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NCT ID: NCT00460161 Suspended - Phantom Limb Pain Clinical Trials

Acupuncture for Phantom Limb Pain

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

Phantom pain is a common complication following limb amputation, and is thought to result from a system of pathophysiological mechanisms - peripheral, spinal, central and psychological. Treatment is primarily medical, using antidepressant and anticonvulsant medications. At present, there is no evidence-based approach for the management of phantom limb pain (PLP). Acupuncture is an ancient Chinese treatment during which thin needles (diameter 0.20-0.30mm) are inserted into various points on the skin. Studies of this treatment have found significant benefit in a number of conditions with chronic pain. We propose a randomized, double-blind, placebo/sham -controlled study to evaluate whether acupuncture is an effective and safe modality for preventing and reducing PLP in patients following lower limb amputation. Patients requiring lower limb amputation (above-ankle) will be randomized into two groups, for real or placebo/sham acupuncture treatment. Both groups will be treated twice-weekly with a standardized (as opposed to individualized) acupuncture treatment protocol, using either true or placebo needles at sham acupuncture points, for a period of four weeks (eight treatments). The primary outcome to be evaluated will be PLP at 4 weeks, using a site-specific numerical rating pain scale (ss-NRS). Secondary outcome measures to be evaluated are: stump pain (ss-NRS); analgesic use (Tramadol, 100mg Tablet); and depressive symptoms, using the Beck Depression Score. Blinding of the participants will be evaluated using a Validation of Blinding Questionnaire at the end of the treatment period.

NCT ID: NCT00396734 Suspended - Clinical trials for Opioid-Related Disorders

The Effects of Pharmacotherapy on Brain Mechanisms Underlying Cocaine Dependence.

Start date: April 2007
Phase: N/A
Study type: Interventional

The overall aim of this project is to use an advanced brain imaging technique, PET, in order to monitor the progress of pharmacotherapy with modafinil or topiramate for cocaine dependence in methadone-maintained patients who use cocaine in addition. Comparisons will be made within the cocaine dependent methadone maintained subjects, between the start and end of treatment, and between the two medications. This is the first systematic research study of pharmacological treatment for cocaine dependence in Israel. This study is of major clinical use, with implications for the treatment of cocaine dependence in poly-drug abusers in Israel. Successful pharmacotherapy for cocaine dependence is expected in reduction in cue-induced subjective craving and in glucose metabolism in brain areas elicited by cocaine craving. Metabolic activity in regions that are activated by craving should be correlated with dopamine DRD2 receptor occupancy in all patients.

NCT ID: NCT00382395 Suspended - Glaucoma Clinical Trials

SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma

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

Study Objective: To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional surgical treatments have failed.

NCT ID: NCT00365573 Suspended - Tibial Fracture Clinical Trials

Doppler Ultrasonography Evaluation of Tibial Fracture Site Vascularity

Start date: February 2008
Phase: Phase 2
Study type: Observational

The purpose of this study is to evaluate the blood supply to patients that are suffering from fracture in the tibia by UltraSound Doppler.

NCT ID: NCT00345306 Suspended - Clinical trials for Frozen Thawed Embryo Transfer

Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan

Start date: March 2007
Phase: Phase 4
Study type: Interventional

The transfer of frozen-thawed embryos can be performed in a natural ovulatory cycle or in a hormonally manipulated cycle with a comparable pregnancy rate of 15%-20% per ET. When a hormonally modulated ET cycle is scheduled,an artificial endometrial preparation is carried out using estrogen stimulation followed by a concomitant progesterone treatment. Two progestative drugs are currently used in conventional IVF treatment, Utrogetan and Endometrin. Although Endometrin has been be efficiently used to support the luteal phase after embryo transfer in IVF cycles, currently, there is no study that assess its efficacy for clinical use in frozen-thawed ET cycles. The present study aims to compare the outcome of frozen thawed ET cycles when either Endometrin or Utrogestan are used as the progestative substitution in an artificially prepared endometrium.

NCT ID: NCT00307892 Suspended - Post-operative Pain Clinical Trials

Traumeel S for Reduction of Post Operative Pain Following Arthroscopy

Start date: January 2011
Phase: Phase 3
Study type: Interventional

The perception of pain is a complex process that is not yet fully understood. With outpatient knee arthroscopy becoming standard of care, postoperative pain management has become increasingly important in caring for patients. Traumeel S is a homeopathic complex widely used in German-speaking Europe for orthopedic pain and inflammation. It contains a mixture of medicinal plants and minerals, all highly diluted. In some recent studies, Traumeel has shown anti-inflammatory and analgesic activity. In this study, the efficacy of Traumeel S will be compared with placebo in reducing pain during the first 48 hours after arthroscopy. Also compared will be 6 day pain levels, analgesic consumption, quality of life, post operative knee function, quadriceps atrophy and safety. The study design is double blind RCT. 98 patients, aged 18-40 and undergoing arthroscopic meniscectomy or chondroplasty will be enrolled in the trial. Patients will be randomized to receive either intraoperative join irrigation with Traumeel S and oral treatment with Traumeel S, or placebo irrigation and oral ingestion. Patients will continue to take active or placebo medication for 6 days. Pain will be recorded daily by the patient in the patient diary using an 11-point numerical rating score (NRS-11. Patients will also record daily consumption of primary and "rescue" analgesics. Range of motion (RoM) will be measured on days 6 and 30 post-operatively, and the Lysholm knee scale and circumference of thigh above patella will be measured at 30 days. All these measures will be compared with baseline. Patients will be contacted daily by the research assistant to encourage compliance and to record their daily NRS and analgesic consumption in the CRF.

NCT ID: NCT00299585 Suspended - Dental Implants Clinical Trials

A Clinical Study of the Use of Brushite as Primary Stabilizer in Immediate Dental Implantation

Start date: December 2007
Phase: Phase 2
Study type: Interventional

Objective: The evaluation of "PD" VitalOs Cement, an injectable brushite, as a stabilizer of dental implants and a potential source for bone augmentation. Methods: Forty (40) patients needing dental implants will be treated where needed with "PD" VitalOs Cement gapping half of their sites whereas the other half will be gapped with Bio-oss demineralized bone and BioGuide membrane.

NCT ID: NCT00281723 Suspended - Ulcer, Aphthous Clinical Trials

Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

Start date: n/a
Phase: Phase 2
Study type: Interventional

Recurrent Aphthous Stomatitis (RAS) of the oral mucosa is a common and painful condition. Despite advances in therapeutic means there is still necessary to find a way to alleviate the local pain and discomfort induced by the mucosal ulceration. The hypothesis was to study the effectiveness and acceptance of a herbal adhesive tablets in the treatment of RAS. Participants in the study will be examined for oral lesions, will be instructed how to apply the oral-tablet, and will be interviewed during the follow-up period up to one week after the application.

NCT ID: NCT00232323 Suspended - Education, Health Clinical Trials

Simulation Training as a Tool to Decrease Occupational Stress in ICU Personnel

Start date: January 2006
Phase: N/A
Study type: Interventional

The purpose of the study is to check wether training mixed teams of physicians and nurses from intensive care units on patient simulators reduces stress in team members.

NCT ID: NCT00073853 Suspended - Spinal Cord Injury Clinical Trials

Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries

Start date: September 2003
Phase: Phase 2
Study type: Interventional

Autologous Incubated Macrophages (ProCord) is being developed as a therapy for acute, complete spinal cord injury (SCI). The therapy is intended to reverse the loss of motor and sensory function. Following non-CNS tissue injury, macrophages quickly arrive on the scene, where they clean up cell debris, secrete different molecules thus promoting a controlled inflammatory reaction that forms the first phase of the wound healing process. While this process occurs in most tissues, including peripheral nerves, it does not occur in the CNS, where macrophages and other immune cells are relatively rare, and their activities curtailed by a biochemical mechanism known as "immune privilege." In animal studies, it appears that incubated macrophages circumvent the immune privilege, thus supporting the regrowth of axons through the injury site and enabling the recovery of neurological function. The concept derives from the pioneering research of Prof. Michal Schwartz at the Weizmann Institute of Science.