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NCT ID: NCT03003377 Completed - Sevoflurane Clinical Trials

Sevoflurane-remifentanil EC50 (The 50% Effective Concentration) Values for LMA-Supreme Versus LMA ProSeal Insertion

Start date: November 2014
Phase: Phase 4
Study type: Interventional

The study was designed to determine and compare the sevoflurane EC50 optimal concentration for laryngeal mask airway Supreme versus laryngeal mask airway ProSeal insertion during target-controlled infusion of remifentanil.

NCT ID: NCT03003364 Completed - Clinical trials for Spinal Cord Injury, Chronic

Intrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury

Start date: December 27, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/IIa, randomized, double-blind, two-arms, two-dose administration, placebo controlled, two-way crossover clinical trial in which 10 patients from 18 to 65 years of age affected with chronic traumatic spinal cord will enter the study with the objective to assess the safety and to obtain efficacy data in intrathecal administration of expanded Wharton's jelly mesenchymal stem cells.

NCT ID: NCT03002584 Completed - Clinical trials for IBS - Irritable Bowel Syndrome

International Psychometric Validation Study of the Intestinal Gas Questionnaire (IGQ)

PRoVING
Start date: February 10, 2017
Phase:
Study type: Observational

Objective: To confirm the psychometrics properties of the Intestinal Gas Questionnaire (IGQ) in subjects with Irritable Bowel Syndrome (IBS) diagnosis and General population both complaining of Gas-Related Symptoms (GRS). IGQ has been developed previously simultaneously in UK English, French and Spanish through qualitative research with subject interviews. The conceptual framework of the IGQ assesses both GRS and their impact on daily life. Similar concepts were identified for both subjects with IBS diagnosis and general population and complaining of gas-related symptoms. The IGQ consists of a 24-hour recall symptom diary assessing 7 gas-related symptoms (17 items) and a 7-day recall questionnaire which assesses the impact of those symptoms (26 items)

NCT ID: NCT03002558 Completed - Hypertension Clinical Trials

Long-term Cardiovascular Outcomes in Patients With RH and OSA With or Without Treatment With CPAP

SARAH
Start date: April 29, 2016
Phase:
Study type: Observational [Patient Registry]

Objectives: Main objective: To assess the impact of obstructive sleep apnea (OSA) and its treatment on cardiovascular outcomes (morbidity and mortality) in patients with resistant hypertension (RH). Secondary objectives: i) to identify the subclinical organ damage profile at baseline and its association with OSA, and to identify if long term blood pressure control and number of antihypertensive drugs needed is different depending on OSA diagnosis and its treatment; ii) to identify epigenetic profiles and clinical, biological and polygraphic variables with a predictive value for cardiovascular outcomes in RH patients with OSA; iii) to validate the HIPARCO-SCORE tool in men in an independent cohort and elaborate a new tool to be used in women; and iv) to perform a cost-effectiveness analysis to evaluate the impact of OSA diagnosis and treatment in patients with RH. Methodology: Prospective cohort study. 1,371 RH patients will be recruited. Ambulatory blood pressure monitoring (ABPM), socio-demographic, clinical, OSA-related, biochemical and subclinical organ damage variables and biological samples at baseline will be collected from all the subjects included. A sleep study will be performed in all the subjects at the study inclusion date. Subsequently, the OSA subjects will be managed as per local standard practice. Follow-up variables will be annually collected (including blood samples). On the basis of OSA and its treatment, three cohorts of RH subjects will be defined: control (non-OSA), OSA-treated and OSA nontreated.

NCT ID: NCT03002220 Completed - Prostate Cancer Clinical Trials

Trial of Rad-223 Activity in Asymptomatic Patients With mCRPC While on Abiraterone or Enzalutamide Besides AR-V7 Status

Start date: November 2016
Phase: Phase 2
Study type: Interventional

Radium-223 is indicated for the treatment of patients with mCRPC with symptomatic bone metastases and no known visceral metastatic disease. However, very few data have been reported in patients with mCRPC who are asymptomatic or mildly symptomatic. Recently, results from an International Expanded Access Program have also suggested a benefit of radium-223 in asymptomatic patients with mCRPC. In addition, the mechanism of action of radium-223 should not be correlated with the presence/absence of the AR-V7 mutation, although this issue has not yet been evaluated. The aim of this study is to assess the efficacy of radium-223 in asymptomatic patients with mCRPC, and to establish the association between AR-V7 status and radium-223 activity.

NCT ID: NCT03001882 Completed - Clinical trials for Non-Small Cell Lung Cancer

An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

CheckMate 592
Start date: March 29, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).

NCT ID: NCT03001648 Completed - Infertility Clinical Trials

Cumulative Live Birth Rates in Patients With Repeated Implantation Failure (RIF) Undergoing Preimplantation Genetic Screening (PGS )

Start date: January 2014
Phase: N/A
Study type: Observational

This is a single centre retrospective study in repeated implantation failure patients: < 39 years old, at least 4 D3 good quality embryos or 2 good quality blastocysts transferred without implantation, absence of known causes of implantation failures (uterine malformation, thrombophilia, severe male factor, uncontrolled thyroid disfunction, autoimmune disease). Patients scheduled for PGS underwent one or more stimulation cycles (oocyte or blastocyst banking) in order to maximize chances of embryo transfer. PGS cycles are analyzed globally. Aditionally, PGS cycles with a single stimulation cycle are analyzed in comparison to standard IVF cycles.

NCT ID: NCT03000907 Completed - Sarcopenia Clinical Trials

Efficacy of an Intervention to Prevent Frailty in Obese Elderly People (PRE-FROB)

PRE-FROB
Start date: January 23, 2017
Phase: N/A
Study type: Interventional

Rationale: There is increasing evidence that obesity may be a risk factor for frailty in the elderly. Obesity favors a state of chronic inflammation and insulin resistance, involves a fatty infiltration of the muscle and an increased cardiovascular risk and, in addition, obese people usually perform less physical activity. All this favors the loss of mass and muscular function (sarcopenia), a key component of the fragility and the functional deterioration. Objectives: To evaluate the effectiveness of a multimodal intervention to lose weight in the prevention of frailty in obese elderly people, as well as to know the main mechanisms involved in the frailty process. Methodology: Design: Controlled, randomized, open-label clinical trial with two parallel intervention arms and 2 years follow-up. Study population: People between 65 and 75 years of age, obese (BMI ≥30), without criteria of fragility and living in the community. Study intervention: multimodal and personalized intervention with the support of a "personal trainer" that has two main axes of action: a) diet: assessment of nutritional status and nutritional requirements and establishment of personalized nutritional plan with monthly dietetic controls and b) physical exercise: a multi-component physical exercise program that will include aerobic exercise and strengthening, balance and flexibility exercises as well as a weekly group session of health education, during six months. Main outcome measures (to be evaluated annually for 2 years): Fragility (according to the L Fried criteria) and Sarcopenia (according to the criteria of the European Working Group on Sarcopenia in Older People -EWGSOP). Sarcopenia is considered if there is a decrease in gait velocity or muscle grip strength (measured with a dynamometer) and a decrease in muscle mass assessed by bioimpedance (BIA). Intermediate outcome measures (at 6, 12 and 24 months): a) weight loss, b) changes in body composition and distribution of body fat, c) glycemic control (HbA1) and insulin resistance (by HOMA index (HOmeostasis Model Assessment)), d) cardiovascular risk according to the REGICOR algorithm, e) functional capacity (according to Barthel Index and 2 Minute Walking Test), f) inflammatory markers (IL-6, CRP(C reactive protein), TNF(Tumor Necrosis Factor)-alpha and leptin) and g) anabolic hormones (IGF-1, ghrelin and testosterone).

NCT ID: NCT03000777 Completed - Clinical trials for Fatigue Syndrome, Chronic

Oral Melatonin Plus Zinc Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)

MELATOZINC
Start date: February 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effects of oral melatonin plus zinc supplementation in relieving self-reported fatigue in CFS/ME

NCT ID: NCT03000647 Completed - Clinical trials for Urinary Incontinence

Guided Versus Non-guided Pelvic Floor Exercises for Urinary Incontinence in Relapsing-Remitting Multiple Sclerosis

Start date: October 2015
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the effectiveness of guided versus non guided pelvic floor exercises for urinary incontinence in patients with Relapsing-Remitting Multiple Sclerosis