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NCT ID: NCT05128981 Completed - Clinical trials for Myocardial Infarction

Internet-delivered Cognitive Behavioral Therapy Following Myocardial Infarction

MI-CBT
Start date: October 28, 2021
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: NCT05122390 Completed - Pregnancy Related Clinical Trials

DIGItal Early Labour. A Digital Application for Coping in Early Phase of Labour.

DIGI-EL
Start date: October 15, 2022
Phase: N/A
Study type: Interventional

All first-time mothers in Sweden are offered parental support, but local conditions mean that not everyone gets the opportunity to take part in this. Studies show that there is a lack of evidence-based guidelines for the design of parental support in maternal health care. Early labour or latent phase of labour is the part of childbirth were women often feel insecure, in stress and left out from care. First-time mothers who have no experience of one labour before are particularly vulnerable. Many women today use digital applications during pregnancy and in connection with childbirth. There are several digital applications that will help the woman by guiding her and her partner in different decisions about labour, but it is necessary to offer evidence-based, credible electronic and digital solutions for expectant parents. A meta-synthesis from 2018 showed that women use the internet often and the information they receive there has a great influence on their different choices in connection with childbirth. Volume, accessibility, and convenience about digital solutions play a crucial role for women and partners. The digital application Contraction Coper is designed and tested by the company Birth By Heart © in order to facilitate in early labour for the pregnant woman and her partner. The overall purpose of the project is to evaluate whether the application Contraction Coper can contribute to reduced anxiety and stress during pregnancy and childbirth and whether an additional support from a midwife can increase the application use and satisfaction of women when using the application. A randomized controlled trial is planned where first-time mothers after pregnancy week 25 are invited to participation via social platforms. Participating first-time mothers are randomly assigned to one of three groups; experiment group one, which gets access to the application Contraction Coper, experiment group two Contraction Coper Plus which gets access to both the application and support of midwives, so-called "blended" care, or three, the control group offered customary maternity care only. Data collection is conducted using questionnaires, mobile application and activity bracelet.

NCT ID: NCT05118529 Completed - Mobilization Clinical Trials

Physiological Response and Experience Between Sitting in Bed and Sitting in a Chair in ICU

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Background: In the work with early mobilization (EM), in intensive care, several types of EM are used A sitting in bed in semi- Fowler's position, sitting on the edge of the bed, and sitting in a chair. Nowadays, it is often possible to achieve a comfortable sitting in the beds in ICU. However, in a recent study by the same author group one of the findings was the importance to get out of bed. Getting out of bed was associated with decreasing feelings of hopelessness and being less ill. It also encouraged the will to fight for recovery. There are few studies in intensive care that have examined what happens to circulation and oxygenation in various forms of sitting. Studies that examined the patient's own experience of sitting in bed compared to sitting in a chair are missing. The aim is therefore to investigate physiological response and experience in patients in intensive care when sitting in bed or in a chair Method: Repeated measures randomized cross-over study Selection: Patients with respiratory and / or circulatory insufficiency requiring intensive care, Inclusion criteria: Approximately 30 respiratory and circulatory stable patients with emergency admission to intensive care. Aged over 18 years, who understands Swedish. The patient and / or relative are asked after the physician in charge has given medical approval. Recruitment is planned to be done by nurses in charge at the unit. Exclusion criteria: Patients who have undergone planned surgery without complications. Intervention: The participants in the study will be measured in two different positions; sitting in bed and sitting in chair. They are randomized to start either sitting in bed or in a chair and will sit for 20 minutes in each position, at 4 - hour intervals. Data collection, physiological variables: The following physiological variables will be measured: Blood pressure and oxygenation by arterial needle and pulse by ECG. They will be measured before the intervention, at the beginning of the intervention, after ten minutes, at the end of the intervention and ten minutes afterwards Data collection, qualitative variables: Rating of the experience of exertion, pain and satisfaction. Data analysis: Statistical analysis of differences between the two positions. For quantitative variables that are normally distributed, paired t-tests will be used. For qualitative variables and non-normally distributed quantitative variables, Wilcoxon character rank test or Mc Nemar test will be used

NCT ID: NCT05112276 Completed - Clinical trials for Healthy, Overweight, Obese

Food4GutMarKIT - Evaluation of a Tailored Personalized Food Concept for a Healthy Gut Microbiota and Validation of Biomarkers for Monitoring of Its Effects

Start date: October 27, 2021
Phase: N/A
Study type: Interventional

The overall aim in this "proof-of-concept" study is to evaluate if a diet concept, based on foods that have individually been reported to beneficially affect gut microbiota in fact has an effect on gut microbiota composition and activity among healthy and obese subjects and whether the effects are associated with altered cardiometabolic risk factors. The aim is further to investigate if such alterations are reflected in changes of the fecal and plasma metabolome. In total, 40 men and women, who meet all the inclusion criteria and none of the exclusion criteria will be invited to participate in the study. The participants will follow an intervention diet for 6 weeks and a control diet for 6 weeks, with a 6-week wash-out period in between and will be randomized to either begin with the intervention diet or the control diet. The study will be running over 18 weeks (including a 6-week wash-out period) and it will include 9 visits at the clinic.

NCT ID: NCT05111951 Completed - Stroke Clinical Trials

Mobile Health to Promote Physical Activity Post Stroke

ENAbLE-Swe
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Support for physical activity is necessary to sustain health and reduce the risk of stroke recurrence after stroke or transient ischemic attack (TIA). Still, rehabilitation services are not available to many of those who potentially would benefit from such services largely due to barriers related to accessibility. While mobile health is a promising strategy to support physical activity, there is a gap in knowledge regarding the implementation of technology that meet the needs of people post stroke or TIA in order to foster adherence and engagement in physical activity. This project therefore seeks to improve health and reduce the risk of recurrent stroke among people post stroke or TIA by increasing the access to physical activity through telehealth. The present project builds on experiences of telehealth-delivered physical activity in Australia where restricted access to health-care services is a longstanding problem. Collaborating researchers in Australia have developed a telehealth program (i-REBOUND- Let's get moving) which has been designed and tested in collaboration with end users, through a series of feasibility and pilot studies. The i-REBOUND program provides support for physical activity through physical exercises supervised by a physiotherapist and behavior change techniques for physical activity (i.e. individual counseling, information, recommendations, goal-setting, self-monitoring and structured follow-ups) across 6 months. The intervention is delivered to people post stroke or TIA in their own homes via video-meeting. This study, which is conducted in Sweden, aims to evaluate if the i-REBOUND program supported by a new mobile application could be delivered as intended through a pilot randomized controlled trial in order to determine the feasibility and preliminary effects in people post stroke or TIA living in urban and rural regions of Sweden.

NCT ID: NCT05111704 Completed - Clinical trials for Neck Pain, Posterior

Short-term Effects of Postural Taping on Pain and Neck Posture

Start date: January 16, 2018
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the effects of a short treatment period with Balance Body Tape on the intensity of perceived neck, shoulder and back pain and neck posture.

NCT ID: NCT05111535 Completed - Acute Kidney Injury Clinical Trials

Stockholm Acute Kidney Injury Cohort

SAKIS
Start date: January 1, 2009
Phase:
Study type: Observational

Since 2009, adult patients with acute kindney injury (AKI) at the department of Nephrology, Danderyd University Hospital and Karolinska Institutet, have been included in a prospective cohort. All patients were treated and evaluated according to a detailed clinical memorandum, and data collected prospectively. By 2020, 1861 patiens have been included of which 1519 fulfill current AKI criteria (as defined by KDIGO AKI guidelines) and will be evaluated regarding the following main research questions: 1. Descriptive study on patient characteristics, changes in biomarkers and in-hospital outcome. 2. One year outcome with focus on renal and cardiovascular outcomes. 3. Long-term outcome (up to 10 years) with focus on renal and cardiovascular outcomes.

NCT ID: NCT05111457 Completed - Injury;Sports Clinical Trials

Injuries in Swedish Padel

Start date: November 1, 2021
Phase:
Study type: Observational

The purpose of this project is to investigate the injury panorama of acute and overuse injuries in women and men who regularly participate padel. The intention is to provide insights on injury prevalence, injury location, injury consequences, gender differences and risk factors . This study will be conducted as a retrospective cohort study where the participants consist of female and male padle players, both at the recreational and competition level, with at least 6 months' experience in the sport. The information from this project can be valuable in the work of identifying risk factors for padle injuries and injury prevention strategies.

NCT ID: NCT05109741 Completed - Depression Clinical Trials

Internet-based Psychodynamic Therapy Compared to Behavioral Activation - a Randomized Controlled Trial

ELSA
Start date: October 4, 2021
Phase: N/A
Study type: Interventional

There are several treatment options for depression, including Internet-delivered psychotherapy. While a majority of this research is based on cognitive behavior therapy (ICBT), there are also several recent studies investigating Internet-delivered psychodynamic therapy (IPDT). Importantly though, these treatments have never been directly compared in a randomized controlled trial. In this project, we aim to include 350 patients with depression randomized to ten weeks of IPDT (N=150), ICBT in the form of behavioral activation (N=150) or waiting list (N=50). After the end of the treatment period, patients on the waiting list will also be offered treatment. A secure web platform (KI eHealth Core Facility) will be used to provide treatment via the Internet. Symptoms of depression will be measured weekly and the effect will be evaluated by comparing the change in the treatment groups with each other and with the change in the waiting list group. Treatment effects and predictors of treatment response will be examined. In summary, this project is an important step in the continued evaluation of internet-based psychological treatments for depression.

NCT ID: NCT05103657 Completed - Clinical trials for Post-Traumatic Stress Disorder

A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder

Start date: December 7, 2021
Phase: Phase 2
Study type: Interventional

This study is open to people aged 18 to 65 who have post-traumatic stress disorder. The purpose of this study is to find out whether a medicine called BI 1358894 improves symptoms in people with post-traumatic stress disorder. Participants are put into 2 groups randomly, which means by chance. Participants take BI 1358894 or placebo as tablets every day for 2 months. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 4 phone calls from the trial staff. During the study, participants answer questions in interviews and complete questionnaires so the doctors can check whether their symptoms change. The doctors also regularly check participants' health and take note of any unwanted effects.