Clinical trials

236

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Condition / disease
Location
Status: Recruiting

Holistic Approach Supporting the Uptake of Innovative Diagnostic Technologies for Respiratory Infections

This observational diagnostic validation study aims to evaluate the clinical performance of novel lateral flow and microfluidic-based technologies for the detection of upper and lower respiratory tract infections in children and adults presenting with respiratory symptoms in Uganda, Ethiopia, and Senegal. The main questions it aims to answer are: 1. whether the novel multiplex lateral flow tests and point-of-care microfluidic platform demonstrate sufficient sensitivity and specificity for detecting respiratory pathogens compared with standard laboratory reference methods, and 2. whether these technologies are feasible and usable in low-resource clinical settings. Participants presenting with suspected respiratory tract infections as part of routine clinical care will provide respiratory and blood samples for diagnostic testing and biobanking, and demographic and clinical information will be collected during a single study visit. Some adult participants and community stakeholders will also complete surveys or interviews regarding the acceptability of biobanking and diagnostic implementation.

Participants needed: 2,160
Trial details
Age: 6+Biological sex: AllType: ObservationalSponsor: Karolinska InstitutetUpdated: Jun 29, 2026Locations: 3
Eligibility criteria

Age ≥ 6 months [+7]

Refusal or inability to provide informed consent/assent [+6]

Status: Recruiting

Evaluation of ALLERgen Specific Vaccination of DOG Allergic Patients in Swedish Practice

STUDY DESIGN A single-center prospective before-and-after study evaluating the effect of Alutard SQ Dog in 40 men and women with moderate-to-severe dog allergy. Participants will serve as their own controls. STUDY OUTLINE The study will begin in the fall of 2026 and will be conducted over a one-year period. At baseline, participants will be asked to record their allergic symptoms, and assessments of lung function and nasal airflow will be performed. Blood samples will also be collected. Following the baseline assessments, participants will undergo allergen provocation by entering a facility containing dogs. After a 30-minute exposure to dogs, participants will again be asked to record their allergic symptoms and will undergo the same assessments performed at baseline. Allergen immunotherapy (AIT) with Alutard SQ Dog will then be initiated according to the standard treatment regimen and continued for one year. At the end of the treatment period, the same provocation procedure and assessments will be repeated. Participants will enter a facility containing dogs, followed by symptom recording and evaluation of lung function, nasal airflow, and relevant laboratory parameters.

Participants needed: 40
Trial details
Phase: Phase 4Age: 18-50Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: Jun 29, 2026Locations: 2
Eligibility criteria

Age 18-50 years. [+5]

Pregnancy or breastfeeding. [+19]

Status: Recruiting

Yogabased Movements for Primary Headaches (Migraine and/or Cluster Headache) - YOURHEAD

Brief Summary: Migraine and/or Cluster Headache: Study Overview \*\*Background:\*\* Migraine and cluster headache are two primary headache disorders that significantly impact quality of life and functionality in those affected. According to the WHO's recurring burden of disease reports, migraine is among the neurological conditions responsible for the highest number of years lost due to illness. The headaches associated with migraine and cluster headache range from moderate to severe and cause great suffering. Available treatments do not work for everyone and are often associated with adverse side effects. Physical activity has been shown in several studies to have a positive effect on headache. Given the high prevalence of mental health issues, stress, and sleep problems within this patient group, relaxation and low-intensity exercise such as yoga-based movements (YB) could potentially help individuals improve sleep and well-being, while also providing some preventive effect on headaches. \*\*Hypothesis:\*\* Individuals with severe migraine or cluster headache have a strong need for new treatment options. Alternative therapies such as yoga-based exercises, when combined with standard medical treatment as per clinical guidelines, may positively impact: Headache symptoms, Sleep quality and Overall life quality * Purpose and Goals:\*\* This randomized controlled study aims to evaluate the effect of a web-based yoga (YB) or live face to face (FTF) intervention in individuals suffering of primary headaches-mainly chronic migraine and/or cluster headache. The study will assess the effect of YB on health-related changes in headache frequency, intensity, and duration associated with primary headache conditions, with a focus headache frequency. A secondary objective is to analyze quality of life, sleep quality, mental health as depression and anxiety. The RCT will also measure objective sleep and biomarkers. We are now summarizing the effects after a pilot study. * Relevance for the Patient Group:\*\* The core objective of the project is to determine whether yoga-based exercises can serve as a complementary treatment to enhance quality of life and health in patients with severe primary headache. To ensure equal healthcare access, this intervention will be delivered in digital format and/or FTF to optimize availability and expand care for individuals with primary headache disorders. These efforts aim to improve life quality and well-being in a vulnerable patient population. Headache conditions often affect individuals in their most productive years, and many live with symptoms for decades. Both work and private life are frequently disrupted, resulting in sick leave and social isolation. Close relatives are also affected, as those suffering from headaches require more recovery time to cope with daily life. With this proposed project, we aim to use physical yoga, rooted in holistic traditional medicine, to help individuals with severe primary headache achieve better physical and mental health-particularly improved sleep quality, which in turn enhances overall life quality.

Participants needed: 80
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: Jun 26, 2026Locations: 1
Eligibility criteria

Diagnosed chronic migraine and/or cluster (Hortons) headache [+7]

Recent or planned operations during the last 6 weeks [+7]

Status: Not yet recruiting

Home-based Pulmonary Rehabilitation for COPD Patients

Objectives The objective of this project is to motivate patients with COPD to incorporate the habit of doing daily mindful physical activity by using the proposed home-based pulmonary rehabilitation program that integrates video guided exercises, activity monitoring daily steps and health coaching. This program will allow patients to complete Pulmonary Rehabilitation (PR) at home and promote behavior change and lead to a more active lifestyle for patients with COPD who have been prescribed PR. The program will be able to effectively monitor daily step count. A health coach will receive more this detailed data and will guide weekly health coaching sessions designed to increase awareness of the physical activities completed and ignite inner motivation for healthy behaviors. The proposed PR program is innovative and responds to an unmet need in chronic care for COPD patients in the context of COVID-19 pandemic and it mitigates the common accessibility barriers.

Participants needed: 80
Trial details
Age: 40-100Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: Jun 26, 2026Locations: 1
Eligibility criteria

Men and women age 40 years and older [+3]

Unable to perform low intensity exercise. [+2]

Status: Recruiting

USE LESS, a Comparative Cohort Study of Climate Change Impact From Orthopedic Surgery

A prospective comparative cohort study with the objective to quantify and compare carbon dioxide equivalent (CO₂e) emissions from orthopedic surgeries performed in two different operating room (OR) settings using different sets of materials and staff.

Participants needed: 80
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Karolinska InstitutetUpdated: Jun 18, 2026Locations: 1
Eligibility criteria

The following surgeries will be included: release of carpal tunnel or trigger fi...

None

Status: Not yet recruiting

Patient Controlled Propofol Sedation Versus Nurse-assisted Propofol Sedation in Diagnostic Colonoscopies With a Focus on Patient Satisfaction

The goal of this clinical trial is to learn if patient administered propofol sedation results in superior patient satisfaction compared to nurse administered propofol sedation in diagnostic colonoscopies. • Does self administration of the sedative propofol increase patient satisfaction? Researchers will compare patient administered propofol sedation (where the patient administers propofol by pushing a button) with nurse administered propofol sedation (where a nurse gives the patient bolus doses of propofol as deemed necessary) Participants will: * Be randomized to either sedation route. * Answer a preendoscopy questioneere and a postendoscopy questioneere 1 hour after the examination as well as one week after the examination.

Participants needed: 135
Trial details
Phase: Phase 4Age: 18-90Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: Jun 17, 2026Locations: 2
Eligibility criteria

Scheduled for elective diagnostic colonoscopy in propofol sedation [+4]

ASA >=III [+6]

Status: Not yet recruiting

Infection Prevention for "Bellwether" Surgery in Ethiopia

The study examines surgical site infections and antimicrobial resistance following life-saving surgeries like C-sections and leg fracture repairs in Ethiopia. It does not include healthy volunteers because it specifically focuses on patients who require these urgent operations due to medical necessity. Eligible participants are those undergoing these specific procedures at Tikur Anbessa Specialized Hospital or other participating public hospitals. While the birth-related portion is for females, the trauma portion includes both men and women, generally of reproductive or working age with no upper age limit. People are excluded if they are having elective surgeries, cannot provide consent, or cannot be reached for the two-year follow-up period. The researchers use a mixed intervention based on the "Clean Cut" safety bundle, which includes staff training, surgical checklists, and regular audits. The main goals are to measure infection rates within 30 days of surgery and track how well patients can function in their daily lives using the WHODAS scale up to 24 months later.

Participants needed: 1,000
Trial details
Biological sex: AllType: ObservationalSponsor: Karolinska InstitutetUpdated: Jun 15, 2026Locations: 1Duration: 24 Months
Eligibility criteria

Emergency Caesarean section. [+2]

Elective or non-bellwether surgeries. [+2]

Status: Not yet recruiting

Endoscopic Retrograde Cholangiopancreatography Access and Complication Rates After Cholecystectomy With Common Bile Duct Stones

The aim of this retrospective, register-based study is to investigate whether access, or no access, to endoscopic retrograde cholangiopancreatography (ERCP) at a surgical unit is associated with the risk of complications in patients undergoing laparoscopic cholecystectomy with common bile duct stones detected on intraoperative cholangiography.

Participants needed: 10,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Karolinska InstitutetUpdated: Jun 10, 2026Duration: 30 Days
Eligibility criteria

≥18 years old [+2]

Open surgery [+2]

Status: Not yet recruiting

Patient Controlled Propofol Sedation Versus Standard Sedation in Advanced Therapeutic Colonoscopy With a Focus on Patient Satisfaction

The goal of this clinical trial is to learn if patient administered propofol sedation results in superior patient satisfaction compared to standard conscious sedation in advanced therapeutic endoscopy. • Does self administration of the sedative propofol increase patient satisfaction? Researchers will compare patient administered propofol sedation (where the patient administers propofol by pushing a button) with standard conscious sedation Participants will: * Be randomized to either sedation route. * Answer a preendoscopy questioneere and a postendoscopy questioneere 1 hour after the examination as well as one week after the examination.

Participants needed: 40
Trial details
Phase: Phase 4Age: 18-90Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: Jun 9, 2026Locations: 2
Eligibility criteria

Scheduled for elective diagnostic colonoscopy in propofol sedation [+4]

ASA >=III [+6]

Status: Not yet recruiting

REcovery After Cancer Application

The RECapp study is a clinical trial evaluating a digital tool designed to support patients recovering from surgery for oesophageal or stomach cancer. The goal is to reduce symptoms and improve quality of life during recovery. Each year in Sweden, around 1,400 people are diagnosed with these cancers. Although more people are surviving thanks to better treatments, recovery after surgery is often long and challenging, with lasting physical and emotional effects. At the same time, healthcare systems are under pressure to provide long-term support. RECapp is a digital platform developed together with patients and healthcare professionals. It includes a mobile app for patients and a web portal for healthcare staff. Patients can track their symptoms, receive personalised self-care advice, and get guidance on when to contact healthcare. Healthcare providers can follow patients' progress remotely. In this study, 250 patients from across Sweden will take part. They will be randomly assigned to either standard care or standard care plus RECapp. Participants will be followed for six months after surgery, and their symptoms and quality of life will be regularly assessed through questionnaires. If RECapp proves effective, it could become part of future cancer care in Sweden-helping patients feel better supported while also making care more efficient.

Participants needed: 250
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: Jun 11, 2026Locations: 7
Eligibility criteria

Patients who have undergone invasive surgery with curative intent for oesophagea... [+3]

Status: Recruiting

A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease

Unhealthy lifestyle behaviors are well-established risk factors for cardiovascular disease (CVD) which is the leading cause of death globally and in Sweden. Digitalization offers new and better possibilities for healthcare to fulfil their responsibility to support healthier lifestyles, however, to ensure scalability and sustained implementation of digital tools within healthcare, digital interventions need to be systematically maintained and delivered by the primary healthcare. The aim of this project is to evaluate whether a digital lifestyle intervention, developed within Swedish primary healthcare, can improve clinically important cardiovascular health outcomes and lifestyle behaviors. In this multi-center randomized controlled trial patients, 40-60 years, in Swedish primary healthcare will be recruited and randomized to the control or intervention group. All participants will receive standard care consisting of one structured health dialogue focused on lifestyle habits. The intervention group will also receive support through the digital lifestyle intervention for creating healthy habits regarding diet, physical activity, alcohol consumption, and tobacco usage. The primary outcome is LDL-cholesterol at 6 months post-randomization. Secondary outcomes 6 months post-randomization are HDL-, total cholesterol, fasting blood glucose, triglycerides, non-HDL, blood pressure, weight, height, BMI, waist circumference, cardiovascular risk evaluation (SCORE2), dietary intake, physical activity, sleep, stress, alcohol consumption, tobacco use, and health-related quality of life.

Participants needed: 1,000
Trial details
Age: 39-61Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: Jun 9, 2026Locations: 6
Eligibility criteria

Attended a Health dialogue visit to primary healthcare for patients 40-60 years... [+1]

diabetes [+4]

Status: Recruiting

Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) With Self-injury Within Child and Adolescent Mental Health Services

The overall purpose of the study is to implement and evaluate IERITA (Internet-delivered Emotion Regulation Individual Therapy for Adolescents) within child and adolescent mental health services for adolescents engaging in nonsuicidal self-injury (NSSI) and optimize treatment outcomes for those adolescents at risk of non-remission (continued NSSI).

Participants needed: 341
Trial details
Age: 13-17Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: Jun 8, 2026Locations: 1
Eligibility criteria

13-17 years old [+2]

Immediate suicide risk [+3]

Status: Recruiting

Evaluation of a Psychosocial Support Model for Adolescents and Young Adults Newly Diagnosed With Cancer

Rational: Adolescents and young adults (AYAs) newly diagnosed with cancer is a small but vulnerable group with many psychosocial needs persisting for a long time. No standardized psychosocial support program exists for this group of patients in Sweden. The program: The program in the present project aims at offering all AYAs, newly diagnosed with cancer, at two Comprehensive Cancer Centres in Sweden, an individual information meeting with a "Team Young" to assess psychosocial needs and then offer available psychosocial support including a structured psychosocial program labelled Promoting Resilience in Stress Management (PRISM). PRISM aims to strengthen key resilience resources such as stress-management, goal setting, cognitive reframing, and meaning-making. It has been developed and evaluated in the US. Evaluations from the US have proven to be promising among AYAs with cancer. PRISM was associated with clinically and statistically significant improvements in resilience, hope, benefit-finding, disease-related quality of life, and reductions in psychological distress, compared to usual care. Our research group has translated and adopted PRISM to a Swedish context with a participatory research approach involving clinicians, researchers, and end-users. The first version of PRISM has been evaluated in a feasibility study and based on the findings revised. A second feasibility study was finalised during 2024 at two Comprehensive Cancer Centers in Sweden with preliminary findings indicating positive experiences from participants. In parallel to this project, comparison data on primary and secondary outcomes, has been collected from the general population in the same age group. The findings indicate so far promising psychometric properties for the main outcome resilience. Aim: The overall aim of this research project is to evaluate a psychosocial support program for adolescents and young adults (AYAs) newly diagnosed with cancer. It includes offering all AYAs, newly diagnosed with cancer, an information meeting with a "Team Young" to assess psychosocial needs and then offer available psychosocial support including a structured psychosocial program labelled Promoting Resilience in Stress Management (PRISM). Method: The design is a longitudinal cohort study and will include approximately 130 AYAs (16-30 years) newly diagnosed with cancer at Karolinska- and Sahlgrenska University Hospitals. All participants will complete questionnaires on three occasions: at enrolment in PRISM, after 4 modules in PRISM and six months after enrolment. The primary outcome measure is psychological resilience and secondary outcomes are psychological well-being, quality of life and level of hope. Relevance: Implementing a structured psychosocial support program for AYAs newly diagnosed with cancer has the potential to mean a lot for each patient and their families and facilitate for health care professionals involved in their cancer care. If this research project shows promising results on resilience, psychological wellbeing, quality of life and/or hope, PRISM can be implemented as standard care at hospitals in Sweden treating AYAs with cancer.

Participants needed: 142
Trial details
Age: 16+Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: Jun 9, 2026Locations: 2
Eligibility criteria

Participants will be AYAs newly diagnosed with cancer at Karolinska University H... [+1]

Status: Recruiting

Dementia With Lewy Bodies: Clinical Symptoms, Biomarkers and Progression

The goal of this observational study is to improve the detection of dementia with Lewy bodies (DLB) and its prodromal phases, as well as advancing our current understanding of biological mechanisms and therapeutic options. The data is acquired at cognitive clinics in Stockholm (Sweden) and combined with national and international data to increase statistical power, representativeness and replication of results. Participants undergo collection of clinical assessments, neuroimaging and fluid biomarkers.

Participants needed: 600
Trial details
Biological sex: AllType: ObservationalSponsor: Karolinska InstitutetUpdated: Jun 5, 2026Locations: 1
Eligibility criteria

At least one core clinical feature of dementia with Lewy bodies such as visual h...

Causes of cognitive impairment other than those related to dementia or MCI. Curr...

Status: Recruiting

Evaluating Effects of Group-based CBT for Emotion Regulation in Adult ADHD

This study will evaluate if a specific treatment for emotion regulation in ADHD, GEARS, effectively reduces symptoms of emotional dysregulation. GEARS will be evaluated through a randomized controlled trial (RCT) and a qualitative interview study. This project aims to investigate two main questions: 1. Is GEARS an effective treatment for emotion regulation difficulties in adult ADHD patients? 2. How do participants perceive the impact of completing the GEARS treatment? Study 1 investigates research question 1 through an RCT comparing GEARS to a passive control group. Data are collected using validated measures before and after treatment/waiting period, as well as at six and 12 months follow ups. Sample size: 150 participants, ensuring sufficient statistical power to detect significant between-group differences, even with some attrition. Study 2 examines the patients' perspectives on the treatment by interviewing 15-20 participants about their experience with GEARS. The interviews focus on GEARS' perceived impact. Interviews will be recorded, transcribed, and analyzed using thematic analysis to identify key recurring themes.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: Jun 4, 2026Locations: 1
Eligibility criteria

being diagnosed with ADHD according to DSM criteria, [+2]

diagnosis of intellectual disability, [+6]

Status: Not yet recruiting

Addressing HPV Vaccine Hesitancy by Co-Designing a Digital Health Intervention

This study looks at a digital platform that supports HPV vaccination in schools. The goal is to see if it is useful, easy to use, and practical in real school settings, especially in areas where fewer people get vaccinated. Researchers will give Year 5 pupils (aged 11-12) and their parents or caregivers access to the platform. It provides clear, trusted information about the HPV vaccine for young people, parents, and school nurses. The aim is to make the vaccine easier to understand and to help answer any questions or concerns. After using the platform, participants will be asked to share their thoughts.

Participants needed: 100
Trial details
Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: Jun 8, 2026
Eligibility criteria

The school provides education to pupils in school year 5 and is scheduled to be... [+3]

Failure to meet the inclusion criteria

Status: Recruiting

The CARBO CARBON Study

This study examines the environmental impact of two common treatment pathways for hand fractures (metacarpal shaft fractures): surgical and non-surgical management. Healthcare contributes significantly to climate change, and orthopedic surgery in particular generates substantial greenhouse gas emissions. Although surgical treatment is frequently favored for these fractures, it is not always superior to non-surgical treatment, and the difference in environmental impact between these options is not well understood. In this study, researchers will measure and compare the environmental impact of each treatment pathway, from inclusion to twelve months follow-up. This includes environmental impact related to single-use material, medical equipment, energy use, medications, and waste. A Life Cycle Assessment (LCA) will be performed and a mean difference in environmental impact between treatments pathways will be calculates. A Hotspot analysis will also be performed to highlight key sources of environmental impacts. The findings may help guide more sustainable healthcare practices without compromising patient care.

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Karolinska InstitutetUpdated: Jun 4, 2026Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

Walking and Thinking - Brain Activity During Complex Walking in Stroke

Everyday life requires individuals to function in complex environments and perform tasks that involve the integration of motor and cognitive abilities. However, stroke often leads to impairments in motor-cognitive interaction, which can negatively affect mobility, balance, attention, and the ability to live independently. Although motor-cognitive performance has been identified as an important rehabilitation target after stroke, limited knowledge exists regarding the underlying brain function associated with these difficulties and how rehabilitation and exercise interventions can best address them. Improving treatment for motor-cognitive difficulties after stroke, such as dual-task walking and navigation, remains a major challenge. An important step is developing assessment methods that accurately capture these impairments in ecologically valid settings that reflect real-world mobility demands. The investigators therefore aim to explore brain function during complex walking after stroke by investigating motor-cognitive performance and its neural correlates during three walking conditions: dual-task walking, navigation, and a combination of both. Non-invasive measures of brain activity using functional near-infrared spectroscopy (fNIRS) together with advanced real-time gait analysis will be used to better understand how stroke affects motor-cognitive functioning during complex walking tasks.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Karolinska InstitutetUpdated: Jun 3, 2026Locations: 1
Eligibility criteria

18 years or older [+2]

Individuals post stroke with cognitive impairment [+3]

Status: Recruiting

Registry-randomized Comparison of Rehabilitation Regimens After Flexor Tendon Injury in the Thumb

Flexor tendon injuries in the thumb occur across all ages and genders. Each year, approximately 400 patients undergo surgery for a flexor tendon injury in Sweden. These injuries are exclusively treated at one of the seven specialized hand surgery clinics, as the surgery is technically demanding, and postoperative rehabilitation is critical, specialized, and requires expertise from hand therapists. To prevent tendon adhesions and stiffness in the thumb or fingers, controlled active motion therapy is usually initiated within a few days after surgery. Studies on finger flexor tendon injuries have shown that early active movement therapy leads to better mobility compared to immobilization. Consequently, early active training is now the standard treatment following flexor tendon repair. However, during postoperative rehabilitation, the repaired flexor tendon may rupture, often necessitating revision surgery. The rupture rate after flexor tendon repair in the thumb is approximately three times higher than in other fingers (10% vs. 3%). While most studies on flexor tendon injuries focus on finger tendons, research on the outcomes of thumb flexor tendon injuries is limited. The biomechanics and anatomy of the thumb's flexor tendon differ significantly from those of finger tendons. The objective of this study is to determine whether the rupture rate following thumb flexor tendon surgery can be reduced by immobilizing the thumb in a cast for four weeks postoperatively, compared to standard early active motion therapy, without negatively affecting joint mobility and thumb strength. Additionally, the study will evaluate patient-reported outcomes one year post-surgery for both rehabilitation regimens (immobilization vs. mobilization). This study is a registry-randomized clinical trial (RRCT) involving five hand surgery clinics in Sweden. Data following randomization between the two rehabilitation protocols will be collected through follow-up in the Swedish National Hand Surgery Quality Registry (HAKIR).

Participants needed: 380
Trial details
Age: 15+Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: Jun 3, 2026Locations: 5
Eligibility criteria

Not listed

Status: Not yet recruiting

ProspectiveMaleAYA - Frequency and Prediction of Therapy-induced Testicular Dysfunction in AYA Cancer Survivors

This study describes the ProspectiveMaleAYA cohort, a multicentre, prospective, longitudinal European study designed to investigate the long-term impact of cancer and cancer treatments on reproductive and endocrine health in adolescent and young adult (AYA) male cancer patients. Addressing major gaps in standardized prospective data, particularly for long-term fertility, hypogonadism, and the effects of newer systemic therapies, the study will harmonize data collection across centres and follow patients from diagnosis through post-treatment survivorship. Comprehensive clinical, oncologic, reproductive, hormonal, biological, and patient-reported outcomes will be collected at predefined intervals to evaluate testicular dysfunction, fertility impairment, oligo/azoospermia, sexual health, and quality of life. Sub-cohorts will enable focused analyses of genetic and epigenetic sperm changes, whole-genome sequencing to identify susceptibility to reproductive and organ toxicity, accelerated aging markers following specific treatments, access to and satisfaction with fertility counselling, and sexual health dysfunctions. The overarching aim is to identify risk factors and predictive markers, develop individualized risk stratification and prediction models, and support precision, patient-centred survivorship care for male AYA cancer survivors.

Participants needed: 1,000
Trial details
Age: 15-39Biological sex: MaleType: ObservationalSponsor: Karolinska InstitutetUpdated: May 29, 2026
Eligibility criteria

Subjects with male internal and external genitalia [+5]

individuals presenting with relapse or secondary cancers at time of inclusion [+3]

Status: Not yet recruiting

Late Effects of Cancer Therapies on Gonadal Function, Fertility, Efficiency of Fertility Preservation Procedures and Pregnancy Outcomes

In the past two decades, evidence-based knowledge on the prevalence and risk factors for fertility impairment, including infertility, following cancer and numerous cancer treatment regimens has significantly increased. However, data remains mostly insufficient for individualized prediction of (future) fertility potential, including success of artificial reproductive technologies (ART). Furthermore, therapies have become increasingly complex. Recent treatment regimens have continuously implemented novel treatment approaches (e.g. immune therapies such as checkpoint inhibitors) for which no comprehensive data regarding its impact on fertility and pregnancy outcomes is available, yet. It is crucial to carefully balance risk-benefit between fertility preservation (FP) procedures and potential of gonadal function/fertility impairment, to examine the efficiency and safety, as well as to assess patients' satisfaction regarding the FP procedures. Answering these questions is highly relevant as it has been shown that fertility capacity and post-treatment gonadal function may represent a significant part of the quality of life in young cancer survivors. The study therefore aim to set up a large-scale network structure of emerging data collection programmes to evaluate the gonadotoxic risks, including the prevalence and course of ovarian/testicular dysfunction and/or fertility impairment and premature ovarian insufficiency/oligo/azoospermia following specific treatments, identification of further risk factors and predictive markers to enhance precision survivorship research in this field. Additionally, data on the use of fertility preservation/fertility treatment and patients' satisfaction related to these procedures in Europe shall be analysed to support patient-centric care. Reproductive health counselling should not be restricted to evaluating the individual risk of gonadotoxicty and offering fertility preservation to those at risk. It also includes the sexual health, the use of post-cancer treatment contraception for those recommended to delay attempting pregnancy after a cancer diagnosis and the identification of potential obstetrical and neonatal risks to provide individualized, risk-adapted follow-up during pregnancy. An increased risk of obstetrical and neonatal complications has been reported for several conditions, including preterm delivery, pre-eclampsia, cardiac dysfunction, and gestational diabetes. Most available studies are based on population registry and lack of detailed information on critical factors such as the impact of the timing of pregnancy, method of conception or the type of cancer treatment received (e.g pelvic irradiation, anthracycline, targeted therapy, immunotherapy…), all of which may influence the outcomes. The main objectives of this retrospective analysis of European ongoing adolescent and young adult (AYA) cancer patient cohorts are: • To establish harmonized databases with clinical data on pre- and post-cancer therapy and reproductive outcomes in AYA patients followed longitudinally. • To evaluate the impact of cancer treatment on long-term fertility according to cancer type and individual patients' characteristics (pre- and post-treatment) in male and female AYA populations. • To evaluate effect of cancer therapies on ovarian function in female AYA patients • To evaluate long-term effect on the endocrine function of the testis in male AYA patients i.e., the frequency of hypogonadism. • To evaluate the obstetrical and neonatal outcomes according to the disease and treatment.

Participants needed: 4,000
Trial details
Age: 15-39Biological sex: AllType: ObservationalSponsor: Karolinska InstitutetUpdated: Jun 3, 2026
Eligibility criteria

Female and male cancer patients aged between 15 and 39 years at diagnosis. [+3]

Pre-existing known POI at cancer diagnosis [+3]

Status: Not yet recruiting

ProspectiveFemaleAYA - Late Effects of Cancer Therapies on Gonadal Function, Fertility, Efficiency of Fertility Preservation Procedures and Pregnancy Outcomes

In the past two decades, the evidence-based knowledge on the prevalence and risk factors for gonads impairment, including infertility, following cancer and numerous cancer treatment regimen has significantly increased. However, data remains mostly insufficient for individualized prediction of (future) fertility and pregnancy potential, including the use and success of artificial reproductive technologies (ART). Furthermore, therapies have become increasingly complex as more recent treatment regimen have continuously also implemented novel treatment approaches (e.g. immune therapies such as checkpoint inhibitors) for which no comprehensive data regarding its impact on fertility and pregnancy outcomes is available, yet. It is crucial to carefully balance risk-benefit between fertility preservation (FP) procedures and potential of gonadal function/fertility impairment, to examine the efficiency and safety, as well as to assess patients' satisfaction regarding the FP procedures. Answering these questionsis highly relevant as it has been shown that fertility capacity and post-treatment gonadal function may represent a significant part of quality of life in young cancer survivors. The study therefore aim to set up a large-scale registry of emerging data collection programmes to evaluate the gonadotoxic risks, including the prevalence and course of ovarian dysfunction and/or fertility impairment and premature ovarian insufficiency following specific treatments, identification of further risk factors and predictive markers to enhance precision survivorship research in this field. Additionally, data on the use of fertility preservation/hormonal treatment and patients' satisfaction related to these procedures in Europe will be analysed to support patient-centric care. Reproductive health counselling should not be limited to evaluating the risk of gonadotoxicity and offering fertility preservation to those at risk. It should also include evaluating the impact on post-treatment sexuality, menopausal symptoms management, and the counselling on contraception. In addition to clinical information, whole genome sequence data will be generated for selected study participants with evidence of varying impact of gonadotoxic therapies on reproductive function to find genetic variants associated with risk of reproductive and organ toxicity. The data collection will focus on all different cancer diseases, including diseases which are less common such as different types of sarcomas. This will be a significant development to the current state of information in existing registries. The primary objectives of this prospective analysis of European ongoing adolescent and young adult (AYA) cancer patient cohorts are: 1. To establish a database with relevant clinical characteristics at time of diagnosis, cancer therapy received and post-cancer clinical and reproductive outcomes by following AYA cancer patients longitudinally. 2. To evaluate the effect of cancer therapies on ovarian function and reproductive potential. 3. To evaluate fertility preservation measures performed, their risks and efficacy. 4. To evaluate the impact of fertility preservation measures on the risk of cancer relapse. 5. To evaluate occurrence of pregnancies/live births naturally conceived (including unplanned) or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue. 6. To set up a genetic database based on whole genome sequencing of AYAs of the cohort. For this objective a Substudy 1 : " Development of risk prediction models based on clinical and genetic data " will be conducted. 7. To develop prediction models for organ toxicities in cancer patients (objective included in Substudy 1). 8. To evaluate the effect of cancer therapies on sexuality and quality of life. For this objective a Substudy 2 : "Sexual Health" will be conducted. 9. To evaluate the use and counselling on contraception. For this objective, a Substudy 3 : "Contraception" will be conducted. 10. To describe management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms. For this objective a Substudy 4 "Management of POI and Menopause Symptoms" will be conducted. 11. To explore patient's satisfaction receiving counseling and/or undergoing fertility preservation. For this objective a Substudy 5 on "Satisfaction with Fertility Preservation" will be conducted.

Participants needed: 3,000
Trial details
Age: 15-39Biological sex: FemaleType: ObservationalSponsor: Karolinska InstitutetUpdated: Jun 3, 2026
Eligibility criteria

Female cancer patients aged between 15 and 39 years at diagnosis. [+3]

Pre-existing known POI at cancer diagnosis. [+3]

Status: Recruiting

Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam

Preterm babies often have trouble breathing because their lungs are not fully developed. This condition is called respiratory distress syndrome (RDS). A medicine called surfactant helps their lungs open up and work better. It is usually given through a procedure called INSURE, where a breathing tube is placed into the baby's trachea (via an endotracheal tube) to deliver the medicine. While effective, this method is invasive and can be uncomfortable and risky for the baby. A newer, less invasive method called SALSA uses a soft mask placed in the throat (a laryngeal mask airway) instead of an endotracheal tube to give the surfactant. This randomized controlled trial will compare SALSA to the traditional INSURE method to see if it works just as well in preventing the need for invasive breathing support within three days of treatment. The study will include preterm babies born before 34 weeks of pregnancy and weighing at least 750 grams, at Phu San Hanoi Hospital in Vietnam. If SALSA is found to be safe and effective, it may offer a gentler, less invasive, and easier-to-perform option for treating respiratory distress syndrome in premature babies.

Participants needed: 440
Trial details
Age: Up to 48Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: May 27, 2026Locations: 1
Eligibility criteria

Inborn neonate (=born in the hospital), AND [+5]

Severe respiratory insufficiency in need of intubation at delivery room [+8]

Status: Recruiting

Unloaded Minds - How Prolonged Unloading Shapes Human Performance in Lunar Gravity

During spaceflight and lunar missions, reduced gravitational loading causes the muscles and nervous system to decondition rapidly. While muscle wasting is well documented, much less is known about how the brain and spinal cord adapt to the absence of normal mechanical loading - and how these central changes interact with muscle deterioration to impair movement control. This study investigates how two weeks of simulated lower limb unloading affects the brain's movement programs (motor engrams), the functional connection between nerves and muscles, and overall movement quality. Healthy participants undergo 14 days of Unilateral Lower Limb Suspension (ULLS), a model in which one leg is kept unloaded using a raised shoe and crutches while the other leg functions normally. After the unloading period, participants travel to Bordeaux, France, where they walk on a treadmill for the first time - in lunar gravity - during a parabolic flight. Before and after the unloading period, participants are assessed with MRI (muscle size), force plate tests (jump performance and balance), nerve stimulation (number of functional motor units), and treadmill gait analysis combining brain activity (EEG), muscle activity (EMG), joint movement, and plantar pressure measurements. The same gait analysis is repeated during the parabolic flight under lunar gravity (0.16G). The results will shed light on how the brain and muscles adapt to disuse and reactivate under partial gravity - with direct relevance to astronaut safety and rehabilitation, as well as clinical conditions involving prolonged limb immobilization.

Participants needed: 24
Trial details
Age: 18-60Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: May 26, 2026Locations: 1
Eligibility criteria

high activity level according to the GLTEQ [+16]

Status: Recruiting

A Randomised Waitlist Controlled Clinical Trial of the Restory Treatment Program

This project aims to evaluate Restory - a newly developed anonymous, iCBT prolonged exposure therapy program specifically tailored for victims of sexual abuse - using a pre-registered randomized controlled trial with waitlist control. The primary research question is whether Restory is more effective than a waitlist control in reducing PTSD symptom severity score, as measured by PCL-5.

Participants needed: 140
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: May 27, 2026Locations: 1
Eligibility criteria

Not listed