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NCT ID: NCT00917332 Not yet recruiting - Pain at Childbirth Clinical Trials

Effects of Relaxation and Guided Imagery Training on Pain at Childbirth

Start date: August 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether relaxation and guided imagery techniques are effective in reducing childbirth pain.

NCT ID: NCT00916994 Completed - Rotator Cuff Tear Clinical Trials

Prospective Study for Safety and Efficacy of InSpaceā„¢ in Rotator Cuff Tear Subjects

Start date: July 2009
Phase: N/A
Study type: Interventional

Title: One-arm, international, multi-center with competitive recruitment, prospective study to assess the safety and efficacy of OrthoSpace's InSpaceā„¢ in rotator cuff tear subjects scheduled for surgery of the rotator cuff - A pivotal study Device: OrthoSpace's Biodegradable Implanted Balloon (InSpace) Study population: Rotator Cuff tear subjects scheduled for arthroscopy. Number of subjects: Up to 70 subject for data analysis. Number of sites: At least 4 sites in Israel. Main Inclusion criteria: Informed consent, diagnosed with Rotator Cuff tear. Main Exclusion criteria: Former surgery on affected shoulder, sever illness, significant shoulder co morbidities. Follow up period: 12 months. Visits at hospital before discharge at 1-2 days post implantation, 7-10 days post implantation, 3 weeks post implantation, 6 weeks post implantation, 3,6 and 12 months post implantation. Primary goal: To assess the safety of the SpaceGuard in Rotator Cuff tear subjects. Secondary goals: To assess the effectiveness of the SpaceGuard in the study population. The effectiveness will be assessed by terms of good positioning of the SpaceGuard and subsequent follow-up non migration, surgeon satisfaction, pain relief and time to pain relief, Range of Motion (ROM) and time to ROM with the SpaceGuard. Primary end point: Serious Adverse Event rate related to the device and/or system complication. Secondary end points: Surgeon dissatisfaction following the deployment of SpaceGuard, migration of the balloon shown by ultrasound/ X-ray/MRI at relevant follow-up visits, lost of ROM and pain enhancement.

NCT ID: NCT00916409 Completed - Clinical trials for Glioblastoma Multiforme

Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)

Start date: June 2009
Phase: Phase 3
Study type: Interventional

The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care in the treatment of newly diagnosed GBM patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

NCT ID: NCT00916396 Recruiting - Clinical trials for Hypoactive Sexual Desire Disorder

Dehydroepiandrosterone (DHEA) Treatment in Women and Men Experiencing Hypoactive Sexual Desire Disorder

Start date: June 2005
Phase: N/A
Study type: Interventional

Hypoactive Sexual Desire Disorder (HSDD) is a common syndrome characterized by low sexual desire causing marked distress. The involvement of DHEA in sexual function is unknown, however, DHEA treatment increased desire in depressed subjects. In the current research, we will treat 45 women and men suffering from low sexual desire with DHEA or placebo for 6 weeks. The study's primary goal is to determine the effect of DHEA treatment on sexual desire, and to find if there is a connection between levels of hormones and change in desire. Outcome measures will include hormonal levels and psychological state. Our secondary goal is to compare baseline hormones measures in individuals with low sexual desire to normal controls. For that purpose we will measure the hormonal baseline levels among 20 normal subjects.

NCT ID: NCT00915187 Completed - Influenza Clinical Trials

Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly

Start date: October 2009
Phase: Phase 2
Study type: Interventional

To examine the safety and immunogenicity of two formulation of liposomal adjuvant / delivery system (VaxiSomeTM=CCS-Cholesterol [CCS/C]), combined with commercial influenza vaccine in an elderly healthy population when given once intramuscularly (IM).

NCT ID: NCT00915044 Recruiting - Clinical trials for Inflammatory Bowel Disease

Interactions Between Immune Cells of Intestinal Mucosa or Peripheral Blood With the Extracellular Matrix in Inflammatory Bowel Disease (IBD)

IBD
Start date: July 2007
Phase: N/A
Study type: Observational

The purpose of this study is to examine the effects of different environmental factors on immune cells in patients with IBD.

NCT ID: NCT00915018 Completed - Breast Cancer Clinical Trials

Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer

NEFERTT
Start date: August 21, 2009
Phase: Phase 2
Study type: Interventional

This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.

NCT ID: NCT00914979 Terminated - Clinical trials for Bifurcation Coronary Disease

AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study)

ABC
Start date: September 2008
Phase: Phase 3
Study type: Interventional

Assess the impact of lesion preparation using the AngioSculpt balloon in the treatment of bifurcation lesions in native coronary arteries.

NCT ID: NCT00914836 Withdrawn - Bursitis Clinical Trials

Comparison of 2 Doses of Corticosteroid Subacromial Injections for the Treatment of Painful Shoulder

Start date: June 2009
Phase: N/A
Study type: Interventional

The use of corticosteroid subacromial injections have been found to be effective for the treatment of shoulder pain. Higher doses may be better than lower doses for subacromial corticosteroid injection for rotator cuff tendonitis. The investigators aim this study to compare 2 doses of corticosteroids.

NCT ID: NCT00914784 Not yet recruiting - Dyspnea Clinical Trials

The Incidence of TRALI in Patients Undergoing Orthopedic-Oncology Surgery

Start date: August 2009
Phase: N/A
Study type: Observational

Currently Transfusion-related acute lung injury (TRALI) is the leading cause of transfusion-related mortality in the United States, and one of major post-transfusion complications. TRALI is defined as new ALI occurring within 6 hours from the onset of transfusion. It is manifested by acute dyspnea, hypoxemia and bilateral infiltrates in chest radiograph. TRALI may be caused by any blood product and is not dose-dependent. Associated risk factors include prolonged storage of blood products and underlying conditions such as severe IHD hematologic malignancies or active infections. Since TRALI has only recently been defined as a clinical entity, and its prevalence has been largely underestimated - the epidemiology of TRALI is not well established. Therefore the objective of this work is to study the incidence of TRALI in a patient population that receive blood products frequently, namely orthopedic-oncologic.