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NCT ID: NCT02895555 Completed - Low Back Pain Clinical Trials

The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumented Posterolateral Fusion The IVANOS-study

IVANOS
Start date: March 2012
Phase: N/A
Study type: Interventional

The average life expectancy in Denmark is increasing resulting in an increasing part of the population having age-related disease, ex lumbar spinal stenosis (LSS). LSS causes constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back, especially when standing and walking, known as neurogenic claudicatio(Goh KJ FAU - Khalifa et al.). LSS occurs in a combination of degenerative changes in the lower back, including hypertrophy of the ligamentum flavum, arthrosis of the facet joints and bulging of the disc. Current treatment of LSS is varied ranging from non-operative conservative treatment to operation. Operative intervention shows very good results according to physical ability and pain(Christensen FB et al.;Hee HT and Wong;McGregor AH FAU - Hughes and Hughes;Xu et al.), but the most optimal treatment is still debated. Nevertheless, a decompression and, if needed, a spinal fusion is recommended. The investigators want to se whether i-FACTOR improves clinical outcomes compared to using allograft in spinal fusion in the elderly, and thereby find an improved methods operating this difficult patient population. The hypothesis is, that there is no difference in clinical outcomes whether you use i-FACTOR or allograft i non-instrumented spinal fusion surgery in patients with spinal stenosis due to degenerative listhesis.

NCT ID: NCT02894814 Completed - Medical Patients Clinical Trials

My Health - My Medication. Patient Involvement in Administration of Medication

Start date: April 2016
Phase: N/A
Study type: Interventional

The primary purpose of this study is to investigate if patient involvement in the medication procedures through elements of the medication system One-Stop Dispensing (use of own medication, placed in bedside locker, partly or self-administration of medication) and focused dialogue about medication can maintain or improve the patients' health literacy to perform the prescribed medical treatment during and after hospitalization. The hypothesis is, that involving the patient in the medication procedure and focused dialogue about the medicine during hospitalization will improve the patients' health literacy measured by patient adherence, patient knowledge and perceptions of safety about the medication. It is further expected that more time will be spent together with the patient, and that the new medication procedures will be cost-neutral.

NCT ID: NCT02893137 Completed - Glioblastoma Clinical Trials

Enhancing Optune Therapy With Targeted Craniectomy

Start date: October 1, 2016
Phase: Phase 1
Study type: Interventional

The present study proposes a new and potentially superior clinical approach to Optune™ therapy of selected glioblastoma patients. The approach is based on combining TTFields with targeted surgical skull remodeling, such as minor craniectomy or a distribution of burr holes, designed for the individual patient. Pre-clinical modeling results suggest that such procedures may enhance the induced electrical field strength by up to ~100% and thereby potentially improve the clinical outcome of treated patients to a significant extent. The study is an open label phase 1 clinical pilot experiment designed to investigate feasibility, safety and efficacy of the concept. Fifteen patients with first recurrence of glioblastoma will be included in the trial. All patients will receive TTFields therapy with targeted craniotomy and best physician's choice chemotherapy.

NCT ID: NCT02892656 Completed - Low Back Pain Clinical Trials

Reliability and Responsiveness of One Questionnaire Used on a Low Back Pain Population

Start date: August 10, 2017
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to determine the reliability and responsiveness of the Pain Self-Efficacy Questionnaire (PSEQ) in a chronic low back pain (CLBP) population referred to The Danish Rheumatism Associations´ rehabilitation centre Sano Aarhus.

NCT ID: NCT02891850 Completed - Clinical trials for Pulmonary Arterial Hypertension

Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy

REPLACE
Start date: January 11, 2017
Phase: Phase 4
Study type: Interventional

To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5 inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients

NCT ID: NCT02891668 Completed - Hypothyroidism Clinical Trials

Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition

HYMAQ
Start date: May 2015
Phase:
Study type: Observational

This project has the following primary aims: The main objective is to delineate the association between changes in Resting energy expenditure (REE) and QOL in hypothyroid patients before and after one year of L-T4 treatment. To achieve this, the investigators plan to compare newly diagnosed hypothyroid patients soon after diagnosis before L-T4 therapy has been initiated after 6 months and after 1 year of treatment. Primary endpoint is changes in REE compared to changes in QOL Secondary endpoint is changes in cognitive function and changes in body composition before and after one year of treatment and furthermore changes in insulin resistance following changes in body composition and free fatty acids (FFA).

NCT ID: NCT02890836 Completed - Clinical trials for Pregnancy in Diabetics

Blood Pressure, Antihypertensive Treatment and Preeclampsia in Pregnant Wom-en With Pre-existing Diabetes

Start date: February 2016
Phase:
Study type: Observational

Aim: First, to investigate the prevalence of a) confirmed hypertension, b) white coat hypertension and c) normal blood pressure in pregnant women with pre-existing diabetes. Second, to explore the prevalence of preeclampsia and preterm delivery in women with pre-existing diabetes with a) confirmed hypertension, b) white coat hypertension and c) normal blood pressure before entering the third trimester of pregnancy. Third, to explore the influence of lifestyle, gestational weight gain and mental well-being on confirmed hypertension and preeclampsia in pregnant women with diabetes.The recruitment period was in 2018 extended to 2020 to perform the following studies: First whether home BP in early pregnancy is superior to office BP to predict preeclampsia. Second to evaluate the prevalence of preeclampsia after initiation of a new treatment strategy including prophylactic aspirin and, in case of insufficiency, vitamin D supplementation. Design: A prospective multicentre observational study where approximately 400 pregnant women with pre-existing diabetes are offered measurements of office blood pressure (BP) and home BP for three days three times during pregnancy as well as when the routinely measured office BP exceeds 135/85 mmHg. The prevalence of confirmed hypertension (office BP >135/85 mmHg and home BP >130/80 mmHg) and white coat hypertension (office BP >135/85 mmHg but home BP ≤130/80 mmHg) will be determined. Women with confirmed hypertension are offered antihypertensive treatment mainly with methyldopa. In women with a) confirmed hypertension, b) white coat hypertension, and c) normal blood pressure before entering third trimester of pregnancy, the prevalence of preeclampsia and preterm delivery will be evaluated. Possible side effects of antihypertensive treatment including impaired fetal haemodynamics and lower infant birth weight will be recorded. The women will complete food diaries and questionnaires on lifestyle and mental health three times in pregnancy in order to evaluate the influence of these parameters on hypertension and preeclampsia.

NCT ID: NCT02890745 Completed - Clinical trials for Diabetes Mellitus, Type 2

The Effect Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes

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

The purpose of this study is to investigate the effect of empagliflozin on oxidative stress in patients with type 2 diabetes. The association is examined by comparing the difference in oxidative modifications before and after 14 days treatment with 25 mg empagliflozin compared to placebo treatment. The study is randomised, double-blinded, and placebo controlled. Each treatment group consists of 17 males with type 2 diabetes. Oxidative modifications are measured by urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine and 8-oxo-7,8-dihydroguanosine. A student t-test will be performed to compare the drug treatment with placebo. The results will be published in a peer-review journal.

NCT ID: NCT02889536 Completed - Hernia Clinical Trials

Living With a Parastomal Bulge - a Phenomenological-hermeneutic Study of Patients Lived Experiences

Start date: June 2016
Phase: N/A
Study type: Observational

A parastomal bulge (PB) is a frequent long-term complication after stoma formation. Most parastomal bulging occurs within two years of stoma formation but is seen up to 20 years post-surgery. A bulge may be relatively obvious or extremely difficult to diagnose, and descriptions of symptoms vary from 'asymptomatic', 'symptomatic' to 'high symptom load'. Previous studies report that quality of life as well as physical, psychological and social function are affected in patients with parastomal bulging. However, there is a lack of knowledge of patients' lived experiences with parastomal bulging. Insight into patients' experiences of symptoms in relation to parastomal bulging and the impact on everyday life may help identify issues of importance from the patient perspective. This, in turn, may help professionals to better understand and support patients with PB, and be of help when identifying patients' symptoms and determining relevant treatment strategies.

NCT ID: NCT02888691 Completed - Type 1 Diabetes Clinical Trials

Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes

HiLo12
Start date: August 2016
Phase: N/A
Study type: Interventional

The aim of the study is to investigate glycemic control during a low carbohydrate diet compared with during a high carbohydrate diet in adults with insulin pump treated type 1 diabetes.