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NCT ID: NCT04593251 Completed - Celiac Disease Clinical Trials

Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis

Start date: September 28, 2020
Phase: Phase 1
Study type: Interventional

This is a single and multiple ascending study to characterize the safety, PK, PD and clinical effect in healthy volunteers and participants with Celiac Disease and Eosinophilic Esophagitis.

NCT ID: NCT04577534 Completed - Covid19 Clinical Trials

COVID-19: Salvage TOcilizumab as a Rescue Measure

COVIDSTORM
Start date: August 14, 2020
Phase: Phase 3
Study type: Interventional

Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care).

NCT ID: NCT04577079 Completed - Clinical trials for Emergency Medical Services

Klinik - Intelligent Patient Flow Management

Start date: September 1, 2020
Phase:
Study type: Observational

Digital health technologies (DHT) are increasingly developed to support healthcare systems around the world. However, they are frequently lacking evidence-based medicine and medical validation. There is considerable need in the western countries to allocate healthcare resources accurately and give the population detailed and reliable health information enabling to take greater responsibility for their health. Intelligent patient flow management system (IPFM, product name Klinik Frontline) is developed to meet these needs. In practice, IPFM is used for decision support in the triaging and diagnostic processes as well as automatizing the management of inflow of the patients. The core of the IPFM is a clinical artificial intelligence (AI), which utilizes a comprehensive medical database of clinical correlations generated by medical doctors. The study population of this research consists of patients from the Emergency Department of Kuopio University Hospital (KUH). Data will be gathered during 2 weeks of piloting, after which the results will be analysed. Anticipated number of patients to the study is minimum of 246 patients, with objective to be several hundreds. When attending to the hospital, patients will report their demographics, background information and symptoms using structured IPFM online form. Patients entering the unit in an ambulance or with need of immediate care of healthcare professionals due to severe and acute conditions are referred similar to normal process to ensure the patient safety. Results obtained from IPFM are blinded from the healthcare professional and IPFM does not affect professional's clinical decision making in any way. The data obtained from IPFM online form and clinical data from the emergency department and KUH will be analysed after the data collection. The main aim of the research is to validate the use of IPFM by evaluating the association of IPFM output with 1) urgency and severity of the conditions (using Emergency Severity Index [ESI], an international triaging protocol for emergency units, and an assessment by triage nurse); and 2) actual diagnoses diagnosed by medical doctors. The main hypotheses of the research are that 1) IPFM is safe and sensitive in evaluating the urgency of the conditions of arriving patients at the emergency department and that 2) IPFM has sufficient correlation of differential diagnosis with actual diagnosis made by medical doctor.

NCT ID: NCT04571996 Completed - CNS Disease Clinical Trials

Blood-Brain Barrier Penetration of Therapeutic Agents in Human

BRIAN
Start date: October 29, 2020
Phase: Phase 1
Study type: Interventional

This is a phase 1, open-label, non-randomized, exploratory, repeated dose PK study performed at a single centre. Up to 6 evaluable subjects are planned. The subjects will receive p.o. doses of ODM-104 for 5-7 days. Single dose of paracetamol will be administered p.o. together with ODM-104 for purposes of comparison.

NCT ID: NCT04571463 Completed - Clinical trials for Fetal Alcohol Spectrum Disorders

Ethyl Glucuronide in Urine Samples of Pregnant Women Within the HUS ja PHHYKY Area

Start date: October 1, 2020
Phase:
Study type: Observational

In order to find how many women continue using alcohol during their pregnancies the plan is to anonymously test routine urine samples collected during pregnancies for ethylglucuronide (ETG), a metabolite of ethanol that is detectable in urine up to several days after alcohol consumptions. Altogether 600 samples are taken in the prenatal care units and the prenatal care units dedicated for the alcohol and drug abusing mothers both in the Helsinki and Lahti areas. Test results are used to estimate and compare the prevalence of severe maternal drinking in the different populations.

NCT ID: NCT04564105 Completed - Airway Management Clinical Trials

Simulation Training and Teamwork Concerning Intubation on the Icu

Start date: September 4, 2020
Phase: N/A
Study type: Interventional

To assess effects of the simulation education on the group intubating patients in the iCU, in this prospective study investigators will video-record real-life intubations and simulations. From videos will be assessed correlation of technical and non-technical skills before and after the education and performance in real-life vs simulation intubation.

NCT ID: NCT04558801 Completed - Obesity Clinical Trials

Effects of Mobile Application-based Lifestyle Counselling on Body Weight Loss in Obese Subjects

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

The aim of the trial is to study the effect of a mobile application-based lifestyle change program on body weight loss in adult subjects with obesity. The main focus is to motivate and support beneficial lifestyle changes targeting long-term weight management. This study comprises two randomly assigned study arms: mobile application-based lifestyle change program and "waiting-list" control. The mobile application-based lifestyle change program consists of twice a week content for the first 6 months, continuing with less frequent contents for the following 6 months (the length of intervention 12 months). The "waiting-list" control group will receive mobile application-based lifestyle change program after 6 months followed by intervention for 12 months. The main aim is to demonstrate that the users of mobile application-based lifestyle change program lose more weight than controls at 6 month timepoint and weight loss is maintained for 18 months (6 months after the end of mobile application-based lifestyle change program use). Weight is measured and blood samples (lipids, glucose and metabolic syndrome measures) are collected at 0, 6, 12, and 18 months. The mobile application-based counselling contains aspects of cognitive behavior therapy and persuasive system design and consists of twice a week reminders, tasks, self-monitoring, and reflection. The main outcome is the decrease in body weight. Secondary outcomes are changes in eating behavior, psychological factors, components of metabolic syndrome (waist circumference, plasma lipid and glucose values, blood pressure), and calculated scores of metabolic condition and adiposity.

NCT ID: NCT04556422 Completed - Blood Pressure Clinical Trials

Comparison of Acute Sauna With Exercise and Sauna

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

Sauna bathing has been associated with a lower risk for cardiovascular disease (CVD) outcomes, improved vascular endothelial and cardiac function, reduced oxidative stress and lower blood pressure. Earlier studies conducted by the investigators have showed positive alterations of arterial stiffness and hemodynamics through sauna bathing. Some studies have sought to utilize sauna bathing as an intervention after exercise with promising and synergistic results, although the effects on populations with cardiovascular risk factors are less clear. Furthermore, studies investigating the use of both exercise and sauna bathing in combination has been somewhat limited. However, results from some studies speculate that adjunctive exercise and sauna interventions may be useful for aging and clinical patient population groups. Given that heat therapy and sauna use is gaining more worldwide popularity, the investigators sought to compare the acute hemodynamic effects between sauna use alone and a short bout of exercise followed by sauna exposure. It was hypothesize that the combination of exercise and sauna will elicit greater changes than sauna alone. To achieve this, we standardized the protocol duration (30 minutes).

NCT ID: NCT04546425 Completed - Clinical trials for Pneumococcal Disease

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants

Start date: September 9, 2020
Phase: Phase 3
Study type: Interventional

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants

NCT ID: NCT04540718 Completed - Clinical trials for Cardiovascular Risk Factor

Exercise and Sauna on Blood Pressure and Cardiovascular Health

ES2019
Start date: August 8, 2019
Phase: N/A
Study type: Interventional

The study aims to investigate the effects of including regular heat therapy when included to exercise. Specifically, participants in the sauna intervention group will undergo 15 minutes of sauna exposure immediately after a 50-minute session of exercise, 3 times a week, while participants in the exercise intervention group will follow only the same exercise protocol. The 50-minute exercise session consists of 20 minutes of moderate intensity strength exercise, followed by 30 minutes of moderate-vigorous aerobic exercise on stationary bikes. This exercise intervention protocol was selected in order to meet and adhere to the recommended physical activity guidelines.