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NCT ID: NCT02964624 Completed - Osteoarthritis Clinical Trials

Ostearthritis Biomarkers and Rehabilitation

Knee
Start date: July 2, 2018
Phase: N/A
Study type: Interventional

Osteoarthritis (OA) is the most common type of degenerative joint disease. Furthermore, despite its incidence being amongst the highest in chronic diseases, effective biomarkers, diagnostic aids and imaging technology are not available to assist in the management of OA. Mounting evidence suggests that non-pharmacological treatment such as exercise/physical therapy may lower the risk for onset or progression of OA by mitigating inflammation. However, the mechanical unloading and overloading, as seen in disuse and overuse, lead to upregulation of several proinflammatory molecules and enhance tissue degradation, whereas, dynamic moderate mechanical loading exerts anti-inflammatory and anti-catabolic effects on articular cartilage by suppressing mediators of inflammation. However, the lack of robust biomarkers to measure the effectiveness of physical therapies, represent a critical gap in biotechnology, obliterating the progress in the optimal application of these therapies. Our central hypothesis is that the circulating levels of specific molecules could serve as robust biomarkers for quantitative measures of OA burden, prognosis, progression or treatment efficacy. The objective of this project is to identify and evaluate mediators that serve as biomarkers of OA progression and treatment. Recently, high mobility group box chromosomal protein 1 (HMGB-1) has been suggested to be markedly upregulated in OA. However, presently there are no inhibitors of HMGB1 that could be used therapeutically. Previous results showed that that gentle exercise is the only tool that can mitigate HMGB1 production by local and systemic macrophages, and thus inflammation. Serum concentration of HMGB1 will be evaluate as a biomarker in OA patients and relate it to the functional capacity of knee joints in OA patients after rehabilitation protocol (RP). The RP will consist of three rehabilitation session/week during eight weeks. The efficacy of a RP will be evaluated by functional scale Western Ontario & McMaster Universities Osteoarthritis (WOMAC), Scale for the measurement of health related quality of life using EuroQol five dimensions questionnaire (EuroQOL), Visual Analog Scale (VAS), and physical function tests. Besides all clinical assessment, serum levels of classical pro-inflammatory cytokines, hyaluronan and HMGB1 will be evaluated. A correlation of physical improvement after RP and serum biomarkers will be performed.

NCT ID: NCT02964247 Completed - Clinical trials for Diabetes Mellitus, Type 2

LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors.

Start date: March 3, 2017
Phase: Phase 3
Study type: Interventional

The trial is conducted in Asia, Europe, North America and South America. The aim of the study is to compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor with or without metformin on glycaemic control in subjects with type 2 diabetes mellitus.

NCT ID: NCT02963844 Completed - Clinical trials for Sleep Apnea, Obstructive

The Inspiratory Muscle Training Improves the Severity of Obstructive Sleep Apnea and Sleep Quality?

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

Introduction: Obstructive sleep apnea (OSA) is characterized as a disorder that causes recurrent episodes of partial or complete obstruction of the upper airways during sleep. Objectives: In this way, the study will investigate the efficacy of inspiratory muscle training in improving the severity of obstructive sleep apnea and sleep quality of the research participants. Methods: The investigators will invite individuals of both sexes diagnosed with obstructive sleep apnea moderate and / or severe, arising from the Sleep Laboratory of the Hospital PROCAPE, located in Recife. This is a randomized-controlled trial, double-blind to be held in two groups: A) Individuals with OSA (moderate or severe) - Experimental Group: The components of this group hold the IMT with load of 75% of Pimáx. ( assessed weekly) for eight weeks. B) Individuals with OSA (moderate or severe) -Group control: This group will simulate training, performing no-load training for the same period the intervention group. All guidance on training and weekly evaluations will be made by the responsible for the research physiotherapist in Cardiopulmonary Physiotherapy Laboratory (LACAP - UFPE). Before and after the eight weeks, the groups will be evaluated by polysomnography, acoustic pharyngometry, tests for respiratory muscle strength (Manovacuometry) and lung function (spirometry). Expected results: Improvement of severity of OSA and sleep quality of research subjects after the completion of eight weeks of TMI when compared to the control group.

NCT ID: NCT02963766 Completed - Type 2 Diabetes Clinical Trials

A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes

AWARD-PEDS
Start date: December 29, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes. The study duration is approximately 60 weeks.

NCT ID: NCT02962713 Completed - Dental Caries Clinical Trials

Giomer vs Glass Ionomer Cement for ART Occlusoproximal Restorations: a Randomized Clinical Trial

Start date: November 6, 2017
Phase: N/A
Study type: Interventional

Although the Atraumatic Restorative Treatment (ART) is well settled in the literature regarding occlusal-proximal cavities, the longevity of these restorations is still lower when compared to occlusal ones. This factor is often associated with low mechanical properties of glass ionomer cements (GIC). The objective of this randomized clinical trial is to evaluate the long-term cost-effectiveness of two different materials: an encapsulated GIC - Equia (GC Corp), compared with Giomer (Beautifill Bulk Restorative - Shofu) used as restoratives materials in occlusal-proximal ART restorations of primary molars. Children aged between 4 and 8 years, will be selected in schools in the city of Cerquilho, São Paulo. All restorations will be held following the precepts of the ART and the manufacturer's instructions. The restorations will be evaluated after 3, 6, 12, 18 and 24 months according to Roeleveld et al. (2006) criteria. To verify the survival of the restorations will be used Kaplan-Meier survival analysis and log rank test. To evaluate the association between the clinical variables, Cox regression test will be applied. For the cost analysis will be used analysis of variance. The level of significance for all tests will be considered to 5%.

NCT ID: NCT02961972 Completed - Clinical trials for Endothelial Dysfunction

Effects of Oral Supplementation With Creatine on Systemic Microvascular Endothelial Function in Vegetarian Individuals

Start date: January 2015
Phase: N/A
Study type: Interventional

The present study aims at investigating the effects of the oral supplementation with creatine on the systemic microvascular reactivity and plasma levels of homocysteine in vegetarian individuals of the vegan type.

NCT ID: NCT02961829 Completed - HIV Clinical Trials

Multi Interventional Study Exploring HIV-1 Residual Replication: a Step Towards HIV-1 Eradication and Sterilizing Cure

Start date: July 2015
Phase: N/A
Study type: Interventional

It is becoming clear that a combination of interventions will be desirable to achieve HIV cure. Therefore the investigators propose a pilot proof of concept study, using combination of a number of different interventions for eradicating residual plasma viremia and decreasing HIV reservoirs. The investigators hypothesize that, (i) antiretroviral intensification using Maraviroc, and/or dolutegravir with (ii) Dendritic Cell vaccination using autologous HIV, and (iii) purging intervention using the Class III HDACs, Sirtuin-1, and (iv) decreasing the ratio of long-lived central memory (TCM)/transitional memory (TTM) CD4+ T-cells using Auranofin will provide a synergistic impact leading to a sterilizing cure of HIV infection. Results of this study may provide insightful evidence for planning the next steps using the more efficacious combination of intervention strategies towards HIV sterilizing cure.

NCT ID: NCT02961543 Completed - Clinical trials for Anterior Cruciate Ligament Injury

Effect of Rehabilitation Programs Based on Eccentric Exercise of Knee Extensor Muscles in Isotonic and Isokinetic Conditions After Anterior Cruciate Ligament Reconstruction

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

A randomized clinical trial involving 30 individuals submitted to ACL reconstruction will be conducted. Participants will be randomized into: Group I, submitted to a muscular rehabilitation program based on eccentric isokinetic exercise; and Group II, submitted to a muscular rehabilitation program based on eccentric isotonic exercise. Concomitantly with the muscular rehabilitation protocols, individuals will undergo the same physiotherapeutic protocol with analgesia, edema reduction, range of motion, proprioception and functionality goals. Muscle rehabilitation programs based on eccentric isotonic and isokinetic exercise will begin 45 days after ACL reconstruction. The programs will last six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.

NCT ID: NCT02961530 Completed - Meniscal Tear Clinical Trials

Effect of Rehabilitation Programs Based on Eccentric Exercise of Knee Extensor Muscles in Isotonic and Isokinetic Conditions After Partial Menisectomy

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

A randomized clinical trial involving 32 individuals submitted to partial menisectomy will be conducted. Participants will be randomized into: Group I, submitted to a muscular rehabilitation program based on eccentric isokinetic exercise; and Group II, submitted to a muscular rehabilitation program based on eccentric isotonic exercise. Concomitantly with the muscular rehabilitation protocols, individuals will undergo the same physiotherapeutic protocol with analgesia, edema reduction, range of motion, proprioception and functionality goals. Muscle rehabilitation programs based on eccentric isotonic and isokinetic exercise will begin 15 days after partial menisectomy. The programs will last six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.

NCT ID: NCT02960165 Completed - Aged Clinical Trials

Real and Virtual Tasks in Older Adults

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

Objective: Evaluate whether a task practiced in virtual environment could provide better performance than the same task in real environment and if performing a task in virtual environment could enable transfer to the same task in real environment and vice versa. Method: the investigators evaluated 65 older adults of both genders, aged 60-82 years. The investigators applied a timing coincident task to measure the perceptual-motor ability to perform a motor response. The participants were divided into two groups: a) started in a real interface and b) started in a virtual interface.