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NCT ID: NCT04966897 Completed - Cystic Fibrosis Clinical Trials

Assessment of a PERT-free Nutritional Therapeutic Delivery System for Cystic Fibrosis

Start date: August 31, 2018
Phase: N/A
Study type: Interventional

This is a single center, randomized, double-blind, cross-over trial (with a follow-on single-blind safety evaluation stage), assessing a ready-to-drink nutritional supplement used without PERT ("PERT-free"), nutritional supplement for blood lipid levels, safety and tolerability compared to a standard of care nutritional supplement used concomitantly with PERT.

NCT ID: NCT04966871 Completed - Malaria Clinical Trials

Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults

Start date: September 27, 2021
Phase: Phase 1
Study type: Interventional

This is a randomized, double blind, placebo-controlled, single site, trial of a condensed regimen of PfSPZ Vaccine administered on Days 1, 8 and 29 by direct venous inoculation (DVI) to assess safety, tolerability, immunogenicity and vaccine efficacy (VE) against heterologous controlled human malaria infection (CHMI) conducted at varying time intervals after the third immunization (14, 42 or 70 days). The trial is designed to simulate pre-deployment immunization of military personnel. Prior studies with this regimen show high level protection (>80%) against CHMI at 21 days, but the onset and duration of protection have not been fully defined.

NCT ID: NCT04966741 Completed - Clinical trials for Bardet-Biedl Syndrome

Setmelanotide in Pediatric Patients With Rare Genetic Diseases of Obesity

Start date: February 16, 2022
Phase: Phase 3
Study type: Interventional

This is a phase 3 open-label, one-arm, clinical study to evaluate the efficacy, safety and tolerability of setmelanotide over 1 year of treatment, in pediatric patients aged 2 to <6 years with obesity due to either biallelic variants of the POMC, PCSK1 or LEPR genes or Bardet-Biedl Syndrome (BBS).

NCT ID: NCT04966325 Completed - Gout Clinical Trials

Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects

Start date: September 23, 2021
Phase: Early Phase 1
Study type: Interventional

This is a Phase 1, single-center, randomized, partially double-blind, placebo- and positive controlled, 4-way crossover study to evaluate the effect of a therapeutic and a supratherapeutic dose of LC350189 on the QTcF in healthy male and female subjects.

NCT ID: NCT04966013 Completed - COVID19 Clinical Trials

Evaluation of the RD-X19 Treatment Device in Individuals With Mild to Moderate COVID-19

Start date: June 17, 2021
Phase: N/A
Study type: Interventional

This is a randomized, sham controlled, dose finding study of the EmitBio RD-X19 device in individuals with symptomatic COVID-19 in the outpatient setting.

NCT ID: NCT04965415 Completed - Life Style Clinical Trials

Small+Safe+Well: A Longitudinal Study of TWH in Small Business

SSWell
Start date: April 1, 2017
Phase: N/A
Study type: Interventional

Workers in small businesses bear a disproportionate burden of occupational fatalities, illnesses, and injuries. The investigators conducted an intervention research project to determine how an intervention at the organizational level modifies business Total Worker Health (TWH) practices, safety climate, and health climate. In turn, the investigators aimed to determine whether organizational TWH adoption impacts individual workers' lifestyle health outcomes. In addition, the investigators also evaluated the use of the RE-AIM public health impact evaluation framework in the small business setting, with the intention of improving generalizability, maintenance, and dissemination of interventions and of guiding future TWH intervention design for both research and practice. The investigators conducted a lagged randomized controlled trial (L-RCT) to determine how different doses of an organizational-level TWH intervention (Health Links vs. Health Links + TWH Leadership Training) resulted in improvement and maintenance of TWH programming and organizational climates for safety and health, in small enterprises, over 36 months. The investigators also evaluated whether it resulted in improvements in workforce lifestyle health risks. In the short and mid-term, the goals and outputs of this project is a greater understanding of the theoretical underpinnings of TWH interventions and a model to test the implementation of the TWH interventions as well as an improvement the ability of TWH researchers and practitioners to apply this knowledge to TWH intervention design, implementation and evaluation to ensure generalizability. The long-term goal of this project is to impact worker safety, health and well-being through the continued use of these principles in small businesses.

NCT ID: NCT04965402 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese Participants

Start date: July 15, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986166 in healthy Japanese male and female participants of non-childbearing potential.

NCT ID: NCT04965116 Completed - Contraception Clinical Trials

Progestin-Only Pill Use and Breastfeeding Study

Start date: October 25, 2021
Phase: Phase 4
Study type: Interventional

This study will assess the impact of early initiation (less than one week postpartum) and delayed initiation (4 weeks postpartum) of two types of progestin-only contraceptive pills (POPs) on maternal, breastmilk, and infant outcomes.

NCT ID: NCT04964726 Completed - Clinical trials for Emotional Dysfunction

Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity

Start date: May 11, 2021
Phase: N/A
Study type: Interventional

This study will examine the effect of a real-time functional magnetic resonance imaging (fMRI) dyadic neurofeedback protocol with mothers and their adolescent daughters. Mothers will view a moving bar showing their daughters' brain activity on a computer screen while talking to their daughters.

NCT ID: NCT04964609 Completed - Oximetry Clinical Trials

EmbracePlus SpO2 Accuracy Validation

Start date: June 16, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to test the accuracy of EmbracePlus computed SpO2 during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing the reading of the the subject device during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample processed in a laboratory.