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NCT ID: NCT03364114 Recruiting - Clinical trials for Barrett's Esophagus With Dysplasia

Endorotor Resection In Refractory Barrett's Dysplasia Patients

Start date: February 9, 2018
Phase: N/A
Study type: Interventional

The aim of the clinical trial is to evaluate the EndoRotor®'s ability to completely remove areas of Barrett's esophagus considered refractory after 3 failed ablation treatments (Radiofrequency Ablation (RFA) and/or Cryotherapy) or in patients with at least 1 failed ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.

NCT ID: NCT03343236 Recruiting - Inflammation Clinical Trials

Nutrition and Inflammation in Patients With Head and Neck Cancer

Start date: November 1, 2015
Phase:
Study type: Observational

An estimated 1500 people in Sweden will annually be diagnosed with head and neck cancer (HNC). Five year survival is approximately 69%. Long-term sequelae are common and in particular nutritional problems and fatigue. Radiotherapy (RT) is the cornerstone of treatment, either as single modality treatment or combined modality treatment. RT can induce immune responses at the site of tumor. It has been demonstrated that RT can lead to a strong systemic immune response . We have previously shown that an increase of conventional measures of systemic immune response to RT varied significantly across individuals. We predict that local immune response plays a major role in the antitumor effect. We also predict that a strong systemic immune response contributes to malnutrition and influence on survival. And malnutrition may lead to a worse response to RT. The overall aim of this multicenter observational longitudinal study is to prospectively identify immunological and metabolic variables that affect the outcome of HNC patients. We will systematically investigate the local and systemic immune response induced by RT as well as explore alterations in metabolite composition induced by disease and treatment through global metabolite profiling. A platform for studies on immuno-metabolic changes in HNC patients has been established in the Uppsala-Orebro and Northern regions. Approximately 370 patients per year are eligible. Findings in this study can have implications on the development of personalized therapy in patients with HNC. The long-term benefit of the study will be the identification of measures for improved patient surveillance in order to improve the general and nutritional outcomes.

NCT ID: NCT03325699 Recruiting - Mild Dementia Clinical Trials

Support Monitoring and Reminder Technology

SMART4MD
Start date: December 3, 2016
Phase: N/A
Study type: Interventional

This multicentre randomized control trial aims to evaluate the effects of an intervention consisting of an health application developed to improve the quality of life (QoL) in older people with mild dementia and their informal caregivers. The study is a collaboration between five European countries where the clinical trials will be conducted in four of these countries (Sweden, Belgium, Spain and Czech Republic). In total 1200 dyads (consisting of a person with mild dementia (PWD) and their informal caregiver (carer) will be recruited for this study. Participant dyads will be randomized in a 1:1 ratio in two parallel groups: PWD to receive either usual care from primary or specialized providers (control group) or to receive usual care plus access to a tablet with the SMART4MD health application (intervention group). Participants in the trial will be assessed for a period of 18 months. After the baseline visit, all participants will have follow-up visits every 6 months together with a checkup of the PWDs capacity to remain in the study. In the follow up visits, investigators will assess the PWD's quality of life, their cognitive and functional status, adherence to prescribed medication and attendance at healthcare appointments and admissions to healthcare services institutions. Investigators will also assess the burden of the informal caregivers.

NCT ID: NCT03324152 Recruiting - Dermatomyositis Clinical Trials

Effects of High-intensity Interval Training (HIIT) in Recent Onset Polymyositis and Dermatomyositis

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

Polymyositis and dermatomyositis are rare inflammatory systemic conditions. Reduced muscle function is a cardinal symptom and lung involvement is very common. Knowledge of heart involvement in these patients is very limited, as is knowledge of exercise effects in recent onset, active disease. The aim of this project is to investigate effects of high-intensity interval training (HIIT) compared to standard low-intensity home exercise as to tolerance, physical capacity, quality of life, depression, disease activity, inflammation, muscle mass/fat mass, muscle metabolism and heart function in patients with recent onset, active polymyositis and dermatomyositis. This is a randomized controlled trial. Muscle biopsies are taken at time of diagnosis and after 12 weeks of exercise. Muscle biopsies will be analyzed as to baseline kynurenine pathway, calcium release, gene expression and inflammatory infiltrates and as to changes in these parameters following exercise. Muscle function (primary outcome), maximal oxygen uptake, muscle mass/fat mass, disease activity, systolic and diastolic heart function, as well as quality of life and depression is measured at baseline and after 12 weeks of exercise. After all assessments, patients are randomized to HIIT or standard low-intensity home exercise. The HIIT group will perform 6 sets of 30-60 second biking bouts reaching 85-100% of maximal heart rate, in combination with strength training, three days a week for 12 weeks. The control group will perform a standardized home exercise program five days a week for 12 weeks. After 12 weeks, all assessments are preformed again. If the HIIT is well tolerated, patients in the control group will be invited to HIIT exercise according to the same protocol. Clinical assessments will be performed at 3, 6 and 9 months follow-up in an open extension. This study will improve our understanding of heart function, muscle metabolism as well as tolerance and effects of intensive exercise as well as heart function early in the disease course and could also improve treatment and prognosis in patients with polymyositis and dermatomyositis.

NCT ID: NCT03320252 Recruiting - Clinical trials for AAA - Abdominal Aortic Aneurysm

Endurant CHevAr New Indication Trial: ENCHANT

ENCHANT
Start date: October 26, 2017
Phase:
Study type: Observational

The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.

NCT ID: NCT03310788 Recruiting - Clinical trials for Glaucoma Open-Angle Primary

Monitoring of the IOP After SLT Using iCare Home

Start date: October 3, 2017
Phase:
Study type: Observational

The purpose of this study is to investigate how much selective trabeculoplasty (SLT) influences intraocular pressure (IOP) fluctuations measured with iCare Home rebound tonometry (RTHome) in patients with primary open-angle glaucoma (POAG) or pseudo-exfoliation glaucoma (PEX).

NCT ID: NCT03302117 Recruiting - Clinical trials for Pulmonary Inflammation

Pulmonary and Systemic Effects of Exposure to Wood Smoke

Start date: June 14, 2017
Phase: N/A
Study type: Observational

This is study is to assess pulmonary and systemic effects of exposure to wood smoke. Healthy volunteers will be expose under two different occasion to wood smoke and filtered air under two separated occasions with an interval of 3 weeks in-between. The aim of this study was to determine whether exposure to wood smoke from incomplete combustion would elicit airway inflammation in humans.

NCT ID: NCT03292068 Recruiting - Tonsillitis Clinical Trials

Children Recovering From Tonsil Surgery

TONIST
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Children recovering from tonsil surgery following day surgery Tonsil surgery - self-care and treatment - the TONIST-study The main objective of this study is to evaluate the effect and experience of acupuncture, acupressure, specially designed diet and telephone counselling on children's surgery-related symptoms, quality of life and costs during recovery after tonsillectomy (TE) or tonsillotomy (TT). Early discharge from hospitals means that patients have to deal with much of the post-operative care during recovery process on their own or with the help of relatives. The recovery period may be a progressive process of physical weakness (1,2). In Sweden, 14 000 tonsil surgeries per year are performed, about 50% children under 15 years because of obstruction, of TE, tonsillectomy, and TT, tonsillomy. Children's tonsil surgery following day surgery are in focus for this study. Both qualitative and quantitative methods will be used.

NCT ID: NCT03289637 Recruiting - Clinical trials for Vitamin D Deficiency

Supplementation With Vitamin D to Patients With Heart Failure (D-Heart).

D-Heart
Start date: February 1, 2018
Phase: N/A
Study type: Interventional

In 200 patients with documented systolic heart failure give supplementation with vitamin D in those with a 25-OH- vitamin D < 50nmol/L - or placebo. In those with a vitamin D level <25nmol/L a substitution of 2400IU will be given, and in those with a vitamin D level 25-50nmol/L a substitution of 1600IU will be given. Intervention time 12 months. Biomarkers of heart function, quality of life, and hospitalisation will be analysed.

NCT ID: NCT03283020 Recruiting - Clinical trials for Pharyngeal Dysfunction

Opioid-Induced Swallowing Dysfunction - The Impact of Bolus Volume

Start date: November 11, 2017
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate the impact of different bolus volumes and viscosity on remifentanil-induced swallowing dysfunction in healthy volunteers.Hence, whether swallowing tasks can be done safer during sedation by altering bolus volumes and viscosities will be revealed. Furthermore, the study will clarify underlying mechanisms (central vs. peripheral effects) of remifentanil-induced swallowing dysfunction. If methylnaltrexone reverses the remifentanil-induced effects on swallowing, this would suggest a dominant peripherally mediated mechanism.