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NCT ID: NCT01467700 Terminated - Clinical trials for Acute Depressive Episode

Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder

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

The purpose of this study is to determine the efficacy and safety of Ramelteon, once daily (QD), sublingual (SL), in adult patients with acute depressive episodes associated with Bipolar I disorder.

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: NCT01393431 Terminated - Clinical trials for Ventilator Associated Pneumonia

Futility of Exhaled Breath Condensate pH Measurements in Ventilated Patients in Intensive Care Unit (ICU)

Start date: August 2007
Phase: N/A
Study type: Observational

Measurement of pH in Exhaled breath condensate has been mentioned as a robust variable from lung inflammation. It is non-invasive and reproducible. The investigators measured pH in the water condensed in the trap of expiratory arm of ventilator.In ICU the investigators measured pH in condensed water without interfering with patients treatment. A group of critically ill patients mechanically ventilated due to non pulmonary cause were followed until successful weaning, death or pneumonia. The investigators found that pH did not change along the study and it did not predict worsening condition.

NCT ID: NCT01390545 Terminated - Clinical trials for Rheumatoid Arthritis

VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis

VELVET
Start date: August 2011
Phase: Phase 2
Study type: Interventional

This is a multi-national, multi-centre, placebo-controlled, double-blind, randomized, 4-arm parallel group trial, comparing three different dose levels (80 mg, 160 mg and 320 mg) of veltuzumab to placebo, administered weekly (days 1, 8, 15 and 22) by subcutaneous (sc) injection to subjects with moderate to severe rheumatoid arthritis (RA) (cumulative veltuzumab doses 320 mg, 640 mg, and 1280 mg, respectively). All subjects will be on continued stable co-medication with methotrexate (MTX).

NCT ID: NCT01362608 Terminated - Gouty Arthritis Clinical Trials

Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective

Start date: June 20, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 & CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.

NCT ID: NCT01361555 Terminated - Depression Clinical Trials

Long-term Safety and Tolerability of BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

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

The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.

NCT ID: NCT01347645 Terminated - Rectal Cancer Clinical Trials

Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer

Start date: September 30, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the Phase Ib portion is to find out the highest dose of study drug that can safely be given when tested in a small group of subjects. The purpose of the Phase II portion is to find out how safe the study drug is when taken at the highest dose in a larger group of subjects.

NCT ID: NCT01345669 Terminated - Clinical trials for Head and Neck Neoplasms

LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

Start date: October 17, 2011
Phase: Phase 3
Study type: Interventional

This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.

NCT ID: NCT01338025 Terminated - HIV Disease Clinical Trials

Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Strategy

P1094
Start date: March 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study was to compare the use of lamivudine (3TC) or emtricitabine (FTC) alone vs. continuing a failing highly active antiretroviral therapy (HAART) regimen in HIV infected children, adolescents and young adults. The study was to see if there were changes in the HIV virus and if there were differences in immune function, viral load and medication side effects between the two groups over 28 weeks. Participants were assigned to either take 3TC or FTC alone or continue on his/her current failing HAART regimen. During the first 28 weeks of this study, if the participant was randomized to the continue HAART arm, he/she was not switched to a different or new, potentially suppressive HAART regimen, but continued on the current failing HAART regimen. However, if continuing HAART, the participant might be switched to a new regimen if their provider felt that it was clinically needed or the participant met certain study endpoints (e.g., drop in CD4, increase in viral load). At the end of 28 weeks, the participant had the choice of remaining on the assigned study group medication(s) or starting a new HAART regimen prescribed by his/her doctor. Then, they would be followed for another 24 weeks to compare the difference in immune function, viral load and medication side effects between the different groups.

NCT ID: NCT01332331 Terminated - Clinical trials for Hypertension, Pulmonary

Efficacy and Safety of Ambrisentan in Children 8-18yrs

Start date: January 4, 2011
Phase: Phase 2
Study type: Interventional

A 6-month (24-week), randomized, open label evaluation of the safety, tolerability, and efficacy of a high and low dose ambrisentan (adjusted for body weight) treatment group in subjects aged 8 years up to 18 years with pulmonary arterial hypertension (PAH). An additional objective is to determine the ambrisentan population pharmacokinetics in the paediatric population. The study will include a screening/baseline period and a treatment period. The treatment period will be 24 weeks or until the subject's clinical condition deteriorates to the point that alternative/additional treatment is necessary. Patients who participate in the study and in whom continued treatment with ambrisentan is desired will be eligible to enrol into a long term follow-up study. The primary comparison will be the safety and tolerability of the two ambrisentan dose groups (Low vs. High) in the paediatric PAH population The secondary comparison will be the change from baseline for the efficacy parameters between the two treatment groups.