive pre-study drug/alcohol screen.
* A positive test for HIV antibody.
* Have history of any pre-existing cardiac arrhythmias (including sinus tachycardia, atrial fibrillation or flutter) or finding on baseline examination that, in the opinion of the investigator, may place the subject at an unacceptable risk as a participant in this trial or may interfere with interpretation of cardiovascular safety results during the conduct of the trial.
* Current or history of asthma (with the exception of a history of asthma in childhood only).
* Urinary cotinine levels indicative of smoking or a history of regular use of tobacco nicotine-containing products within 6 months prior to screening.
* History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 21 units. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* Use of prescription or non-prescription drugs, with the exception of simple analgesics but including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* Unwillingness or inability to follow the procedures outlined in the protocol.
* Subject is mentally or legally incapacitated.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01640990
| 183,794
|
{
"NCT_ID" : "NCT02499406",
"Brief_Title" : "Dialectical Behavior Therapy Skills Group Pilot Evaluation",
"Official_title" : "Dialectical Behavior Therapy Skills Group Pilot Evaluation",
"Conditions" : ["Suicidal Ideation", "Emotions"],
"Interventions" : ["Behavioral: Dialectical behavior therapy skills group"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-03",
"Study_Completion_Date(Actual)" : "2017-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-06-01",
"First_Submitted_that_Met_QC_Criteria" : 2019-12-10",
"First_Posted(Estimated)" : 2015-07-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-07-13",
"Last_Update_Posted(Estimated)" : 2021-01-20",
"Last_Verified" : 2020-01"
}
}}
|
#Study Description
Brief Summary
Uncontrolled pilot study examines feasibility, acceptability, and preliminary efficacy of Dialectical Behavior Therapy skills group for Veterans with suicidal ideation and emotion dysregulation.
Detailed Description
Uncontrolled pilot study to examine feasibility, acceptability, and preliminary efficacy of Dialectical Behavior Therapy skills group for Veterans with suicidal ideation and emotion dysregulation. Outcome measures will occur at pre-treatment, mid, end, and follow-up.
#Intervention
- BEHAVIORAL : Dialectical behavior therapy skills group
- Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
|
#Eligibility Criteria:
Inclusion Criteria:
* Veterans at VACHS who are referred or self-referred to DBT Skills Group
* Ages 18 <= age <= 65
* Able to understand written and spoken English
* DERS score 105 or greater
* Suicidal ideation within past 3 months
* Seeing an individual mental health provider at VACHS at least monthly
* Willing to create or review a Mental Health Safety Plan, and stated willingness to use this plan to maintain safety
* Consent to participate in study assessments
* Consent to recording of group sessions
Exclusion Criteria:
* Inability to understand written or spoken English
* Diagnosis of schizophrenia, schizoaffective disorder, bipolar I, antisocial personality disorder, or thought disorder in CPRS problem list and confirmed by current mental health provider
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02499406
| 139,820
|
{
"NCT_ID" : "NCT00603291",
"Brief_Title" : "BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus",
"Official_title" : "A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients With Type 2 Diabetes Mellitus Managed With Oral Hypoglycemic Agent(s)",
"Conditions" : ["Obesity"],
"Interventions" : ["Drug: Lorcaserin 10 mg twice a day (BID)", "Drug: Matching Placebo", "Drug: Lorcaserin 10 mg once daily (QD)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-06",
"Study_Completion_Date(Actual)" : "2010-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-01-17",
"First_Submitted_that_Met_QC_Criteria" : 2013-01-04",
"First_Posted(Estimated)" : 2008-01-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-01-17",
"Last_Update_Posted(Estimated)" : 2019-10-02",
"Last_Verified" : 2019-08"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral hypoglycemic agents.
#Intervention
- DRUG : Lorcaserin 10 mg once daily (QD)
- Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
- Other Names :
- APD356
- DRUG : Lorcaserin 10 mg twice a day (BID)
- Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
- Other Names :
- APD356
- DRUG : Matching Placebo
- Matching placebo tablet each morning and evening for a duration of 52 weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* Overweight/obese men and women with type 2 diabetes mellitus that is managed with oral anti-hyperglycemic agent(s).
* Body mass index (BMI) 27 to 45 kg/m2, inclusive.
* Ability to complete a 1 year study
Exclusion Criteria:
* Pregnancy
* Use of insulin in any form, exenatide (Byetta) or pramlintide (Symlin) within 3 months prior to screening
* History of symptomatic heart valve disease
* Serious or unstable current or past medical conditions
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00603291
| 43,874
|
{
"NCT_ID" : "NCT04208841",
"Brief_Title" : "Quality Improvement of Person-Centered Care for Maternal Health in Public Facilities in India, Phase 2",
"Official_title" : "Strengthening Person-centered Accessibility, Respect, and Quality of Maternal Health Services in India, Phase 2",
"Conditions" : ["Reproductive Health"],
"Interventions" : ["Behavioral: Person-Centered Care Quality Improvement Collaborative Sustain", "Behavioral: Person-Centered Care Quality Improvement Collaborative Spread"],
"Location_Countries" : ["India"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-05-14",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-06-29",
"Study_Completion_Date(Actual)" : "2019-06-29},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-12-18",
"First_Posted(Estimated)" : 2019-12-23"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-12-19",
"Last_Update_Posted(Estimated)" : 2019-12-23",
"Last_Verified" : 2019-12"
}
}}
|
#Study Description
Brief Summary
Evaluating the spread of a quality improvement (QI) change package working to improve person-centered care (PCC) for maternal health (MH) services.
Detailed Description
After implementing a quality improvement (QI) collaborative in public facilities in Uttar Pradesh, India, a second phase was done to evaluate if the 'change package' developed during phase one could be implemented in similar facilities to improve the quality of person-centered care (PCC) for a maternal health (MH) services.
#Intervention
- BEHAVIORAL : Person-Centered Care Quality Improvement Collaborative Sustain
- Sustain improvements during QI collaborative focused on PCC
- BEHAVIORAL : Person-Centered Care Quality Improvement Collaborative Spread
- Implement change package developed during QI Collaborative
|
#Eligibility Criteria:
Inclusion Criteria for Women:
* Women aged 18 <= age <= 49 years
* Who agreed to participate
* Who delivered a baby at the facility where data collection is taking place within the last 7 days
Exclusion Criteria for Women:
* Not a women aged 18 <= age <= 49
* Did not agree to participate
* Did not deliver a baby at the facility where data collection is taking place within the last 7 days
Inclusion Criteria for Providers:
* Agreed to participate
* Purposive sampling
* Permanent staff at the facility
Exclusion Criteria for Providers:
* Did not agree to participate
* Not permanent staff at the facility
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04208841
| 190,013
|
{
"NCT_ID" : "NCT03959449",
"Brief_Title" : "Action Observation and Motor Imagery Induced Hypoalgesia in Asymptomatic Subjects",
"Official_title" : "Action Observation and Motor Imagery Induced Hypoalgesia in Asymptomatic Subjects",
"Conditions" : ["Analgesia", "Exercise"],
"Interventions" : ["Behavioral: Exercise plus action Observation and motor imagery", "Behavioral: Action Observation plus motor imagery", "Behavioral: Motor imagery"],
"Location_Countries" : ["Spain"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-06-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-06-30",
"Study_Completion_Date(Actual)" : "2019-07-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-05-20",
"First_Posted(Estimated)" : 2019-05-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-05-20",
"Last_Update_Posted(Estimated)" : 2019-07-23",
"Last_Verified" : 2019-07"
}
}}
|
#Study Description
Brief Summary
This study evaluates the influence of motor imagery and the observation of actions on pain perception. Participants in this study are asymptomatic subjects who will perform an IM and AO protocol of an aerobic exercise.
Detailed Description
Motor Imagery (MI) is defined as a dynamic mental process that involves the representation of an action, in an internal way, without its actual motor execution. The Action Observation (AO) evokes an internal, real-time motor simulation of the movements that the observer is perceiving visually. Both mental processes trigger the activation of the neurocognitive mechanisms that underlie the planning and execution of voluntary movements in a manner that resembles how the action is performed in a real manner. The phenomenon of exercise-induced hypoalgesia is well known. This is why it has been suggested that these techniques could produce pain modulation similar to that produced by real exercise.
#Intervention
- BEHAVIORAL : Action Observation plus motor imagery
- Action observation (video) and motor imagery of running.
- BEHAVIORAL : Motor imagery
- Motor imagery of running
- BEHAVIORAL : Exercise plus action Observation and motor imagery
- Real exercise of running during 6 min plus action observation (video) and motor imagery of running.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 60
* Healthy and with no pain subjects
Exclusion Criteria:
* Any cognitive impairment that hindered viewing of audiovisual material.
* Difficulty understanding or communicating.
* Presence of systemic pathology, Central Nervous System or rheumatic disease.
* Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
* Collaboration of pregnant women.
* Underage subjects
* Subjects with pain at the time of the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03959449
| 134,740
|
{
"NCT_ID" : "NCT02572986",
"Brief_Title" : "A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies",
"Official_title" : "A Randomized, Double-Blind, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% to Elimite™ Cream 5% in the Treatment of Scabies",
"Conditions" : ["Scabies"],
"Interventions" : ["Drug: Permethrin"],
"Location_Countries" : ["United States", "El Salvador", "Panama"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-06",
"Study_Completion_Date(Actual)" : "2016-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-10-08",
"First_Posted(Estimated)" : 2015-10-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-10-08",
"Last_Update_Posted(Estimated)" : 2016-10-14",
"Last_Verified" : 2015-10"
}
}}
|
#Study Description
Brief Summary
Scabies is an infestation of the skin by the human itch mite (Sarcoptes scabiei). Diagnosis of scabies is made based on clinical symptoms, such as nocturnal itching, and appearance and distribution of the rash. Definitive diagnosis includes the microscopic identification of the mite, mite eggs, or mite fecal matter in the skin. Topical permethrin is considered the drug of choice for the treatment of scabies. It is a synthetic pyrethroid that is safe for use in adults and children 2 months and older.
This study will evaluate the therapeutic equivalence of a generic permethrin cream 5% to Elimite® in the Treatment of Scabies.
#Intervention
- DRUG : Permethrin
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed Informed Consent that meets all criteria of current FDA regulations.
* Male or non-pregnant, non-lactating female at least 2 years or older.
* Diagnosis of active scabies by presence of a burrow and/or typical scabietic lesions at the classic sites of infestation.
* Parasitological confirmation of clinical diagnosis with demonstration under light microscope of mites and/or their products (larvae, eggs or fecal material).
* Symptom score of 2 or 3 on a 4-point rating scale of 0 <= age <= 3 for nocturnal itching.
* Women must be either 1 year post-menopausal (no menstrual periods for at least 12 months), surgically sterile, or if they are of child-bearing potential, they must:
* Have been using systemic birth control, intrauterine device, or used barrier methods such as diaphragm plus spermicide or condom plus spermicide consistently, at least 14 days before study cream administration.
* Had a normal menstrual cycle for the month before start of treatment.
* Have a negative urine pregnancy test result upon entry into the study.
* Agree to use a medically accepted form of birth control (oral, implant, injectable or transdermal contraceptives, intrauterine device, condom plus spermicide, diaphragm plus spermicide) or practice abstinence throughout the study period.
* Free from any systemic or dermatologic disorder that, in the opinion of the Investigator, will interfere with the study results or increase the risk of adverse events.
* Ability to apply study product to self or to other person if a child. If patient is a child, then parent/guardian will apply study product to him/her.
Exclusion Criteria:
* Known hypersensitivity to permethrin cream or any of its components, ragweed or chrysanthemums, synthetic pyrethroids or pyrethrin.
* Use of any systemic or topical acaricide 1 month before enrollment.
* Patients with crusted/Norwegian scabies.
* Patients with an underlying immunodeficient state (including prolonged treatment with corticosteroids), immunosuppressive disorders requiring therapy, severe systemic disease and history of HIV infection.
* Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study.
* Women who are pregnant, planning pregnancy or lactating.
* Family members of employees of the clinic or Investigator.
* Patients who, in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol.
* Patients whose close personal contacts will not or are not willing to comply with standard of care for Scabies management.
* Patients less than 2 years.
* Patients or guardians of patients, who are unable or unwilling to give informed consent or assent respectively.
* Receipt of any drug as part of a research study within 30 days before screening.
* History of seizures.
* Severe cutaneous bacterial or fungal infections requiring therapy (including systemic and topical antibiotics) or coexisting dermatological disorder that could interfere with the diagnosis and subsequent monitoring of scabies.
* Treatment with systemic or topical corticosteroids less than 2 weeks and less than 1 week from enrollment, respectively.
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02572986
| 90,556
|
{
"NCT_ID" : "NCT01945996",
"Brief_Title" : "Harnessing mHealth and Social Support to Improve Diabetes Related Health Behavior for Inner-city Patients",
"Official_title" : "Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter",
"Conditions" : ["Diabetes Mellitus"],
"Interventions" : ["Behavioral: FANS", "Behavioral: TExT MED"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-05",
"Study_Completion_Date(Actual)" : "2014-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-08-30",
"First_Submitted_that_Met_QC_Criteria" : 2018-03-06",
"First_Posted(Estimated)" : 2013-09-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-09-16",
"Last_Update_Posted(Estimated)" : 2018-11-06",
"Last_Verified" : 2018-03"
}
}}
|
#Study Description
Brief Summary
In this study, an existing mobile health intervention to improve diabetes self-management will be combined with a social support module and tested for feasibility. The investigators hypothesize that this combination will be feasible and acceptable to both patients and their loved ones.
Detailed Description
This will be the first ever evaluation of a highly scalable and low-cost social support intervention for patients with diabetes delivered entirely via mobile phones. TExT-MED FANS (Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter) will unite the benefits of mHealth (scalability, ease of access) and social support interventions (personalized motivation, emotional support). The Diabetes FANS text message based curriculum will make it easier for friends and family to become supporters. Additionally, augmenting TExT-MED with the FANS social support module will be more effective than TExT-MED alone. The personalized support of TExT-MED FANS will also be more effective than providing TExT-MED in combination with a community health worker supporter who lacks a pre-existing relationship with the patient. Through this innovative combination, I can create a more cost-effective and diffusible mHealth solution that maintains the personal connection of social support interventions. To date there has only been one study evaluating social support interventions for patients with diabetes using mHealth, but in this study participants were paired with other subjects with diabetes (not friends or family) and it required intensive face-to-face support group time. TExT-MED FANS will provide key insights into the utility of combining social support interventions delivered solely via mHealth in low-income Latino patients. These insights will help future interventions achieve maximal impact on diabetes and other chronic disease management.
#Intervention
- BEHAVIORAL : TExT MED
- educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone
- BEHAVIORAL : FANS
- supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
|
#Eligibility Criteria:
Inclusion Criteria:
* type II diabetes
* HbA1c >or=8 at enrollment
* speak English or Spanish
* has support person willing to participate
Exclusion Criteria:
* unable to consent
* pediatric patient
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01945996
| 258,254
|
{
"NCT_ID" : "NCT00584116",
"Brief_Title" : "Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement",
"Official_title" : "Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement",
"Conditions" : ["Aortic Stenosis"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-03",
"Study_Completion_Date(Actual)" : "2008-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-12-26",
"First_Posted(Estimated)" : 2008-01-02"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-12-26",
"Last_Update_Posted(Estimated)" : 2017-05-30",
"Last_Verified" : 2017-05"
}
}}
|
#Study Description
Brief Summary
Prospective, two academic center, non-randomized pilot, acute in-patient study correlating pre-operative imaging studies, intra-operative measurements and intra-operative balloon aortic valvuloplasty (BAV) in patients with degenerative aortic stenosis undergoing surgical aortic valve replacement (SAVR) to understand the requirements (device size and radial strength) of emerging percutaneous heart valve technologies in the treatment of aortic stenosis.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* Any patient with severe, symptomatic calcific aortic stenosis (AS) referred for elective surgical aortic valve replacement.
* Severe AS: aortic valve area (AVA) <= 1.0 cm2
* Symptoms: dyspnea on exertion, heart failure, angina or syncope believed to be secondary to AS
Exclusion Criteria:
* Emergent surgical aortic valve replacement.
* Inability to undergo TTE or TEE intra-operatively.
* Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00584116
| 93,647
|
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