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NCT ID: NCT00368537 Completed - Clinical trials for Skin Diseases, Bacterial

Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections

Start date: September 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).

NCT ID: NCT00368316 Completed - Shigellosis Clinical Trials

Safety, Immunogenicity and Efficacy of Shigella Conjugate Vaccines in 1-4 Year Olds in Israel

Start date: January 2003
Phase: Phase 3
Study type: Interventional

Shigellosis remains a serious and frequent disease throughout the world. Development of vaccines has been difficult because shigellae are habitants of and pathogens for humans only and there is no consensus about the mechanism(s) of immunity to this pathogen. Incomplete, but compelling evidence, indicates that a critical level of serum IgG anti-LPS confers immunity to shigellosis. Important data come from our clinical trial in the Israel Defense Forces (IDF) recruits. A randomized, double-blind, vaccine-controlled study showed that the S. sonnei-rEPA elicited 74% protection against shigellosis occurring about 3 months after vaccination (p=0.001). This vaccine conferred 43% (p=0.04) protection in one company during an outbreak up to 14 days following vaccination suggesting that our Shigella conjugates might be of value in epidemics. The efficacy of S. sonnei-rEPA was correlated with the level of vaccine-induced IgG antibodies. The highest incidence, morbidity, and mortality of shigellosis is in young children. But serum antibody responsiveness to polysaccharide-based vaccines is age-dependent and infants and young children respond poorly or not at all to both disease and vaccination. The safety and immunogenicity of these Shigella conjugates in 4 to 6 years-old children in Israel was demonstrated. But although the fold rise in anti-LPS was similar in the children, the level of anti-LPS elicited by the conjugates was lower than in adults. We improved the immunogenicity of Shigella conjugates as shown in mice and then in adult humans. Now we apply to evaluate the safety, immunogenicity and efficacy of these improved conjugates in 1 to 4 years-old children in Israel. In Israel, shigellosis is common especially in children. S. sonnei (Group D) comprise about 60% of the isolates followed by S. flexneri (Group B): Shigella dysenteriae type 1 (Group A) is not found. We propose to administer 2 injections of either S. sonnei-CRM9 or S. flexneri type 2a-rEPAsucc 6 weeks apart in a random double-blind fashion to about 6,000 1 to 4 year-olds. Active surveillance of the vaccinees for enteric infections will be maintained for at least 2 years to evaluate the effect of vaccination.

NCT ID: NCT00368251 Completed - Clinical trials for Unverricht-Lundborg Disease

Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and Adults

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

The study will compare the efficacy and safety of Brivaracetam with placebo in patients with Unverricht- Lundborg Disease (ULD).

NCT ID: NCT00368173 Completed - Laron Syndrome Clinical Trials

IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome

Start date: n/a
Phase: Phase 2/Phase 3
Study type: Interventional

STUDY OBJECTIVE To evaluate the safety, tolerability, and efficacy, as growth velocity (statural growth), of rhIGF-I/rhIGFBP-3 administered for 12 months in pre-pubertal children and adolescents with GHIS. STUDY DESIGN This study is an open-label, multi-center clinical trial to evaluate the safety and effectiveness of rhIGF-I/rhIGFBP-3 to increase rate of growth when administered once daily for 12 months in children and adolescents with growth hormone insensitivity syndrome (GHIS) such as Laron Syndrome. At the end of the initial twelve-month treatment period, additional safety and long-term efficacy data will be assessed in a second 12 month treatment period.

NCT ID: NCT00367848 Completed - Fractures, Occult Clinical Trials

Efficacy of Ultrasound in Evaluating Occult Fractures

Start date: November 2006
Phase: N/A
Study type: Observational

The purpose of the study is to examine the efficacy and accuracy of Ultrasound in evaluating occult fractures. We want to examine it on children that suffer from suspected fractures of the foot and ankle and the results of the x-ray are either negative or inconclusive.

NCT ID: NCT00367705 Not yet recruiting - Crohn's Disease Clinical Trials

VSL#3 Treatment in Children With Crohn's Disease

Start date: August 2009
Phase: Phase 4
Study type: Interventional

Crohn's disease (CD) in childhood is a chronic relapsing and remitting condition that has a significant impact on growth and development. The disease is characterized by an increased and unregulated immune response. The main therapy over the last 30 years has been corticosteroids leading to remission in 50-80% of patients within 2-4 weeks. However, the use of steroids in children is limited by side-effects including acne, moon-face, hirsutism, hypertension, metabolic disturbances and above all reduced growth. Hence, pediatricians are very interested to find alternative therapies. Therapeutic manipulation of gut flora with probiotics promises to be a useful strategy for several disorders including inflammation of the gut. The efficacy of the highly concentrated probiotic VSL#3 has been documented in maintenance and prophylaxis treatment of pouchitis in double blind, placebo controlled studies in adults. The aim of this study is to compare probiotic therapy with VSL#3 versus placebo in maintenance therapy of children with mild to moderate CD, treated with either 5-ASA, corticosteroids (local or budesonide), imuran/6 mercaptopurine (MP), as long as no change in medication dosage has been made in the previous 12 weeks (for imuran/6MP) or 4 weeks (for corticosteroids).

NCT ID: NCT00367679 Completed - Clinical trials for Non-Small Cell Lung Cancer

Pazopanib As Pre-Surgical Therapy In Treatment-Naive Subjects With Non-Small Cell Lung Cancer

Start date: November 2006
Phase: Phase 2
Study type: Interventional

This is a phase 2 open-label, multicenter, non-randomized study to evaluate the safety and efficacy of oral pazopanib as neoadjuvant treatment for patients with stage 1A, 1B, IIA or IIB (to T2) resectable Non-Small Cell Lung Cancer (NSCLC).

NCT ID: NCT00367367 Recruiting - Infertility Clinical Trials

Endometrial Curettage Before Embryo Transfer

Start date: December 2005
Phase: N/A
Study type: Interventional

Studies have shown that endometrial sampling in the month prior to embryo transfer may increase pregnancy rates. We wish to test this hypothesis by performing a hysteroscopy and curettage in the month proceeding embryo transfer during IVF, IVF/ICSI or Frozen/Thawed cycles.

NCT ID: NCT00367289 Completed - Knee Arthroplasty Clinical Trials

CT for Diagnosis of Implant Stability in Revision Arthroplasty

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

All patients over 18 who undergo a revision of hip or knee arthroplasty will be included. Patients undergo a CT of the hip joint. A radiologist will mark the presence of cysts and bone loss and will assess implant stability. After the surgery, the surgeon will fill a similar form.

NCT ID: NCT00367107 Not yet recruiting - Autism Clinical Trials

Autism in Adult Patients and the Effects on Caregivers

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

Background: The number of adults with autism is expected to rise significantly in the near future, due to two main reasons: First, a dramatic increase in the estimates of the prevalence of autism starting in the mid 1980s; Second, the clinical diagnosis of autism was first introduced during the 1950s, and those diagnosed with autism back then are only now entering middle age. Few studies, however, have focused on the outcomes of adult autistic individuals, and very little is known about the course of autism in adulthood and on the familial burden resulting from caring for an autistic adult. We therefore propose to study adult outcomes in autism, and to examine the influence of raising an autistic individual on the parents. Working hypothesis and aims: The primary objectives of the study are: 1. Determine clinical status and functioning of autistic adults. 2. Study the influence of raising and caring for an individual with autism on the well-being of the parents.