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NCT ID: NCT01361516 Not yet recruiting - Urolithiasis Clinical Trials

Comparison of General Anaesthesia and Sedation on the Stone Fragmentation in Lithotripsy

Start date: July 2011
Phase: N/A
Study type: Interventional

The aim of the study is to compare the impact intravenous sedation versus general anesthesia on the efficacy of stone fragmentation in extracorporeal shock wave lithotripsy treatment.

NCT ID: NCT01361373 Recruiting - Clinical trials for Dystonic Cerebral Palsy

Dopamine Treatment in Children With Cerebral Palsy With Dystonia- A Double Blind Controlled Study

Start date: May 2010
Phase: Phase 4
Study type: Interventional

Background: Cerebral palsy (CP) is the main cause of childhood immobility and is defined as a non progressive injury to the developing central nervous system in children younger than 3 years, resulting in neurological and musculoskeletal abnormalities. The main pathophysiological causes are encephalopathy of prematurity (periventricular leukomalacia) hypoxic ischemic encephalopathy. Infections, infracts and migration defects are other less common causes of CP. The brain injury leads to functional motor impairment impacting on daily activities commonly manifests as a movement disorder: pyramidal, leading to spasticity and extra-pyramidal leading to dystonia and chorea. In most cases extensive brain injury causes a mixed movement disorder. Dystonia is defined as involuntary muscle contractions causing twisting and abnormal postures. While the neurological underpinnings of CP remain unknown, a link between low dopamine and increased acetylcholine release has recently been reported in dystonia. Dopamine is considered the first line of treatment in children with dystonia and CP followed by anticholiergic treatment with trihexphenidyl. The recommendation of dopaminergic treatment is based on need to rule out dopamine-responsive-dystonia, a rare genetic disorder, and on single case study reporting improvement in CP. A double blind study support or refute the use of dopamine treatment for dystonic CP was never reported. Working hypothesis and Aims: In children with CP due to a clear underlying pathology, dopamine treatment will not improve daily function. Methods: the investigators will perform a double blinded randomized controlled crossover study. 50 children ages 4-18 years with a clear pathophysiological cause for CP will be enrolled. Each child will receive dopamine and placebo treatment for 2 weeks with a 2 week washout interval. Participants will be randomized into 2 groups; one will receive placebo followed by dopamine and the other vice versa. The primary outcome measure, goal-attainment-scale, and secondary outcome functional measures (such as box and blocks, 9 hole pegs, pronation/ supination, finger sequencing) will be assessed at the beginning and end of each treatment as well as parent questionnaires regarding satisfaction and side effects. Expected results: No functional improvement with dopamine treatment compared to placebo. Importance: supplying sufficient data to support or refute the use of dopamine treatment for dystonic CP. Probable implications to Medicine: this may lead to a change in medical treatment guidelines for children with CP.

NCT ID: NCT01361321 Completed - Clinical trials for Alveolar Ridge Augmentation

Bone Quality and Quantity Following Guided Bone Regeneration

Start date: February 2012
Phase: N/A
Study type: Observational

Edentulism refers to a state of full or partial lack of teeth. This situation may interfere with essential functions such as mastication, speech and even appearance. Dental implants inserted to the mandible or maxilla is a common treatment modality aiming to restore edentulus alveolar ridges by providing support and anchorage for removable or fixed dental prosthesis.There are cases which in addition to a lack of teeth suffer from lack of sufficient bone tissue volume to support the dental implant.A situation like this may originate from a variety of reasons such as residual bone atrophy, prior alveolar bone destruction due to periodontal disease and even a traumatic tooth extraction. In such cases, a routine alveolar bone augmentation is done to enable a dental implant installation at this site.Guided bone regeneration (GBR) is a widely used technique used to augment edentulus bone ridges. It relies on an inert membrane covering a bone substitute placed over the bony site requiring augmentation. The bone substitute provides a scaffold to alveolar regeneration by the host's osteoblasts while the membrane prevents unwanted epithelial cells to migrate to the bony defect area. The investigators research is a aimed to preform a follow up after patients who already went through a GBR procedure and before inserting a dental implant. Patients answering the inclusion but not the exclusion criteria will go through an alveolar computerized tomography (C.T) done routinely before inserting dental implants.At the day of Dental implantation - residual bone left from the site of implantation (after preparing the site with a trephine bur) will be taken to a histological analysis. The results from the C.T and the histological examination will be analyzed for bone quantity (volume) and quality and will allow a comparison of bone characteristics obtained by using different routinely used bone substitutes.

NCT ID: NCT01361256 Withdrawn - Clinical trials for Age Related Macular Degeneration

Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration

Start date: May 2011
Phase: Early Phase 1
Study type: Interventional

This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.

NCT ID: NCT01361139 Completed - Asthma Clinical Trials

Diagnosis of Cardio-Pulmonary Pathology Using Transthoracic Parametric Doppler (TPD)

Start date: August 2011
Phase: N/A
Study type: Observational

This is a study that seeks to characterize data obtained from patients with a variety of lung diseases using ultrasound signals obtained from the lung tissue. A standard ultrasound instrument in the doppler mode (not the imaging mode used in examination of pregnant women for instance) is placed on the chest wall and the unique software the investigators have developed analyzes the signal reflected back from within the lung. On the basis of pilot studies performed previously the investigators expect to receive different signals from different diseases. The investigators seek to further characterize these signals to enable accurate diagnosis of different lung diseases using our technology.

NCT ID: NCT01361126 Completed - Hemophilia B Clinical Trials

A Safety and Efficacy Study of a Recombinant Factor IX in Patients With Severe Hemophilia B

Start date: July 2011
Phase: Phase 1/Phase 2
Study type: Interventional

This study will examine the safety and efficacy of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B. The study consists of a screening period, a pharmacokinetic (PK) period, followed by approximately a 5 month treatment period. Subjects will receive weekly routine prophylactic therapy and on-demand treatment for bleeding episodes. In addition, subjects who are not on routine factor replacement therapy prior to the study will receive only on-demand treatment for bleeding episodes.

NCT ID: NCT01359969 Completed - Clinical trials for Hereditary Angioedema

Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients

Start date: January 17, 2012
Phase: Phase 2
Study type: Interventional

This open-label study is being conducted to confirm the safety, pharmacokinetic profile and efficacy of Ruconest at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in patients, from 2 up to and including 13 years of age.

NCT ID: NCT01359514 Completed - Pain Clinical Trials

Mechanism-based Choice of Therapy for Neuropathic Pain

Start date: April 2008
Phase: N/A
Study type: Interventional

Mechanism-based choice of therapy for neuropathic pain: Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain modulation profile?

NCT ID: NCT01359475 Completed - Clinical trials for Other Unsatisfactory Restoration of Tooth

A Clinical Trial of an Acetal Resin Crown for Restoration of Primary Molars

Start date: April 2010
Phase: Phase 3
Study type: Interventional

Preformed stainless steel crowns have been used in Pediatric Dentistry to restore badly broken down primary teeth since 1950. They are generally considered more expedient to place than large multi-surface amalgam or composite restorations and have a longer life. They have been used successfully in clinical practice for many years and have presented little in the way of adverse events. The major drawback is the poor esthetics along with lingering concerns over potential health hazards associated with the nickel content. Several attempts have been made to improve upon the esthetics of stainless steel crowns such as veneering the buccal and occlusal surfaces and substituting composite resin for the entire crown, but to date none of these approaches have been very successful. Acetal resin has been used in a number of applications in medicine and dentistry, and recently has met with early success when tested as a substitute for stainless steel crowns. It has a number of excellent physical and mechanical properties including a low coefficient of friction, good wear resistance, high fatigue resistance, good impact strength and resistance to creep. The purpose of this trial is to compare the clinical performance of preformed acetal resin crowns and preformed stainless steel crowns. 2.0 OBJECTIVES The objective of this study is to compare the clinical performance of acetal resin crowns with preformed stainless steel crowns when used to restore primary molar teeth.

NCT ID: NCT01359176 Completed - Healthy Volunteers Clinical Trials

Capnography Data Collection From Healthy Participants

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

Capnography is the non-invasive monitoring of the concentration or partial pressure of carbon dioxide (CO2) in the expired respiratory gases; it is thus a non-invasive monitoring technique which allows fast and reliable insight into ventilation, circulation and metabolism. The capnogram is a direct monitor of the inhaled and exhaled concentration or partial pressure of CO2, and an indirect monitor of the CO2 partial pressure in the arterial blood. The purpose of this study is to create a waveform library by collecting CO2 waveform data from healthy volunteers.