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NCT ID: NCT02666404 Terminated - Shock Clinical Trials

Impact of Amount of Fluid for Circulatory Resuscitation on Renal Function in Patients in Shock

VoluKid
Start date: January 2016
Phase: N/A
Study type: Interventional

Volume resuscitation is the mainstay of treatment in most types of shock, especially in hemorrhagic and septic shock. Septic shock is a main cause of morbidity and mortality worldwide. Although there has been a lot of research to evaluate optimal amount and composition of fluids for volume resuscitation (e.g. colloids, crystalloids, red blood cell transfusion, albumin, fresh frozen plasma) particularly in the past decade, results remain inconclusive and to some extent contradictive. The investigators would like to contribute to the establishment of new endpoints for the guidance of shock therapy focusing on the first 24 and 48 hours, amending the currently used parameters (i.e. cardiac output, heart rate, blood pressure, central venous pressure) with new measurements (see study specific measurements). The goal is to decrease the need for renal replacement therapy, thereby eventually reducing patient morbidity and mortality.

NCT ID: NCT02665364 Terminated - Clinical trials for Systemic Lupus Erythematosus

Phase IIb Study of IFN-K in Systemic Lupus Erythematosus

Start date: September 23, 2015
Phase: Phase 2
Study type: Interventional

The safety and immunogenicity of the IFNα-Kinoid (IFN-K) have been evaluated in a phase I clinical study conducted in subjects with Systemic Lupus Erythematosus (SLE). Preliminary results showed acceptable safety profile and patients developped antibodies response. The principal aim of the present study is to confirm the neutralization of the interferon gene signature and the clinical efficacy of IFN-K in subjects with SLE. In addition, the immune responses and the safety elicited by IFN-K will also be evaluated.

NCT ID: NCT02656615 Terminated - Prostate Cancer Clinical Trials

Abiraterone-Rechallenge Study for CRPC Patients

ABI-RE
Start date: January 2016
Phase: Phase 2
Study type: Interventional

To assess activity of abiraterone-re-challenge in patients with advanced prostate cancer and prior response to abiraterone.

NCT ID: NCT02641795 Terminated - Clinical trials for Sensory Hearing Loss

Robotic Assisted Cochlear Implantation Feasibility Study

MIRACI
Start date: July 1, 2016
Phase: N/A
Study type: Interventional

A first in man clinical trial to asses the the use of am image guided robotic system to safely and effectively create a minimally invasive access tunnel to the middle ear cavity to allow access to the round window for cochlear implant electrode insertion.

NCT ID: NCT02641392 Terminated - Crohn's Disease Clinical Trials

A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

Start date: July 25, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study. The GED-0301-CD-003 trial was not initiated; see detailed description.

NCT ID: NCT02640534 Terminated - Prostate Cancer Clinical Trials

Investigation of Metformin in Patients With Castration Resistant Prostate Cancer in Combination With Enzalutamide vs. Enzalutamide Alone

Start date: June 10, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to test if the combination of enzalutamide and metformin in patients with castration resistant prostate cancer CRPC progressing on androgen deprivation therapy ADT is more effective compared to enzalutamide alone. The half of the patients will receive the experimental treatment combination, enzalutamide and metformin, while the other half will receive enzalutamide alone.

NCT ID: NCT02639468 Terminated - Stroke Volume Clinical Trials

Electric Impedance Tomography

SVEIT
Start date: April 2016
Phase: N/A
Study type: Interventional

Evaluation of electrical impedance tomography to non-invasively monitor stroke volume when compared to reference measurements performed via right heart thermodilution

NCT ID: NCT02632253 Terminated - Clinical trials for Congenital Heart Defects

Effects of High-intensity Interval Training on Exercise Capacity in Patients With Grown-up Congenital Heart Disease

HIIT-GUCH
Start date: January 2016
Phase: N/A
Study type: Interventional

Patients with congenital heart disease have long been discouraged from participating in physical exercise which has led to impaired exercise capacity in this population. Since low physical and cardiorespiratory fitness has been shown to be a predictor for hospitalization and mortality in grown-up patients with congenital heart disease (GUCH), aerobic endurance training has been recommended recently to improve exercise capacity. The aim of this study is to compare two types of training, namely high-intensity interval training (HIIT) and moderate-intensity continuous exercise (MICE), with regard to improving exercise capacity without adverse effects on heart structure, function and rhythm in the setting of a 12-week outpatient cardiac rehabilitation (CR) program in GUCH with a remaining pathology involving the right and/or left ventricles. Primary endpoint will be change in exercise capacity (maximal oxygen consumption) over the 12-week CR. Secondary endpoints will be changes of the right or left ventricles as well as vascular function. Patients with GUCH and reduced function of the right ventricle will be recruited and informed about the study within the first two weeks of CR. At the end of week 3 of the CR with supervised MICE, randomization to 9 weeks of twice weekly either HIIT or MICE takes place. MICE training is performed at an intensity of 70-85% of maximum heart rate (HRmax) for 38 min. HIIT consists of four 4 min bouts of high-intensity exercise (90-95% of HRmax), interspersed by 3 min low-intensity intervals (50-60% of HRmax). All patients complete one additional endurance activity per week in their own time with a duration of 30-60 min at moderate intensity monitored by their smart phone. Change in peak oxygen uptake as well as maximal exercise capacity at the end of an incremental cardiopulmonary exercise test will be assessed between week 3 and 12. Vascular function will be assessed at the same time. Volumes and function of the right and left ventricles will be measured by cardiac magnetic resonance imaging (CMR) upon inclusion into the study and at completion of the intervention. Furthermore, laboratory markers for heart failure as well as occurrence of irregular fast heart beats will be assessed.

NCT ID: NCT02625922 Terminated - Clinical trials for Chronic Heart Failure

Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure

RELAX-Cardio
Start date: February 5, 2016
Phase: Phase 2
Study type: Interventional

This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.

NCT ID: NCT02621749 Terminated - Cerebral Embolism Clinical Trials

Cerebral Microembolism in the Critically Ill With Acute Kidney Injury

COMET-AKI
Start date: January 2017
Phase: N/A
Study type: Interventional

The primary objective of this study is to investigate the impact of continuous renal replacement therapy and intermittent renal replacement therapy on microbubble / cerebral microemboli generation in a cohort of critically ill patients with dialysis-dependent acute kidney injury.