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NCT ID: NCT02838134 Completed - Surgery Clinical Trials

Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery

RELAX
Start date: November 2016
Phase: Phase 4
Study type: Interventional

Postoperative recovery after live donor nephrectomy (LDN) is largely determined by the consequences of postoperative pain and analgesia consumptions. The investigators' goal is to establish the relationship between the use of deep neuromuscular blockade (NMB) during laparoscopic donor nephrectomy (LDN) and the early quality of recovery. Therefore, the investigators designed a trial in which patients scheduled for living donor nephrectomy are randomized into a group with deep NMB or moderate NMB. The primary outcome measurement will be the Quality of Recovery-40 questionnaire (overall score) at 48 hours after extubation.

NCT ID: NCT02837419 Recruiting - Critically Ill Clinical Trials

Cost-effectiveness of Extracorporeal Life Support Treatment

Start date: December 1, 2017
Phase:
Study type: Observational [Patient Registry]

This study evaluates patients on ECLS treatment as considered appropriate with mortality and health related Quality of life and costs.

NCT ID: NCT02836548 Recruiting - Melanoma Clinical Trials

HDAC Inhibitor Vorinostat in Resistant BRAF V600 Mutated Advanced Melanoma

Start date: June 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is a mono-center open-label proof-of-concept pharmacologic study to explore the efficacy and safety of vorinostat in advanced BRAF mutated melanoma, which became resistant for BRAF-inhibitors or the combination of BRAF- and MEK-inhibitors.

NCT ID: NCT02836340 Terminated - Cardiac Arrest Clinical Trials

TIBOHCA: Safety, Tolerability and Pharmacokinetics of 2-Iminobiotin (2-IB) After OHCA

TIBOHCA
Start date: May 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Following successful cardiopulmonary resuscitation (CPR) after out of hospital cardiac arrest (OHCA), 50% of patients admitted to the Intensive Care Unit (ICU) die. As most patients die due to brain damage sustained during cardiac arrest and the subsequent reperfusion phase, effective neuroprotective strategies could potentially improve outcome. In animal experiments, 2-Iminobiotin (2-IB), a selective neuronal and inducible nitric oxide synthase (NOS) inhibitor, given upon reperfusion has been shown to improve memory function. Since 2-IB has not shown any safety issues in preclinical and clinical studies. Before embarking on large studies with efficacy as primary endpoint, safety, tolerability and pharmacokinetics need to be established. Objective: Evaluate short term safety and tolerability, and the pharmacokinetic properties of 2-IB in adult patients after OHCA. Study design: Phase 2, single-centre, open-label, dose-escalation intervention study. Study population: Three cohorts of eight evaluable patients admitted to the ICU after OHCA due to a cardiac cause. Intervention: The first eight patients will receive 0,055 mg/kg 2-IB every 4 hours intravenously, 6 times in total (part A). The second eight patients (cohort B) will receive 0,165 mg/kg every 4h iv, 6 times in total. The third eight patients (cohort C) will receive 0,5 mg/kg every 4h iv, 6 times in total. Medication has to be given as soon as possible and within 6h after OHCA. Escalation to the next dose level will only be done after pharmacokinetic analyses have performed, no relevant safety issues have been encountered, and the DSMB approves to move to the next dose level. Main study parameters/endpoints: Study parameters to evaluate short term safety and tolerability will be vital signs (heart frequency, blood pressure, cardiac ischemia) before and until 15 minutes after administration. (Serious) Adverse Events will be recorded on the ICU (up to 7 days) or until discharge from the ICU. For evaluation of the pharmacokinetics profile of 2-IB, 9 plasma samples will be analysed. Secondary parameters: Biochemical markers Neuron specific Enolase and s100b at 24h and 48h after start of study drug, occurrence of SAEs until 30 days after OHCA including death, long term term efficacy as determined by the Cerebral Performance Category (CPC), the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) or the Telephone Interview Cognitive Status (TICS) scale at 30 days after OHCA.

NCT ID: NCT02836002 Completed - Malaria Clinical Trials

Controlled Human Malaria Infection Model for Evaluation of Transmission‐Blocking Interventions - Study 1

CHMI-trans1
Start date: June 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single-center, open label study. The primary aim of this project is to develop a controlled human malaria infection transmission model ("CHMI-trans") or "challenge model" to evaluate the capacity of vaccines, biologics (monoclonal antibodies, or mAbs), and drugs to block malaria parasite transmission by assessing infectiousness of Plasmodium falciparum (Pf) gametocyte carriers for Anopheles mosquitoes.

NCT ID: NCT02835664 Completed - Obesity Clinical Trials

Nicotinamide Riboside and Metabolic Health

Start date: December 2016
Phase: N/A
Study type: Interventional

This study will investigate the effects of 6 week Nicotinamide Riboside supplementation (1000 mg/day) on metabolic health in healthy (pre)obese humans. The primary objective will be hepatic and whole body insulin sensitivity. Secondary objectives, to provide information about the underlying mechanism, will be muscle mitochondrial function, brown fat activity, ectopic lipid accumulation, energy metabolism, cardiovascular risk parameters, body composition and acetylcarnitine levels.

NCT ID: NCT02835651 Completed - Dyslipidemia Clinical Trials

Saturated Fatty Acids and HDL Metabolism

Start date: April 14, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether palmitic acid (C16:0) and stearic acid (C18:0) have different effects on HDL metabolism during the fasted state.

NCT ID: NCT02835274 Completed - Parkinson Disease Clinical Trials

Study to Characterize Acute and Chronic Directional Aspects of Deep Brain Stimulation

DIRECT-DBS
Start date: July 19, 2016
Phase: N/A
Study type: Interventional

The primary objective is to characterize the programming effects of Boston Scientific Verciseā„¢ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings.

NCT ID: NCT02834884 Recruiting - All Tumor Types Clinical Trials

SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access

SPECTA
Start date: May 3, 2017
Phase:
Study type: Observational [Patient Registry]

SPECTA is a quality assured platform for collecting clinicopathologically annotated biological material, imaging data, operative images, environmental assessment, questionnaires as well as patient-reported outcomes from cancer patients to support biospecimen-based translational research and clinical cancer research, including biomarker discovery to improve the understanding of tumor biology and cancer patients care.

NCT ID: NCT02833948 Completed - Clinical trials for Cardiovascular Diseases

Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT)

GALILEO-4D
Start date: May 2016
Phase: Phase 3
Study type: Interventional

The aortic valve is located between the left ventricle and the aorta. Patients with symptomatic, severe aortic valve stenosis conventionally have it surgically replaced requiring direct access to the heart through the chest. Transcatheter aortic valve replacement (TAVR) is now a well-established alternative for treating severe aortic valve stenosis. Both types of intervention improve prognosis and alleviate symptoms. The optimal choice of blood thinning therapy after TAVR is unknown. It has been reported that leaflet thrombosis with reduced leaflet motion can occur and this phenomenon has been suggested to be potentially related with neurological events. In addition, the occurence of this phenomenon can be reduced with anticoagulation blood thinning therapy. The purpose of this study is to evaluate if anticoagulation compared to the usual double platelet inhibitor therapy after TAVR can reduce the risk of leaflet thrombosis.