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NCT ID: NCT04598295 Completed - Clinical trials for Irritable Bowel Syndrome

SH-DS01 on Fecal Metagenomic Stability

Start date: October 20, 2020
Phase: Phase 2
Study type: Interventional

This is a randomized, double blind, Phase 1 study. There will be a 12-week comparison of the safety of DS-01 versus placebo with a secondary outcome measure of the efficacy in a cohort of 100 men or women with IBS with constipation. 50 IBS-C or IBS-M patients will receive DS-01 (Daily Synbiotic, once daily) for 12 weeks, while 50 IBS-C or IBS-M patients will receive the placebo (once daily). Safety is a paramount concern in the study design and will be monitored carefully throughout the study. Study subjects will also receive extensive education on use of the synbiotic.

NCT ID: NCT04598269 Completed - Atopic Dermatitis Clinical Trials

Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis

Start date: September 30, 2020
Phase: Phase 2
Study type: Interventional

This is a first-in-human, randomized, double-blind, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, tolerability, and PK of ATI-1777 solution following twice-daily applications to target areas of participants with moderate or severe atopic dermatitis (AD).

NCT ID: NCT04597957 Completed - Clinical trials for Diabetes Mellitus, Type 2

The Fruit and Vegetable Prescription Program Study

Start date: July 12, 2018
Phase: Early Phase 1
Study type: Interventional

The Fruit and Vegetable Prescription Program Study is a pilot randomized controlled trial of patients with type 2 diabetes participating in a fruit and vegetable prescription program from a Federally Qualified Health Center in Detroit, MI . Changes in hemoglobin A1C (%), blood pressure (BP) and weight (lbs.) will be assessed changes to discern the impact on those that participated in a fruit and vegetable prescription program compared to those that received non-incentivized diabetes standard of care.

NCT ID: NCT04597918 Completed - Clinical trials for Diabetic Macular Edema

A Study to Investigate Aqueous Humor and Multimodal Imaging Biomarkers in Treatment-Naïve Participants With Diabetic Macular Edema Treated With Faricimab

ALTIMETER
Start date: November 25, 2020
Phase: Phase 2
Study type: Interventional

This is an exploratory, prospective, multicenter, open-label, single-arm, interventional, Phase IIb study designed to explore the associations over time between clinical assessments, multimodal imaging assessments, aqueous humor (AH) biomarker patterns, and genetic polymorphisms in participants with diabetic macular edema (DME) who are treated with faricimab.

NCT ID: NCT04597749 Completed - Clinical trials for Sleep Apnea, Obstructive

Nebula Study - Screener Apps and HSAT vs. PSG Comparison

Start date: October 27, 2020
Phase: N/A
Study type: Interventional

This is a prospective, unblinded, open-label, single group study. All subjects will undergo concurrent screener app, HSAT testing, and in-lab polysomnography.

NCT ID: NCT04597632 Completed - Clinical trials for Neovascular Age-related Macular Degeneration

An Extension Study Assessing the Efficacy and Safety of Brolucizumab in a Treat-to-Control Regimen in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study

TALON Ext
Start date: December 16, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this extension study was to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control-regimen for treatment of patients with neovascular age-related macular degeneration who have completed the CRTH258A2303 (TALON) study. The main objective was to assess brolucizumab's potential for long durability up to 20 weeks. All eligible participants were treated with brolucizumab regardless of their treatment in the TALON study. The study period was 56 weeks including post-treatment follow-up.

NCT ID: NCT04597619 Completed - Nephrolithiasis Clinical Trials

Evaluation of a Nonopioid Recovery Pathway Following Surgery for Kidney Stones

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Evaluation of a nonopioid recovery pathway after percutaneous nephrolithotomy is a pragmatic pilot study that will apply the knowledge and experience gained with development of an outpatient opioid reduction protocol to percutaneous nephrolithotomy (PCNL). We have previously demonstrated that outpatient ureteroscopy and stent placement without postoperative opioid prescriptions is possible in the vast majority of patients. The success of this is dependent upon a multimodal approach to the patient's experience of undergoing endoscopic kidney stone surgery (ureteroscopy) and focuses on the preoperative, perioperative, and postoperative stages of intervention. Our hypothesis is that a novel nonopioid pathway after PCNL is both feasible and safe and will reduce postoperative prescriptions for opioids without impacting clinical outcomes, patient satisfaction or outpatient resources.

NCT ID: NCT04597554 Completed - Clinical trials for Nutrition Immunology

Cranberry Supplementation, Viral Defense, Antibody Response to the Flu Shot

Start date: September 21, 2020
Phase: N/A
Study type: Interventional

This study will investigate the effect of 8-weeks cranberry supplementation on the antibody response to influenza vaccination and ex-vivo anti-viral activity. The hypothesis is that 8-weeks ingestion of cranberry supplement relative to placebo will improve the antibody response to influenza vaccination and ex-vivo anti-viral defense.

NCT ID: NCT04597502 Completed - Human Microbiome Clinical Trials

The Effects of Terminalia Chebula Fruit Extract on the Gut Microbiome and Skin Biophysical Properties

Start date: October 15, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the use of oral Terminalia chebula fruit extract on the gut microbiome and skin biophysical properties. The fruit is commonly used for skin treatments in India. It is thought to have antioxidant properties, reduce inflammation and affect the microorganisms in the gut. The information the investigators will learn from this study may indicate how and if oral dosing can affect the skin and gut microbiome. This may lead to an improved understanding of the skin and determine whether these oral products are effective for improving the skin's appearance.

NCT ID: NCT04597450 Completed - PTSD Clinical Trials

Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)

Start date: September 30, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the effect of Lu AG06466 after multiple doses of 30 milligrams (mg) in participants with PTSD.