There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The objective of this study is to compare weight loss (6 mos.) and maintenance (18 mos.) between an individual home visit intervention (IH) and an intervention delivered remotely via video conferencing to groups of overweight/obese adults with Mobility Related Disabilities (MRDs) in their homes (GR). The primary aim will be to compare weight loss (0-6 mos.) between the two interventions (IH vs. GR). Secondarily, the study team will compare the mean weight loss from 0-18 mos., the proportion of participants achieving >=5% weight loss from baseline, changes in cardiovascular risk factors and quality of life, and conduct a cost analysis. In addition, factors that will be explored include the influence of behavioral session attendance, compliance with the recommendations for diet (energy intake, number of entrees/shakes, servings of fruits/vegetables), Physical Activity (PA, min of moderate vigorous PA, min sedentary time), and self-monitoring of diet and PA, self-efficacy for dietary change and PA, dietary self-regulation, social support for diet/PA, barriers to PA, sleep and medications on weight loss at 6 and 18 mos.
This is a multi-center, non-randomised Phase 1b study to evaluate the safety and tolerability of ATP128 alone or in combination with BI 754091 and of heterologous prime-boost ATP128 + VSV-GP128 in combination with BI 754091. ATP128 is a self-adjuvanted chimeric recombinant protein vaccine being developed in combination with programmed cell death 1 (PD-1) blockade for the treatment of microsatellite stable (MSS) patients not responding to PD-1 blockade. The PD-1 inhibitor being tested with ATP128 is the BI 754091 (Ezabenlimab) compound which belongs to the human immunoglobulin G4 (IgG4) subclass of antibodies. VSV-GP is a recombinant chimeric vesicular stomatitis virus (VSV, Indiana strain Rhabdoviridae) which carries the envelope glycoprotein (GP) of the visceral non neurotropic WE-HPI strain of the Lymphocytic choriomeningitis virus (LCMV, Arenaviridae) instead of the native VSV glycoprotein (G) and is developed as integral part of the prime-boost regimen together with ATP128. The Sponsor plans to enrol 96 patients with histologically or cytologically confirmed stage IV colorectal cancer coming form three different patient populations: - Cohort 1a: 6 patients with stage IV colorectal cancer (CRC) having failed standard of care (SoC) therapies - Cohorts 1b, 2a, 2c: 30 patients with stage IV microsatellite stable/mismatch repair-proficient (MSS/MMRp) CRC being in stable disease (SD) or partial response (PR) after first line of SoC (4-6 months duration at minimum) - Cohorts 2b, 4b: 30 patients with stage IV MSS/MMRp liver-limited disease Patients eligible for this study will be enrolled in one of the 8 cohorts depending on their disease: - Patients in Cohort 1a will receive ATP128 as single agent - Patients in Cohorts 1b, 2a, 2b, 2c will receive ATP128 in combination with BI 754091 - Patients in Cohorts 3, 4a, 4b will receive ATP128 and VSV-GP128 in combination with BI 754091
This is the first in human treatment with ST-920, a recombinant AAV2/6 vector encoding the cDNA for human a-Gal A. The purpose of this study is to evaluate the safety and tolerability of ascending doses of ST-920. ST-920 aims to provide stable, long-term production of α-Gal A at therapeutic levels in subjects with Fabry disease. The constant production of α-Gal A in humans should, importantly, enable reduction and potentially clearance of Fabry disease substrates Gb3 and lyso-Gb3. On Day 1, patients will be infused intravenously with a single dose of ST-920 and followed for a period of 52 weeks.
Bladder cancer is a common disease with high rates of mortality, especially at advanced stages. Neo-adjuvant cisplatin-based chemotherapy (NAC) followed by radical cystectomy is considered standard of care for patients with muscle invasive disease, as NAC improves surgical outcomes in these patients. However, some patients are ineligible for cisplatin-based chemotherapy due to other medical issues. Although a combination of carboplatin and gemcitabine has been used with limited success, most patients proceed directly to cystectomy without realizing the potential survival benefit afforded by NAC. Intravenous ascorbate (vitamin C) administration (IVC) has been shown to improve both carboplatin and gemcitabine-based therapy in other models. This trial will add IVC to gemcitabine/carboplatin chemotherapy to evaluate whether co-treatment will increase therapeutic efficacy.
This study is to determine how 8-week Tai Chi intervention alters plasma endocannabinoid and its receptors in monocytes/marcrophages, plasma oxylipinds, plasma brain-derived neurotrophic factor, brain white matter connectivity/efficiency, and functional/clinical outcomes in women with knee OA.
Patients enrolled in the study will receive standard of care adjuvant or definitive breast, chest wall or thoracic radiation therapy.Cardiac mitochondrial dysfunction is a hallmark of radiation-induced cardiac injury. Reactive oxygen species (ROS) produced by ionizing radiation cause oxidation of mitochondrial proteins and alter oxidative phosphorylation and pyruvate metabolism(5). The goal of this study is to detect early changes in the mitochondrial metabolism in situ as a marker for subclinical radiation-induced cardiotoxicity.
Many adults with obesity continue to gain weight even though they do not want to. This project will test the effects of a primary care intervention in which people with obesity receive an electronic scale and recommendations to weigh themselves daily. This will help us understand whether daily self-weighing might be a way to prevent continued weight gain.
This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20 (subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of IgPro20 subcutaneous (SC) doses in comparison to placebo in adult subjects with DM, as measured by responder status based on Total Improvement Score (TIS) assessments.
The objective of this clinical study is to evaluate the safety of an intraarticular injection of an investigational biologic product (IBP), PSC-01, the patient's own adipose-derived stromal vascular fraction cells (SVF) extracted from a lipoaspirate sample, to treat the pain of osteoarthritis in a single knee. The secondary objective is to get initial data on efficacy of the PSC-01.
This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Safety, tolerability, and pharmacokinetics will be assessed throughout the study. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort.