There are about 9745 clinical studies being (or have been) conducted in Israel. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
1. To determine and compare the efficacy of Tacrolimus/Rapa versus Tacrolimus/MMF-based immunosuppression (in conjunction with initial short-term steroids and polyclonal antibody administration) in Type 1-diabetic patients undergoing simultaneous pancreas/kidney allograft transplantation. 2. To evaluate the safety of Tacrolimus/Rapa versus Tacrolimus/MMF in terms of drug-related complications and overimmunosuppression-associated complications, particularly under monitoring of the pharmacokinetic profile of all drugs administered.
Creatine plays a pivotal role in brain energy homeostasis. Creatine supplementation is widely used in enhancing sports performance, and has been tried in the treatment of neurological, neuromuscular and atherosclerotic disease with a paucity of side effects. Dechent et al (1999) studied the effect of oral creatine supplementation for 4 wk demonstrating a statistically significant increase of mean concentration of total creatine across brain regions. These findings suggest the possibility of using oral creatine supplementation to modify brain high-energy phosphate metabolism in subjects with various brain disorders, including schizophrenia and major depression. Recently, Rae et al (2003) reported that creatine supplementation for 6 weeks had a significant positive effect on both working memory and Raven matrices. Several independent lines of evidence suggest the possible involvement of altered cerebral energy metabolism in schizophrenia. We are performing a double blind cross-over study of creatine in schizophrenia. Forty patients will be treated with creatine for 3 months in a double-blind crossover design. Rating scales will include scales for assessing negative and positive symptoms of schizophrenia, clinical global impressions scale, scales for side-effects and a cognitive battery Creatine effects on brain energy metabolism and its possible cognitive enhancing properties raise the possibility of developing a new therapeutic strategy in schizophrenia focusing on treating metabolic hypoactive brain areas including frontal regions.
Valproic acid is a leading mood stabilizer for the treatment of bipolar disorder. Its well-known teratogenicity limits its use in young women of childbearing age. According to toxicologic studies the teratogenicity of valproate stems from its free carboxylic group. Valnoctamide is an isomer and an analog of valpromide. Unlike valpromide, valnoctamide does not undergo a biotransformation to the corresponding free acid. It is also likely or at least possible that valnoctamide is anti-bipolar. In mice valnoctamide has been shown to be distinctly less teratogenic than valproate. An injection at day 8 of gestation produced only 1% exencephaly (as compared to 0-1% in control mice and 53% in valproate treated mice). The investigators are performing a double-blind controlled trial of valnoctamide as an anti-bipolar drug. If shown to be anti-bipolar, valnoctamide could be an important valproate substitute for young women with bipolar disorder who are at risk of pregnancy. Patients newly admitted to the Beersheva Mental Health Center may participate if they meet Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for mania or schizoaffective disorder, manic type. Patients admitted to the study are treated with risperidone at doses of the physicians' discretion beginning with 2 mg daily on days 1 and 2. Valnoctamide or placebo is begun at doses of 600 mg per day (200 mg three times daily) and increased to 1200 mg (400 mg three times daily) after four days. Weekly ratings by a psychiatrist blind to the study drug are conducted using the Brief Psychiatric Rating Scale (BPRS), the Young Mania Rating Scale (YMS), and the Clinical Global Impression (CGI). Weekly blood is drawn for drug levels of valnoctamide to be measured by gas chromatography. Each patient receives valnoctamide or placebo for 5 weeks. Low teratogenic mood stabilizers are a high priority for current research.
Controlled studies using the orthomolecular approach have been few (Deutsch, Ananth, & Ban, 1977). Those that were done were performed in chronic schizophrenia or in populations that included bipolar and schizoaffective patients. Both of these diagnostic groups are not today considered to benefit from the orthomolecular approach. Moreover, some negative studies of high-dose niacin were done in patients who were not otherwise given general counseling for good diet as described above. Therefore, this proposal is to study in a controlled manner carefully defined first onset schizophrenic patients using the protocol advocated by Osmond and Hoffer (1962). Patients can enter the study if they have been ill less than 1 year and are in their first hospitalization.
The success of sildenafil in the treatment of erectile dysfunction has led to efforts to find similar treatments for prevalent disorders of female sexual dysfunction. Daily transdermal testosterone has been shown to improve sexual function in women after oophorectomy (Shifren et al, Transdermal testosterone treatment in women with impaired sexual function after oophorectomy, New England Journal of Medicine, 343; 682-8, 2000). In laboratory measures of sexual arousal, a single application of transdermal testosterone enhanced vaginal blood and increased erotic fantasy in normal volunteer women in the laboratory setting, four hours after application (Tuiten et al, Can sublingual testosterone increase subjective and physiological measures of laboratory-induced sexual arousal?, Arch Gen Psychiatry, 59;465,2002). We therefore planned a study of transdermal testosterone (25mg) marketed as Androgel in female hypoactive sexual desire disorder. Patients are recruited from the sexology clinics at Soroka Hospital and the Beersheva Mental Health Center. They are randomized to Androgel or placebo and given 10 packets and instructed on application to the abdomen and shoulders, four hours before planned intercourse. Patients unable to discuss planned intercourse with their partner are offered psychosexual counseling and those still unable after three sessions are excluded. After one month patients on active Androgel are crossed over to placebo or vice versa. Patients self-rate sexual response after each intercourse using the Brief Index of Sexual Functioning for Women, and Arizona Sexual Experiences Scale (ASEX)-Female and are rated in interview at the end of each month of treatment using the Sexual Function Questionnaire (SFQ-V1). Our prn technique avoids the androgenizing side effects of continuous daily treatment.
The goal of the present study is to evaluate the effect of D-serine, added to antipsychotic treatment, on negative and cognitive symptoms in schizophrenia. The investigators are hypothesizing that D-serine will improve cognitive functioning and negative symptoms.
The primary objective of this study is to evaluate the efficacy and safety of induction therapy R-ICE in comparison to R-DHAP after 3 cycles adjusted to successful mobilization of stem cells in patients with previously treated diffuse large B-cell lymphoma CD20. The goal is to detect a difference in mobilization adjusted response rate of 15% between R-ICE and R-DHAP. The other objective is to evaluate the efficacy and safety of MabThera maintenance therapy after transplantation as measured by the event free survival. The goal is to obtain a 15% increase of event free survival at 2 years.
The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010 (BMS-734016) administered with or without Prophylactic Oral Budesonide.
The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level of 100 mg three times a day (t.i.d.).
This study is being conducted to compare the safety and effectiveness of switching treatment from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from patients who were taking lamivudine and then switched to telbivudine will be compared with the results from patients who continued on lamivudine alone.