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NCT ID: NCT01235169 Not yet recruiting - Clinical trials for Proximal Femur Fracture

Evaluation of the Proximal Femoral Nail Antirotation With Cement Augmentation in Osteoporotic Femoral Neck Fractures

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open multicenter study, evaluating a new operative technique in femur neck fractures. The treatment consist of augmentated nails in cases of subtrochanteric or inter fracture due to osteoporosis.There two routine surgical techniques in femoral neck fractures: 1. Insertion an intramedullary nail (without augmentation) to the bone. 2. insertion a nail and metal plateto the bone. The major disadvantage of these methods is the relative high rate (4-10 precentages) of failure because of the femur head bone which is very brittle and osteoporotic. This new approach enables the nail a better grip as a result of the cement augmentation which consists of PMMA (Polymethyl methacrylate). The investigators main goal is to evaluate the use of this surgical technique

NCT ID: NCT01237925 Not yet recruiting - Sunburn Clinical Trials

Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Gel) in the Relief of Sunburn Related Symptoms

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

Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.

NCT ID: NCT01257321 Not yet recruiting - Clinical trials for Post Tonsillectomy Respiratory Complications

Risk Stratification of Post Tonsillectomy Respiratory Complications in the Pediatric Population

Start date: n/a
Phase: N/A
Study type: Observational

Obstructive sleep apnea syndrome (OSAS) is the most common indication for tonsillectomy and adenoidectomy in young children. According to previous studies, as much as 8 to 20% of patients will develop post operative respiratory complications requiring medical intervention. The pre-operative risk factors that could predict respiratory complications retrospectively analyzed were young age, obesity and high preoperative apnea-hypopnea index. Despite the removal of obstructing lymphoid tissue, upper airway obstruction occurs on the first postoperative night in children with OSA. There is a debate regarding the post-operative duration and monitoring needed in children with OSA. Hypothesis: Pre-operative, operative and immediate post-operative parameters could predict post tonsillectomy respiratory complications.

NCT ID: NCT01269359 Not yet recruiting - Clinical trials for Vertebral Body Augmentation

Robotic Assisted Vertebral Body Augmentation - a Radiation Reduction Tool

Start date: n/a
Phase: N/A
Study type: Observational

Modern orthopedic and spine surgeons strive towards minimizing surgical exposure and towards increased precision in the placement of implants. This trend requires an increased use of fluoroscopic guidance, which leads to increased exposure of the patient, surgeon and the operating room staff to radiation. Robotic assisted spine surgery is routinely performed in the authors' institution for a variety of indications such as degenerative conditions, trauma, tumors , infections and deformity correction11. The objective of this study is to compare the radiation exposure time during robotic guided vertebral body augmentation to the published results for similar surgeries.

NCT ID: NCT01269398 Not yet recruiting - Lumbar Fusion Clinical Trials

GO-LIF With Percutaneous Facet Fusion

Start date: n/a
Phase: N/A
Study type: Interventional

Utilization of trans-pedicular trans-discal implants for stabilization of a single lumbar motion segment, in conjunction with posterior facets fusion. The trajectories are planned and achieved by means of the SpineAssist® system - a computerized, image-based guidance system that assists surgeons in precisely guiding spinal surgical tools and implants in line with a CT-based pre-operative plan. GO-LIF and SpineAssist are CE marked products. Thy study's objective is to to collect data regarding the ability to achieve solide fusion, comibing the GO-LIF procedure for spinal fixation and stabilization with percutaneous posterior facets fusion.

NCT ID: NCT01280071 Not yet recruiting - Clinical trials for Venoarteriolar Reflex

Adenosine Activity in Producing Venoarteriolar Reflexes

Start date: n/a
Phase: N/A
Study type: Interventional

Veno-arteriolar and veno- arteriolar-myogenic reflexes (VAR and VMR, respectively) are of the most important contributors to local vasoregulation. In a recent research we showed that VAR is affected in the affected lower limbs of CRPS (chronic regional pain syndrome) patients. {Dayan, 2008 1 /id} That is, local venous congestion (40 mmHg) results in a decreased blood flow in the affected, sick limb compared with its contralateral. The myogenic reflex, however, that is induced by lowering the leg 40 cm below heart level, which causes both venous and arteriolar congestion, was intact in the sick leg. We concluded that the pathophysiology of CRPS might involve a defect in the neural reflex between venous and arteriolar vessels. Arteriolar smooth muscle action, on the other hand, is intact and might compensate for the overwhelmed VAR. Trying to explain the fact that VAR, but not VMR, was different between the affected and unaffected limbs, we raise the hypothesis that since VMR is a local vasoregulatory reflex composed of two components: the venous and myogenic, opposed to the VAR, the myogenoic component of the reflex might compensate for the inappropriate VAR. Many mechanisms that might affect vascular muscles may occur, one of them is related to adenosine. Adenosine is considered a retaliatory autacoid, whose main function is to protect tissues against ischemia. It is a very potent vasodilator. Adenosine is also considered an important mediator of ischemic preconditioning, a phenomenon by which an initial brief period of ischemia protects the tissue from the damage produced by a subsequent more intense ischemic episode. Adenosine has a pivotal role in local vasoregulation. In many researches it was shown that adenosine contributes to exercise hyperaemia in skeletal muscle. The 'adenosine hypothesis' states that blood flow is regulated by interstitial adenosine, released from cardiac or skeletal muscle fibers when there is a mismatch between O2 supply and O2 demand. When there is insufficient O2 to regenerate ATP, ADP and AMP accumulate leading to adenosine generation. By causing vasodilatation, adenosine helps to restore the O2 delivery, reversing the mismatch and allowing ATP to be regenerated. Adenosine is a naturally occurring ligand of 4 subtypes of G-protein-coupled cell membrane receptors (A1, A2A, A2B, and A3) involved in cellular signaling. Dipyridamole produces coronary hyperemia by indirectly activating adenosine A2A receptors by inhibiting tissue uptake of adenosine and thereby increasing levels of endogenous adenosine. Taking all these considerations into account we hypothesize that local vascular reflexes like VAR, and eventually VMR are mediated by adenosine. That is, adenosine produced at a constant rate in vascular bed contributing to constant blood flow under a wide range of local circumstances. A local increase in venous blood flow (as in lower limbs veins during prolonged standing) causes adenosine "wash out", which leads to local arterial vasoconstriction to reduce blood flow to the limb, which is, in fact, the purpose of VAR. if our hypothesis turns to be true, then when we will see exaggeration of the reflexes with adenosine blockade and vice versa, a decrease its abolishment with adenosine reuptake inhibition.

NCT ID: NCT01281072 Not yet recruiting - Clinical trials for Giving a Vaccination in Three Months

Study To Evaluate Long Term Treatment Effect Of Diapep277® In Patients Who Have Completed Study 901 And Study 910** (Extension To 901)

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

Open label study to evaluate long term treatment effect of diapep277.

NCT ID: NCT01322477 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Contribution of F-18 Fluoro-Deoxy-Glucose PET/CT (Positron Emission Tomography) to the Assessment of HCC (Hepato-cellular Carcinoma) Treatment Efficiency

HCC
Start date: n/a
Phase: N/A
Study type: Observational

HCC (Hepato-cellular Carcinoma) is the fifth most frequent cancer in humans and its prevalence is growing. The most effective treatment of HCC is surgical and includes resection and liver transplantation; however, only 20% of the patients can be treated surgically. Local interventional therapy, such as radiofrequency (RF) ablation and transarterial embolization is also used. Recurrence rate is very high, and extrahepatic disease develops in about 30% of the cases and in up to 20% after liver transplantation. Systemic treatment is thus an option. Sorafenib (multi-kinase inhibitor) is the first agent to significantly improve the overall survival in advanced HCC. However, the drug has serious side effects and is very expensive. PET/CT with F18-FDG is a common tool for systemic evaluation and staging of various tumors. The value of the FDG PET for evaluation of HCC is controversial, in particular due to the unique metabolic pathway of glucose in the HCC cells. Since 2007 more and more studies suggest the feasibility of FDG PET/CT for monitoring local recurrence (especially after RF) and metastatic spread of HCC, including detection of active disease only suspected by AFP (alphafoetoprotein) elevation. Early detection of treatment response to therapy by whole body FDG PET/CT allows for change of treatment as early as possible,when the tumor is non-responsive before serious side effects appear or before depletion of body resources. The aim of our study is to investigate the contribution of FDG PET/CT to assessment of treatment response.

NCT ID: NCT01343875 Not yet recruiting - Clinical trials for Biceps Tendon Rupture

Evaluation the Operative Procedure Among Patients That Suffer From Tear of the Distal Tendon of the Biceps

Start date: n/a
Phase: N/A
Study type: Observational

Background: rupture of the distal tendon in biceps muscle is a rare injury. The state of the art treatment is surgical procedure. Objective: Evaluation of the Surgical procedure among patients that suffered from Methods: The investigators will review files from 2003-2010 of patients that gone through the operation. The investigators will record pre-operation and post-operation process including complications and rehabilitation. The investigators will invite them to the clinic for exams, clinical questionnaires.

NCT ID: NCT01353066 Not yet recruiting - Clinical trials for Atherosclerotic Cardiovascular Disease

Gastric Bypass Versus Best Medical Treatment on Progression of Carotid-intima Media Thickness in Type 2 Diabetes Mellitus (T2DM)

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

Background: Type 2 Diabetes Mellitus (T2DM) is associated with an increased burden for cardiovascular disease (CVD). Multifactorial interventions are necessary to reduce the CV risk in T2DM. Bariatric surgery appears to be an alternative for the multifactorial intervention in T2DM associated with obesity. Data have shown, that clinical trial aiming at the control of CVRF in T2DM may not translate in the reduction of CV events. Hypothesis: Intensive medical treatment (IMM) including Roux-en-Y Gastric Bypass (RYGBP) could be superior in the control of the progression of subclinical atherosclerotic disease, as evaluated by carotid ultrasound, in subjects with T2DM and a BMI between 30.0 and 34.9 kg/m2.The primary aim of the study is To compare the effects of intensive medical treatment (IMM) including Roux-en-Y Gastric Bypass (RYGBP) and IMM alone on the progression of the carotid intima media thickness (CIMT) at 24 months after entry into the trial relative to baseline.Methodology: Two-year Randomized Clinical Trial, including 240 patients