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NCT ID: NCT00534898 Withdrawn - Schizophrenia Clinical Trials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: NCT00534573 Completed - Clinical trials for Clozapine-induced Hypersalivation

Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation

CIH
Start date: November 2008
Phase: Phase 3
Study type: Interventional

Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable adverse effect of clozapine therapy, and until now there is not enough effective treatment for this side effect leading to noncompliance. In previous studies it was found that substitute benzamide derivatives with higher selective binding to the D2/D3 dopamine receptor - amisulpride and sulpiride may be effective in treatment of clozapine-induced hypersalivation (CIH). Today, in psychiatric practice in Israel, there are four medications which belong to substitute benzamide derivatives group: amisulpride, sulpiride, tiapride and moclobemide. We hypothesized that antisalivation effect is universal for the whole group of benzamide. The aim of our study was to compare efficacy of amisulpride, moclobemide (reversible monoamine oxidase inhibitor-A (RIMAS)), and tiapride (dopamine D2 antagonist) as an additional possibility for management of CIH.

NCT ID: NCT00533715 Completed - Healthy Clinical Trials

Forced Inspiratory Flow Volume Curve in Healthy Young Children

Start date: January 2003
Phase: N/A
Study type: Observational

Spirometry testing should include both expiratory and inspiratory measurements as it may influence the expiratory flow volume curve indices. The ability to inhale medication may by judged by inspiratory flows. However, the inspiratory portion of the forced flow/volume maneuver in young healthy children has not yet been described.Objectives: To document and analyze the forced inspiratory flow volume curve indices in healthy young children. Settings: Community kindergartens around Israel. participants; Healthy preschool children (age 2.5-6.5 years). Methods: The teaching method included multi-target, interactive spirometry games (SpiroGame®) and accessory games for inspiration (e.g. inspiratory whistle). Results: One hundred and fourteen of 157 children performed duplicate full adequate inspiratory maneuvers. Repeatability between two maneuvers was 5.6%, 4.0%, 5.1%, 7.3% for inspiratory capacity (IVC), forced inspiratory capacity (FIVC), peak inspiratory capacity (PIF), and mid inspiratory flow (MIF50), respectively. Inspiratory flow indices were significantly lower than the parallel expiratory flow indices and the time to reach PIF was significantly slower than the time to reach peak expiratory flow (meanSD; 22921ms vs. 92 8ms; p<0.0001). The shape of the inspiratory curve was parabolic and did not change with age. Predicted equations that were formed were in agreement with the extrapolated prediction equation values of older children. We found that the majority of healthy young children can produce reliable inspiratory curves. Our results provide a framework for reference equations for inspiratory flow volume curve in the young ages. The clinical applications of these equations are yet to be explored.

NCT ID: NCT00533689 Not yet recruiting - Electrophysiology Clinical Trials

Study of the Long-Term Effect of Frequent Anti-VEGF Dosing on Retinal Function in Patients With Neovascular AMD

Start date: January 2008
Phase: Phase 3
Study type: Interventional

THis study aims to determine whether frequent dosing of intravitreal injections of Ranibizumab (Lucentis) or Bevacizumab (Avastin), which act as VEGF inhibitors, has a deleterious effect on the retina, studied by electrophysiologic testing. This prospective, non-randomized clinical study will include patients assigned to intravitreal injection of Ranibizumab or Bevacizumab due to neovascular AMD. The patients will undergo repeat ophthalmic evaluation and intravitreal injections every 4-6 weeks, as long as will be deemed necessary. Periodic electrophysiologic evaluation including Electroretinogram (ERG), electro-oculogram (EOG) and Visual Evoked Potentials (VEP) tests will be performed every 3 months.

NCT ID: NCT00533494 Completed - Clinical trials for Type 2 Diabetes Mellitus

The Effect of Patients' Participation in Improving Diabetes Care

Start date: January 2000
Phase: Phase 3
Study type: Interventional

Despite the advent of efficacious medicines, there is a gap between ideal and actual care in the achievement of recommended outcomes among diabetic patients. The study enrolled 429 diabetic patients attending four HMO clinics in Israel, two in the northern region and two in the southern region. All clinics were randomly selected from all clinics affiliated with the Faculty of Health Sciences of the Ben Gurion University. The objective of the study was to compare the effects of a multi-component physician-patient intervention to physician feedback alone on a combined outcome of diabetes, blood pressure and serum lipids control. We hypothesized that in medical practices where physicians have received feedback on quality of care indicators, patients who received a letter encouraging them to discuss a list of important diabetes-related issues with their doctors, would experience better outcomes compared to patients who did no received such a letter.

NCT ID: NCT00533013 Completed - Heart Failure Clinical Trials

Comprehensive Heart Failure Disease Management Community Program

Start date: August 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a nurse-led, comprehensive disease management program is effective in reducing recurrent hospital admissions and deaths in community dwelling patients with moderate to severe heart failure.

NCT ID: NCT00532558 Terminated - Clinical trials for Hypercholesterolemia

Efficacy of Lapaquistat Acetate on Blood Cholesterol Levels in Treating Subjects With Hypercholesterolemia

Start date: October 2007
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine the reduction of LDL-cholesterol level after treatment with 50 mg per day of lapaquistat acetate once daily (QD).

NCT ID: NCT00532519 Not yet recruiting - Prurigo Nodularis Clinical Trials

Effectiveness of the Selective Serotonin Reuptake Inhibitor,Citalopram (Cipralex), in Prurigo Nodularis

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

Prurigo nodularis (PN) is a common dermatological disorder, manifested as scaly nodules which appear mainly on the extensor surfaces of the limbs. PN may appear secondarily to skin scratching in chronic hepatitis, liver cirrhosis, uremia, hypothyroidism etc. Nevertheless, in many cases no underlying physical disease is present. According to the literature, in fifty percent of the patients there is co-morbidity with depression, anxiety or somatoform disorders. We hypothesize that a group of these patients may benefit from antidepressant therapy.

NCT ID: NCT00532259 Completed - Clinical trials for Primary Mediastinal Large B-Cell Lymphoma

CT-011 MAb in DLBCL Patients Following ASCT

Start date: October 2007
Phase: Phase 2
Study type: Interventional

Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL) following relapse of the disease. Although many people are cured of their lymphoma with this therapy, the disease comes back in a certain proportion of patients. The purpose of this study is to test the safety and effectiveness of the monoclonal antibody, CT-011, in patients with DLBCL who have received autologous peripheral blood stem cell transplantation. All final eligible patients will receive an IV infusion of CT-011 on Day 1 (30 to 90 days post autologous PBSCT). Treatment will be repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85. Follow-up for safety and clinical outcome will be conducted throughout the study till 18 months post autologous PBSCT. Approximately 70 patients will participate in this study.

NCT ID: NCT00531804 Completed - Alzheimer's Disease Clinical Trials

A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.

Start date: December 2006
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of R1450 in patients with mild to moderate Alzheimer Disease. Patients will be randomized to receive either R1450 or placebo by intravenous infusion for a total of 7 doses. The starting dose will be escalated in subsequent cohorts of patients in an adaptive manner, after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.