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NCT ID: NCT04518410 Completed - Covid19 Clinical Trials

ACTIV-2: A Study for Outpatients With COVID-19

Start date: August 19, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community. This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.

NCT ID: NCT04513730 Completed - Low Back Pain Clinical Trials

Positional Device Aimed at Patients With Low Back Pain

Start date: August 11, 2020
Phase: N/A
Study type: Interventional

The project aims to idealize a pelvic suspension device as an auxiliary physiotherapeutic resource for patients with reduced mobility and functional capacity, which should favor autonomous and independent performance in personal, social and work tasks of the target population. This is a controlled clinical trial study. The research sample will be composed of patients of both sexes, aged 21 to 65 years, diagnosed with low back pain, referred to UEAFTO/UEPA, through the SUS care network. The research participants will be evaluated by posture, active mobility and muscle strength of the spine, evaluation of pain intensity and functional capacity. A device will be built with the function of keeping the user in position of pelvic suspension promoting lumbar traction that will consist of a structure of pvc pipes and connections and padded material. Participants will be submitted to 10 sessions of use of the device, after which they will be reevaluated through the same procedures. The information collected will be analyzed through the Graphpad prism software. To compare measured values, the Shapiro-Wilk test will be used for normality distribution. Student's t-tests will be used for the treatment of variables with normal distribution, and Fisher's and Mann-Whitney's exact tests for variables without normal distribution. It is expected to collaborate in the social integration, labor and quality of life of people affected by low back pain, as well as to promote the development of low-cost technologies in the routine of Physiotherapy and public health in the State of Pará.

NCT ID: NCT04512677 Completed - Clinical trials for Respiration, Artificial

Ventilatory Weaning Guided by a New Index

Start date: October 29, 2019
Phase: N/A
Study type: Interventional

Mechanical ventilation (MV) is an essential therapy for patients with acute respiratory failure. The ventilatory weaning process should be started when the precipitating causes of the use of the ventilatory prosthesis are resolved. Inappropriately slow weaning exposes the patient to unnecessary discomfort, increases the risk of complications and increases the cost of hospital treatment. In this sense, indices that can predict successful weaning are of great value.

NCT ID: NCT04512651 Completed - Pain Clinical Trials

The Thrust Technique of Tibiotarsal Joint on the Symptomatology of Pain at Classical Ballet Dancers

Start date: June 10, 2017
Phase: N/A
Study type: Interventional

Classical ballet is a type of high performance dance that requires great effort and extreme joint positions by its dancers, not to mention a precise control of the ankle joint when on pointe position. Ballet dancers excessively dorsiflex, and especially plantar flex the ankle, which predisposes anterior displacement of the talus, possibly causing mobility restrictions of the tibiotarsal articulation and making it difficult and painful to move the ankle while dancing. The Thrust technique of tibiotarsal joint is a manipulation that aim to improve mobility and articular function through a high-speed and short-range movement. The purpose of the study is to verify the effect of the Thrust technique of tibiotarsal joint on the pain symptomatology in classical ballet dancers. Ballerinas included in the study presented pain in the ankle when dancing classical ballet, tenderness to palpation in the anterior and posterior tibiotarsal articulation, and dysfunction after compression of the tibiotarsal articulation. The sample consisted of 20 ballerinas, out of which 10 were subjected to manipulation (IG) and 10 formed the control group (CG). Algic symptomatology in classical ballet dance was assessed after some practice with the Visual Analogue Scale (VAS). After that, an algometer was used to quantify the threshold of pain in the anterior and posterior ankle joint that presented restrictions in mobility. The Tug technique was performed in the tibiotarsal articulation in the IG, and in the CG it was simulated. The threshold of pain in the anterior and posterior tibiotalar joint was measured again immediately after the intervention or simulation. The ballerinas were reassessed using algometry and the Visual Analogue Scale (VAS) one week after the manipulation.

NCT ID: NCT04512079 Completed - COVID-19 Clinical Trials

FREEDOM COVID-19 Anticoagulation Strategy

FREEDOM COVID
Start date: September 8, 2020
Phase: Phase 4
Study type: Interventional

Coronavirus Disease (COVID-19), caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has led to unprecedented morbidity and mortality in the modern era. To date, nearly 13 million people have contracted COVID-19, leading to more than 550,000 deaths worldwide. As the number of affected individuals continues to climb, effective strategies for treatment and prevention of the disease are of paramount importance. SARS-CoV-2 is understood to directly invade cells via the human angiotensin-converting enzyme 2 (ACE2) receptor, which is expressed predominantly in the lungs but also throughout the cardiovascular system. Thus, while acute respiratory distress syndrome remains a feared complication, new thromboembolic disease has emerged as a common and potentially catastrophic manifestation of COVID-19.

NCT ID: NCT04510389 Completed - Sarcopenia Clinical Trials

Impact of Whey Protein Supplementation on Body Weight and Metabolic Parameters of Bariatric Patients

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Obesity is a metabolic disorder, characterized by an increase in the body's fat mass, which will reflect an increase in total body weight. In Brazil, overweight accounts for 53.8% of the population, and of these 18.9% are obese. Surgical treatment is currently the most successful method for weight loss in patients with Grade III obesity and reduced associated morbidities. The general objective is to evaluate genetic, inflammatory, and dietary factors that would influence weight loss and the appearance of protein deficiency or sarcopenia in patients undergoing bariatric surgery and to evaluate the effects of protein supplementation for 8 weeks after the 18th postoperative month in the parameters evaluated. The study has a randomized, placebo-controlled, double-masked model. The patients will be selected in two bariatric surgery services accredited by the Brazilian Health Unic System (SUS) in the city of Belo Horizonte, Brazil. The project has already been approved by the Brazilian Ethics committee CONEP/UFMG by nº. 75415317.8.0000.5149. Patients of both sexes over 20 years of age will be included, attending the hospitals of the project with regular follow-up in the postoperative period. Data on anthropometry, body composition, muscle strength, energy expenditure, and inflammatory profile will be collected. The data will be correlated with the evaluation of the presence of genetic polymorphisms.

NCT ID: NCT04509674 Completed - Clinical trials for Myocardial Infarction

EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction)

Start date: December 16, 2020
Phase: Phase 3
Study type: Interventional

This is a study in adults who had a heart attack (myocardial infarction). The purpose of this study is to find out whether a medicine called empagliflozin helps to lower the chances of having to go to the hospital for heart failure and whether it lowers the chances of dying from cardiovascular disease. People who are in hospital may join the study soon after being treated for their heart attack. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes 1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. All participants continue their standard treatment. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. Empagliflozin is a medicine that helps people with type 2 diabetes to lower their blood sugar. Researchers think that empagliflozin might also help people after heart attack who are at risk for heart failure, whether or not they have diabetes. Participants are in the study for about 1 to 2 years. During this time, there are about 4 visits inperson, 2 visits are done either by phone or by use of an mobile application. Results between the empagliflozin and placebo groups are compared. The doctors also regularly check the general health of the participants.

NCT ID: NCT04505722 Completed - Clinical trials for Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol

A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants

ENSEMBLE
Start date: September 7, 2020
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.

NCT ID: NCT04504877 Completed - Covid19 Clinical Trials

Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling wIth COVID-19

BONSAI
Start date: June 16, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of this work is to monitor the level of stress and overload of a group of front-line health workers (physicians, nurses and physiotherapists) who will participate in the care of patients with COVID-19 at Hospital das Clínicas in Ribeirão Preto and its Emergency Unit (HCRP), for four weeks, and evaluate the cannabidiol - CBD's effectiveness in reducing stress for those who wish to use it.

NCT ID: NCT04502251 Completed - Fibromyalgia Clinical Trials

LDN and tDCS in Fibromyalgia

Start date: August 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Fibromyalgia is a complex generalized and diffuse musculoskeletal chronic pain; and pharmacological approaches are widely used to relieve pain and increase life quality. In this context, low-dose naltrexone (LDN) was able to increase nociceptive threshold in patients with fibromyalgia. Moreover, non-pharmacological techniques, like Transcranial Direct Current Stimulation (tDCS), have been shown effective for pain management. This study aims to evaluate the analgesic and neuromodulatory effect of combined LDN followed by tDCS in fibromyalgia patients. This is a randomized, double-blinded, parallel, placebo/sham-controlled trial, in which 92 (10% loss) women with fibromyalgia will be included included and signed the informed consent. Patients will be allocated into 4 groups: tDCS+LDN (n=21), Sham-tDCS+LDN (n=22), tDCS+Placebo (n=22), and Sham-tDCS+Placebo (n=21). LDN or placebo (p.o.) intervention lasts 26 days, in the last five, tDCS will be applied (sham or active, 20min, 2mA). Questionnaires assessed are: Sociodemographic, Visual Analog Pain Scale (VAS), Pain Catastrophizing Scale (PCS), State-Trait Anxiety Inventory (STAI), Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI-II), Chronic Pain Profile Scale (CPP). Also, pain measures were taken: Pain Pressure Threshold (PPT) and Conditioned Pain Modulation (CPM). Blood samples will be collected to analyze Brain Derived Neurotrophic Factor (BDNF) serum levels.