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NCT ID: NCT03945188 Completed - Ulcerative Colitis Clinical Trials

Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

ELEVATE UC 52
Start date: June 13, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.

NCT ID: NCT03944642 Completed - Breastfeeding Clinical Trials

Design and Piloting of a Complex Intervention to Support Breastfeeding Self-efficacy (CRIAA Program)

CRIAA
Start date: August 9, 2019
Phase: N/A
Study type: Interventional

The aim of the study is to design and pilot the effect of a complex intervention to support mothers' breastfeeding self-efficacy and professional self-efficacy to support breastfeeding families, considering breastfeeding as a health promoting behavior. Specific objectives are the evaluation of feasibility and acceptability of the intervention, and estimate the preliminary effect on maternal and professional self-efficacy.

NCT ID: NCT03931954 Completed - Severe Asthma Clinical Trials

Prevalence of the Eosinophilic Phenotype Among Severe Asthma Patients

PREPARE
Start date: May 15, 2019
Phase:
Study type: Observational

The purpose of this cross-sectional, multicenter study is to determine the prevalence of an eosinophilic phenotype of blood eosinophil count ≥ 300 cells/mm3 among severe asthma patients who attend to sites specialized in the management of severe asthma in several countries in the AstraZeneca International Region. The prevalence of an atopic phenotype and asthma control, will also be studied.

NCT ID: NCT03930732 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation

BOREAS
Start date: April 15, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate-or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by - Annualized rate of acute moderate and severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on - Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo - Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) - Pre-bronchodilator FEV1 over 52 weeks compared to placebo - Lung function assessments - Moderate and severe COPD exacerbations - To evaluate safety and tolerability - To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies (ADA)

NCT ID: NCT03924115 Completed - Clinical trials for Essential Hypertension

Evaluation of a Transmedial Psychoeducational Program to Improve Pharmacological Adherence

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

Population in Chile has experienced an accelerated process of demographic aging, which leads to changes in the composition of morbidity and mortality, with chronic noncommunicable diseases currently predominating. One of the main problems in the treatment of people with chronic and asymptomatic pathologies such as essential arterial hypertension is the lack of pharmacological adherence, where approximately 50% farewell to the treatment, while the remaining 50% partially adheres, does not adhere or interrupt within the first year. The solution is a Psychoeducational Transmedial Program to improve pharmacological adherence (PTA), as a support to the current treatment found in centers of primary health (CESFAM). The PTA program offers health promotion and education proposals through video capsules transmitted in CESFAM. The full PTA program also includes an AFAM-Health phone application in which older adults can know and control the administration of their medications, schedule medication registration alerts, have access to healthy life information and pathology information, Incorporated a community through a chat that generates support and accompaniment among the participants themselves. The aim of the study is to evaluate if Transmedial Psychoeducational Program improves the pharmacological adherence of the antihypertensive treatment in elderly people receiving medical attention at CESFAM Hualpen, in Chili. A clinical trial was conducted with 3 parallel groups of older adults diagnosed with Essential Arterial Hypertension. There were 2 treatment groups (A and B) and a control group (C). Group A was exposed to the full PTE transmedial psychoeducational program that includes a cell phone with the application developed to improve adherence and data plan. Group B received the program without the mobile application. All participants were given a Morisky-Green test to measure pharmacological adherence and an instrument developed by the clinical team to measure the biopsychosocial characteristics of elderly under study. t is expected to find that the pharmacological adherence of those receiving the full PST is significantly superior to the control group, and those who receive the partial PST are significantly superior to the control group.

NCT ID: NCT03921853 Completed - Obesity Clinical Trials

Resistance Training in Patients With Morbid Obesity

ExinMO
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

The researchers will conduct a study for avoiding the metabolic syndrome in morbid obese patients. Thus, the aim of the present will be determine the effects of a resistance training programme (RT) in preventing or attenuating metabolic syndrome (MetS) in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of improvements in MetS markers and other co-variables considered.

NCT ID: NCT03917927 Completed - Edentulous Jaw Clinical Trials

A Clinical Study of the Eztetic Dental Implant System

RoseQuartz
Start date: January 8, 2019
Phase: N/A
Study type: Interventional

This will be a prospective, observational multicenter study. All implants will be placed in the anterior maxilla or mandible and immediately loaded with a provisional prosthesis out of occlusion. Final restorations insertion will take place no later than 6 months following implant placement surgery. All implants will be restored with a single crown or splinted to a pre-existing implant if in the pre-molar region (no 2 adjacent edentulous sites).

NCT ID: NCT03917576 Completed - Hyperglycemia Clinical Trials

Heart Rate During Exercise in Type 2 Diabetes

HRinT2DM
Start date: January 4, 2018
Phase: N/A
Study type: Interventional

Exercise training is a cornerstone for the prevention and treatment of metabolic disorders and associated cardiometabolic complications such as type 2 diabetes mellitus (T2D) and hypertension. Similar to the beneficial health effects after performing conventional continuous exercise modalities, high intensity interval training (HIIT) has been reported as an effective alternative exercise-modality to improve glucose homeostasis in both prediabetes subjects and individuals with T2D diagnosed. In this regard, although multiple HIIT-based interventions commonly report acute and long term benefits on body composition, cardiorespiratory fitness and insulin sensitivity in metabolically compromised subjects, little is known about the acute cardiovascular response (i.e., at heart rate level) during HIIT in subjects with different glucose control. HIIT is described as performing brief periods of exercise at vigorous or maximal intensity, interspersed with inactive or low intensity recovery phases of variable duration. In order to characterize different HIIT-based protocols, exercise intensity is usually defined as relative percentages of individual maximal cardiorespiratory fitness (VO2max) or relative maximal power output values. Nevertheless, the need for specific technological equipment to assess these parameters usually limit the prescription and recommendations of HIIT in clinical settings and other public health contexts at massive level. Additionally, the use of self-perceived exertion scales and heart rate (HR) variations upon HIIT have been demonstrating to be accessible and feasible strategies to regulate exercise intensity during HIIT. For example, it was reported that HR and self-perceived exertion scores increased progressively in T2D subjects, parallel to the oxygen consumption rate throughout an acute HIIT session performed on cycle ergometer. Consequently, it is conceivable to hypothesize that determining HR variations during HIIT might optimize the recommendation of this training methodology in metabolically compromised subjects as those at risk or with T2D diagnosed. Therefore, the aim of the present study was To describe and compare the acute heart rate changes in response to an incremental maximal exercise test and a single HIIT session between normoglycaemic (NG), prediabetes (Pre-T2D) and type 2 diabetes mellitus (T2D) subjects.

NCT ID: NCT03905525 Completed - Sjögren Syndrome Clinical Trials

Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome

TWINSS
Start date: October 1, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome.

NCT ID: NCT03896789 Completed - Clinical trials for TBI (Traumatic Brain Injury)

Pediatric Guideline Adherence and Outcomes- Argentina

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

Pediatric traumatic brain injury (TBI) is the leading killer of children worldwide but effective treatments for TBI are limited. Although evidenced-based pediatric TBI guidelines exist, adherence to these guidelines is low,leading us to develop a new Pediatric Guideline Adherence and Outcomes (PEGASUS) program to increase TBI guideline adherence. We propose to test the PEGASUS program's ability to improve TBI guideline adherence and outcomes.