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NCT ID: NCT02817594 Completed - Chronic Hepatitis C Clinical Trials

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C

3DUTCH
Start date: January 20, 2016
Phase:
Study type: Observational

The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions. This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in the Netherlands in a clinical practice patient population.

NCT ID: NCT02817230 Completed - Atherosclerosis Clinical Trials

Effect of Statins on Trained Immunity

Start date: June 2015
Phase:
Study type: Observational

In this study, the investigators will determine whether patients with elevated levels of LDL are characterized by specific epigenetic changes in circulating cells of the innate immune system, compared to control subjects with healthy levels of LDL and whether regular statin treatment influences these changes.

NCT ID: NCT02815969 Completed - Clinical trials for Neuroendocrine Tumors

The Indol Profile; Exploring the Metabolic Profile of Neuroendocrine Tumors

Start date: September 2016
Phase:
Study type: Observational

This is an observational and exploratory study. Participants will be asked for a blood collection and a 24- hour collection of urine. The indol profile and levels of catecholamine and metabolites in PRP, as well as in 24- hour collection of urine will be measured with LC-MS/MS and analyzed.

NCT ID: NCT02815527 Completed - Critically Ill Clinical Trials

Time to Protein Target Using a High Whey Protein Enteral Nutrition in Critically Ill Patients

Start date: March 2016
Phase: N/A
Study type: Observational

This study evaluates the feasibility of a high whey-protein enteral nutrition formula in 20 ventilated ICU patients. The primary endpoint of study is the feasibility to attain the individualized protein target (≥1.2 g/kg ideal body weight/day) 96-hours after ICU admission. Secondary endpoints include tolerance and efficacy in terms of the amino acid response in blood.

NCT ID: NCT02815033 Completed - Clinical trials for Prostate Cancer Metastatic

Imaging Staging and Response Prediction in Metastatic Hormono-Sensitive Prostate Cancer Patients Receiving Enzalutamide

Start date: July 2015
Phase: Phase 2
Study type: Interventional

The aim of the study is to assess the clinical utility of 11C or 18F-Choline Positron Emission Tomography (PET)/Computed Tomography (CT) scan, Whole Body Magnetic Resonance Imaging (MRI) versus conventional bone scan and prostate-specific antigen (PSA) measurements in response prediction to treatment with Enzalutamide in Hormono-Sensitive Metastatic Prostate Cancer patients. The study will assess how these 2 imaging modalities perform compared to traditional serial PSA measurements and bone scan in assessing metastatic tumour load, progressive disease and response to treatment with Enzalutamide. In addition measurements of serially collected circulating tumour cell (CTC) samples, cell-free tumour DNA and RNA will be performed in order to evaluate their predictive value in terms of response measurement.

NCT ID: NCT02814968 Completed - Clinical trials for Prostate Cancer Metastatic

PET/CT and WB MRI for Staging and Response in CRPC Patients Receiving Enzalutamide

Start date: February 2015
Phase: Phase 2
Study type: Interventional

The aim of the study is to assess the clinical utility of 18F-fluoro-deoxyglucose Positron Emission Tomography (PET)/Computed Tomography (CT) and Whole Body Magnetic Resonance Imaging (MRI) versus conventional bone scan and prostate-specific antigen (PSA) measurements in response prediction to treatment with Enzalutamide in castration-resistant prostate cancer patients. The study will assess how these 2 imaging modalities perform compared to traditional serial PSA measurements and bone scan in assessing metastatic tumour load, progressive disease and response to treatment with Enzalutamide in castration-resistant prostate cancer patients. In addition measurements of serially collected circulating tumour cell (CTC) samples, cell-free tumour DNA and RNA will be performed in order to evaluate their predictive value in terms of response measurement.

NCT ID: NCT02812251 Completed - Healthy Clinical Trials

Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-61393215 in Healthy Participants

Start date: July 7, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety and tolerability of JNJ-61393215 versus placebo after single oral dose administration under fasted (ascending dose levels) and fed condition, to characterize the pharmacokinetics of JNJ-61393125 in plasma, cerebrospinal fluid (CSF) and urine after single oral dose administration and to investigate the effect of food (high fat/high calorie) on the pharmacokinetics of JNJ-61393215 following single oral dose administration.

NCT ID: NCT02811302 Completed - Clinical trials for Respiratory Depression

PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY

PRODIGY
Start date: April 7, 2017
Phase: N/A
Study type: Interventional

PRODIGY is a prospective, multi-center, post-market, international cohort study. The primary objective of this study is to derive a score to identify subjects at risk to have respiratory depression (RD) episodes in patients undergoing opioid therapy in the hospital ward and monitored by capnography. The score will be derived by using subjects within the derivation cohort and internally validated using subjects within the validation cohort. The primary endpoint used to derive the score will be the occurrence of RD episodes derived by Capnostream 20p device memory data combined with clinical data and validated by an independent Clinical Endpoint Committee (CEC) during the study course.

NCT ID: NCT02811237 Completed - Pulmonary Embolism Clinical Trials

Hospitalization or Out-treatment ManagEment of Patients With Pulmonary Embolism: a Randomized Controlled Trial

HOME-PE
Start date: January 2017
Phase: N/A
Study type: Interventional

Several studies have demonstrated the possibility of outpatient management or early discharge for certain patients presenting acute pulmonary embolism (PE), providing a suitable structure is in place. The approach featured in the most recent guidelines on acute PE of the European Society of Cardiology, refers to an all-cause mortality risk assessment using the Pulmonary Embolism Severity Index (PESI) score or the simplified PESI score (sPESI). The sPESI takes into account demographics (age), patient history (cancer, cardiac or respiratory disease), and clinical data (systolic blood pressure, heart rate, oxygen saturation). Outpatient care is offered to low-risk patients, providing that all the conditions pertaining to start anticoagulant treatment and follow-up at home are met. An alternative approach based on a list of simple criteria has been developed as the one used in HESTIA study. The main criteria included in the HESTIA rule consist of absence of the following: hemodynamic instability, need for oxygen therapy, high-risk of hemorrhage, renal or liver failure, or other medical or social conditions requiring hospitalization. The investigators hereby propose comparing these two approaches in an open-label, controlled randomized international trial with blinded adjudication of endpoints. The main objective is to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is at least as safe as regards the 30-day-rate of adverse events (recurrent VTE, major bleeding or death). The major secondary objectives are to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is more effective : - As regards the rate of patients eventually managed as outpatients. - As regards the rate of patients, in theory, eligible for outpatient care,

NCT ID: NCT02810795 Completed - Clinical trials for Coronary Artery Disease

Dynamic Stress Perfusion CT for Detection of Inducible Myocardial Ischemia

SPECIFIC
Start date: June 7, 2016
Phase:
Study type: Observational

The purpose of this study is to determine the diagnostic accuracy of MPICT for the detection of hemodynamically relevant coronary stenosis (as determined by invasive FFR) in patients with suspected or known CAD clinically referred for invasive angiography.