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Eligibility: |
People aged 55 years and older with a body mass index of 27 or higher. |
Design: |
Participants will have 6 clinic visits over 8 weeks. |
Participants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function. |
UA gelcaps are taken by mouth every morning at home. Half of participants will take UA. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking. |
Participants will have tests during the study including: |
Oral glucose tolerance: Participants will drink a sweet liquid. Blood will be drawn at intervals over the next 3 hours. |
Continuous glucose monitor: A sensor with a needle that goes just under the skin will be placed on the upper arm. Participants will wear this sensor throughout the study. |
Exercise. Participants will walk on a treadmill while their heart rate, hearth rhythm, and blood pressure are monitored. They will walk in a hallway at normal and fast paces. |
Imaging scans of the thigh; scans of the brain are optional.... conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOM... |
<|newrecord|> nctId: NCT06274736 id: CLINP-001012 briefTitle: Safety and Performance of Motiva® Sizers overallStatus: RECRUITING date: 2023-04-10 date: 2027-04-10 date: 2027-07-10 date: 2024-02-23 date: 2024-02-23 name: Establishment Labs class: INDUSTRY briefSummary: The Motiva® Sizer clinical study is a four-year, mu... |
The research will include 330 women, divided into two groups of 165 participants each (150 breast augmentation participants and 15 reconstruction participants). The Motiva® Sizer exposed group will consist of women who will undergo breast augmentation or reconstruction surgery with the use of Motiva® Sizer during the p... |
The main goal is to evaluate the safety and the performance of the Motiva® Sizer. To this end, the results of both groups will be compared in terms of surgical complications, surgeon's, and participant's satisfaction level as well as reoperation rates. |
After the augmentation or reconstruction surgery, participants will be scheduled for the following follow-up visits, (1) between 3 and 7 postoperative days, (2) between 3 and 6 postoperative weeks, (3) at 3 and (4) 6 postoperative months, and (5, 6 and 7) annually thereafter for a period of three consecutive years. In ... |
<|newrecord|> nctId: NCT06274723 id: STUDY00001220 id: 1K99CA281094-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1K99CA281094-01A1 briefTitle: Responses to E-cigarette Message Source and Presentation overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-23 date:... |
<|newrecord|> nctId: NCT06274710 id: 23-5554 briefTitle: ODYSSEE Kidney Health Trial acronym: ODYSSEE-KH overallStatus: RECRUITING date: 2023-12-13 date: 2026-04-13 date: 2026-04-13 date: 2024-02-23 date: 2024-02-23 name: University Health Network, Toronto class: OTHER name: Sunnybrook Health Sciences Centre name: Scar... |
Severe CKD is defined as a risk of greater than 10% for progressing to RRT \[home hemodialysis (HHD), home peritoneal dialysis (HPD), and transplantation\] within 2 years. There is a need to improve access to CKD self-care counselling and RRT education for patients with severe CKD. Trials of CKD self-care education hav... |
HYPOTHESES |
The primary hypothesis is that ODYSSEE-KH versus usual care (UC) will significantly increase the incidence of home RRT, measured by a composite index of HHD, HPD, and preemptive kidney transplant at trial completion (median = 19 months; range: 12 to 27 months). |
The secondary hypothesis is that ODYSSEE-KH for CKD self-care and RRT education improves Home RRT, RRT preparation, annual hospitalization rate, engagement with CKD self-care resources at months 6 and 12 and trial completion and scores on outcome measures. |
RECRUITMENT |
Patients diagnosed with CKD who are 18 years of age or older were recruited from University Health Network (UHN), Sunnybrook Hospital, Scarborough Health Network, and The Ottawa Hospital. |
DESIGN |
ODYSSEE-KH is a double-arm, parallel-group, randomized controlled trial that has assessments at baseline, months 6 and 12, and trial completion (median = 19 months; range: 12 to 27 months). This is a single-blind design with research personnel masked. |
ODYSSEE-KH combines automated digital counselling of CKD self-care with renal replacement therapy (RRT) education. UC enhances the standard of usual care by providing patients with conventional digital CKD education. Over 27 months, patients will be emailed on a weekly basis with a digital link to log on to their respe... |
ANALYSIS |
Separate GLMs will evaluate if Digital Counselling versus UC is independently associated with outcomes at months 6 and 12 and trial completion (median = 19; range: 12 to 27 months). Dependent variables include the KDQOL-SF, SF-36, EUROIA, PHQ-9, GAD-7, MIDLS, ESSI, PWB, BMPN, AI, as well as a modified SEMCD-6. Multivar... |
<|newrecord|> nctId: NCT06274697 id: RECHMPL22_0391 id: 2023-A01784-41 type: REGISTRY domain: ID-RCB briefTitle: Validation of a Magnetic Sensor in Arterial Flow Recording, Compared With the Reference Method, at Various Peripheral Arterial Sites acronym: COMADO overallStatus: RECRUITING date: 2024-04-02 date: 2025-04 d... |
The magnetic susceptibility of iron in the circulating blood and the ionic currents in the blood stream generate a very weak induced magnetic current, which can be detected by the micro-sensor of the prototype investigators wish to study. |
Proving the validity of this prototype would make it a new diagnostic and even prognostic tool, non-invasive, less costly and more accessible than Doppler for screening peripheral arterial disease. conditions: Lower Extremity Artery Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_G... |
<|newrecord|> nctId: NCT06274684 id: 2023-01100 briefTitle: Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia. overallStatus: NOT_YET_RECRUITING date: 2024-02-19 date: 2025-05-01 date: 2025-07-01 date: 2024-02-23 date: 2024-02-28 name: University Hospital, Geneva class: OTHER briefSumm... |
The main question it aims to answer: |
- Is there a significant decrease on anxiety level thanks to VR-assistance? |
Participants will be equipped with VR headset providing an immersive visual experience accompanied with a hypnoses oriented audio during the entire procedure. |
Researchers will compare standardised anxiety scores with a control group. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Use of Virtual Reality Assistance during prostate biopsi... |
<|newrecord|> nctId: NCT06274671 id: 23-24-09 briefTitle: Glymphatic MRI in Clinically Isolated Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-05-15 date: 2025-05-15 date: 2024-02-23 date: 2024-02-23 name: University of Exeter class: OTHER briefSummary: The brain possesses a system to get rid of... |
Doctors think that GS dysfunction plays a role in MS too. In this research therefore, the aim is to study whether it drives inflammation, and disease progression in MS patients. |
The researchers have developed a new way to find signs of alteration of the GS using a scan named Magnetic Resonance Imaging (MRI) and will use it in a pilot study on patients with a condition named Clinically Isolated Syndrome (CIS), which often represents the very beginning of MS. It would therefore be demonstrated t... |
Should this study be successful, this would provide preliminary evidence to perform a larger research study to assess if GS dysfunction drives the progression of MS. conditions: Clinically Isolated Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMA... |
<|newrecord|> nctId: NCT06274658 id: STUDY00006517 briefTitle: The Effects of an Acute High-intensity Exercise on Heart and Brain Function in People With Spinal Cord Injury overallStatus: RECRUITING date: 2024-02-14 date: 2025-06-30 date: 2025-08-31 date: 2024-02-23 date: 2024-02-23 name: State University of New York a... |
<|newrecord|> nctId: NCT06274645 id: IVUS CHIP China Registry briefTitle: IVUS CHIP China Registry overallStatus: RECRUITING date: 2024-03-12 date: 2026-07 date: 2028-02 date: 2024-02-23 date: 2024-04-26 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: The goal of this observational study is to learn about ... |
<|newrecord|> nctId: NCT06274632 id: 2023P001913 briefTitle: ADELANTE: A Randomized Controlled Trial to Improve Engagement in Care for Latinos With HIV overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-02-28 date: 2027-02-28 date: 2024-02-23 date: 2024-04-03 name: Massachusetts General Hospital class: OTHER... |
<|newrecord|> nctId: NCT06274619 id: 23HH8541 id: MISP 59717 type: OTHER_GRANT domain: MSD id: 57276 type: REGISTRY domain: CPMS id: 324970 type: OTHER domain: IRAS briefTitle: Novel Mucosal Correlates Of RSV Protection In Older Adults acronym: CHIRP01 overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-02 date:... |
However, little is known about the way human immune responses to RSV infection in older individuals differ from those of younger people. Further understanding of the mechanisms underlying immunity and potential impairments in these higher-risk people are therefore necessary. This project aims to study the factors that ... |
<|newrecord|> nctId: NCT06274606 id: HSR230106 briefTitle: Exercise Training Study Before Bariatric Surgery acronym: BaSE overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-01-01 date: 2025-03-15 date: 2024-02-23 date: 2024-02-23 name: University of Virginia class: OTHER briefSummary: The goal of this clinic... |
Adults planning to have bariatric surgery will be recruited from the Charlottesville VA area. Before they have their surgery, participants will be randomly assigned (like flipping a coin) to a group that participates in 8 weeks of walking on a treadmill (2-3 times a week) or a group that does their normal care before b... |
Researchers will compare the effects of walking before bariatric surgery on: |
* Insulin sensitivity (diabetes risk factor) |
* Health of blood vessels |
* Rate of complications after surgery |
* Weight |
* Body Fat |
* Fitness level conditions: Bariatric Surgery Candidate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In accordance with a parallel study design, 30 pre-bariatric-surgery patients will be randomized in a 1:1 ratio to either undergo 8-weeks of pre-o... |
<|newrecord|> nctId: NCT06274593 id: AP_JBD_MJ_003 briefTitle: Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma acronym: OGA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-09 date: 2024-02-23 date: 2024-02-23 name: Nantes University Hospital class: OTHER briefSummary: ... |
To date, to our knowledge, there is no work analyzing the progression of angiographic OCT in patients with glaucoma. |
The main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl). conditions: Glaucoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name:... |
<|newrecord|> nctId: NCT06274580 id: 5916 briefTitle: Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2026-03-01 date: 2024-02-23 date: 2024-02-23 name: Ospedale Policlinico San Martino class: ... |
<|newrecord|> nctId: NCT06274567 id: 2024P000348 briefTitle: Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-08-31 date: 2029-03-31 date: 2024-02-23 date: 2024-02-23 name: Massachusetts General Hospital class: OTHER nam... |
<|newrecord|> nctId: NCT06274554 id: 23-11026746 briefTitle: Testing the Role for Anti-fungal Therapy in Improving the Response to Medicine for Crohn's Disease overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-12 date: 2029-12 date: 2024-02-23 date: 2024-02-23 name: Weill Medical College of Cornell University ... |
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