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NCT ID: NCT03516916 Enrolling by invitation - Quality of Life Clinical Trials

Surviving Rectal Cancer at the Cost of a Colostomy International Validation of the Colostomy Impact Score

Start date: February 1, 2019
Phase:
Study type: Observational [Patient Registry]

The formation of a colostomy following surgery for rectal cancer changes body image, challenges patient practical skills and threatens quality of life. As the oncological results have improved over the last decades the number of survivors from rectal cancer who have to adjust to a cancer free life in their own homes is increasing. To enable the identification of the patients with stoma-related reduced health-related Quality of life (HRQoL) in a quick and reliable way we recently developed the Colostomy Impact Score (CI-score) comprising 7 items of stoma related factors with significant impact on HRQoL. The purpose of the present project is to perform an international validation of the CI-score and to demonstrate its applicability. The construct validity of the CI-score will be studied internationally on crosssectional cohorts of patients with permanent colostomy after abdominoperineal excision (APE) or Hartmann's procedure in Denmark, Sweden, Spain, the Netherlands, United Kingdom, Turkey, Brazil, Egypt, Russia, Lithuania, Israel, Portugal, South Africa, Australia and China. This will be done by testing the CI-score against five anchor questions stoma impact on HRQoL, the 5 Level version og the EuroQol measuer (EQ-5D-5L) and version 3.0 of the Quality of Life Questionnaire from the European Organisation for Research and Treatment of Cancer (EORTC QLQ C30 questionnaire v3.0). The impact of the challenges related to having a stoma may vary with different demographic, socioeconomic and cultural factors. Supplementary data on stoma care, demographics and socioeconomic status will be gathered to study the impact of patient-related factors and cultural differences on HRQoL in rectal cancer survivors with an ostomy.

NCT ID: NCT03514576 Enrolling by invitation - Clinical trials for Hypoglycemia, Reactive

Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

Start date: June 1, 2018
Phase: Phase 4
Study type: Interventional

Postprandial hyperinsulinemic hypoglycemia is a well-known and potentially severe complication of Roux-en-Y gastric bypass (RYGB), and the treatment options are limited. Pasireotide has shown to be effective in preventing hypoglycemia in RYGB operated subjects, however treatment often leads to increased hyperglycemia. The purpose of this study is to investigate two doses of pasireotide that are lower than doses previously used in RYGB operated subjects with postprandial hyperinsulinemic hypoglycemia.

NCT ID: NCT03444194 Enrolling by invitation - Clinical trials for Liver Metastasis Colon Cancer

Treatment Response Evaluation in Patients With Non-resectable Colorectal Liver Metastases A Feasibility Study

TRICOMA
Start date: May 12, 2017
Phase: N/A
Study type: Interventional

More than 4200 new cases of colorectal cancer (CRC) are diagnosed each year in Denmark, and 30.000 patients live with the diagnosis. Up to 40% of CRC patients will have synchronous liver metastases (LM) at the time of the diagnosis or will develop metachronous LM during the course of their disease. CRC-LM are treated with a combination of chemotherapy and liver surgery, but less than 25% of the referred patients with CRC-LM may be treated with curative intend. If looking at population-based data this figure drops to less than 5%. During pre-operative chemotherapy the treatment response is monitored by CT and MR scans, and the patients are then discussed on multidisciplinary team (MDT) conferences. However, monitoring is inaccurate since the simple measurement of size of the liver lesions cannot provide reliable evidence of the treatment response. The cancer cells may actually have been replaced by scar tissue but without any shrinkage. The question is how may we improve the evaluation of treatment response? With the goal of improving the assessment of the response to chemotherapy, and thereby only treat the patients that will benefit from chemotherapy?

NCT ID: NCT03439176 Enrolling by invitation - Ileostomy - Stoma Clinical Trials

Investigating the Adhesion of New Adhesive to the Skin

Start date: January 15, 2018
Phase: N/A
Study type: Interventional

The adhesion of the new adhesive strips is investigated on healthy volunteers

NCT ID: NCT03431753 Enrolling by invitation - Prostate Cancer Clinical Trials

Early and Accurate Detection of Prostate Cancer in General Practice

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

Prostate cancer (PC) is the most common malignancy (4500 new cases/year) and the second leading cause of cancer-associated mortality (1200 deaths/year) among men in Denmark. PC is generally diagnosed on the basis of an elevated prostate specific antigen blood test followed by transrectal ultrasound (TRUS)-guided prostate biopsy. This study aims to test early detection of PC in general practice, using the STHLM3 model with superior specificity and sensitivity for clinically significant PC, combined with multiparametric magnetic resonance imaging (mpMRI) of the prostate and MR guided biopsy.

NCT ID: NCT03429426 Enrolling by invitation - Clinical trials for Arthritis, Rheumatoid

Progression of Bone Erosions in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray

RACTX
Start date: February 15, 2018
Phase:
Study type: Observational

Today, regular X-ray examination is not sufficiently sensitive for detecting progression of bone destruction in rheumatoid arthritis, but a new type of high-resolution CT scanner, the High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT) can detect very early and minor joint injuries. The purpose of this study is to use HR-pQCT techniques to look at the damage and disease activity progression in the hand and wrist joints of patients with rheumatoid arthritis.

NCT ID: NCT03395509 Enrolling by invitation - Hypertension Clinical Trials

The Intersectional Viborg Screening Program: Cost-(Effectiveness) of Screening for Diabetes and Cardiovascular Diseases

VISP
Start date: August 1, 2014
Phase:
Study type: Observational

This is an intersectional and interdisciplinary screening program in Viborg Municipality, including 67 years old citizens. This observational study will estimate the cost-effectiveness of a combined screening program for the following conditions: Abdominal aortic aneurysm, peripheral arterial disease, carotid plaque, hypertension, arrhythmia, and type-2-diabetes. Furthermore, the incidence of the outlined conditions will be described and so will the result of the intervention initiated (secondary medical prophylaxis, smoking cessation, introduction to nutritionally deficient diet etc.)

NCT ID: NCT03391999 Enrolling by invitation - Quality of Life Clinical Trials

Health-Related Quality of Life in Upper Secondary Schools in Denmark

Start date: October 15, 2017
Phase:
Study type: Observational

Measuring Quality of Life in an upper secondary school in Denmark

NCT ID: NCT03384927 Enrolling by invitation - Spasticity, Muscle Clinical Trials

Effect of Treatment Dairy for Spasticity

Start date: December 11, 2017
Phase:
Study type: Observational

1. Assessing whether the treatment diary can help optimize the overall treatment of patients. 2. To assess whether the patient finds the treatment diary useful and worth spending time on. Also if the patient finds it easier to evaluate the treatment and, if necessary, set new goals. 3. To assess whether the patient's quality of life is increased by the use of the treatment diary.

NCT ID: NCT03334045 Enrolling by invitation - Clinical trials for Adjustment Disorder With Work Inhibition

Neurobiological Effects of Work-related Adjustment Disorder

NeuroWAD
Start date: May 1, 2018
Phase:
Study type: Observational [Patient Registry]

INTRODUCTION: Stress is one of the greatest burdens of our society and often imply impairments in cognitive and emotional functions. The investigators hypothesize that changes in the brain's dopamine(DA)-based mesocorticolimbic projections in patients with work-related stress (adjustment disorder) will manifest in altered glucose metabolism in relation to neural activity and altered DA radiotracer binding potential at neurotransmitter and receptor level. MATERIAL AND METHODS: Subjects and healthy controls undergo neuropsychiatric tests and PET/MR imaging with three tracers: [18F]FDG to measure glucose metabolism as a marker of neural activity, [11C]raclopride to investigate the DA binding potential in the striatum, and [11C]FLB 457 to study possible impaired mesocortical dopaminergic transmission. To demonstrate difference in glucose metabolism ≥2x41 patients/controls are needed. OUTCOME: The investigators expect to find that symptoms of cognitive and motivational/reward deficits could be attributable to changes in frontal lobe and striatal glucose metabolism in >50% of patients and that changes in striatal D2 receptors and impaired mesocortical dopaminergic transmission in the prefrontal cortex are contributing factors. CONCLUSION: This project aims to generate entirely new and objective evidence of stress-induced cerebral illness and provide a basis for in depth research and more rational management of this strenuous disorder.