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NCT ID: NCT03073564 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Effect of Expiratory Positive Pressure on Dynamic Hyperinflation and Ability to Exercise With Upper Limbs in COPD

Start date: December 1, 2015
Phase: N/A
Study type: Interventional

The study will evaluate the effect of positive airway expiratory pressure (EPAP) on patients with chronic obstructive pulmonary disease (COPD) during submaximal upper limb exercise.

NCT ID: NCT03073317 Completed - Premature Birth Clinical Trials

PREPARE, Prematurity Reduction by Pre-eclampsia Care

PREPARE
Start date: December 1, 2016
Phase: N/A
Study type: Interventional

Investigators will test a novel system of integrated care, to promote the use of the WORLD HEALTH ORGANIZATION Guidelines for the management of pre-eclampsia and initiate the use of a structured risk assessment strategy to reduce the incidence of preterm delivery from pre-eclampsia by providing obstetricians with the confidence to safely defer delivery of women with pre-eclampsia, identified to be of low risk.

NCT ID: NCT03073135 Completed - Excoriation of Skin Clinical Trials

Group Psychodrama for Skin Picking

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

This study aims to evaluate the effectiveness of psychodrama group therapy (PGT) compared with supportive group therapy (SGT) for excoriation disorder (ED). Patients will be randomly allocated for either PGT or SGT. The Skin Picking Scale Revised (SPS-R) will be the primary outcome and emotional regulation measured by the Difficulties in Emotion Regulation Scale (DERS) will be evaluated as a potential intermediator. The Clinical Global Impression Scale (CGI); Beck Depression Scale (BDI); Beck Anxiety Scale (BAI), and the Social Adjustment Scale (EAS) will assess secondary outcomes.

NCT ID: NCT03072355 Completed - Healthy Volunteers Clinical Trials

Reliability and Validity of a Shoulder Fatigue Test

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

Introduction: The exercise performed with elastic tools has been appearing in the current scenario as a clinical tool because it presents advantages such as easy handling, low cost and safety. However, its use as an assessment tool, specifically for localized muscular resistance, is reduced and not standardized. In addition, there are no records of the physiological / neurofunctional effects of tests that use such a tool, since it allows a differentiated degree of prescription. Objective: To determine the reliability and reproducibility of a shoulder abduction resistance test in two tools, elastic tube and isokinetic dynamometer. In addition to analyzing the metabolic profile of both comparative order and targeting subsequent training prescription. Method: The study will consist of a sample of 30 participants and will be carried out in 2 stages, 15 participants will perform step 1 and the other 15 will perform step 2. The difference between the steps is the order of the tools used to perform the test . Each stage will consist of 5 sessions (Orientation, Familiarization 1 and 2, Test and Retest). During the test and retest sessions the physiological response of the test will be analyzed. In order to observe the response, will be analyzed the lactic anaerobic parameter (lactate concentration), allelic anaerobic (post-exercise oxygen uptake analysis - EPOC), aerobic parameter (VO2 values) and electromyographic measurements. Will be used the statistical package SPSS Statistics 22.0, Pearson's correlation and their respective confidence intervals will indicate the relationship between the numerical variables and multivariate models will be constructed by means of linear regression. The significance level of 5% will be adopted.

NCT ID: NCT03072264 Completed - Clinical trials for Generalized Anxiety Disorder

Randomized Clinical Trial of a Mindfulness Based Intervention in Generalized Anxiety Disorder

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

The literature suggests that Mindfulness Based Intervention may be effective in the treatment of anxiety symptoms. The objective of this study is to compare the clinical effectiveness of a Mindfulness Based Intervention - the Mind in Body Training (MBT) - with a selective serotonin reuptake inhibitor (Fluoxetine) and an active control group (Quality of Life) through different biological and clinical outcomes, as well as evaluate some possible mechanisms of treatment response. Methods: it is a three armed randomized, controlled clinical trial. Participants with General Anxiety Disorder will be recruited. A community sample of 192 participants will be randomly allocated to the MBT, Fluoxetine or Quality of Life Group. Instruments measuring anxiety, worry and meta-worry symptoms, quality of life, acceptance and self-compassion, mindfulness, rumination and emotion regulation will be applied. The patients will be submitted to Error Related Negativity (ERN) and Heart Rate Variability (HRV) measures. The primary outcome is the effectiveness of MBT compared with Fluoxetine and Quality of Life Group in symptomatic outcomes. The secondary outcome are the effectiveness os these interventions in emotional regulation process and biological measures (ERN and HRV), and the evaluation of BMT mechanisms through possible mediation of treatment response for emotional processes like mindfulness, acceptance and self-compassion, biological changes (ERN and HRV), and metacognition.

NCT ID: NCT03072238 Completed - Clinical trials for Metastatic Prostate Cancer

Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer

IPATential150
Start date: June 30, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).

NCT ID: NCT03071341 Completed - Clinical trials for Mucopolysaccharidosis I

Extension Study Evaluating Long Term Safety and Activity of AGT-181 in Children With MPS I

Start date: October 2016
Phase: Phase 1/Phase 2
Study type: Interventional

AGT-181 is a fusion protein containing alpha-L-iduronidase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously. This is a long term safety and tolerability study of AGT-181 in patients with MPS I who completed the previous 26-week study, AGT-181-101. Information on the biological activity of the investigational drug will also be collected.

NCT ID: NCT03071302 Completed - Keratoconus Clinical Trials

Evaluation of Tomographic and Genetic Aspects of Keratoconus Patients Compared to Sounds Corneas

Start date: August 1, 2015
Phase: N/A
Study type: Interventional

Evaluation of tomographic (Pentacam) parameters and genetic parameters of Visual System Homeobox 1 (VSX1), Superoxide Dismutase (SOD1), Tissue Inhibitors of Metalloproteinases (TIMP3) genes of keratoconus patients diagnosed by clinical exam and topographic pattern. Basically we are screening patients that don't have keratoconus that those have keratoconus. The pentacam index of corneal curvature, thinnest point, corneal high order aberrations, posterior and anterior elevation, corneal densitometry, corneal volume were investigated. To analyze the genes, we took corneal epithelium samples of patients submitted to cross linking compared to (PRK) Photo Refractive Keratectomy ones. Also will be evaluated the genes of peripheral blood.

NCT ID: NCT03069573 Completed - Clinical trials for Gastroesophageal Reflux

Phenotypic Characterization and Biomarkers Investigation for Eosinophilic Esophagitis in Pediatric Patients

Start date: January 1, 2015
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to find out some potential biomarkers for the Eosinophilic Esophagitis (EoE) in pediatric patients through the prospective clinical characterization and assessment of samples collected during the diagnostic process

NCT ID: NCT03068780 Completed - Clinical trials for Epidermolysis Bullosa

Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa

EASE
Start date: March 29, 2017
Phase: Phase 3
Study type: Interventional

This was a Phase III, Efficacy and Safety Study of Oleogel-S10 in Participants with Inherited Epidermolysis Bullosa (EB). EB is a rare group of genetic skin fragility disorders characterised by blistering of the skin in response to minor injury. In most cases, onset of EB is at birth or shortly after. All participants affected by any type of EB share the main characteristic of repeatedly developing painful wounds that take days to months to heal. Current treatment of EB is primarily preventative and supportive including protection from mechanical forces by avoiding rubbing, early treatment of wounds to prevent infections, and protection of the wound with adequate non-adhesive dressings to enable healing. The active pharmaceutical ingredient in Oleogel-S10 is a refined birch bark extract, quantified to 72 to 88% betulin. This clinical study of Oleogel-S10 in patients with inherited EB has been carried out to investigate whether Oleogel-S10 is effective for treatment of EB wounds and safe for long-term use. Oleogel-S10 was compared to a control gel. The control gel matched Oleogel-S10 in terms of texture and visual appearance to allow for double-blinding. The packaging for Oleogel-S10 gel and the control gel were identical. The participant received either Oleogel-S10 or control gel for a double-blind study phase of 90 days. The probability that the participant received Oleogel-S10 was 50%, which means that they had a 1 in 2 chance of receiving Oleogel-S10. However, in the follow-up phase of the study all participants were treated with Oleogel-S10 for a period of 24 months. This clinical study was performed at 49 study sites in 26 countries (Argentina, Australia, Austria, Brazil, Chile, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong [China], Hungary, Ireland, Israel, Italy, Romania, Russia, Serbia, Singapore, Spain, Switzerland, Ukraine, United Kingdom, and the United States)Íž 223 participants participated in total.