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NCT ID: NCT06309316 Recruiting - Graves Disease Clinical Trials

The Impact of Person Centred Care (PCC) in Grave's Disease

Start date: March 25, 2024
Phase: N/A
Study type: Interventional

Mental fatigue (MF) is prevalent after Graves' disease (GD), which is the most common form of hyperthyroidism. We have reported that 38% of patients, compared to 11% of control subjects, suffer from MF more than 1 year after successfully reversing of their hyperthyroidism and that MF is an entity of its own, separated from MF combined with anxiety or depression. The brain pathophysiology is unknown and there is no medical treatment, which requires patients to simply adapt to the situation. In the new national guideline for hyperthyroidism (Jan 2023), rehabilitation is recommended, but currently rarely offered to these patients. The problem is significant for patients, as illustrated by frequent media appeals. In this project, we hypothesise that person-centred care (PCC), which promotes positive coping strategies and increases self-efficacy by engaging patients as partners in their own care, improves MF, reduces sick leave, and lowers the recurrence rate of GD. In two work packages (WP), we will: WP1 Evaluate the effect of PCC eHealth intervention (telephone and digital platform) as an add-on to usual care vs usual care alone in a randomized controlled trial (RCT) of 220 patients on self-efficacy, days of sick-leave (composite score as primary outcome), MF, recurrence rate of disease, coping strategies, perceived stress, quality of life (QoL) and personality. WP2 Investigate the cost-effectiveness of the intervention Patients with GD have impaired long-term QoL. PCC could improve long-term outcomes of this autoimmune disease and may apply to other patient groups. This is in line with the societal aim to reduce mental illness.

NCT ID: NCT06307652 Recruiting - Clinical trials for Heart Failure and Impaired Kidney Function

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

BalanceD-HF
Start date: April 12, 2024
Phase: Phase 3
Study type: Interventional

This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.

NCT ID: NCT06307418 Not yet recruiting - Clinical trials for Head and Neck Cancer

Internet-based Support for Informal Caregivers of Patients With Head and Neck Cancer - Carer eSupport

Start date: May 6, 2024
Phase: N/A
Study type: Interventional

The aim of this randomized controlled trial is to investigate the effects of internet-based support (Carer eSupport) on preparedness for caregiving in informal caregivers of patients with head and neck cancer. The main question[s] it aims to answer are: - What are the effects of internet-based support on informal caregivers preparedness for caregiving? - What are the effects of internet-based support on informal caregivers burden and wellbeing? Informal caregivers who are randomized to Carer eSupport will have access to Carer eSupport for 18 weeks and they will be asked to complete questionnaires (outcome measures) at: - baseline (before randomization) - 18 weeks (post-intervention) and at - 3 months after the intervention is completed (long term follow-up). Informal caregivers in the intervention group will be compared to informal caregivers who receive standard care support regarding preparedness for caregiving, caregiver burden and wellbeing.

NCT ID: NCT06306066 Completed - Clinical trials for Coronary Artery Disease

Coronary Thermo-dilution Derived Flow-indices in Chronic Coronary Syndrome

Start date: September 2, 2015
Phase:
Study type: Observational

Patients scheduled for elective coronary angiography due to chronic coronary syndrome are recruited at admission to hospital before the coronary anatomy is known. Immediately after coronary angiography measures thermo-dilution derived flow indices are obtained in the left left anterior descending artery (LAD). The patients are followed through telephone-calls and medical records at 1 and 2 years after inclusion and at completion of the study. The hypothesis is that elevated index of microcirculatory resistance (IMR),(>25) is associated with all-cause death, myocardial infarction (MI) and hospitalization due to congestive heart failure (CHF). The primary analysis is the relationship between IMR and the composite outcome all-cause death, MI and hospitalization due to CHF.

NCT ID: NCT06305767 Recruiting - Bladder Cancer Clinical Trials

A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005)

Start date: March 28, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of V940 in combination with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. The primary study hypothesis is that V940 in combination with pembrolizumab results in a superior disease-free survival (DFS) as assessed by the investigator compared to pembrolizumab alone in participants with high-risk MIUC after radical resection.

NCT ID: NCT06304363 Not yet recruiting - Clinical trials for Psychiatric Disorder

Braining - Evaluation of Acute Effects of Physical Exercise

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

"Braining" is a clinical method for physical exercise as adjunctive therapy in psychiatric care. The core components are personnel-led group training sessions and motivating contact with psychiatric staff, as well as measurements and evaluations before and after a training period. The scientific purpose of this study is to investigate immediate and short-term effects of a booster-session of several Braining classes.

NCT ID: NCT06302270 Recruiting - Cystic Fibrosis Clinical Trials

CFTR Modulators in Pregnancy and Postpartum

Start date: March 15, 2024
Phase:
Study type: Observational

Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children. Registration on maternal health parameters and effects of CFTR-modulators in the newborn infant as well as effects of exposure through mother's own milk.

NCT ID: NCT06301360 Recruiting - Clinical trials for Somatic Symptom Disorder

Internet Based Emotional Awareness and Expression Therapy for Functional Somatic Disorder With and Without Therapist Support

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Functional somatic syndromes (e.g. irritable bowel syndrome, fibromyalgia) and medically unexplained symptoms (e.g. chronic primary pain) are very common in primary care. These patients make 14 times more doctor visits than the general population, but describe themselves as less satisfied with the care they receive. Although Region Stockholm in Sweden recently developed care flows based on 'step up' care for the most common patient groups in primary care, patients with functional or medically unexplained symptoms are not mentioned. Short-term psychodynamic therapies such as Emotional Awareness and Expression Therapy (EAET) and Intensive Short Term Psychodynamic Therapy (ISTDP) have recently been evaluated in three systematic reviews and show good results for patients with medically unexplained symptoms. Short-term psychodynamic therapy considers that good treatment outcomes for patients with functional somatic syndromes can be achieved by increasing awareness of emotions and teaching patients to better experience, express and regulate emotions. In several randomized studies, short-term psychodynamic therapy has shown good effects even compared to other treatments, including cognitive behavioral therapy (CBT). The overall purpose of this research project is to to evaluate psychodynamic emotion-focused interventions (EAET and ISTDP) for patients with medically unexplained symptoms/functional somatic symptoms (MUS/FSD). The project includes several studies that will clarify effects and contribute to information on how care flows in primary care for the patient group can be created. The research question for this specific study is: Is internet-based Emotional Awareness and Expression Therapy (I-EAET) with therapist more effective than without therapist support for patients with FSD?

NCT ID: NCT06300541 Recruiting - Sarcopenia Clinical Trials

Prevalence and Impact of Sarcopenia in Patients With Inflammatory Bowel Disease

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

Sarcopenia is a condition characterized by significant muscle loss resulting in impaired muscle function. This condition is likely associated with a biological deviation leading to reduced reserves to withstand stressors, resulting in a poorer prognosis. The incidence of sarcopenia among patients with inflammatory bowel diseases (Ulcerative Colitis and Crohn's disease) is currently approximately 40-60%. This is likely a consequence of the preference for drug treatment over surgery, while many patients have continuous inflammation in their intestines leading to muscle loss and subsequently increased morbidity and mortality. The purpose of the study is to identify the prevalence of sarcopenia among patients experiencing a severe flare-up of their bowel disease and to evaluate whether the removal of the colon results in improved nutritional status. Furthermore, the investigators aim to investigate whether there is a specific microbiota composition related to an unfavorable course. The participants are longitudinally monitored with measurements taken at the flare-up/before surgery and one year afterward, including body composition, function, dietary recording, quality of life, blood tests, fecal samples, and intestinal biopsies that will be analyzed. The investigators plan to correlate body composition with a biological profile and then evaluate if there is an association. Additionally, the investigators aim to analyze if these markers are linked to different outcomes after colectomy. This study will contribute to an enhanced understanding of patients with advanced IBD and possibly change the perspective on how the clinicians should prioritize these patients for surgery. The investigators believe this study will lead to an improvement in healthcare quality and an enhanced understanding of how these disease processes function.

NCT ID: NCT06299501 Completed - Domestic Violence Clinical Trials

How Can Child Health Services Identify and Respond to Family Violence

Start date: August 23, 2017
Phase: N/A
Study type: Interventional

Family violence has severe impacts on children's health and development. The Child Health Services (CHS) in Sweden reaches almost 100% of families with young children and provides a unique setting to facilitate identification of family violence. This study is a three-armed randomized controlled trial (RCT) conducted to assess the effectiveness of different approaches to identify family violence within CHS. Two different approaches are tested and compared to treatment as usual; 1) information about family violence at home visit when child is newborn, and questions posed to all mothers at the 6-8-week visit; 2) information about family violence at home visit when child is newborn, and questions posed to mothers on evidence based indication. Nurses who are randomized into any of the two intervention arms receive training and supervision. The outcomes of the study are related to knowledge, attitudes, and practices around identification and support in case of family violence and number of identified cases of family violence.