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NCT ID: NCT05517837 Terminated - Clinical trials for Healthy Participants

A Phase 1, First-in-Human Study of BMS-986421 in Healthy Participants

Start date: September 13, 2022
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of BMS-986421 in healthy adult participants.

NCT ID: NCT05517226 Terminated - Hepatic Impairment Clinical Trials

Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment

Start date: September 6, 2022
Phase: Phase 1
Study type: Interventional

This study will assess the pharmacokinetics (PK), safety, and tolerability of a single subcutaneous injection of cotadutide in participants with mild, moderate or severe hepatic impairment compared to participants with normal hepatic function.

NCT ID: NCT05515250 Terminated - Chronic Pain Clinical Trials

Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain

Start date: March 29, 2023
Phase: N/A
Study type: Interventional

Chronic abdominal pain is extremely common in individuals with Cystic Fibrosis (CF). Therapy for chronic abdominal pain is very limited and generally consists of osmotic laxatives or drugs that are used to treat irritable bowel syndrome (IBS), most of which are off-label and not proven to be effective for CF patients. Abdominal pain negatively impacts the quality of life (QOL). With the development of novel therapies for CF, life expectancy has significantly increased. There is, therefore, a critical need to identify treatment pathways for chronic abdominal pain in children with CF. In humans, abdominal pain is modulated by the vagus nerve. Stimulation of the vagus nerve has been suggested to reduce visceral sensitivity and abdominal pain. IB-stim is the Percutaneous Electrical Nerve Field Stimulation (PENS) device. It is a non-invasive, outpatient therapy. PENFS has been shown to be efficacious in pediatric patients with abdominal pain. The FDA has cleared and classified this device as class II, suggesting minimal to moderate risk. There is increasing evidence of intestinal inflammation in patients with CF, which could help explain the GI symptoms and differentiate from IBS. Studies have reported increased inflammation in the intestines using fecal calprotectin. With the implementation of this study, investigators hypothesize that the IB -Stim device will reduce their overall GI inflammation and abdominal pain.

NCT ID: NCT05514600 Terminated - Parastomal Hernia Clinical Trials

Fascial Defect Closure for Minimally Invasive Parastomal Hernia Repair

Start date: September 8, 2022
Phase: N/A
Study type: Interventional

Fascial closure was not originally a routine component of minimally invasive parastomal hernia repairs, but several recent advancements have made fascial closure more common in this context. These include barbed self-locking sutures that aid intracorporeal fascial closure under tension, and wristed instrumentation offered by the robotic platform when available. The investigator aims to characterize the clinical significance of closing the fascia adjacent to the stoma during a MIS parastomal hernia repair. The investigator hypothesizes that fascial closure will not have a significant impact on postoperative stoma specific quality of life but will reduce long-term recurrence.

NCT ID: NCT05514002 Terminated - Influenza, Human Clinical Trials

Comparison of Recombinant Influenza Vaccine Versus Standard Egg-Based Inactivated Influenza Vaccine in Adults 18-64 Years

Start date: September 13, 2022
Phase: Phase 4
Study type: Interventional

This randomized, active comparator trial will compare the clinical efficacy of recombinant influenza vaccine (RIV) to standard-dose egg-based inactivated influenza vaccine (SD IIV) among adults aged 18-64 years. The primary study hypothesis is that the clinical efficacy of RIV is superior to that of SD IIV to prevent and attenuate influenza-like illness (ILI)-associated influenza virus infection. Relative efficacy will be assessed by comparing rates of ILI-associated reverse transcription polymerase chain reaction (RT-PCR)-confirmed influenza virus infection and measures of infection and illness attenuation among participants who receive RIV versus SD IIV. A secondary hypothesis is that humoral and cell-mediated immune responses to RIV are superior to responses to SD IIV. Relative immunogenicity will be assessed by comparing markers of humoral and cell-mediated immune responses post-vaccination among a subset of participants who receive RIV versus SD IIV.

NCT ID: NCT05513391 Terminated - Clinical trials for Influenza Immunization

Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years

Start date: November 10, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years and to describe the immunogenicity and safety profile of RIV4 compared to IIV4 in participants aged 3 to 8 years.

NCT ID: NCT05511519 Terminated - Psoriatic Arthritis Clinical Trials

Study of ATI-450 vs Placebo in Patients With Moderate to Severe Psoriatic Arthritis

Start date: July 12, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2a study to investigate the efficacy, safety, tolerability, PK, and PD of ATI-450 versus placebo in patients with moderate to severe psoriatic arthritis.

NCT ID: NCT05510245 Terminated - Type 2 Diabetes Clinical Trials

A Clinical Trial of the Study Medicine (PF-07081532) in People With Diabetes and Kidney Dysfunction

Start date: August 29, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to understand the effects of kidney functional impairment may have on the study medicine (PF-07081532). People with certain level of kidney functional impairment may process PF-07081532 differently from healthy people. PF-07081532 is developed as a potential treatment for type II diabetes. Participants will take the study medicine as a tablet by mouth once at the study clinic and then will stay at the study clinic for about 7 days. During that time, the study team will monitor their treatment experience and take some blood samples to test the level of PF-07081532. This will help us understand if certain degree of kidney functional impairment will have an effect on the study medicine PF-07081532.

NCT ID: NCT05509738 Terminated - Text Messaging Clinical Trials

Feasibility of Text4US Program

Text4US
Start date: November 17, 2022
Phase: N/A
Study type: Interventional

Pediatric Lower Urinary Tract Symptoms (pLUTS) is common in school-age children and can negatively impact the quality of their life. Although at least 50% of children with pLUTS can improve through behavioral changes, how to support parents in helping their children adopt healthy bladder behaviors remains unrevealed. To solve this problem, the investigators developed an early model of a text message-based healthcare assistant. The aim of this study is to examine the feasibility of the text message-based healthcare assistant in pLUTS care.

NCT ID: NCT05506215 Terminated - Diabetic Foot Clinical Trials

Randomized Clinical Study Comparing SynPath to Standard of Care in Treatment of Chronic Diabetic Foot Ulcers

DFUs
Start date: July 10, 2022
Phase: N/A
Study type: Interventional

The study will evaluate the efficacy of SynPath™, a synthetic dermal matrix, in the treatment of diabetic foot ulcers in subjects with diabetes mellitus versus Standard of Care treatment. Half the subjects with be treated using SynPath™ while the other half will receive Standard of Care treatment