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NCT ID: NCT03685838 Recruiting - Varicose Veins Clinical Trials

Compression Stockings Therapy Following Mechano-Chemical Ablation (Clarivein®)

COMMOCA
Start date: February 13, 2019
Phase: N/A
Study type: Interventional

This study will be looking at the effect of compression therapy in patients having Mechano-Chemical Ablation (MOCA) therapy for truncal incompetence of their varicose veins using the ClariVein® device. Patients will be randomised to either the compression group (group A) or the no compression group (group B). The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as the cost effectiveness of each intervention will be assessed.

NCT ID: NCT03672058 Recruiting - Cystic Fibrosis Clinical Trials

Steps Ahead: Optimising Physical Activity and Health in Adults With Cystic Fibrosis

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Physical activity is widely documented as one of the cornerstones of Cystic Fibrosis (CF) management as it is directly linked to mortality and quality of life. Levels of physical inactivity and sedentary behaviour have been poorly investigated among the CF population in Ireland. The measurement of these behaviours is important in order to monitor prevalence amongst people with CF (PWCF) and determine methods by which health care providers can assist with maintaining and enhancing physical activity. The use of physical activity monitoring can provide health care providers with insightful real world analysis of physical activity and exercise behaviours. Over the last decade there has been many advancements in technology and fitness tracking with positive results being demonstrated in the healthy population and in chronic diseases such as Diabetes Mellitus II, post surgery and Multiple Sclerosis. Limited research has been conducted among PWCF to date. The aim of this research project is to examine physical activity levels amongst PWCF and determine the effect of a 12 week randomised parallel intervention on a number of health outcomes. Participants will be provided with an accelerometer to assess physical activity and sedentary behaviour at baseline. The participants will then undergo further baseline testing to determine exercise capacity, body composition, quality of life, breathlessness, sleep quality and wellbeing. Baseline short and long term goals will be established together with the participant and physiotherapist. Participants will then be randomly allocated to either the intervention or the comparator. A researcher independent of the recruitment process (MC) will complete the first random allocation using a sealed opaque envelope. Following this a minimisation randomisation procedure will be completed based on lung function, where FEV1 of <70% predicted lung function will be classified as having mild lung disease. While those with an FEV1 of 30-50% predicted lung function will be classified as having moderate lung disease, with <30% indicating severe lung disease. Allocation will be revealed after recruitment and baseline assessments have occurred. Both groups will receive a fitness tracker which will be linked to an online monitoring system (Fitabase) for 24 weeks. The intervention group will receive personalised feedback via a text message every week on their physical activity levels as measured by their fitness tracker and progress on attainment of their goals established at the start of the study. Feedback will be provided from their CF physiotherapists. The comparator group will not receive any feedback on their Fitbit data. After 12 weeks both groups will be re-assessed. Thereafter, both groups will continue with the Fitbits alone for 12 weeks. Finally outcome measures including lung function, physical activity levels, aerobic capacity, quality of life, sleep quality, muscle mass and well-being will be re-assessed again at 24 weeks. Following the intervention semi structured interviews will be conducted to qualitatively establish satisfaction with the interventions and provide insight into barriers and enablers to achieving goals and physical activity levels.The results of this study may provide valuable insights into potential interventions to optimise the health and well-being of PWCF.

NCT ID: NCT03656536 Recruiting - Clinical trials for Metastatic Cholangiocarcinoma

A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

FIGHT-302
Start date: June 3, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.

NCT ID: NCT03640689 Recruiting - Venous Leg Ulcer Clinical Trials

DEep VEin Lesion OPtimisation (DEVELOP) Trial

Develop
Start date: July 15, 2019
Phase: N/A
Study type: Interventional

This is a prospective, single centre, randomised controlled, feasibility study recruiting patients with lower limb venous ulceration and Great Saphenous incompetence. Patients will be randomised to undergo either truncal ablation and compression therapy or truncal ablation, simultaneous iliac interrogation with intravascular ultrasound and stenting of significant (>50%) iliac vein lesions plus compression therapy. The primary endpoints will be ulcer healing and procedural safety. Secondary endpoints include time to healing, quality of life and clinical scores, ulcer recurrence rates and rates of post-thrombotic syndrome. Follow up will be over a five-year period. This feasibility study is designed to include 60 patients. Should it be practicable a total of 594 patients would be required to adequately power the study to definitively address ulcer-healing rates.

NCT ID: NCT03623061 Recruiting - Low Fibrinogen Clinical Trials

F-Point Validation Study

F-Point
Start date: May 14, 2018
Phase:
Study type: Observational

The F-Point investigation is an open label, single centre prospective observational study in 3 cohorts of patients, one with low fibrinogen concentration, one with normal fibrinogen concentration, and one with high fibrinogen concentration To show statistical agreement between the fibrinogen level as recorded by the standard lab Clauss fibrinogen, and the fibrinogen level as recorded by the novel F-Point device.

NCT ID: NCT03562546 Recruiting - Clinical trials for Chronic Venous Insufficiency

The Effect of Structured Exercise on Chronic Venous Insufficiency

CVI
Start date: August 1, 2018
Phase: N/A
Study type: Interventional

Individuals with Chronic Venous Insufficiency (CVI) face a number of complications, such as, muscular dysfunction, limited ankle range of motion(ROM) and diminished calf muscle pump function. Exercise therapy has been shown to improve calf muscle pump function and symptoms and may provide additional therapeutic benefits. It has been reported that structured exercise has the ability to improve ankle joint range of motion, calf muscle strength and calf muscle pump function. Participants will receive the 12-week structured resistance exercise programme, 'Strength from Within', a warm up and cool down, walking programme and range of motion exercises. Participants will complete the Short Form quality of life (SF-36) Health Survey and the venous clinical severity score questionnaire. Baseline testing will be conducted. The following measures will be employed in the study through a baseline testing and repeated at the end of the study period (week 12): Functional ambulatory measurements, physical activity measurements (muscle endurance), isokinetic testing (strength), duplex ultrasound scanning. A combination of upper and lower body structured exercise as well as, ankle join range of motion and a walking regimen has the potential to have a significant impact on an individual's calf muscle pump function and avoid these potentially harmful side effects of lower body exercise programmes

NCT ID: NCT03551860 Recruiting - Hip Replacement Clinical Trials

Quadratus Lumborum Block Versus Fascia Iliaca Nerve Block for Patients Undergoing Total Hip Replacement

Start date: April 10, 2018
Phase: N/A
Study type: Interventional

Investigators hypothesise that for patients undergoing elective total hip replacements, a single injection Transmuscular Quadratus Lumborum (TQL) block, when compared to a single injection Fascia Iliaca Block (FIB), will provide better analgesia and less motor block in the initial 24 hour period.

NCT ID: NCT03524677 Recruiting - Pancreatic Cancer Clinical Trials

Mutation of K-RAS, CDKN2A, SMAD4 and TP53 in Pancreatic Cancer: Role of Liquid Biopsy in Preoperative Diagnosis

Start date: January 23, 2019
Phase:
Study type: Observational

Pancreatic cancers represent a challenge for the multidisciplinal team. A patient-tailored treatment plan requires an accurate preoperative staging. Currently more than 40% of patient taken to the OR are actually unresectable and another 40% will shortly recur with dismal prognosis. Among patients that meet upfront surgery some would have benefit of a neoadjuvant treatment and vice versa. Accuracy of preoperative staging is of primary importance in treatment decisional making. Due to its location, invasive preoperative diagnostic tests on pancreatic cancer are expensive and risky. Liquid biopsy provides a non-invasive signature of the tumor. Analyzing mutations on cell-free nucleic acids gives translational information on tumor biology and therefore on its clinic-pathological features and likely on its progression. This study would be the first -in our knowledge- analyzing the relationship of a pattern of 4 major genes involved in pancreatic cancer progression on liquid biopsy and the time to recurrence and T-stage, with particular attention to vascular invasion. A properly staged patient provides a better resource allocation, an optimal treatment plan and improves patient's outcomes.

NCT ID: NCT03519945 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

Start date: July 18, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.

NCT ID: NCT03501108 Recruiting - Clinical trials for Frail Elderly Syndrome

Discontinuation of Long-term Medications in Older People Entering Nursing Home Care

STOPPFrail
Start date: March 27, 2018
Phase: N/A
Study type: Interventional

Older people often have several chronic diseases requiring several medications all at once. Taking several medications all at once is called polypharmacy. Polypharmacy is common in nursing home residents. When people take the same medication long term, the original reason for prescribing the medication may no longer be important or a priority. Polypharmacy is associated with an increased risk of harmful side effects. STOPPfrail is a tool, designed for doctors, that highlights situations where medications may be inappropriate or harmful to frail older people. When these situations are identified, reducing or stopping the inappropriate medication should be considered. The STOPPfrail tool was developed by an expert group specializing in geriatric pharmacotherapy. In the present research study, the investigators wish to examine whether medications can be safely reduced and stopped using the STOPPfrail tool in hospitalized frail older people who are awaiting transfer to a nursing home. The investigators will assess this method by comparing its effects with those of the current standard practice of medication management. In the trial, participants are allocated to one of two groups. One group will have their medications evaluated using the STOPPfrail tool (intervention group). The other group will have their medications reviewed in the standard way (control group). The allocation of participants into these two groups will be done randomly to avoid any bias in the study. When participants are allocated to the intervention group, their physician will receive written advice designed to help him/her to adjust medications so as to minimize the risk of withdrawal reactions. The advice will be based on the STOPPfrail tool. The hospital case notes and discharge summaries of the participants taking part in the trial will be reviewed at the time of discharge from hospital. Three months after recruitment, the participant's nursing home will be contacted. Information about the number and type of medications prescribed will be requested as well as details about hospitalizations, falls and the participant's well general well-being. The main aim is to examine whether it is possible to significantly reduce the number of medications that an older frail person takes using the STOPPfrail tool. The investigators will also examine whether reducing the number of medications in this way has an effect on quality of life, unscheduled medical care, falls and the cost of medications.