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Found 8 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating whether using the World Health Organization's Labour Care Guide (LCG) instead of standard care for monitoring labor progress can improve outcomes for newborns and mothers. This study compares these two guidelines to see if the LCG can reduce adverse neonatal outcomes, such as perinatal mortality, neonatal complications, and the need for cesarean sections during labor. The research also looks at other perinatal interventions, complications, and economic factors, using a multicenter, stepped-wedge cluster randomized trial design conducted from 2023 to 2025 in Sweden. Participants will receive care based on either the WHO's LCG or standard labor monitoring guidelines. The LCG is a next-generation partograph designed to follow the latest intrapartum care recommendations. The study involves multiple delivery units where women in active labor receive monitoring according to the assigned guideline. Researchers will compare outcomes such as neonatal morbidity, cesarean section rates, use of oxytocin, postpartum hemorrhage, labor duration, and experiences of women, their partners, and healthcare providers. Throughout the study, participants will be monitored for neonatal complications including low Apgar scores, hypoxic ischemic encephalopathy, intracranial hemorrhage, seizures, meconium aspiration syndrome, and neonatal unit admissions. The study will also assess maternal outcomes and collect feedback via questionnaires and interviews about childbirth experiences and guideline compliance. The primary outcomes are adverse neonatal events and intrapartum cesarean rates, with follow-up from 12 weeks up to 18 months after birth to gather comprehensive data on health and safety.
Actively Recruiting
Researchers are evaluating the PLUSS project, a collaborative effort involving guardians, healthcare providers in J f6nk f6ping County, preschools, and social services. The project studies a "One way in" model that coordinates screening, evaluation, and treatment for toddlers with behavioral problems. It also offers parental education and teacher training. The goal is to assess how well the PLUSS model works, including its impact on behavioral issues in preschool children, parental wellbeing, and satisfaction, aiming to reduce mental health problems in children and families over time. Parents participate in a group-based PRIMUS parent training program consisting of five half-day sessions designed for preschool children with developmental challenges. Preschool teachers join a half-day group session with parents. Families needing more support can receive further interventions from the PLUSS toddler team, which creates a management plan and may refer to specialists such as speech therapists or child psychiatrists. Additional support includes targeted parent groups, web courses, and help with the child's home and preschool environment. Participants and their families are involved through questionnaires and assessments from both parents and preschool teachers, focusing on the child's behavior and mental health. Data is handled with privacy protections and reported only in group form. The main outcome measured is the change in the Strengths and Difficulties questionnaire scores over 24 weeks. The study also monitors parental wellbeing, satisfaction, and the implementation of the PLUSS model within the community, with ethical approval and informed consent obtained from all involved parties.
Actively Recruiting
Spontaneous intracerebral hemorrhage (ICH) is a severe type of stroke accounting for 10-15% of all strokes but causing about half of stroke-related deaths and disabilities. Many patients with ICH have decreased consciousness when admitted, yet intensive care and neurosurgical treatments are not common. Prior studies in low- and middle-income countries showed that a treatment package including early intensive blood pressure lowering and managing fever and high blood sugar improved outcomes. The I-CATCHER study aims to test a similar structured Care Bundle approach in Sweden, Australia, and other high-income countries to improve treatment and prognosis for patients with spontaneous ICH. This study compares a Care Bundle involving early intensive blood pressure control, reversal of oral anticoagulation within 30 minutes, fever management, blood sugar control, and timely referrals to intensive care or neurosurgery against standard care. The Care Bundle targets specific blood pressure levels depending on initial readings and aims to avoid do-not-resuscitate orders or withdrawal of care for 48 hours. Repeat brain imaging is done as needed. Hospitals are randomized in batches over three phases lasting 18 months each: usual care, randomized evaluation, and post-implementation follow-up, with the entire study rolling out over 2.5 years. Participants are adults aged 18 or older with spontaneous ICH confirmed by imaging and admitted within 24 hours of symptom onset. Patient information, treatments, and outcomes are recorded, including functional status measured by the Utility Weighted modified Rankin Scale at 180 days. The study collects data on various treatments, monitoring, and complications to assess if the Care Bundle improves recovery. Safety and sustainability of the Care Bundle are evaluated through continued hospital participation and follow-up.
Actively Recruiting
Patients with established or probable liver cirrhosis, also known as end-stage liver disease (ESLD), face high risks of liver cancer (hepatocellular carcinoma or HCC), portal hypertension, and muscle loss called sarcopenia. These complications cause significant health problems and increase the chance of serious illness or death. The annual chance of developing HCC in these patients is about 2-8%, which is why regular ultrasound screenings for HCC are typically done every six months. This research evaluates a rapid, non-invasive method using a single neck-to-knee magnetic resonance (MR) scan to assess sarcopenia, clinically significant portal hypertension, and HCC. The MR scan measures body composition, including fat and muscle volumes, muscle fat infiltration, liver fat, spleen size, and liver stiffness. The study will also use an abbreviated MRI technique to detect HCC, which has shown higher sensitivity and specificity compared to ultrasound. The study involves 150 patients who will have four or five visits spaced six months apart over about two years. During each visit, patients will undergo clinical examinations, medical history reviews, FibroScan, MR scans, blood tests, muscle function and mobility tests, quality of life questionnaires, and assessments for hepatic encephalopathy and symptom development. Researchers will monitor measurements like body composition, muscle fat infiltration, liver and spleen health, muscle strength, and liver function scores to study disease progression, risk of complications, and HCC detection over time.
Actively Recruiting
This research aims to evaluate the effectiveness of adding a sinus tarsi implant (STI) to medial displacement calcaneal osteotomy (MDCO) surgery in adults with mobile adult acquired flatfoot deformity (AAFD) stage II. AAFD is a complex foot deformity causing pain and difficulty walking, involving misalignment in three planes. While MDCO corrects the deformity in one plane, the STI is studied as an internal splint to better support soft tissues and improve foot correction, appearance, and long-term function. This is a phase 4, multicenter randomized controlled trial involving 130 patients aged 16 to 75 years. Participants will be randomly assigned to receive either MDCO with the sinus tarsi implant or MDCO alone. The surgical procedures include tendon transfers, ligament repairs, and other possible osteotomies as needed. Surgery is performed by experienced orthopedic specialists across nine centers in Sweden. After surgery, patients will wear a cast with weight-bearing restrictions depending on additional procedures performed. The study includes a thorough screening process, randomization, and follow-up visits scheduled at 4-5 months, 1 year, and 2 years postoperatively. Throughout the study, patients will complete questionnaires assessing foot and ankle function, quality of life, pain, and satisfaction with surgery at multiple time points. Clinical examinations by blinded physiotherapists or nurses will measure physical function and perform radiographic imaging to assess foot alignment changes, focusing on Meary's angle. Safety is monitored continuously, and any adverse events are recorded. The total participation duration includes preoperative assessments and two years of postoperative follow-up.
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Healthy Volunteer
The SWEtick project aims to improve understanding of various clinical forms of emerging tick-borne diseases (eTBD) in Sweden. It seeks to evaluate the significance of these diseases for human health, develop and validate new laboratory tests for diagnosis, and create guidelines to help healthcare providers manage patients suspected of having eTBD more effectively within the Swedish healthcare system. This prospective multicenter study involves both children and adults with a clinical suspicion of tick-borne disease, as assessed by a physician based on medical history, symptoms, clinical signs, and sometimes lab results. The study focuses on collecting data to enhance diagnosis and patient care but does not specify particular treatments or interventions. Participants will be assessed using tools such as the EuroQoL-5 Dimension Questionnaire (EQ-5D) and the Visual Analogue Scale for Health (VAS) at 6 months to measure health outcomes. The study monitors participant health and disease impact over time to support better management of tick-borne diseases in Sweden.
Actively Recruiting
Researchers are studying the relationship between different levels of physical activity, sedentary time, and health outcomes in patients who have had a myocardial infarction (heart attack). The main goal is to understand how activity measured by accelerometers relates to clinical outcomes and how changes in physical activity over time affect these outcomes after a heart attack. The study plans to include about 4000 patients over two years who have experienced a myocardial infarction. Participants will wear an accelerometer device attached to their right hip during waking hours for seven consecutive days at two follow-up visits: once at 2 months and again at 1 year after hospital discharge. They will also keep a paper diary to record device wear time and working hours, then return both by mail. This process is repeated at the 1-year follow-up. During the study, participants attend follow-up visits where their physical activity data are collected and analyzed. Researchers will explore how different intensities of activity relate to major adverse cardiovascular events one year after the heart attack. Safety and adherence are monitored by collecting activity diaries and accelerometer data. Participation spans from hospital discharge through at least one year after the event to track outcomes and physical activity changes over time.
Actively Recruiting
Researchers are investigating the effects of tinzaparin, a commonly used anti-coagulant, on women with epithelial ovarian cancer (EOC) who are undergoing neoadjuvant chemotherapy (NACT). This pilot Phase II randomized controlled trial focuses on patients with advanced FIGO stage III-IV EOC, aiming to evaluate tinzaparin's potential antitumoral effects by measuring changes in the cancer biomarker CA-125. The study also explores how tinzaparin influences immune and coagulation factors and monitors patient adherence and any side effects from the treatment. Participants are randomly assigned to receive either daily subcutaneous injections of tinzaparin or no tinzaparin alongside their standard chemotherapy with carboplatin and paclitaxel every 21 days. Blood samples for various biomarkers are collected before treatment, before each chemotherapy cycle, before delayed primary debulking surgery (DPDS), and after surgery. Patients undergoing DPDS will receive tinzaparin for 28 days postoperatively and continue chemotherapy for an additional two to three cycles. Those initially on tinzaparin may choose to continue it during these cycles. Patients not undergoing surgery remain in the study for three chemotherapy cycles. The total study duration ranges from 22 to 29 weeks. During the trial, participants undergo clinical and imaging evaluations after three chemotherapy cycles to determine surgical eligibility. Researchers collect blood samples to analyze markers of cancer, inflammation, and coagulation, including CA-125 levels at week 14 as the primary outcome. Patient safety, treatment compliance, and adverse events are carefully monitored throughout the study period. This comprehensive approach allows assessment of tinzaparin's impact on cancer progression and patient health during and after chemotherapy.