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NCT ID: NCT03602560 Completed - Clinical trials for Primary Biliary Cholangitis

ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.

NCT ID: NCT03600818 Terminated - Clinical trials for Polymyalgia Rheumatica

Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica

Start date: October 9, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of KEVZARA (sarilumab) in participants with polymyalgia rheumatica (PMR) as assessed by the proportion of participants with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen. Secondary Objectives: - To demonstrate the efficacy of sarilumab in participants with PMR compared to placebo, in combination with a CS taper with regards to: - Clinical responses (such as components of sustained remission, disease remission rates, time to first disease flare) over time. - Cumulative CS (including prednisone) exposure. - To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with PMR. - To measure sarilumab serum concentrations in participants with PMR. - To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire.

NCT ID: NCT03600805 Terminated - Clinical trials for Giant Cell Arteritis

Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

Start date: November 20, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course. Secondary Objective: - To demonstrate the efficacy of sarilumab in participants with GCA compared to placebo, in combination with CS taper with regards to: - Clinical responses (such as responses based on disease remission rates, time to first disease flare) over time. - Cumulative CS (including prednisone) exposure. - To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with GCA. - To measure sarilumab serum concentrations in participants with GCA. - To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).

NCT ID: NCT03599856 Active, not recruiting - Critical Illness Clinical Trials

TraceBook: the Clinical Proof of Concept on the Intensive Care.

TraceBook
Start date: June 2, 2018
Phase: N/A
Study type: Interventional

The effectiveness of current checklists is hampered by lack of acceptance and compliance. Recently, a new type of checklist with dynamic properties has been created to provide more specific checklist items for each individual patient. The proof of concept of this dynamic clinical checklist (DCC; BJA 2017 (DOI: 10.1093/bja/aex129)) was tested in a simulation trial with improved outcomes and high acceptance scores. The purpose of this study is to investigate if the outcomes of this real-life clinical proof of concept study are similar with the outcomes of the simulation trial for the intensive care unit (ICU) ward.

NCT ID: NCT03599622 Terminated - Crohn's Disease Clinical Trials

An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease

Start date: July 16, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and effectiveness of BMS-986165 compared to placebo in participants with moderately to severely active Crohn's Disease.

NCT ID: NCT03599245 Active, not recruiting - Multiple Sclerosis Clinical Trials

This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)

Start date: July 12, 2018
Phase: Phase 3
Study type: Interventional

This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).

NCT ID: NCT03596827 Completed - Diarrhea Clinical Trials

The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection

MIRRE
Start date: September 26, 2018
Phase: N/A
Study type: Interventional

The existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already suitable for dietary interventions in its current form, targeted to impact on the immediate clinical symptoms upon E. coli infection. In order to make the model also suitable for dietary interventions that are aimed at support of the protective response against reinfection, the immune response triggered by the primary infection should be suboptimal. The MIRRE pilot study is set up to determine how much the primary inoculation dose of diarrheagenic E. coli should be lowered in order to result in a reduced protective response upon a secondary infection.

NCT ID: NCT03596671 Recruiting - Clinical trials for Treatment of Patients Suffering From Overactive Bladder (OAB)

BlueWind RENOVA iStimâ„¢ System for the Treatment of OAB

OASIS
Start date: June 12, 2019
Phase: N/A
Study type: Interventional

The OASIS study is prospective, interventional, multi-center study to evaluate the safety and efficacy of the BlueWind RENOVA iStimâ„¢ implantable tibial neuromodulation System for the treatment of patients diagnosed with overactive bladder.

NCT ID: NCT03596645 Active, not recruiting - Colitis, Ulcerative Clinical Trials

A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

PURSUIT 2
Start date: October 29, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.

NCT ID: NCT03596294 Completed - Healthy Subjects Clinical Trials

A Study in Healthy Male Subjects to Investigate Whether Administration of Rifampicin Can Affect the Fate of Clazosentan in the Body of Clazosentan

Start date: July 19, 2018
Phase: Phase 1
Study type: Interventional

A study in healthy male subjects to investigate whether administration of rifampicin can affect the fate in the body (amount and time of presence in the blood) of clazosentan