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NCT ID: NCT00361452 Terminated - Rsv Bronchiolitis Clinical Trials

Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study

Start date: December 2000
Phase: Phase 4
Study type: Interventional

Bronchiolitis is a common disease of infancy and a main reason for infants' hospital admissions in the first 2 years of life. The main cause of bronchiolitis is RSV (respiratory syncytial virus). Though, Treatment is mainly supportive, the treatment benefit of nebulized epinephrine or albuterol has been largely debated for the past years. Most of the clinical studies used clinical parameters to detect and compare the effectiveness of such medical interventions. In this study we will use non invasive computerized method of wheeze and crackles quantification to compare the effectiveness of nebulized epinephrine vs albuterol in RSV Bronchiolitis.

NCT ID: NCT00361426 Withdrawn - COPD Patients Clinical Trials

EarlySense Monitoring Device Evaluation on COPD, CHF and Pneumonia Patients

Start date: January 2008
Phase: N/A
Study type: Observational

Continuous measurement of breathing patterns, heart rate, restlessness and cough in sleep using EarlySense ES 16 device. Predicting worsening in COPD patients' condition using the above parameters.

NCT ID: NCT00361413 Terminated - Clinical trials for Graft Versus Host Disease

Alefacept for Prevention of Graft Versus Host Disease (GVHD)

Start date: June 2006
Phase: Phase 3
Study type: Interventional

Alefacept (AMEVIVE®) is an immunosuppressive dimeric fusion protein. It was shown to interfere with lymphocyte activation by specifically binding to the lymphocyte antigen, CD2, and inhibiting LFA-3/CD2 interaction. Alefacept was evaluated in two randomized, double-blind, placebo-controlled studies in adults with chronic (>1 year) plaque psoriasis and a minimum body surface area involvement of 10% who were candidates for or had previously received systemic therapy or phototherapy. The response to alefacept was significantly better in both studies. In both studies, onset of response to alefacept treatment (defined as at least 50% reduction of baseline Psoriasis Area and Severity Index (PASI)) began 60 days after the start of therapy. Graft versus host disease (GVHD) is the most ominous side effect of allogeneic stem cell transplantation (SCT). It causes severe inflammatory process, which is usually located to the skin, gut and liver. Treatment of GVHD consists of various immuno-suppressive and immuno-modulating drugs, including steroids, cyclosporine, tacrolimus, methotrexate etc. These drugs unfortunately can also cause severe immunologic failure that makes the patient prone to infection and malignancy, and other medication-specific side effects. In spite of this effect on the immune system, not all of the patients achieve control of GVHD, which usually rapidly leads to death. Despite the use of innovative immunosuppressive modalities, the prognosis of steroid resistant GVHD is usually poor. It was shown that CD2 depletion of allografts could prevent GVHD. Alefacept was never systemically tried in GVHD but A phase II study of BTI-322, a rat monoclonal IgG2b directed against the CD2 antigen in steroid-refractory acute GVHD showed a total response rate of 55%. We showed that alefacept might have a beneficial effect in controlling steroid resistant aGVHD and chronic GVHD. It was also shown to dramatically change the nature of transfusion associated GVHD.

NCT ID: NCT00361322 Completed - Acne Vulgaris Clinical Trials

Efficacy and Safety of a Preparation Containing an Antibiotic and Anti-Inflammatory Agent in Acne Vulgaris

Start date: April 2005
Phase: Phase 1/Phase 2
Study type: Interventional

The concept behind our study was to combine an effect of antibiotic and anti-inflammatory agents for a more efficient acne therapy directed at the factors involved in the pathophysiology of the disease. For this purpose we evaluated a combination of clindamycin phosphate and salicylic acid in a non-irritating carrier.

NCT ID: NCT00361192 Recruiting - Temporal Arteritis Clinical Trials

Sensitivity and Specificity of Color Doppler Directed Temporal Artery Biopsy as Compared to Standard Random Biopsy in the Diagnosis of Temporal Arteritis

Start date: August 2006
Phase: Phase 0
Study type: Interventional

Introduction Temporal arteritis (TA) is the most common primary vasculitis in the adult population. TA is a systemic multi-organ disease but primarily involves the cranial arteries, especially the temporal artery. The signs and symptoms of the disease are variable and therefore the differential diagnosis is often difficult. The annual incidence of the disease in the population above the age of 50 in Jerusalem is about 10 per 100,000. Diagnosis is based on the clinical findings and confirmed by biopsy of the temporal artery, positive for histologic findings of arteritis. Though the biopsy procedure is minor and can be accomplished under local anesthesia, it is not without morbidity. Along with minor pain, more serious complications - facial nerve injury, ptosis, stroke, and local necrosis of skin - have been reported. A negative biopsy does not completely rule out the diagnosis of TA because of the segmental nature of the inflammation. Even if one removes an appropriate length of artery (usually 1-2 cm) the possibility exists that an involved segment may not have been included and the biopsy will be reported as normal. It has recently been reported that color Doppler ultrasonography can be used to diagnose TA. Arterial inflammation causing peri-vascular edema appearing as a "dark halo" and segmental stenosis of the temporal artery are characteristic ultrasound findings suggestive of TA. If there is no dark halo sign, a diagnosis of TA cannot be supported and temporal artery biopsy can be avoided in most of these patients. The presence of the dark halo sign has a positive predictive value of only 50%. As noted above the disease is characterized by segmental involvement of the artery and to avoid a false negative biopsy, excision of up to 3cm of the artery has been recommended, thereby increasing the morbidity, and leading patients to refuse the procedure. Use of ultrasound-guided biopsy of the artery may dramatically raise the sensitivity and specificity of the biopsy and reduce the requirement for excising long segments of artery. Objective The objective of this study is to examine the use of ultrasound-guided biopsy of the temporal artery in the diagnosis of TA. Ultrasound-guided biopsy will be compared to the standard random biopsy generally in use. Appropriate statistical methods will be employed. Methods The Vascular Laboratory in Shaare Zedek Medical Center performs approximately 200 Doppler ultrasound studies of the temporal artery each year at the request of community-based physicians. Some of these patients are then also referred for biopsy of the temporal artery at various surgical facilities in the city. In collaboration with the referring physician, the patients will be offered a combined diagnostic Doppler ultrasound and guided biopsy on the basis of clinical guidelines and according to the ultrasound findings as described below. Patients suffering from signs and symptoms consistent with TA and who have not undergone previous temporal artery biopsy will be included. Patients suffering from isolated polymyalgia rheumatica will be excluded. Patients who are already undergoing steroid treatment will be excluded. Patients with an ultrasound study that is positive for the dark halo sign will be divided into two groups on a random basis after obtaining informed consent. One group will undergo ultrasound-guided biopsy, while the other will undergo biopsy as is the standard practice in our institution - a 1-2cm length of temporal artery will be excised from the preauricular area. If the ultrasound is negative, no biopsy will be done in the setting of this study. It is expected that about 50 patients will be accrued during the 6-month study period. Differences in outcome will be analyzed using Fishers exact test. Approval from the Helsinki committee of Shaare Zedek Medical Center has been requested.

NCT ID: NCT00361062 Completed - Aggression Clinical Trials

Aggressive Behavior Induced by Selective Serotonin Reuptake Inhibitors (SSRIs) During the First Month of Treatment

Start date: September 2006
Phase: N/A
Study type: Interventional

SSRIs are the first line of therapy for anxiety and depressive disorders and for many other clinical diagnoses. One of the most disturbing side effects that is observed is a tendency towards aggressiveness among patients receiving medications from this group, mainly during the first month of therapy. Aggressive behavior tends to occur in some individuals but not in others. In some sub-groups of people, personality and character traits might make a person more prone to aggressive behavior. In this study the investigators try to estimate the tendency towards aggressive behavior in patients prescribed to a medication from the SSRI group. By using a comparative computer simulation they hope to be able to detect delicate changes and to maybe get some clues of the personalities prone to aggressive behavior in the future.

NCT ID: NCT00359762 Completed - Clinical trials for Type 2 Diabetes Mellitus

Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

Start date: September 2006
Phase: Phase 3
Study type: Interventional

This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.

NCT ID: NCT00359437 Terminated - Liver Cirrhosis Clinical Trials

Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver

SPARe-1
Start date: July 2006
Phase: Phase 3
Study type: Interventional

Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites. Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

NCT ID: NCT00359190 Completed - Neoplasms, Breast Clinical Trials

Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer

Start date: June 29, 2004
Phase: Phase 1
Study type: Interventional

This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three dosing schedules of lapatinib.

NCT ID: NCT00359008 Completed - Clinical trials for Age Related Macular Degeneration

PHP Home Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)

Start date: July 2006
Phase: Phase 3
Study type: Observational

The primary objective of this study is to assess the ability of the PHP & HPHP to detect newly diagnosed non treated Chorodial neovascularization (CNV) lesion associate with advanced age related Macular Degeneration (AMD) and differentiate them from Early/intermediate/GA AMD