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NCT ID: NCT00750880 Completed - Clinical trials for Rheumatoid Arthritis

An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.

Start date: September 2008
Phase: Phase 3
Study type: Interventional

This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.

NCT ID: NCT00739635 Completed - Subjective Tinnitus Clinical Trials

Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus

EASE
Start date: September 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.

NCT ID: NCT00737100 Completed - Cystic Fibrosis Clinical Trials

Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis

Start date: September 2008
Phase: Phase 2
Study type: Interventional

This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations

NCT ID: NCT00735397 Completed - Epilepsy Clinical Trials

Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Start date: October 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.

NCT ID: NCT00735137 Completed - Preterm Birth Clinical Trials

Randomized Study of Pessary Versus Standard Management in Women With Increased Chance of Premature Birth

Start date: August 2008
Phase: Phase 3
Study type: Interventional

The aim of the study is to determine the effect of cerclage pessary on the incidence of spontaneous delivery between randomization (at 20-24+6 weeks) and 33+6 weeks in asymptomatic women with singleton pregnancies found at routine mid-trimester screening to have a cervix of <25 mm in length and in twin pregnancies.

NCT ID: NCT00734591 Completed - Diabetes Mellitus Clinical Trials

Follow-Up Study for Exubera

FUSE
Start date: August 2008
Phase: N/A
Study type: Observational

In studies of Exubera in persons with diabetes, lung cancer occurred in a few more people who were taking Exubera than in people who were taking other diabetes medicines. All subjects diagnosed with lung cancer had a history of smoking and the number of lung cancer cases observed fell within the expected range based on population-based data. There is currently not enough information to determine if any of the observed lung cancer cases were related to Exubera use, therefore, the study is being conducted to further investigate whether Exubera use makes the appearance of lung cancer more likely.

NCT ID: NCT00729703 Completed - Tachycardia Clinical Trials

Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications

OPTION
Start date: June 2006
Phase: Phase 4
Study type: Interventional

This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and mortality and inadequate therapy in medically stable, ICD-indicated patients with impaired left ventricular function (LVEF ≤ 40%) who do not have pacing indications and no indication for Cardiac Resynchronization Therapy (CRT). It compares a new pacing mode avoiding ventricular stimulation when not needed combined with dual chamber detection with a pure ventricular back up pacing and single chamber detection criteria with pure ventricular back up pacing. Therapies are compared in a prospective, randomized, single-blinded, parallel trial with a 24-month randomized treatment period. Randomization follows a 1:1 ratio. ICD therapy is enabled for all patients throughout the study. All patients receive optimal drug therapy for arrhythmia and heart failure treatment.

NCT ID: NCT00729235 Completed - Clinical trials for Biventricular Tachycardias

Biventricular Tachycardias Outcome Trial

BITAC
Start date: May 2006
Phase: Phase 4
Study type: Interventional

This clinical investigation is a device-based open, prospective, multicenter two-arm randomized trial, comparing patients who are treated in the slow VT zone versus patients who are not treated in that zone. The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and health authorities will be informed prior to any use of a newer device if applicable. All patients will have a 3-zone detection configuration programmed. The slow VT zone will be defined by programming the detection parameters as follows: - Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we recommend to adjust this parameter to: resting rate + 30 bpm) - VT detection rate: 150 bpm PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones. The Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF are also left to the investigator's judgment. Patients will be randomized at implant to have the slow VT zone programmed as a monitoring zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm). The randomization table will be generated by Sorin Group/ELA Medical.

NCT ID: NCT00725985 Completed - Multiple Sclerosis Clinical Trials

Oral Cladribine in Early Multiple Sclerosis (MS)

ORACLE MS
Start date: December 31, 2008
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome). Participants in either the cladribine or placebo group may also enter treatment periods with open-label interferon-beta or open-label cladribine depending upon the disease status. The primary objective of this study is to evaluate the effect of two dosage regimens of oral cladribine versus placebo on the time to conversion to multiple sclerosis (MS) (from randomization) according to the Poser criteria in participants with first clinical demyelinating event at high risk of converting to MS.

NCT ID: NCT00725387 Completed - Neoplasms Clinical Trials

Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy

Start date: August 2007
Phase:
Study type: Observational

Fluorine-18 Fluorodeoxyglucose (F-18 FDG) PET/CT is established as a powerful imaging tool for cancer detection and monitoring response to therapy. Sodium Fluorine-18 (F-18) was used in the 1970s for bone scanning and can be used as a skeletal tracer in current PET/CT scanners. The combined administration of F-18 and F-18 FDG in a single PET/CT scan for cancer detection was not attempted to date. We hope to learn what is the best approach for detection of cancer and thus to improve cancer treatment.