Clinical Trials Logo

Filter by:
NCT ID: NCT02602925 Completed - Psoriasis Clinical Trials

Tight Control Dose Reductions of Biologics in Psoriasis Patients With Low Disease Activity

Start date: March 2016
Phase: Phase 4
Study type: Interventional

Rationale/hypothesis: Moderate-to-severe psoriasis can be treated with biologics. Objective To investigate whether the dose of biologics can be reduced in patients with psoriasis with stable disease. Study design: A pragmatic, multicentre, randomized, controlled, non-inferiority study with cost-effectiveness analysis. Study population: Patients with disease remission using normal dose of biologics. Intervention: 120 patients will be randomized into two groups: (1) dose reduction and (2) normal dose. Main study parameters/endpoints: The primary outcome is clinical effectiveness. Secondary outcomes are: health-related quality of life (HRQoL), number and time to disease flares, costs, health status, anti-drug antibody formation and serious adverse events

NCT ID: NCT02602041 Completed - Breast Cancer Clinical Trials

Knowledge and Attitudes Regarding Healthy Lifestyle and Health Behavior Change in Cancer Patients and Their Partners; A Pilot Study

Start date: November 2015
Phase:
Study type: Observational

The investigators will perform a pilot study to gain insight into attitudes, barriers and facilitators for health behavior change in cancer patients and their partners. Results of this pilot will be used to design suitable questionnaires to investigate health behavior change in a larger cohort of patients and their partners. It will also direct future interventions to adequately target patients and, potentially, their partners to improve their lifestyle following a cancer diagnosis.

NCT ID: NCT02601937 Completed - Synovial Sarcoma Clinical Trials

A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

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

This is a Phase I, open-label, dose escalation and dose expansion study with BID (suspension) and TID (tablet) oral dose of tazemetostat. Subjects will be screened for eligibility within 14 days of the planned first dose of tazemetostat. A treatment cycle will be 28 days. Response assessment will be evaluated after 8 weeks of treatment and subsequently every 8 weeks while on study. The study has two parts: Dose Escalation and Dose Expansion. Dose escalation for subjects with the following relapsed/refractory malignancies: - Rhabdoid tumors: - Atypical teratoid rhabdoid tumor (ATRT) - Malignant rhabdoid tumor (MRT) - Rhabdoid tumor of kidney (RTK) - Selected tumors with rhabdoid features - INI1-negative tumors: - Epithelioid sarcoma - Epithelioid malignant peripheral nerve sheath tumor - Extraskeletal myxoid chondrosarcoma - Myoepithelial carcinoma - Renal medullary carcinoma - Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) (with Sponsor approval) - Synovial Sarcoma with a SS18-SSX rearrangement Dose Escalation cohorts are closed to enrollment. Dose Expansion at the MTD or the RP2D - Cohort 1 - ATRT (closed to enrollment) - Cohort 2 - MRT/RTK/selected tumors with rhabdoid features (closed to enrollment) - Cohort 3 - INI-negative tumors: - Epithelioid sarcoma - Epithelioid malignant peripheral nerve sheath tumor - Extraskeletal myxoid chondrosarcoma - Myoepithelial carcinoma - Renal medullary carcinoma - Chordoma (poorly differentiated or de-differentiated) - Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) with Sponsor approval - Cohort 4 - Tumor types eligible for Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement (closed to enrollment)

NCT ID: NCT02601313 Completed - Clinical trials for Relapsed/Refractory Mantle Cell Lymphoma

Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)

ZUMA-2
Start date: November 9, 2015
Phase: Phase 2
Study type: Interventional

The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).

NCT ID: NCT02600325 Completed - Hepatitis C Clinical Trials

Dutch Acute HCV in HIV Study (DAHHS-2): Grazoprevir/Elbasvir for Acute HCV

DAHHS-2
Start date: February 2016
Phase: Phase 3
Study type: Interventional

New and recently EMA/FDA approved direct acting antiviral (DAA) combination therapies cure 95% or more of the patients chronically infected with HCV genotype 1 and 4. Grazoprevir (MK-5172) and elbasvir (MK-8742) combination therapy is such a, albeit not yet EMA/FDA approved combination DAA therapy. It is likely that the synergistic effect of the host's immune response and antiviral therapy when given during the first 6 months of HCV infection makes antiviral therapy during acute HCV infection more effective. In this study the investigators would like to document that treatment of acute HCV with grazoprevir (MK-5172), elbasvir (MK-8742) is effective and can ben shortened from 12 to 8 weeks for HCV genotype 1 and 4 infection without substantial loss in efficacy. Study design and intervention: Prospective open label interventional clinical trial in which 80 acute HCV genotype 1 or 4 patients co-infected with HIV will receive 8 weeks of grazoprevir and elbasvir (a once-daily combination tablet). Study population: 80 Adult HIV positive patients with an acute HCV genotype 1 or 4 infection from 10 HIV treatment centers in the Netherlands and Belgium will be included. Primary endpoint: Sustained viral response (SVR) 12 weeks after the end of therapy in ITT study population (=genotype 1 and 4).

NCT ID: NCT02600169 Completed - Melanoma Clinical Trials

Retrospective Analysis of Response Markers and Adverse Events in Melanoma Patients Treated With Pembrolizumab

Start date: July 2015
Phase:
Study type: Observational

This study is a retrospective cohort study. A database will be created from the data available of all patients that have participate in the named patient program for pembrolizumab in the Netherlands. This database will be used for analysis of response markers and for an evaluation of adverse events.

NCT ID: NCT02600143 Completed - Melanoma Clinical Trials

Identification of Predictive Parameters for Colitis in Melanoma Patients Treated With Immunotherapy.

COLIPI
Start date: August 2013
Phase:
Study type: Observational

The aim of this trial is to identify biomarkers and genetic predisposition for the development of immune checkpoint related colitis.

NCT ID: NCT02598960 Completed - Solid Tumors Clinical Trials

An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.

Start date: October 14, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.

NCT ID: NCT02598544 Completed - Obesity Clinical Trials

Endocrine Regulation of Lipolysis in Obesity and Diabetes

ERLO
Start date: May 2013
Phase: N/A
Study type: Interventional

Adipose tissue (AT) dysfunction is a commonly observed feature of metabolic dysfunction in obesity and diabetes. An important characteristic when examining AT function is the capacity to break down stored lipids (i.e. lipolysis) and its regulation. In the present study, the aim was to investigate whether atrial natriuretic peptide-mediated lipolysis is altered in different adipose tissue depots (subcutaneous and visceral adipose tissue) of obese subjects with or without type 2 diabetes, compared to age-matched lean men. Eventually, the knowledge gained from this research will contribute to a better understanding of the present adipose tissue dysfunction and to the optimization of exercise programs for people with obesity and diabetes.

NCT ID: NCT02598193 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Start date: January 14, 2016
Phase: Phase 4
Study type: Interventional

This clinical study will evaluate the safety and tolerability of combination treatment of nintedanib and pirfenidone in participants with IPF. Eligible participants must have received pirfenidone for at least 16 weeks on a stable dose. Nintedanib will be added on Day 1 of the study as a combination treatment for IPF for 24 weeks.