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NCT ID: NCT00543725 Completed - HIV Infections Clinical Trials

TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors

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

The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics and Medical resource utilization and treatment adherence.

NCT ID: NCT00542919 Completed - B-Cell Lymphoma Clinical Trials

A Study for Patients With Non-Hodgkin's Lymphomas

Start date: November 2007
Phase: Phase 2
Study type: Interventional

In this study, all patients will get investigational drug. There will be no comparator drug. This study will evaluate three tumor types: T-cell lymphoma, Indolent B-cell lymphoma, and Aggressive B-cell lymphoma. Each tumor type will include several tumor subtypes: - T-cell lymphoma: Peripheral and Cutaneous T-cell lymphoma (PTCL, CTCL) - Indolent B-cell lymphoma: Small lymphocytic lymphoma, follicular lymphoma (Gr 1 or 2) and marginal zone lymphoma - Aggressive B-cell lymphoma: Primary CNS lymphoma, follicular lymphoma (Gr 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma.

NCT ID: NCT00542880 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide®

SPEED
Start date: September 2007
Phase: Phase 4
Study type: Interventional

This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities.

NCT ID: NCT00540449 Completed - HIV Infections Clinical Trials

TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.

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

The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics, medical resource utilization and treatment adherence.

NCT ID: NCT00539149 Completed - Otitis Media Clinical Trials

Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children

COMIT1
Start date: April 1996
Phase: Phase 4
Study type: Interventional

This clinical trial was conducted in a population where tympanic membrane perforation occurs in 60% infants in the first year of life. Nasopharyngeal colonisation (nasal contamination) with pathogenic bacteria occurs within weeks of life and predicts persistent middle ear infection throughout childhood. The trial aimed to assess whether twice daily antibiotics commencing at first detection of middle ear effusion would cure the infection and/or prevent disease progression, compared to placebo. The study was conducted in three remote Aboriginal communities in the Northern Territory of Australia. The annual birth cohort was 45. Aboriginal infants were seen as soon as possible after birth, and at 2 weekly intervals until middle ear effusion was detected by pneumatic otoscopy and tympanometry. Following consent, infants were randomised to either amoxycillin(50 mg/kg/d BD) or placebo equivalent for up to 24 weeks, or until normal middle ear status was detected at 2 consecutive monthly scheduled examinations. At monthly examinations the infant also had a general health check, parents were interviewed, child's medical record was reviewed, and nasopharyngeal swabs were collected.

NCT ID: NCT00538356 Completed - Clinical trials for Congestive Heart Failure

Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function

IN-TIME
Start date: July 2007
Phase: Phase 4
Study type: Interventional

Re-hospitalizations or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as atrial or ventricular arrhythmia, activity, heart rate variability, or ventricular ectopy. The Home Monitoring™ capability offered by BIOTRONIK active implants has the potential to detect some of these trends early and thus to offer the possibility to intervene in time for prevention of fatal worsening of heart failure. To investigate the predictive value of Home Monitoring parameters, patients with symptomatic heart failure and reduced ejection fraction receiving an implantable cardioverter-defibrillator (ICD) or an ICD in combination with cardiac resynchronization therapy (CRT-D) will be randomized between prospective patient management by Home Monitoring analysis or standard care. The influence of Home Monitoring on the clinical status of heart failure patients will be assessed.

NCT ID: NCT00538057 Completed - Asthma Clinical Trials

Comparing Two Respiratory Drugs When Used In Combination And Separately From A Novel Inhaler Device In Healthy Subjects

Start date: October 2, 2007
Phase: Phase 1
Study type: Interventional

A combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is being developed for once daily administration for the maintenance treatment of asthma and COPD. GW642444M and GW685698X will be simultaneously co-administered from a single device and compared with GW642444M and GW685698X administered separately in order to determine whether co-administration affects the safety, tolerability, pharmacodynamic and/or pharmacokinetics of either compound.

NCT ID: NCT00535171 Completed - Venous Thrombosis Clinical Trials

Venous Thromboembolism Taskforce Audit Program

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

To determine the effect of an interventional campaign run by a dedicated "VTE Nurse Educator" over a 6-month period and the effect on prophylaxis rates. To determine the proportion of medically admitted patients with risk factors for VTE. To assess and compare the use of venous thromboembolism (VTE) prophylaxis in hospitalized medical patients versus recommendations and current guidelines. To determine the patient characteristics of those deemed to be at risk of VTE. To determine the proportion of patients receiving appropriate thromboprophylaxis for their risk. To determine the type and duration (where possible) of prophylaxis used.

NCT ID: NCT00533377 Completed - Tibial Fractures Clinical Trials

ACTiF- Assessment of Closed Tibial Fractures

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

The purpose of this study is to find out the good and bad effects of an investigational drug called CP-533,536 in patients with closed fracture of the tibial shaft undergoing internal fixation using reamed inter-locked IM nailing procedure

NCT ID: NCT00533273 Completed - Clinical trials for Advanced Dupuytren's Disease

Non-US Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease

CORD-II
Start date: August 2007
Phase: Phase 3
Study type: Interventional

This 12-month study had two phases: a 90-day double-blind, randomized, placebo-controlled phase and a nine-month open-label extension phase. Before treatment, eligible subjects were stratified by the primary joint type (30 metacarpophalangeal [MP] joints and 30 proximal interphalangeal [PIP] joints) and by severity of the primary joint contracture (ie, up to 50° or >50° for MP joints and up to 40° or >40° for PIP joints) and then randomized in a 2:1 ratio to either AA4500 0.58 mg or placebo. Upon completion of the double-blind phase (ie, 90-day evaluation after the first injection), all subjects were eligible to enter the open-label extension phase of the study in which they were followed for an additional nine months. Subjects who required further treatment because they either did not achieve reduction in contracture to 5° or less, the cord affecting the primary joint received placebo, another cord received less than three injections of AA4500, or they had untreated cords that were affecting other joints had the option to receive up to five additional injections of AA4500 0.58 mg in the open-label extension phase, with individual cords receiving up to three injections of AA4500. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 [NCT00528606] and AUX-CC-859 [NCT00533273]) and 7 non-pivotal studies were evaluated.