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NCT ID: NCT00182390 Completed - Clinical trials for Anemia of Prematurity

Premature Infants in Need of Transfusion (PINT)

Start date: February 2001
Phase: Phase 3
Study type: Interventional

Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined as one or more of retinopathy of prematurity, bronchopulmonary dysplasia, or periventricular leukomalacia/ventriculomegaly). Primary Objective: To determine whether either a liberal or more restrictive threshold of hemoglobin level for red cell transfusion in ELBW infants is safer, by randomizing to either a high transfusion hemoglobin threshold or a low transfusion hemoglobin threshold. Follow-up at a corrected age of 18 months represents a conventional age at which to first assess neurodevelopmental outcomes, and to predict long-term outcomes.

NCT ID: NCT00182364 Completed - Critically Ill Clinical Trials

PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT Pilot)

Start date: February 2003
Phase: Phase 3
Study type: Interventional

PROTECT Pilot objective is to assess: 1) the feasibility of timely enrollment and complete, blinded study drug administration, 2) the bioaccumulation of LMWH in patients with acquired renal insufficiency and its association with bleeding, 3) the feasibility of scheduled twice weekly lower limb ultrasounds, and 4) recruitment rates for a future randomized trial.

NCT ID: NCT00182312 Completed - Clinical trials for Apnea of Prematurity

Caffeine for Apnea of Prematurity (CAP)

Start date: October 1999
Phase: Phase 3
Study type: Interventional

At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams at birth. Approximately 30-40% of these high-risk infants either die or survive with lasting disabilities. The aim of this research is to reduce this heavy burden of illness. A multi-center randomized controlled trial has been designed in which 2000 very low birth weight infants will be enrolled. Our goal is to determine whether the avoidance of methylxanthine drugs will improve survival without disability to 18 months, corrected for prematurity. Methylxanthine drugs such as caffeine are used to prevent or treat periodic breathing and breath-holding spells in premature infants. However, there is a striking lack of evidence for the long-term efficacy and safety of this therapy. Methylxanthines block a naturally occurring substance, called adenosine, which protects the brain during episodes of oxygen deficiency. Such episodes are common in infants who are treated with methylxanthines. It is possible that methylxanthines may worsen the damage caused by lack of oxygen. Therefore, this trial will clarify whether methylxanthines cause more good than harm in very low birth weight infants.

NCT ID: NCT00182143 Completed - Critical Illness Clinical Trials

PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)

Start date: May 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.

NCT ID: NCT00182104 Completed - Triscupid Atresia Clinical Trials

International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures

Start date: August 1998
Phase: Phase 4
Study type: Interventional

Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures.

NCT ID: NCT00179777 Completed - Clinical trials for Diabetes Mellitus, Type 1

TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk

TRIGR
Start date: May 6, 2002
Phase: N/A
Study type: Interventional

The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) is an international effort to conduct a primary prevention nutrition trial for type 1 (insulin-dependent) diabetes. The TRIGR study was targeted at newborns who are at genetic risk for type 1 diabetes because their mother, father and/or full sibling has type 1 diabetes. All families were encouraged to breast feed their infants for as long as possible. Prior to birth, the child was randomly assigned to receive one of two infant formulas, should formula be required prior to 8 months of age. The study determined whether weaning to a possibly protective infant formula decreases these children's chances of developing diabetes - as it does in the animal models for diabetes.

NCT ID: NCT00175903 Completed - Epilepsy Clinical Trials

Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy

Start date: February 2005
Phase: Phase 3
Study type: Interventional

Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.

NCT ID: NCT00175877 Completed - Clinical trials for Rheumatoid Arthritis

A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

Start date: June 2005
Phase: Phase 3
Study type: Interventional

An open ended study in which patients who completed the double-blind study CDP870-027 [NCT00152386] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).

NCT ID: NCT00174863 Completed - Prostatic Neoplasm Clinical Trials

Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer

ODYSSEY
Start date: October 2003
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy of SR31747 given at 75 or 125mg per day versus placebo in androgen prostate cancer patient without distant metastases with Time to Clinical progression as main objective and PSA parameters, Tumor response, survival , safety,Tumor-related symptoms deterioration Quality of Life, PK analysis as secondary objectives

NCT ID: NCT00174837 Completed - Clinical trials for Head and Neck Squamous Cell Carcinoma

TRACE: Tirapazamine-Radiation And Cisplatin Evaluation

TRACE
Start date: April 2005
Phase: Phase 3
Study type: Interventional

The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.