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.
This study evaluates the Visual Acuity and refraction of patients post 4-point Scleral fixation of BunnyLens (Intra Ocular Lens- IOL) with GoreTex sutures. All patients underwent secondary IOL implantation or IOL exchange during 2014-2017.
The objective of the study is to assess the long term safety, durability of clinical effectiveness and cost effectiveness of the NeuGuide™ system when used for vaginal colpopexy in the treatment of uterine prolapse.
The proneness to react to noxious stimuli varies widely between individuals and pain ratings of seemingly identical noxious stimuli may range from "no pain" to "excruciating pain" . Imaging studies in healthy subjects have provided useful information on the identification of the inter-individual variability in pain perception [2,3,4]. These studies have shown that subjective pain reports are closely related to the degree of neuronal activity in several brain regions known to be identified in pain processing. Furthermore, there has been a growing interest in understanding structural and functional mechanisms of inter-individual variability in responses to identical noxious stimuli [5,6,7]. Yet, the relationship between pain perception and various anatomical and functional connectivity within resting state brain networks is not completely understood. With regard to the anatomical correlate of pain sensitivity, differences in grey matter may reflect neural processes contributing to the construction and modulation of pain in healthy individuals. As such, studies are inconsistent regarding this issue, showing positive [7] or inverse connections [6] between pain sensitivity and brain morphology. The inconsistency regarding this issue warrant further investigation which may elucidate the relationship between differences in pain sensitivity and regional grey matter and may provide novel insights into brain mechanisms contributing to that topic. Understanding brain morphology and connectivity within specific regions associated with pain processing can provide reliable anchor for the individual differences in pain response. A widely used approach to examine brain morphology from MRI images is voxel based morphometry (VBM). VBM tests for statistically significant differences in regional gray matter (GM) density between study groups, and its temporal changes. Diffusion tensor imaging (DTI) is a type of diffusion weighted imaging with the advantage of being able to resolve individual functional tracts within the white matter (WM) thus, DTI parameters serve as indirect measures of structural connectivity via the degree of integrity of WM tracts.
The purpose of this study is to assesses the benefit, safety, and pharmacokinetics (PK) of BST-236 in patients with newly-diagnosed Acute Myeloid Leukemia (AML) who are not eligible for standard induction chemotherapy due to advanced age or comorbidities. The Complete Remission (CR) rate following treatment with BST-236 will be compared to the CR rate reported in historical data in a similar population.
All patients scheduled for lumbar spine surgery due to discogenic low back pain and/or sciatica, will be screened by the principal investigator for presence of inclusion/exclusion criteria. Their baseline neurological function before surgery will be assessed and recorded for recruitment into one of the three study groups. MRI scans will be assessed for the calculation of disc protrusion size. Experimental sensory and pain assessments and questionnaires will be performed at list 24 hours before surgery. Blood sample for pro-inflammatory mediator will be obtained at the same time as the experimental sensory and pain tests. Pre-operative pain and MPQ will be assessed pre-operatively (back and leg pain separately), and again on day 30 after surgery. Blood tests for ESR, CRP will be drawn before surgery, during the surgery, and on 30 after surgery. During surgery, intervertebral disc material will be harvested and divided into 4 specimens for culture and inflammatory mediator analysis. Repeat neurological assessment will be performed 30 after surgery.
The aim of this study is to evaluate the accuracy and reliability of intra-operative TEE after the induction of anesthesia when assessing proximal thoracic aorta diameters in a cohort of aortic aneurysm patients.
The purpose of this study is to: a) establish the recommended phase 2 dose (RP2D) and to evaluate the antitumor activity and safety of niraparib combination therapies (Combinations 1 and 2) and b) to determine the relative bioavailability of niraparib and abiraterone acetate (AA) in combination (Combination 3) in participants with metastatic castration-resistant prostate cancer (mCRPC).
The purpose of this research study is to evaluate the efficacy and safety of an empagliflozin dosing regimen and one dose of linagliptin in patients with type 2 diabetes who are aged 10 to below 18 years and are currently taking metformin, insulin or both drugs (DINAMO TM) or who are treatment naïve or not on active treatment after metformin withdrawal (DINAMO TM MONO) . Empagliflozin and linagliptin are both approved for use in adult patients with type 2 diabetes. This study will assess how well empagliflozin and linagliptin work by finding out how these treatments affect blood glucose (sugar) levels compared to placebo (a pill that contains no active drug), in children and adolescents. Empagliflozin and linagliptin are considered investigational products in this study since while they have been approved for use in adults, they have not been approved for children and adolescents due to lack of clinical studies in this specific population. Patients with type 2 diabetes have higher levels of blood glucose (sugar) than patients who do not have this disease. The high level of sugar in the blood can lead to serious short-term and long-term medical problems. The main goal of treating diabetic patients is to lower blood glucose to a normal level. Lowering and controlling blood glucose help prevent or delay complications of diabetes such as heart disease, kidney, eye and nerve diseases, and the possibility of amputation. Empagliflozin is a drug that helps to reduce blood glucose (sugar) levels by causing glucose to be excreted in the urines. Linagliptin works by increasing the production of insulin (a hormone that controls the level of blood glucose) after meals when blood glucose (sugar) levels are too high. This helps to lower blood sugar levels. The subject will either receive one of the active study drugs or a placebo. This study will be double blind; this means that neither the subject, nor the study doctor will know which treatment the subject will receive. Which treatment the subject receives is decided by a computer, purely by chance; this is called a "random assignment". For this study, there will first be a screening visit, followed by a 2-week placebo run-in period (all subjects will take placebo once daily). This run-in period is designed to ensure subjects are able to take the study drugs as described in the study protocol. Thereafter there will be a 26-week treatment phase (week 1-week 26) and a 26-week safety extension period (week 27-week 52). Following this there will be a follow-up visit at week 55. On Day 1 after the placebo run-in phase, the subject will be randomly assigned to receive one of the 3 treatments: empagliflozin 10 mg, linagliptin 5 mg or placebo in a blinded manner. This treatment will continue up to week 14. Then after week 14, the subject will be assigned to receive one of the following 4 treatments: empagliflozin 10 mg, empagliflozin 25 mg, linagliptin 5 mg or placebo in a blinded manner. The drugs assigned after week 14 will be the same drugs as on Day 1 but some subjects will receive a higher dose of empagliflozin. After the completion of the 26-week treatment period, the subject will enter a 26-week safety extension period. The same active treatment that the subject had been assigned to at week 14 visit will be continued. Subjects assigned to placebo on Day 1 will be randomly assigned to receive one of the 3 active treatments: empagliflozin 10 mg, empagliflozin 25 mg or linagliptin 5 mg in a blinded manner. This safety extension period is primarily designed to provide additional information on how well empagliflozin and linagliptin are tolerated. Following the treatment phases, there will be a follow-up visit at week 55 Intervention model description: Eligible subjects with HbA1c of 6.5% to 10.5% at screening will be randomized in a 1:1:1 ratio to receive empagliflozin 10 mg, linagliptin 5 mg or placebo. HbA1c assessment will be performed at Week 12. All subjects with Week 12 HbA1c < 7% will remain on previously assigned randomized treatment. Subjects taking empagliflozin with Week 12 HbA1c >= 7% will be re-randomized in a 1:1 ratio to continue on the low dose treatment (empagliflozin 10 mg) or up-titrate to the high dose treatment (empagliflozin 25 mg). Subjects taking linagliptin or placebo with Week 12 HbA1c >= 7% will remain on previously assigned treatment. All subjects will get new medication kits dispensed at Week 14 to maintain the blinding. At Week 26, all subjects previously assigned to placebo will be re-randomized in a 1:1:1: ratio to receive one of the active treatments: empagliflozin 10 mg, empagliflozin 25 mg or linagliptin 5 mg. All subjects will get new medication kits dispensed at Week 14 to maintain the blinding.
External warming is routinely used in general surgery to offset the deleterious effects of hypothermia. It entails deployment of a disposable, external heating blanket attached to a regulated hot-air pump. The need for external warming in the morbidly obese population undergoing short laparoscopic procedures is unclear. If proven to be unnecessary, time and momentary costs could be lowered. The study will compare core-temperature dynamics during laparoscopic bariatric procedures anticipated to last <2h. The study group will be left without a warming blanket while the control group will receive routine external warming. Post-anesthesia care unit (PACU) arrival temperature will also be recorded.
People with schizophrenia spectrum disorders are faced with significant metacognitive impairments that include difficulties in their ability to form complex representations of the self and others. These impairments are associated with increased symptoms, impaired subjective self-experiences, and lower social functioning. As a result, interventions that enhance metacognitive capacity have been recently developed and explored. One of these interventions is Metacognitive Reflection and Insight Therapy (MERIT; Lysaker et al., 2014). MERIT is an integrative model of psychotherapy that seeks to promote holistic metacognitive capacity and consequently increase a positive sense of agency and sense of meaning in life among clients with schizophrenia. Several case studies (including in Bar-Ilan's community clinic), as well as a recent pilot study, showed increased metacognitive abilities and a decrease in symptoms following MERIT. The current study will explore both the effectiveness and the change mechanisms that underlie MERIT interventon among clients diagnosed with schizophrenia spectrum disorders, via both pre- and post-measures of the intervention's outcome and session-by-session estimations of the therapeutic process. **Till now (July 2019) 34 clients have been recruited: 7 clients completed the MERIT therapy; 12 clients are receiving MERIT therapy now days; 6 clients are on the waiting list; 9 dropouts.