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NCT ID: NCT03358433 Recruiting - Depression Clinical Trials

Effectiveness of Exercise in the Treatment of Depression

DEP-EXERCISE
Start date: June 1, 2016
Phase: N/A
Study type: Interventional

The main objective is to test the non-inferiority of supervised exercise versus antidepressant treatment in reducing depressive symptoms in patients with clinical criteria for depression (according to ICD 10) over a period of 6 months follow-up.

NCT ID: NCT03358056 Recruiting - Anxiety Disorders Clinical Trials

Effects of Mindfulness Based Cognitive Therapy on Emotional Processing

MESI
Start date: September 1, 2017
Phase: N/A
Study type: Interventional

Background: In the last 30 years mindfulness-based approaches have been extensively used for a variety of mental disorders, including affective disorders characterized by emotional instability. Mindfulness based cognitive therapy (MBCT) is an 8-week intervention that combines mindfulness practices with cognitive behavioural therapy. Although changes in emotional processing have been postulated as one of mindfulness mechanisms of action, the effects of mindfulness-based programs on objective tasks of emotional processing have been poorly studied. Objective: To explore the effects of mindfulness-based cognitive therapy (MBCT) on emotional processing in a sample of individuals with emotional instability attended in a mental-health public service. Methods: The sample (n = 30) will be recruited from public mental-health outpatient centers in Barcelona, Spain. Inclusion criteria: 1) high emotional instability defined as scores above 96 on the Difficulties in Emotion Regulation Scale (DERS), 2) age between 18 and 65 years, 4) no prior experience with mindfulness/meditation. Exclusion criteria: 1) risk of suicide (attempted suicide in the last year or current suicidal ideation). Psychotropic medication will be permitted, as long as there are no changes in dose/type during the study period. Measures Diagnostic measures (MINI, DERS, CGI) and a complete medical register will be collected prior inclusion in the study. Additional measures on personality (ZKPQ) and temperament (Temps-A) will be collected as well. Primary outcome: Emotional processing task: Participants will complete the FERT task at two time points: baseline (pre-treatment) and 8 weeks (post-treatment). Secondary outcomes: In addition, participants will complete the following assessments (pre-and-post- treatment): - Depressive Symptoms (QIDS-16) - Anxiety Symptoms (STAI) - Mindfulness (FFMQ and EQ). Treatment Mindfulness-based cognitive therapy (MBCT) is a manualized, 8 weeks-group-based training derived from mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT). In MBCT participants are trained in how to be more aware of their bodily sensations, thoughts and feelings associated with negative emotional states. Mindfulness exercises and cognitive-behavioral skills are practiced both during the sessions and through homework assignments. The program is structured in 2.30 h group sessions over 8 consecutive weeks.

NCT ID: NCT03357991 Recruiting - Hiv Clinical Trials

E6/E7 mRNA Performance to Detect HSIL and Cost-effectiveness Analysis of This Screening Strategy in HIV + MSM

ELAVI-67
Start date: January 11, 2015
Phase: N/A
Study type: Observational [Patient Registry]

This study evaluates the positive and negative predictive value of E6/E7 mRNA expression for anal HSIL and its capacity to predict incident HSIL in HIV + MSM. We also analyse the cost-effectiveness of this new screening strategy. It is an ambispective study with 355 participants and a follow-up period of 2 to 5 years.

NCT ID: NCT03357237 Recruiting - Diarrhea Clinical Trials

EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN

PEDXIL01
Start date: December 1, 2017
Phase: N/A
Study type: Interventional

Acute gastroenteritis (GEA) is an inflammation of the intestinal mucosa that clinically translates into an acute episode of diarrhea and vomiting and is generally associated with an intestinal infectious disease. It is one of the most common diseases in children and an important cause of morbidity and mortality worldwide. The important loss of liquids can lead to dehydration, acidosis and hydroelectrolitic alteration. Infants are more vulnerable to gastrointestinal infection and its consequences, dehydration and malnutrition. There is no specific treatment, so it is exclusively symptomatic A new type of products considered as mucoprotectors has been developed, such as gelatin tannate or xyloglucan, still with little data to establish recommendations on its use in the GEA. They would be able to reproduce in the intestine a muco-adhesive film or sheet protective It must be considered in this sense that mucus is the first barrier that protects the gastrointestinal tract against microorganisms or antigens and that bacterial invasion is related to the opening of narrow junctions. Xyloglucan was approved in Europe as a medical device IIa to restore the physiological functions of the intestinal wall in the form of capsules for adults and envelopes for children.

NCT ID: NCT03345862 Recruiting - Clinical trials for Social Isolation, Loneliness (Descriptors Included in the MeSH)

Effectiveness of a Intervention to Reduce the Social Isolation and Loneliness of Elderly Residents at Home

ASyS
Start date: May 15, 2018
Phase: N/A
Study type: Interventional

- Objectives: To evaluate the effectiveness, in terms of reducing social isolation and improving the Health Related Quality of Life (HRQOL), of a non-pharmacological multicomponent intervention in elderly telecare users. - Design: Clinical trial randomized by cluster, multicentric. - Location: 14 health centers of the Andalusian Health Service (Spain). - Subjects and methods: Subjects with social isolation. Age 65 or older. Residents in your home. Persons with cognitive impairment or dementia, difficulty in responding to scales, legal incapacitation or not giving consent will be excluded. 9 health centers will be randomly assigned to the intervention and control groups. The people of both groups will be evaluated at baseline, at 4 and at 6 months. 57 subjects will be included in each group (n = 114). Variables: a) Independent: of the professional and of the patients (sociodemographic, healthcare, morbidity, intervention performed -multicomponent vs. non-intervention-) b) Dependents: social support, loneliness and HRQoL. The intervention includes 8 sessions at home [1 hour], every 15 days and 4 telephone [30 minutes] -1 monthly-. To measure the effectiveness of the intervention, the Duke-UNC Functional Social Support Questionnaire (DUFSS), the De Jong-Gierveld Scale of loneliness, and the EuroQol-5D will be used to measure HRQoL. Univariate, bivariate and multivariate statistical analysis (multiple linear regression). -Aspects ethico-legal: Standards of good clinical practice and ethical principles of the Declaration of Helsinki. Informed consent. Application for authorization to the management of the Sanitary District.

NCT ID: NCT03343886 Recruiting - Aging Clinical Trials

Trajectories of Health in Spanish Population

Start date: July 2011
Phase: N/A
Study type: Observational

Age with Health is a longitudinal cohort study aimed to examine trajectories of health, disability and wellbeing and their determinants for Spanish ageing population. Two waves have carried out so far. Wave 1 (2011-2012) and Wave 2 (2014-2015). Wave 3 will be conducted 2018, including also a new cohort of participants (Called 2018 Cohort). The study will provide reliable measures of population ageing and adult health in Spain - and will provide the basis for cross-country comparisons with longitudinal studies conducted in other countries.

NCT ID: NCT03340688 Recruiting - Preterm Birth Clinical Trials

Cerclage for Twins With Short Cervical Length ≤ 15mm

TWIN-UIC
Start date: June 22, 2017
Phase: N/A
Study type: Interventional

This is a multicenter randomized study designed to determine if ultrasound indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and cervical length ≤15mm, diagnosed by transvaginal ultrasound between 16 to 23 6/7 weeks of gestation.

NCT ID: NCT03340506 Recruiting - Melanoma Clinical Trials

Dabrafenib and/or Trametinib Rollover Study

Start date: December 28, 2017
Phase: Phase 4
Study type: Interventional

This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.

NCT ID: NCT03337958 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Education With Inhalers in Patients With COPD Exacerbation

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

Chronic obstructive pulmonary disease (COPD) is a public health problem with great morbidity. The main therapeutic strategy is inhalers. The objective of this study is to determine the efficacy of an educational intervention in the use of inhalers in patients with COPD including ventilatory re-education and video recordings of the patients themselves.

NCT ID: NCT03333083 Recruiting - HIV Infections Clinical Trials

Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen

RALAM-II
Start date: May 3, 2018
Phase: Phase 3
Study type: Interventional

Phase 3b, single arm, simplification study with dual therapy including Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen.