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NCT ID: NCT04856098 Completed - Healthy Volunteers Clinical Trials

Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler

FINDA
Start date: May 7, 2021
Phase: Phase 1
Study type: Interventional

The objective of this study is to assess pharmacokinetics (PK) of indacaterol and glycopyrronium, and methodology and practical arrangements for future studies.

NCT ID: NCT04854291 Completed - Parkinson Disease Clinical Trials

A Trial of Fecal Microbiome Transplantation in Parkinson's Disease Patients

Start date: April 25, 2021
Phase: N/A
Study type: Interventional

48 PD patients (age 35-75y; H&Y 1-3) testing positive in a stool PD-dysbiosis test will be randomized in a 2:1 ratio to receive either donor FMT or their own stool through intracaecal infusion. The main outcome measure will be the sum of MDS-UPDRS I-III at 6 months to cover motor and non-motor symptom changes. A wide array of secondary clinical outcome measures will be assessed longitudinally and a large array of measurements, biospecimens (stool, urine, blood, colonic biopsies), and imaging data will be collected for further analysis at baseline, 1, 6, and 12 months.

NCT ID: NCT04850144 Completed - Healthy Volunteers Clinical Trials

Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®

TESSA
Start date: April 26, 2021
Phase: Phase 1
Study type: Interventional

Absorption of inhaled tiotropium is compared between five Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler without charcoal. Absorption of tiotropium is compared between one Easyhaler product variant administered with and without charcoal.

NCT ID: NCT04833153 Completed - Clinical trials for Nurse-Patient Relations

Continuing Education Intervention Named "Person First - Please"

PFP
Start date: August 30, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effectiveness of the Person-First - Please (PFP) intervention in supporting nurse's competence and collective competence of Person-Centred Care (PCC) in older people Long-Term Care (LTC). The goal is to promote PCC culture in older people LTC. Research question 1: What is the effectiveness of the PFP intervention on the PCC collective competency of nurses in older people LTC? Hypothesis for research question 1 are: 1. Nurses in intervention group will have higher level of competence of PCC than control. Research question 2: How PCC climate has been maintained in older people LTC from the point of view of the nurses, next of kin and older people? Hypothesis for research question 2 are: 1. PCC climate will be better in intervention group than control from point of view of the nurses, next of kin and older people. 2. The higher competence of nurses the higher level of PCC climate from point of view of the next of kin and older people. 3. The higher collective competence of the nurses the higher level of the PCC climate from point of view of the next of kin and older people.

NCT ID: NCT04826861 Completed - Clinical trials for Overweight or Obesity

Supporting Lifestyle Change in Obese Pregnant Mothers Through Wearable Internet-of-Things (SLIM)

SLIM
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Maternal obesity increases risks for the mother and her child. It is crucial to arouse the pregnant and postpartum women´s willingness of change and motivation to take care of their own and their unborn child´s health. Wearable devices can be helpful for weight-management, e.g. in improving participant's self-efficacy in making healthy behavior changes, improving self-awareness, in goal setting and getting feedback. More comprehensive research is required to implement the optimal weight-management intervention for overweight women during pregnancy and the postpartum period and to develop appropriate and feasible implementation strategies to support nurses to deliver interventions in maternity clinics. The aim of this study is to evaluate the effectiveness of the Supporting Lifestyle Change in Obese Pregnant Mothers Through Wearable Internet-of-Things (SLIM) intervention. Secondary aim is to evaluate the implementation of SLIM intervention in maternity care. Intervention was developed based on findings of overweight women and their care givers interview study. The intervention targeting overweight pregnant women to improve their weight-management will be delivered during routine perinatal visits from the first visit to three months after child birth. Interventions core components will be goalsetting, motivational interviewing, feedback and health technology. Health technology includes Oura-ring and ZotCare -application. ZotCare -application combines data from Oura Smart Ring, electronic food diary and it´s also platform for researchers to send e.g. questionnaires and surveys to participants. Oura-smartring is an advanced technology ring that monitors e.g. heart rate, heart rate variability (HRV), steps, body temperature and sleep) and a smartphone application that includes data from Oura, and electronic food diary. Data collected with Oura -smartrings will be transmitted to cloud servers via a smartphone. The cloud will be responsible for storing the data and for performing the data preprocessing and analysis methods. Interventions primary outcome will be self-efficacy. Secondary outcomes will be womens weight, depression symptoms, quality of life, pregnancy anxiety, perceived stress, sence of coherence and acceptability, appropriateness and feasibility of Intervention. Data will be collected via Oura smartring, electronic food diary and validated measures: Weight Efficacy Life-Style Questionnaire (WEL), Self-Efficacy for Physical Activity Scale (PASE), six-factor questionnaire (6-FQ), Three Factor Eating Questionnaire (TFEQ-R18), WHOQOL-BREF, Sense of coherence (SOC-13), Pregnancy anxiety (PRAQ-R2), Perceived stress and Edinburgh Postnatal Depression scale (EPDS). Intervention implementation will be evaluated with process evaluation. Data will be collected from public health nurses working in maternity clinics using focus group interviews and workshops.

NCT ID: NCT04826172 Completed - Clinical trials for Coronary Artery Disease

Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease (IMPROVE-Ischemia)

Start date: April 23, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of IMB-1018972 in subjects with obstructive CAD and inducible ischemia.

NCT ID: NCT04819113 Completed - Clinical trials for Meningococcal Vaccine

Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age

Start date: April 9, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and immunogenicity of a single dose of Nimenrix in infants at 3 months of age, followed by a second dose at 12 months of age. Current posology allows for 2 doses of Nimenrix before 6 months of age, where the first dose is administered from 6 weeks onwards with a second dose at least 2 months later, with a booster at 12 months; and in infants from 6 months of age, a single dose at 6 months, with a booster dose at 12 months. This study will provide valuable immunogenicity and safety data for a single dose in healthy infants <6 months of age, followed by the booster at 12 months

NCT ID: NCT04816643 Completed - Clinical trials for SARS-CoV-2 Infection, COVID-19

A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

Start date: March 24, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants <6 months of age may subsequently be evaluated.

NCT ID: NCT04792385 Completed - Safety Clinical Trials

Safety, Compliance and Pharmacokinetics of Estetrol Monohydrate/Drospirenone 15/3 mg in Post-menarchal Female Adolescents

Start date: December 28, 2020
Phase: Phase 3
Study type: Interventional

To evaluate the safety, compliance, and pharmacokinetics profile of estetrol monohydrate (E4) 15 mg combined with drospirenone (DRSP) 3 mg in post-menarchal participants between the age of 12 and 17 years + 2 months.

NCT ID: NCT04783935 Completed - Multiple Sclerosis Clinical Trials

Extension to the MAGNIFY MS Trial on Mavenclad® (Magnify MS Extension)

Start date: March 10, 2021
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to evaluate the long-term effectiveness of Mavenclad® tablets, in terms of disease activity and safety, in participants with highly-active relapsing multiple sclerosis (RMS) previously participating in the MAGNIFY MS trial MS700568_0022 (NCT03364036).