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NCT ID: NCT01069614 Not yet recruiting - Wounds Clinical Trials

A Skin Stretching Wound Closure System

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

A skin stretching device has been designed to stretch tissue prior to surgery, during surgery and in order to secure wounds following surgery. The device may be used in non-invasive and invasive applications.

NCT ID: NCT01066975 Not yet recruiting - Healthy Clinical Trials

Mechanical Load on the Shoulders While Carrying a Backpack- Towards a Knowledge-Based Backpack Design

Start date: February 2010
Phase: N/A
Study type: Observational

Soldiers and recreational backpackers are often required to carry heavy loads on their body during military operations or hiking. Despite the advances in backpack design, the loads carried by soldiers still impose an extreme physiological strain (soft tissue deformation) which frequently results in discomfort, pain,musculoskeletal injuries, and loss sensorimotor function. In the current study, characterization of the pressures, evaluation of the deformations of the soft tissues, specifically the fat, muscles, Brachial plexus and subclavian vessels applied on the shoulder while sitting with a heavy backpack will performed. The data acquired in the current trials will be used for development of a finite element (FE) 3D shoulder model. The purpose is to better understand the mechanical loads that are being transferred to the underlying tissue below the shoulder straps during walking/marching with a backpack. During the 2nd phase of this project, data collected during this research will be used to develop gear that will alleviate the strain on the shoulders, prevent injury, and enhance performance. Hypothesis - High focal strain (hot-spots) on the shoulder tissue that are observed with the pressure mapping will be observed also in the MR scans. - The strain at those hot-spots can be reduced by personal-geometry adjusted straps. Volunteers Five young (18-30 yrs), healthy, and fit males will participate in this study. Trials design 1. MR Scans- The scan will be performed for analysis of personal shoulder anatomy, and will be used for developing a 3D FE model. The sagittal view will be used to develop the 3D model. The coronal and axial sectional views will be used to assess the deformations applied on the shoulder tissue. The scan will then be repeated while carrying a 25 kg standard commercial backpack while sitting in the same position, for the assessment of shoulder girdle tissues deformations. Time estimation for each scan is 40 min (80 min total). The subjects are not required to carry the backpack prior to those scans. 2. Static pressure measurement- each volunteer will be asked to sit for 30 seconds while carrying the 25 kg backpack. During this session, pressure will be measured using a pressure mapping pad (Sensor Products Inc., USA) placed between the shoulder strap and the underlying tissue. The maximal total participation time of each volunteer will be 2 hours total (inside and outside the MR). Data acquired in the current trials will be used for the development of a FE (finite element) 3D shoulder model. MR scans will be utilized for composing geometry and for the boundary conditions assessment (strain magnitude). Pressure measurements will be used as boundary conditions (stress magnitude). MR scans and pressure measurements will be performed in the Sheba medical center facilities.

NCT ID: NCT01066117 Not yet recruiting - Clinical trials for Urinary Incontinence

Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence

Start date: February 2010
Phase: N/A
Study type: Interventional

The purpose of the proposed study is to test the effect of the new gel pad on the quality of life of urinary incontinent men and women and to assess to what extent the gel pad improves the quality of life of incontinence persons.

NCT ID: NCT01058590 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea Syndrome

Inflammatory Markers in Infants With Obstructive Sleep Apnea

Start date: February 2010
Phase: N/A
Study type: Observational

Obstructive sleep apnea syndrome (OSAS) is a common disorder in children (2-3%). OSAS in turn, is associated with significant behavioral, learning, and heart problems. Adenotonsillectomy (T&A, meaning the removal of tonsils and adenoids) is the most common treatment for the problem .Diagnosis of OSAS in children is based on overnight polysomnography (sleep study). Recent studies suggest that upper airway and systemic inflammatory changes exists in school-age children and adults with OSAS, and that anti inflammatory therapy can improve respiratory parameters during sleep and reduce adenoid size, similar to surgery. However, there are no data in the literature on inflammatory changes in infants with the disorder. Healthcare resources utilization, a sensitive marker for diseases is consumed by young children (<3y) with OSAS more then healthy children, from their first year of life We hypothesize that infants and young children with OSAS present local inflammatory changes of the airways as well as systemic inflammation (in the blood or urine) that contribute to the learning, growing and heart associated medical problems. The Aims of the present study are to characterize the local and systemic inflammatory changes of young children with OSAS, and to evaluate their associated medical problems at diagnosis and after therapy (T&A) If indeed inflammation is "responsible" for the development of OSAS at such a young age it should be reduced following therapy (i.e. T&A). In such a case bio-markers may become a part of the algorithms for diagnosis and follow up of such patients.

NCT ID: NCT01050088 Not yet recruiting - Clubfoot Clinical Trials

Sucrose Analgesia in Infants Undergoing Casting for Club Foot

SCF
Start date: March 2010
Phase: N/A
Study type: Interventional

Babies with congenital clubfeet are treated by the Ponseti casting method. The procedure may cause discomfort to the patient. This study will examine the use of 5 CC Sucrose solution as a comforting agent for the babies.

NCT ID: NCT01043055 Not yet recruiting - Breast Cancer Clinical Trials

Evaluation the Diagnostic Ability of the Cancer Detection Technology (CDT) to Detect Breast Cancer Among Women Population Over Age 40

Start date: January 2010
Phase: N/A
Study type: Observational

This study aimed to validate the diagnostic ability of the CDT (cancer detection technology) software to detect breast cancer among women population.

NCT ID: NCT01042431 Not yet recruiting - Nutritional Status Clinical Trials

Nutrition Day in Hospitals, Nursing Homes and Community. Israel January 2010

Start date: January 2010
Phase: N/A
Study type: Observational

This study is a one-day international cross-sectional nutritional audit in one ward. The purpose of this study is to generate a risk and level of nutritional intervention profile for an individual unit/ward based on case-mix, structures and social environment.

NCT ID: NCT01039831 Not yet recruiting - Clinical trials for White Matter Lesions

White Matter Pathology in Parkinson's Disease (PD)

Start date: January 2010
Phase: N/A
Study type: Observational

The relationship between WM lesions (WM) and Postural Instability Gait Disorders (PIGD-PD)in Parkinson's disease patients is largely unknown. We hypothesize that sub-clinical WM pathology may be a major contributing factor to PIGD-PD. We will compare two groups of patients with Parkinson's disease (PD): those with PIGD and patients with dominant tremor (n=120)to assess the role of brain WM changes.

NCT ID: NCT01039623 Not yet recruiting - Healthy Clinical Trials

Assessment of Safety and Immunogenicity of Intradermal Unadjuvanted Portion of Pandemrix® Via a Microneedle Device With Intramuscular Adjuvanted Pandemrix® as Reference

Start date: January 2010
Phase: N/A
Study type: Interventional

Healthy volunteers will be vaccinated against H1N1 pandemic influenza. One group will receive the adjuvant vaccine while the other group will get intradermal antigen, without the adjuvant. The antibody production will be compared.

NCT ID: NCT01034722 Not yet recruiting - Clinical trials for Fat Globules in Breast Milk

Fat Globules in Breast Milk

Start date: December 2009
Phase: N/A
Study type: Observational

The aims of this study is: 1. To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet. 2. To study the changes in globules distribution along one session of lactation and during the day. Study design: Subjects: This will be a open label study. Each subject will serve as his own control. Study population will include 45 volunteer mothers, that will divide to 3 groups: 15 vegetarians, 15 western diet and 15 Bedouins. Each participant will be nursing a 2-5 months baby. Each participant will sign an informed consent. Each participant will be ask to collect 2 milk samples twice a day i.e.- once on the first nursing in the morning (in the beginning and at the end of the nursing session), and once in the evening on last nursing again, (in the beginning and at the end). Each sample will contain 5 ml of milk. Participants will be asked to repeat the procedure one month later.