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NCT ID: NCT03560505 Completed - Ultrasonography Clinical Trials

High-resolution Ultrasound in Lower Extremity Nerves and Common Fibular Neuropathies.

Start date: May 16, 2018
Phase:
Study type: Observational

This study establishes reference material of selected lower extremity nerves at pre-defined sites with high-resolution ultrasound. Furthermore in this study, high-resolution ultrasound of patients with common fibular compression neuropathy and patients with type 2 diabetic polyneuropathy involving the common fibular nerve will be examined and compared to healthy controls. High-resolution ultrasound measurements will be correlated with history, clinical information and electrophysiological data.

NCT ID: NCT03560024 Completed - Headache, Migraine Clinical Trials

The Effect of PACAP27 on the Extra- and Intracerebral Arteries Assessed by Magnetic Resonance Angiography (MRA) on Healthy Volunteers

Start date: May 31, 2018
Phase: N/A
Study type: Interventional

Studying Pituitary adenylate cyclase-activating peptide 27 (PACAP27) effects on extra- and intracerebral arteries assessed by MRA on healthy volunteers.

NCT ID: NCT03559699 Completed - Clinical trials for Pyruvate Kinase Deficiency

A Study Evaluating the Efficacy and Safety of AG-348 in Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)

Start date: June 26, 2018
Phase: Phase 3
Study type: Interventional

Study AG348-C-007 was a multicenter study designed to evaluate the efficacy and safety of treatment with AG-348 in a minimum of 20, with up to 40, participants with pyruvate kinase (PK) deficiency, who were regularly receiving blood transfusions. The study was composed of two parts. During Part 1, Dose Optimization Period, participants started on a dose of 5 mg AG-348 administered twice daily. Over the course of Part 1 each participant's dose of AG-348 was sequentially increased to 20 mg twice a day, followed by 50 mg twice a day depending on their tolerance. During Part 2, Fixed-Dose Period, participants received AG-348 at their optimized dose from Part 1.

NCT ID: NCT03559062 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis

Start date: May 17, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the F508del mutation (F/F) or heterozygous for F508del with an eligible residual function mutation (F/RF).

NCT ID: NCT03558698 Completed - Sleep Clinical Trials

Are Cognition and Sleep Affected by Exposure to Carbon Dioxide and Bio Effluents During Sleep?

Start date: January 23, 2018
Phase: N/A
Study type: Interventional

The aim of the project is to examine whether children's sleep and cognition are affected by exposure to CO2 and other bio effluents during sleep. The participants of the study are 36 children recruited from local schools in Aarhus, Denmark. The study takes place in the climate chambers at the Department of Public Health, Aarhus University. These chambers allow for experimental testing on humans with advanced exposure generation while avoiding contamination from other sources and controlling temperature, humidity, noise, odor, and light. The children will be sleeping in the chambers under three different conditions: - One night of good ventilation with a CO2 level of maximum 800 ppm - One night of good ventilation with high levels of CO2 (3,000 ppm) - One night of poor ventilation with high concentrations of CO2 (3000 ppm) and other bio effluents. The study is a within-group design, and groups of six children will be sleeping in the chambers for three nights (separated by seven days). The different groups of children are exposed to the conditions in a randomized order. The study is double-blinded (of security reasons the persons responsible for CO2 concentrations in the chambers are not blinded). The study takes place on schools nights. The children arrive at 6 pm and leave for school the morning after. In the evening the children are tested for approximately 30-40 minutes to measure their cognitive performance using CANTAB (Cambridge Neuropsychological Test Automated Battery) on iPads. After completing the test, dinner is served and the children have some spare time before going to bed. During night, the quality of sleep (awake time and different sleep stages) will be monitored using Fitbit devices. Sleep quality will also be evaluated using a short sleep questionnaire. The next morning the cognitive performance of the children will be tested again using CANTAB before the children leave for school. Our primary hypothesis is that children will perform worse on the cognitive test when exposed to high levels of CO2 and other bio effluents than compared to low levels of CO2 and bio effluents in a well-ventilated room. In addition to that our secondary hypotheses are: - Children will perform worse on the cognitive test when exposed to high levels of CO2 and other bio effluents than compared to CO2 alone. - Children will sleep less well in an environment with poor ventilation and high levels of CO2 and other bio effluents compared to sleeping in a well-ventilated room with low levels of CO2. - Children will sleep less well in an environment with poor ventilation and high levels of CO2 and other bio effluents compared to sleeping in a room with high levels of CO2 alone. - Children will sleep less well and perform worse on the cognitive test when exposed to high levels of CO2 compared to low levels of CO2.

NCT ID: NCT03558308 Completed - Clinical trials for Acquired Brain Injury

CBCR for Executive Functions in Patients With ABI in the Chronic Phase

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

This study examines the effects of computerbased cognitive rehabilitation on executive functions in the chronic phase after acquired brain injury

NCT ID: NCT03557307 Completed - Asthma Clinical Trials

Study to Evaluate Efficacy and Safety of Benralizumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma

PONENTE
Start date: August 1, 2018
Phase: Phase 3
Study type: Interventional

This is a study designed to evaluate efficacy and safety of Benralizumab in reducing the Oral Corticosteroid (OCS) use in adult patients with severe asthma who are receiving OCS with or without additional asthma controller medications.

NCT ID: NCT03556735 Completed - Clinical trials for Depression, Unipolar

Pulsed Electro Magnetic Fields (PEMF) in Depression

PEMF
Start date: September 2016
Phase: N/A
Study type: Interventional

PEMF (Pulsed Electro Magnetic Fields) therapy has been used to stimulate bone repair in non-union since the 1970s. This is an accepted use, which has been approved by the Food and Drug Administration in the US. The mode of action of PEMF is based on creating small electrical fields in tissue and thereby promoting healing. Besides it has been shown that PEMF enhance regeneration of nerve fibers exposed to a lesion For treatment of depression the PEMF equipment, which are provided by the company Re5 A/S, consists of a 220 V impulse generator that creates electrical impulses and an applicator which consists of an electrical cable connected to a helmet on which there are 7 electrical coils on the inside. In comparison with the rTMS (Transcranial Magnetic Stimulation) equipment, which uses stimuli approaching neuronal firing level, the PEMF fields in human is very much lower.

NCT ID: NCT03556449 Completed - Scapular Winging Clinical Trials

High Resolution Ultrasound of Scapulae Alatae - a Prospective Case Control Study

Start date: April 12, 2018
Phase:
Study type: Observational

Scapula alata, caused by disturbance in the scapulothoracic stabilizer muscles due to nerve injury, is a relatively rare but also underreported disease. It can lead to years of invalidity of the affected upper extremity, considerable pain and social and emotional consequences for the patients. Unrecognized and misdiagnosed scapula alata and, consequently, wrong or delayed treatment is a general problem in this patient group. Today the diagnosis is based on the clinical examination and the electrophysiological examination. One of the problems is that the electrophysiological examination in a fair part of the patients is not showing any pathology even though the history of the patient and the clinical evaluation are indicating scapula alata. This study is a single-blinded, prospective, controlled multicentre study. The aim of the study is to investigate whether ultrasound can be used as a supplement to the electrophysiological examination when diagnosing scapula alata. Ultrasound will be used to visualize possible thickening of the cross-sectional area of nerves and the degree and pattern of muscle involvement in patients with scapula alata. By comparing measurements from scapula alata patients with the measurements from healthy controls, we are able to see if ultrasound can distinguish these two groups from each other. Furthermore, we will examine whether the ultrasound measurements correlate with the electrophysiological findings in patients and, when available, compare the ultrasound measurements of muscle thickness with MRI (magnetic resonance Imaging) findings. The use of ultrasound in scapula alata patients may help determine the presence and severity of a nerve lesion and the subsequent degree of muscle involvement and may therefore serve as a supplement to the clinical diagnosis.

NCT ID: NCT03556098 Completed - Clinical trials for Diabetes Mellitus, Type 1

Glucose-dependent Insulinotropic Polypeptide as a Safeguard Against Hypoglycemia in Patients With Type 1 Diabetes

Start date: February 22, 2019
Phase: N/A
Study type: Interventional

In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in patients with T1D.