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NCT ID: NCT02066415 Completed - Clinical trials for Treatment for Prevention of Chronic Migraine

A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention

Start date: March 5, 2014
Phase: Phase 2
Study type: Interventional

To evaluate the effect of erenumab compared to placebo on the change from baseline in the number of monthly migraine days in adults with chronic migraine.

NCT ID: NCT02066220 Active, not recruiting - Brain Tumors Clinical Trials

International Society of Paediatric Oncology (SIOP) PNET 5 Medulloblastoma

Start date: June 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The study PNET 5 MB has been designed for children with medulloblastoma of standard risk (according to the risk-group definitions which have been used so far; e.g. in PNET 4). With the advent of biological parameters for stratification into clinical medulloblastoma trials, the ß-catenin status will be the only criterion according to which study patients will be assigned to either treatment arm PNET 5 MB - LR or to PNET 5 MB - SR, respectively. The initial diagnostic assessments (imaging, staging, histology, and tumor biology) required for study entry are the same for both treatment arms. With the amendment for version 12 of the protocol, patients who have a WNT-activated medulloblastoma with clinically high-risk features can be included in the PNET 5 MB WNT-HR study, and patients with a high-risk SHH medulloblastoma with TP53 mutation (both somatic or germline including mosaicism) can be included in the PNET5 MB SHH-TP53 study. Data on patients with pathogenic germline alteration or cancer predisposition syndrome, who cannot be included in any prospective trial due to unavailability or due to physician or family decision, can be documented within the observational PNET 5 MB registry.

NCT ID: NCT02064998 Completed - Binge Drinking Clinical Trials

Two Consecutive Randomized Controlled Trials Using Mobile Phone Applications for Risky Alcohol Use

Start date: September 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy of three mobile phone applications, Promillekoll, PartyPlanner and TeleCoach among university student union members with problematic drinking. Two trials are conducted, one a three-armed randomized controlled study, and the second a two-armed randomized control study. Outcomes are measured in terms of changes in problematic alcohol use at follow up 6,12 and 18 weeks after baseline data gathering. Both the Promillekoll and PartyPlanner apps feature real time registration of alcohol consumption and give feedback of estimated blood alcohol concentration levels. PartyPlanner also allows for planning an alcohol consumption event in advance and for later comparison of the plan with actual consumption. Study 1 compares these two apps with a control group. In Study 2, participants reporting alcohol consumption above the weekly recommended level are redirected to randomized assignment to an in-depth app, TeleCoach, which offers different exercises for reducing alcohol use. After 6 weeks the controls are offered the TeleCoach intervention for 6 weeks, and the first intervention group loses app access. In both studies, followup occurs 6, 12 and 18 weeks after baseline registration. Hypotheses: Study 1: 1. The groups receiving the Promillekoll and PartyPlanner interventions will reduce their alcohol use to a larger extent than the control group at follow-up compared to the baseline level. 2. The planning function in PartyPlanner will be associated with an increased decrease in alcohol consumption compared to only real-time use for Promillekoll. Study 2: The proportion of participants with risky use above recommended levels will decline faster in the group that receives the intervention first, in comparison to controls.

NCT ID: NCT02064439 Completed - Pulmonary Embolism Clinical Trials

Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)

EinsteinChoice
Start date: March 5, 2014
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial

NCT ID: NCT02064309 Active, not recruiting - Clinical trials for Long-standing Type 1 Diabetes Mellitus

An Open Label, Pilot Investigation, to Assess the Safety and Efficacy of Transplantation of Macro-encapsulated Human Islets Within the Bioartificial Pancreas Beta-Air in Patients With Type 1 Diabetes Mellitus

Start date: February 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this clinical investigation is to investigate the safety of implantation of the human islet containing device Beta-Air in type 1 diabetic subjects. The secondary objective of this clinical investigation is to investigate if the transplantation of macro-encapsulated human islets within the Beta-Air device can provide improved glycaemic control in type 1 diabetes patients with reduced incidences of hypoglycaemic episodes.

NCT ID: NCT02064192 Completed - Clinical trials for Coronary Artery Disease

Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe

EU-CERT-ICD
Start date: May 2014
Phase:
Study type: Observational

The "EUropean Comparative Effectiveness Research to assess the use of primary prophylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD)" is a modular research project to study the effectiveness of prophylactic ICDs in a prospective study, a retrospective registry, and meta-analyses of existing evidence on the subject.

NCT ID: NCT02063659 Completed - Carcinoid Syndrome Clinical Trials

Telotristat Etiprate for Carcinoid Syndrome Therapy

TELECAST
Start date: March 11, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

NCT ID: NCT02062762 Completed - Depression Clinical Trials

Internet-based Stress Reduction Training for Students

IBSR-stud
Start date: February 2014
Phase: N/A
Study type: Interventional

The main objective of the current study is to evaluate whether a mindfulness based intervention delivered online can provide an effective resource for increasing psychological well-being among students. In addition, explore potential mechanisms through which the training lead to improvements by means of mediational analyses, with hypothesized variables like positive/negative affect and attention regulation.

NCT ID: NCT02061722 Completed - Clinical trials for Huntington's Disease

[PETDE10] Imaging of PDE10A Enzyme Levels in Huntington's Disease Gene Expansion Carriers and Healthy Controls With PET.

PEARL-HD
Start date: January 2013
Phase: Phase 0
Study type: Interventional

The aim of this study is to measure the availability of the PDE10A enzyme in Huntington disease gene expansion carriers (HDGECs) using the recently developed radioligand [18F]MNI-659. The study will be cross-sectional, examining HDGECs at different stages of the disease (pre-manifest, stage 1 and stage 2), in comparison with Healthy Controls (HCs). The HDGECs included in this study will be recruited from the large database of the REGISTRY (NCT01590589) or ENROLL-HD (NCT01574053) studies.

NCT ID: NCT02061527 Completed - Breast Cancer Clinical Trials

Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment

Start date: April 2014
Phase: N/A
Study type: Interventional

To evaluate breast reconstruction with implants using biological mesh (Stratticeā„¢) in the setting of breast cancer treatment.