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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: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Urolithin A name: Placebo measure: To determine if urolithin A supplementation will influence insulin secretion in response to oral glucose at 4 and 8 weeks after supplementation. measure: To determine if UA supplementation will increase incretin secretion in response to oral glucose at 4 and 8 weeks after the supplementation. measure: To determine if UA supplementation will enhance mitochondria respiration, based on p31 spectroscopy by thigh MRI/MRS at baseline and 8 weeks after supplementation. measure: To determine if UA will increase brain oxidative metabolism, based on brain MRS at baseline and 8 weeks after supplementation. measure: To determine if UA supplementation will alter gut microbiome composition. sex: ALL minimumAge: 55 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institute of Aging, Clinical Research Unit status: RECRUITING city: Baltimore state: Maryland zip: 21224 country: United States name: Josephine Egan, M.D. role: CONTACT phone: 410-558-8414 email: eganj@mail.nih.gov lat: 39.29038 lon: -76.61219 hasResults: False
<|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, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.
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 procedure, and a non-exposed group will consist of women who will undergo breast augmentation or reconstruction surgery without the use of Motiva® Sizer. This study will be conducted in Costa Rica.
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 case any participant has an adverse event due to the procedure, and if required by the physician, an additional visit will be made to assess her, and this information as well as that of the scheduled visits should be recorded in the electronic data collection notebook. conditions: Breast Implant; Complications conditions: Breast Implantation; Methods, Safety and Performance conditions: Mammaplasty conditions: Breast Reconstruction conditions: Breast Augmentation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 330 type: ESTIMATED name: Motiva Sizer measure: Motiva Sizers Safety (complications) measure: Motiva Sizers Performance (satisfaction) measure: Motiva Sizers Safety (reoperations) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Establishment Labs status: RECRUITING city: Coyol state: Alajuela zip: 20102 country: Costa Rica lat: 10.00126 lon: -84.26124 hasResults: False
<|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: 2024-02-23 name: University of Massachusetts, Worcester class: OTHER name: National Cancer Institute (NCI) briefSummary: The goal of this clinical trial is to use crowdsourcing to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape. conditions: Vaping studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 800 type: ESTIMATED name: Expert name: Peer name: 1 Sided name: 2 Sided measure: Message acceptance measure: Harm perceptions measure: Psychological reactance measure: Message liking measure: Source trust measure: Attitudes measure: Behavioral intentions to vape or try vaping sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-01-17 uploadDate: 2024-01-31T10:44 filename: SAP_000.pdf size: 176839 hasResults: False
<|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: Scarborough General Hospital name: The Ottawa Hospital briefSummary: INTRODUCTION
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 have achieved therapeutic benefits with moderate to high patient-provider contact. There is high potential for a trial of digital counselling for CKD self-care and RRT education to enhance patient health and quality of life.
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 respective program using a password-protected, personal account.
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. Multivariable models will adjust for baseline assessments of each outcome and potential baseline covariates (noted above). In all GLMs, significant interactions will be followed by subgroup analyses with Bonferroni post hoc tests. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 344 type: ESTIMATED name: ODYSSEE-KH measure: Incidence of home RRT measure: Improvement of Home RRT measure: Improvement of RRT preparation with planned dialysis access measure: Incidence of annual hospitalization rate measure: Engagement with RRT education and CKD self-care counselling resources measure: Self-reported engagement in activities for living well measure: Self-reported assessment for health-related quality of life due to kidney disease measure: Self-reported assessment of people's aspirations and goals measure: Self-reported measure of overall health (e.g. pain, mental health, physical, role and social functioning) measure: Self-reported depression measure: Self-reported perceived social support measure: Self-reported psychological wellbeing measure: Self-reported anxiety measure: Self-reported feeling of value to self and others measure: Self-reported measure of psychological wellbeing and happiness measure: Self-reported measure of overall life experience measure: Self-reported measure of well-being measure: Self-reported readiness for change (motivation) measure: Self-reported confidence in doing life activities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network status: RECRUITING city: Toronto state: Ontario zip: M2N 7A2 country: Canada name: Robert P Nolan, PhD role: CONTACT phone: (416) 340-4800 phoneExt: 6400 email: rob.nolan@uhnresearch.ca name: Karly Gunson, HBA, BHSc role: CONTACT phone: (416) 340-4800 phoneExt: 6400 email: karly.gunson2@uhn.ca lat: 43.70011 lon: -79.4163 hasResults: False
<|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 date: 2025-04 date: 2024-02-23 date: 2024-04-11 name: University Hospital, Montpellier class: OTHER name: phymedexp briefSummary: The measurement of magnetic fields emitted by cardiac activity has already been studied in magneto-cardiography. To date, however, this technology has never been evaluated in the peripheral circulation.
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_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 70 type: ESTIMATED name: Evaluation by magnetic sensor measure: Correlation of the two curve amplitudes (y) versus time (x) between the signal recording obtained by the CapMagic prototype on the radial artery and the pulsed echo-Doppler recording on the radial artery measure: Correlations of the two curve amplitudes (y) versus time (x) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording, measured on the plantar artery on one side and on the pulpal artery on the other measure: Correlation of the Pulsatility index (or Gosling Pulsatility index) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording measure: Correlation of the Systolic rise time (SRT) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording measure: Correlation of the Systolic peak between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording measure: Correlation of the Type of flow according to Saint-Bonnet classification between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording measure: Correlation of Presence of critical ischemia measured by the CapMagic prototype and the pulsed echo-Doppler recording sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Center status: RECRUITING city: Montpellier country: France name: Gudrun BOGE, MD role: CONTACT phone: 467336279 phoneExt: 33 email: g-boge@chu-montpellier.fr name: Gudrun BOGE role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False
<|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 briefSummary: The goal of this clinical trial is to test the impact of Virtual Reality (VR) assistance for anxiety management of patients undergoing prostate biopsies in local anaesthesia.
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 biopsies measure: Anxiety level measure: Anxiety level of the surgeon measure: Biopsies complications sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|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 unwanted substances, named Glymphatic System (GS). When this system is faulty, these accumulate, there is local inflammation, and progressive death of the cells. This occurs in neurological diseases including Parkinson's, or Alzheimer's. Inflammation and progressive death of the cells are also present in another neurological disorder, named Multiple Sclerosis (MS).
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 that the GS is a new mechanism of disease in CIS, which may associate with the symptoms, or the alterations in the levels of some substances in the blood suggestive of brain cells damage.
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: ESTIMATED name: Magnetic Resonance Imaging measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by Structural MRI measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by microstructural MRI measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by diffusion-weighted MRI measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by perfusion-MRI measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by ALS-MRI measure: To correlate in vivo measures of altered glymphatic system with MRI measures of structural integrity in CIS measure: To correlate in vivo measures of altered glymphatic system with MRI measures of disease activity in CIS measure: To correlate in vivo measures of altered glymphatic system with MRI measures of enlarged Wirchow-Robin spaces in CIS measure: To correlate in vivo measures of altered glymphatic system with MRI measures of microstructural altertions in CIS measure: To correlate in vivo measures of altered glymphatic system with MRI measures of brain perfusion in CIS measure: To correlate in vivo measures of altered glymphatic system in CIS with clinical measures of disease severity measure: To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of axonal injury in CIS measure: To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of astrocytis integrity in CIS measure: To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of glymphatic activity in CIS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Exeter city: Exeter country: United Kingdom name: Edoardo R de Natale, MD role: CONTACT email: e.de-natale@exeter.ac.uk lat: 50.7236 lon: -3.52751 hasResults: False
<|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 at Buffalo class: OTHER briefSummary: The heart and brain are regulated by the autonomic nervous system. Control of these organs can be disrupted in people with spinal cord injury (SCI). This may affect their ability to regulate blood pressure during daily activities and process the high-level information. Previous studies show that high-intensity exercise induces better outcomes on heart and information processing ability in non-injured people compared to moderate-intensity exercise. However, it is unknown the effects of high-intensity exercise on heart and brain function in people with SCI. Therefore, this study aims to examine the effects of a single bout of high-intensity interval training on heart and brain function in this people with SCI compared to age- and sex-matched non-injured controls. conditions: Autonomic Nervous System Disease conditions: Spinal Cord Injuries conditions: Cognition studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: High-intensity interval exercise measure: Low frequency of systolic blood pressure variability measure: High frequency of heart rate variability measure: Blood pressure measure: Heart rate measure: Cerebral blood flow velocity measure: Symbol Digit Matched Test score measure: California Verbal Learning Test score measure: Color-Word Stroop Test score measure: Controlled Word Association Task score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University at Buffalo, South Campus status: RECRUITING city: Buffalo state: New York zip: 14214 country: United States name: Wenjie Ji role: CONTACT phone: 716-907-2508 phoneExt: 1 email: wji4@buffalo.edu lat: 42.88645 lon: -78.87837 hasResults: False
<|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 in patients with complex coronary lesions undergoing PCI. The main question\[s\] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients with complex coronary lesions undergoing PCI, as well as clinical outcomes up to 2 years. Participants will be treated with IVUS-guided PCI. conditions: Complex Higher Risk Indicated Patients Undergoing PCI studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2020 type: ESTIMATED name: The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston Scientific measure: Time-to-first-event analysis of these three event including cardiac death, target vessel myocardial infarction will be primarily used for clinical endpoints. measure: Time-to-first-event analysis will be primarily used for clinical endpoints. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan Zhongshan Hospital status: RECRUITING city: Shanghai country: China name: Chenguang Li, Doctor role: CONTACT email: li.chenguang@zs-hospital.sh.cn lat: 31.22222 lon: 121.45806 hasResults: False
<|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 name: Baylor College of Medicine name: University of Miami briefSummary: The goal of this study is to test the effectiveness of ADELANTE on viral suppression among Latinos with HIV and viral non-suppression. Participants will receive ADELANTE (5-session, community health worker-delivered, problem-solving intervention) or enhanced care condition (ECC, 5 reminder phone calls). We will evaluate the overall effectiveness of ADELANTE compared with ECC on rates of viral suppression and emergency room visits and hospitalizations. Our hypothesis is that ADELANTE participants will achieve higher rates of viral suppression and will have lower rates of emergency room visits and hospitalizations compared with ECC at 12 months post-randomization. conditions: HIV/AIDS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: ADELANTE measure: 12-month viral suppression measure: Number of Emergency department visits measure: Number of Hospitalizations measure: 6-month viral suppression measure: Retention in care sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami city: Miami state: Florida zip: 33146 country: United States name: Allan Rodriguez, MD role: CONTACT phone: 305-243-3711 email: arodriguez2@miami.edu lat: 25.77427 lon: -80.19366 facility: Baylor College of Medicine city: Houston state: Texas zip: 77030 country: United States name: Thomas P Giordano, MD role: CONTACT phone: 713-798-8918 email: tpg@bcm.edu lat: 29.76328 lon: -95.36327 hasResults: False
<|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: 2026-02 date: 2024-02-23 date: 2024-03-07 name: Imperial College London class: OTHER briefSummary: Respiratory syncytial virus (RSV) is one of the most common causes of chest infection worldwide. Despite this, it remains an underappreciated health problem, with the first effective RSV vaccines only approved by the FDA in May 2023 and unlikely to be widely available for some time. Although RSV infection is most frequent in young children, most deaths occur in older adults, particularly in those with underlying heart and lung disease. This is believed to be due in part to the ageing immune system's reduced ability to protect against infection and symptomatic disease.
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 influence whether or not older people develop symptomatic RSV disease in healthy older volunteers after being given an RSV-induced common cold. Samples will be taken from the blood and nose in order to identify changes in the immune system associated with susceptibility or protection in older adults. Participants will be carefully screened to ensure there are no underlying health problems that might make them more at risk of severe disease and will be monitored closely throughout the course of infection. It is anticipated that differences in immune markers in the nose and/or blood of healthy older people will predict whether or not such individuals become infected or develop symptoms. By analysing the networks of genes that are switched on and off, the aim is to identify the pathways in the immune system responsible for these differences, to ultimately develop improved diagnostic tests, vaccines and treatments. conditions: Respiratory Tract Infections studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: RSV A Memphis 37 measure: Number of solicited and unsolicited adverse events (AEs) measure: Infection rate measure: Nasal Viral Load measure: Antibody levels by serum neutralisation assay measure: Antibody levels by ELISA sex: ALL minimumAge: 65 Years maximumAge: 75 Years stdAges: OLDER_ADULT facility: Imperial College London city: London zip: W12 0NN country: United Kingdom name: Polly Fox role: CONTACT email: polly.fox@imperial.ac.uk name: Christopher Chiu role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False
<|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 clinical trial is to figure out if 8 weeks of walking exercise before bariatric surgery improves risk factors for diabetes and other markers of health. This is important as it may help reduce complications after surgery, improve health markers and increase physical activity levels after surgery (which is an important marker of maintaining bariatric weight loss). The main question that this study is trying to answer is whether walking improves a risk factor for type 2 diabetes called insulin sensitivity (how well your body is able to use glucose).
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 bariatric surgery.
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-operative standard of care or 8-weeks of pre-operative standard of care plus moderate exercise prior to undergoing bariatric-surgery. Randomization scheme: The randomization will be generated utilizing a permuted block randomization scheme in which 5 blocks of 6 treatment assignments (3 per treatment) will be generated via a computer algorithm. The 6 treatment assignments of each block will be listed in random sequential order and the treatment assignments will be assigned according to the random sequential order. The randomization will be generated by our biostatistician. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Randomization will be completely random and will only be known by biostatistician and study coordinator in department but not on study to retain true randomization unaffected by study team. count: 30 type: ESTIMATED name: Exercise Group measure: Insulin sensitivity measure: Surgical outcomes - readmission within 30 days of surgery measure: Surgical outcomes - IV treatment as an outpatient measure: Surgical outcomes - emergency department visits measure: Surgical outcomes - time of surgery measure: Surgical outcomes - length of stay after surgery completion measure: Flow-mediated dilation (FMD) measure: Pulse-wave analysis (PWA) measure: Pulse-wave velocity (PWV) measure: Body fat measure: Lean body mass measure: Bone mineral density measure: Visceral adiposity measure: Weight measure: Blood Lipids measure: Plasma glucose measure: Plasma insulin measure: Hemoglobin A1c measure: Cardiorespiratory fitness measure: Quality of life (SF-36) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of Virginia city: Charlottesville state: Virginia zip: 22902 country: United States name: Damon L Swift, PhD role: CONTACT phone: 434-924-1436 email: dls3s@virginia.edu name: Emily E Grammer, MS role: CONTACT phone: 8508968401 email: erk9nk@virginia.edu lat: 38.02931 lon: -78.47668 hasResults: False
<|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: Glaucoma is a chronic disease of the optic nerve, characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second leading cause of blindness after cataracts, and the leading cause of irreversible blindness.
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: OCT measure: Compare the progression of vascular density (VD) in advanced glaucoma patients. measure: Compare the progression of peripapillary retinal nerve fiber (RNFL) thickness) in advanced glaucoma patients. measure: Compare the progression of visual field in advanced glaucoma patients. measure: CV-OCTrnfl correlation study and CV-OCTa correlation study on measurements made at inclusion and on measurements made during follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jean-Baptiste Ducloyer city: Nantes zip: 44093 country: France name: Jean-Baptiste Ducloyer, MD role: CONTACT email: jeanbaptiste.ducloyer@chu-nantes.fr lat: 47.21725 lon: -1.55336 hasResults: False
<|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: OTHER briefSummary: Embotrial-1 is an Italian multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE) to assess the superiority of MMA embolization compared to conservative treatment. The intervention group is MMA embolization and comparator control group is the conservative management with best medical treatment. Patients are randomized 1:1. conditions: Subdural Hematoma, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: embolization of the middle meningeal artery measure: Rate of incomplete hematoma resolution or surgical rescue measure: treatment complication measure: treatment successful sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|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 name: University of Pennsylvania briefSummary: The objective of this study protocol is to test whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) can strengthen functional connectivity with a key region in emotion regulation (ER) neurocircuitry (anterior insula, AI) and improve performance on ER-related tasks in patients with bipolar disorder. Individual IPL sites for stimulation will be identified through baseline, pre-TMS functional magnetic resonance imaging (fMRI) scans. Patient-specific IPL subregions showing positive functional connectivity with the anterior insula and falling within the patient-specific frontoparietal control network will be used as individualized target sites for TMS stimulation. Patients will be randomized to receive 24 sessions of active versus sham iTBS to patient-specific IPL targets (6 sessions/day, 4 days, 43,200 pulses total). Post-iTBS resting-state and task-based fMRI scans will be acquired 3 days after the final day of iTBS administration (Day 4) following identical procedures as baseline. Effects of iTBS-TMS on ER will be evaluated by comparing pre-TMS versus post-TMS functional connectivity and behavior during performance on ER tasks. conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized allocation primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: We will use an active/placebo TMS coil. TMS operator and participant will be blinded to active versus sham. Investigator will be blinded to participant condition assignment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 136 type: ESTIMATED name: Transcranial Magnetic Stimulation (TMS) name: Sham (placebo) TMS measure: Correlated functional magnetic resonance imaging (fMRI) time series (functional connectivity) measure: Affective Multisource Interference Task measure: Balloon Analogue Risk Task sex: ALL minimumAge: 24 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Martinos Center for Biomedical Imaging city: Charlestown state: Massachusetts zip: 02129 country: United States lat: 42.37787 lon: -71.062 hasResults: False
<|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 class: OTHER name: The Leona M. and Harry B. Helmsley Charitable Trust briefSummary: The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to or are undergoing standard of care treatment with an IL-23 therapy for their Crohn's disease.