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.
Normal pressure hydrocephalus (NPH) is an uncommon cause of dementia possibly reversible with treatment. First described in 1965 it consists of a triad of gait disturbance, cognitive deterioration, and urinary incontinence together with enlarged cerebral ventricles and normal cerebrospinal fluid (CSF) pressure. Foregoing trauma and hemorrhage, infection, mass lesions, or aqueductal stenosis can contribute to hydrocephalus. These symptomatic or secondary forms of NPH are not considered here and the focus lies on the idiopathic type (iNPH). Prevalence of iNPH increases significantly with age. General estimates range from 21.9 per 100,000 in total population surveys but increase up to 181.7 per 100,000 for people 70 to 79 years of age. The clinical presentation varies significantly in severity and progression of symptoms. For diagnosis the entire triad does not have to be present. In typical cases gait and balance disturbances appear either before or concurrently with urinary incontinence or the onset of dementia. Current treatment recommendations are based on surgical diversion of CSF , with shunts placed either into the ventricular system or the lumbar subarachnoid space to a distal site, such as the peritoneal or the pleural cavity or the venous system, where the CSF can be reabsorbed . Even though immediate response rate to shunt treatment might be favorable and rates of 80% responders have been reported , the perioperative and long-term morbidity and mortality of CSF shunting procedures are significant. A meta-analysis of 44 articles found that the pooled, mean rate of shunt complication was 38% . Even though acute surgical complication rates are low, shunt dysfunctions and long-term complications are relatively common. Shunt malfunction (20%), subdural hematoma (2-17%), seizure (3-11%), shunt infection (3-6%) and intracerebral hematoma (3%) are the most common complications . In those with good long-term survival, sustained improvement is possible, with a rate of 39% documented after 5 years .In view of the complication rates, the lack of alternative treatment options and clinical studies is surprising. Even though iNPH per definition lacks raised intracranial pressure on spinal tap, monitoring of ICP prior to surgery reveals an increased amount of brief (usually 30 seconds to 1 minute) increases in the static ICP, called Lundberg B waves, in patients which improve by shunt placements . When patients are scheduled for shunt treatment there is a waiting period of several weeks between diagnosis and operation due to congested waiting list. Acetazolamide (Diamox) has been shown to reduce the production of CSF in clinical cases of raised intracranial pressure . It is considered the drug of choice for the treatment of idiopathic intracranial pressure (pseudotumor cerebri). Intuitively a connection between Acetazolamide as a treatment option in iNPH seems logical. Encouraging case studies have been published previously showing a fascinating improvement and success of treating iNPH with Acetazolamide. A systematic placebo controlled study concerning the use of Acetazolamide in iNPH is missing and would possibly pave the way to an alternative treatment option avoiding surgery and its complications.
Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin receptor agonist that may be beneficial in medical disorders associated with thrombocytopenia. Eltrombopag has been shown to increase platelet counts in patients with thrombocytopenia from various etiologies (Idiopathic thrombocytopenic purpura [ITP], liver disease, aplastic anemia and chemotherapy induced thrombocytopenia). Approximately 350 subjects will be randomized in a 1:1 ratio (175 into the eltrombopag arm and 175 into the placebo arm). Approximately 55 subjects will be enrolled into the azacitidine. Subjects with intermediate-1, intermediate-2 or high risk MDS by IPSS, and baseline platelet count of <75 Giga (10^9) per liter (Gi/L) will only be enrolled. This is a randomized, double-blind, parallel group, placebo-controlled study designed to explore the platelet supportive care effects of eltrombopag versus placebo in combination with the standard of care hypomethylating agent, azacitidine. The primary objective of this study is to determine the effect of eltrombopag versus placebo on the proportion of subjects who are platelet transfusion free during the first 4 cycles of azacitidine therapy. Key secondary endpoints include overall survival, disease response, and disease progression.
The purpose of this study is to evaluate the safety and efficacy of oral Pyridorin 300 mg BID in reducing the rate of progression of nephropathy due to type 2 diabetes mellitus.
Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the Maximum Tolerated Dose and Schedule (MTDS) Expansion Cohort Segment (closed). Having characterized safety and determined the maximum tolerated dose and schedule, the primary objective of this study now is to assess the anti-neoplastic activity of flotetuzumab in patients with PIF/ER AML, as determined by the proportion of patients who achieve CR or CRh. Starting with Cycle 2, patients who are benefiting from flotetuzumab may receive up to a maximum of 8 cycles of treatment. Patients will receive daily increasing doses of flotetuzumab for the first week of Cycle 1 (Lead-In Dosing) followed by 3 weeks of continuous intravenous infusion at a the assigned dose. Subsequent cycles are each 4 weeks of continuous infusion at the assigned dose. Dosing may continue for up to 8 cycles. Follow up visits may continue for 6 months after treatment is discontinued.
The purpose of this study is to check the medical efficacy and economic benefits of multidisciplinary care in patients with unexplained medical complaints and consume medical services frequently.
To evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in patients with symptomatic PH (pulmonary hypertension) associated with IIP (idiopathic interstitial pneumonias).
Nutritional therapy has a major role in diabetes care, achieving and maintaining metabolic control: normal glucose homeostasis, normal lipid profile, normal blood pressure and desirable weight. Controlled nutritional diet, as introduced by the professional committees aims at achieving better general health condition. There is a growing body of evidence showing that Mediterranean diet has a major role in prevention of diabetes sequelae in type 2 diabetes patients. Hitherto, the effects of Mediterranean diet on patients with type 1 diabetes has not been studied, with the exception of one Italian study. Six months after education to consume Mediterranean diet in a cohort of 96 children with type 1 diabetes the authors observed decreased fat and cholesterol consumption, increased dietary fiber consumption, lower LDL cholesterol levels and better HDL to LDL cholesterol ratio. The proposed study is aimed to assess the impact of Mediterranean nutrition compared to the accepted nutritional guidelines, in newly diagnosed type 1 children and adolescents on lipid profile, metabolic control, C peptide, daily insulin dose, Inflammatory parameters, endothelial function and anthropometric parameters 12 months following diagnosis. The study designed as a two parallel arms, randomized, single center, intervention study. Patients enrolled to the study will be randomly assigned, to one of the following groups in a 1:1 ratio. Interventional Arm: Patients assigned to the interventional arm will receive nutritional instructions of Mediterranean diet and Control Group: Patients assigned to the interventional arm will receive regular nutritional instructions in accordance with the accepted nutritional guidelines
This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of insulin detemir versus insulin Neutral Protamine Hagedorn (NPH) in combination with the maximum tolerated dose of metformin and diet/exercise on glycaemic control in children and adolescents with type 2 diabetes insufficiently controlled on the maximum tolerated dose of metformin with or without other oral antidiabetic drug(s) with or without basal insulin.
The objective of study is to assess the possible impact of assisted hatching on the implantation, pregnancy rate and delivery rate after transfer of vitrified-warmed human embryos.
The purpose of this study was to determine if ruxolitinib, in combination with regorafenib, is safe and effective in the treatment of metastatic colorectal cancer.