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NCT ID: NCT02206477 Not yet recruiting - Dimethyl Sulfoxide Clinical Trials

DMSO for Prevention of Capsular Contraction in Alloplastic Breast Reconstruction

Start date: August 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Capsular contraction is the one of the most common complications of both esthetic and reconstructive breast surgery, with high incidence after radiotherapy. The mechanism of the contraction is unclear, but is believed to be similar to the formation of hypertrophic scarring. Dimethyl sulfoxide (DMSO) has demonstrated its use as an anti-inflammatory, anti-proliferative, and antibacterial agent. The aim of this study is to test the effect of DMSO on the incidence and severity if capsular contracture after breast alloplastic reconstruction in irradiated patients. We conduct a prospective randomized-control single-surgeon study in the tertiary academic Rabin Medical Center. 110 female candidates for mastectomy, radiotherapy and immediate two-stage reconstruction will be included. They will be divided into two groups: the DMSO treatment group, which will be treated according to our protocol, and the control group, that will be treated with the same protocol but with 0.9% saline instead. Several measures will be taken, including: capsular contracture grading by two plastic surgeons, a VAS-score of breast pain, maximal capsular thickness (MCT) in sonography evaluation, and pathology examination of the capsule (biopsy will be taken during the second stage operation). Rates and grades of capsular contracture evident clinically, radiologically and pathologically, will be evaluated and compared.

NCT ID: NCT02202603 Completed - Drug Safety Clinical Trials

A Three Stage, Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) in Healthy Subjects

Start date: July 2011
Phase: Phase 1
Study type: Interventional

A Double blinded (oral), Open Label, Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) in healthy Subjects to establish the safety, tolerability, bioavailability, pharmacokinetic, and pharmacodynamic profile and the of Entera's oral PTH(1 - 34) in adult healthy human volunteers.

NCT ID: NCT02202135 Terminated - Clinical trials for Complicated Skin and Soft Tissue Infection

Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.

Start date: June 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.

NCT ID: NCT02201108 Active, not recruiting - Multiple Sclerosis Clinical Trials

Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis

TERIKIDS
Start date: July 16, 2014
Phase: Phase 3
Study type: Interventional

Primary Objective: To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis (MS). Secondary Objective: - To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain magnetic resonance imaging (MRI) and on cognitive function. - To evaluate the safety and tolerability of teriflunomide in comparison to placebo. - To evaluate the pharmacokinetics (PK) of teriflunomide.

NCT ID: NCT02201017 Recruiting - Clinical trials for Heart Rate Variability Ischemia Detection

HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia

Start date: June 2014
Phase: N/A
Study type: Observational

A total of 621 consecutive male and female subjects, without established CAD, referred to exercise stress testing (EST) due to 1) chest pain syndromes or equivocal/equivalent angina with intermediate pretest probability for CAD; 2) , or asymptomatic subjects with diabetes mellitus who are referred EST for risk assessment prior to initiation of an exercise program. To validate the diagnostic performance of the HeartTrends device for the detection and ruling out of myocardial ischemia in a population of subjects who are currently referred for cardiovascular evaluation using EST. Prospective multicenter single-armed study, assessing the diagnostic accuracy of HRV analysis by the HeartTrends device for the detection of myocardial ischemia, as determined by stress echocardiography.

NCT ID: NCT02200770 Completed - Clinical trials for Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders

Start date: April 1, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

To compare the efficacy of inebilizumab (MEDI-551) versus placebo in reducing the risk of an neuromyelitis optica/neuromyelitis optica- spectrum disorders (NMO/NMOSD) attack in participants with NMO/NMOSD.

NCT ID: NCT02200614 Completed - Clinical trials for Castration-Resistant

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

ARAMIS
Start date: September 12, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.

NCT ID: NCT02200107 Recruiting - Osteoarthritis Knee Clinical Trials

Integrated Treatment Program for Osteoarthritis of the Knee

Start date: September 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the ability to assimilate and implement an integrated treatment program osteoarthritis of the knee, including the diagnosis and follow-up by a family physician in primary care clinics, combined with patient self-care training and physiotherapy program

NCT ID: NCT02199587 Completed - Precocious Puberty Clinical Trials

The Effect of Medical Clown on the Pain and Anxiety Perception During LRH Analog Treatment or GH Provocation Test

Start date: December 17, 2014
Phase: N/A
Study type: Interventional

The investigators would like to examine the contribution of medical clowns in routine medical procedures in the endocrine clinic. This will be the first time that will objective evaluate the effect of medical clown on stress hormone such as adrenaline cortisol and prolactin, and also evaluate the effect of mental stress on growth hormone secretion in children. The aim of the current study is testing the pain and anxiety of the patient and the accompanying parent and medical staff in the presence or absence of medical clown at the time: 1. LRH analog (decapeptyl) intramuscular injections for precocious puberty. 2. Growth hormone tests. Secondary end point will be: 1. Changes in stress hormones: cortisol , prolactin and adrenalin during growth hormone tests in the presence of a clown. 2. Does the presence of a medical clown and the mental stress affect the secretion of growth hormone? 3. Are there differences in growth hormone secretion and stress hormones between the various tests for growth hormone secretion (glucagon, clonidine or arginine) in the presence of a clown? 4. Are there differences in response to stress and the secretion of growth hormone in children with obesity?

NCT ID: NCT02198157 Completed - Labor, Second Stage Clinical Trials

Urinary Catheterization and Second Stage of Labor

cath2stage
Start date: July 2014
Phase: N/A
Study type: Interventional

- Labor is divided into three stages: the first stage is from labor onset until full dilation, second stage is from full dilation until delivery of the baby, and the third stage from the delivery of the baby until the delivery of the placenta - The mean duration of second stage in nulliparas as defined by the American college of obstetricians and gynecologists (ACOG) is 54 minutes - Epidural anesthesia is a known cause for prolongation of the second stage of labor. Prolonged second stage in nullipara women with epidural is defined as more than 3 hours, and more than 2 hours in those without epidural. - Although perinatal outcome is not compromised with a prolonged second stage , there is evidence that maternal morbidities such as perineal trauma, chorioamnionitis ,instrumental delivery and postpartum hemorrhage increase with prolonged second stage - Another effect of epidural anesthesia during labor is urinary retention and a need for catheterization. - Full bladder may behave as a tumor previa and interfere to fetal head descent in the birth canal, increasing by that the duration of the second stage. - This study aims to investigate the effect of intermittent versus continuous catheterization on the duration of the second stage of labor