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NCT ID: NCT03111966 Completed - Hepatitis C Clinical Trials

Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort

Start date: March 31, 2017
Phase:
Study type: Observational [Patient Registry]

This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases).

NCT ID: NCT03111407 Completed - Knee Osteoarthritis Clinical Trials

iAssist vs. Conventional Instrumentation in Total Knee Arthroplasty

Start date: April 2014
Phase: N/A
Study type: Interventional

The purpose of this prospective study is to evaluate Zimmer® iASSIST™ with respect to radiographic, clinical and economic outcomes and compared to conventional instrumentation in primary total knee arthroplasty (NexGen or Persona knee implants).

NCT ID: NCT03110991 Completed - Depression Clinical Trials

Cognitive-behavioral Intervention Via a Smartphone App for Depressive Symptoms in Caregivers

App Depression
Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Major depression is a common disorder among non-professional caregivers, and it can be disabling and costly. Although there are effective psychological interventions to prevent depression, most of them involve in-person treatment. New technologies have the potential to overcome the barriers this format presents, which limit accessibility to such interventions. The main objective of this project is to evaluate the effectiveness of a cognitive-behavioral intervention in the prevention of depression, administered through a smartphone application (App), both with and without telephone contact through multiconferencing. Secondary objectives are: (a) test the moderating or mediating effect of the variables in the theoretical model underlying the intervention; (b) analyze the variables that are predictors of intervention outcomes; (c) analyze the acceptability and satisfaction with interventions. A randomized controlled trial will be perform. Caregivers with clinically significant depressive symptoms who do not meet the diagnostic criteria for depressive episode will be included. Recruitment of 174 participants is planned, with random allocation to one of the three conditions (58 participants per intervention): (a) a cognitive-behavioral intervention administered via a smartphone App (CCIA); (b) a cognitive-behavioral intervention administered via a smartphone App + telephone contact via conference call (CCIA+CC); (c) attention control group (ACG). Both interventions will be administered in 5 modules via an App for Smartphones and one group additionally will receive telephone contact via conference call in group format during 4 sessions of 30 minutes. These phone sessions will be recorded to assess the therapists adherence to the intervention protocols. All participants will be evaluated at pre and posttreatment, and 1-, 3-, 6- and 12-month follow-up by trained interviewers who will be blind to the aims of the study, the interventions employed, and the group to which any given participant belongs. Incidence of depression will be examined as the primary measure, with secondary measures being depressive symptoms, symptoms related to the model (pleasant activities, negative thoughts and social contacts) and the acceptability of and satisfaction with the intervention.

NCT ID: NCT03108664 Completed - Dry Eye Disease Clinical Trials

HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye Disease (DED)

Start date: May 18, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether SYL1001 ophthalmic solution is safe and effective in the treatment of signs and symptoms of Dry Eye Disease.

NCT ID: NCT03108625 Completed - Clinical trials for Depressive Disorder, Major

Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age

Start date: March 1, 2017
Phase: Phase 3
Study type: Interventional

Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD

NCT ID: NCT03108508 Completed - Clinical trials for Absorption; Disorder

Non-inferiority Bioavailabilty Study of 3 Silicon-rich Supplements

BIOSILICI
Start date: May 1, 2017
Phase: N/A
Study type: Interventional

The objective of the present study is to evaluate the non-inferiority of the absorption parameters of three silicon supplements in human volunteers.

NCT ID: NCT03108157 Completed - EMBRYO IMPLANTATION Clinical Trials

Endometrial Scratch Effect on Pregnancy Rates in Patients Undergoing Egg-donation IVF

Start date: January 12, 2017
Phase: N/A
Study type: Interventional

Clinical trial about the effect of endometrial scratch on pregnancy rates in patients undergoing a treatment with in-vitro fertilization with donor eggs, when doing the endometrial biopsy during the cycle prior to the embryo transfer.

NCT ID: NCT03107793 Completed - Crohn Disease Clinical Trials

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab

STARDUST
Start date: April 19, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of a treat to target strategy coupled with early endoscopic assessment versus a clinically driven (routine care) approach in achieving endoscopic response.

NCT ID: NCT03107650 Completed - Rectal Cancer Clinical Trials

Preoperative Prediction Model of Pathological Outcomes (Mesorectum Quality and Positive Circumferential Resection Margin) in Patients With Mid-low Rectal Cancer

PREMARE
Start date: January 1, 2018
Phase:
Study type: Observational

Elaboration of a preoperative prediction model of the quality of the mesorectum and the involvement of the circumferential margin in patients with mid-low rectal cancer who undergo laparoscopic anterior rectal resection. In a second phase the investigators will study the utility of the prediction model in classifying patients with high risk of suboptimal quality of mesorectum and/or positive circumferential margin. Patients with high preoperative risk will undergo a transanal total mesorectal excision and patients with low risk a laparoscopic transabdominal mesorectal excision. The investigators finally will compare pathological outcomes ( quality of mesorectum and circumferential margin), survival and recurrence between the two groups.

NCT ID: NCT03107442 Completed - Clinical trials for Systemic Lupus Erythematosus

Exercise and Arterial Stiffness in Systemic Lupus Erythematosus

EJERCITALES
Start date: April 12, 2017
Phase: N/A
Study type: Interventional

Patients with Systemic Lupus Erythematosus (SLE) have increased arterial stiffness, which leads to cardiovascular diseases (CVD) of arteriosclerotic origin, which are the main cause of mortality in these patients. Exercise is a modifiable factor that reduces cardiovascular mortality and associated risk factors in the general population. Preliminary studies suggest that exercise may improve endothelial function and lipid profile in patients with SLE. However, whether meeting the international physical activity guidelines from the American College of Sports Medicine (ACSM; i.e. ≥150 min / week of moderate to vigorous intensity physical activity) can improve arterial stiffness (subclinical atherosclerosis marker) and inflammation is unknown. The primary aim of this study is to assess the effect of an exercise program based on meeting the ACSM physical activity guidelines on arterial stiffness and inflammation in patients with SLE. The secondary aim is to assess the effect of an exercise program based on meeting the ACSM physical activity guidelines on endothelial function, oxidative stress, as well as other cardiometabolic risk factors, physical fitness, health-related quality of life, and other psychosocial outcomes. Our hypothesis is that meeting the ACSM guidelines will improve arterial stiffness and inflammation in patients with SLE. The study is a non-randomized clinical trial. To minimize selection bias, participants in the intervention and control groups will be matched by age, BMI, and disease activity (SLEDAI), which are important contributors to arterial stiffness.