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NCT ID: NCT04736628 Completed - Clinical trials for Chronic Kidney Disease

A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease

Start date: April 27, 2021
Phase: Phase 2
Study type: Interventional

This study is open to adults who have kidney disease that is not caused by diabetes. The purpose of the study is to find out whether a medicine called avenciguat (BI 685509) improves kidney function. Three different doses of avenciguat are tested in this study. Participants get either one of the three doses of avenciguat or placebo. It is decided by chance who gets which avenciguat dose and who gets placebo. Participants take avenciguat or placebo as tablets 3 times a day. Placebo tablets look like avenciguat tablets but do not contain any medicine. Participants continue taking their usual medicine for kidney disease throughout the study. Participants are in the study for about 7 months. During this time, they visit the study site about 11 times. Where possible, about 6 of the 11 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Kidney function is assessed based on the analysis of urine samples, which participants collect at home. At the end of the trial the results are compared between the different doses of avenciguat and placebo. During the study, the doctors also regularly check the general health of the participants.

NCT ID: NCT04736407 Completed - Clinical trials for Ventriculitis, Cerebral

Diagnostics of External Ventricular Drain Infections in Neurosurgical Patients

EVD-Infect
Start date: October 5, 2017
Phase:
Study type: Observational

External ventricular drains (EVD) are small tubes used in neuro-critical care inserted to measure pressure and treat acute build-up of fluid in the brain by draining the cerebrospinal fluid (CSF) in the ventricles, often following an event of traumatic or spontaneous bleeding. While essential to the care of these patients, EVDs run the risk of introducing bacteria into the brain of the patient, causing an EVD associated infection (EVDI). EVDIs are feared complications that are difficult to identify and predict in an intensive care setting. In order to allow for early identification of these infections, CSF is routinely sampled from the EVDs and its constitution analyzed for signs of infection. However, the constitution of the CSF in neuro-critical care patients are often difficult to assess as it is frequently mixed with blood that often clouds clinical decision making. No fast parameter has been found to yet reliably predict or identify these infections, resulting in excessive treatment with broad-spectrum antibiotics in this patient group. EVDI diagnostics rely on mainly CSF analyses and cultures (growth of bacteria in the laboratory). Growing bacteria in the lab may take many days and can seldom guide early decision-making for these infections. Thus, EVDI diagnostics mainly rely on the analysis of the CSF constitution. Many diagnostic criteria rely on the relationship between white and red blood cells in the CSF, with red blood cells being introduced in the CSF following the brain bleed , and white blood cells being seen as a response to infection. These criteria assume that the blood is homogeneous in the CSF. However, from computed tomography (CT) imaging of these patients, it is seen that blood can settle in the brain ventricles. In this study we aim to test the assumption that blood is homogeneously distributed in the CSF by sampling from the CSF in patients. Two samples are serially drawn allocated to a period between where patients are planned for a clinical repositioning, or not. We hypothesise that a heterogeneous distribution of blood in the CSF (as seen on CT imaging) may allow for the CSF constitution to change in serially drawn CSF samples, and that these changes may be exacerbated in repositioned patients as it may disturb the blood that has settled at the bottom of the ventricles as a result of gravity sedimentation. We further believe that these changes may affect clinical decision making and further complicate EVDI diagnostics.

NCT ID: NCT04734886 Completed - Covid19 Clinical Trials

The Effect of Probiotic Supplementation on SARS-CoV-2 Antibody Response After COVID-19

Start date: November 27, 2020
Phase: N/A
Study type: Interventional

This study will explore how a well-known probiotic strain L. reuteri DSM 17938 impacts SARS-CoV-2 specific antibody response upon and after infection in healthy adults.

NCT ID: NCT04731454 Completed - Depression Clinical Trials

Feasibility and Acceptability of a Healthy Nordic Diet Intervention in Depressed and Non-depressed Adults

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

In the future, we plan to conduct an 8-week diet intervention to investigate whether a healthy Nordic diet improves depression symptoms. The present pilot study tested whether the planned meals and diets were well-liked and accepted by participants (both depressed and non-depressed) in order to ensure that the future diet intervention will be feasible and successful. We also investigated whether any changes in health occurred after 8 days of this diet intervention.

NCT ID: NCT04729634 Completed - Heart Diseases Clinical Trials

Survey Of Mobilisation and Breathing Exercises After Thoracic and Abdominal Surgery

SOMBATA
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Background Thoracic or abdominal surgeries are followed by a shorter or longer period of immobilization and after major surgery there is a higher risk of developing cardiorespiratory complications. To prevent these complications, the patient is encouraged to change position and exercise in bed, get out of bed as early and as much as possible after the operation and to breathe with or without aids. There is no general definition of early mobilization and may start within a few hours to a few days after surgery. There is currently a lack of knowledge nationally and internationally about when the mobilization starts and what it contains. Many patients also receive breathing training in connection with the surgery. There is currently no consensus on which method is preferable for which groups of patients. There are similarities and differences in practice in the world regarding postoperative breathing training. There are studies that have mapped practice after primarily thoracic surgery but also abdominal surgery. However, there are no studies that have mapped when the prescribed breathing training starts after different types of operations. The purpose of the study is to map when mobilization and breathing training starts after abdominal and thoracic surgery and what is then performed Method The study will be carried out as a quality follow-up with mapping of practice. Patients ≥ 18 years of age who are undergoing a planned or acute open, keyhole or robot-assisted surgery, who are extubated and who breathe spontaneously will be included. Exclusion criteria are completed plastic, trauma, orthopedic or transplant surgery. The material will be recruited from Swedish university hospitals and county hospitals for 20 days of surgery (Monday through Thursday) for five consecutive weeks. Clinical benefit The study will mean that clinical practice is presented which, with regard to mobilization, is the first study ever that will present when this takes place and what is done and, with regard to breathing training, the first that shows when this training is initiated.

NCT ID: NCT04728555 Completed - Anxiety State Clinical Trials

Intervention of a Game About Radiotherapy for Children With Cancer

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

Background: Radiotherapy (RT) can be stressful and challenging for children exposed to a highly technical environment with large radiation equipment and immobilization devices. A pedagogical digital game about RT has been developed. Children who have received RT participated in work-shops and contributed with their experiences and suggestions. Aim: To explore whether the intervention with a pedagogical digital game facilitate understanding, choice of distraction, creation of a sense of calmness and self-efficacy prior to and during RT and to describe the children's and the parents experiences and use of the game as a pedagogical tool. Further, to investigate feasibility in terms of reach, usability and acceptability. Method: A feasibility and prospective waiting list control design is planned by recruiting 60 children (5-14 years) and their parents, for randomization into two groups. The first group will receive the game five days before start of RT. All children will have standard information one day before RT. The second group will have access to the game three days after start of treatment. The effects of the game will be investigated before and during RT and between groups as they receive the game at different time. Children will answer questionnaires about self-assessed anxiety, understanding of the procedure, distraction strategies, self-efficacy to remain motionless. Statistical comparative and correlational analyses will be calculated. Interviews will be performed with 12 children and 24 parents. Changes and further development of the game will be implemented based on the results of the responses. Significance: The game can support children to undergo RT and be used nationally to prepare for RT. Thus all children receive similar information regardless of where they live, and contribute to increased knowledge, autonomy, reduce fear and anxiety. In the long term, the use of anesthesia could decrease for children.

NCT ID: NCT04723368 Completed - Clinical trials for Out-Of-Hospital Cardiac Arrest

AED-delivery Using Drones in Suspected OHCA

Start date: April 21, 2021
Phase: N/A
Study type: Interventional

Time to defibrillation is the most important predictor of survival in cardiac arrest. Traditional emergency medical system response is often to slow. The overall aim of this pilot study is to evaluate if drones can deliver Automated external defibrillators (AEDs) to the scene of suspected out-of-hospital cardiac arrest (OHCA) prior to ambulance arrival with clinically relevant time benefits.

NCT ID: NCT04721678 Completed - Clinical trials for Major Depressive Disorder

Internet-administered Interpersonal Psychotherapy for Depressive Symptoms

Start date: January 22, 2021
Phase: N/A
Study type: Interventional

The aim of the study is to test the efficacy of a treatment for depression based on interpersonal psychotherapy (IPT). The treatment will be accessed via an internet platform built for this study. A therapist will provide support weekly, as well as on-demand when needed. The treatment lasts for 10 weeks.

NCT ID: NCT04719351 Completed - Clinical trials for Stress, Psychological

The Use of a Mobile Application to Reduce Work-related Stress Symptoms Among Healthcare Workers

DIARY
Start date: February 22, 2021
Phase: N/A
Study type: Interventional

The current pandemic highlighted an urgent need for early interventions to mitigate the psychological effects of extreme work demands that healthcare workers currently experience. This project aims at developing a data driven monitoring system to efficiently track work-related stress reactions over time. The system will also include a self-awareness intervention grounded on evidence-based strategies to improve workers' recovery. The solution will be delivered through a mobile application for a rapid implementation among healthcare workers and related professions. The mobile application will be developed through an initial analysis of pilot data, a factorial experiment and a user-experience analysis. Qualitative user experience data will also be used to validate the functionality of the monitoring system. The solution developed in this project will be easily scalable to related occupations, for example workers at elderly homes and social workers. After the pandemic, it can also be used as a preventive intervention for workers who are at risk of burnout and as a support for patients returning to work after treatment for common mental disorders.

NCT ID: NCT04718545 Completed - Clinical trials for Gingival Recession, Localized

Effectiveness of Modified-free Gingival Graft for Treatment of Localized Gingival Recession Defects

Start date: March 10, 2021
Phase: N/A
Study type: Interventional

The aim of the present study is to evaluate, whether use of the modified free gingival graft (mod-FGG) technique improves treatment outcomes after surgical root coverage at mandibular incisors with gingival recession defects.