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NCT ID: NCT03345836 Completed - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

Start date: November 29, 2017
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

NCT ID: NCT03345823 Active, not recruiting - Crohn's Disease Clinical Trials

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

U-ENDURE
Start date: March 21, 2018
Phase: Phase 3
Study type: Interventional

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

NCT ID: NCT03344653 Completed - Clinical trials for Coronary Artery Disease

A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients

Onyx ONE
Start date: November 2, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.

NCT ID: NCT03339401 Terminated - Adenovirus Clinical Trials

The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation

AdAPT
Start date: December 22, 2017
Phase: Phase 2
Study type: Interventional

This study was designed to assess the safety, overall tolerability, and antiviral activity of "short course" brincidofovir (BCV) therapy, as compared with current standard of care (SoC), for the treatment of adenovirus (AdV) infections in high-risk (i.e., T cell depleted) pediatric allogeneic hematopoietic cell transplant (HCT) recipients. A virologic response-driven approach to the duration of treatment was to be evaluated, in which subjects randomized to BCV therapy were to be treated until AdV viremia was confirmed as undetectable or until a maximum of 16 weeks of therapy, whichever occurred first. The formulation of BCV used in this study was oral tablet/suspension.

NCT ID: NCT03337971 Recruiting - Clinical trials for Osteoporosis, Postmenopausal

Nutritional Supplement and Bone Health in Post-Menopausal Women

MBPS
Start date: October 3, 2017
Phase: N/A
Study type: Interventional

The process of bone remodeling exhibits pronounced diurnal pattern that is important for bone health. A balanced rate of bone resorption is required to maintain bone health, a balance that can be disturbed during the lifecycle to effect net rate of formation (as occurs during growth and development to adulthood) or net resorption (as occurs, for example, during the menopause).The research to be undertaken investigates the pluripotent effect of dairy-based products on the regulation of the diurnal process of bone metabolism in post-menopausal women at risk of osteoporosis.

NCT ID: NCT03330847 Active, not recruiting - Clinical trials for Metastatic Triple Negative Breast Cancer

To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.

Start date: March 7, 2018
Phase: Phase 2
Study type: Interventional

This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related protein kinase (Ceralasertib [AZD6738]) and olaparib monotherapy versus olaparib in combination with an inhibitor of WEE1 (adavosertib [AZD1775]) in second or third line setting in patients with Triple-negative breast cancer (TNBC) prospectively stratified by presence/absence of qualifying tumour mutation in genes involved in the homologous recombination repair (HRR) pathway. Treatment arms are olaparib monotherapy, olaparib+ Ceralasertib and olaparib+adavosertib. The study subject population will be divided into Stratum A, Stratum B, and Stratum C. Due to the different schedules of administration of each of the treatment options as well as their different toxicity profiles, the study is not blinded. Study has two stage consent process- stage 1 consent (molecular screening for HRR defects) and stage 2 consent (main study). Patients with TNBC and with known qualifying BRCAm, non BRCAm HRRm and non HRRm status will be offered the option of consenting to the main part of the study within the 28-day screening period. Following the ISRC meeting on 17 April 2019 a recommendation was made to close the adavosertib+olaparib treatment arm across all biomarker strata. Patients receiving treatment with adavosertib+olaparib treatment were offered the opportunity to continue treatment on olaparib monotherapy at the approved dose (300 mg bd). Following the closure of this arm the total number of patients randomised will be lower (approximately 350 patients). Approximately 300 patients will be randomised (using randomisation ratio 1:1) to 2 ongoing treatment arms plus an additional 47 patients to a 3rd arm (olaparib+adavosertib) prior to the arm being discontinued.

NCT ID: NCT03329846 Completed - Melanoma Clinical Trials

An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma

Start date: November 30, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated

NCT ID: NCT03325439 Terminated - Clinical trials for Electroencephalographic Neonatal Seizures

A Study to Test the Pharmacokinetics, Efficacy, and Safety of Brivaracetam in Newborns With Repeated Electroencephalographic Seizures

Start date: May 7, 2019
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the pharmacokinetics (PK) of brivaracetam (BRV) in neonates who have seizures that are not adequately controlled with previous antiepileptic drug (AED) treatment, and to identify the optimal BRV dose (Exploratory Cohort) for the treatment of subjects enrolled into the Confirmatory Cohorts of this study.

NCT ID: NCT03325283 Completed - Aortic Stenosis Clinical Trials

The PROTEMBO SF Trial

Start date: August 9, 2017
Phase: N/A
Study type: Interventional

The PROTEMBO SF Trial is a prospective, observational, multi-center, intention-to-treat study of the safety and feasibility of the ProtEmbo Cerebral Protection System in subjects with severe symptomatic native aortic valve stenosis indicated for TAVR.

NCT ID: NCT03322566 Completed - Lung Cancer Clinical Trials

A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)

Start date: January 9, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).