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NCT ID: NCT03737656 Recruiting - Pharmacokinetics Clinical Trials

Characterization of the Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women

Start date: November 1, 2018
Phase: Phase 1
Study type: Interventional

This is a single site, open-label, randomized, single-dose, Phase 1 study in post-menopausal women.

NCT ID: NCT03736785 Not yet recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

Start date: November 15, 2018
Phase: Phase 2
Study type: Interventional

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes that have already been treated with basal insulin.

NCT ID: NCT03732586 Recruiting - Alcoholic Hepatitis Clinical Trials

Effect of Omega 5 Fatty Acid as an Adyuvant Treatment to Prednisone in Patients With Severe Alcoholic Hepatitis

Start date: September 30, 2018
Phase: N/A
Study type: Interventional

In Mexico, alcoholic liver disease is the fourth cause of mortality (INEGI). Patients with severe alcoholic hepatitis have a high mortality at 28 days and 6 months, patients receiving standard treatment with prednisone that are non responders (Lille> 0.45) have a survival of 53.3 ± 5.1 % to 28 days. At present, there is not a completely effective treatment this non responders patients, with a high mortality, so it is necessary to look for other therapeutic strategies. The omega-5 fatty acid (punicic acid) has been considered a powerful antioxidant, it is an agonist of PPAR gamma, has been shown to reduce lipid peroxidation, and restore levels of antioxidant enzymes such as superoxide dismutase (SOD), catalase and glutathione peroxidase. It has also been shown to inhibit the expression of proinflammatory cytokines (such as IL6, IL8, IL23, IL12 and TNFalpha) through PPAR and modulation delta. The objective of this study is to evaluate the effect of Omega 5 fatty acid on inflammatory markers and antioxidant-oxidant balance markers in patients with severe alcoholic hepatitis treated with prednisone. HYPOTHESIS. Omega 5 fatty acid being a PPARgamma agonist reduces lipid peroxidation and protein damage, restoring reduced glutathione levels, as well as decreasing proinflammatory cytokines, in patients with Severe Alcoholic Hepatitis treated with prednisone and supplementation with fatty acid Omega 5.

NCT ID: NCT03730662 Not yet recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk

SURPASS-4
Start date: November 19, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits.

NCT ID: NCT03720158 Recruiting - Quality of Life Clinical Trials

Enteral Omega 3 During Radiotherapy to Improve the Quality of Life and Functionality of Head and Neck Cancer Patients

Start date: October 10, 2018
Phase: N/A
Study type: Interventional

Health-related Quality of Life (QoL) is a multidimensional construct that allows us to know the patient's perception of well-being, and how this perception is related to their illness and treatment. In clinical research, especially clinical trials, the QoL measurement has become an important element to evaluate. In patients with Head and Neck Squamous Cell Carcinoma (HNSCC), low QoL is associated with Malnutrition (MN), and Cancer Cachexia (CC) is a principal component in its multifactorial etiology. The exacerbated hypercatabolic state of CC is caused by the increase of pro-inflammatory cytokines, Reactive Oxygen Species (ROS), and other catabolic mediators. The clinical manifestation of CC is a continuous decrease in muscle mass (with or without loss of fat mass), which is not entirely reversible with nutritional support and which leads to the functional deterioration of patients. Due to CC, the patients with HNSCC who receive total enteral nutritional support have difficulties in maintaining an optimal nutritional status, and this situation is more frequent during RadioTherapy (RT). An immune-modulator nutrient, Omega-3 fatty acids (O3) have shown efficacy in improving the nutritional and inflammatory parameters of patients with HNSCC; however, little is known about their impact on patients' QoL and Functionality (Fx). Therefore, this clinical trial is proposed to provide information about the usefulness of O3 for improving the Fx and QoL of patients with HNSCC receiving total enteral nutrition during RT.

NCT ID: NCT03714672 Completed - Acute Pain Clinical Trials

Tramadol/Diclofenac Fixed-dose Combination Phase III Trial in Acute Pain After Third Molar Extraction

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

This study evaluates a new drug combination tablet called tramadol/diclofenac at two different strengths (fixed doses of 25 milligrams [mg] of tramadol and of diclofenac or of 50 mg each). Tramadol and diclofenac each relieve pain, but they do so by different mechanisms. They will be used alone as comparator drug in this study. Both are marketed drugs and are standard treatments for pain after wisdom tooth removal.

NCT ID: NCT03714438 Completed - Glucose Tolerance Clinical Trials

Effect of Medicago Sativa on Oral Glucose Tolerance in Healthy Adults

Start date: February 7, 2017
Phase: Phase 2
Study type: Interventional

Previous preclinical investigations have found that Medicago sativa promotes the decrease of glucose concentrations. To evaluate the acute effect of Medicago sativa administration on glucose tolerance, insulin secretion, and insulin sensitivity in healthy individuals.

NCT ID: NCT03710460 Recruiting - Obesity Clinical Trials

Effect of Dapagliflozin/Metformin XR vs Monotherapies on Anthropometric Indicators in Obesity

Start date: September 10, 2018
Phase: Phase 4
Study type: Interventional

Obesity has increased to alarming levels in the world. Currently it is estimated that it occurs in a third of the world's population and it is expected that by 2030, 20% of the world's adult population will suffer from obesity and 38% will be overweight, and it is important to highlight that Mexico is among the first in obesity in adults and children. Obesity leads to the development of diseases such as diabetes mellitus type 2, dyslipidemias, metabolic syndrome, heart problems, among others. The treatment for obesity in the first instance are changes in lifestyle, changes in diet and exercise that have shown, in most patients, have little long-term adherence. There are also drugs that promote weight loss by modifying the appetite or absorption of macronutrients. Dapagliflozin plus metformin XR is a medicine composed with an oral antidiabetic of the group of inhibitors of SGLT2 that has shown to have significant side effects in the weight reduction and visceral adiposity in people with obesity and in patients with diabetes mellitus type 2, it is also composed with metformin which also has effects on weight loss in people with and without type 2 diabetes mellitus. For these reasons, evaluating this compound drug in people with obesity could provide high impact information as a complement for the treatment of this condition when compared to the effects produced by monotherapies.

NCT ID: NCT03709160 Recruiting - Heart Failure Clinical Trials

Oral dIuretics in Very Intensive Treatment, an Early Intervention in Outpatients With Heart Failure

DIVINE
Start date: October 15, 2018
Phase: Phase 4
Study type: Interventional

In the present study, consecutive patients, older than 18 years, of both genders will be included. The diagnosis of reduced Heart Failure (HfrEF) according to: Clinical pattern, laboratories and Cardiac imaging (ESC criteria). Treatment will be assigned in two groups: Bumetanide and another group will be received Indapamide. Each group received maximum tolerated dose for seven days with Clinical and labs evaluations will be every 48 hrs. (Face-to-face and/or telephone visits). Serum and urinary labs, EKG´s, Echo will be evaluated. Daily in-home register will made. Final points were: Mortality, Urinary failure, Clinical Impairment, Hospital admissions, Oedema. (MUCHO). All patients will be followed for 30 days.

NCT ID: NCT03704077 Not yet recruiting - Gastric Cancer Clinical Trials

An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Start date: November 20, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy.