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NCT ID: NCT04652141 Recruiting - Asthma Clinical Trials

Asthma Diagnosis Verified by Lung Function

ADVERT
Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Guidelines suggests that asthma should not be treated prior to a reversibility test and/or an assessment with peak expiratory flow (PEF) unless there is a clinical urgency for the patient to be treated. Approximately one third of patients with diagnosed asthma can safely step-wise withdraw their asthma medication and diagnosis based on repeated objective lung function measurements. AsthmaTuner is CE-marked and provides doctors and nurses with information on patient spirometry incl. reversibility test and diurnal or weekly variability of PEF in relation perceived symptoms. Thereby, digital supported asthma care with AsthmaTuner can improve objective diagnosis of asthma. The objectives of this study are to evaluate the sensitivity and specificity to establish objective asthma diagnosis with spirometry including reversibility test and PEF-monitoring with AsthmaTuner, and secondary, assess the number of asthma patients with objective verified asthma diagnosis with use of spirometry including reversibility test and/or periodic variability with PEF/FEV1 between traditional trial treatment and treatment with AsthmaTuner. At least 146 patients will be included who are at least six years old, with respiratory symptoms that can be signed to asthma last month or with physician-diagnosed asthma last five years without intake of anti-inflammatory treatment in the last three months. This is a randomised controlled trial evaluating a diagnostic two step algorithm that firstly includes dynamic spirometry with a reversibility test and PEF/FEV1 monitoring with AsthmaTuner during 2-4 weeks, and secondly randomization to traditional trial treatment with dynamic spirometry with a reversibility test, or AsthmaTuner incl. PEF/FEV1 monitoring during trial treatment. We plan to include in total 146 patients in primary care with either undiagnosed asthma having respiratory symptoms that can be signed to asthma last month, or patients with a asthma diagnosis last 5 years but no intake of regular anti-inflammatory asthma medication last 3 months. The study start in early 2021 and finish in 2023.

NCT ID: NCT04651673 Recruiting - Knee Osteoarthritis Clinical Trials

Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)

Start date: September 9, 2020
Phase:
Study type: Observational [Patient Registry]

The study is a non-controlled retro- and prospective multi center patient registry study. Subjects will be given a study ID number assigned at first brace fitting after consenting to partake. Participants will be asked to fill in a questionnaire either in electronic or paper version at first fitting. Additional follow up questionnaires will be implemented at 4 weeks, 6 months and 1 year post initial brace fitting. After that period patients will be contacted every year, until brace termination/ knee surgery or death.

NCT ID: NCT04651621 Recruiting - Clinical trials for Auditory Hallucination

SMA Targeted Magnetic Stimulation Against Auditory Verbal Hallucinations

SMA-AVH
Start date: November 2, 2020
Phase: N/A
Study type: Interventional

Auditory verbal hallucinations (AVH) are prevalent among patients with psychiatric disorders. Not only being highly stressful and functionally impairing, AVH often persist despite treatment. Recent attempts to treat AVH with add-on repetitive transcranial magnetic stimulation (rTMS) when targeting the temporoparietal junction (TPJ), a language node in the brain, has gained limited success. The aim of this investigation is to reduce AVH with rTMS using continous theta-burst stimulation over a novel target, the supplementary motor area (SMA), in participants with frequent AVH, while also assessing potential neurophysiological mechanisms underlying the symptom.

NCT ID: NCT04651400 Completed - Covid19 Clinical Trials

Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection

Start date: October 19, 2020
Phase:
Study type: Observational

Multicentre, multinational, non-interventional, observational, retrospective, patient record study to evaluate changes in coagulation parameters in patients with severe COVID-19 infection receiving/not treatment with antithrombin (AT) III

NCT ID: NCT04649879 Completed - Covid19 Clinical Trials

Convalescent Plasma for Treatment of COVID-19

Start date: December 3, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicate that it is safe for treatment of COVID-19. We found that viremia upon admission identifies patients at 7 fold increased risk of admission to intensive care and 8 fold increased risk of death. CP treatment appeared to result in rapid viral clearance in a small case series. CP appeared to be well tolerated in a phase I study in which patients only received one dose of CP and a phase II study in which CP was given until viremia disappeared (unpublished data). Randomised controlled studies assessing the efficacy of CP are lacking and thus the efficacy of CP is unknown. Preliminary data indicate that treatment should be given early, prior to development of severe illness. Detection of viremia upon admission identifies a group at high risk of severe disease and death that has the most to benefit from CP. Phase II study data indicates that treatment should be given until SARS-CoV-2 is no longer detected in serum and the donor antibody neutralization titres should be ≥1/640. A randomised controlled trial in which viremic patients are treated with CP with the equivalent of an antibody titre ≥1/640 is thus required to determine if CP can be an effective COVID-19 treatment.

NCT ID: NCT04649593 Completed - Dystocia Clinical Trials

The Study of Giving Birth, a Study About Treatment of Labor Dystocia

GB
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Labor dystocia is an intransigent, high-profile issue in obstetric care, which causes significant maternal morbidity in low resource settings and maternal dissatisfaction, and increased healthcare costs worldwide. Amniotic fluid lactate, (AFL), values have recently been shown to reflect the metabolic status of the uterus and high levels have a strong association with subsequent need for operative intervention due to dystocia. In sports medicine, it is known that lactic acid can affect muscular performance but be decreased by bicarbonate given orally before physical activity. Main Outcome Measures: If an intake of bicarbonate, one hour before stimulation with oxytocin in cases with a high AFL value, changes the AFL levels and enhances delivery outcome in dystocic deliveries. Design: Randomized controlled trial

NCT ID: NCT04649437 Completed - Atrial Fibrillation Clinical Trials

Atrial Fibrillation Symptoms and Pain Sensitization

Start date: November 26, 2020
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is the most common sustained arrhythmia and the number of patients with AF is expected to increase substantially in the coming decades. One third of patients with AF report no AF-associated symptoms, but up to one fourth report severe symptoms such as chest pain. It is well recognized, but unclear why patients' experience of AF-related symptoms, including chest pain, varies so much. Patients with chronic pain show a high degree of central sensitization, i.e. facilitated pain responses to repeated painful stimulation and impaired conditioned pain modulation, compared with controls. It is possible that patients with symptomatic AF may have developed pronounced pain sensitization even in the absence of chest pain as a symptom. No previous study has investigated pain sensitization in patients with AF. The primary objective is to assess differences in pain sensitization in patients with symptomatic AF compared with patients with asymptomatic AF. Secondary objectives are to study the association of age, sex, AF duration, comorbidities and health-related quality of life to pain sensitization. A total of 30 patients with permanent AF (15 symptomatic and 15 asymptomatic) will be recruited. Patients will complete an AF-specific symptom score and a generic health-related quality of life questionnaire, and physicians will assess AF-related symptoms. Quantitative sensory testing recordings will be collected by pressure algometry. Assessment of temporal summation of pressure pain and conditioning pain modulation will be used to investigate the involvement of pain sensitization. This preliminary pilot study will be used to estimate sample size for a larger study in which both patients and control subjects will be recruited, to further investigate whether patients with symptomatic AF have increased pain sensitization compared with patients with asymptomatic AF and controls. The studies may have an impact on individualized management of patients with AF in the future.

NCT ID: NCT04649307 Completed - Clinical trials for Myocardial Infarction

Cognitive Behavioral Therapy Following Myocardial Infarction

MI-CBT
Start date: December 29, 2020
Phase: N/A
Study type: Interventional

Myocardial infarction (MI) is one of the leading cause s of health loss globally, representing a large proportion of general disability. Anxiety and depression occur in 20-30 percent of patients following MI and have been identified as risk factors for recurrent adverse cardiac event. The purpose of our this study is to develop and evaluate a disease specific cognitive behavioral therapy (C BT) protocol to reduce cardia anxiety, depression, increase physical inactivity and quality of life (Q oL) in patients following MI.

NCT ID: NCT04649281 Recruiting - Chronic Pain Clinical Trials

Insomnia and Sleep Disturbances in Chronic Pain Patients - Relation to Physical Activity Level and Opioid Use

Start date: October 12, 2020
Phase: N/A
Study type: Interventional

Pain is one of the most common causes of healthcare contact and long-term sick leave, with negative consequences on physical and mental health. Poor sleep is common in chronic pain patients. Epidemiological studies indicate that 5-7% of patients with chronic pain are treated regularly with strong opioids. Negative side effects of pain modulating drugs on sleep quality have been reported, which may have negative influence on overall disease management in chronic pain patients. However, to date there are conflicting results regarding the effects of opioids on sleep, since the pain relieving effect of opioids seem to affect sleep positively. There is data suggesting that physical activity has positive effects on both pain perception and sleep quality (and duration). The aim of the study is to explore insomnia and characteristics of sleep in patients with chronic pain and the relationship with physical activity level and opioid use.

NCT ID: NCT04649242 Recruiting - Pediatric Migraine Clinical Trials

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Start date: January 15, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.