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NCT ID: NCT02139085 Recruiting - Varicose Veins Clinical Trials

Great Saphenous Vein Electrocoagulation

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

Introduction: Lower extremity Chronic Venous Insufficiency is a prevalent disease that adversely affects an individual's Quality of Life. Varicose vein endovenous radiofrequency treatment have a lower risk of iatrogenic injuries and offer faster return to work activities, when compared with open surgical techniques. Endovenous electrocoagulation can selectively and safely cause Great Saphenous Vein (GSV) wall necrosis but its clinical results has never been studied before. Objective: The objective of this study is to compare Great Saphenous Vein electrocoagulation and radio frequency (RF) endovascular varicose vein treatment clinical results and quality of life improvement in a prospective double blind randomized controlled clinical trial. Methods: Consecutive patients with varicose veins and primary GSV reflux will be randomized to Electrocoagulation or Radiofrequency endovenous treatment. The primary outcome measure will be GSV occlusion rate at 3 and 6 months after treatment verified by Duplex Scanning (DS). Secondary outcome measures will be pain visual analogue scale (VAS), bruising, neuropathy and vein thrombosis frequency in the immediate postoperative period (1 week); and Clinical Etiology Anatomy and Pathophysiology (CEAP) classification ,Venous Clinical Severity Scale (VCSS), and Aberdeen Varicose Vein Questionnaire (AVVQ), obtained preoperatively, at 3 and 6 months postoperatively. For statistical analysis, we will use the Student's t test, the Mann-Whitney test and Pearson's correlation, considering positive statistical significance when level of p <0.05.

NCT ID: NCT02138643 Active, not recruiting - Dysphagia Clinical Trials

Laparoscopy Heller Myotomy With Fundoplication Associated Versus Peroral Endoscopic Myotomy (POEM)

Start date: February 2016
Phase: N/A
Study type: Interventional

Achalasia is a disorder benign esophageal motor, which is characterized by failure to relax the lower esophageal sphincter ( LES) in response to swallowing associated with lack of peristalsis of the esophageal body. Its most common clinical presentation is dysphagia , and occasionally chest pain , regurgitation , aspiration pneumonia and weight loss , resulting in a large impact on daily activities and quality of life of affected individuals . There is currently considered curative treatment for achalasia , dysphagia relief being the primary therapeutic target and is forced to relax the LES by endoscopy or surgery. Thus , the most commonly used endoscopic treatments are forced dilatation of the cardia and botulinum toxin. Laparoscopic Heller myotomy with antireflux procedure with therapy is considered "gold standard " because of excellent results and minimal invasiveness. Currently , pneumatic dilation and surgical treatment with the Heller myotomy with fundoplication are strongly associated with the best therapeutic options available . In recent years, the possibility of using endoluminal access in the treatment of achalasia patients through the technique originally described as Natural orifices Translumenal Endoscopic Surgery ( NOTES) and continuing advances in the submucosal dissection has enabled the concomitant development of a new approach described as perioral endoscopic myotomy . In 2007, Pasricha et al , described the feasibility of endoscopic esophageal myotomy through a submucosal tunnel initially in an animal model . The first performance of this procedure in humans was described by Inoue et al , in 2010 , introducing the concept of transluminal endoscopic surgery through natural orifices , with the objective of minimizing the trauma and all the stress resulting from open surgical procedure . These authors call the procedure as POEM ( Per Oral Endoscopic myotomy ) .

NCT ID: NCT02138058 Completed - Compulsive Shopping Clinical Trials

Topiramate Trial for Compulsive Buying

TFO
Start date: January 2015
Phase: Phase 2
Study type: Interventional

It is a double blind controlled study to test the hypothesis that Topiramate is more effective than placebo in the treatment of compulsive buying, during a period of 12 weeks

NCT ID: NCT02137434 Recruiting - Obesity Clinical Trials

Calcium Over Postprandial Effects of Fatty Meal on Metabolism, Blood Pressure, Oxidative Stress, Endothelial Function.

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

The purpose of the study is to investigate calcium acute influence over the postprandial effects of a fatty meal on serum calcium, plasma glucose and triglycerides, blood pressure, oxidative stress, and endothelial function in obese women.

NCT ID: NCT02136550 Active, not recruiting - Smoking Cessation Clinical Trials

Smoking Cessation on the Human Airway: Mucus Secretion, Inflammatory and Proteomic Profile in Nose and miRNAs in Blood

Start date: February 2013
Phase: N/A
Study type: Interventional

Smoking cessation improves health conditions with reduction of the risk factors for cardiovascular and respiratory disease, as functional capacity and quality of life. Smoking cessation has positive effects on the miRNAs regulation, however, genomics has been little explored. Smoking and aging induces changes miRNAs. Among the changes in airway epithelial cells, miR-125 called attention because it is enrolled in the suppression of ERBB7 (tirosin kinase receptors), a codified sequence of the growth factor receptor (EGFR) frequently expressed in cancer. The reduction of miR-125 expression may reduce cancer suppression resulting in cancer development. Other miRNA changes can be observed, such as miR-218 that were found in smokers airway epithelial cells as in MiR-15b that were found in lung tissue of COPD smokers. These miRNAs participated in the signalling pathway of TGF-β enrolled in leukocyte migration and cell proliferation. The investigators hypothesize that smoking cessation has a role in the regulation or reduction in the genetic changes smoking-induced. The investigators will assess the subject genomic profile at the baseline, 6 months and 12 months after smoking cessation.

NCT ID: NCT02136134 Completed - Multiple Myeloma Clinical Trials

Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

Start date: August 15, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effects of administration of daratumumab when combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and dexamethasone alone, for participants with relapsed or refractory multiple myeloma.

NCT ID: NCT02135952 Active, not recruiting - Periodontitis Clinical Trials

Metronidazole and Amoxicillin for the Treatment of Type 2 Diabetic Subjects With Periodontitis

Start date: September 2011
Phase: Phase 4
Study type: Interventional

Diabetes mellitus (DM) is a widely prevalent disease associated with several major systemic and oral complications, such as periodontitis. The use of adjunctive local and/or systemic antimicrobials has been proposed to improve the clinical and glycemic outcomes of the scaling and root planing (SRP) in diabetic subjects. The combination of metronidazole (MTZ) and amoxicillin (AMX) has been largely recognized as an effective therapy for improving the clinical and microbiological outcomes of SRP in the treatment of with chronic periodontitis (ChP). However, no previous clinical trials to date have evaluated the effects of this antibiotic combination in the treatment of diabetic subjects with periodontitis. Therefore, the aim of this randomized clinical trial (RCT) will be to evaluate the clinical and microbiological effects of the use of MTZ+AMX as adjuncts to SRP for the treatment of type 2 diabetic subjects with generalized ChP.

NCT ID: NCT02135471 Completed - Gingival Recession Clinical Trials

Root Coverage in Smokers With Acellular Dermal Matrix Graft and Enamel Matrix Derivative

Start date: June 2009
Phase: Phase 2
Study type: Interventional

Smoking has a negative effect on the predictability and stability of root coverage procedures because of decreased blood supply and fibroblast activity. Long-term evaluation of this procedure in smokers is important for clinical decision making, because it provides information about the stability of results over time. In smokers, enamel matrix derivative (EMD) used at acellular dermal matrix graft (ADMG)/ soft tissue interface could be an alternative to improve the deficient healing potential, since EMD has the capability of stimulating angiogenesis. At the ADMG/ root surface interface, it could improve the deficient fibroblast activity in smokers and therefore reduce the presence of a long junctional epithelium. The aim of this randomised controlled clinical study was to investigate whether EMD contributes to the root coverage of gingival recessions performed with ADMG in smokers during a 12-month follow-up. Twenty smokers with bilateral Miller Class I or II gingival recessions ≥ 3 mm will be selected. The test group will be treated with an association of ADMG and EMD, and the control group with ADMG alone. Some clinical parameters as: probing depth, relative clinical attachment level, gingival recession height, gingival recession width, keratinized tissue width and keratinized tissue thickness will be evaluated before surgery and after twelve months.

NCT ID: NCT02134743 Completed - Clinical trials for Dental Implant Failed

Evaluation of the Stability of Implants With Two Different Surface Treatments

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

The aim of this study is to compare the stability of dental implant surface treated by sandblasting abrasive particles and acid subtraction (Control) with hydrophilic surfaces dental implants (chemical) and with a higher surface energy (Test) for a period of 16 weeks after installation. The evaluation will be made by analyzing the resonance frequency (Ostell). The hypothesis to be tested will be that implants with hydrophilic surface show increased secondary stability prior to the implants treated by acid etching.

NCT ID: NCT02134626 Completed - Liver Cirrhosis Clinical Trials

Simvastatin Effect on Portal Hypertension

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

It´s a clinical research of the effects in portal hypertension caused by simvastatin. We are going to use the hepatic venous pressure gradient(HVPG) measurement and the azygos flow at echoendoscopy to evaluate the benefits of the drug. Preliminary studies demonstrated that simvastatin can lower portal pressure.