[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"complication\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:complication":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,48,78,108,136,166,189,222,251,273,305,327,344,372,398,419],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100512029","pasca-mm-study-impact-of-the-pasca-parcours-de-sant-au-cours-du-cancer-program-on-complications-associated-with-multiple-myeloma-andor-its-treatments-in-the-context-of-a-first-hematopoietic-stem-cell-autograft-in-adults-aged-18-to-70-100512029",false,"NCT05947136","PASCA-MM Study. Impact of the PASCA (PArcours de Santé au Cours du CAncer) Program on Complications Associated With Multiple Myeloma and\u002For Its Treatments in the Context of a First Hematopoietic Stem Cell Autograft, in Adults Aged 18 to 70.","PASCA -MM","Inclusion Criteria:\n\n1. Age ≥ 18 years old and ≤ 70 years old.\n2. Patient treated in an investigation center.\n3. Symptomatic multiple myeloma eligible for autologous hematopoietic stem cell transplantation (HSCT).\n4. In complete response, complete response, very good complete response, or partial before HSCT.\n5. First induction-type treatment (Isa-KRD\u002Fdara-VRD\u002Fdara-VTD\u002FVRD\u002FVTD\u002Fdara-VRD), intensification therapy with melphalan, HSCT, consolidation, maintenance including at least one drug immunomodulator.\n6. ECOG performance status WHO ≤ 2.\n7. No history or coexistence of other primary cancer apart from basal cell cancer cutaneous\n8. Able to understand, read and write French.\n9. Having signed and dated the informed consent.\n\nExclusion Criteria:\n\n1. Unable to be monitored for medical, social, family, geographical or psychological, throughout the duration of the study.\n2. Deprived of liberty by court or administrative decision.\n3. Not affiliated with a health insurance plan.\n4. Not having declared an attending physician.\n5. Not domiciled in the Auvergne-Rhône-Alpes region or in the Saône-et-Loire department.\n6. Not available and\u002For not willing to participate in the project for the entire duration of the study.\n7. Pregnant women, breastfeeding women, people in emergency situations, people incapable of personally giving their consent including adults under guardianship","ALL","18 Years","70 Years",{"count":20,"type":21},204,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a prospective, multicentre, phase III, randomised, controlled intervention study.\n\nTwo groups of patients with equal numbers will be studied and each patient will be allocated to one of the two groups described below by randomisation (ratio 1:1).\n\nEach patient will be allocated to one of the two groups described below by randomisation (ratio 1:1).\n\n\\- PASCA interventional group\n\nFor both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective), a specific and proactive referral will be made systematically after each screening assessment, depending on the level of risk, estimated according to decision trees (management guide) and through the dedicated PASCA network of healthcare professionals, in order to initiate early treatment and follow-up if necessary.\n\n\\- Control group\n\nFor the 7 complications of interest (primary objective) as well as for the 13 complications (secondary objective): all the data from each identification check-up will be sent to the onco-haematological transmitted to the referring onco-haematologists, so that they can initiate their own management.\n\n=\\> For all patients, regardless of group\n\nAll patients will receive four screening assessments covering the 7 complications of interest and 13 secondary complications:\n\n* Visit No.1 (T1), 1-2 months after the autologous haematopoietic stem cell transplantation (aHSCT), corresponding to the patient's visit to his or her Multiple Myeloma (MM) monitoring consultation and\u002For the start of his or her consolidation treatment.\n* Visit No.2 (T2), 4 months after aHSCT, corresponding to a patient's visit for the end of consolidation treatment;\n* Visit No.3 (T3), 14 months after the last aHSCT, corresponding to a visit by the patient during his or her maintenance treatment;\n* Visit No.4 (T4), 24 months after the last aHSCT, corresponding to a visit by the patient for a MM monitoring consultation.",[27,28],"Multiple Myeloma","Complication",[27,30,31,32,33,34],"Complications","Detection","Intervention","Autologous stem cell transplant","Randomized controlled trials","RECRUITING","2026-06-09",{"date":38,"type":39},"2026-06-11","ACTUAL",{"date":41,"type":39},"2024-01-19",{"date":43,"type":21},"2029-09-14",{"name":45,"class":46},"Centre Leon Berard","OTHER",6,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100630329","advance-forsee-advanced-video-monitoring-for-early-signaling-of-adverse-events-and-optimal-discharge-planning-100630329","NCT07486258","ADVANCE-FORSEE. ADVANCEd Video Monitoring FOR Early Signaling of Adverse Events and Optimal dischargE Planning.","Inclusion Criteria:\n\n* Patients admitted to the cardiothoracic ward after cardiac surgery\n* Age ≥ 18\n* Willing and able to sign informed consent form\n\nExclusion Criteria:\n\n* Pregnancy\n* Inability to provide written informed consent\n* Mental disability\n* Language barrier",{"count":55,"type":21},250,"1 Week","OBSERVATIONAL","In this study cameras placed at the bedside will be evaluated for their ability to safely and accurately measure vital signs, such as heart rate and breathing, continuously after heart surgery. Camera-based measurements will be compared with the usual checks that nurses perform several times a day using sensors on the skin or finger clip.\n\nThe goal is to see whether camera monitoring can help notice changes in a patient's condition earlier. Another aim of the study is to find out whether the camera monitoring can predict if a patient's health is improving or worsening.\n\nPatients and healthcare staff will be asked by the investigators about their experience to learn whether this type of monitoring is acceptable in daily care.",[60,28,61],"Vital Signs Monitoring","Discharge Planning",[63,60,64,65,66],"ADVANCE FORSEE","Video-based Monitoring","Complication Prediction","Discharge Readiness Planning","NOT_YET_RECRUITING","2026-03-17",{"date":70,"type":39},"2026-03-20",{"date":72,"type":21},"2026-07",{"date":74,"type":21},"2028-07",{"name":76,"class":46},"Catharina Ziekenhuis Eindhoven",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":16,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":89,"studyType":57,"phases":4,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100628414","surgeons-prediction-of-dental-surgery-complications-and-the-influence-of-patient-characteristics-development-of-an-ai-model-100628414","NCT07461324","Surgeons' Prediction of Dental Surgery Complications and the Influence of Patient Characteristics: Development of an AI Model","Systematic Risk Assessment Prior to Oral Surgery","Inclusion Criteria:\n\n* Patients reffered from a general dentist practicioner for the following surgeries: third molar removal, apicoectomy, dental implant placement.\n* Patients \\>15 years of age\n* A valid diagnosis prior to the surgery\n* Cases with fully completed questionnaires.\n\nExclusion Criteria\n\n* Pathological condition requiring hospital refferal\n* Complications following re-surgery\n* Re-assesment of the diagnosis from the general dentist practicioner\n\nSpecific for apical surgery:\n\n* Root fracture present.\n* Buccal bone height \\\u003C3mm.\n\nSpecific for third molar removal:\n\n\\- if coronectomy is conducted instead of total root removal.\n\nSpecific for dental implant:\n\n* if an implant has been placed before in the same region of interest.\n* Health conditions were dental implants are contraindicated.",true,"15 Years",{"count":88,"type":21},3000,"1 Year","The goal of this observational study is to learn how to better predict and prevent intra- and postoperative complications in oral surgery in adult patients referred for oral surgical procedures. The study aims to understand how accurately surgeons can foresee complications and which patient, tooth, and surgery related factors influence the outcomes.\n\nThe research questions are:\n\n* What is the incidence of intra and postoperative complications in oral surgery?\n* Which factors predict these complications, and how accurately can surgeons anticipate them?\n* Can the development of an AI tool reduce postoperative complications?\n\nParticipants will:\n\n* Receive standard oral surgery treatment at a private referral clinic (Specialtandlægerne Sjælland).\n* Have clinical information collected about their procedure, medical history, and personal characteristics (including anxiety level).\n* Conduct a short questionnaire, the STAI-6 and the I-PANAS-SF.\n* Have the surgeon record their prediction of whether complications are expected.\n* Be followed in the postoperative lapse to document whether complications occur after surgery.",[92,93,94,28,95,96,97],"Postoperative Infections","Mandibular Nerve Injuries","Alveolar Osteitis","Dental Implantation","Tooth Extraction","Apical Surgery","2026-03-04",{"date":100,"type":39},"2026-03-10",{"date":102,"type":21},"2026-04-01",{"date":104,"type":21},"2030-06-01",{"name":106,"class":46},"University of Copenhagen",2,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":119,"studyType":57,"phases":4,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":77},"100610878","complications-of-the-alveolar-opening-maneuver-in-children-on-mechanical-ventilation-100610878","NCT07233304","Complications of the Alveolar Opening Maneuver in Children on Mechanical Ventilation","Incidence of Complications From the Alveolar Opening Maneuver in Mechanically Ventilated Children With Respiratory Distress Syndrome","Inclusion criteria:\n\n* Patients under 14 years of age admitted to the HCANK PICU\n* More than 4 hours of invasive mechanical ventilation (IMV)\n* An oxygenation index (OI) ≥4 or an oxygen saturation index (OSI) ≥5\n* Indication for ARM and PEEP as determined by the treating team\n\nExclusion criteria:\n\n* Predicted body weight (PBW) \\>45.5 kg\n* Recent pulmonary resection surgery (\\\u003C7 days)\n* Presence of broncho-pleural fistula or peri-tube leak \\>25% of the tidal volume\n* Hemoglobin decline \\\u003C7 g\u002FdL\n* Patients with congenital or acquired heart diseases with significant intracardiac shunt.","1 Month","14 Years",{"count":118,"type":21},143,"1 Day","The objective of this research is to analyze the overall incidence of complications associated with a therapeutic maneuver known as alveolar opening and subsequent titration of positive end-expiratory pressure (PEEP) in pediatric patients with acute respiratory distress syndrome (ARDS). These procedures are part of the standard care provided in the Pediatric Intensive Care Unit (PICU) and are used to improve pulmonary oxygenation and respiratory mechanics. Through this study, we aim to gather information that will help improve the safety and effectiveness of these interventions in critically ill patients.",[122,123,124,125,126,28],"Positive End-expiratory Pressure (PEEP)","Oxygenation Index","Pediatric Intensive Care Unit","Pediatric Acute Lung Injury","Respiratory Distress Syndrome, Pediatric","2025-11-14",{"date":129,"type":39},"2025-11-18",{"date":131,"type":39},"2025-08-18",{"date":133,"type":21},"2026-08",{"name":135,"class":46},"Hospital de Alta Complejidad en Red",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":144,"enrollmentInfo":145,"targetDuration":147,"studyType":57,"phases":4,"briefSummary":148,"conditions":149,"keywords":152,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":77},"100555087","frailty-in-outpatient-digestive-endoscopy-100555087","NCT06507527","Frailty in Outpatient Digestive Endoscopy","ASSESSMENT OF THE ADEQUACY IN CARE OF THE FRAGILE PATIENT IN A DIGESTIVE ENDOSCOPY UNIT FRIEND Study (FRailty In ENDoscopy) Estudi FRIEND (FRailty In ENDoscopy)","FRIEND","Inclusion Criteria:\n\n* It will include all patients over 70 years of age who are indicated to undergo an ambulatory upper or lower endoscopy.\n\nExclusion Criteria:\n\n* Age below 70 years\n* Non-ambulatory endoscopies\n* Assessment of test contraindications by the endoscopist\n* Non-acceptance to enter the study","100 Years",{"count":146,"type":21},1474,"16 Months","The increase in our society of the proportion of frail people who suffer from disability and dependency forces us to detect modifiable factors and therefore subject to intervention that can adapt health care for frail patients in order to increase the effectiveness and safety of medical treatments and procedures.\n\nA geriatric assessment should be performed on all patients likely to present frailty prior to a digestive endoscopy to assess the risk-benefit of the indication and to improve patient preparation by avoiding adverse effects of endoscopic examinations, increasing the safety and profitability of the tests There are no data in our medium on the prevalence of frailty in patients referred for endoscopy, nor on the incidence in these patients of adverse effects, inadequate preparations, or incomplete examinations, so a frailty study is needed to elaborate multidisciplinary protocols that improve circuits and care in these patients and prevent complications.\n\nThe questions we want to try to answer are:\n\n* Prevalence and severity of fragility in digestive endoscopy.\n* Specific problems related to fragility in digestive endoscopy, mainly the profitability of the examination and the incidence of adverse effects, in order to create protocols for improving care in this group of patients.",[150,151,28],"Frailty","Comorbidities and Coexisting Conditions",[153,154,155,156],"Endoscopy","Indication","Bowell Preparation","Adverse effects","2025-07-28",{"date":159,"type":39},"2025-07-31",{"date":161,"type":39},"2024-06-10",{"date":163,"type":21},"2025-09-30",{"name":165,"class":46},"Parc de Salut Mar",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":173,"targetDuration":175,"studyType":57,"phases":4,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":77},"100390345","study-of-post-anesthesia-management-in-patients-undergoing-neurosurgery-100390345","NCT04362709","Study of Post-anesthesia Management in Patients Undergoing Neurosurgery","A Prospective Cohort Study of Post-anesthesia Management in Patients Undergoing Neurosurgery","Inclusion Criteria:\n\n* Patients received neurosurgery in Beijing Tiantan hospital.\n\nExclusion Criteria:\n\n* Preoperative severe cognitive dysfunction ；\n* Refused to sign informed consent.",{"count":174,"type":21},10000,"3 Years","The postoperative complications of neurosurgery are various and complex, which brings heavy economic and social burden to families. Timely detection and early intervention can help reduce the incidence of adverse events and mortality. The main purpose of this study is to analyze the possible factors related to postoperative complications of Neurosurgery, so as to achieve the prospective prevention and treatment of postoperative complications of neurosurgery.",[178,179,28],"Anesthesia","Neurosurgery","2025-07-17",{"date":182,"type":39},"2025-07-18",{"date":184,"type":39},"2019-12-02",{"date":186,"type":21},"2028-11-22",{"name":188,"class":46},"Beijing Tiantan Hospital",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":202,"conditions":203,"keywords":207,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100327753","phase-4-rectal-indomethacin-as-early-treatment-for-acute-pancreatitis-indomap-trial-100327753","NCT03547232","Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)","Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial): Study Protocol for a Multi-center, Double-blinded, Placebo-controlled, Randomized Clinical Trial","INDOMAP","Inclusion Criteria:\n\n* All patients ages 18-80 years with a diagnosis of AP based on at least 2 of the following criteria:\n* Abdominal pain characteristic of AP\n* Serum amylase and\u002For lipase ≥ 3 times the upper limit of normal\n* Characteristic findings of AP on abdominal CT scan will be screened for study enrollment.\n\nExclusion Criteria:\n\n* Onset time \\>24 hours\n* Presence of renal dysfunction (serum creatinine \\> 1.5 \\*normal upper limit)\n* Severe liver dysfunction\n* Active peptic ulcer disease or GI bleeding\n* Pregnancy or breast-feeding\n* Hypersensitivity to NSAIDs\n* New-onset, exacerbation or uncontrolled hypertension\n* Presence of serious cardiovascular events, including severe heart failure, myocardial infarction (MI) and stroke\n* Mental disability\n* Malignancy-associated acute pancreatitis\n* Post-ERCP pancreatitis\n* Informed consent not signed","80 Years",{"count":199,"type":21},1504,[201],"PHASE4","Acute pancreatitis (AP) is an inflammatory condition of the pancreas following the activated pancreatic enzymes induced by varied causes, with or without other organ(s) dysfunction. The production and release of inflammatory factors is generally considered as the key factor of pathogenesis. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly applied agents for inflammatory diseases. A series studies have proved that indomethacin can reduce the risk of post-endoscopic retrograde cholangiopancreatography (ERCP), but high-quality evidence is still lacking in the field of effectiveness of NSAIDs to treat, rather than prevent, other types of AP. Majority of animal experiments showed that NSAIDs had protective effects for organ functions, but the results of several preliminary clinical studies were inconsistent. Randomized controlled trials are eagerly awaited to elucidate its effects on AP.",[204,28,205,206],"Acute Pancreatitis","Mortality Rate","Organ Failure, Multiple",[208,209,210,211],"Acute pancreatitis","Indomethacin","Prognosis","Organ dysfunction","2025-06-11",{"date":214,"type":39},"2025-06-15",{"date":216,"type":39},"2024-12-01",{"date":218,"type":21},"2028-12-01",{"name":220,"class":46},"Peking Union Medical College Hospital",17,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":231,"conditions":232,"keywords":236,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":77},"100340711","comparison-of-tumor-efficacy-safety-in-laparoscopic-resection-of-gastrointestinal-stromal-tumors-between-favorable-and-unfavorable-site-100340711","NCT03716089","Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site","Prospective Controlled Clinical Trial for Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site（FUGES-016）","Inclusion Criteria:\n\n1. Age between 18 and 75 years old\n2. Primary gastric lesion confirmed pathologically GIST by endoscopic biopsy. Preoperative endoscopy, ultrasound endoscopy or computer tomography, Magnetic resonance suspected GIST, and then postoperative pathology confirmed as the original GIST\n3. Written informed consent\n4. Expected R0 resection by laparoscopy\n5. Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale\n6. ASA (American Society of Anesthesiology) class I to III\n7. Maximum tumor diameter ≤10cm\n\nExclusion Criteria:\n\n1. Pregnant and lactating women\n2. Suffering from a severe mental disorder\n3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)\n4. History of previous gastric surgery (including ESD\u002FEMR for gastric cancer)\n5. Rejection of laparoscopic resection\n6. History of other malignant disease within the past five years\n7. History of unstable angina or myocardial infarction within the past six months\n8. History of a cerebrovascular accident within the past six months\n9. History of continuous systematic administration of corticosteroids within one month\n10. Requirement of simultaneous surgery for another disease\n11. Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer\n12. FEV1\\\u003C50% of the predicted values\n13. Maximum tumor diameter \\>10cm","75 Years",{"count":55,"type":21},"Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy.",[233,234,235,28],"GIST of Stomach","Gastric Cancer","Surgery",[237,238,239,240,241],"GIST","laparoscopic resection","early complication","mortality","tumor sites","2025-04-07",{"date":244,"type":39},"2025-04-08",{"date":246,"type":39},"2018-10-11",{"date":248,"type":21},"2027-04-01",{"name":250,"class":46},"Fujian Medical University",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":5},"100527323","russian-registry-of-surgical-outcomes-100527323","NCT06146270","Russian Registry of Surgical OutcomeS","National Register of Postoperative Outcomes in the Russian Federation: a Multicenter Observational Study","RuSOS","Inclusion Criteria:\n\n* Adult patients (age 18 years and older) undergoing elective surgery:\n\n  * In obstetrics\n  * In gynecology\n  * Breast\n  * In urology and kidneys\n  * In endocrine surgery\n  * In maxillofacial surgery\n  * In orthopedics and traumatology\n  * On the lower abdominal cavity\n  * On the liver and biliary tract\n  * On the upper abdominal cavity\n  * In thoracic surgery\n  * In vascular surgery\n  * In neurosurgery\n  * In cardiac surgery\n  * In other areas (with mandatory specification)\n* Adult patients (age 18 years and older) undergoing emergency surgery in the listed and other areas of surgery (for example, in purulent surgery).\n\nExclusion Criteria:\n\n1. Lack of informed consent from the patient\n2. Complications associated with the manipulations of an anesthesiologist\n3. Interventions without the participation of an anesthesiologist-resuscitator\n4. Incomplete checklists\n5. Errors when filling checklists\n6. Deviations from the Register protocol",{"count":260,"type":21},162000,"Identification of risk factors that cause a high probability of an unfavorable outcome in the postoperative period is an urgent problem. The creation of national databases (registries) makes it possible to maximally cover a certain patient population by identifying its characteristic risk predictors. As literature data show, existing registries differ in the criteria for inclusion in the study, in the characteristics of the populations studied, and there is often no common view on the classification of postoperative outcomes. Goal of a study is a creation of a Russian national calculator for the risk of postoperative complications and mortality.\n\nTwo-level observational retrospective-prospective study was planned. Setting: National multicenter study of surgical inpatients. Patients: Adult patients undergoing elective and emergency surgery. Types of interventions: in obstetrics, in gynecology, on the breast, in urology and kidneys, in endocrine surgery, in maxillofacial surgery, in orthopedics and traumatology, on the lower floor of the abdominal cavity, on the liver and biliary tract, on the upper floor of the abdominal cavity cavities, in thoracic surgery, in vascular surgery, in neurosurgery, in cardiac surgery, in other areas (with mandatory specification).\n\nThe study was organized by the Federation of Anesthesiologists and Reanimatologists of Russia. Primary (30-day mortality, 30-day complications) and secondary (hospital mortality, hospital complications, length of stay in anesthesiology, resuscitation and intensive care departments, length of hospital stay, multiple organ failure (2 or more points on the SOFA scale (Sequential)) Organ Failure Assessment), 90-day mortality, 90-day complications, intensive care after-effects syndrome, readmission, 1-year mortality) outcomes were determined. The required sample size and statistical analysis methods are described. The planned duration of the study is 2024-2028.",[235,178,263,28],"Outcome, Fatal","2025-04-01",{"date":266,"type":39},"2025-04-04",{"date":268,"type":39},"2025-01-09",{"date":270,"type":21},"2029-01-31",{"name":272,"class":46},"Russian Federation of Anesthesiologists and Reanimatologists",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":280,"minAge":17,"maxAge":18,"enrollmentInfo":281,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":77},"100497748","assessment-of-womens-sexual-quality-of-life-after-benign-adnexal-surgery-using-vnotes-approach-100497748","NCT05761275","Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach","Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach in Comparison to Conventional Laparoscopy: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Women aged from 18 to 70 years\n* Discernment capacity with oral and written consent signed\n* Heterosexual intercourse (with vaginal penetration) within four weeks prior to inclusion in the study\n\nExclusion Criteria:\n\n* History of rectal surgery.\n* Suspected rectovaginal\u002Fretrocervical endometriosis.\n* History of brachytherapy or pelvic radiation.\n* Suspected malignancy.\n* History of severe pelvic inflammatory disease.\n* Active lower genital tract infection.\n* Pregnancy.\n* Women who do not speak fluent French or English.\n* Patients under tutelage (with or without capacity of judgement).","FEMALE",{"count":282,"type":21},62,[24],"Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is a recent innovation in minimally invasive surgery which has already proven its non-inferiority to conventional abdominal laparoscopy (CAL) for hysterectomy in terms of efficiency and safety. However, the investigators note a lack of medical literature and no specific randomized controlled trial (RCT) assessing women's sexual function after vNOTES for benign adnexal surgery.\n\nThe aim of this RCT is to confirm the non-inferiority of the vNOTES approach for benign adnexal pathology compared to CAL on women's sexual function. Secondary outcomes will evaluate vNOTES's efficiency, morbidity and postoperative complications compared to CAL for benign adnexal surgery. The relationship between adnexal mass morcellation\u002Faspiration and the quality of the histological analysis on surgical specimens will also be evaluated as secondary outcome.",[286,287,288,289,290,291,292,293,294,295,28],"Gynecologic Disease","Adnexal Mass","Adnexal Cyst","Sexuality","Adnexal Diseases","Sexual Dysfunction","Quality of Life","Pathology","Dyspareunia","Pelvic Pain","2025-03-24",{"date":298,"type":39},"2025-03-27",{"date":300,"type":39},"2024-01-01",{"date":302,"type":21},"2027-04-03",{"name":304,"class":46},"Jean Dubuisson",{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":107},"100444077","sebbin-round-anatomical-and-biconvex-gluteal-implants-100444077","NCT05062733","SEBBIN Round, Anatomical and Biconvex Gluteal Implants","Prospective Observational Study About SEBBIN Gluteal Implants","Inclusion Criteria:\n\n* The patient is a man or a woman ≥ 18 years old at the time of inclusion.\n* The patient is planned for a unilateral or bilateral gluteal implant placement with SEBBIN implants as per investigator decision\n* The patient has been informed of the study, has read the patient informed consent and provided consent for the study in writing.\n\nExclusion Criteria:\n\n* Patient implanted with silicone implants somewhere else in the body.\n* Patient candidate for implantation with custom-designed implants.\n* Participation in another interventional clinical study (participation into an observational study is permitted) with a medicinal product or a medical device in the 30 days prior to enrolment.",{"count":313,"type":21},60,"This study is part of the clinical evaluation of SEBBIN silicone gel-filled gluteal implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.",[28,316],"Prosthesis Durability","2024-10-30",{"date":319,"type":39},"2024-10-31",{"date":321,"type":39},"2021-11-20",{"date":323,"type":21},"2035-03",{"name":325,"class":326},"Groupe SEBBIN","INDUSTRY",{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":338,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":107},"100436838","sebbin-silicone-gel-filled-testicular-implants-100436838","NCT04968470","SEBBIN Silicone Gel-filled Testicular Implants","Prospective Observational Study About SEBBIN Silicone Gel-filled Testicular Implants","Inclusion Criteria:\n\n* The patient is an adult or a child at the time of implant placement with SEBBIN implant.\n* The patient is candidate to a unilateral or bilateral testicular implant placement with SEBBIN implant.\n* The patient has been informed of the study, has read the patient information letter and -provided oral consent.\n\nExclusion Criteria:\n\n* The patient has silicone implants somewhere else than in the scrotal sac.\n* The patient was diagnosed with one of the following pathologies:\n\n  * Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.\n  * Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.\n  * Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.\n* The patient has a pathology that could delay healing.\n* Custom-designed implants are used for surgery.",{"count":335,"type":21},100,"This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.",[28,316],{"date":319,"type":39},{"date":340,"type":39},"2021-03-16",{"date":342,"type":21},"2035-09",{"name":325,"class":326},{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":280,"minAge":17,"maxAge":144,"enrollmentInfo":351,"targetDuration":353,"studyType":57,"phases":4,"briefSummary":354,"conditions":355,"keywords":357,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":370,"locationsCount":77},"100509246","efficacy-of-angiography-with-indocyanine-green-in-the-identification-of-complications-after-breast-surgery-100509246","NCT05910931","Efficacy of Angiography With Indocyanine Green in the Identification of Complications After Breast Surgery","Prospective Study for the Evaluation of the Efficacy and Concordance of Angiography With Indocyanine Green in the Identification of Complications After Oncoplastic Surgery and Skin and Nipple-skin Sparing Mastectomy","Inclusion Criteria:\n\nThe study population includes two type of patients:\n\n* Women who underwent oncoplastic procedures for breast conservation. This group is made up of women with breast cancer in whom the Breast Unit tumor committee recommended a breast-conserving surgical procedure. The techniques included for this study are vertical mammoplasty, horizontal mammoplasty, and local flaps by displacement or rotation.\n* Women undergoing a skin or skin\u002Fnipple-sparing mastectomy with immediate breast reconstruction. This group is made up of patients with a diagnosis of breast carcinoma, who require a mastectomy as surgical treatment, as well as those high-risk women whose mastectomy is aimed at reducing the risk of breast cancer. The surgical techniques included in this group are Carlson type 1, 2, 3 and 4 skin-sparing mastectomies and nipple and skin-sparing mastectomies using inframammary and vertical approaches. In all patients, the type of breast reconstruction will be the placement of a definitive implant in the prepectoral position.\n\nExclusion Criteria:\n\n\\- Women with iodine allergy or thyroid disease are excluded from this study.",{"count":352,"type":21},221,"3 Months","During the performance of oncoplastic surgery and skin-sparing or skin-nipple mastectomy there is a significant loss in the perfusion of the cutaneous envelope of the breast, which can produce areas of vascular suffering of the skin that sometimes cause necrosis of the same. Skin necrosis is the most important adverse event in oncoplastic and reconstructive surgery of the breast, since it causes delays in adjuvant treatments to surgery, worsening of the cosmetic result, and, on occasions, loss of the implant and reconstruction.\n\nIndocyanine color green (ICG) angiography has been proposed as a diagnostic alternative to determine the vascular perfusion of the skin envelope of the breast during surgery, which would allow the removal of tissue at risk of necrosis to avoid this complication during the postoperative period. However, the scientific literature does not currently allow an adequate assessment of this diagnostic procedure due to the absence of prospective studies that have evaluated its sensitivity, specificity, and predictive values.\n\nThe objective of this prospective study is to evaluate ICG angiography of skin flaps of the breast and the surgeon's decision in women with breast cancer or at high risk for breast cancer undergoing oncoplastic surgery or mastectomy with the help of skin or skin-nipple. Based on the results of this study, the sensitivity, specificity, and predictive values of this technique for the prediction of adverse events during the postoperative period will be established.",[356,28],"Skin Necrosis",[358,359,360,361,362,363],"breast cancer","oncoplastic surgery","breast reconstruction","skin sparing mastectomy","nipple-skin sparing mastectomy","indocyanine color green","2024-07-20",{"date":366,"type":39},"2024-07-23",{"date":368,"type":39},"2023-06-01",{"date":159,"type":21},{"name":371,"class":46},"University Hospital A Coruña",{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":85,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":379,"targetDuration":381,"studyType":57,"phases":4,"briefSummary":382,"conditions":383,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":77},"100379463","endoscopic-resection-of-large-colorectal-polyps-an-observational-cohort-study-100379463","NCT04220905","Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study","Large Polyp Study (LPS) III - Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study","Inclusion Criteria:\n\n* Any patient ≥18 who presents for an upper endoscopy or colonoscopy and who does not have criteria for exclusion\n* Patients with a ≥20mm colon polyp\n* Patients with a ≥10mm duodenal polyp\n\nExclusion Criteria:\n\n* Patients who are receiving an emergency endoscopy\n* Patients with coagulopathy with an elevated INR ≥1.5, or platelets \\\u003C50\n* Poor bowel preparation\n* Pregnancy",{"count":380,"type":21},1500,"5 Years","This protocol describes a prospective cohort study. It addresses an important challenge in the prevention of colorectal cancer and duodenal cancer: how to safely and effectively remove large polyps.",[384,385,28,386,387],"Colonic Polyp","Colonoscopy","Recurrence","Duodenal Polyp","2024-07-01",{"date":390,"type":39},"2024-07-05",{"date":392,"type":39},"2017-11-01",{"date":394,"type":21},"2025-05",{"name":396,"class":397},"White River Junction Veterans Affairs Medical Center","FED",{"id":399,"slug":400,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":77},"100486728","application-of-antiosteoporosis-therapy-in-osteolysis-100486728","NCT05617846","Application of Antiosteoporosis Therapy in Osteolysis","Efficacy and Safety of Antiosteoporosis Therapy in Patients After Bone Tumor Resection: a Multicenter, Real-world Prospective Cohort Observational Study","Inclusion Criteria:\n\n1. No age restriction, male or female.\n2. A subtype of bone tumor (including benign, malignant, and metastatic cancer) was confirmed in the pathology department of the research institution.\n3. Received excision of bone tumor in research institution.\n\nExclusion Criteria:\n\nNot applicable.",{"count":335,"type":21},"To report the postoperative complications and limb function of patients with osteolysis after surgery for bone tumors of the extremities who received anti-osteoporosis therapy in Henan Cancer Hospital in the next 10 years.",[408,28],"Limb; Fusion","2024-01-16",{"date":411,"type":39},"2024-01-18",{"date":413,"type":21},"2024-12-28",{"date":415,"type":21},"2032-11-30",{"name":417,"class":418},"Henan Cancer Hospital","OTHER_GOV",{"id":420,"slug":421,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":229,"enrollmentInfo":425,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":77},"100365418","real-world-study-of-end-stage-liver-disease-in-china-100365418","NCT04037995","Real World Study of End-stage Liver Disease in China","Inclusion Criteria:\n\n1. Informed consent of patients.\n2. Diagnosis of any of the following diseases: acute decompensation of cirrhosis, chronic and acute liver failure, chronic liver failure and hepatocellular carcinoma (stage III-IV)\n\nExclusion Criteria:\n\n1. HIV antibody positive and AIDS patients\n2. Serious psychiatric history, especially depression. Severe mental illness is defined as major depression or psychosis, suicide attempts, hospitalization due to mental illness or a period of disability due to mental illness.\n3. Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs.\n4. Patients with other malignant tumors (excluding those cured).\n5. Pregnant, lactating women or women of childbearing age who are ready to conceive.",{"count":174,"type":21},"The aims of this study are exploring the current situation of end-stage liver disease in China, and the optimization of diagnosis and treatment. Liver cirrhosis often accompanied by a series of complications. Therefore, it is necessary to standardize the diagnosis and treatment of liver cirrhosis and its complications. End-stage liver disease mainly refers to the late stage of liver disease caused by various chronic liver damage. Its main feature is that liver function can not meet the physiological needs of human body. This study is a single-center, prospective and observational real-world study aimed at investigating and analyzing the current diagnosis and treatment of liver cirrhosis and end-stage liver disease in China.",[428,28],"End Stage Liver DIsease","2019-07-29",{"date":431,"type":39},"2019-07-30",{"date":433,"type":21},"2019-09-01",{"date":435,"type":21},"2029-09-01",{"name":437,"class":46},"Huashan Hospital"]