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NCT ID: NCT00778505 Terminated - Anesthesia Clinical Trials

Use of Closed-loop Anesthesia in Pediatric Patients

LoopPed
Start date: October 2008
Phase: Phase 4
Study type: Interventional

To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during pediatric anesthesia

NCT ID: NCT00778479 Terminated - Clinical trials for Adhesion Prevention (Abdominal)

Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

Start date: October 2008
Phase: N/A
Study type: Interventional

This study will examine the Performance of Sepraspray in Patients undergoing open abdominal surgery NOTE regarding reason for study termination: A patient death reported during the trial warranted temporary suspension for review by the independent data review committee. Although the committee recommended continuing enrollment, enrollment was electively terminated by the sponsor. A preliminary analysis did not identify any new risk that was not listed on the investigational labeling for this product. A full analysis of the results is expected to allow characterization of the risk/benefit and clinical utility of the product in the exposed patient population.

NCT ID: NCT00774878 Terminated - Breast Neoplasms Clinical Trials

Study of AVE1642 (IGF-1R/CD221) in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer

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

The purpose of this study is to evaluate the clinical activity of AVE1642 in combination with fulvestrant and of fulvestrant alone in terms of clinical benefit as the rate of "complete response", "partial response" and "stabilization of the disease". The additional objectives are to evaluate the safety profile of AVE1642 in combination with fulvestrant and of fulvestrant alone, to assess the rate of patients without disease progression at 6 months and the overall progression-free survival time. An evaluation of the pharmacokinetics and pharmacodynamics interactions between AVE1642 and fulvestrant will also be performed. The biological activity of treatment will be assessed on tumor biopsies, when possible The potential immunogenicity of AVE1642 will be studied

NCT ID: NCT00774631 Terminated - Clinical trials for Bacterial Meningitis

IHPOTOTAM : Induced HyPOthermia TO Treat Adult Meningitis

IHPOTOTAM
Start date: March 2009
Phase: Phase 4
Study type: Interventional

Bacterial meningitis is a severe infection of the envelope which surrounds the brain. It is sometimes responsible for a cerebral oedema mattering with a loss of consciousness (coma). The usual treatment of this affection is based on the antibiotic therapy, anti-inflammatory drug and resuscitation measures in intensive care setting but the prognosis of comatose patients remains poor. Moderate hypothermia (body temperature is downed between 32 and 34°C°) made the proof of its efficiency in certain cerebral pathologies (notably the cerebral distress after cardiac arrest or oxygen lack in neonates) but was never evaluated in meningitis. In meningitis animal studies and in severe traumatic brain injury, moderate hypothermia is able to diminish cerebral oedema and brain inflammation. Thus, the objective of this study is to compare two strategies: only usual care or usual care completed by moderate hypothermia. The body temperature will be lowered between 32 and 34°C by means of a catheter placed in a big vein and connected to a machine in which circulates a cold liquid, or by means of an external cooling (ice-cold blanket, ice packs placed on the body). Whatever technique is chosen, the technique is perfectly mastered by the teams which take charge of the patients. After 48 hours, the technique of hypothermia will be suspended and body temperature will return passively and gradually to normal. The investigators believe that moderate hypothermia will improve the prognosis of the most severe patients.

NCT ID: NCT00774033 Terminated - Burn Clinical Trials

Epidermal Cells Delivery and Acute Burns

ENSEM
Start date: December 2008
Phase: Phase 3
Study type: Interventional

The aim of the study is to compare results obtained with epidermal cell spray and classic skin grafting for epidermal replacement in acute burns

NCT ID: NCT00773383 Terminated - Clinical trials for Non-Small Cell Lung Cancer

A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Having Received Tarceva Monotherapy.

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

This single arm study in patients with advanced Stage IIIb/IV NSCLC who have progressive disease after deriving clinical benefit (defined as response or stable disease after 12 weeks) from second or third line Tarceva monotherapy will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva. Patients will receive R1507 (9mg/kg iv) weekly in combination with Tarceva (150mg oral daily) for up to a maximum of 24 months. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

NCT ID: NCT00772239 Terminated - Cardiac Surgery Clinical Trials

Perioperative Coagulation Management in Cardiac Surgery.

ROTEM
Start date: October 2008
Phase: N/A
Study type: Interventional

Cardiac surgery is bleeding requiring transfusion surgery . The haemorrhagic is related to the need to use high doses of anticoagulants to prevent thrombosis of blood . Moreover, this type of surgery is platelets and coagulation factors consumming despite conducting a thorough anticoagulation. All these changes contribute to increase the need for transfusions during heart surgery. The main objective of this study is to compare the need for transfusions in patients suffering from bleeding complications after cardiac surgery with a therapeutic algorithm based on the use of ROTEM ® versus standard tests based solely on standard laboratory tests. 100 pateinst (50 in each arm) should be included in this trial.

NCT ID: NCT00768989 Terminated - HIV Clinical Trials

Phase IIB Pilot of Atazanavir + Raltegravir

SPARTAN
Start date: November 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if the combination of atazanavir and raltegravir taken together is safe and effective in the treatment of human immunodeficiency virus (HIV).

NCT ID: NCT00768300 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF

ARTEMIS-IPF
Start date: December 2008
Phase: Phase 3
Study type: Interventional

The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to evaluate its safety, and to evaluate its effect on development of pulmonary hypertension, quality of life, and dyspnea (shortness of breath) symptoms in this participant population. Participants were randomized in a 2:1 ratio to receive ambrisentan or placebo, respectively. Participation in the study was to be up to 4 years, depending on how long it would take to enroll participants and observe study events. After randomization, visits to the clinic took place every 3 months, and laboratory procedures were performed every month.

NCT ID: NCT00766779 Terminated - Clinical trials for Acute Myeloid Leukemia

HCT Versus CT in Elderly AML

Start date: January 2010
Phase: Phase 3
Study type: Interventional

A study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.