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NCT ID: NCT01596049 Terminated - Clinical trials for Primary Inguinal Hernia

The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair

Start date: May 2012
Phase: N/A
Study type: Observational

This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia. The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center. The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).

NCT ID: NCT01582672 Terminated - Clinical trials for Renal Cell Carcinoma

Phase 3 Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma

ADAPT
Start date: November 2012
Phase: Phase 3
Study type: Interventional

This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.

NCT ID: NCT01558960 Terminated - Retinoblastoma Clinical Trials

Intravitreal Injections of Melphalan for Retinoblastoma

Start date: March 2012
Phase: N/A
Study type: Interventional

Retinoblastoma treatment has become more and more focused in the last years. New treatments developed by Dr. Kaneko from Japan in 1995 are now being tested in clinical trials. Intra-arterial chemotherapy with Melphalan has shown success in some patients but with limited response when there is marked vitreal seeding. For these cases Intravitreal injections of Melphalan have been successful in Japan. In this study the same chemotherapy (melphalan) will be administered intravitreally (directly through the eye wall) and the response (short and long term) will be monitored.

NCT ID: NCT01558635 Terminated - Clinical trials for Longstanding Persistent Atrial Fibrillation

Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation

CRYO-AF
Start date: November 2011
Phase: N/A
Study type: Interventional

Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial Fibrillation (AF) with the Cardioblate CryoFlex Surgical Ablation System. The system is approved and commercially available with CE mark. The purpose of this study is to support clinical evidence that the Cardioblate System is safe and effective to treat AF.

NCT ID: NCT01545050 Terminated - Crohn's Disease Clinical Trials

Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease

Start date: June 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor (anti-TNF) therapy.

NCT ID: NCT01538251 Terminated - Ulcerative Colitis Clinical Trials

Efficacy, Safety and Tolerability of Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis

Start date: April 2012
Phase: Phase 3
Study type: Interventional

The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine modified release tablets 1g/die in reducing the symptoms of the disease with respect to the proportion of patients with disease remission at the end of the 8 weeks of treatment. It will also aim to investigate capability of the treatment in the maintenance of remission after four weeks of treatment interruption; histological changes will be also evaluated and finally, improvement in the overall quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)will be investigated.

NCT ID: NCT01536418 Terminated - Crohn's Disease Clinical Trials

An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease

SHIELD-4
Start date: November 11, 2011
Phase: Phase 3
Study type: Interventional

This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for 12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease Activity Index [CDAI] decrease from baseline of at least 100 points) and/or remission (CDAI score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission. Safety will be assessed by recording of adverse events and assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D, and Work Productivity and Activity Impairment-Crohn's Disease.

NCT ID: NCT01534091 Terminated - Obesity Clinical Trials

Enhancing the Amount of Physical Activity Carried Out by Overweight Children at Leisure Time

Start date: May 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to examine if internet supervised by pedometer will contribute to enhance the amount of physical activity at leisure time by obese children. The investigators hypothesize that using pedometer will increase the amount of physical activity done by obese children in the afternoon and will improve the likelihood of success in the intervention program.

NCT ID: NCT01530347 Terminated - Type 1 Diabetes Clinical Trials

Non Invasive Breath Based Acetone-meter- Easy Check

Start date: March 2012
Phase: Phase 1
Study type: Interventional

Segment 1- this segment will include two main steps: Step 1-Calibration: During this step we plan to collect paired measurements of capillary blood glucose using reference method and data generated by the non invasive study device. Samples will be obtained at specific time points during 4 hours: at fasting, and after consuming standard liquid meal at 60, 120, 180 and 240 minutes. At each time point capillary blood glucose will be measured using the invasive reference method. The paired reference and study device data will be analyzed using multivariate regression model to formulate a calibration algorithm model. This model will convert the acetone values measured by study device to blood glucose values. step 2-Validation: During this segment the second step of this segment we plan to evaluate the validity and reliability of the non-invasive breath-based glucometer compared to standard invasive reference glucometer. Results will be compared using a Clark error grid. Segment 2- During this segment we plan to collect paired measurements of capillary blood glucose beta Hydroxybutyrate using reference method and acetone values generated by the non invasive breath based study device. Samples will be obtained at specific time points during 4 hours after overnight fasting, while basal insulin will be suspended, which is accepted to produce ketosis.

NCT ID: NCT01529034 Terminated - Epilepsy Clinical Trials

Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters

Start date: July 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.