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NCT ID: NCT00698568 Completed - Clinical trials for Prophylaxis for Herpes Simplex

Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects

Start date: October 1996
Phase: Phase 3
Study type: Interventional

This study will evaluate, versus a placebo, the safety of Herpes simplex candidate vaccine with adjuvant in initially HSV seropositive or seronegative subjects who have no genital herpes disease.

NCT ID: NCT00698165 Completed - Alzheimer's Disease Clinical Trials

Observational Study on Costs and Caregiver Burden in Alzheimer's Disease

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

Objective of study is to assess the costs of care, objective and subjective caregiver burden and quality of life in relation to disease severity measured by cognitive function, ADL capabilities and presence of behavioral disturbances in Alzheimer's disease

NCT ID: NCT00697099 Completed - Clinical trials for Venous Thromboembolism

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Total Hip Replacement Surgery

SAVE-HIP1
Start date: June 2008
Phase: Phase 3
Study type: Interventional

The primary objective was to compare the efficacy of once daily [q.d.] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of enoxaparin for the prevention of Venous Thromboembolic Events [VTE] in patients undergoing elective total hip replacement surgery. The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective total hip replacement surgery, and to document AVE5026 exposure in this population.

NCT ID: NCT00697086 Completed - Atrial Fibrillation Clinical Trials

European Study of Dronedarone in Atrial Fibrillation

ERATO
Start date: August 2002
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of dronedarone for the control of ventricular rate at rest and during exercise in patients with atrial fibrillation (AF) and to assess the tolerability of dronedarone in the target population.

NCT ID: NCT00697008 Completed - GERD Clinical Trials

Asociación Española de Gastroenterologia (Spanish Gastroenterology Association) Gastroesophageal Reflux Disease Guideline - Prospective Study

Prospect
Start date: December 2007
Phase: N/A
Study type: Observational

To evaluate symptomatic outcome and HRQoL in GERD patients treated following a new CP Guideline.

NCT ID: NCT00696657 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide

Start date: June 3, 2008
Phase: Phase 2
Study type: Interventional

This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.

NCT ID: NCT00696332 Completed - ALS Clinical Trials

Talampanel for Amyotrophic Lateral Sclerosis (ALS)

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

The purpose of this study is to assess the efficacy, tolerability and safety of oral administration of talampanel compared to a placebo in subjects with ALS.

NCT ID: NCT00694642 Completed - Clinical trials for Coronary Artery Disease

Safety and Efficacy of Autologous Endothelial Progenitor Cell CD 133 for Therapeutic Angiogenesis

PROGENITOR
Start date: May 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether transendocardial injections of autologous endothelial progenitor cells CD 133 is safe and feasible in patients with refractory angina.

NCT ID: NCT00694629 Completed - Clinical trials for Pulmonary Tuberculosis

TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment

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

Protocol Synopsis The goal of this Phase 2 clinical trial is to evaluate the antimicrobial activity and safety of an experimental intensive phase (first 8 weeks of treatment) tuberculosis treatment regimen in which rifapentine is substituted for rifampin. Primary Objective - To compare the antimicrobial activity and safety of standard daily regimen comprised of rifampin (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (RHZE) to that of an experimental regimen comprised of rifapentine (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (PHZE). Secondary Objectives - To determine and compare for each regimen the time to culture-conversion, using data from 2-, 4-, 6-, and 8-week cultures (10, 20, 30, 40 doses). - To determine and compare for each regimen the proportion of patients with any Grade 3 or 4 adverse reactions - To determine the correlation of the MGIT/BACTEC liquid culture growth index and other mycobacterial and clinical biomarkers with time to culture conversion and treatment failure - To store serum for future assessment of biomarkers of TB treatment response and hypersensitivity to study drugs. - To compare adverse events and 2-month culture conversion rates among HIV-infected patients vs. HIV-uninfected patients - To determine the tolerability and safety, and estimate the antimicrobial activity, of experimental regimens that include isoniazid + pyrazinamide + ethambutol plus either rifapentine 15 mg/kg/dose or rifapentine 20 mg/kg/dose, all administered daily. Assessment of these doses of rifapentine will be performed as an extension to the main study after enrollment in the main study has been completed. Design This will be a prospective, multicenter, open-label clinical study. Adults suspected of having pulmonary tuberculosis who meet eligibility criteria will be randomized to receive either the experimental intensive phase tuberculosis treatment regimen or the standard intensive phase tuberculosis treatment regimen. Randomization will be stratified by presence/absence of cavitation on baseline chest radiograph, and by geographic continent. All doses of study drugs will be given under direct observation and administered 5 days per week. After a subject completes intensive phase therapy, he/she then will be treated with a non-experimental continuation phase tuberculosis treatment regimen. The study extension will be a prospective, multicenter clinical trial. Eligibility criteria will be the same as for the main study. Participants will be randomized to one of four regimens: the standard intensive phase treatment regimen, an investigational regimen in which rifapentine 10 mg/kg/dose is substituted for rifampin, an investigational regimen in which rifapentine 15 mg/kg/dose is substituted for rifampin, or an investigational regimen in which rifapentine 20 mg/kg is substituted for rifampin. Randomization will be stratified by the presence/absence of cavitation on baseline chest radiograph, and by study site. Study drugs will be administered 7 days per week. After a subject completes intensive phase therapy, he/she then will be treated with a non-experimental continuation phase tuberculosis treatment regimen. Subjects will have blood drawn for one pharmacokinetic determination of rifapentine concentration at or after the week 2 visit during intensive phase therapy. This study is being conducted in 2 phases. 1. The main study compares a 10 mg/kg dose of rifapentine, open label, against 10 mg/kg rifampin in an otherwise standard intensive phase regimen of treatment for pulmonary tuberculosis. The projected sample size was 480 enrollments; 530 patients were actually enrolled. 2. The study extension evaluates higher doses of rifapentine, with the specific rifapentine doses (10 mg/kg, 15 mg/kg, and 20 mg/kg) blinded to patients and clinicians, with data collection and endpoints otherwise similar to the main study. The projected sample size for the study extension is 320 enrollments.

NCT ID: NCT00694538 Completed - Clinical trials for Shoulder Musculoskeletal Disorders

Efficacy of Interferential Laser Therapy in Shoulder Pain

PI070046
Start date: January 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the advantages of the interferential laser therapy in shoulder pain reduction compared with the conventional low level laser therapy modality.