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NCT ID: NCT02090413 Completed - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis

ASSURE
Start date: May 2014
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to evaluate whether 150 mg enteric-coated aspirin (acetyl salicylic acid [ASA]) taken twice a day (BID) with DMF (dimethyl fumarate) administration or 75 mg enteric-coated ASA taken once daily in the morning (QAM) with DMF administration reduces the incidence and/or severity of flushing events in subjects with relapsing-remitting multiple sclerosis (RRMS) compared with ASA-placebo administered with DMF in the clinical practice setting. Secondary objectives of this study are: To evaluate the safety and tolerability of DMF administered with and without enteric-coated ASA in the clinical practice setting; To evaluate the impact of DMF administration on quality of life as measured by the Short Form 36 (SF-36®) and European Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L) questionnaires.

NCT ID: NCT02080364 Terminated - Alzheimer's Disease Clinical Trials

Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease

STEADFAST
Start date: April 2015
Phase: Phase 3
Study type: Interventional

This is a study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease. Patients will receive either azeliragon or placebo with a patient's participation lasting approximately 18 months.

NCT ID: NCT02073006 Completed - Constipation Clinical Trials

A Study to Evaluate the Effects of a Natural Supplement in Adults With Chronic Functional Constipation

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

Constipation is common in the general population, especially in women and in the elderly. Hard stool is a complaint often associated with constipation, which suggests that stool softening would provide a major benefit in the strategy of treatment. This investigative fibre product is primarily a soluble dietary fibre with added probiotics and a prebiotic. It is not digested in the small intestine and partly remains undigested by bacteria in the gut. Also, as probiotics are believed to help restore a healthy gut flora, reduce pH, assist with digestion of food and reduce gaseous by-products they may aid the improvement of intestinal motility. The objective of this study is to assess if this investigative, fibre product effects the number of bowel movements per week and if this in turn impacts quality of life and symptoms of constipation.

NCT ID: NCT02069509 Recruiting - Friedreich's Ataxia Clinical Trials

Patient Registry of the European Friedreich's Ataxia Consortium for Translational Studies (EFACTS)

EFACTS
Start date: May 2010
Phase:
Study type: Observational [Patient Registry]

This is a multi-centre, multi-national, prospective, observational study of Friedreich's Ataxia (FRDA) with a control group to: - obtain natural history data on individuals affected by FRDA - relate clinical assessments and results from proteomic analyses - expedite identification and recruitment of participants for clinical trials - develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of FRDA which may also be potential outcome measures for use in future clinical trials and clinical care - plan for future research studies

NCT ID: NCT02066467 Completed - Heartfailure Clinical Trials

Maximizing CRT Delivery by Using MultipolAr Coronary Sinus Lead FamiLy ACUITY® X4 - RALLY X4 Study

RallyX4
Start date: February 2014
Phase:
Study type: Observational [Patient Registry]

The objective of this study is to collect clinical data on safety and performance of ACUITY X4® leads when used in a standard clinical setting. It is a prospective, non-randomized, observational multicenter study evaluating standard of care. For Post Market Clinical Follow up (PMCF) purposes the 3 month implant success rate, adverse events and basic parameters of the lead will be assessed. The cohort of subjects included in this evaluation will be the first 200 subjects which are indicated for PMCF in Rally X4 to receive an ACUITY X4® lead implant. Study endpoints: Phrenic Nerve Stimulation (PNS) related CFR through 6 months post-implant (Defined as: rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold) Lead-related Complication-Free Rate (CFR) from Implant through 3 months post-implant.

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: NCT02060188 Active, not recruiting - Clinical trials for Microsatellite Stable Colorectal Cancer

A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

CheckMate142
Start date: March 12, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in participants with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.

NCT ID: NCT02059291 Completed - Clinical trials for Hereditary Periodic Fevers

Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers

Start date: June 27, 2014
Phase: Phase 3
Study type: Interventional

This study is to determine whether canakinumab is able to induce and maintain a clinically meaningful reduction of disease activity in participants with Hereditary Periodic Fevers (HPF) compared to placebo.

NCT ID: NCT02057601 Completed - Postoperative Pain Clinical Trials

Postoperative Analgesia for Fractured Neck of Femur With Periarticular Infiltration of Local Anaesthetic

Start date: January 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine that periarticular levobupivacaine infiltration after surgical fixation of fractured neck of femur will improve the early postoperative pain sensation.

NCT ID: NCT02057484 Completed - Kidney Transplant Clinical Trials

A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant

ADDRESS
Start date: March 3, 2014
Phase:
Study type: Observational

The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients. This study will also evaluate the overall long-term impact of Advagraf on kidney and liver allograft recipients.