Clinical Trials Logo

Filter by:
NCT ID: NCT03053050 Terminated - Clinical trials for Nonalcoholic Steatohepatitis

Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

STELLAR-3
Start date: February 13, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.

NCT ID: NCT03052517 Terminated - Asthma Clinical Trials

Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment

Start date: March 21, 2017
Phase: Phase 3
Study type: Interventional

This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma. The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients: 1. Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and 2. New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039. By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.

NCT ID: NCT03050606 Active, not recruiting - Fibromyalgia Clinical Trials

Effectiveness and Cost-effectiveness of Modified Pilates Method Versus Aerobic Exercise in Patients With Fibromyalgia

Start date: February 15, 2017
Phase: N/A
Study type: Interventional

Fibromyalgia is a rheumatologic disease characterized by generalized chronic pain, hyperalgesia and allodynia. Physical exercises are recommended as the first choice of non-pharmacological therapy. Thus, the purpose of this study is to evaluate the effectiveness and cost-effectiveness of modified Pilates method exercises compared to aerobic exercises in the treatment of patients with fibromyalgia. The hypothesis is that Pilates exercises will be as effective as aerobic exercise in the improvement of clinical outcomes, and that this improvement will be maintained over the medium to long term. It is also expected that aerobic exercises will be more cost-effective.

NCT ID: NCT03049735 Completed - Uterine Fibroid Clinical Trials

LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Start date: April 26, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.

NCT ID: NCT03048799 Recruiting - Clinical trials for Urinary Incontinence

Radiofrequency in the Treatment of Urinary Incontinence After Radical Prostatectomy

Start date: December 5, 2016
Phase: N/A
Study type: Interventional

Post-prostatectomy urinary incontinence (IUPP) is a difficult to treat complication that causes a profound negative impact on the individual's quality of life, as well as seriously disrupts the physician-patient relationship and is a substantial public health problem . Urinary incontinence (UI) can occur both in the treatment of benign prostatic hyperplasia (BPH) and in the treatment of prostate cancer. In the treatment of benign disease, this complication is associated with a very low prevalence, initially of 9% and about 1% in 12 months postoperatively. In radical prostatectomy, the prevalence is higher, varying from 2% to 87%, depending on the populations and sites studied, the definitions used, the different methodologies employed in the evaluation of incontinence, and also the different degrees of intensity of the disease . Several authors have evaluated the incidence of incontinence after robotic radical prostatectomy, open and laparoscopically. With these techniques, the reported total UI incidence varies from 4% to 40% . With the high prevalence of IUPP, accelerating the recovery of urinary control is an important priority for patients and their caregivers, and the search for effective and low-risk treatments is a constant. Thus, the possibility of treatment with the radiofrequency (RF) feature arises.

NCT ID: NCT03048422 Completed - HIV Infections Clinical Trials

Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants

VESTED
Start date: January 19, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study was to compare the virologic efficacy and safety of three antiretroviral (ARV) regimens, dolutegravir plus emtricitabine/tenofovir alafenamide, dolutegravir plus emtricitabine/tenofovir disoproxil fumarate, and efavirenz/emtricitabine/tenofovir disoproxil fumarate in pregnant women living with HIV-1 and to compare the safety of these regimens for their infants.

NCT ID: NCT03047642 Completed - Clinical trials for Acute Febrile Illnesses

Validation of Promising Biomarker Assays to Assess Their Diagnostic Performance Characteristics

Start date: April 27, 2017
Phase:
Study type: Observational

This project aims to evaluate the performance characteristics of rapid tests to differentiate bacterial from non-bacterial infection in febrile adults and children presenting at OPDs (outpatient departments) i.e.("fever triage assays") in three LMICs. The evaluation will include a different commercial biomarker combinations as well as individual biomarkers to assess their individual or combined value in the target population. Markers will be evaluated onsite in ELISA or RDT format, as appropriate. Further, this study aims to contribute to a centralized biobank of well-characterized specimens for use by IVD companies and academic institutions for the development and evaluation of emerging assays.

NCT ID: NCT03046680 Recruiting - Clinical trials for Hypertension, Resistant to Conventional Therapy

Health Coaching Based Treatment Versus Usual Treatment of Systemic Arterial Hypertension and Comorbidities

Start date: December 1, 2016
Phase: N/A
Study type: Interventional

Hypertension is a multifactorial clinical condition, it may not cause symptoms and its diagnosis is often delayed. And even when it is diagnosed early, some patients cannot manage an adequate blood pressure. There are several hypotheses for the non-control of blood pressure, among them the difficulty of lifestyle change, irregular treatment with antihypertensive drugs, non-individualized treatment. Studies haven shown that tools such as multiprofessional team and hypertension leagues are important strategies to obtain a better outcome in the hypertension treatment, but new approaches are still necessary. Health Coaching is an individualized form of follow-up, promoting better adherence, better nutrition, smoking cessation, regular physical exercise and regular use of drugs, thus reducing cardiovascular mortality.

NCT ID: NCT03045133 Completed - Pain, Postoperative Clinical Trials

QUALITY OF RECOVERY AFTER INTRAOPERATIVE MORPHINE OR METHADONE

Start date: June 20, 2016
Phase: Phase 4
Study type: Interventional

Introduction. Despite the advantages associated with the use of remifentanil during total intravenous anesthesia (TIVA), it has been observed a frequent difficulty in the control of postoperative pain due to the risk of developing hyperalgesia and acute tolerance associated with the administration of this opioid. There is evidence that NMDA receptors are involved in the development of these changes. Methadone is an opioid that exhibits analgesic potency similar to that of morphine but has NMDA antagonist activity and longer duration of action as additional features. The objective of the study was to evaluate the quality of recovery (QoR40) of patients undergoing TIVA for laparoscopic cholecystectomy and who received morphine or methadone to control postoperative pain. Methods. Patients aged 18 to 65 years, physical status ASA I and II, submitted to total venous anesthesia (propofol and remifentanil) for laparoscopic cholecystectomy and eligible to participate in this prospective and randomized clinical study will be evaluated. After induction of anesthesia, patients will receive a solution containing 0.1 mg.kg-1 morphine (MF group) or 0.1 mg.kg-1 methadone (MT group). Data on the presence of pain, nausea, vomiting, tremor, drowsiness, presence of SpO2 <92%, even with O2 face mask (5 L.min-1) and length of stay will be recorded at PACU. The pain will be evaluated every 15 minutes on a verbal numerical scale (ENV) from 0 to 10. E.v. morphine 0.1 mg.kg-1 (MF group) or methadone 0.1 mg.kg-1 (MT group) will be administered every 15 minutes to obtain the score below 3. After discharge from the PACU, all patients will receive intravenous ketoprofen every 12 hours and dipyrone every 6 hours. For cases where the patient considers the analgesic regimen insufficient, tramadol (100 mg) will be administered intravenously at 8-hour intervals. The consumption of analgesics, the intensity of pain, the occurrence of nausea, vomiting and other complications in the ward will be recorded. The application of the questionnaire (QoR40) will be performed in the ward the morning after the surgery by a medical student.

NCT ID: NCT03044938 Completed - Asthma Clinical Trials

Acute Effect of Salbutamol on Heart Rate and Blood Pressure During Exercise in Patients With Moderate or Severe Asthma and Healthy Subjects

Start date: August 6, 2016
Phase: Phase 4
Study type: Interventional

Contextualization: Exercise is a common triggers of bronchospasm in patients with asthma and healthy subjects. To prevent these symptoms frequently they have to use Short-Acting Beta2-Agonists. However, the cardiovascular effects of salbutamol during and after exercise remain poorly known. Objective: To evaluate the effect of salbutamol on heart rate and blood pressure during exercise in patients with moderate or severe asthma and healthy individuals. Methods: A randomized, double-blind, crossover study will be conducted which 13 individuals with moderate or severe persistent asthma and 13 healthy individuals aged between 20 to 59 years. Patients will perform a maximal effort test on 2 nonconsecutive days, with either 400mcg Salbutamol or 4 placebo puffs. The order of use of placebo or salbutamol will be drawn. During the protocol, heart rate, blood pressure, perception of exertion and peak expiratory flow will be monitored.