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NCT ID: NCT03579719 Recruiting - Healthy Volunteers Clinical Trials

A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers

Start date: July 10, 2018
Phase: Phase 1
Study type: Interventional

This study will be a non-randomized, open-label, one-sequence, two-period within-subject study to investigate the effect of CYP3A inhibition on the PK of balovaptan in healthy male and female volunteers using itraconazole as a CYP3A inhibitor. The study will be conducted at 1 site in the Netherlands.

NCT ID: NCT03578809 Recruiting - Clinical trials for ST Elevation Myocardial Infarction

A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction

REAL-TIMI 63B
Start date: June 5, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy, safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult subjects presenting with acute STEMI (ST segment elevation myocardial infarction). The study will enrol subjects presenting with acute STEMI who are planned for primary percutaneous coronary intervention (pPCI). For all subjects, an end of study CMR will be performed at 10-12 weeks (70-84 days following Dose 1). A subset of subjects will also undergo an index and an end of study CTA.

NCT ID: NCT03578510 Completed - Clinical trials for Patients With End Stage Renal Disease on Hemodialysis

Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis

Start date: September 17, 2012
Phase: N/A
Study type: Interventional

Intradialytic hypotension (IDH) is a frequent and serious complication that may occur during hemodialysis treatment. The investigators and others have shown that the Hemocontrol biofeedback system is associated with improved hemodynamic stability. Hemocontrol is a technique that guides the patients' blood volume along a pre-set trajectory by continuously adjusting the ultrafiltration rate and dialysate conductivity. In a recent pilotstudy, the investigators found significantly higher plasma vasopressin levels during the first hour of dialysis with Hemocontrol in comparison with standard hemodialysis. Increased vasopressin levels may contribute to intradialytic hemodynamic stability during hemodialysis by enhanced vasoconstriction. These results, however, did not prove directly that the improved hemodynamic stability with Hemocontrol is indeed caused by higher initial plasma vasopressin levels. Alternative explanations might be that 1) the higher initial plasma sodium levels with Hemocontrol dialysis enhance activity of the sympathetic nervous system directly, causing vasoconstriction and thereby improved hemodynamic stability and/or 2) that the higher initial plasma levels of sodium in Hemocontrol inhibit the release of nitric oxide by the vascular endothelium. Another goal of this study is to investigate whether vasopressin is removed with hemodialysis.

NCT ID: NCT03577405 Recruiting - Critical Illness Clinical Trials

Simple Intensive Care Studies II

SICS-II
Start date: May 14, 2018
Phase:
Study type: Observational [Patient Registry]

Critically ill patients admitted to the intensive care unit (ICU) frequently suffer from circulatory shock or respiratory distress, with high morbidity and mortality up to 40%. After initial fluid resuscitation other complications associated with either treatment or disease may arise. A consequence of treatment might be fluid overload or overfilling. Multiple studies have shown the possible negative effects of - too much - fluid administration, such as venous congestion. Venous congestion entails venous fluid overload, manifested by for example an increased central venous pressure (CVP) or peripheral oedema. This venous congestion may contribute to the occurrence of short-term organ failure by causing a high ''afterload'' in the venous tracts of organs. There is no consensus on how to measure venous congestion. It is important to identify variables that reflect the development of venous congestion in order to investigate whether venous congestion is associated with short-term organ failure. Variables that indicate venous congestion may be obtained with clinical examination and biochemical analyses, supplemented by hemodynamic variables derived from critical care ultrasonography (CCUS) with information about organ perfusion, and both arterial and venous function. The development of short-term organ failure can be assessed by collecting clinical, biochemical and hemodynamic variables at multiple moments. Using repeated measurements is likely to add dynamic information about the diagnostic and prognostic value of these variables. The dynamics of variables, in any direction, over time might improve the diagnostic accuracy and prognostic value of clinical, biochemical and hemodynamic variables that can be collected at the beside of the critically ill patient. Aim and hypotheses This study aims to investigate the association between dynamic variables that reflect venous congestion and the development of short-term organ failure and mortality in the critically ill. The primary objective of this study is to identify the combination of variables at different time points that indicate venous congestion and predict patient outcome. Secondary objectives are to identify a combination of CCUS variables that precede serum creatine rises in patients who develop acute kidney injury (AKI) after an acute ICU admission {diagnostic}; to identify a combination of variables per organ system or subset of populations to predict short-term organ deterioration and 7-day mortality {prognostic}; to identify a combination of variables over 48 hours of ICU admission that predict long-term (90 day) morbidity and mortality {prognostic} and; to validate multiple prognostic risk scores developed for critically ill ICU patients.

NCT ID: NCT03577262 Not yet recruiting - Healthy Clinical Trials

A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic Density

Start date: June 25, 2018
Phase: Early Phase 1
Study type: Interventional

Up to 20 subjects will receive an injection with [11C]-UCB-J followed by a PET scan on Days 1 and 28

NCT ID: NCT03577197 Recruiting - Clinical trials for Metastatic Breast Cancer

Southeast Netherlands Advanced Metastatic Breast Cancer Registry

SONABRE
Start date: January 1, 2007
Phase:
Study type: Observational [Patient Registry]

The Southeast Netherlands Advanced Breast Cancer (SONABRE) Registry is a real life multi-center study. The registry aims to include all patients diagnosed with advanced breast cancer as of 2007 in 14 hospitals in the Netherlands. Data on patient, tumor and treatment characteristics are collected retrospectively from electronic medical files by trained registry clerks.

NCT ID: NCT03577015 Recruiting - Clinical trials for Disseminated Intravascular Coagulation

International Prospective Registry of Disseminated Intravascular Coagulation

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

Objectives: to evaluate the current diagnostic and therapeutic approaches for sepis-associated disseminated intravascular coagulation (DIC) in a large prospective registry. Design: prospective, multicenter, international registry. Study population: patients 18 years or older with severe infection to be potentially associated with DIC will be eligible for the study. The clinical visits and monitoring of the patients will follow local routine practices. No specific imaging tests or laboratory evaluations will be required and patients will be evaluated and treated according to local policy. All the involved centers will be asked to update information on included patients at 2, 4, 6, 8, 10 and 28 days after severe infection diagnosis. Study outcomes: The primary outcome of the study is the development of DIC. Secondary outcomes are thrombotic (arterial and venous) and bleeding events, overall mortality at 28 days. Study sample, feasibility, and analysis plan: We plan to enroll a minimum of 1000 patients.

NCT ID: NCT03575533 Not yet recruiting - Heart Failure Clinical Trials

Bayesian Hemodynamics Model for Personalized Monitoring of Congestive Heart Failure Patients

Start date: August 1, 2018
Phase:
Study type: Observational

Heart failure (HF) is a serious and challenging syndrome. Globally 26 million people are living with this chronic disease and the prevalence is still increasing. Besides this growing number in prevalence, HF is also responsible for almost 1 million hospitalizations a year in the US and in Europe. Consequently, this has a major economic impact especially due to recurrent admissions of these patients. Adequate prediction of decompensation could prevent (un)necessary admissions as a result of heart failure. Philips is developing a Bayesian Hemodynamics model for general practitioners. This model uses different observables, which can be measured at home. The outcome of the model could be used as an aid in clinical decision making in HF patients.

NCT ID: NCT03573596 Recruiting - CML, Relapsed Clinical Trials

Persistence of MR3 in Chronic Myeloid Leukemia (CML) After a 2nd Stop of TKI Treatment

DASTOP2
Start date: February 1, 2018
Phase: Phase 2
Study type: Interventional

This study will enroll CML patients who have failed a first TKI stopping attempt. After failure and at least a year of TKI treatment, patients will proceed to dasatinib treatment for another 2 years. If MR4 or better is re-achieved and maintained for at least one year, patients will be eligible for a second stop. After verification of MR4, TKI treatment will be stopped and patients followed in the same manner as after first stop. If MMR is lost (BCR-ABL >0.1% (IS)), TKI treatment will once again be restarted.

NCT ID: NCT03571789 Recruiting - Atrial Fibrillation Clinical Trials

Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients

CAPTURE
Start date: September 12, 2017
Phase: N/A
Study type: Interventional

Vine™ is a permanent carotid filter designed to provide protection against embolic stroke in people with atrial fibrillation. It is implanted bilaterally in the common carotid arteries from a thin needle under ultrasound guidance. The procedure is performed without general anesthesia and takes minutes. The safety, feasibility and tolerability of Vine™ will be evaluated. Patients who are eligible will receive Vine™ and will be followed-up for a year after device implantation.