Clinical trials: sponsored by Region Skane
Pelvic Floor Dysfunction, Perineal Laceration
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
The goal of this clinical trial is to determine whether using a soft perineal protection device (BabySlide®) in addition to standard manual perineal support during vaginal delivery can reduce the risk of perineal trauma in…
- Conditions
- Pelvic Floor Dysfunction, Perineal Laceration, Wound Dehiscence, Anal Incontinence
- Trial name
- PeriPROTECT (NCT07862660)
- Testing
- Perineal protection device, BabySlide, Standard manual perineal support
- Where
- Sweden
- Volunteers
- 4,226 people
- Sponsor
- Region Skane
Myocardial Infarction, Chest Pain
AI-based Decision Support in Acute Chest Pain
The AIDE-CP1 trial will test whether a decision support tool based on artificial intelligence (AI) can improve care for patients who come to an emergency department with chest pain.
- Trial name
- AIDE-CP1 (NCT07864038)
- Testing
- AIDE-CP available
- Volunteers
- 4,500 people
- Sponsor
- Region Skane
Septic Shock
Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
The objective of this trial is to assess the beneficial and harmful effects of a restrictive strategy for administration of non-resuscitation fluids in adult patients with septic shock.
- Trial name
- REDUSE (NCT06140147)
- Testing
- Protocolised reduction of non-resuscitation fluids, Usual care
- Where
- 22 sites in Finland, Sweden and 1 more
- Volunteers
- 1,850 people
- Sponsor
- Region Skane
Gender Dysphoria, Adult
GLOW: Gender-Affirming Care and Mental Health: A Longitudinal Study On Quality of Life, Work Life, and Healthcare Outcomes
Gender-Affirming Care and Mental Health (GLOW) investigates the psychological, medical, and social factors that influence the outcomes of gender-affirming care, as well as its impact on mental health, work capacity, and quality…
- Trial name
- GLOW (NCT07480590)
- Where
- Sweden
- Volunteers
- 500 people
- Sponsor
- Region Skane
Latent Tuberculosis, Persistent Infection
New Strategies for Assessment of the Persistence of Viable Bacilli in Latent and Active Tuberculosis
Current diagnostic tools such as interferon gamma release assay (IGRA) and purified protein derivative (PPD) can not distinguish patients with latent tuberculosis infection (LTBI) and persistence of live mycobacteria.
- Conditions
- Latent Tuberculosis, Persistent Infection, Mycobacterium Tuberculosis
- Trial name
- TB-LIVE (NCT05621343)
- Where
- Sweden
- Volunteers
- 89 people
- Sponsor
- Region Skane
Head and Neck Cancer (H&N), Free Tissue Flaps
Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction (VISION Trial)
This is a prospective multicentre randomised controlled trial evaluating whether intraoperative indocyanine green (ICG) fluorescence angiography improves outcomes in head and neck free flap reconstruction compared with standard…
- Conditions
- Head and Neck Cancer (H&N), Free Tissue Flaps, Free Flap, Free Flap Evaluation
- Trial name
- VISION (NCT07635420)
- Testing
- Indocyanine Green, Standard clinical perfusion assessment
- Where
- Sweden
- Volunteers
- 244 people
- Sponsor
- Region Skane
Stroke, Sleep Apnea Syndrome (OSAS)
Sleep and Stroke Rehabilitation Study
The study aims to map sleep disorders and their impact on the ability to engage in an active daily life among people who have had a stroke, with particular focus on how sleep apnea can be identified.
- Conditions
- Stroke, Sleep Apnea Syndrome (OSAS), Insomnia, Excessive Daytime Sleepiness
- Trial name
- SnSRehabS (NCT07579871)
- Where
- Sweden
- Volunteers
- 226 people
- Sponsor
- Malin Eleonora av Kák Gustafsson, MD, PhD
Mental Disorder, Mental Health Issue
A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress.
This pilot randomized controlled trial evaluated the feasibility of a Swedish translation of an Acceptance and Commitment Therapy protocol targeting repetitive negative thinking (RNT-ACT) compared with therapist-supported…
- Conditions
- Mental Disorder, Mental Health Issue, Mental Depression, Anxiety
- Trial name
- RNTACTSweden (NCT05946382)
- Testing
- RNT-ACT Protocol, iCBT Treatment
- Where
- Sweden
- Volunteers
- 13 people
- Sponsor
- Region Skane
Hypertension
Sustainable Hypertension Management in Primary Health Care in Sweden
New sustainable models of patient-focused and team-based care for patients with hypertension should be developed to achieve health improvements and cost-efficiency.
- Trial name
- SHIP-CARE (NCT06580613)
- Testing
- New model of Hypertension Management, Control
- Where
- Sweden
- Volunteers
- 500 people
- Sponsor
- Region Skane
Breast Cancer Stage IV, Oligometastatic Disease
Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer
TAORMINA is an international, multicentre, randomised phase 3 trial for patients with oligometastatic breast cancer (OMBC) that will be allocated to combined stereotactic ablative radiotherapy (SABR) + systemic therapy…
- Trial name
- TAORMINA (NCT05377047)
- Testing
- SABR
- Where
- 19 sites in Ireland, Israel and 4 more
- Volunteers
- 345 people
- Sponsor
- Vastra Gotaland Region
Central Venous Catheter, Coagulation
Contact Activation of Coagulation in Newly Inserted Central Venous Catheters
A central venous catheter (CVC) is a thin plastic tube placed into one of the body's large veins, typically in the neck or near the clavicle. CVCs are crucial for administering medications, fluids, and secure blood samples.
- Conditions
- Central Venous Catheter, Coagulation, Coagulation Activation, Central Venous Catheter Complications
- Trial name
- CAS-2 (NCT07014722)
- Testing
- MERITMEDICAL Careflow™ Two-Lumen Central Venous Catheter, ARROW Two-Lumen Central Venous Catheter, ARROWg+ard Blue Plus® Two-Lumen Central Venous Catheter
- Where
- Sweden
- Volunteers
- 88 people
- Sponsor
- Thomas Kander
Obsessive-Compulsive Disorder, Autism Spectrum Disorder
ICBT for OCD in Children With Autism
The purpose of this trial is to evaluate the clinical efficacy, the cost-effectiveness and the effect durability of a therapist-guided, internet-delivered cognitive-behavior therapy intervention for obsessive-compulsive disorder…
- Trial name
- NCT06582225
- Testing
- Internet-delivered exposure and response prevention (I-ERP), Internet-delivered stress management (I-SM)
- Where
- 3 sites in Sweden
- Volunteers
- 220 people
- Sponsor
- Karolinska Institutet
Chronic Subdural Hematoma
Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma
The SWEMMA trial is an open, national, multi-center, prospective, randomized (1:1), superiority trial designed to assess impact on reoperation rates for chronic subdural hematoma with a head-to-head comparison of embolization of…
- Trial name
- SWEMMA (NCT05267184)
- Testing
- Endovascular treatment of the middle meningeal artery, Standard neurosurgical hematoma evacuation
- Where
- 4 sites in Sweden
- Volunteers
- 288 people
- Sponsor
- Region Skane
Atherosclerosis, Atherosclerotic Plaque
Atherosclerotic Plaque Imaging Project (CPIP)
The rupture or erosion of an atherosclerotic plaque with thrombosis or embolization often underlie heart attacks and strokes. The early identification of patients with atherosclerotic plaques prone to rupture or erosions…
- Trial name
- APIP (NCT05821894)
- Testing
- Observational study
- Where
- Sweden
- Volunteers
- 3,500 people
- Sponsor
- Lund University
Heart Arrest
Naloxone for In-Hospital Cardiac Arrest
The goal of this clinical trial is to learn if the drug naloxone in addition to cardiopulmonary resuscitation improves outcomes of in-hospital cardiac arrets.
- Trial name
- naloxone-IHCA (NCT07806565)
- Testing
- naloxone
- Volunteers
- 850 people
- Sponsor
- Region Skane
Head and Neck Cancer Squamous Cell Carcinoma, Head and Neck Cancer
Improved Oral Health in Head and Neck Cancer Survivors
The goal of this clinical trial is to learn if an oral care programme, designed as a multicentre two-armed randomised controlled trial (RCT), can prevent or mitigate late oral sequalae following completion of head and neck cancer…
- Trial name
- OHHNC (NCT07173270)
- Testing
- Oral health support
- Where
- Sweden
- Volunteers
- 300 people
- Sponsor
- Uppsala University
Anxiety, Depression
Mindfulness as a Method of Improving the Well-being, Quality of Life and Health of Primary School Pupils
This study evaluates the short and long-term effect of 5-10 minutes daily mindfulness and compassion training in school among children aged between 6-16 years old.
- Trial name
- NCT03327714
- Testing
- Mindfulness and compassion
- Where
- Sweden
- Volunteers
- 1,750 people, healthy volunteers welcome
- Sponsor
- Lund University
Surgical Complications
To Evaluate If Preoperative 7 Days Low Calorie Diet Reduces Postoperative Morbidity in Liver Surgery
The rationale for this study is to evaluate whether a standardized, preoperative, short-term Low Calorie Diet (LCD) reduces intraoperative bleeding and postoperative morbidity in liver surgery.
- Trial name
- LowCaLi (NCT07801716)
- Testing
- Low calorie meal replacement plan
- Where
- Sweden
- Volunteers
- 200 people
- Sponsor
- Region Skane
POTS - Postural Orthostatic Tachycardia Syndrome
The Effect of Physical Activity on Postural Orthostatic Tachycardia Syndrome
Postural orthostatic tachycardia syndrome (POTS) is a disorder of unknown origin characterized by orthostatic intolerance and increased heart rate (HR) of ≥ 30 beats/minute during orthostasis in the absence of orthostatic…
- Trial name
- POTS (NCT05554107)
- Testing
- Training program
- Where
- Sweden
- Volunteers
- 200 people
- Sponsor
- Lund University
Skin Transplantation, Skin Grafting
Lower Extremity Graft Study (LEGS): A Multicentre Randomised Controlled Trial of Negative Pressure Wound Therapy Versus Conventional Dressings for Split-thickness Skin Grafts After Lower Leg Skin Tumour Excision
The goal of this clinical trial is to compare the effect of negative pressure wound therapy (NPWT) versus traditional dressings on the incidence of transplant infection in adult patients undergoing split-thickness skin grafting…
- Conditions
- Skin Transplantation, Skin Grafting, Split Thickness Skin Graft, Negative-Pressure Wound Therapy
- Trial name
- LEGS (NCT07040683)
- Testing
- Negative Pressure Wound Therapy (NPWT), Traditional Dressing
- Where
- Sweden
- Volunteers
- 232 people
- Sponsor
- Region Skane