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NCT ID: NCT01254019 Completed - Clinical trials for Muscular Dystrophies

A Clinical Study to Assess the Efficacy and Safety of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

DMD114044
Start date: December 2, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether GSK2402968 is effective in the treatment of ambulant boys with Duchenne muscular dystrophy resulting from a mutation thought to be corrected by exon 51 skipping.

NCT ID: NCT01253681 Completed - Ovarian Cancer Clinical Trials

Study of AMG 386 in Combination With Paclitaxel and Carboplatin in Subjects With Ovarian Cancer

Start date: November 2010
Phase: Phase 1
Study type: Interventional

To evaluate whether AMG 386 in combination with paclitaxel and carboplatin is safe and well tolerated in the first-line treatment of high-risk stage I and stages II-IV epithelial ovarian, primary peritoneal and fallopian tube cancers. The hypothesis is that AMG 386 in combination with carboplatin and paclitaxel is safe and well tolerated.

NCT ID: NCT01253629 Completed - Fragile X Syndrome Clinical Trials

Safety and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome

Start date: November 2010
Phase: Phase 2
Study type: Interventional

This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective in treating the behavioral symptoms of Fragile X Syndrome.

NCT ID: NCT01252940 Completed - HIV-1 Infection Clinical Trials

Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment. Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which participants will switch treatment regimens at the start of the study, and the Stay on Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their baseline regimen during the first 24 weeks of the study (designed to provide an initial active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit. After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF STR per protocol before switching to a commercially available source.

NCT ID: NCT01252160 Completed - Clinical trials for Neuralgia, Postherpetic

Safety and Effectiveness of Repeated Administration of QUTENZA Patches for Treatment of Pain Caused by Nerve Damage

STRIDE
Start date: October 28, 2010
Phase: Phase 4
Study type: Interventional

In this study all patients will be treated with the same medicine, the QUTENZA patch. Subjects will receive up to 6 QUTENZA patch applications over 12 months.

NCT ID: NCT01252069 Completed - Uterine Fibroids Clinical Trials

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)

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

This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment. This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.

NCT ID: NCT01251536 Completed - Colorectal Cancer Clinical Trials

Cetuximab Standard or Dose Escalation in First Line Colorectal Cancer

Everest2
Start date: December 2010
Phase: Phase 2
Study type: Interventional

The purposes of this study are to determine whether administering escalating doses of cetuximab in patients with no early skin toxicity could delay the progression of disease in a significant proportion of patients and to study the molecular signatures of response.

NCT ID: NCT01250379 Completed - Breast Cancer Clinical Trials

A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA)

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

This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.

NCT ID: NCT01250223 Completed - Clinical trials for Lymphoma, Follicular

Study of Prognosis of Follicular Lymphoma Through a Prospective Collection of Data (F2-study)

Start date: February 2003
Phase:
Study type: Observational

The F2-study is a complement of the previous studies of the Follicular Lymphoma Prognostic Factors Project which permitted the development of the Follicular Lymphoma International Prognostic Index (FLIPI). The F2-study is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed Follicular Lymphoma patients, and its purposes are to validate the FLIPI and to verify whether a prognostic collection of data would allow the development of a more accurate prognostic index.

NCT ID: NCT01250080 Completed - Clinical trials for Moderate to Severe Trauma, as Defined by an

Effect of Gutamine Administration in the Innate Immune System Response in ICU Patients.

Start date: January 2007
Phase: N/A
Study type: Interventional

Glutamine is the most abundant nonessential amino acid in the human body. Besides its role as a constituent of proteins and its importance in amino acid transamination, glutamine may modulate immune cells. The innate immune system is the first line of host defence against pathogens and in most cases sufficient to eliminate invading microbes. Mammalian Toll-like receptors (TLR) comprise a family of germ line-encoded trans-membrane receptors which activation leads to the induction of inflammatory responses, phagocytosis but also to the development of antigen specific adapative immunity. It has been postulated though not formally proven yet that glutamine beneficial effect could be due to a positive effect on the innate immune system. Given the importance of TLRs and TLRs-dependent signalling in host defence against infections we hypothesized that glutamine may increase the expression and/or functionality of TLRs which in turn may have beneficial effects to clear infections.