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Found 8 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the impact of two different guidelines for monitoring labor progress on neonatal and maternal outcomes. The study compares the World Health Organizations Labour Care Guide LCG with standard delivery care in Sweden. The goal is to see if using the LCG can reduce adverse neonatal outcomes and lower the rate of intrapartum Cesarean sections. This study uses a multicenter, stepped-wedge cluster randomized design to explore these effects along with economic considerations and experiences related to childbirth. Participants will receive labor monitoring either according to the WHOs LCG guidelines or standard care. The study will involve multiple delivery units in Sweden, and women in active labor will be randomly assigned to either group as the new guidelines are gradually introduced. Alongside the main study periods, researchers will examine perinatal interventions, labor complications, and collect qualitative data through questionnaires, focus groups, and interviews with women, their partners, and healthcare providers. During participation, women and their partners will be asked about their childbirth experiences, while providers compliance and views on using the LCG will also be assessed. The study will track outcomes such as perinatal mortality, neonatal morbidity, cesarean section rates, and obstetric events like postpartum hemorrhage and labor duration. Data collection and follow-up will occur from 12 weeks up to 18 months after delivery, including economic evaluations and provider experiences to fully understand the effects of the labor monitoring methods.

FEMALEPhase Not Applicable
24 locations
E

Actively Recruiting

Researchers are evaluating the PLUSS model, a collaborative approach involving guardians, healthcare, preschools, and social services in Jnkping County. The study focuses on early detection, evaluation, and treatment of behavioral problems and developmental delays in preschool children. It also assesses parental wellbeing and satisfaction with the model, aiming to reduce mental health issues among children and their families over time. The study includes a control group receiving usual care and an intervention group where parents participate in the PRIMUS parent training program over five half-day sessions. Preschool teachers may join a half-day education session alongside parents. For families needing additional support, a PLUSS toddler team develops individualized management plans and refers to specialists or provides targeted interventions like parent groups and web courses. Participants undergo assessments using questionnaires and observations, including the Strengths and Difficulties Questionnaire and Childrens Engagement Questionnaire, to measure changes before and up to 24 weeks after intervention. Data collection involves parents, preschool teachers, and healthcare professionals, with privacy protections in place. The study observes childrens behavior, parental wellbeing, and family psychosocial problems, with results reported at the group level.

Age: 18Months - 72MonthsAll GendersPhase Not Applicable
1 location
S

Actively Recruiting

Spontaneous intracerebral hemorrhage ICH is a serious type of stroke with high death and disability rates. Researchers are investigating whether a structured treatment package called a Care Bundle can improve the 3-month outcomes for patients with acute ICH compared to standard care. The study is an international, multicenter, parallel, cluster-randomized clinical trial focusing on implementing this Care Bundle in high-income countries, building on results from previous trials mostly done in low- and middle-income countries. The Care Bundle includes early intensive blood pressure lowering, treatment of fever and high blood sugar, rapid reversal of oral anticoagulation, and timely referrals to intensive care or neurosurgery when needed. Hospitals are randomized in batches through three phases usual care, randomized evaluation of the Care Bundle versus usual care, and a post-implementation follow-up where all hospitals apply the Care Bundle. Each batch lasts 18 months, with 6 months per phase, and the overall study rollout spans 2.5 years. Participants are adults aged 18 or older diagnosed with spontaneous ICH confirmed by imaging within 24 hours of symptom onset. During the study, patient management details and outcomes will be closely monitored, including brain imaging, blood pressure, glucose levels, and functional status. The primary outcome is functional recovery measured by a utility-weighted modified Rankin Scale score at 180 days. Secondary outcomes include disability, death, and health-related quality of life. The study also collects data on treatments and care decisions to evaluate the Care Bundles effectiveness and sustainability.

Age: 18Years +All GendersPhase 4
54 locations
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Actively Recruiting

Patients with established liver cirrhosis or end-stage liver disease face a high risk of developing liver cancer, portal hypertension, and muscle loss called sarcopenia, which can lead to serious health problems and death. This research aims to evaluate these conditions using a single short magnetic resonance MR scan. The goal is to improve early detection of liver cancer and better predict liver complications to help guide treatment decisions. The study involves 150 patients who will undergo four visits every six months over about two years, with an additional visit for some patients. Each visit includes a detailed clinical assessment, medical history review, FibroScan, MR examination, blood tests, muscle strength and mobility tests, quality of life questionnaires, and assessments for liver-related symptoms. The MR scan will capture body composition and liver measurements, including muscle volume, muscle fat, liver fat, spleen size, and liver stiffness. Specialized software will analyze these images to monitor sarcopenia and portal hypertension while liver cancer screening will be done using advanced MR techniques. Participants will be actively involved throughout the study period, attending scheduled visits alongside their routine clinical appointments. Researchers will measure changes in body composition, muscle fat, liver function scores, muscle strength, liver cancer presence, and other liver complications at multiple timepoints. Quality of life and symptom assessments will also be collected. The study aims to provide comprehensive data on liver disease progression, muscle loss, and cancer detection, helping to improve patient care and outcomes over the two-year follow-up.

Age: 18Years +All Genders
3 locations
E

Actively Recruiting

Researchers are evaluating surgical treatments for adult acquired flatfoot deformity AAFD, a condition causing foot pain and changes in walking. This trial compares the standard medial displacement calcaneal osteotomy MDCO alone with MDCO combined with a sinus tarsi implant STI, which may provide better correction by supporting soft tissues and improving foot alignment. The study is a randomized controlled trial involving patients aged 16 to 75 with mobile AAFD stage II who have not improved after physiotherapy. Participants will be randomly assigned to receive either MDCO with STI or MDCO without STI. Both groups may also receive additional procedures like Strayers gastrocnemius recession, flexor digitorum longus tendon transfer, spring ligament repair, and possibly a Cotton osteotomy if needed. Surgery will be performed by experienced foot and ankle surgeons at multiple orthopedic centers. Postoperative care includes casting and weight-bearing instructions tailored to the procedures performed. Patients will be assessed before surgery and at 4-5 months, 1 year, and 2 years after surgery through clinical exams, questionnaires measuring foot function and quality of life SEFAS and EQ-5D, and weight-bearing foot X-rays to measure angles like Mearys angle. Researchers will also evaluate pain, satisfaction, heel-rise endurance, sick-leave duration, and complications. Follow-up involves blinded examiners and radiologists to ensure unbiased assessments, with patients encouraged to complete all visits and questionnaires over the two-year period.

Age: 16Years - 75YearsAll GendersPhase 4
10 locations
S

Actively Recruiting

Healthy Volunteer

Researchers are conducting a prospective multicenter study in Sweden called SWEtick to better understand emerging tick-borne diseases eTBD. The study aims to explore the different ways these diseases present clinically, assess their impact on human health, develop and validate diagnostic laboratory methods, and create recommendations to improve patient care within the Swedish healthcare system. The study includes several patient groups those with confirmed tick-borne diseases, those suspected of having tick-borne diseases but diagnosed otherwise, patients undergoing spinal anesthesia during knee or hip replacement surgery due to arthrosis, patients with autoinflammatory joint diseases, and healthy blood donors. This observational study gathers data from these diverse groups to support its goals. Participants will be followed and evaluated using tools such as the EuroQoL-5 Dimension Questionnaire EQ-5D and the Visual Analogue Scale for Health VAS at six months to assess health outcomes. The study involves collecting clinical information, symptoms, and laboratory results to support diagnosis and management. Participation may last several months, with ongoing data collection and assessments to better understand tick-borne diseases and their effects.

Age: 1Year +All Genders
12 locations
S

Actively Recruiting

Researchers are investigating how different levels of physical activity, measured objectively, relate to health outcomes in patients who have had a type 1 myocardial infarction. The study aims to explore links between activities of varying intensity, sedentary time, and the risk of major cardiovascular events after a heart attack, as well as how changes in physical activity over time affect these outcomes. Participants in this observational study will be asked to wear an accelerometer device on their right hip during waking hours for seven consecutive days at two follow-up visits2 months and 1 year after hospital discharge. They will also keep a diary recording their wear time and working hours if applicable. About 4000 patients aged 18 to 79 diagnosed with myocardial infarction are expected to be included, and the study will analyze the dose-response relationship between accelerometer data and clinical outcomes. Throughout the study, participants will attend cardiac rehabilitation follow-up visits and provide accelerometer and diary data. Researchers will assess outcomes such as major adverse cardiovascular events, including heart failure, stroke, death, and coronary revascularization, at 1 and 3 years after the initial cardiac event. The study will monitor these outcomes while participants continue their usual care, with a total follow-up period extending to 3 years after the heart attack.

Age: 18Years - 79YearsAll Genders
35 locations
S

Actively Recruiting

Researchers are evaluating the potential antitumor effects of tinzaparin, a commonly used anticoagulant, in women with advanced epithelial ovarian cancer EOC who are receiving neoadjuvant chemotherapy NACT. This pilot Phase II clinical trial aims primarily to assess how tinzaparin affects the levels of the tumor marker CA-125 during treatment. The study also explores how tinzaparin influences various immune and coagulation factors, and monitors compliance and side effects related to its use. Participants are randomly assigned to either receive daily subcutaneous injections of tinzaparin dose based on weight alongside standard chemotherapy with carboplatin and paclitaxel or to receive chemotherapy alone without tinzaparin. The treatment period spans 21 to 28 weeks, starting with chemotherapy and continuing through delayed primary debulking surgery DPDS and postoperative care. Blood samples for biomarker analysis are collected at multiple time points, including before each chemotherapy cycle, pre- and post-surgery, and after the last chemotherapy session. Patients in the tinzaparin group may choose to continue the anticoagulant following surgery and initial chemotherapy cycles. Throughout the study, women undergo clinical evaluations and imaging to guide surgery decisions. Researchers collect blood to measure markers such as hemoglobin, platelets, leucocytes, C-reactive protein, albumin, CA-125, and several coagulation and inflammation-related proteins. Compliance with tinzaparin injections and any treatment-related adverse events are closely monitored. The total participation time ranges from 22 to 29 weeks, covering chemotherapy, surgery, and follow-up periods.

Age: 18Years +FEMALEPhase 2
8 locations