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NCT ID: NCT00548106 Withdrawn - Growth Failure Clinical Trials

Safety Study of Infant Formula With Partially Hydrolized Whey

Start date: n/a
Phase: N/A
Study type: Interventional

The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color. Neither the investigators nor the parents will know which product the infant is receiving. The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age. There will be two study groups, each receiving one of the following formulas: 1. The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula containing partially hydrolyzed whey protein, produced and packaged by Materna Laboratories, Maabarot. 2. The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging identical to the Materna product, except for the lid color

NCT ID: NCT00545636 Withdrawn - Clinical trials for Duration of Preoperative Fasting

The Influence of Education of Medical Team on Duration of Fasting Before Elective Medical Interventions Performed Under General Anesthesia in Children

Start date: March 2008
Phase: N/A
Study type: Interventional

The purpose of the study is to examine if an education program of the medical teams can help implementation of of NPO (nothing-per-os)orders in children before anesthesia for ambulatory medical interventions under anesthesia and decrease unnecessary long fasting. We shall ask parents of such children to fill in a questionnaire regarding pre-anesthesia fasting and regular eating and drinking habits. Thereafter, all medical teams involved with the administration of NPO orders will receive an educational program to explain and implement the NPO orders as are recommended by the American Society of Anesthesiologists. We will examine if the educational program was successful in reducing unnecessary long period of fasting, and if such a program is not associated with increased rate of delay of cases.

NCT ID: NCT00542711 Withdrawn - Healthy Clinical Trials

Bio-availability of a New Liquid Tumeric Extract

Start date: n/a
Phase: Phase 1
Study type: Interventional

Curcumin is a commonly-used spice and food coloring. Evidence suggests that curcumin can suppress tumor initiation, promotion and metastasis in a variety of tumor cell lines. The current available curcumin has low bioavailability restricting the effect of curcumin in non-colon cancer. In this study we plan to test a new liquid tumeric/curcumin extract, Curcumol (patent pending, Israel Patent Application No. 181,121). We predict the bioavailability of the liquid tumeric/curcumin extract will be better compared to the currently used curcumin powder.

NCT ID: NCT00535457 Withdrawn - Anxiety Clinical Trials

The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children

Start date: n/a
Phase: Phase 1
Study type: Interventional

It is not uncommon for children to undergo surgery. Surgery is a threatening event that is composed of various stress-provoking stimuli. Pre-operative anxiety is a common emotional response among operated children and their parents. In the current study we are going to examine if tricks done by the anesthesiologist before anesthetic induction are equally as effective as oral midazolam premedication in the reduction of pre-operative anxiety in children before and after surgery. A successful anxiety reduction may be advantageous over pharmacological premedication by cost reduction, a possibly shorter post anesthesia care stay and by reducing postoperative maladaptive behavior rate. Study hypothesis: 1. similar anxiety scores will be observed in children that will watch their anesthesiologist performing tricks and in those who will receive oral midazolam premedication but no tricks. 2. Similar rates of postoperative maladaptive behavior will be found in children that that will see tricks and in those that will receive midazolam premedication.

NCT ID: NCT00534898 Withdrawn - Schizophrenia Clinical Trials

Bexarotene and Fenretinide as Addition to Antipsychotic Treatment in Schizophrenia Patients

Start date: n/a
Phase: Phase 3
Study type: Interventional

Background: In this proposed study, we aim to investigate safety and efficacy of two synthetic retinoids - bexarotene (Targretin; LGD1069; 4-[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl] benzoic acid) and fenretinide (Dihydroceramide N-(4-Hydroxyphenyl retinamide) on severity of psychopathology and cognitive impairment in schizophrenia patients in an double-blind, placebo-controlled study. The rationale behind add-on these medications to ongoing antipsychotic treatment in schizophrenia patients is based on both the retinoid dysregulation hypothesis: the growth factors deficiency and synaptic destabilization hypothesis of schizophrenia. Furthermore, in our preliminary open clinical trial, we found that a low dose of bexarotene (Targretin, 75 mg/day) was safe and led to significant improvement on total PANSS scores, general psychopathology, on the positive and the dysphoric mood factor scores. The aim of the present study was to provide further insight into the safety and efficacy of bexarotene in comparison to fenretinide (a medication with smaller potential of adverse effects) and placebo in patients suffered from schizophrenia.

NCT ID: NCT00524953 Withdrawn - Clinical trials for Allogeneic Transplantation (Non T-cell Depleted)

Phase I Clinical Trial to Assess Safety of UV Phototherapy for the Prevention of GVHD Post Allogeneic SCT

Start date: September 2007
Phase: Phase 1
Study type: Interventional

The primary goal of thos study is to assess safety of Ultraviolet (UV) Phototherapy for the Prevention of Graft versus Host Disease after allogeneic stem cell transplantation (Phase I - Clinical trial). Following allogeneic BMT, patients will be placed on standard GVHD preventive therapy (cyclosporine). Secondary goals - - monitoring immune system recovery - the influence of stem cells origin on therapy and/orGVHD prevention - the influence of UV-c treatment on survival clinical data and samples will be collected, during UV-c therapy, 100 days after discharge & 6 months after discharge - to examine the long-term effect of UV-c treatment on the patient's GVHD status.

NCT ID: NCT00521963 Withdrawn - Arthritis Clinical Trials

Intraarticular Injection of Infliximab

Start date: March 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Intra-articular (IA) injection of medication is a common procedure in the management of joint disorders. In particular, the procedure is effective in the treatment of inflammatory conditions, with long acting corticosteroids most commonly used. These agents have been shown to reduce the signs and symptoms of inflammation, expressed primarily in the synovium of the joint, and are probably capable of slowing the progression of damage to joint cartilage and bone in some of these inflammatory conditions. Arthritis that is refractory to IA corticosteroid injections may respond to surgical, chemical, or, radioisotope synovectomy, procedures in which the inflamed synovial tissue is eradicated. It has been noted that infliximab, a monoclonal antibody directed to Tumor Necrosis Factor (TNF) - α, has high affinity for the TNF-α rich inflamed synovium. Recently, clinical benefit from IA injections of infliximab has been reported in some cases that were refractory to IA injections of corticosteroids. Similarly, the effectiveness of IA infliximab in suppression of joint inflammation has also been demonstrated in patients who could not receive systemic therapy with infliximab. These reports examined the effect of a single injection of infliximab100 mg injected into a large inflamed joint or 2 IA injections 24 hours apart. We propose to further evaluate the use of IA infliximab in patients with intractable knee monoarthritis, explore the optimal mode of its employment, and assess the degree of infliximab systemic absorption from the IA injection. In a pilot study 40 knees will be evaluated, 20 injected with infliximab and 20 injected with a corticosteroid comparator reflecting the current standard of care.

NCT ID: NCT00521768 Withdrawn - Clinical trials for Post Traumatic Stress Disorder

Effectiveness of Prolonged Exposure of PTSD in a Community Setting of PTSD Sufferers

Start date: n/a
Phase: N/A
Study type: Interventional

Introduction: Efforts to bridge the gap between research based treatment modalities advancements and clinical practice have received the highest priority in the research community. In the child psychiatry field there is an urging need to promote bridging this gap. Parents and child health providers hesitate to refer children to child psychiatrist due to stigma but also due to lack of awareness of available and efficient treatment options. In the field of trauma treatment another reason for lack of treatment is lack of recognition of trauma related symptoms in children. After the second Lebanon war scarce referrals to psychiatric clinics have been registered and access to treatment is low as indicated by 20 referrals in the past year to Emek Hospital. We propose to explore the effectiveness of well-established adult treatment for PTSD, the Prolonged Exposure (PE), in community-based general pediatric clinics, serving an underprivileged diverse population. Methods: Twenty children age 6 to 18 attending general pediatric clinic and in Afula region will included. children will be diagnosed using the Hebrew translation of the Childhood version of the Schedule for Affective Disorders and Schizophrenia (Apter et al., 1989 Children will receive the Children's Depression Inventory (CDI) and the. CPSS All subjects will be treated with a manualized 12-week Prolonged Exposure protocol Ratings will be made at baseline, 6weeks, and 12 weeks using CDI and CPSS Hypothesis: 1. PE adapted for pediatric population will be effective in treating single-event traumas in a community setting.

NCT ID: NCT00518921 Withdrawn - Clinical trials for Chronic Stable Angina

Capadenoson in Angina Pectoris

Start date: March 2008
Phase: Phase 2
Study type: Interventional

This is a multi-center and multi-national,randomized, double blind, placebo-controlled, 28-day treatment study with BAY 68-4986 taken orally or a matching placebo.

NCT ID: NCT00502450 Withdrawn - Acute Otitis Media Clinical Trials

Is There Hearing Loss After Acute Mastoiditis

Start date: September 2007
Phase: N/A
Study type: Observational

Following acute mastoiditis there is a possible risk to develop hearing loss. The cause could be either possible involvement of the inner ear, or in cases that underwent surgery, secondary to the effect of the drill's noise. Extended hearing test will be performed for 25 children that suffered acute mastoiditis that resolved with conservative treatment and compared with 25 children that needed surgical intervention.