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.
Retinoblastoma is a cancer of the eye that occurs exclusively in children. The treatment for retinoblastoma may include surgery, chemotherapy, radiation and local treatments to the eye such as freezing (cryotherapy) and local radiation (brachytherapy). In some cases, a child with retinoblastoma will have active cancer in a single remaining eye with useful vision. In such cases, it is sometimes necessary to remove this eye. In such cases, the injection of chemotherapy directly into the artery that supplies the eye and the tumor may lead to regression of the tumor without the need to remove the eye. This form of treatment was pioneered by a group in New York (Abramson et al). In this study the investigators will assess the efficacy and safety of the technique in a group of children with retinoblastoma.
The objective of this study is to evaluate the effects of 'high' versus 'low' volume intraoperative fluid administration (Ringer Lactate, RL) on intra- and postoperative parameters, in obese patients undergoing laparoscopic bariatric surgery (i.e., gastric bypass), in order to establish evidence-based data for perioperative fluid management in this patient population. Based on their experience as well as several reports in the literature, the investigators hypothesized that a restrictive approach to intraoperative hydration will reduce the incidence of postoperative complications and the recovery time of gastrointestinal (GI) function, and shorten hospital stay.
It is well known that femoral neck fractures carry a significant increase in patients' mortality and that surgical intervention is the preferred treatment. Any delay in operating on such patients would inevitably increase their risk of developing complications. One of the reasons for such unintentional delay would be the hypercoagulative status of patients taking warfarin. The CHEST 2008 guidelines suggest reversing warfarin with Vitamin K for patients who need urgent operation. The aim of this study is to compare different roots and doses of Vitamin K.
Name of Device: Eraser Tattoo Removal Device Device Description: The Eraser device is a mechanical device, resembling tattoo devices but with an innovative mechanism for dripping treatment fluid over reciprocating needles and returning used fluid into a reservoir chamber. The device is intended for removal of tattoos. Objectives: This study is a continuation of a previous feasibility study, which tested the ability of the device to remove tattoos from small skin areas. The purpose of this study is to evaluate the safety and effectiveness of the Eraser Tattoo Removal system for removal of skin tattoos in their entirety. Subject Population: 20 patients in the medical center. Subject enrollment will include (i) a variety of tattoo colors (multiple colors) (ii) a variety of tattoo composition, contour lines and shadings (iii) Subjects with different skin colors (white, tanned, dark, etc…) (iv) professional and amateur tattoos. Structure: A prospective, non-randomized, open, clinical study designed according to FDA guidelines; ISO 14155: standard for clinical studies of medical devices; and the procedures of the Israeli Ministry of Health for clinical studies. After informed consent is signed, demographic details and medical history will be taken and a physical examination performed. Subjects will be treated with the Eraser device, using salicylic acid (5%) as washing fluid. The skin will be examined by a physician and the tattoo area will be photographed. The Eraser device will be used to remove the tattoo from the entire tattoo area (up to 30 minutes in a single session). An absorbent bandage will be put on the treated area for one-hour post treatment. After Care Treatment, based on a Dermatologist's consultation, will be performed on a case-by-case basis (for example, use of antibiotic ointments in case of infection). All subjects must refrain from exposure to the sun for 90 days following each treatment. Follow-up: The subject will return for follow-up at one week, two weeks, 1 month and two months (if tattoo removal and skin healing is complete), or up to six months (if skin healing/ tattoo removal are not complete by two months), or until the healing of the tattoo removal site is completely resolved or until the investigator determines that additional treatments will provide no further benefit to the patient. In each follow-up visit, a physician will perform a physical examination, check the skin over and around the treatment area, and take photographs of the treated area. Images from last follow-up will be compared with images of the same site taken before the removal procedure, for evaluation of treatment efficacy and safety. Repeat treatments: if tattoo removal is not complete, up to two additional treatments will be performed, based on the investigator's discretion. After each treatment, follow-up will continue as described above. Blinding: Non-Applicable Concurrent Control: There is no concurrent control group in this study. Images of tattoos before treatment will serve as the reference measure, to which images of healed skin, several weeks after tattoo removal, will be compared. Sample Size: 20 subjects will be enrolled in the study. Primary Effectiveness Variables: The primary measure of effectiveness will be the pigment clearance, as evaluated by image comparison on a 1-5 analog scale (5 - 81-100% clearance- excellent removal; 4 - 61-80% - good removal; 3 - 41-60% - moderate removal; 2 - 21-40% - fair removal; 1 - 0-20% - poor removal). Effectiveness will be calculated for the total study group and for individual sub-groups (skin type, pigment colors, etc.). Effectiveness will be analyzed separately for the area affected (percentage of treated area that showed any reaction to treatment) and for the change in color brightness (if, due to technical reasons, part of the tattoo showed a major effect, this area will be evaluated for the change in color brightness). For both analyses, the same scale will be used. For safety assessment, the rate of systemic and dermatologic adverse events will be calculated and reported. The data will be listed by type of event and by severity. Specifically, textural change, hypo- and hyper- pigmentation will be followed and their rates calculated. Data Analysis: For this clinical study, descriptive statistics will be used. Successful treatment will be a result of 3 or more (at least, moderate tattoo removal) on the brightness change scale. Study Sponsor: Hawk Medical Technologies Ltd.
The purpose of this study is to compare the neuropsychiatric adverse event profiles of etravirine 400mg once daily versus efavirenz 600mg once daily, in combination with 2 N(t)RTIs, in approximately 150 treatment-naÃ-ve HIV-1 infected patients. Safety, tolerability and efficacy of both treatment arms will be assessed throughout the study.
The AC-055B201/MUSIC study is a Phase II study, comparing one dose of ACT-064922 (macitentan) 10 mg with placebo in patients with idiopathic pulmonary fibrosis (IPF). The main study objective is to demonstrate that macitentan positively affects the forced vital capacity (FVC) in comparison with placebo in patients with idiopathic pulmonary fibrosis (IPF). The secondary objectives are to evaluate the effect of macitentan on the time to disease worsening or death in patients with IPF, and to evaluate the benefit/risk profile of macitentan in the treatment of patients with IPF.
The purpose of this study is to determine whether the safety, tolerability and pharmacodynamics of SB656933 in patients that have cystic fibrosis
The purpose of this study is to evaluate the efficacy and safety of various doses of YM150 (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in patients that are undergoing elective hip replacement surgery.
This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.
Study Title: Arthroscopic rotator interval closure in shoulder instability repair - a prospective study Objective: To evaluate the effect of arthroscopic rotator interval closure (ARIC) on patients with recurrent shoulder dislocations undergoing arthroscopic bankart repair (ABR) in terms of recurrence, rehabilitation and function. Hypothesis: 1. Although Hyperlax patients undergoing ABR have higher incidence of recurrent shoulder dislocations than those without hyperlaxity, adding ARIC will lower the recurrent dislocation rate. 2. Patients with arthroscopic bankart repair (ABR) and ARIC are slower in gaining the range of motion (ROM) but within 6 months are equal to those with ABR only.