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NCT ID: NCT04880395 Recruiting - HIV-1-infection Clinical Trials

Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3

DOLCE
Start date: May 20, 2021
Phase: Phase 4
Study type: Interventional

Protocol Title: DOLCE: Dolutegravir-Lamivudine for naïve HIV-Infected Patients with ≤200 CD4/mm3 Protocol Number: FH-57 Study Objectives: To assess the antiviral activity at week 48 of DTG+3TC among naïve HIV patients with a CD4 count ≤200 cells /mm3.

NCT ID: NCT04877522 Recruiting - Clinical trials for Chronic Myelogenous Leukemia

Asciminib Roll-over Study

Start date: August 30, 2022
Phase: Phase 4
Study type: Interventional

This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment

NCT ID: NCT04877340 Recruiting - Clinical trials for Pancreatic Neoplasms

Comparation Between Needles for EUS-guided Sampling of Solid Pancreatic Lesions

Start date: November 26, 2020
Phase: N/A
Study type: Interventional

This is a randomized study in order to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. Secondary outcomes are the number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry and the adverse event rate.

NCT ID: NCT04876859 Suspended - Chronic Pain Clinical Trials

Comparative Study Between Steroid Plus Anesthetic Block and CRF in Participants With Hip Osteoarthritis

Start date: June 8, 2021
Phase: Phase 3
Study type: Interventional

This will be a prospective, multi-center, double-blinded, randomized study designed to compare the efficacy of Conventional Radiofrequency (CRF) and the anesthetic block of the anterior sensory branches to the hip to control pain and improve function related to hip osteoarthritis.

NCT ID: NCT04876430 Terminated - Clinical trials for Bloodstream Infection

Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With High Level of Resistance to Carbapenems

ABOVE
Start date: May 4, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Enterobacterales resistant to carbapenem are cause of severe concern in hospital-acquired infections since therapeutic options are limited. Recently approved drugs, such as bela-lactam/beta-lactamase inhibitor, have been the drug of choice. However, its use is limited in low- and middle-income countries. Thus, therapy of these infections mostly relies on polymyxins and other old drugs. The role of adjuvant carbapenem therapy in combination with polymyxins, aminoglycosides and other drugs is under investigation. From a pharmacokinetic/pharmacodynamic (PK/PD), there is an elevated probability that high-dose, extended infusion administered meropenem reach the PK/PD target of 40% above the minimal inhibitory concentration (MIC) of the pathogen when the MIC is 32mg/L or lower (non-susceptible isolates have MICs of 4mg/L or higher). However, the MIC is not routinely determined in clinical laboratories. In addition, high-level (above 32mg/L) resistance to carbapenems have been reported in many studies. This open-label, randomized clinical trial aim to assess if the addition of meropenem to the best available therapy can increase the number of days alive and free of hospitalization in patients with bloodstream infections by Enterobacterales with MIC of meropenem above 32mg/L.

NCT ID: NCT04875403 Recruiting - Clinical trials for Human T-Lymphotropic Virus Type 1 Associated Myelopathy

Rehabilitation in Patients With Human Lymphotropic Virus Type I

Start date: April 27, 2021
Phase: N/A
Study type: Interventional

In our times, it is known that approximately 5% of patients seropositive for HTLV-1 may desengage a frame with several neurological disorders, which is called myelopathy associated with HTLV-1, characterized for gait, decreased dynamic balance and limitation of walking independence the use of walkers, crutches as in wheelchairs. This evolution of the disease is based, above all, on muscle changes, such as inflammation of the muscles, which contributes to the attenuation of muscle capacity . In addition, muscle changes caused by HTLV-1 also affect the respiratory muscles, causing a change in respiratory mechanics, which can impair alveolar ventilation and, therefore, the development of a restorative respiratory disorder, reducing total lung capacity. Therefore, it is perceived the importance of offering planned rehabilitation according to the global assessment of the health status of these patients, considering their influence on activities of daily living.The focus of this study is on the weekly respiratory muscle training, as assessed by mensuration maximal inspiratory pressure, showed significant results in improving lung capacity and in this way promoting the prevention of pulmonary complications. Therefore, the protocol proposed by the present study includes respiratory muscular training plus resistance exercise, assessing the impact on both the strength muscular respiratory to as peripheral muscles, through the palmar pressure test and consequent enhancement of quality life and functionality of these patients. Furthermore, it will be possible to contribute to the knowledge of society and the scientific community about this theme, which is still very small in the world literature.

NCT ID: NCT04875195 Active, not recruiting - Hodgkin's Lymphoma Clinical Trials

A Study of Pembrolizumab (MK-3475) in Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-B68)

Start date: June 7, 2021
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the objective response rate (ORR), by cohort, rrcHL and rrPMBCL, as assessed by the investigator according to Lugano classification criteria 2014 in participants treated with pembrolizumab Q6W.

NCT ID: NCT04875143 Recruiting - Clinical trials for To Evaluate the Effect of Supplementation of Citrus Aurantium in Active Individuals

Effects Of Acute Supplementation Of Citrus Aurantium L. On The Recovery Of Autonomic And Cardiovascular Activity After A Sub-Maximum Aerobic Exercise Session In Healthy Individuals

Start date: February 1, 2021
Phase: Phase 3
Study type: Interventional

INTRODUCTION: Non-pharmacological interventions for the treatment of cardiovascular and metabolic disorders have been investigated. In this context, Citrus aurantium L., popularly known as Bitter Orange, rich in synephrine (p-synephrine), a phenylethylaminic alkaloid that is present in the bitter orange peel, has been used as an adjunct in metabolic disorders. Given the effects, the components of Citrus aurantium L. diverge from other thermogens by being able to activate metabolism and lipolysis without interfering with the performance of the cardiovascular system, making this an advantage for its use in diets. In studies, it has been observed that the activation of β-3 receptors plays an important role in the regulation and activation of other receptors, modulating and, when they are stimulated in excess, and thus, it presents effects that in addition to not causing overload in the cardiovascular system. OBJECTIVE: To evaluate the effect of supplementation of Citrus aurantium L. in combination with submaximal aerobic exercise on autonomic and cardiovascular parameters of physically active. METHODOLOGY: This is a prospective, randomized, placebo-controlled, double-blind crossover trial. 40 physically active volunteers will participate in the study. They will be qualified for the voluntary study of the male gender, who are aged between 18 and 30 years old and have a Body Mass Index (BMI) between 18.5 kg / m² and 29.9 kg / m². Do not use any medication that may interfere with cardiac autonomic modulation and do not have skeletal muscle damage. They will be considered as exclusion criteria for clinical patients, as well as those who have already used anabolic steroids or who have cardiorespiratory, neurological disorders and other known impairments that prevent the subject from performing the procedures. EXPECTED RESULTS: Speculated that the protective effects of flavonoids and their antioxidant properties found in Citrus aurantium L., optimize autonomic recovery after aerobic exercise. In addition, HRV can be used to ascertain its SNA activation effects and validate the safety of the applicability of this supplement for overweight populations, considering that it is used for this purpose.

NCT ID: NCT04874883 Recruiting - Diarrhea Clinical Trials

Effect of the Use of Symbiotics in Patients With Colon Cancer

Start date: December 1, 2019
Phase: Phase 4
Study type: Interventional

Due to the high incidence, cancer and the concomitant presence of malnutrition are currently a worldwide public health problem. The loss of weight and body tissues is a common condition in cancer patients with lesions of the airways and digestive tract and is related to anorexia and the presence and duration of gastrointestinal symptoms, such as diarrhea. The latter directly interferes with the progression of enteral diets, which are administered in order to provide adequate nutritional support for the recovery of patients and nutritional status. In this sense, the importance of measures to help reduce diarrhea episodes is reinforced, aiming at the adequate infusion of enteral diets and, consequently, nutritional needs. It is known that the use of antimicrobials is closely related to the increased incidence of nasocomial diarrhea, as it facilitates colonization by pathogenic bacteria, such as Clostridium difficile. In addition, nosocomial diarrhea is a very relevant occurrence due to the financial burden it causes for the hospital institution, which can also worsen the patient's clinical condition, since he is weakened due to the underlying disease. Despite these important aspects, studies carried out with the aim of reducing diarrhea episodes in patients with airway and digestive lesions are still not described in the literature. In this context, the use of symbiotics presents itself as a possibly beneficial alternative, considering the role of probiotics and prebiotics in the modulation of intestinal function. In this sense, this work aims to evaluate the impact of perioperative supplementation with symbiotic on clinical outcomes and intestinal function of patients with colon cancer and digestive airways undergoing colorectal resection. It is assumed that the use of symbiotics could have better results than the use of probiotics and isolated prebiotics.

NCT ID: NCT04874012 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Taurine Effect on Glycemic, Lipidic and Inflammatory Profile in Individuals With Type 2 Diabetes

TAUGLIP-DM2
Start date: June 12, 2021
Phase: Phase 2
Study type: Interventional

Type 2 diabetes mellitus (DM2) is characterized by chronic hyperglycemia, which is a risk factor for comorbidities and death. Although conventional pharmacotherapy is effective, some individuals do not reach the glycemic targets, requiring adjuvant therapies. Taurine is a semi-essential amino acid with antioxidant and osmoregulatory properties, commonly used as a nutritional supplement. Pre-clinical studies show its effectiveness in reducing blood glucose and cholesterol, but there are no well-conducted clinical studies evaluating the effect of taurine on glycated hemoglobin. Additionally, animal models showed that taurine had a protective effect from diabetic nephropathy. The hypothesize of this study is that taurine administration improves the glycemic, lipid, inflammatory, and anthropometric parameters in DM2 individuals.