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NCT ID: NCT03570749 Active, not recruiting - Alopecia Areata Clinical Trials

A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata

BRAVE-AA1
Start date: September 24, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.

NCT ID: NCT03570619 Active, not recruiting - Solid Tumor Clinical Trials

Immunotherapy in Patients With Metastatic Cancers and CDK12 Mutations

IMPACT
Start date: December 14, 2018
Phase: Phase 2
Study type: Interventional

This study will attempt to determine the efficacy of checkpoint inhibitor immunotherapy with nivolumab and ipilimumab combination therapy followed by nivolumab monotherapy in patients with metastatic prostate cancer and other tumor solid tumor histologies harboring loss of CDK12 function as well as monotherapy nivolumab treatment in patient with metastatic prostate cancer harboring loss of CDK12 function.

NCT ID: NCT03570333 Active, not recruiting - Gingival Recession Clinical Trials

Progenitor Potential of Mesenchymal Stem Cells in Palatal Tissue Harvested From Molar and Premolar Sites

Start date: September 17, 2018
Phase: N/A
Study type: Interventional

The primary purpose of this protocol is to isolate, investigate and compare the regenerative and differentiation potential of mesenchymal stem cells (MSC's) in the gingival (gum) tissue harvested from two different locations from the roof of the mouth (palate), that is from the front part(premolar)and back part(molar). MSC's are known for their capacity to form different kinds of hard and soft tissue including bone, fibers for periodontal ligaments, cementum and dentin, thus this study can help in optimizing their clinical application and transplantation approaches in tissue regeneration.

NCT ID: NCT03570034 Active, not recruiting - Obesity Clinical Trials

Obalon Balloon System Post-Approval Study

PAS
Start date: June 15, 2018
Phase:
Study type: Observational

The Obalon Balloon System - Post-Approval Study is a prospective, observational, and multi-center study.

NCT ID: NCT03569956 Active, not recruiting - Clinical trials for Pseudofolliculitis Barbae

Shaving Satisfaction in Males With Skin Irritation From Shaving

Start date: October 29, 2018
Phase: N/A
Study type: Interventional

The purpose of this research study is to evaluate the improvement in overall shave satisfaction, the appearance of skin irritation from shaving, and the razor related inflammation of the hair follicles when using a new razor technology in a regular shaving regimen as well as a new razor technology in a shaving regimen that includes a pre-shave gel, cleansing brush and shaving gel.

NCT ID: NCT03569891 Active, not recruiting - Hemophilia B Clinical Trials

HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients

Start date: June 27, 2018
Phase: Phase 3
Study type: Interventional

This is an open-label, single-dose, multi-center, multinational trial to demonstrate the efficacy of AMT-061 and to further describe its safety profile. The study drug is identified as AAV5-hFIXco-Padua (AMT- 061). AMT-061 is a recombinant adeno-associated viral vector of serotype 5 (AAV5) containing the Padua variant of a codon-optimized human FIX complementary deoxyribonucleic acid (cDNA) under the control of a liver-specific promoter. The pharmaceutical form of AMT-061 is a solution for intravenous infusion administered at a dose of 2 x 10^13 gc/kg.

NCT ID: NCT03569878 Active, not recruiting - PTSD Clinical Trials

IT Enhanced Peer Integrated Collaborative Care for US Trauma Care Systems

TSOS 7 Peer
Start date: August 6, 2018
Phase: N/A
Study type: Interventional

This study evaluates two readily implementable approaches to the delivery of transitional care for injured patients treated emergently in US trauma care systems. The two approaches to be compared are a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists to trauma surgical team notification of patient emotional distress with recommended mental health consultation. The collaborative care intervention will be supported by a novel Emergency Department (ED) health information exchange technology platform.

NCT ID: NCT03569449 Active, not recruiting - Health Behavior Clinical Trials

Family Partner Navigation for Children

Start date: June 24, 2019
Phase: N/A
Study type: Interventional

Family Navigation (FN), an evidence-based care management strategy which is a promising intervention to help low income and minority families access timely mental health services. Despite significant evidence supporting the effectiveness of FN, concerns exist about the ability to disseminate FN to a broad population due to inefficiency and cost. The proposed study employs an innovative research methodology, the Multiphase Optimization STrategy (MOST), a framework for developing highly efficacious, efficient, scalable, and cost-effective interventions. The investigators will conduct a randomized experiment to assess the individual components of FN and identify which components and component levels have greatest effect on access to, and engagement in, diagnostic and treatment services for children with mental health disorders. This information then guides assembly of an optimized FN model that achieves the primary outcomes with least resource consumption and participant burden

NCT ID: NCT03569293 Active, not recruiting - Atopic Dermatitis Clinical Trials

Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)

Measure Up 1
Start date: August 13, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

NCT ID: NCT03569228 Active, not recruiting - Hearing Loss Clinical Trials

Efficacy of a Coupler-based Fitting Approach for Experienced Users Receiving Replacement Hearing Aids

Start date: October 28, 2019
Phase: N/A
Study type: Interventional

Hearing loss is among the top service-connected disabilities in Veterans. Hearing aids are the primary intervention for hearing loss. Half of the hearing aids dispensed in the VA are to Veterans who are receiving replacement amplification. Many Veterans would like their replacement hearing aids mailed to them, but they are required to travel to the clinic so that the fit of the hearing aid can be verified. There are standard fitting procedures, such as those used in infants and children, that use a coupler to simulate the patient's real ear to verify the hearing aid fitting. The results of this study should determine the efficacy of a coupler-based hearing-aid fitting protocol that would not require the Veteran to attend the fitting appointment, thereby contributing to improved Veteran-Centric care.