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NCT ID: NCT02396277 Suspended - Clinical trials for Distal Radius Fracture

Structural and Functional Nerve Changes Following Immobilisation After Distal Radius Fracture - a Pilot Study (NRP)

NRP
Start date: March 2024
Phase:
Study type: Observational

Immobilization after radius fracture seems to increase the risk of developing a Complex regional pain syndrome (CRPS), a condition associated with pain, increased skin sensitivity and reduced epidermal nerve density. The purpose of the study is to determine whether 5-week immobilisation leads to functional and structural sensory changes, and whether the changes are associated with persistent pain. The investigators plan an explorative, pilot study on six consenting patients immobilised after a distal radius fracture. The baseline measurements will be recorded at the day of or the day after trauma: Demographics, psychological and physical comorbidity, pain characteristics and intensity, hand function, health related quality of life (HRQOL), quantitative sensory testing will be recorded while skin biopsies are analyzed for epidermal nerve fiber density. Following variables such as pain characteristics and intensity, hand function, health related quality of life, quantitative sensory testing and skin biopsies will be reassessed when the cast is removed and two months later.

NCT ID: NCT02395224 Active, not recruiting - Neoplasm Metastasis Clinical Trials

A Longitudinal Study of Colorectal Cancer Patients With Metastatic Disease in Middle-Norway

Start date: September 2014
Phase:
Study type: Observational

The main objective is to provide original research results that may change clinical practice related to metastatic colorectal cancer. The study will evaluate treatment and patient care at different stages of the disease trajectory and the use of health care for this large group of patients. It will be possible to compare the effectiveness of chemotherapy, radiotherapy and symptomatic treatment given to "real life" patients with the efficacy reported in randomised clinical trials. By using longitudinal information on imaging, biomarkers, clinical staging and place of care it will be possible to improve patient classification at various stages of the disease. Based on this, a more appropriate, individualized treatment for colorectal cancer may be recommended during the phases of the disease trajectory. Participation in this project will not influence the treatment for colorectal cancer. All patients will be treated and followed-up according to current regional and national guidelines.

NCT ID: NCT02393859 Completed - Clinical trials for Leukemia, Acute Lymphoblastic

Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)

Start date: November 10, 2015
Phase: Phase 3
Study type: Interventional

B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according to risk characteristics to ensure that appropriate treatment is administered to patients with high-risk of relapse. In general, pediatric treatment regimens are more intense than those employed in adults and include courses of combination chemotherapy. Standard of care chemotherapy is associated with considerable toxicity. There is a lack of novel treatment options for subjects who relapse or are refractory to treatment. Therefore, innovative therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing cells. This study will evaluate the event-free survival (EFS) after treatment with blinatumomab when compared to standard of care (SOC) chemotherapy. The effect of blinatumomab on overall survival and reduction of minimal residual disease compared to SOC chemotherapy will also be investigated.

NCT ID: NCT02392559 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders

HAUSER-RCT
Start date: March 24, 2016
Phase: Phase 3
Study type: Interventional

A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.

NCT ID: NCT02391922 Withdrawn - Injury Clinical Trials

Better First Aid With First Aid Training and Dispatcher Central Instructions?

Start date: October 2014
Phase: N/A
Study type: Interventional

The study evaluates the effect of a first aid course on first aid skills compared to no training. The study also evaluates the effect of first-aid instructions given by emergency dispatch central over mobile phone on first aid performance to no instructions. Half the participants will perform first aid in two scenarios prior to first aid training. Half the participants will perform first aid in two scenarios 4 to 5 months after attending a first aid course. Half the participants (overall) will receive first aid instructions by mobile phone during the scenarios.

NCT ID: NCT02390999 Completed - Cardiac Arrest Clinical Trials

Neurological Prognostication of Patients in Therapeutic Hypothermia After Cardiac Arrest

Start date: March 2013
Phase: N/A
Study type: Interventional

3500 people suffer from out of hospital cardiac arrest each year in Denmark. Therapeutic hypothermia to 33 degrees celsius is now standard treatment of comatose cardiac arrest patients. The investigators are challenged in our attempt to predict outcome of these patients by both low body temperature in itself and the sedative and relaxing drugs used to keep the patient in a coma. This study is a substudy in a large international multicenter randomized trial that investigates the possible benefit of 48 hours of therapeutic hypothermia versus todays standard of 24 hours. In this substudy the investigators will approach early prediction of neurological outcome using a combination of new examinations backed up by well established ones to engage this challenge from different angles and find a battery of combined examinations, that together will enable us to accurately predict outcome at an earlier stage. Our examinations have been chosen from the three fields of neurophysiology, biochemistry and neurology and consist of electroencephalography (EEG), somatosensory evoked potentials (SEP), biomarkers and clinical examinations such as brain stem reflexes chosen for their prognostic reliability.

NCT ID: NCT02388906 Active, not recruiting - Melanoma Clinical Trials

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma

CheckMate 238
Start date: March 19, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.

NCT ID: NCT02388113 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effect of Exercise Frequency on Metabolic Control and Heart Function in Type 2 Diabetes

Start date: October 2014
Phase: N/A
Study type: Interventional

This study will compare two interventions with the same exercise intensities and caloric expenditure but with different exercise frequency, on metabolic control and other risk factors in individuals with type 2 diabetes.

NCT ID: NCT02386917 Active, not recruiting - Obesity Clinical Trials

Impact of Body Weight and Weight Loss on Drug Bioavailability, Cardiovascular Risk Factors and Metabolic Biomarkers

COCKTAIL
Start date: March 18, 2015
Phase: N/A
Study type: Interventional

Drug bioavailability and disposition vary according to body weight and weight loss after bariatric surgery. This study evaluates the impact of body weight and weight loss on the pharmacokinetics of various probe drugs, and compares these effects in three groups of patients receiving either a gall bladder operation, gastric bypass or a very low calorie diet.

NCT ID: NCT02384031 Completed - Clinical trials for Post-dural Puncture Headache

Post-dural Puncture Headache - Needles and Biomarkers in CSF

Start date: February 2012
Phase: N/A
Study type: Interventional

Post-dural puncture headache (PDPH) is the most common complication following lumbar puncture (LP). The frequency varies widely depending on a number of factors, among which patient characteristics, case ascertainment, gauge and type of needle used are of significant importance. In 2001, Strupp et al. showed that over 12 % of 115 patients who were subjected to diagnostic lumbar puncture with a 22 gg (0.7 mm) atraumatic needle suffered post-dural puncture headache, while over 24 % of 115 who were given a lumbar puncture with a 22 gg traumatic needle suffered a headache. This finding provided the basis for an American recommendation to use a 22 gg atraumatic needle for diagnostic lumbar puncture. A later study with 58 patients has shown an even greater difference (36 % versus 3 % post-dural puncture headache) when an atraumatic needle is used. Despite these findings, European Neurologist continue to hold on to the cutting needle. Here the investigators propose a prospective randomized study design with double masking; neither patient nor evaluator of PDPH aware of the needle design used, and with an active ascertainment of the occurrence of PDPH in accordance with updated headache classification guidelines. The investigators also intend to investigate whether specific neuroinflammatory substances and metabolites (different outcome variables) in the cerebrospinal fluid (CSF) will affect the explanatory variable.