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NCT ID: NCT04120402 Completed - Clinical trials for Osteoarthritis, Knee

Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee

Start date: September 10, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of EP-104IAR in patients with osteoarthritis (OA) of the knee

NCT ID: NCT04119856 Completed - COPD Clinical Trials

Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD

Start date: September 25, 2017
Phase: N/A
Study type: Interventional

This study examines the effects of the work of an outgoing lung team in the Municipality of Aarhus, Denmark to patients with COPD (Chronic obstructive pulmonary disease) at risk of exacerbation of COPD. The outgoing lung team is a cross-sectorial team of nurses and doctors from Department of Respiratory Diseases and Allergy at Aarhus University Hospital and nurses from the Acute Team in the Municipality of Aarhus. The work of the outgoing lung team takes place in the patient's home and involves the following: - The outgoing lung team teaches the patients, relatives and primary care staff about symptoms, treatments and instructions related to COPD. - The patients, relatives and primary care staff can contact the outgoing lung team by telephone day and night. - The outgoing lung team initiates appropriate treatment by telephone or a home visit in consultation with a doctor. - The patients report symptoms and measurements to the outgoing lung team using telemedicine solutions (AmbuFlex). - The outgoing lung team initiates acute consultations at Department of Respiratory Diseases and Allergy based on patient reported outcomes, home visit or telephone call. Half of the participants are affiliated to the outgoing lung team, while the other half are not, and continue their usual practice by contacting the general practitioners in case of exacerbation of COPD. The main hypothesis of the project is that outgoing lung team has a positive impact on continuity of care across sectors in the Danish healthcare system for patients with COPD. More specifically the hypotheses are: 1. Affiliation to the outgoing lung team reduces admissions, readmissions, length of hospital stay and outpatient consultations. 2. Affiliation to the outgoing lung team reduces anxiety and depression and increases patient involvement, and improves patients' health status and self-efficacy. 3. Affiliation to the outgoing lung team increases patients' level of health literacy.

NCT ID: NCT04118426 Completed - Radiation Toxicity Clinical Trials

Cognitive Function After Radiation Therapy for Brain Tumours

WP-12-pre
Start date: February 7, 2017
Phase:
Study type: Observational

This study will assess cognitive function in adult patients with a primary brain tumour treated with surgical resection with or without radiation therapy (RT). All types of brain tumours apart from glioblastoma will be included

NCT ID: NCT04117178 Completed - Alzheimer Disease Clinical Trials

Monitoring Anti-Dementia Drugs by Serum Levels

MONANTI
Start date: February 4, 2020
Phase: Phase 4
Study type: Interventional

The main objective of the MONANTI study is twofold: Firstly, to determine the amount of the anti-dementia drugs donepezil and memantine in the blood (henceforth mentioned as 'serum level) in a broadly defined clinical population of patients suffering from dementia treated with the two drugs in question. Secondly, to determine whether adjustment of treatment of anti-dementia medication according to serum levels will benefit patients in terms of cognitive performance, quality of life, frequency and severity of side effects. The reason for conduction of this study is that the relationship between serum-level of anti-dementia drugs, clinical efficacy, compliance and side effects has only been scarcely investigated. Both a previously published study and a preliminary (pilot)study conducted imply that roughly 50 % of patients on donepezil have serum-levels outside the recommended interval. Thus, MONANTI will investigate if this is indeed the case in a broadly comprised population of patients suffering from dementia treated with donepezil or memantine. In addition, MONANTI will link serum levels to co-morbidity, level of compliance, medication interactions. It is hypothesized that the efficacy of anti-dementia medication can be significantly improved by adjustment of treatment according to serum levels. Also, it is hypothesized that the burden of side effects can be reduced in patients in whom too high serum levels are detected, if dosage reduction or change of treatment drug is done. MONANTI is a randomized study, in which the assessor is blinded to avoid related biases to the extent possible. To fit the enrollment criteria a patient must be newly diagnosed with either Alzheimer's disease, dementia with Lewy-bodies or Parkinson's disease with dementia and be described treatment with either donepezil or memantine. Also, the patient must not meet a list of (exclusion) criteria, which have been set up in order to avoid blur and biases of the results. Patients can be selected as participators on account of the above, including an informed consent to participation. Next, the participators will randomized be assigned to one of two study arms. In the first of these, the control arm, the participators receive only standard treatment and follow-up at the outpatient clinic, except for measurement of serum level of the anti-dementia medication with which they are treated and a genetic test for a few key genes thought to be relevant for the study (two liver enzymes, two genes linked to Alzheimer's disease). In the other arm, the intervention arm, the participators will be closely monitored for side effects after prescription of anti-dementia drugs. All these participators will be offered a measurement of serum level in case they experience possible side effects within 2 months of treatment initiation. If, not a measurement of the serum level will be done after 6 months. All patients in the intervention arm, will be offered adjustment of their treatment with the anti-dementia drug based upon serum level. To assess the possible effects of treatment adjustment seven clinical scoring tests will be used (MMSE, ACE, clock-drawing test, NPI-Q, DAD, GCI, GDS). Assessment includes symptom severity and level of compliance according to close relatives. To measure the effect of donepezil on brain (cholinergic) function 30 participants will be recruited for electroencephalography (EEG). These participants will have an EEG done at enrollment and after 6 months. In addition to the quantitative part study a qualitative part study with relatives of enrolled patients will be conducted. All the needed approvals have been obtained according to Danish law (approval by the Danish Data Protection Agency, Scientific Ethics Committee for Region Sjaelland, The Danish Medical Agencies).

NCT ID: NCT04115462 Completed - Itch Clinical Trials

A Relation of Morphine-induced Itch and Pain Processing

Start date: January 15, 2020
Phase: N/A
Study type: Interventional

In This experiment, the investigators would like to test the two following hypotheses regarding the mechanisms by which opioids cause itch: 1. Opioids cause itch by a spinal disinhibition mechanism (central nervous system (CNS) effect). 2. Opioids cause itch through a mast cell-destabilizing effect leading to release of histamine and tryptase in the skin where itch is evoked (peripheral mechanism).

NCT ID: NCT04114773 Completed - Clinical trials for Cardiac Arrest With Successful Resuscitation

Rehabilitation for Survivors of Cardiac Arrest Focused on Fatigue

SCARF
Start date: October 11, 2019
Phase: N/A
Study type: Interventional

More people are surviving a cardiac arrest due to improvements in bystander resuscitation and acute hospital care. However, many survivors of cardiac arrest are left with physical, mental and social problems impacting negatively on their quality of life. At present there are no specialist interventions for survivors of cardiac arrest in Denmark and very few have been evaluated internationally. Rehabilitation for people after cardiac events or brain injury have shown significant physical and mental well-being benefits, indicating the same may be true for survivors of cardiac arrest. This pilot study will test the feasibility and acceptability of a residential rehabilitation intervention focused on fatigue, and the physical, mental and social consequences of cardiac arrest. In addition, the pilot study will discover if the intervention has any effect on self-report measures, including fatigue, mental well-being and activity of the survivors of cardiac arrest who participate, and on the mental well-being of relatives of these survivors.

NCT ID: NCT04114695 Completed - Stroke Clinical Trials

Aortic Calcification and Central Blood Pressure in Patients With Chronic Kidney Disease

ACCEPT
Start date: October 15, 2019
Phase:
Study type: Observational

Aim and background: This study will seek to identify physiological and biochemical factors explaining and predicting a higher than expected central (aortic) blood pressure (BP) in patients with chronic kidney disease (CKD). The basic hypothesis of the study is that the degree of aortic calcification is an important component of elevated central BP, which, in turn, is important for the organ-damage and increased risk of cardiovascular disease associated with CKD. Methods: Adult patients with varying degrees of CKD undergoing scheduled coronary angiography (CAG) at Aarhus University Hospital will be included in this study. During the CAG procedure, systolic and diastolic BP is determined in the ascending part of aorta by a calibrated pressure transducer connected to the fluid-filled CAG catheter. Simultaneous with the registration of invasive aortic BP, estimation of central BP is performed using radial artery tonometry (SphygmoCor®), while a corresponding brachial BP is also measured. Prior to the CAG, a non-contrast CT scan of aorta in its entirety will be performed to enable blinded quantification of calcification in the wall of aorta and coronary arteries. Furthermore, echocardiography, resting BP measurement and a range of blood- and urine samples will be performed.

NCT ID: NCT04114097 Completed - Atopic Dermatitis Clinical Trials

The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover

Start date: August 22, 2019
Phase: Phase 4
Study type: Interventional

The investigators believe that the emerging epidemiological evidence connecting topical use of corticosteroids to the development of type 2 diabetes and osteoporosis point to potentially massive, yet clinically unacknowledged problems associated with topical corticosteroid treatment. Using state-of-the-art methodology, the present study will delineate the impact of topical corticosteroid use on insulin sensitivity and bone turnover markers in patients with atopic dermatitis and, thus, provide important data that may have implications for millions of people using topical corticosteroids.

NCT ID: NCT04111484 Completed - Headache, Migraine Clinical Trials

Adrenomedullin Effect on Migraine Without Patients

Start date: September 28, 2019
Phase: N/A
Study type: Interventional

AM is a naturally occurring peptide in the body and consists of 52 amino acids. AM belongs to the calcitonin gene-related peptide (CGRP) superfamily and has several structural, physiological and pharmacological similarities to CGRP, intermdine and amylin. In a randomized double-blind, placebo controlled cross-over design 20 migraine patients without aura recruited to receive infusion of adrenomedullin or placebo (saline).

NCT ID: NCT04109313 Completed - Clinical trials for Chronic Spontaneous Urticaria

An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU

Start date: October 24, 2019
Phase: Phase 2
Study type: Interventional

The main objective to assess the long-term safety and tolerability of LOU064 in patients with chronic spontaneous urticaria (CSU) who have participated in study CLOU064A2201 (NCT03926611)