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NCT ID: NCT03098719 Completed - Health Behavior Clinical Trials

GISMO - Geographical Information Support for Healthy Mobility

GISMO
Start date: March 20, 2017
Phase: N/A
Study type: Interventional

GISMO combines spatial information with findings on the health effects of sustainable, active forms of mobility in the work environment in order to derive evidence-based decision-making bases for a health-promoting, operational mobility management. Existing approaches - with regard to spatial information systems, decision-support systems and health effects of active mobility - are considered and supplemented by our developments and investigations. Achieved non-personal results are provided through standardized web interfaces, ensuring integration into existing and prospective tools of an innovative and health-promoting mobility management.

NCT ID: NCT03097133 Completed - Clinical trials for Depressive Disorder, Major

54135419SUI3002: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide

Aspire II
Start date: June 15, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.

NCT ID: NCT03096834 Completed - Episodic Migraine Clinical Trials

A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies

Start date: March 20, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have failed other preventive migraine treatments.

NCT ID: NCT03096821 Completed - Clinical trials for Relapsed Hematologic Malignancy

Extended Analysis for Leukemia/Lymphoma Treatment

EXALT
Start date: September 2015
Phase:
Study type: Observational

Patients with relapsed/ refractory acute leukemia and relapsed/ refractory aggressive lymphoma harboring an activating genetic alteration (gene mutation, gene fusion) or drug-able biomarker / activated signal transduction pathway and resistant to any approved treatment modality will be eligible for this study. The investigators aim to combine DNA sequencing-based molecular profiling with an ex vivo high-throughput drug screening strategy. For the latter method, viable cells are obtained from the individual patient's lymphoma or leukemia in order to determine i)the expression of relevant therapeutic target molecules and ii)the ex vivo response of the patient's cancer cells to a panel of agents with anticancer activity. In addition, analysis of tumor stroma cells will provide information about the differential target expression and cellular sensitivity aiming at the evaluation of a therapeutic safety window. Thereby, biological material will have to be accessed within 4 weeks before onset of individualized treatment (real-time biopsy). Bioinformatic data-management based on a Bayesian statistical approach will support individualized treatment decisions in this controlled clinical approach.

NCT ID: NCT03093883 Completed - Heathy Volunteers Clinical Trials

Bioequivalence Study Comparing Single Dose of Ferrinemia® Injection With a Single Dose of Venofer® Injection in Healthy Male Volunteers

Start date: March 13, 2017
Phase: Phase 1
Study type: Interventional

The aim of this pharmacokinetic study is to assess the bioequivalence of the generic Ferrinemia® Iron Sucrose injection solution 20 mg/mL manufactured by Help S.A., Greece (test product), to Venofer® Iron Sucrose injection solution 20 mg/mL manufactured by Vifor AG, Switzerland (reference product). Both formulations contain iron as an active ingredient. Intravenous iron sucrose is primarily indicated for the treatment of iron deficiency anemia in adult patients.

NCT ID: NCT03093818 Completed - Clinical trials for Adverse Drug Reaction

PREemptive Pharmacogenomic Testing for Preventing Adverse Drug REactions

PREPARE
Start date: March 20, 2017
Phase: N/A
Study type: Interventional

PREPARE is an international, prospective, multi-center, open, randomized, cross-over implementation study assessing the impact of pre-emptive pharmacogenomic testing, of a panel of actionable pharmacogenomic variants, on adverse event incidence. Additional outcomes include, healthcare expenditure, process indicators for implementation and provider adoption of pharmacogenomics.

NCT ID: NCT03093259 Completed - Ulcerative Colitis Clinical Trials

ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

Start date: November 16, 2017
Phase: Phase 2
Study type: Interventional

This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in subjects with moderate to severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids followed by a one-month follow-up period.

NCT ID: NCT03091322 Completed - Clinical trials for Cardiac Resynchronization Therapy

BIO|MASTER.Edora Family Study

Start date: February 12, 2017
Phase:
Study type: Observational

This study is designed as post market clinical follow-up study with CE-marked products to evaluate the AV Opt and LV VectorOpt features in the respective Edora family pacemakers under clinical conditions. Furthermore, adverse events will be evaluated to identify residual risks associated with the use of the BIOTRONIK Edora family pacemakers. The study is further designed to address potential regulatory needs of clinical data for countries and regions not covered by the CE approval.

NCT ID: NCT03091127 Completed - Multiple Myeloma Clinical Trials

Real-world Use of Carfilzomib Among Multiple Myeloma Patients in Europe

Start date: March 14, 2017
Phase:
Study type: Observational

With the recent addition of carfilzomib as a treatment option for multiple myeloma, no data is available yet on how the drug is being used outside of the clinical trial setting. This study will therefore provide essential data to demonstrate the real world utilization of carfilzomib in routine clinical practice, including dosage, administration schedule, regimen, duration of treatment and reason for discontinuation in Europe.

NCT ID: NCT03087773 Completed - Clinical trials for Acute Myocardial Infarction

Impact of EMpagliflozin on Cardiac Function and Biomarkers of Heart Failure in Patients With Acute MYocardial Infarction

EMMY
Start date: May 11, 2017
Phase: Phase 3
Study type: Interventional

This study is planned to investigate the impact of Empagliflozin on biomarkers of heart failure in patients with myocardial infarction with and without type 2 diabetes mellitus within 6 months after the event.