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NCT ID: NCT03254784 Not yet recruiting - Psoriasis Clinical Trials

A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation

Start date: September 11, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165 capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie meal and increased gastric pH on the BMS-986165 tablet formulation.

NCT ID: NCT03253796 Not yet recruiting - Spondyloarthritis Clinical Trials

Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (MK-8259-038)

Start date: October 17, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effect of treatment withdrawal vs continued treatment with golimumab (GLM) administered by subcutaneous (SC) injection on the incidence of a "flare" in non-radiographic axial spondyloarthritis over up to 12 months. The primary hypothesis is that continued treatment with golimumab is superior to treatment withdrawal, based on the percentage of subjects without a "flare" during up to 12 months of blinded therapy.

NCT ID: NCT03253458 Recruiting - Prostate Cancer Clinical Trials

Focal Prostate Imaging With CLE and OCT

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

The current limitations in prostate cancer diagnostics lead to over- and undertreatment for a significant fraction of patients. Confocal Laser Endomicroscopy (CLE) and Optical Coherence Tomography (OCT) are focal imaging modalities with potential for in-vivo prostate imaging. The investigators anticipate that integrating focal imaging with MRI/TRUS fusion will further improve prostate cancer detection and provides a real-time histopathological threedimensional representation of the tumor lesions. This is an investigator-initiated, prospective in-vivo safety and feasibility study with transperineal template mapping biopsies (TTMB) and two focal imaging methods, CLE and OCT, in prostate tissue.

NCT ID: NCT03253367 Recruiting - Clinical trials for Schizophrenia Spectrum and Other Psychotic Disorders

Phenomics and Genomics of Clozapine Pharmacotherapy

Start date: January 19, 2016
Phase: N/A
Study type: Observational

Clozapine (CLZ) is generally prescribed if at least two trials of antipsychotic agents have not led to satisfactory clinical improvement, thereby implying that patients on CLZ generally suffer from more severe and/or persistent symptoms than patients suffering from schizophrenia spectrum disorders (SCZ) on other antipsychotic agents. Unraveling the (functional) genetic variation underlying this severe SCZ phenotype therefore has the potential to deepen the understanding of the biological underpinnings of SCZ beyond the boundaries of DSM-based consensus criteria. Such knowledge in turn has the potential to shape future pharmacotherapeutic research. It is hypothesized that targeting this phenotype in genome-wide association studies and next-generation sequencing studies will signal genetic risk loci implicated in this severe SCZ phenotype. In the future, this may lead to early detection of severe SCZ, which in turn will enable tailoring of pharmacotherapeutic strategies to such SCZ subtypes. The results of this genetic part of the study will be combined with the results from our other research protocol 'Phenomics and genomic of clozapine pharmacotherapy - New Users'.The overarching goal of both projects is to create a prediction model for clozapine outcome (response (and side effects). This model includes genetic, epigenetic and clinical data.

NCT ID: NCT03253172 Active, not recruiting - Hypertension Clinical Trials

Potassium Supplementation in CKD

K+ in CKD
Start date: July 1, 2017
Phase: N/A
Study type: Interventional

The current high-sodium, low-potassium diet contributes to the high prevalence of high blood pressure (hypertension). Indeed, the anti-hypertensive effects of potassium supplementation are well-established. Hypertension is even more prevalent and resistant in patients with chronic kidney disease (CKD) and contributes to further decline in kidney function. Four recent epidemiological studies (published 2014 - 2016) showed that higher dietary potassium intake was associated with better renal outcomes. All studies recommended an intervention study with potassium supplementation in patients with CKD, but this has not been performed. The aim of this study is to study the renoprotective effect of potassium supplementation in patients with CKD (stage 3b or 4, i.e. estimated glomerular filtration rate [eGFR] 15 - 45 ml/min/1.73 m2).

NCT ID: NCT03252353 Not yet recruiting - Acromegaly Clinical Trials

Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

Start date: September 1, 2017
Phase: Phase 3
Study type: Interventional

Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated maintenance of biochemical response up to 13 months in the majority of patients with acromegaly previously managed with somatostatin analog injections (reference below).

NCT ID: NCT03250039 Recruiting - Healthy Clinical Trials

Absorption, Metabolism, Excretion and Absolute Bioavailability

Start date: July 10, 2017
Phase: Phase 1
Study type: Interventional

This study will investigate the absorption, metabolism and excretion of 14C-PF 04965842 and characterize plasma, fecal and urinary radioactivity and identify any metabolites, if possible, of 14C PF-04965842 in humans. In addition, this study will provide a better understanding of the pharmacokinetic disposition of PF-04965842 by obtaining intravenous (IV) clearance and delineating the extent of oral absorption (absolute bioavailability (F) and fraction absorbed (Fa)).

NCT ID: NCT03249532 Not yet recruiting - Hemodialysis Clinical Trials

Effect of Dialysis Techniques on Blood Pressure and Cardiac Function During Dialysis

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Online hemodiafiltration confers a reduced mortality risk. However, it is not clear why HDF improved survival. To gain more insight in this issue, the effect of 4 dialysis techniques (differing in dialysate temperature and the absence/presence of convective clearance) on intradialytic hemodynamic stability and cardiac function will be investigated in a prospective cross over trial.

NCT ID: NCT03248349 Recruiting - Critical Illness Clinical Trials

Population Pharmacokinetics of Antibiotics in Critically Ill Children (POPSICLE)

Start date: May 24, 2017
Phase: N/A
Study type: Observational

Infections are common on the Intensive Care for both adult and pediatric patients. Adequately dosing antibiotic treatment is of vital importance but both under- and overdosing is frequent due to pathophysiological changes during critical illness. Moreover, the interplay of age and critical illness is even more understudied. To optimize antibiotic dosing and outcome of infectious disease, personalized dosing guidelines in critically ill patients are highly needed. In this prospective observational population pharmacokinetic study we will evaluate if target attainment for antibiotics is reached in critically ill children with current dosing guidelines. Using these data, individualized dosing guidelines will be developed.

NCT ID: NCT03247114 Completed - Healthy Clinical Trials

fMRI of Hypothalamic Responses to Glucose, Fructose, Sucrose and Sucralose

Start date: February 22, 2015
Phase: N/A
Study type: Interventional

The study will consist of five occasions with one week in between. BOLD signal intensity of the hypothalamus will be measured using fMRI. Measurements will be done before and after drinking 300 ml plain water (reference) or water to which different sweeteners will be added.