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NCT ID: NCT01083732 Completed - Clinical trials for Venous Thromboembolism

Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age

Start date: March 2010
Phase: Phase 2
Study type: Interventional

To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data

NCT ID: NCT01083472 Terminated - Hernia Clinical Trials

Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)

StAR
Start date: March 2010
Phase: Phase 4
Study type: Interventional

The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by standard repair. It is hypothesized that the use of Strattice(TM) TM to reinforce the repair will reduce the incidence of these post-repair complications.

NCT ID: NCT01082549 Completed - Clinical trials for Squamous Cell Lung Cancer

Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)

ECLIPSE
Start date: March 2010
Phase: Phase 3
Study type: Interventional

To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer receiving the combination of gemcitabine/carboplatin either with or without Iniparib. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

NCT ID: NCT01082471 Completed - Postoperative Pain Clinical Trials

An Efficacy and Safety Study to Compare Morphine 6-glucuronide (M6G) and Morphine in Patients Suffering With Post-Operative Pain for at Least 24 Hours

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

To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24 hour post-operative period. Pain relief and nausea will be determined by measuring the areas under the curves of pain intensity and nausea verbal rating scale scores.

NCT ID: NCT01081951 Active, not recruiting - Ovarian Cancer Clinical Trials

Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

Start date: February 4, 2010
Phase: Phase 2
Study type: Interventional

To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.

NCT ID: NCT01081860 Not yet recruiting - Clinical trials for Carpal Tunnel Syndrome

Stiffness of the Skin and Joints in Relation to Carpal Tunnel Syndrome

STIF-CTS
Start date: May 2010
Phase: N/A
Study type: Observational

The exact etiology of CTS remains yet unknown. A rise in carpal tunnel pressure is well documented, but why this phenomenon occurs is yet unknown in most patients. There is an absolute or relative narrowing of the carpal tunnel, which results in a compression of the median nerve. The investigators postulate, that a stiffer flexor retinaculum (roof of carpal tunnel) will be less compliant. As a consequence of this stiffer retinaculum the pressure in the carpal tunnel will rise more quickly in stiff patients resulting in CTS-complaints. A relation between connective tissue composition and joint stiffness is proven. This relationship possibly extends to a relation between stiffness of the skin, joint stiffness and the prevalence of CTS.

NCT ID: NCT01081678 Completed - Fracture Healing Clinical Trials

Study To Assess FRacTure Healing With SclerosTin Antibody - Hip

STARTT-Hip
Start date: June 20, 2010
Phase: Phase 2
Study type: Interventional

This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.

NCT ID: NCT01081613 Completed - Breast Cancer Clinical Trials

Imaging HSP90 Inhibitor AUY922 on VEGF-89ZR-bevacizumab Positron Emission Tomography (PET)

Start date: February 2010
Phase: N/A
Study type: Observational

Inhibition of Heat Shock Protein (HSP)90 is a new, promising treatment modality for cancer patients, particularly in the setting of resistance. A reliable read out system (biomarker) for the evaluation of early treatment effect is of great importance in the development of this treatment modality, and could contribute to customize this treatment for individual patients. So far, no reliable biomarker has been described for HSP90 effect. Visualizing the effect of HSP90 on vascular endothelial growth factor (VEGF) secretion in vivo in the patient, by whole body 89Zr-bevacizumab uptake, can be of great importance in this respect, and may contribute to tailored made cancer treatment. The purpose of the present study is to evaluate the effect of HSP90 inhibition by AUY922 on VEGF by means of 89ZR-bevacizumab PET.

NCT ID: NCT01081600 Completed - Breast Cancer Clinical Trials

89Zr-trastuzumab PET for Imaging the Effect of HSP90 Inhibition

AUY922
Start date: February 2010
Phase: N/A
Study type: Observational

HSP90 inhibition is a potentially new targeted drug modality in the treatment of HER2 positive, trastuzumab refractory breast cancer. Little is known about the pharmacodynamics of HSP90 inhibitors in vivo, but non-invasive PET/CT imaging in a xenograft mouse model could visualize and quantify HER2 reduction after AUY922 treatment by 89Zr-trastuzumab PET imaging. Two doses of 50 mg/kg AUY922 resulted in a decrease in HER2 expression of approximately 50%, quantified 6 days after the last administration of AUY922. Visualizing HER2 expression in breast cancer patients before and early following HSP90 inhibition by means of 89Zr-trastuzumab PET, is likely to provide insight in the early in vivo effect of HSP90 inhibition and could potentially support patient tailored therapy.

NCT ID: NCT01081236 Recruiting - Liver Cirrhosis Clinical Trials

Intestinal Barrier Function and Liver Cirrhosis

Start date: May 2010
Phase: N/A
Study type: Observational

Patients with liver cirrhosis have an increased risk to develop life-threatening complications such as spontaneous bacterial peritonitis (SBP). Impairment in the intestinal barrier, changes in numbers and composition of the intestinal microbiota and alterations in immune defenses have been suggested to be involved in liver cirrhosis and its complications. Dysfunction in the intestinal barrier for example results in the ongoing passage of toxic substances from the gastrointestinal tract that may damage the liver, leading to oxidative stress, inflammation and eventually liver cirrhosis. In addition, bacterial translocation is considered a key step in the development of spontaneous infections, mainly SBP, in patients with liver cirrhosis. The investigators hypothesize that patients with decompensated liver cirrhosis have a more impaired intestinal epithelial barrier and altered intestinal microbiota than patients with compensated liver cirrhosis.