[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"randomized-controlled-study\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:randomized-controlled-study":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,58,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100610370","phase-3-suzetrigine-in-total-hip-arthroplasty-100610370",false,"NCT07226700","Suzetrigine in Total Hip Arthroplasty","A Randomized, Placebo-controlled, Double-blind Trial of Suzetrigine in Total Hip Arthroplasty","Inclusion Criteria:\n\n* Patients undergoing primary THA (posterior approach) with participating surgeons\n* Age 18 to 80 years old\n* Planned discharge to home\n* Planned use of neuraxial anesthesia\n* American Society of Anesthesiologists (ASA) Physical Status 1 - 3\n\nExclusion Criteria:\n\n* ASA greater than 3\n* Chronic opioid use (daily MME of greater than 30 mg for at least 3 months and within 1 month of surgery)\n* History of chronic pain syndromes or uncontrolled pain (i.e. complex regional pain syndrome, fibromyalgia, implanted spinal cord stimulator)\n* History of QT prolongation\n* Presence of automated implantable cardioverter defibrillator, pacemaker or cardiac resynchronization device\n* Evidence of misuse, aberrant use, or addiction to alcohol or an illicitly used drug of abuse, or had a positive test for drugs of abuse\n* Inability to comply with any component of the study protocol\n* Younger than 18 or greater than 80 years old at the time of enrollment\n* Patient already on Suzetrigine\n* Allergy or contraindication to Suzetrigine or excipients (eg moderate to severe liver disease\u002FChild Pugh B or C, use of strong CYP3 inhibitors or inducers)\n* Contraindications to neuraxial anesthesia or any other part of the study protocol\n* Participation in another investigational drug or device study\n* Pregnancy",true,"ALL","18 Years","80 Years",{"count":21,"type":22},210,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Total hip and knee joint replacements are among the most common and painful orthopedic procedures performed worldwide, often requiring intensive analgesia to support early ambulation and recovery. Despite widespread use of multimodal regimens, many patients still rely on opioids, which can cause sedation, nausea, constipation, and long-term dependency. Evaluating Suzetrigine in this high-need population may improve recovery trajectories, reduce opioid consumption, and support enhanced recovery protocols. Given the growing surgical volume and the emphasis on opioid-sparing strategies, rigorous investigation of Suzetrigine's efficacy in joint replacement is of high clinical value. In this study, patients undergoing primary total hip replacement will be randomized to receive either Suzetrigine or placebo for seven days, with the loading dose administered prior to surgery. The primary outcome is cumulative 48-hour opioid consumption in oral morphine equivalents starting from entry into the post-anesthesia care unit (PACU).",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Total Hip Arthroplasty (THA)","Total Hip Arthroplasty \\(THA\\)","Total Hip Replacement","Total Hip Replacement Surgery","Total Hip Replacements","Total Hip Replacement Arthroplasty","Suzetrigine","Pain Management","Pain","Nav 1.8","JOURNAVX","Opioid Cessation","Opioid Consumption, Postoperative","Multimodal Analgesia","Randomized Controlled Trial","Randomized Controlled Study","Randomized Controlled Trials","RECRUITING","2026-06-02",{"date":48,"type":49},"2026-06-03","ACTUAL",{"date":51,"type":49},"2025-11-03",{"date":53,"type":22},"2028-11-01",{"name":55,"class":56},"Hospital for Special Surgery, New York","OTHER",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":65,"minAge":18,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":23,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":57},"100549283","a-study-of-the-intervention-of-time-restricted-eating-in-high-risk-populations-of-gdm-100549283","NCT06431997","A Study of the Intervention of Time-restricted Eating in High-risk Populations of GDM","Effects of Time-restricted Eating on the Incidence of Gestational Diabetes Mellitus in High-risk Populations: a Randomized Controlled Study","Inclusion criteria:\n\n1. Aged 18-50 years;\n2. The risk for GDM includes overweight or obesity (BMI ≥ 24 kg\u002Fm2 before pregnancy), first-degree relative with diabetes, history of cardiovascular disease, hypertension (≥130\u002F80 mmHg or on therapy for hypertension), HDL cholesterol level \\\u003C 1 mmol\u002FL and\u002For a triglyceride level \\> 2.8 mmol\u002FL, history of GDM, history of macrosomia delivery, individuals with polycystic ovary syndrome, repeated positive fasting urine glucose in the first trimester, or age\\>45 years according to Guideline of Diagnosis and Treatment of Hyperglycemia in Pregnancy (2022);\n3. Less than 14 weeks of gestation;\n4. Able to read and complete questionnaires in Chinese;\n5. singleton pregnancy.\n\nExclusion criteria:\n\n1. Pregestational diabetes (including diabetes diagnosed before conception; fasting blood glucose ≥ 7.0 mmol\u002FL or HbA1c ≥ 6.5% in the first trimester; typical symptoms of hyperglycemia or hyperglycemic crisis with optional blood glucose ≥ 11.1 mmol\u002FL);\n2. Impaired glucose tolerance (including fasting blood glucose ≥ 5.6 mmol\u002FL or two fasting blood glucose ≥ 5.1 mmol\u002FL in the first trimester);\n3. Current or recent use of drugs that affect glucose metabolism such as metformin, glucocorticoids and Orlistat;\n4. Severe comorbidities (including cardiac diseases, kidney diseases, hepatopathy, autoimmune diseases, uncontrolled thyroid disease, previous or current malignant tumors, etc.);\n5. Fetal malformations or chromosomal abnormalities;\n6. Cervical insufficiency (including ultrasonic cervical length \\\u003C 25 mm before 24 weeks of gestation, history of spontaneous preterm birth at 14-36 weeks of previous pregnancy, or cervical dilation in the past or current pregnancy);\n7. Exercise contraindications (including continuous vaginal bleeding, threatened premature labor, placenta previa, premature rupture of membranes, severe anemia, etc.);\n8. Drug abuse, which refers to the repetitive, heavy use of drugs with dependent characteristics such as narcotic, psychotropic substances, tobacco and alcohol;\n9. Hyperemesis gravidarum, which refers to the severe and persistent nausea and vomiting, unable to eat or eat little that leads to dehydration, ketosis and even acidosis;\n10. On a special or prescribed diet for other reasons;\n11. Eating window\\\u003C10 h.\n\nExit criteria：\n\n1. Failure to comply with or assume the corresponding responsibilities and obligations of the informed agreement;\n2. Pregnant women who terminate their pregnancy before completing GDM diagnosis and screening at 24-28 weeks of pregnancy will automatically withdraw from the group, such as severe fetal malformation, eclampsia, abortion, etc.\n3. Major diseases, such as particularly serious obstetric medical events, malignant tumors, serious cardiovascular and cerebrovascular diseases, brain injuries, paralysis and other major diseases, can not continue to accept this intervention plan and follow-up, and withdraw from the study;\n4. Accidental disability or death caused by non-intervention factors occurred during the study period, and he withdrew from the study;\n5. Subjects are subjectively unwilling to continue to accept the intervention program, and sign the withdrawal agreement to withdraw from the group on a voluntary basis, and decide whether to continue to follow up the pregnancy process and outcome according to the specific contents of the withdrawal statement.","FEMALE","50 Years",{"count":68,"type":22},240,[70],"NA","This is a randomized controlled trial, aiming to investigate whether a time-restricted eating (TRE) can reduce the incidence of gestational diabetes mellitus (GDM) in high-risk pregnant women. Investigators intend to conduct a 3-month randomized controlled study to compare the effects of 10-hour TRE and habitual eating time on GDM .",[73,74,75,43],"Gestational Diabetes Mellitus","Dietary Habits","Lifestyle Intervention",[73,77],"Metabolic Diseases","2025-11-18",{"date":80,"type":49},"2025-11-21",{"date":82,"type":49},"2024-04-17",{"date":84,"type":22},"2026-12",{"name":86,"class":56},"Fudan University",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":4},"100576944","nurture-and-play---a-pilot-study-100576944","NCT06791876","'Nurture and Play' - a Pilot Study","'Nurture and Play' - a Randomized Controlled Pilot Study of a Perinatal Intervention to Strengthen Parenting Among Women with Psychosocial Vulnerabilities and Their Partners.","Inclusion Criteria:\n\n* Known with a current or previous history of anxiety and\u002For depression\n* Referred for labour at Slagelse Hospital\n\nExclusion Criteria:\n\n* Age under 18 years old\n* A need for an interpreter\n* Expecting more than one child\n* Known with schizophrenia or other serious mental illness\n* Expecting a child with a known illness\n* A history of alcohol or drug abuse",{"count":95,"type":22},20,[70],"The aim of this randomised controlled pilot study is to evaluate the feasibility of the Nurture and Play (NnP) offered to a Danish population of psychosocial vulnerable pregnant women and their partners.\n\nMore specifically the objectives of the study are to:\n\n* Test the feasibility of the NnP including both parents\n* Evaluate the recruitment procedure, the adherence as well as the participant's and professional´s experience of the intervention\n* Evaluate the collaboration between the hospitals and the municipalities.\n\nThe study consists of:\n\n1. A randomized controlled pilot study (n=20 women\u002Fcouples) carried out according to the Standard Protocol Items: Recommendations for Interventional Trials SPIRIT statement for clinical trials. The parents who agree to participate in the study will be randomly assigned in a 1:1 ratio to either the intervention or the control group. In addition to care-as-usual, the intervention group will be offered to participate in the NnP adapted to include partners. The intervention consists of 11 group sessions (4 perinatal and 7 postnatal sessions) and will be provided to the parents in the intervention group from around 26 weeks gestation until the baby is around seven months old. Each group session will be led by a midwife and a health nurse and will consist of four to five mothers\u002Fcouples.\n2. A qualitative descriptive interview study aiming to evaluate the participants' and professionals´ experience of the intervention.\n\nData will be collected through:\n\n* Online Questionnaires.\n* Interviews.\n* Videotaped settings.",[99,100,43],"Depression, Anxiety","Intervention","NOT_YET_RECRUITING","2025-01-24",{"date":104,"type":49},"2025-01-28",{"date":106,"type":22},"2025-02-15",{"date":108,"type":22},"2026-10-15",{"name":110,"class":111},"Center for Clinical Research and Prevention","NETWORK"]