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NCT ID: NCT03242018 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control

SOTA-CKD4
Start date: August 16, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment Secondary Objectives: - To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c - To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo - To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo

NCT ID: NCT03235947 Completed - Clinical trials for Urinary Tract Infection

Perioperative Fosfomycin in the Prophylaxis of Urinary Tract Infection in Kidney Transplant Recipients

PERIFOS
Start date: September 7, 2016
Phase: Phase 4
Study type: Interventional

A clinical controlled, randomized and double blind trial that included adult patients (≥18 years) receiving kidney transplantation (KT) at the INCMNSZ. The intervention group will receive disodium fosfomycin 4 g intravenously in three moments: preoperative of transplant surgery, prior to removal of the urinary catheter and finally prior to removal of ureteral catheter. The control group will receive placebo in the same moments. Both groups will receive prophylaxis standard for urinary tract infection (UTI), with trimethoprim/sulfamethoxazole 160/800 mg per day. This prophylaxis will be administered once the estimated glomerular filtration rate is greater than 30 mL/min/1.73m2. The primary objective is to compare the average number of episodes of UTI´s and asymptomatic bacteriuria in both groups after 7 weeks of follow-up. The secondary objectives are to know the incidence of asymptomatic bacteriuria, the incidence of hospitalizations for IVU, the days of hospital stay, the pattern of bacterial resistance, the safety of disodium fosfomycin, and assessment of the function of the graft and rejection rate.

NCT ID: NCT03235050 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes

Start date: August 2, 2017
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose control and weight loss effects, as well as to further explore the safety profile of MEDI0382

NCT ID: NCT03234946 Active, not recruiting - Metabolic Syndrome Clinical Trials

Effect of the CAIPaDi Care Model in Relatives of Patients With Type 2 Diabetes Mellitus

CAIPaDi
Start date: June 19, 2017
Phase: N/A
Study type: Interventional

Diabetes is a chronic disease that requires long-term lifestyle changes that may affect the whole family. Hence, during the last decade, studies have focused mainly in the role of the members of the family and their influence in life quality or clinical outcomes of patients with diabetes. Therefore, the delivery of education only to the patients with type 2 diabetes mellitus may restrict the expectations of success in achieving the necessary modifications in lifestyle. Objectives: To assess the effect of the CAIPaDi (Centre of Comprehensive Care for the Patients with Diabetes) program interventions on various health indicators relatives of patients with type 2 diabetes mellitus.

NCT ID: NCT03233815 Active, not recruiting - Clinical trials for Cardiovascular Surgical Procedure

Benefits of Total Intravenous Anesthesia Compared With Inhaled Anesthesia in Cardiovascular Surgery

Start date: November 13, 2017
Phase:
Study type: Observational

This study compares the difference in proinflammatory markers Interleukin 6 (IL-6), Tumor necrosis factor alpha (TNFα) and cortisol in patients undergoing cardiovascular surgery to asses if there is a benefit of using intravenous total anesthesia (TIVA) over inhaled anesthesia for this procedures.

NCT ID: NCT03233230 Completed - Clinical trials for Rheumatoid Arthritis

Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis

Start date: September 18, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine the efficacy, dose response, and safety of M52951 in participants with Rheumatoid Arthritis (RA), and to consider a dose to took forward into Phase III development.

NCT ID: NCT03232515 Completed - Blood Pressure Clinical Trials

The Use of Electrical Bioimpedance to Evaluate Dry Weight in Patients With Chronic Renal Failure in Hemodialysis

Start date: August 7, 2017
Phase: N/A
Study type: Interventional

INTRODUCTION: Accurate estimation of dry weight (DW) is an important and difficult problem in clinical practice. DW is defined as the lowest weight after hemodialysis (HD) where the patient will not develop symptoms of hypotension and edema, in addition to not using antihypertensives. Achieving a fluid balance benefits the control of blood pressure and reduces cardiovascular risk. In most HD centers, the DW is estimated using a subjective method dependent on the signs and symptoms that the patient presents. Recently, several approaches have been studied to develop a standardized DW evaluation technique. Among these, the analysis of electric bioimpedance vectors (BIVA) has been recognized as a simple and promising method with high reproducibility. OBJECTIVE: To use BIVA to improve dry weight estimation in patients with chronic renal failure undergoing hemodialysis. Methods: This is a non-randomized pre-test / post-test clinical trial, where the universe of patients comes from the hemodialysis unit of the General State Hospital of Sonora. Patients who have limb amputations, pacemakers, metal implants, who are under renal transplant protocol or who have a renal transplant, and presence of infectious foci will be restricted from participating. The diagnosis of DW in the patients will be performed for modification and follow-up. Fluid status will be evaluated using BIVA. Measurements will be made before and after HD in three consecutive weekly periods and one one final assessment at three months. At the beginning of each period, weight, electrolytes, creatinine, total proteins, albumin, pre-albumin, urea and blood pressure will be measured to calculate the Malnutrition Inflammation Score and Bilbrey Index. At the end of the HD protocol of each period, body composition and muscle strength will be evaluated through triceps skinfold, mid-upper arm circumference and dynamometry. The dialysis dose received will be modified according to BIVA. The main variables to be considered will be DW, extracellular water and blood pressure. The duration of the study will be approximately 6 months. In addition, at the end of each measurement, each participant will be given a nutritional recommendation (feeding guide) specific to their energy requirements.

NCT ID: NCT03232073 Completed - Multiple Sclerosis Clinical Trials

Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis

OPTIMUM-LT
Start date: July 5, 2017
Phase: Phase 3
Study type: Interventional

The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of this long term extension of the core study AC-058B301 is to characterize the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.

NCT ID: NCT03230838 Completed - Pyelonephritis Clinical Trials

MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)

Start date: April 26, 2018
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) compared with that of meropenem in pediatric participants with cUTI, including pyelonephritis.

NCT ID: NCT03229824 Completed - Breast Cancer Clinical Trials

Use of Clorhexidine Dressings to Reduce Surgical Site Infections in Breast Cancer Surgery. A Controlled Clinical Trial

Start date: October 3, 2016
Phase: N/A
Study type: Interventional

Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of sick woman could delay the adjuvant therapy and result increase morbidity and mortality. Also this increased costs associated with health care.Surgical drains have been noted as a potential source for surgical site infections. The primary aim of the study is to determine if chlorhexidine occlusive dressings applied to the intervention drain sites effectively decreases rates of bacterial colonization in drain fluid and drain tips compared to standard care.