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NCT ID: NCT05310071 Active, not recruiting - Alzheimer's Disease Clinical Trials

A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease

ENVISION
Start date: June 2, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease.

NCT ID: NCT05309057 Active, not recruiting - Obesity Clinical Trials

Network Meta-analysis of Intermittent Fasting and Cardiometabolic Risk

Start date: November 1, 2020
Phase:
Study type: Observational

Intermittent fasting is a method of restricting calories over a defined period of time and includes regimens such as whole-day fasting, alternate-day fasting, and time-restricted feeding. There is emerging evidence that intermittent fasting or energy restriction might be more beneficial than continuous energy restriction for some risk factors. The effect of intermittent fasting on risk factors associated with obesity, diabetes, and cardiovascular disease, however, is not clear. The European Association for the Study of Diabetes (EASD) has yet to make any recommendations regarding the role of intermittent fasting in the management of diabetes. To inform the update of the EASD Clinical Practice Guidelines for Nutrition Therapy, tthe Diabetes and Nutrition Study Group (DNSG) of the EASD has commissioned a systematic review and network meta-analysis of randomized controlled trials of the effect of different intermittent fasting strategies on established cardiometabolic risk factors. The findings generated by this proposed knowledge synthesis will shape guide current guidelines and improve health outcomes by educating healthcare providers and patients, and by guiding future research design.

NCT ID: NCT05304325 Active, not recruiting - Obesity Clinical Trials

Adipose Tissue Pre and Post Bariatric Surgery

ETAPP
Start date: April 25, 2012
Phase:
Study type: Observational

Published data suggest that inflammation and fibrosis of adipose tissue could be factors favoring the development of insulin resistance in obese individuals and that a decrease in the activity of the AMP-activity kinase protein (AMPK) could lead to these dysfunctions. However, very few data are available in humans. There is also growing interest in persistent organic pollutants (POPs) as a cardiometabolic and type 2 diabetes (T2D) risk factor. There is some evidence to suggest that POPs directly contribute to lipid metabolism dysfunction and insulin resistance. Additionally, POPs are stocked in adipose tissue. The accumulation of POPs in adipose tissue therefore limits their bioavailability to other organs, thus reducing their systemic toxicity. It has been observed that a large amplitude weight loss leads to a significant increase in POPs in the blood. The goal of this project is to identify adipose tissue factors/dysfunctions that contribute to insulin resistance and type 2 diabetes associated with obesity in humans and thus raise avenues for screening and treatment of these metabolic complications. More specifically, the objectives are: - To study the relationship between AMPK, fibrosis and inflammation of adipose tissue and their role in the development of insulin resistance and T2D associated with obesity; - To examine the relationship between POPs and the cardiometabolic profile.

NCT ID: NCT05301179 Active, not recruiting - Aging Clinical Trials

Protein Quantity and Quality in Older Subjects

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

After the age of ~50, humans start to lose muscle mass at a rate of about 1-3% per year. However, the loss of muscle mass beyond a certain point can make it increasingly difficult to perform activities of daily living such as rising from a chair, going up and downstairs, carrying groceries, etc. A reason why muscle mass is lost with age is that skeletal muscles become less sensitive to the growth-promoting effects of physical activity and protein ingestion. This loss of sensitivity can be overcome by consuming larger amounts of protein; however, many older adults have difficulties simply consuming greater amounts of protein from whole-food sources. Therefore, the research in this study aims to investigate how different amounts and types of protein, of either a 100%-plant-based or Lacto-vegetarian (plant-based plus dairy) protein sources, affect muscle growth. This information will be important when providing information to older adults about the amount and type of protein that should be consumed by older adults to help prevent the loss of muscle mass that typically occurs with advancing age.

NCT ID: NCT05298878 Active, not recruiting - COVID-19 Clinical Trials

Virtual Physical Rehabilitation for Patients Living With Long COVID

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether a timely, virtual home-based physical rehabilitation program for patients living with long COVID can improve functional mobility compared to usual care.

NCT ID: NCT05298254 Active, not recruiting - Herpes Simplex Clinical Trials

A Study on the Reactogenicity, Safety, Immune Response, and Efficacy of a Targeted Immunotherapy Against HSV in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes

Start date: March 7, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this first-time-in-human (FTiH) study is to evaluate the reactogenicity, safety, immune response, and efficacy of an investigational herpes simplex virus (HSV)-targeted immunotherapy (TI). The study will be conducted in 2 parts: Part I assessing different formulations of the Herpes Simplex Virus-targeted immunotherapy (HSVTI) in healthy participants aged 18-40 years; Part II assessing the 2 formulations of the HSVTI in participants aged 18-60 years with recurrent genital herpes.

NCT ID: NCT05297448 Active, not recruiting - Clinical trials for Hepatic Encephalopathy

Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

RED-C-3132
Start date: August 3, 2022
Phase: Phase 3
Study type: Interventional

Study RNLC3132 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.

NCT ID: NCT05295732 Active, not recruiting - Ichthyosis Clinical Trials

The ASCEND Study: Evaluating TMB-001 in the Treatment of RXLI or ARCI Ichthyosis

ASCEND
Start date: June 21, 2022
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind and vehicle-controlled Phase III study to evaluate the safety and efficacy of topical TMB-001 0.05% ointment for the treatment of CI in subjects with either the RXLI or ARCI subtypes. In addition, a subset of preselected centers will recruit subjects in parallel with either the RXLI or ARCI subtypes for enrollment into an Optional Maximal Use arm for evaluation of the systemic exposure and safety of topical TMB-001 0.05% ointment for the treatment of CI. The Phase III Study is designed in three periods: • Period 1 - Induction (3 weeks): At the beginning of the 3-week Induction Period, eligible subjects will be randomized (2:1 ratio) to either TMB-001 0.05% once-a-day (QD) or Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™) provided by the Sponsor. • Period 2 - Treatment (9 weeks): The dosing frequency in the 9-week treatment period will be increased in each treatment group to TMB-001 0.05% BID or Vehicle BID. Mandatory bland emollient will be discontinued. • Period 3 - Maintenance (12 weeks): At Week 12, eligible subjects in the TMB-001 treatment group will be randomized (1:1 ratio) to an open-label treatment with TMB-001 0.05% BID or TMB-001 0.05% QD. To be eligible, subjects must have achieved a ≥1-point reduction in IGA score from Baseline. Subjects with less than a 1-point reduction in IGA score from Baseline will be discontinued from the study. Vehicle-treated subjects who achieved <1-point reduction in IGA score from Baseline are eligible to cross over to the TMB-001 0.05% BID treatment group. Subjects with a ≥1-point reduction in IGA score from Baseline will be discontinued from the study. Subjects at the end of the study or subjects discontinued from the study at any time will be followed-up for additional 2 weeks for AEs.

NCT ID: NCT05288166 Active, not recruiting - Prostatic Neoplasms Clinical Trials

A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)

CYCLONE 3
Start date: April 14, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.

NCT ID: NCT05287412 Active, not recruiting - Clinical trials for Multisystem Inflammatory Syndrome in Children (MIS-C)

Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children

MUSIC
Start date: September 30, 2020
Phase:
Study type: Observational

Multi-system Inflammatory Syndrome in Children (MIS-C) is a new condition related to COVID-19, the study investigators are still learning about its causes, effects, and long-term impact. "Long-Term Outcomes after the Multisystem Inflammatory Syndrome In Children", the Coronavirus MUSIC Study, is a research study funded by NIH and the National Heart, Lung, and Blood Institute. The study investigators hope to enroll at least 900 young people with MIS-C at children's medical centers in the U.S. and Canada. This research study will help us learn more about MIS-C and its effects on the long-term health of children.