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NCT ID: NCT06318195 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Condensed Digital Prolonged Exposure for Individuals Treated Within Somatic Trauma Care.

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

The purpose of the study is to investigate the feasibility of implementation aspects, treatment effects and change processes regarding a brief trauma-focused Internet-based CBT treatment, for patients who have been treated in trauma care at Karolinska University Hospital and who exhibit symptoms of psychological consequences of the traumatic event. Another aim is to explore factors (predictors, moderators and mediators) that influence the effect of the treatment, in order to better understand who responds to the treatment.

NCT ID: NCT06318039 Not yet recruiting - Clinical trials for Anterior Cruciate Ligament Reconstruction

Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction

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

Scientific Research Question Overall Purpose: Regarding rehabilitation after anterior cruciate ligament reconstruction (ACLR), there is a knowledge gap - a lack of evidence. Important questions such as how rehabilitation should be structured, what it should include, and how it should be evaluated are currently not clear. Therefore, the investigators plan to conduct a two-year follow-up randomized controlled trial (RCT) on post-ACLR rehabilitation. Moreover, detailed information on how/under what circumstances the ACL injury occurred is not satisfactorily described in the literature. Therefore, the investigators are planning a new survey that can identify, explain, and prevent the risk factors causing a person to suffer from an anterior cruciate ligament injury. Specific Objectives: How should guidelines for rehabilitation after ACLR be structured, what should they include, and how should they be evaluated to best restore knee function in the patient? Can a detailed and comprehensive survey identify, explain, and prevent the risk factors causing a person to suffer from an ACL injury?

NCT ID: NCT06315192 Not yet recruiting - Atrial Fibrillation Clinical Trials

Stroke Alarm Efficacy Trial

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

The aim of this study is to test the efficacy of the CE-marked wearable system Stroke Alarm to identify the onset of a stroke with unilateral arm motor deficit within 3 hours of onset. This is a multicenter, prospective observational single-arm trial with a registry-based propensity matched control population. A total of 500 patients will be included in the trial. An interim analysis will determine if the stroke onset frequency is sufficient to determine the main outcome. Should the number of stroke events differ from what is expected at interim analysis, study enrollment will continue to increase cohort size. Patients who meet the criteria for participation will, after signing consent, be included and receive the Stroke Alarm bracelets that are used for 3 months. Study data will be collected as baseline at inclusion, at follow-up 3 months after inclusion and by using national Swedish registry data after completion of the study. Patients with elevated stroke risk according assessed by presence of specific criteria associated with elevated risk caused by: 1. recent TIA, OR 2. recent stroke without persisting arm motor deficit, OR 3. atrial fibrillation A control population matched for age, sex, NIHSS score and health care region will be identified in the Swedish national stroke registry, Riksstroke, and used for comparison. The combined efficacy goal is at least 60% sensitivity for Stroke Alarm b of stroke with unilateral arm motor deficit within 3 hours of onset (with a 95% confidence interval above 30%) and a specificity of at least 80% using a clinical stroke diagnosis as gold standard.

NCT ID: NCT06310798 Not yet recruiting - Oral Health Clinical Trials

Inter-organizational Health Planning for Older Adults: Public Dental Care and Municipal Care

GAPA
Start date: March 1, 2025
Phase: N/A
Study type: Interventional

Patient participation is key for healthy ageing and essential in health planning and decision-making. Oral health is an important but sometimes neglected part of general health and there is little research on health planning in ordinary home settings where older adults, dental and nursing staff participate. It has been concluded that shared tools, such as common documentation, and working in teams enables person-centered care in ordinary home settings. Therefore, this protocol outlines the design of a randomized controlled trial (RCT) measuring and comparing effect of two models of team based oral health planning with a common tool (digital platform) in ordinary home care settings in Sweden. The overall aim of this project is to evaluate a person-centered inter-professional and inter-organizational model for oral health planning supported by a digital platform to enable healthy ageing. Following ethics approval, a study design was developed guided by the seven action-steps of the knowledge to action framework. In the sixth action-step, older adults within the existing dental care remuneration program in Sweden will serve as a base for the RCT. From there older adults,dental hygienists (DH) and nursing assistants (NA) will be randomized into test and control groups. The test group (n= 12 DH and 12 NA) will participate in a two-day course, where a three-step person-centered oral health model will be taught. Control group will be 12 DH within dental care remuneration program conducting business as usual (with unknown number of NA, due to present guidelines). In total 360 older adults/patients will be asked to participate. Test group and control group will respectively have 180 patients each, as such, each team (DH + NA) have 15 patients. Primary outcomes include diverse oral health aspects - the Revised Oral Assessment Guide and the Geriatric Oral Health Assessment Index. Secondary outcomes include a retrospective record review, a health economic evaluation, Person Centered care Assessment Tool and Oral Hygiene Ability Index. Additionally, qualitative studies from theoretical perspectives of change and learning based on interviews with key stakeholders will be conducted in both test and control group.

NCT ID: NCT06309641 Not yet recruiting - Anemia Clinical Trials

Methemoglobinemia Following Intravenous Iron Treatment

Start date: September 2024
Phase:
Study type: Observational

Methemoglobinemia as a side effect of treatment with intravenous iron has not previously been described. This study aims to assess methemoglobin levels in patients with anemia following treatment with intravenous iron, administered as ferric carboxymaltose or ferric derisomaltose.

NCT ID: NCT06307652 Not yet 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: 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: NCT06298864 Not yet recruiting - Clinical trials for Acute Coronary Syndrome

Internet-based Behavioral Intervention Following ACS

ACS-CBT
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate if an online Cognitive Behavioral Therapy (CBT) protocol customized for patients following Acute Coronary Syndrome (ACS), reduce cardiac anxiety, enhance Quality of Life (QoL), and promote increased physical activity while controlling for caregiver attention, utilizing an active control group receiving internet-based cardiac lifestyle intervention.

NCT ID: NCT06295094 Not yet recruiting - Gastric Cancer Clinical Trials

The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients.

EPICURE
Start date: September 2024
Phase: Phase 2
Study type: Interventional

The goal of this randomized clinical trial is to investigate whether pressurized intraperitoneal chemotherapy (PIPAC), delivered immediately after minimally invasive D2 gastrectomy and repeated 6-8 weeks later, improves 12-month peritoneal disease-free survival in patients with high-risk gastric adenocarcinoma when compared to standard treatment.