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NCT ID: NCT02602964 Completed - Pneumoperitoneum Clinical Trials

A Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum

LEOPARD-3
Start date: April 2015
Phase: Phase 4
Study type: Interventional

Live kidney transplantation is first choice for patients with end-stage kidney disease. Therefore, the safety and well-being of kidneys donors are highly important objectives in live kidney donation. Low pressure pneumoperitoneum can decrease postoperative pain and therefore also concomitant use of opioids.

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: NCT02602314 Active, not recruiting - Clinical trials for Chronyc Myeloid Leukemia

Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia

SUSTRENIM
Start date: November 11, 2016
Phase: Phase 4
Study type: Interventional

The study will investigate in newly diagnosed CP-CML patients the efficacy of NIL frontline therapy vs IM followed by switch to NIL in the case of absence of optimal response as defined by the ELN criteria.

NCT ID: NCT02602093 Recruiting - Clinical trials for Lumbar Disk Herniation

Percutaneous Transforaminal Endoscopic Discectomy vs. Open Microdiscectomy for Lumbar Disc Herniation (PTED-study)

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

Rationale: Lumbosacral radicular syndrome (LSRS) is caused by a herniated lumbar nucleus pulposus (HNP) and the estimated annual incidence in The Netherlands ranges between 60,000 to 75,000 people. Open microdiscectomy is the standard surgical technique. In recent years, several surgical techniques have been developed including, percutaneous transforaminal endoscopic discectomy (PTED). While PTED is gaining popularity in The Netherlands, evidence of its effects is lacking, leading to a heated debate. The current position of Zorginstituut Nederland (ZiN) is that there is insufficient evidence to support its use; therefore, PTED is not financially covered. The consequence is, patients are forced to pay the costs of treatment themselves. This study is expected to provide the necessary data to answer the question regarding effects and costs of PTED vs. open microdiscectomy, and help resolve the current debate.

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: NCT02601378 Terminated - Uveal Melanoma Clinical Trials

A Phase I Study of LXS196 in Patients With Metastatic Uveal Melanoma.

Start date: February 1, 2016
Phase: Phase 1
Study type: Interventional

This study was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of LXS196 as a single agent and in combination with HDM201 in patients with metastatic uveal melanoma.

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: NCT02600234 Active, not recruiting - Heart Failure Clinical Trials

REDUCE LAP-HF RANDOMIZED TRIAL I

Start date: December 2015
Phase: N/A
Study type: Interventional

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.