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NCT ID: NCT01239732 Completed - Ovarian Cancer Clinical Trials

A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer

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

This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Patients will receive 15 mg/kg Avastin intravenously on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (AUC 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitaxel 175 mg/m2 on Day 1 every 3 weeks or 80 mg/m2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.

NCT ID: NCT01239498 Recruiting - Blepharoptosis Clinical Trials

Saline Injection - Assisted Anesthesia in Eyelid Surgery

Start date: November 2010
Phase: Phase 4
Study type: Interventional

The investigators hypothesize that injection of saline to the upper eyelids prior to lidocaine/adrenaline injection will reduce pain of the local anesthetic in comparison to injection of lidocaine alone.

NCT ID: NCT01239446 Not yet recruiting - Clinical trials for Hodgkin Lymphoma Treated With Mediastinal Irradiation

Hybrid SPECT/CTCA for the Assessment of the Presence and Hemodynamic Significance of CAD in Asymptomatic Patients.

Start date: January 2011
Phase: N/A
Study type: Interventional

Mediastinal irradiation for treatment of malignancy increases the risk for coronary artery disease (CAD), while diabetes mellitus or other known risk factors can be absent at the time of the first coronary event. Radiation-induced atherosclerosis affects the coronary ostia and proximal coronary segments, or causes diffuse microvascular damage. Younger patients and those exposed to high radiation doses (> 35 Gy) have a higher risk for developing premature CAD and likely may benefit from coronary assessment. A novel hybrid imaging technique that combines SPECT and CTCA has been shown to overcome the individual pitfalls and the diagnostic challenges of stand-alone SPECT and CCTA, improve the lesion detectability and sensitivity in patients with balanced diffuse lesions as well as the specificity and mainly PPV of CTCA. The aim of the study is to perform hybrid SPECT/CTCA in asymptomatic patients with HL who have received radiotherapy to the mediastinum in order to allow an early diagnosis of hemodynamically significant CAD that will need further therapeutic interventions.

NCT ID: NCT01238497 Completed - Clinical trials for Severe Aortic Stenosis

SOURCE XT REGISTRY

Start date: September 2010
Phase:
Study type: Observational

This registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing treatment with the commercially available Edwards SAPIEN XTâ„¢ Valve, and delivery devices.

NCT ID: NCT01238471 Completed - Clinical trials for Retinopathy of Prematurity

Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity: A Randomized and Prospective Study

Start date: May 2010
Phase: Phase 1/Phase 2
Study type: Interventional

In premature infants, propranolol (Prop) treatment might suppress continuing neo-vascularization (NV) and decelerate the progression of retinopathy of prematurity (ROP) towards its severe stages (III-V), thus avoiding the need of interventions (CRYO and/or LASER photo-coagulation of the ischemic retina and preventing severe ocular sequelae. We therefore plan to prospectively investigate the influence of prop versus placebo in VLBW infants with ROP stage 1 (zone I), with stage 2 or higher (any zone) or with Plus disease, along with close follow up regarding safety of prop administration and its effect on ROP.

NCT ID: NCT01238406 Completed - Type 1 Diabetes Clinical Trials

Overnight MD-Logic

Start date: March 2011
Phase: N/A
Study type: Interventional

Study design: Multicenter,randomized, prospective, open label, cross over, six segments, pilot trial to evaluate blood glucose control overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes. on the first segment 15 eligible subjects will be enrolled from the three participating centers (5 patients at each center). All 15 patients will participate in the overnight closed loop session in the hospital settings. On the second segment, 54 eligible subjects will be enrolled (18 at each center). Each subject will participate in the two consecutive overnight sessions in diabetes camp settings, one under closed-loop with MDLAP and one under sensor augmented pump therapy. In the third segment,9-20 eligible patients will be enrolled at the Israeli center only.Each subject will participate in up to four consecutive overnight under closed loop with MDLAP and up to four additional overnight under regular sensor augmented pump therapy at home. On the fourth segment, 45-60 patients will be enrolled at the Israeli center only. This segment will be conducted at a diabetes camp and will consist of two main parts. In part 1, 15-20 patients will be randomized to participate in one of the two groups: 2-4 nights under closed loop control while the MD-Logic learning algorithm is activated or 2-4 nights under closed loop control without activating the MD-Logic learning algorithm. In part 2 of the forth segment 30-40 patients will participate in two consecutive24-48 hours sessions,one under closed loop control and the second under sensor augmented pump therapy. On the fifth segment 40-80 eligible patients will be enrolled at the Israeli center only.The first 10 patients will participate in a pilot session and data gathered at this pilot session will not be used at the final analysis.This segment will consist of two parts. At part 1 each subject will participate in 4weeks-1.5 months period of over nights either using closed-loop with MDLAP or using sensor augmented pump (SAP) therapy.At the end of the first 4 weeks-1.5 months of the study, statistical analysis will be performed in order to decide whether to extend the study with an optional period of extra 4 weeks-1.5 months.In case it will be decided to extend the study, additional 4 weeks-1.5 months intervention period following completion of final visit activities will be offered to participants. Subjects that have participated in the control group (sensor augmented pump therapy) will be offered the opportunity to continue to 4 weeks-1.5 months of closed-loop control and the study group will be offered to switch to sensor augmented pump therapy. In segment 5 part 2, up to 40 patients will be enrolled. Each patient will participate in 3 months study period either using overnight closed loop under MDLAP or sensor augmented pump therapy.Participants in segment 5 part 2 will be offered to participate in part 2A. At this part, sleep quality assessment will be made (by using actigraf and sleep questionnaire) At the end of this period an optional 3 months extension period will be offered with the other arm (cross-over) Segment 6 will be consist of two main parts.In part 1, up to 40 eligible patients will be enrolled at the Israeli center only. Each subject will participate in up to 72 hours of closed-loop with MDLAP at home and up to 72 hours under regular sensor augmented pump therapy . The sequence of the treatment intervention will be randomly assigned. The sequence of the treatment intervention will be randomly assigned. In part 2 of this segment 40 eligible patients will enrolled at the Israeli center only. Each subject will participate in up to 2 weeks of closed loop with MDLAP at home and up to 2 weeks under regular sensor augmented pump therapy. The sequence of the treatment intervention will be randomly assigned Objectives: The objective of this feasibility study is to evaluate the safety and efficacy of blood glucose control using the MD-Logic Artificial Pancreas System in individuals with type 1 diabetes in the hospital settings,at a diabetes camp and finally at patient's home.

NCT ID: NCT01238068 Not yet recruiting - Clinical trials for Intertrochanteric Fractures of the Hip

Comparison of the Results of Treatment by Gamma Nail Versus Dynamic Hip Screw for Unstable Intertrochanteric Hip Fractures

Start date: November 2010
Phase: N/A
Study type: Interventional

The study hypothesis is the the results of the use of Gamma nail will be superior to the use of Dynamic hip screw for unstable intertrochantric hip fracture.

NCT ID: NCT01238003 Not yet recruiting - Clinical trials for ANCA-related Vasculitis

Clinical Relevance of Anti-Neutrophil Cytoplasm Antibody (ANCA)in Hospitalized Patients

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

Laboratory testing of Anti-Neutrophil Cytoplasm Antibody (ANCA) is used to confirm diagnosis of patients who have a high level of suspicion for ANCA-related vasculitis. In these patients the specificity and sensitivity to the ANCA test is very high. This study hopes to prove that when this lab test is performed on blood of patients who do not have a high level of suspicion for ANCA-related vasculitis, the sensitivity and specificity is reduced and there are many false positive results. Because of this, it should not be used as a screening test for a more general patient population.

NCT ID: NCT01237964 Not yet recruiting - Clinical trials for Burn's Associated Contracture

Injectable Collagenase For Burns' Associated Contracture

Start date: March 2011
Phase: Phase 2
Study type: Interventional

A pilot experiment to test the efficiency of the enzyme Collagenase in treating contractures which result's from burn's healing process. So far, treatment of choice in patients with burn's created movement limiting contractures, concentrated around supportive care. Patients were referred to surgical intervention only if necessary. Treatment by injecting an external enzyme is avant-garde and hasn't been done under such conditions. This study might introduce a new kind of treatment, which can be done in ambulatory environment .This type of treatment might significantly improve patients' function and quality of life, with no need for a surgical intervention.

NCT ID: NCT01237860 Completed - Foot Drop Clinical Trials

Evaluation of the Safety and Performance of the NESS L300 Plus System

L300Plus
Start date: September 2010
Phase: Phase 3
Study type: Interventional

The study is designed to evaluate the safety and efficacy of using the L300 Plus as a neuroprosthesis device for walking in patients following an UMN injury or disease. The clinical study is proposed to determine the anticipated adverse event rate and treatment outcomes at the conclusion of the study.