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NCT ID: NCT00955968 Completed - HIV Infection Clinical Trials

IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women

Start date: January 1, 2010
Phase: Phase 4
Study type: Interventional

This study was a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but did not otherwise meet criteria to initiate HAART for their own health. The study was designed to determine whether continuation of HAART after delivery or other pregnancy outcome reduced morbidity and mortality compared to discontinuation and re-initiation of HAART when protocol specified criteria were met.

NCT ID: NCT00954603 Terminated - Delirium Clinical Trials

A Double-blind, Randomized, Controlled Trial of Quetiapine Versus Haloperidol for the Treatment of Delirium

QHdelirium
Start date: June 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether quetiapine, and haloperidol are effective and safe in the treatment psychiatric symptoms in patients with delirium.

NCT ID: NCT00954213 Completed - Clinical trials for Autism Spectrum Disorders

A Study of a Developmental,Individual-Difference,Relationship-Bases/Floortime Intervention for Children With Autistic

DIR
Start date: May 2008
Phase: N/A
Study type: Interventional

Thirty eight autistic spectrum disorder children age 2-6 years recruited into the study. The new treatment intervention is based on the DIR Model. Parents will be coached at the start and then every 3-4 months for 1 year. Outcome will be measured at the first session and at the end of the study using Functional Emotional Assessment Scale and Childhood Autism Rating Scales, Functional Emotional Level, and parent satisfaction rating. Hypothesis of the study: Children who get additional treatment of DIR/floortime show much improvement in climbing the developmental "ladder" and declining in the autistic behaviors.

NCT ID: NCT00950300 Completed - Breast Cancer Clinical Trials

A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer

Start date: October 16, 2009
Phase: Phase 3
Study type: Interventional

In this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide) concurrent with either SC Herceptin or IV Herceptin. After surgery, participants will receive a further 10 cycles of SC or IV Herceptin as per randomization to complete 1 year of treatment. All cycles will be 21 days in length. After the end of study treatment, participants will be followed for safety and efficacy for up to 5 years or until disease recurrence, whichever is earlier.

NCT ID: NCT00949910 Completed - Clinical trials for Non-Small Cell Lung Cancer

An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

Start date: November 2004
Phase: Phase 4
Study type: Interventional

This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study.

NCT ID: NCT00949650 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation

Start date: August 14, 2009
Phase: Phase 3
Study type: Interventional

This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.

NCT ID: NCT00949442 Completed - Clinical trials for Diabetes Mellitus, Type 2

Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment

LANCELOT
Start date: July 2009
Phase: Phase 4
Study type: Interventional

Primary Objective: To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period. Secondary Objective: To compare between treatment groups: - Plasma glucose (fasting, nocturnal) over time, - Changes from baseline in HbA1c over time, - Percentage of patients who reach the target of HbA1c <7 and <6.5, - Use of prandial insulin as rescue medication at month 6, - Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe), - Daily dose of insulin, - Change in body weight from baseline, - Evolution of 8-point plasma-glucose (PG) profiles, - Overall safety, - Patient reported outcomes (treatment satisfaction).

NCT ID: NCT00949429 Completed - Postoperative Pain Clinical Trials

Quality of Postoperative Pain Management in Cardiac Surgical Patients

Start date: July 2009
Phase: N/A
Study type: Observational

The purpose of this study is to determine the incidence and risk factors of moderate to severe pain after cardiac surgery, and compare the preoperative pain expectation and postoperative pain experience in the same patient.

NCT ID: NCT00949351 Not yet recruiting - Clinical trials for Type 2 Diabetes With Nephropathy

Safety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy

Start date: September 2009
Phase: Phase 4
Study type: Interventional

Activation of renin-angiotensin plays a crucial role diabetic nephropathy. Angiotensin converting enzyme inhibitor (ACEI) and Angiotensin I receptor blocker (ARB) has been shown renoprotection whether it was used alone or in combination. Aliskiren is a direct renin inhibitor (DRI) that has shown renal benefits and safety when combined with ARB. However, to date, the safety of add on aliskiren to the combination treatment of ACEI and ARB in diabetic nephropathy patients remains to elucidate.

NCT ID: NCT00947609 Completed - HIV Infections Clinical Trials

Improving Latent Tuberculosis (TB) Diagnosis in Thai Children

TB Px
Start date: August 2009
Phase: N/A
Study type: Observational

The study is a prospective study to improve the diagnosis and management of latent TB in HIV-infected and HIV uninfected children in Thailand. The objectives are to assess the sensitivity and specificity of IGRAs (T-Spot®.TB, a T-cell-based assay, and QuantiFERON®-TB Gold In-tube, a whole blood assay), TST, and a refined symptom-based questionnaire in diagnosing latent TB in 166 HIV-infected and HIV uninfected children in Thailand, and to evaluate the influence of age, nutritional and immune status on children's response to the IGRAs. These children will be screened for TB with a detailed TB contact history, symptom-based questionnaire, physical examination, TST, chest radiograph (and abdominal ultrasound for those with abdominal symptoms), IGRAs, and clinical specimens for acid fast bacilli stain and culture. A diagnostic algorithm will be generated using the combination of test modalities with the highest sensitivity and specificity results.