[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"edema\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:edema":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,50,100,130,164,194,231,254,277,294,347],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":36,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100053937","screening-for-bcrl-in-targeted-therapy-for-breast-cancer-100053937",false,"NCT05142800","Screening For BCRL In Targeted Therapy For Breast Cancer","Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer","Inclusion Criteria:\n\n* Subjects who are receiving treatment in the MGH Breast Cancer Center who are enrolled in a DF\u002FHCC-regulated targeted therapy trial for the treatment of early or metastatic breast cancer or patients being treated with a targeted therapy that may alter their risk of developing edema or BCRL will be eligible.\n* Subjects that will be eligible for the study include:\n* Females between 18 and 80 years of age\n* With a history of breast cancer\n* 4 weeks or more post-surgery\n* With or without edema\n* Undergoing treatment with targeted therapy for early or metastatic disease.\n\nExclusion Criteria:\n\n\\- Patients who cannot attain 90 degrees of shoulder abduction (position of measurement with Perometer).","FEMALE","18 Years","80 Years",{"count":20,"type":21},261,"ESTIMATED","OBSERVATIONAL","This a prospective, longitudinal study designed to track edema and Breast Cancer Related Lymphedema (BCRL) onset in breast cancer patients taking targeted therapy treatments for early and metastatic breast cancer.\n\nA Perometer and Sozo devise will be used to measure volume changes",[25,26,27,28,29,30,31,32,33,34,35],"Lymphedema","Lymphedema Arm","Lymphedema of Upper Arm","Lymphedema of Upper Limb","Lymphedema of the Hands","Edema","Edema Arm","Breast Cancer Lymphedema","Breast Cancer Metastatic","Breast Cancer Stage","Breast Cancer",[25,26,27,28,29,30,31,32,33,34,35],"RECRUITING","2026-07-09",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":41},"2018-12-13",{"date":45,"type":21},"2026-09-30",{"name":47,"class":48},"Massachusetts General Hospital","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100383878","pharmacokinetics-pharmacodynamics-and-safety-profile-of-understudied-drugs-administered-to-children-per-standard-of-care-pops-100383878","NCT04278404","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs","POPS or POP02","Inclusion Criteria:\n\n1. Participant is \\\u003C 21 years of age\n2. Parent\u002F Legal Guardian\u002F Adult Participant can understand the consent process and is willing to provide informed consent\u002FHIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n   Below exclusion criteria apply only to:\n\n   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study",true,"ALL","0 Years","20 Years",{"count":63,"type":21},5000,"The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.",[66,67,68,69,70,71,72,30,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89],"Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Primary Hyperaldosteronism","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","Down Syndrome","2026-03-31",{"date":92,"type":41},"2026-04-06",{"date":94,"type":41},"2020-03-05",{"date":96,"type":21},"2027-07",{"name":98,"class":48},"Duke University",51,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":58,"sex":59,"minAge":17,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":49},"100595483","effects-of-red-and-infrared-photobiomodulation-in-rhinoplasty-at-a-single-centre-100595483","NCT07033039","Effects of Red and Infrared Photobiomodulation in Rhinoplasty at a Single Centre","Effects of Photobiomodulation With Red and Infrared Low-level Laser Diodes in Individuals Undergoing Rhinoplasty at a Single Centre: Protocol for a Randomized, Double-blind, Controlled Clinical Trial","Inclusion criteria:\n\n* individuals 18-60 years of age;\n* ASA I or II; no comorbidities (no pre-existing diseases);\n* indication for rhinoplasty;\n* regardless of gender identity.\n\nExclusion criteria:\n\n* use of anticoagulant,\n* anti-inflammatory, or corticosteroid medications;\n* indication for closed rhinoplasty;\n* procedures not performed using the Piezo device (Schuster SW Surgery II);\n* intraoperative complications (e.g., haemorrhage or technical difficulties);\n* prior nasal filler with hyaluronic acid;\n* use of vitamin A derivatives (oral isotretinoin or topical retinoic acid) within 30 days before surgery;\n* or known allergy to any mandatory intra- or postoperative medication.","60 Years",{"count":109,"type":21},60,"INTERVENTIONAL",[112],"NA","This single-centre, randomized, double-blind, sham-controlled clinical trial evaluates whether preoperative photobiomodulation (PBM) with red and infrared light can reduce early postoperative periorbital edema in patients undergoing primary open rhinoplasty with osteotomies. Sixty participants will be randomly assigned to receive active PBM or sham PBM one hour before surgery. The primary outcome is periorbital edema on postoperative day 3 measured using a validated ordinal clinical scale with standardized photographic documentation. Secondary outcomes include ecchymosis, postoperative pain, analgesic consumption, nasal tip skin thickness, and patient-reported functional and aesthetic outcomes. Participants will be followed for up to 12 months after surgery.",[115,30],"Rhinoplasty",[117,118,119,120],"Photobiomodulation","Low-Level Laser Therapy","Postoperative","Inflammation","2026-03-19",{"date":123,"type":41},"2026-03-24",{"date":125,"type":41},"2026-01-30",{"date":127,"type":21},"2030-11-30",{"name":129,"class":48},"University of Nove de Julho",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":59,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":110,"phases":140,"briefSummary":141,"conditions":142,"keywords":145,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":49},"100626954","care-bundle-for-prevention-of-skin-complications-and-edema-in-restrained-patients-100626954","NCT07442344","Care Bundle for Prevention of Skin Complications and Edema in Restrained Patients","Development and Evaluation of the Effectiveness of a Dermatological Complications and Edema Prevention Care Package in the Physical Constraint Zone","SCER-ICU","Inclusion Criteria:\n\n* • 18 years of age or older,\n\n  * For whom a physician has decided to apply physical restraint to the upper extremities and is about to begin doing so,\n  * With intact skin integrity in the area of physical restraint (no lacerations, wounds, ulcerations),\n  * Without oedema in the area of physical restraint,\n  * APACHE-2 score of 17 or higher (In the study by Tian et al. (2022), an APACHE-II score of 17 or higher was found to be associated with a low life expectancy),\n  * Individuals for whom written consent has been obtained from the patient's relatives regarding participation in the study.\n\nExclusion Criteria:\n\n* In the physical restraint area;\n\n  * Those with fractures or dislocations,\n  * Those with peripheral vascular disease or chronic venous insufficiency,\n  * Those with advanced skin disease (psoriasis, etc.),\n  * Those whose physical restraint was discontinued within the first 24 hours after it began for any reason (discharge, transfer to another clinic, death, lifting of the physical restraint decision by the physician, etc.).",{"count":139,"type":21},76,[112],"Physical restraint (restraint) is defined as the restriction of a patient's free body movements and the prevention of the patient's ability to move easily by healthcare professionals using physical or mechanical devices to prevent the patient from harming themselves or others. Physical restraints can be used by healthcare professionals for many purposes, particularly in intensive care units, such as ensuring patient safety, controlling aggressive and disruptive behavior, continuing patient care and treatment, and preventing the removal of medical equipment attached to the patient. However, when looking at the duration of physical restraint applications, it has been determined that they vary between 3-4 days. The longer the duration of physical restraint, the greater the likelihood of complications developing. In particular, long-term physical restraint can result in neurovascular and dermatological complications such as pressure injuries, edema, ecchymosis, redness, numbness, limited movement, increased temperature, discoloration, and nerve damage. The care package application is a model that improves patient care quality by simultaneously and comprehensively implementing 3-5 applications based on strong scientific evidence, prepared for the relevant area in the specified patient group. Care package applications are created to enable evidence-based practices outlined in guidelines to be used more effectively and practically in clinical settings. Within this context, the aim of this study is to develop a care package to prevent dermatological complications and edema that may occur in the restraint area in patients undergoing physical restraint in intensive care and to evaluate the effectiveness of this care package.",[30,143,144],"Dermatologic Complication","Physical Restraints",[146,147,148,149,150,151,152],"physical restraint","edema","laseration","ulceration","intensive care unit","nursing","ecchymosis","NOT_YET_RECRUITING","2026-02-27",{"date":156,"type":41},"2026-03-02",{"date":158,"type":21},"2026-03",{"date":160,"type":21},"2027-04",{"name":162,"class":163},"Kocaeli City Hospital","OTHER_GOV",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":59,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":110,"phases":175,"briefSummary":176,"conditions":177,"keywords":180,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":4},"100625144","infant-massage-for-lymphedema-and-comfort-in-preterm-newborns-100625144","NCT07418814","Infant Massage for Lymphedema and Comfort in Preterm Newborns","The Effectiveness of Infant Massage in Reducing Immobilization-Related Lymphedema Symptoms and Increasing Comfort in Preterm Newborns","Inclusion Criteria:\n\nTo ensure a homogenous and clinically stable sample, infants meeting the following criteria will be recruited:\n\n* Clinical diagnosis of lymphedema.\n* Hemodynamic and clinical stability.\n* No current or recent (within 24 hours) administration of analgesic or sedative medications that could mask comfort assessments.\n* Intact skin integrity with no contraindications for topical massage.\n* Absence of congenital heart disease or neurological disorders (antenatal or postnatal diagnosis).\n* No immediate requirement for endotracheal aspiration.\n* Requirement for only non-invasive respiratory support (e.g., nCPAP).\n* Provision of written informed consent by the legal guardians (parents).\n\nExclusion Criteria:\n\nInfants will be excluded if they present with:\n\n* Major congenital anomalies.\n* Severe respiratory, cardiac, or neurological instability during the study period.\n* Any acute medical contraindication identified by the attending neonatologist.","28 Weeks","37 Weeks",{"count":174,"type":21},40,[112],"This randomized controlled trial investigates the effectiveness of infant massage in reducing symptoms of immobilization-related lymphedema and improving comfort in preterm newborns hospitalized in the Neonatal Intensive Care Unit (NICU). Preterm infants frequently develop lymphedema due to their immature circulatory systems and prolonged lack of movement.\n\nThe study compares two groups of infants: one receiving standard care and another receiving a daily 15-minute massage therapy session for 14 consecutive days in addition to standard care. Researchers will evaluate the impact of the massage by measuring the circumference of the infants' wrists, elbows, ankles, and knees to assess fluid reduction. Additionally, the infants' comfort levels will be assessed using the Premature Infant Comfort Scale (PICS). The goal is to determine if massage can serve as a safe, non-invasive method to manage lymphedema and reduce distress in this vulnerable population.",[25,178,30,179],"Premature Birth","Immobilization",[181,182,25,183,184,179],"Infant Massage","Preterm Infant","Neonatal Comfort","Massage Therapy","2026-02-11",{"date":187,"type":41},"2026-02-18",{"date":189,"type":21},"2026-04-01",{"date":191,"type":21},"2027-04-01",{"name":193,"class":48},"Erzurum Technical University",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":59,"minAge":202,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":205,"conditions":206,"keywords":219,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":49},"100478094","interview-study-of-adult-and-child-patients-and-parents-of-children-with-swelling-due-to-nephrotic-syndrome-100478094","NCT05505500","Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.","Preparing a Clinical Outcomes Assessment Set for Nephrotic Syndrome","Prepare-NS","Criteria for the Observer Reported Outcomes (ObsRO) cohort of the study:\n\nInclusion Criteria:\n\n1. Parents\u002Fguardians must be able to read and understand English;\n2. Parents\u002Fguardians must be caring for a child (ages 2-11.999) with a medically documented diagnosis of idiopathic (primary) Nephrotic Syndrome (NS) or primary or monogenic NS associated kidney disease. Populations with Primary NS Conditions: Focal segmental glomerulosclerosis (FSGS), Minimal Change Disease (MCD), Immunoglobulin M (IgM) Nephropathy, Membranous Nephropathy (MN), and childhood - onset nephrotic syndrome not biopsied;\n3. The child must have a current NS-associated edema\n4. The child must have native kidney function\n5. Parents\u002Fguardians must provide informed consent.\n\nExclusion Criteria:\n\n1\\. Index case with dialysis dependence throughout the 3-month pre-enrollment period\n\nCriteria for the Patient Reported Outcomes (PRO) cohort of the study:\n\nInclusion Criteria:\n\n1. ≥8 years of age\n2. Able to read and understand English\n3. Primary (idiopathic) kidney disease that causes NS or monogenic NS associated kidney disease.\n\n   i. Populations with Primary Nephrotic Syndrome (NS) Conditions include: FSGS, MCD, IgM nephropathy, MN, and childhood - onset nephrotic syndrome not biopsied\n4. Current NS-associated edema\n5. Kidney function with most recent estimated Glomerular Filtration Rate (eGFR) \\> 25 ml\u002Fmin\u002F1.73m2\n6. Informed Consent: For patients ≥8 to \\\u003C18 years of age: a parent or legal guardian provide informed consent and the patient must provide assent. Patients ≥18 years of age must provide informed consent.\n\nExclusion Criteria:\n\n1. Native kidney disease participant with dialysis dependence during the 3-month pre-enrollment period\n2. Co-existing significant chronic or severe acute health condition that has the potential to influence how the participant feels or functions as related to fluid overload in NS","2 Years",{"count":204,"type":21},150,"Researchers from the University of Michigan and Northwestern University are studying people's experiences with swelling caused by Nephrotic Syndrome. Interviews with patients (child and adult) and parents of young children will be conducted. The information collected from the interviews will be used to develop a survey to use when testing new medications for Nephrotic Syndrome.\n\nPlease consider participating in a 1-hour long interview with the Prepare-NS research study to discuss children and adults experiences with swelling.",[207,208,30,209,210,211,212,213,214,215,216,217,218],"Fluid Overload","Glomerulosclerosis, Focal Segmental","Membranous Nephropathy","Minimal Change Disease","Minimal Change Nephrotic Syndrome","IgM Nephropathy","Nephrotic Syndrome","Glomerular Disease","Nephrotic Syndrome, Minimal Change","Nephrotic Syndrome in Children","Nephrotic Syndrome With Edema (Diagnosis)","FSGS",[213,220,221,207,30,218,210,209,212],"Child","Adult","2025-12-15",{"date":224,"type":41},"2025-12-22",{"date":226,"type":41},"2022-04-18",{"date":228,"type":21},"2026-04-30",{"name":230,"class":48},"University of Michigan",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":59,"minAge":17,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":110,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":49},"100420785","diuretic-tuner-clinical-decision-support-100420785","NCT04759274","Diuretic Tuner Clinical Decision Support","Diuretic Tuner Clinical Decision Support Mobile Device Application for Diuretic Titration in Hypervolemic States","Inclusion Criteria:\n\n* The presence of nephrotic range proteinuria (\\> 3 g\u002Fd proteinuria by 24hr urine protein, 24hr urine albumin, spot urine protein\u002Fcreatinine ratio, or spot urine albumin\u002Fcreatinine ratio) or stage 4 or 5 chronic kidney disease (estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m2 by Modification of Diet in Renal Disease equation) PLUS\n* Clinical signs of hypervolemia present (lower extremity edema, ascites, or pleural effusions) with an estimated dry weight (defined as edema-free weight without orthostatic hypotension) 5 lbs less than enrollment body weight\n\nExclusion Criteria:\n\n* Weight \\\u003C 100 lbs or \\> 300 lbs.\n* Autonomic insufficiency resulting in orthostatic hypotension at screening\n* Hypokalemia at enrollment (defined as serum potassium \\\u003C 3.5 mmol\u002FL)\n* Moderate to severe hyponatremia at enrollment (defined as serum sodium \\\u003C 130 mmol\u002FL)\n* Serum creatinine \\> 6 mg\u002FdL or \\> 1.5 times baseline\n* Patients who are unable or unwilling to measure their home blood pressures and weights\n* Patients without a working phone number and smart phone device\n* Expectation that the patient will require dialysis initiation within \\\u003C 3 months\n* Expected lifespan of \\\u003C 6 months\n* The presence of a medical condition that would interfere with effectively using the Diuretic Tuner (dementia, illiteracy, or blindness)\n* Pregnant patients\n* Prisoners",{"count":239,"type":21},30,[112],"This purpose of this study is to determine the effectiveness of a mobile phone application in helping to control body swelling in patients with kidney problems. The application will help in the day to day adjustments in diuretic medication dosing.\n\nParticipants in this study will have an application loaded on to their mobile phone by the study team and be taught how to use it over a 2 hour visit. Participants will need to check their blood pressure and weight daily and enter this information into the mobile phone application every day. Participants will need to follow daily instructions in their medication dosing provided by the application. There will be periodic blood testing. This will happen at 2 weeks, 90 days, and up to 4 other times if necessary. At the end of the study there is a 2 hour study visit during which participants will answer a survey. The total length of the study is 90 days.",[30,243,244,213],"Hypervolemia","Chronic Kidney Diseases","2025-09-14",{"date":247,"type":41},"2025-09-16",{"date":249,"type":41},"2023-11-20",{"date":251,"type":21},"2026-08",{"name":253,"class":48},"University of Texas Southwestern Medical Center",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":59,"minAge":17,"maxAge":261,"enrollmentInfo":262,"targetDuration":4,"studyType":110,"phases":263,"briefSummary":264,"conditions":265,"keywords":266,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":49},"100492728","surgical-evaluation-for-upper-extremity-lymphedema-biobridge-100492728","NCT05695924","Surgical Evaluation for Upper Extremity Lymphedema (BioBridge)","Prospective Evaluation of Nanofibrillar Collagen Scaffold (BioBridge®) as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema","Inclusion Criteria:\n\nThe subject must be a breast cancer survivor, at least 3 years beyond completion of cancer therapy, free of clinical disease, and eligible for surgical intervention. Participants who are not able to safely undergo general anesthesia and\u002For perioperative care for VLNT are excluded.\n\n* Ages 18 to 75 years (inclusive)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2\n* Life expectancy \\> 2 years\n* Acquired (secondary) upper limb lymphedema secondary to breast cancer treatment\n* The participant must be eligible for surgical intervention\n* Swelling of 1 limb that is not completely reversed by elevation or compression\n* Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system\n* Participants must have no evidence of disease (NED), have completed breast cancer therapy 3 years prior to enrollment; use of endocrine therapy is allowed.\n* Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen\n* Willingness to comply with recommended regimen of self care, with consistent use of compression garments from screening through the entire study duration (through the safety follow up visit), excluding the first 3 weeks postoperatively where patients are required to not wear compression. Self bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens are expected to remain consistent from screening though the entire study duration.\n* Consistent use of an appropriately sized compression garment for daytime use.\n* Limb volume (LV) in the affected limb and unaffected limb must be at least 10% of each other.\n* Evidence of abnormal bioimpedance ratio, if feasible, based upon unilateral disease: L Dex \\> 10 units.\n* Willingness and ability to comply with all study procedures, including measurement of skin biopsy, and preoperative and postoperative imaging studies.\n* Willingness and ability to understand, and to sign a written informed consent form document\n\nExclusion Criteria:\n\n* Edema arising from increased capillary filtration will be excluded (venous incompetence).\n* Inability to safely undergo general anesthesia and\u002For perioperative care related to vascularized lymph node transfer\n* Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening or 5 times the drug's half life, whichever is longer\n* Recent initiation (≤ 12 weeks) of CDPT for lymphedema\n* Other medical condition that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure\n* Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (eg, pain, swelling, decreased range of motion)\n* History of clotting disorder (hypercoagulable state)\n* Chronic (persistent) infection in the affected limb\n* Infection of the lymphedema limb within 1 month prior to screening\n* Currently receiving chemotherapy or radiation therapy\n* Current evidence, or a history of malignancy within the past 3 years (except for non melanoma skin cancer or cervical cancer in situ treated with curative intent). If the participant has undergone cancer treatment, this must have been completed \\> 3 years prior to enrollment.\n* Significant or chronic renal insufficiency (defined as serum creatinine \\> 2.5 mg\u002FdL or an estimated glomerular filtration rate \\[eGFR\\] \\\u003C 30 mL\u002Fmin at screening) or requires dialytic support\n* Hepatic dysfunction, defined as alanine transaminase (ALT) or aspartate transaminase (AST) levels \\> 3 × upper limit of the normal range (ULN) and\u002For bilirubin level \\> 2 × ULN at screening\n* Absolute neutrophil count \\\u003C 1500 mm3 at screening\n* Hemoglobin concentration \\\u003C 9 g\u002FdL at screening\n* Body Mass Index (BMI) \\>35\n* Known sensitivity to porcine products\n* Anaphylaxis to iodine\n* Pregnancy or nursing\n* Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening\n* Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study.","75 Years",{"count":109,"type":21},[112],"To investigate whether the addition of Fibralign's BioBridge® Collagen Matrix (BioBridge) devices to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm.",[25,30],[25,30],"2025-03-10",{"date":269,"type":41},"2025-03-11",{"date":271,"type":41},"2023-11-01",{"date":273,"type":21},"2025-12-01",{"name":275,"class":276},"Fibralign Corporation","INDUSTRY",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":59,"minAge":17,"maxAge":261,"enrollmentInfo":283,"targetDuration":4,"studyType":110,"phases":284,"briefSummary":264,"conditions":285,"keywords":286,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":293},"100409019","lymphbridge-surgical-evaluation-for-breast-cancer-associated-lymphedema-biobridge-100409019","NCT04606030","LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge)","LymphBridge: Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema",{"count":109,"type":21},[112],[25,30],[25,30],{"date":269,"type":41},{"date":289,"type":41},"2020-10-26",{"date":291,"type":21},"2025-12-30",{"name":275,"class":276},2,{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":59,"minAge":17,"maxAge":4,"enrollmentInfo":301,"targetDuration":302,"studyType":22,"phases":4,"briefSummary":303,"conditions":304,"keywords":309,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":293},"100569686","muscle-and-subcutaneous-tissue-variation-by-ultrasound-and-impedance-linked-to-fluid-balance-in-icu-patients-100569686","NCT06697470","Muscle and Subcutaneous Tissue Variation by Ultrasound and Impedance Linked to Fluid Balance in ICU Patients","Cross-sectional Study on the Variation of Muscle Thickness and Subcutaneous Tissues by Ultrasound and Bioelectrical Impedance in Association with the Fluid Balance of Patients in Intensive Care","Inclusion Criteria:\n\n* Adults aged over 18 years.\n* Patients present and admitted to the ICU at Epicura Hornu Hospital between October 14, 2024, and November 15, 2024 (to be updated).\n* Informed consent to participate in the study has been signed by the patient or their legal representative.\n\nExclusion Criteria :\n\n* Patients in post-operative or other surveillance with an expected ICU stay of less than 48 hours.\n* Patients for whom a decision to withdraw therapy has been made prior to inclusion.\n* Presence of skin conditions (e.g., wounds or ulcers) that hinder ultrasound measurements or the application of skin electrodes.\n* Pregnancy.\n* Presence of an implanted pacemaker or defibrillator.",{"count":174,"type":21},"5 Days","This cross-sectional study aims to investigate the relationship between variations in muscle thickness and subcutaneous tissue, measured by ultrasound, and fluid compartments, evaluated using bioelectrical impedance analysis (BIA), in critically ill patients in the intensive care unit (ICU). Critically ill patients frequently experience muscle wasting and tissue edema due to a combination of inflammation, immobilization, and aggressive fluid resuscitation protocols designed to counteract hemodynamic instability.\n\nUltrasound is widely used to monitor muscle thickness because it is fast, non-invasive, and repeatable. However, muscle thickness measurements during the first days of ICU admission may be influenced by fluid overload, which causes edema and might lead to an overestimation of actual muscle mass. Bioelectrical impedance analysis (BIA) is a complementary tool that assesses both intra- and extracellular fluid compartments. This study aims to correlate daily fluid balance with changes in muscle thickness and subcutaneous tissue measured by ultrasound, and to determine if BIA can accurately reflect fluid status and potentially identify edema in these patients.\n\nFurthermore, at ICU discharge, patients' muscle strength will be assessed using both the MRC-sum score (0-60) and handgrip strength (using a Jamar dynamometer), to investigate whether the presence of edema at discharge correlates with muscle strength deficits. Data collection will occur daily, tracking fluid balance, clinical parameters, and body weight, alongside ultrasound and BIA measurements in a standardized position. The study will help clarify the interactions between fluid management, muscle mass changes, and clinical outcomes in critically ill patients, providing valuable insight into early rehabilitation strategies.",[305,306,30,207,307,308],"Weakness Acquired in the ICU","Muscle Wasting","Critical Illness","Intensive Care Unit (ICU) Patients",[310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337],"Muscle thickness","Subcutaneous tissue","Ultrasound","Bioelectrical impedance analysis","BIA","Fluid balance","ICU (intensive care unit)","Muscle strength","MRC-sum score","Grip strength","Edema assessment","Critical care","Skeletal muscle","Hydration status","Muscle echogenicity","ICU-acquired weakness","Fluid compartments","Extracellular water","Intracellular water","Body composition","Bedside ultrasound","Fluid management","Early mobilization","Volume overload","Tissue edema","Body water compartments","Length of ICU stay","Muscle quality","2024-11-17",{"date":340,"type":41},"2024-11-20",{"date":342,"type":41},"2024-10-21",{"date":344,"type":21},"2024-11-15",{"name":346,"class":48},"Dr F Duprez",{"id":348,"slug":349,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":59,"minAge":17,"maxAge":353,"enrollmentInfo":354,"targetDuration":4,"studyType":110,"phases":356,"briefSummary":358,"conditions":359,"keywords":362,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":49},"100547959","phase-4-efficacy-and-safety-of-combination-diuretic-therapy-in-patients-with-acute-decompensated-heart-failure-and-volume-overload-100547959","NCT06414759","Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload","Inclusion Criteria:\n\n* Male or female patients with ages ≥ 18 years old, and less than 65 years old.\n* For both elective and emergency hospital admissions, patients with a clinical diagnosis of ADHF must exhibit at least one clinical sign indicative of volume overload. These signs may include edema (score 2 or higher), ascites confirmed through echography, or pleural effusion confirmed by chest X-ray or echography or rales on auscultation, or jugular venous pressure greater than10 mm Hg.\n\nExclusion Criteria:\n\n* Patient diagnosed with acute kidney injury upon hospital admission based on the presence of any of the following criteria: an increase in SCr by at least 0.3 mg\u002FdL within 48 hours, an increase in SCr to at least 2 times the baseline value, known or presumed to have occurred within the prior 7 days, and a urine volume less than 0.5 ml\u002Fkg\u002Fhour for a duration of 6 hours.\n* Patients with acute pulmonary edema caused by increased afterload and fluid redistribution to the lungs in the absence or with minimal fluid accumulation.\n* Anticipated exposure to nephrotoxic agents (such as contrast dye) during hospitalization.\n* Patients who exhibit anuria or are undergoing renal replacement therapy or ultrafiltration.\n* Patients with eGFR less than 30 mL\u002Fmin\u002F1.73m² at the time of screening.\n* Expected use of intravenous inotropes, vasopressors, or nitroprusside during the study.\n* Prior cardiac transplantation and\u002For utilization of a ventricular assist device.\n* Blood pressure below 90 mmHg or mean arterial pressure below 65 mmHg at the time of recruitment.\n* Patients who are pregnant or breastfeeding.\n* Administration of acetazolamide or metolazone within the one-month period preceding randomization.\n* The usage of any diuretic agent during the treatment phase is not specified in the study protocol, except for mineralocorticoid receptor antagonists.","65 Years",{"count":355,"type":21},110,[357],"PHASE4","This study aims to compare two medications, acetazolamide and metolazone, along with loop diuretics, to see which one works better and is safer for patients with ADHF who have volume overload. By comparing these medications, we hope to learn which one can help these patients the most. This will help doctors choose the best treatment for patients with ADHF and volume overload.",[360,361,30],"Acute Decompensated Heart Failure","Volume Overload",[363,360,364,365,333,30,366,367,368,369,370,371,372],"ADHF","AHF","Acute Heart Failure","Loop diuretics","Fusrosemide","Metolazone","Acetazolamide","Carbonic anhydrase inhibitor","Thiazide like diuretics","Thiazide diuretics","2024-07-23",{"date":375,"type":41},"2024-07-24",{"date":377,"type":41},"2024-07-01",{"date":379,"type":21},"2025-03-30",{"name":381,"class":48},"Cairo University"]