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NCT ID: NCT02442726 Completed - Healthy Subjects Clinical Trials

Activation of A-delta-fibres and C-fibres in a First Degree Thermal Injury in Volunteers

BI-Laser
Start date: May 2015
Phase: N/A
Study type: Interventional

The aim of this study is to measure reaction times and thermal detection thresholds to CO2 laser stimulation of the skin, before and after a first degree thermal injury, in the primary and secondary hyperalgesia area, in order to investigate whether different nerve-fiber classes are activated in the post-injury phase. The study results are expected to uncover existence of a peripheral inflammatory input contributing to secondary hyperalgesia.

NCT ID: NCT02440620 Completed - Breast Cancer Clinical Trials

Cardiac Toxicity in Medical Treatment of Breast Cancer

CaTOB
Start date: October 2014
Phase:
Study type: Observational

This study will describe the epidemiology including prognosis of heart failure related to treatment with anthracycline and trastuzumab for breast cancer. In a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer patients scheduled for trastuzumab treatment at Odense University Hospital, will be offered advanced echocardiographic examination, test of bio-markers and genetic markers for the purpose of investigating if early identification of patients in particular risk of developing heart failure is feasible.

NCT ID: NCT02439112 Completed - Multiple Myeloma Clinical Trials

Exercise in Patients With Multiple Myeloma

EMMY
Start date: May 2015
Phase: N/A
Study type: Interventional

The overall aim is to examine whether early initiated, individualized exercise training in patients newly diagnosed with multiple myeloma, irrespective of age and current performance status, will be beneficial for the patients´physical function, level of physical activity and quality of life, pain and bone disease. The investigators will examine the effect of supervised in-hospital exercise training sessions combined with home-based exercise training, initiated at time of diagnosis. The outcomes of interest are physical function, level of physical activity, QOL, pain and bone disease. Furthermore, to describe the disease in patients with newly diagnosed MM in relation to physical function, level of physical activity, QOL, pain and bone condition at time of diagnosis. The investigators hypotheses are: - Individualized exercise starting at time of diagnosis will have positive effects on physical function, physical activity, QOL and pain. - Individualized exercise starting at time of diagnosis will have positive effects on bone disease (bone markers), bone mineral density (BMD) and lean body mass. - A higher level of physical function is associated with a higher level of physical activity, less pain, better QOL, and higher BMD and lean body mass.

NCT ID: NCT02438826 Completed - Clinical trials for Chronic Cluster Headache

A Study of Galcanezumab in Participants With Chronic Cluster Headache

Start date: June 18, 2015
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.

NCT ID: NCT02437578 Completed - Infertility Clinical Trials

Clinical Tests to Predict the Success of Assisted Reproductive Techniques

Start date: May 2015
Phase:
Study type: Observational

Today, it is evident that vitamin D has more widespread effects than the classical actions related to bone mineralization and calcium homeostasis. Vitamin D deficiency results in impaired reproductive performance in various species of animals, and recently the investigators have shown that the Vitamin D receptor (VDR), activating (CYP2R1, CYP27A1, CYP27B1) and inactivating (CYP24A1) enzymes are expressed in the human testis, epididymis, seminal vesicle, prostate and spermatozoa. Functional studies showed that activated vitamin D increases intracellular calcium and sperm motility in mature spermatozoa, and hence may be important not only for spermatogenesis but also for sperm function. Any test that might assist in guiding the treatment of the infertile couple would be beneficial both for most infertile couples and the society in general. The fact that vitamin D may play a role for human semen quality are now being tested clinically. If vitamin D supplementation proves efficient this opens for the first time for a causal, safe and cheap treatment of at least some cases of "idiopathic" impaired semen quality. This may also have consequences in the in vitro setting as activated vitamin D may be used to select high quality sperm during assisted reproductive techniques. The presence of the vitamin D receptor and vitamin D metabolizing enzyme CYP24A1 in particular is able to discriminate spermatozoa from normal and infertile men. CYP24A1 is expressed at the annulus of normal sperm, but it is virtually absent from spermatozoa from infertile men. This indicates that CYP24A1 expression may assist in predicting the chance of success by using insemination (IUI), IVF or ICSI. CYP24A1 expression is induced by activated vitamin D, which indicates that other VDR activated genes also may serve as positive predictive markers of fertility. In addition, vitamin D metabolites and other factors in the female reproductive tract will be measured to determine if they alone or in combination with other markers can determine whether the best solution for the infertile couple would be to do IUI, IVF, or ICSI. The suggested clinical trial may therefore be able to evaluate several secondary endpoints in addition to CYP24A1 in our search for predictive markers for fertilization. For instance several biomarkers in serum, seminal plasma or follicular fluid in conjunction with genetic polymorphisms in several genes important for reproductive function.

NCT ID: NCT02437539 Completed - Breast Cancer Clinical Trials

Evaluation of a New Radiotracer (68Ga-NOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography

uPAR-PET
Start date: May 2015
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to test a new radiotracer called 68Ga-NOTA-AE105 for PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and less aggressive tumors. This is a first in human study to test the radiotracer in cancer patients. The biodistribution and tumor uptake will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).

NCT ID: NCT02435030 Completed - Clinical trials for Niemann-Pick Disease, Type C

A Prospective Non-therapeutic Study in Patients Diagnosed With Niemann-Pick Disease Type C

Start date: September 2015
Phase: N/A
Study type: Observational

This is a prospective non-therapeutic observational study in NP-C patients. The aim is to characterize the individual patient disease progression profile through the historical and 6 months prospective evaluation of clinical, imaging, biological(biomarkers) and quality of life data. Patients will be offered enrollment into a Phase II/III study on arimoclomol at the end of the study.

NCT ID: NCT02434497 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia (HoFH)

A Study to Evaluate the Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia

Start date: June 6, 2015
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia.

NCT ID: NCT02434341 Completed - Clinical trials for Polysomnographic Sleep Characteristics

Sleep in Critically Ill Patients on Mechanical Ventilation in ICU

Start date: May 2015
Phase: N/A
Study type: Observational

15 patients with sepsis, 15 patients with COPD and 15 surgical patients will undergo polysomnographic sleep monitoring up to 24 hours in order to define if there are common sleep features within the groups

NCT ID: NCT02433730 Completed - Hypogonadism Clinical Trials

Testosterone Therapy in Hypogonadal Men Treated With Opioids

Start date: May 1, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy of testosterone replacement therapy in men with low testosterone due to opioid treatment on body composition, the haemostatic system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids, sexual function and quality of life. Male patients on opioids for non-malignant diseases aged 18-59 years diagnosed with hypogonadotrophic hypogonadism, referred from day hospitals and outpatient populations. 40 patients are randomized to either testosterone undecanoate i.m. or placebo i.m., i.e. 20 patients per arm A double blinded randomized placebo controlled trial