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NCT ID: NCT04300465 Recruiting - Clinical trials for Rheumatoid Arthritis

MySlainte: Testing the Effect of Involving Partners in a CVD Prevention Community Lifestyle Program

Start date: March 10, 2020
Phase: N/A
Study type: Interventional

MySláinte is a 12-week community-based, multi-disciplinary preventive and lifestyle intervention program to reduce CVD risk factors. It includes weekly exercise classes with educational workshops on understanding lifestyle risk factors as well as optimisation of cardiovascular medications. It will be delivered by a multidisciplinary team including: a nurse, dietician, physiotherapist and physician and builds on the previously developed protocols of the successful MyAction program. The MySlainte study aims to expand on the MyAction program by looking at a broader range of patients with chronic disease who have suboptimal lifestyle drivers for many preventable diseases. Importantly, MySlainte also aims to assess if there is a difference in outcome between those who complete the program with their partner compared to those who complete the program alone.

NCT ID: NCT04298164 Completed - Clinical trials for Autism Spectrum Disorder

Evaluating the Effectiveness of an Acceptance and Commitment Therapy-based Group Intervention for Parents of Children With a Diagnosis of Autism Spectrum Disorder

Start date: November 25, 2019
Phase: N/A
Study type: Interventional

This study is being conducted to look at whether a group programme designed for parents of children with a diagnosis of Autism is effective. The programme is called The START Programme ©- as it aims to provide a Supportive and Therapeutic environment to help parents gain Acceptance and reach Resolution so that they can Take action to live more consistently with their values. The programme was developed by two psychologists in Longford/Westmeath, Ireland, Dr. Michelle Howard and Kara McDermott in 2013, because they identified a lack of therapeutic support for such parents. The programme draws on research and theory from a branch of therapy called Acceptance and Commitment Therapy, as well as some other psychological techniques. Individuals who agree to participate in the research will be assigned at random to the intervention or to a treatment as usual control condition. They will be asked to fill out 4 questionnaires, on 3 different occasions, with a 7 week gap between the first time and second time, and a 3 month gap between the second and third time.

NCT ID: NCT04297111 Completed - Muscle Weakness Clinical Trials

Probiotic-Muscle Study

Start date: November 25, 2019
Phase: N/A
Study type: Interventional

This study will examine the effect of probiotic supplementation (Bacillus coagulans) on muscle protein synthesis in older adults in response to a plant-based diet. The investigators hypothesize that probiotic supplementation will enhance the digestibility of plant protein, therefore increasing the proportion of ingested amino acids that appear in systemic circulation and enhancing rates of muscle protein synthesis.

NCT ID: NCT04296890 Completed - Clinical trials for Fallopian Tube Cancer

A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

SORAYA
Start date: July 23, 2020
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in patients with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor-Alpha (FRα). Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. All patients will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight administered on Day 1 of every 3-week cycle.

NCT ID: NCT04296045 Completed - Dysglycemia Clinical Trials

A Study to Investigate the Effect of MCE on Glucose and Insulin Responses in Healthy Males

Start date: July 2, 2020
Phase: N/A
Study type: Interventional

Maize Cob Extract (MCE) is intended to be used as a bulking agent in food. The purpose of this study is to determine the glycaemic and insulinemic response of MCE consumed in isolation compared to glucose; the glycaemic and insulinemic response will also be determined for MCE alone and in combination with glucose. This is a randomised, double-blind, single-centre trial in 10 healthy male participants.

NCT ID: NCT04293614 Completed - Clinical trials for Arterio-venous Fistula

Invasive Arterio-Venous Fistula Blood Pressure Monitoring & Fluid Dynamics Study

Start date: August 14, 2019
Phase:
Study type: Observational

The surgical formation of an AVF offers a unique example of vascular remodelling and adaption. Yet, the specific factors which elicit remodelling events which determine successful maturation or failure have not been unambiguously determined. Computational fluid dynamic (CFD) simulations are increasingly been employed to investigate the interaction between local haemodynamics and remodelling and can potentially be used to assist in clinical risk assessment of maturation or failure. However, these simulations are inextricably linked to their prescribed boundary conditions and are reliant on in vivo measurements of flow and pressure to ensure their validity. This study will compare in vivo measurements of the pressure distribution across an AVF against a representative numerical model.

NCT ID: NCT04292041 Active, not recruiting - Prostate Cancer Clinical Trials

Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome

Start date: January 15, 2019
Phase:
Study type: Observational [Patient Registry]

This is a prospective observational cohort study of patients with prostate cancer who have a metabolic syndrome. The study aims to evaluate the role of intermittent fasting (fasting mimicking diet) in these patients. The primary end point is metabolic health and the secondary endpoint is quality of life.

NCT ID: NCT04290637 Suspended - Hypertension Clinical Trials

The Galway Sea Swimmers Study

GS3
Start date: October 2020
Phase: N/A
Study type: Interventional

Cardiovascular disease (CVD) is the leading cause of death worldwide. Hypertension is a well-established risk factor for the development of CVD. Lifestyle modifications, including exercise, remain the cornerstone of blood pressure (BP)-lowering strategy. Swimming has long been a popular recreational activity for exercise, and is recently gaining widespread recognition as an effective option in maintaining and improving cardiovascular health. Previous studies that involved pool swimming as an intervention (versus no pool swimming) demonstrated favorable benefits of the former on BP reduction. However, no studies to date have specifically investigated the effect of cold-water sea swimming on BP. Indeed, the naturally lower water temperature in the sea may engender a 'cold water immersion' experience in sea swimmers with subsequent stress physiology, which have been shown to exert unique effects on cardiovascular hemodynamics. This study primarily aims to determine the impact of cold-water sea swimming on BP in a group of habitual sea swimmers in Galway who will be randomly assigned to either continue or stop swimming for 4-6 weeks. Other objective and subjective health benefits to sea swimming will also be explored in this study. Given the ubiquitous nature of this activity in the Irish general public, particularly in Galway, this study has potential from a public health perspective, and would add to the literature base pertaining to the benefits of sea swimming on cardiovascular health.

NCT ID: NCT04290299 Recruiting - Endometrial Cancer Clinical Trials

Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive

Start date: September 15, 2015
Phase:
Study type: Observational [Patient Registry]

Approximately one fourth of cases of endometrial cancer (EC) are diagnosed in premenopausal women, of whom approximately 40% wish to preserve their fertility. When arising in young women, EC usually presents with favorable prognostic features, as a focal, well differentiated endometrioid tumor, with minimal or absent myometrial invasion. This profile corresponds to the Type 1 EC, which correlates with the estrogen/progesterone receptor positive (ER+/PR+) pattern. On the other hand, these patients frequently present with clinical signs of a hyperestrogenism (chronic anovulation, infertility, obesity). Primary progestin therapy has been demonstrated to be effective in early well differentiated tumors and in poor operative candidates with response rates ranging from 58-100%.Currently, the therapeutic approach to an early stage EC consists of a staging laparotomy/laparoscopy, including a total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH-BSO), peritoneal washings, and lymphadenectomy (pelvic and aortic), depending on the pathological risk profile pre- and intraoperatively determined. Therefore, the current standard of surgical approach is preclusive of fertility. The worldwide experience and data on conservative management of EC are, however, still limited. Most of reports based on cases retrospectively collected, harboring potential methodological bias, using different treatments and drugs, and with insufficient follow-up. Some systematic reviews have been published in the last decade, trying to summarize the literature data. Therapeutic results seem to be promising with a regression rate of approximately 75% and relapse occurring in 25-40% of cases, with anecdotical reports of deaths of disease (DOD). The fertility outcome was, however, not satisfying with about 30% pregnancy rate in patients attempting to conceive, and an overall low rate of assisted reproductive techniques (ART) despite the subfertile clinical profile.Therefore, there is a need for a prospective, multicentre cooperative project able to systematically collect data from consecutive patients treated according to defined (not necessarily identical) protocols, concerning the oncological, as well as, the obstetrical outcomes. Moreover, this project could represent the "template" in which a pretreatment fertility counseling, psychological support, and definitive surgery are routinely included according to shared criteria.

NCT ID: NCT04286932 Completed - Body Weight Clinical Trials

National Children's Food Survey II

NCFS II
Start date: April 1, 2017
Phase:
Study type: Observational

The overall objective of this project is to establish for the Republic of Ireland (ROI) a nationally representative database of food consumption in children aged 5-12 years to update 2003-04 data for this group and to complement more recent data on preschool children and adults. The survey will be comparable with existing survey data in ROI and with surveys in UK (GB & NI). The ROI database will be designed to address both nutrition and food safety issues of relevance to the development and implementation of public health policy, food safety risk assessment and to the needs of the food industry. In addition to detailed data on food consumption, data will be also be collected on body weight, lifestyle, including physical activity, determinants of food choice, urine, and composition of foods and food recipes. Food composition databases will be updated and restructured to facilitate future analyses of food ingredients, packaging materials, residues, contaminants, allergens, bioactives and microorganisms. Urine samples will be stored to facilitate future analyses nutrition and metabolic indicators, markers of food intake and for estimating exposure to food chemicals. Data will be analysed to estimate intakes of foods and nutrients and compliance with dietary recommendations, to establish the prevalence of overweight and obesity, to investigate physical activity patterns and compliance with guidelines, to identify psychological, social and attitudinal determinants of food choice and eating behaviour. Salt intake will be estimated from urine excretion. Findings will be disseminated to relevant stakeholders. The project will be carried out by a multi-disciplinary research team with strong linkages to related on-going research in food and health sciences.