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NCT ID: NCT04701151 Recruiting - Side Effect of Drug Clinical Trials

NORTH-REG Dwell-Time Study

Start date: February 3, 2021
Phase: Phase 4
Study type: Interventional

Previous studies show that the majority NMIBC patients experience side effects to BCG and therefore terminate the instillations before completing all planned instillations. This will increase their risk of recurrence and potential cystectomy. The purpose of this study is to investigate if NMIBC patients who experience severe side effects to BCG instillations will experience fewer or less severe side effects if reducing dwell-time of BCG instillations. The study will include patients from Denmark, Iceland, Norway and Sweden.

NCT ID: NCT04700878 Recruiting - Clinical trials for Psychological Stress

A Randomized Controlled Evaluation of a Compassion-course for Healthcare Professionals

ICOP
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

The aim is to investigate whether an internet-based compassion course of five modules contributes to reducing stress of conscience and work-related stress, increase the experience of professional quality of life and self-compassion in healthcare professionals.

NCT ID: NCT04700748 Recruiting - Brain Metastases Clinical Trials

Diffusion-weighted MRI to Predict Treatment Response in Stereotactic Radiotherapy of Central Nervous System (CNS) Metastases

Start date: December 28, 2020
Phase: N/A
Study type: Interventional

Stereotactic radiation therapy is an important and common method of treating brain metastases in patients with malignant disease. Today, however, there are no methods available to determine the metastasis' radiation sensitivity in advance and treatment responses can only be seen by changing of the size of the metastasis on conventional X-ray examinations, computed tomography (CT) and magnetic resonance imaging (MRI). Changes in the size of the metastases is something that is often seen weeks / months after treatment is completed. At Lund University Hospital, a new imaging technique, diffusional variance decomposition (DIVIDE), has now been developed. With this technique, the scatter in isotropic and anisotropic diffusion can be measured for each measuring point, which provides significantly more information about the properties of the tissue compared to current methods.

NCT ID: NCT04695119 Recruiting - Sepsis Clinical Trials

Sepsis in the ICU-II

Start date: September 17, 2018
Phase:
Study type: Observational

Sepsis-induced cardiac dysfunction (SIMD) is a well-known phenomenon yet its diagnosis remains elusive with no accepted definition, or defining pathophysiological mechanism associated with this disease. Systolic dysfunction occurs in 20-70% of patients, and may be severe, yet does not appear to have any prognostic value for mortality. Diastolic function has also been variably described and seems to be related to short-term mortality. However, the contribution of left ventricular systolic and diastolic dysfunction to mortality in sepsis are still far from clear, with uncertain contribution from previous cardiovascular disease, vasopressor and inotropic drugs and mechanical ventilation. Another poorly investigated area is right ventricular dysfunction. Cor pulmonale occurs in up to 25% of patients with septic shock, and is invariably related to pulmonary haemodynamics and mechanical ventilation, yet very little is known about how this affects prognosis. Finally, although the outcome of disease is a function of multiple parameters, septic cardiomyopathy is most frequently characterized based on individual echocardiographic parameters, without considering their interactions or placing them in the context of biomarkers and clinically available haemodynamic data. Available relevant studies are often monocentric, and many fail to consider the various confounders that influence the clinical outcome in sepsis. Therefore, the diagnostic and prognostic value of combinations of clinical, biochemical and haemodynamic variables remains to be established. Accordingly, the purpose of this study is to identify biomarkers and echocardiographic and haemodynamic signatures characteristic of specific outcomes in SIMD to support the diagnosis and prognosis in SIMD. Specific aims are: 1. To determine the association between left ventricular systolic and diastolic dysfunction, and adverse outcome in SIMD; 2. To determine the association between right ventricular systolic and diastolic dysfunction, and adverse outcome in SIMD; 3. To determine the association between novel biomarkers and adverse outcome in SIMD; 4. To determine the combined value of biomarker, echocardiographic, and haemodynamic variables for predicting adverse outcomes in SIMD; 5. To explore if there are different phenotypes of SIMD using unsupervised machine learning algorithms, and whether they are associated with adverse outcomes. 50 patients will be enrolled in a feasibility study to evaluate the logistical setup for acute echocardiography and biobanking facilities. A further 300 patients will be enrolled with inclusion from peripheral centers once feasibility is confirmed.

NCT ID: NCT04692259 Recruiting - MRI Clinical Trials

May the Risk of PHLF be Predicted With Preoperative Liver Gadoxetate MRI

MR-Predict
Start date: December 29, 2020
Phase: N/A
Study type: Interventional

Post hepatectomy liver failure (PHLF) is one of the most severe complications after liver re-section. Preoperative evaluation of liver function is complicated and imprecise. The volume and function needed for each individual patient is unknown and the methods used for evaluation are uncertain. Preoperative MRI with Gadolinium may give dynamic information regarding liver function correlating with postoperative liver failure. A retrospective analysis will be performed regarding this topic.

NCT ID: NCT04691973 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Evaluation of Health and Lifestyle Tool

Start date: January 1, 2017
Phase:
Study type: Observational

The overall aim of the study is to observe the natural pattern of usage and metabolic outcomes in patients with type 2 diabetes who had access to the new digital tool as a stand-alone support in addition to usual care. The tool is based on self-affirmation theory and has large emphasis on self-reflection to enable sustainable lifestyle changes. The changes in HbA1c, reflecting long-term blood glucose, will be evaluated in patients with type 2 diabetes. Patients are compared to controls on usual care not exposed to the tool.

NCT ID: NCT04678193 Recruiting - Covid19 Clinical Trials

COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy

COROMEC
Start date: December 24, 2020
Phase:
Study type: Observational [Patient Registry]

Researchers are creating real-time epidemiology registry to evaluate the efficacy of COVID-19 subject risk assessment scores based on recording of symptoms, biomarkers, chronic illness and mental health assessments with digital technology using wearables and mobile app tools. Researchers aim to study in Phase 1, epidemiological variations in COVID-19 presentation in both PCR positive and negative subjects in the registry. Assessment of variables, predictive modeling of variables that impact severity of COVID-19 positive and negative subjects and assessment of predictors for post COVID-19 complications. In Phase 2, 2700 subjects with COVID-19 positive test will be studied in the intervention group comparing ECL-19 vs placebo with primary end point of hospital admission assessment. Treatment strategy for PCR positive COVID-19 subjects in the registry who are in Stage I of the disease process with ECL-19 drug compared to placebo in reducing hospital admissions

NCT ID: NCT04676841 Recruiting - Hip Fractures Clinical Trials

Wound Contamination During Orthopaedic Surgery

Clean Care
Start date: September 1, 2019
Phase:
Study type: Observational

In the present study we will compare bacteriological findings and the incidence of SSI in relation to laminar airflow (LAF) ventilated ORs, conventional (also called displacement or mixed) ventilated ORs and conventional ventilated ORs with the addition of tables equipped with units providing a local LAF over the surgical instruments. The hypothesis is that there exist a correlation between number and types of airborne bacteria and bacteria in the surgical wound and on surgical instruments at the time of wound closure.

NCT ID: NCT04674592 Recruiting - Tibia Fracture Clinical Trials

Biomarkers in the Diagnosis of Acute Compartment Syndrome

BioFACTS
Start date: April 5, 2018
Phase:
Study type: Observational

This prospective multinational, multicentre cohort study aims to investigate the hypothesis that biomarkers of muscle cell damage can predict acute compartment syndrome in patients with tibial fractures.

NCT ID: NCT04673773 Recruiting - Low Back Pain Clinical Trials

MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain.

MY-RELIEF
Start date: September 27, 2021
Phase: N/A
Study type: Interventional

Low back pain is the main cause of activity limitation and work absence across the world, leading to a high social and economic burden for individuals, families, the labour market and society. This is particularly true for older adults of working age, employed in sedentary or arduous/strenuous jobs, whose work conditions may influence negatively this health problem and lead to severe persistent low back pain. Pain management is one of the most neglected aspects of healthcare and people suffering from persistent low back pain are often left without specific information, guidance and care from healthcare systems. The MY-RELEF study is a multinational, multicenter, prospective uncontrolled, pre-post intervention feasibility study targeting people over the age of 55 years with persistent low back pain in Northern Lithuania, Ireland, Italy, Sweden and Portugal. Eligible participants will be offered the opportunity to use the MY RELIEF educational platform as part of their care and will undergo evaluations at baseline (enrollment) and at two-weeks and one-month follow-ups.