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NCT ID: NCT01481116 Terminated - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of TAK-875 Compared to Glimepiride When Used With Metformin in Participants With Type 2 Diabetes

Start date: January 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM). The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM).

NCT ID: NCT01480245 Terminated - Clinical trials for Muscular Dystrophies

Open Label Study of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

Start date: September 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to explore long-term safety, tolerability and efficacy of GSK2402968 in DMD subjects who previously participated in either DMD114117 or DMD114044.

NCT ID: NCT01478698 Terminated - Peritoneal Dialysis Clinical Trials

The Safety and Tolerability of Intra-abdominal t-PA and DNase on Peritonitis in Peritoneal Dialysis Patients

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

Hypothesis: Intraperitoneal tPA and DNase is well tolerated at a number of different doses. Different doses of tPA and DNase will have a dose-related effect on inflammatory markers (CRP and intraperitoneal white cell count). Aims: 1. To examine the tolerability of different doses of intraperitoneal tPA and DNase compared to standard treatment. 2. To examine the changes in biochemical and clinical outcomes of PD Peritonitis with the addition of intraperitoneal tPA and DNase to usual therapy.

NCT ID: NCT01458548 Terminated - Clinical trials for Post-transplantation Lymphoproliferative Disorder

Sequential Treatment of CD20-positive Posttransplant Lymphoproliferative Disorder (PTLD)

Start date: December 2002
Phase: Phase 2
Study type: Interventional

Post-transplantation lymphoproliferative disorder (PTLD) develops in one to ten per cent of transplant recipients and can be EBV-associated. To improve long-term efficacy after rituximab monotherapy and to avoid the toxicity of CHOP seen in first-line treatment, the investigators initiated an international multicentre phase II trial to test whether the subsequent application of rituximab and four courses of three-weekly CHOP would improve the outcome of patients with PTLD: PTLD-1, sequential treatment (ST).

NCT ID: NCT01458119 Terminated - Fabry Disease Clinical Trials

Open-Label Phase 3 Long-Term Safety Study of Migalastat

AT1001-041
Start date: October 14, 2011
Phase: Phase 3
Study type: Interventional

This was a long-term, open-label study of migalastat (123 milligrams [mg] of migalastat [equivalent to 150 mg of migalastat hydrochloride]) (migalastat) in participants with Fabry disease who completed treatment in a previous monotherapy trial with migalastat.

NCT ID: NCT01448486 Terminated - Clinical trials for Human Immunodeficiency Virus (HIV)

A Study of the Neurological Effects of Adding Raltegravir to HAART Regimen in Patients With HIV

HANDral
Start date: October 2011
Phase: Phase 4
Study type: Interventional

HIV related cognitive impairment still occurs despite highly active antiretroviral therapy (HAART). HIV disease affects the brain in 20-40% of patients with advancing HIV disease leading to varying degrees of cognitive impairment, recently termed HIV associated neurocognitive disorders (HAND). HAND may occur in patients who are virally suppressed in both blood and CSF. Patients with HIV Associated Neurological Disorders (HAND) who are virally suppressed in both their blood and cerebrospinal fluid (CSF), whilst on a highly active antiretroviral therapy (HAART) regimen may have significant cognitive improvement with HAART intensification with the medication RaltegravirĶ¾ compared to those who remain on their existing regimen. This study will be a prospective, interventional, randomised and unblinded controlled clinical trial. The aim of this study will be to determine whether HAART intensification with the medication Raltegravir, leads to significant improvement in HIV associated neurological disorders (HAND). Patients with the recent progression (within 6 months) of HAND (validated by neuropsychological assessment) on HAART who are virally suppressed (<50 copies per ml) in blood and CSF will be randomised to have their existing HAART regimen intensified with raltegravir 400mg twice daily, or not. The control arm will remain on their medication regimen as prescribed. The target is to enrol 110 patients into the control group, and 110 patients into the Raltegravir intensification group. Patients will undergo baseline neuropsychological testing, MRI, blood tests, and cerebral spinal fluid (CSF) tests (via a lumbar puncture). The methods used to determine the effectiveness of adding Raltegravir, will include further neuropsychological testing at 6 months; and neuropsychological testing, MRI and CSF assessment at 12 months. Neuropsychological testing completed at 6 and 12 months will be completed by a "blind assessor", in that they will have no knowledge of which arm (treatment or control) the participant is enrolled in. An evaluation (neuropsychological testing) will be performed should the patient deteriorate during the course of the study, as recognised by the patient's managing physician. The decision of the Antiretroviral medication regimen to be used in such a case will be determined by the managing physician. At the end of the study protocol (12 months) the patient's HAART therapy will be managed by their primary physician.

NCT ID: NCT01446601 Terminated - Clinical trials for Obstructive Sleep Apnea

Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea

Start date: August 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a potential therapeutic option for individuals with moderate to severe Obstructive Sleep Apnea (OSA) that have failed or do not tolerate positive airway pressure (PAP) therapy.

NCT ID: NCT01435772 Terminated - Pompe Disease Clinical Trials

Extension Study for Patients Who Have Participated in a BMN 701 Study

Start date: August 15, 2011
Phase: Phase 2
Study type: Interventional

This is a Phase 2 open-label, multiple dose study of BMN 701 administered by IV infusion every 2 weeks (qow) to patients with late-onset Pompe disease.

NCT ID: NCT01433354 Terminated - Fragile X Syndrome Clinical Trials

Long-term, Safety and Tolerability Study of AFQ056 in Adolescent Patients With Fragile X Syndrome (Open-label)

Start date: November 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in eligible adolescent patients with FXS who have participated in the CAFQ056B2214 study, the PK study CAFQ056B2131, or another study of AFQ056 which included FXS patients below 18 years of age provided the patient is at least 12 years of age at the time of entry into the current study.

NCT ID: NCT01424423 Terminated - Multiple Sclerosis Clinical Trials

NOGO-A in Multiple Sclerosis FTIH

Start date: February 11, 2010
Phase: Phase 1
Study type: Interventional

The drug being tested in this study is GSK1223249. The drug works by inhibiting a protein that prevents nerve growth. The trial is expected to involve approximately 36 patients. The study objective is to investigate the tolerability, safety and the way the body handles GSK1223249 after a range of single doses in patients with Multiple Sclerosis (MS).