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NCT ID: NCT04763278 Completed - Clinical trials for Amputation; Traumatic, Hand

Validation of User Needs of the Point Digit With Partial Hand Amputees

Start date: January 7, 2021
Phase: N/A
Study type: Interventional

The objective of the device feasibility study will be to validate the user needs of the Point Digit system. This study will be a single group intervention model where one group of 5 partial hand amputees will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.

NCT ID: NCT04763265 Completed - Frown Lines Clinical Trials

Study to Compare 2 Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines

H2H
Start date: December 18, 2019
Phase: Phase 2
Study type: Interventional

The purpose of the study is to provide preliminary comparative data on BoNT/A-DP versus Botox Cosmetic. Subsequently the sample size is primarily based on clinical judgement and practical considerations.

NCT ID: NCT04763226 Completed - Clinical trials for Healthy Participants

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986308 in Healthy Participants

Start date: April 14, 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-986308 compared to placebo in healthy participants.

NCT ID: NCT04763044 Completed - Caries Clinical Trials

Evaluation of the Fluoride Dose Response Using In Situ Caries Model

Start date: March 1, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the fluoride dose response of different dentifrice fluoride concentrations - 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) and a fifth leg of 1100 ppm Stannous Fluoride (SnF2) using an in situ caries model.

NCT ID: NCT04762719 Completed - Diabetes Clinical Trials

PET Imaging to Delineate Macrophage Activation in Diabetic Gastroparesis

Start date: May 10, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Macrophage-driven immune dysregulation has been shown to be involved in pathophysiology of diabetic gastroparesis. Currently, there are no non-invasive ways to study macrophage activation in humans. The researchers are trying to determine the utility of 11C-ER176 based PET-CT scanning to determine pro-inflammatory macrophage activation in gastric wall of patients with diabetic gastroparesis.

NCT ID: NCT04762680 Completed - COVID-19 Clinical Trials

Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older

Start date: February 24, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objectives of the study are: To assess the safety profile of the study vaccines in each study intervention group. To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults. To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a twodose priming series with the monovalent vaccine, and superior to that observed immediately before booster. The secondary objectives of the study are: To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study. To assess the neutralizing and binding antibody responses of booster vaccination. To describe the occurrences of laboratory-confirmed symptomatic COVID19 after primary series and booster vaccination. To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.

NCT ID: NCT04762537 Completed - Opioid-use Disorder Clinical Trials

Surmounting Withdrawal to Initiate Fast Treatment With Naltrexone

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

This study compares two methods of initiating treatment with extended-release naltrexone (XR-NTX) when implemented at community-based inpatient or residential programs. The primary goal of this hybrid effectiveness-implementation study is to determine whether the Rapid Method (5-7 day long) is non-inferior to a Standard Method (13-day long) on the primary effectiveness outcome of successful initiation of XR-NTX (receiving the first injection). Secondary objectives include comparing Rapid versus Standard method on: time from admission to first dose of XR-NTX and time to dropout, craving, withdrawal severity, retention, abstinence, and safety measures, as measured during the inpatient induction process and the first two months of post-induction XR-NTX maintenance. Other exploratory outcomes include predictors of initiation success, and economic analyses. The implementation goal is to operationalize an implementation facilitation strategy that will be used to train clinical sites on the XR-NTX initiation method, to capture fidelity to the rapid induction process, and to study barriers and facilitators to implementation and refine the implementation facilitation strategy accordingly.

NCT ID: NCT04762524 Completed - AKI Clinical Trials

The Impact of CRRT Modality on Filter Life

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

The investigators plan to start patients who need CRRT on either CVVH or CVVHD by block randomization, and then to measure filter life.

NCT ID: NCT04762498 Completed - Chronic Gout Clinical Trials

A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)

FORWARD OL
Start date: January 26, 2021
Phase: Phase 4
Study type: Interventional

This trial is to assess efficacy, safety, blood levels and bodily effects of up to 2 dose levels of intravenous (IV) pegloticase (KRYSTEXXA) infusions at every 4 week intervals (Q4 Weeks) for up to 6 months (Day 1 to 24 weeks with an optional 24 - 48 weeks treatment duration) when given in combination with weekly oral doses of methotrexate (MTX). The goal is to identify an appropriate dose to be administered every 4 weeks to be used for future clinical trials for patients with chronic gout that does not adequately respond to conventional therapy.

NCT ID: NCT04762277 Completed - Clinical trials for Hidradenitis Suppurativa

A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa

Start date: April 6, 2021
Phase: Phase 2
Study type: Interventional

This study is open to adults with a chronic inflammatory skin disease called hidradenitis suppurativa. The purpose of this study is to find out whether a medicine called spesolimab helps people with moderate to severe hidradenitis suppurativa. Participants are put into 2 groups by chance. One group takes spesolimab. The other group takes placebo. Every participant has twice the chance of being in the spesolimab group than in the placebo group. Participants get spesolimab or placebo as an infusion into a vein every week for the first 3 weeks. Afterwards, they get spesolimab or placebo as injections under the skin every 2 weeks. Placebo infusions and injections look like spesolimab infusions and injections but do not contain any medicine. Participants are treated in the study for about 3 months. During this time, they visit the study site about 9 times. After completing this part of the study, participants are offered to join another clinical study in which all participants get spesolimab. Participants who cannot join the other study, stay in this study for about 4 more months. During this time, participants do not take spesolimab nor placebo but they visit the study site 2 times to have their health checked. At study visits, doctors thoroughly check the skin of participants to count lumps (nodules) and boils (abscesses). The results between the spesolimab group and the placebo group are compared after 3 months of treatment. The doctors also regularly check the general health of the participants.