{"source":"clinicaltrials","name":"ClinicalTrials.gov","kind":"lookup","result":{"query":{"q":"","status":""},"studies":[{"protocolSection":{"identificationModule":{"nctId":"NCT07422935","orgStudyIdInfo":{"id":"PPD2025"},"organization":{"fullName":"Nutricia UK Ltd","class":"INDUSTRY"},"briefTitle":"Plant-Protein Dominant Tube Feed Study","officialTitle":"Exploratory Randomised, Controlled Trial To Evaluate The Impact Of Four Nutritionally Complete, Plant-Protein Dominant, Enteral Tube Feeds On Long Term Outcomes In Community-Based Adults"},"statusModule":{"statusVerifiedDate":"2026-02","overallStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2026-01-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2027-03","type":"ESTIMATED"},"completionDateStruct":{"date":"2027-03","type":"ESTIMATED"},"studyFirstSubmitDate":"2025-04-04","studyFirstSubmitQcDate":"2026-02-13","studyFirstPostDateStruct":{"date":"2026-02-20","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-02-13","lastUpdatePostDateStruct":{"date":"2026-02-20","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Nutricia UK Ltd","class":"INDUSTRY"},"collaborators":[{"name":"University Hospitals Coventry and Warwickshire NHS Trust","class":"OTHER"},{"name":"Gateshead Health NHS Foundation Trust","class":"OTHER"},{"name":"University Hospitals of Derby and Burton NHS Foundation Trust","class":"OTHER"},{"name":"Bradford Teaching Hospitals NHS Foundation Trust","class":"OTHER_GOV"},{"name":"University College London Hospitals","class":"OTHER"},{"name":"South Warwickshire NHS Foundation Trust","class":"OTHER"},{"name":"Birmingham Community Healthcare NHS","class":"OTHER_GOV"},{"name":"University Hospital Birmingham","class":"OTHER"},{"name":"Nottingham University Hospitals NHS Trust","class":"OTHER"},{"name":"NORFOLK COMMUNITY HEALTH AND CARE NHS TRUST","class":"UNKNOWN"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study aims to determine whether a reformulated plant-protein dominant protein blend in four existing enteral tube feeds is as effective as animal-protein dominant formulations in patients who are tube fed at home. This is an exploratory randomised, controlled, trial with a 3-day baseline period. Adult home tube feeding patients will be randomised to receive either a plant-protein dominant formulation or a control product (an animal-protein dominant formulation) for a 3-month intervention period followed by a 6-month and 12-month follow-up. The outcomes include gastrointestinal tolerance, compliance, acceptability, anthropometry, nutrient intake, and physical function"},"conditionsModule":{"conditions":["Enteral Nutrition (Food for Special Medical Purposes)","Enteral Feeds"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"Exploratory, randomised, controlled trial","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","whoMasked":["PARTICIPANT"]}},"enrollmentInfo":{"count":110,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Plant-Protein Dominant Intervention","type":"EXPERIMENTAL","description":"During the 3-day baseline period, each patient will receive their usual enteral tube feeding prescription as determined by their dietitian. Following the 3-day baseline period, all patients will enter the 90-day intervention period, where they will receive one (or a combination) of the plant-protein dominant feeds.","interventionNames":["Dietary Supplement: Plant-protein dominant enteral feed"]},{"label":"Animal-Protein Dominant Control","type":"ACTIVE_COMPARATOR","description":"During the 3-day baseline period, each patient will receive their usual enteral tube feeding prescription as determined by their dietitian. Following the 3-day baseline period, all patients will enter the 90-day intervention period, where they will receive one (or a combination) of the animal-protein dominant feed (control) daily.","interventionNames":["Dietary Supplement: Animal-protein dominant enteral feed"]}],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Plant-protein dominant enteral feed","description":"Patients randomised to the Intervention Group will continue their existing tube feed for 3 days (baseline period) after which they will then receive one (or a combination) of the 4 plant-protein dominant enteral feeds (1kcal/ml or 1.5kcal/ml, with or without fibre) for 3 months. Patients who chose to remain on the study feed following the duration of the trial will be invited to participate in the full 12-month follow up (an additional 9 months), where data will be collected at 6- and 12-months. The feed prescription will be determined on an individual basis by the dietitian responsible for the patient's nutritional management but will be a minimum of 500ml feed per day (providing ≥500kcal).","armGroupLabels":["Plant-Protein Dominant Intervention"]},{"type":"DIETARY_SUPPLEMENT","name":"Animal-protein dominant enteral feed","description":"Patients randomised to the Control Group will continue their existing tube feed for 3 days (baseline period) after which they will then receive one (or a combination) of the 4 animal-protein dominant control feeds (1kcal/ml or 1.5kcal/ml, with or without fibre) for 3 months. Patients who chose to remain on the study feed following the duration of the trial will be invited to participate in the full 12-month follow up (an additional 9 months), where data will be collected at 6- and 12-months. The feed prescription will be determined on an individual basis by the dietitian responsible for the patient's nutritional management but will be a minimum of 500ml feed per day (providing ≥500kcal).","armGroupLabels":["Animal-Protein Dominant Control"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in gastrointestinal tolerance","description":"A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea).","timeFrame":"Change from baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months)"},{"measure":"Acceptability","description":"Acceptability (e.g., liking, ease of use, preference) will be assessed by a questionnaire. Questions will be rated on a 7-point Likert scale (1 strongly disagree - 7 strongly agree)","timeFrame":"Baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months)"},{"measure":"Compliance","description":"Compliance with the study product prescription (%) will be assessed daily by recording how much of the study product was prescribed compared to the amount administered.","timeFrame":"Baseline to end of intervention (93 days) and end of follow-up (12 months)"},{"measure":"Nutritional intake","description":"A 24-h dietary recall will be conducted to record all food, drink and nutritional feeds taken in the 24 hours prior for analysis of daily nutritional intake i.e., total energy intake (kcal/day) and macro- and micronutrients (g/day or mg/day).","timeFrame":"Baseline to end of intervention (Day 93) and end of follow-up (12 months)"},{"measure":"Body weight","description":"Body weight (kg) will be measured using standard methods to the nearest 0.1kg using a weighing scale without heavy clothing. Height and weight measures will be used to calculate body mass index (BMI) as kg/m\\^2.","timeFrame":"Baseline to end of intervention (Day 93) and end of follow-up (12 months)"},{"measure":"Height","description":"Height will be measured at baseline only using standard measures to the nearest 0.1cm, without shoes or socks. Height and weight measures will be used to calculate body mass index (BMI) as kg/m\\^2.","timeFrame":"Baseline to end of intervention (Day 93) and end of follow-up (12 months)"},{"measure":"Calf circumference","description":"Calf circumference will be measured using standard measures to the nearest 0.1cm","timeFrame":"Baseline to end of intervention (Day 93) and end of follow-up (12 months)"},{"measure":"30-s Chair Stand Test","description":"Number of times patients can stand up and sit down from a chair within 30 seconds.","timeFrame":"Baseline to end of intervention (Day93) and end of follow-up (12 months)"},{"measure":"Handgrip strength","description":"A novel dynamometer will be used to assess muscle strength (kg) via a maximal grip strength test","timeFrame":"Baseline to end of intervention (Day93) and end of follow-up (12 months)"},{"measure":"Hand Grip Fatiguability","description":"Muscle fatigability (in seconds) will be measured using a fatigue resistance test on a novel hand grip dynamometer","timeFrame":"Baseline to end of intervention (Day93) and end of follow-up (12 months)"},{"measure":"Capacity to Perceived Vitality (CPV) ratio","description":"Vitality capacity, measured as Capacity to Perceived Vitality (CPV) ratio will be calculated using fatiguability, measured with a novel hand grip dynamometer combined, combined with the score from a validated questionnaire","timeFrame":"Baseline to end of intervention (Day93) and end of follow-up (12 months)"},{"measure":"Sarc-CalF tool","description":"Sarcopenia screening tool consisting of a 5 question questionnaire combined with calf circumference measurement. A score ≥ 11 points is suggestive of sarcopenia.","timeFrame":"Baseline to end of intervention (Day93) and end of follow-up (12 months)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female\n\n  -≥16 years of age\n* Using or requiring an enteral tube feed in the community as part of nutritional management plan\n* Expected to receive at least 500ml (≥500kcal) per day from one of the study products\n\nExclusion Criteria:\n\n* Receiving parenteral nutrition\n* Patients with major hepatic dysfunction (i.e., decompensated liver disease)\n* Patients with major renal dysfunction (i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD))\n* Patients receiving inpatient care\n* Known pregnancy or lactation\n* Participation in other clinical intervention studies within 1 month of this study\n* Allergy to any study product ingredients\n* Investigator concern regarding ability or willingness of patient to comply with the study requirements.","healthyVolunteers":false,"sex":"ALL","minimumAge":"16 Years","stdAges":["CHILD","ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"centralContacts":[{"name":"Sophie Bell","role":"CONTACT","phone":"+7717498628","email":"sophie.bell@nutricia.com"},{"name":"Ellen Taylor","role":"CONTACT","email":"ellen.taylor@nutricia.com"}],"locations":[{"facility":"Nutricia Ltd","status":"RECRUITING","city":"Trowbridge","state":"Wiltshire","zip":"BA14 0XQ","country":"United Kingdom","geoPoint":{"lat":51.31889,"lon":-2.20861}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT04478435","orgStudyIdInfo":{"id":"FF-2018-447"},"organization":{"fullName":"Universiti Kebangsaan Malaysia Medical Centre","class":"OTHER"},"briefTitle":"Gastric Volume Estimation by Ultrasonography After Glucose Loaded Clear Fluid Ingestion in Fasted Adult","officialTitle":"The Comparative Gastric Volume Estimation Between Different Time Intervals by Ultrasonography After Glucose Loaded Clear Fluid Ingestion in Fasted Healthy Adult"},"statusModule":{"statusVerifiedDate":"2020-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-01-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-06-01","type":"ACTUAL"},"completionDateStruct":{"date":"2019-07-01","type":"ACTUAL"},"studyFirstSubmitDate":"2020-07-05","studyFirstSubmitQcDate":"2020-07-15","studyFirstPostDateStruct":{"date":"2020-07-20","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-07-15","lastUpdatePostDateStruct":{"date":"2020-07-20","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Universiti Kebangsaan Malaysia Medical Centre","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"Introduction; Pre operative gastric ultrasonography is a newly developed tool used to evaluate gastric content and volume in assessing perioperative aspiration risk and guide anaesthetic management. Gastric antrum is the most amenable and most consistently identified region for sonographic examination during assessment even in empty state. Baseline gastric secretions and clear fluids i.e: water, apple juice and tea have hypoechoeic or anechoic appearance, whilst milk, thick fluids, or suspensions will have increased echogenicity. Evaluation with sonographic assessment were found to be accurately reflective of gastric content in various studies.\n\nIn this study, healthy volunteers were recruited. They will be required to fast at least 8 hours prior to baseline gastric antrum ultrasonography assessment. Following that, they will require to drink 250ml glucose loaded drinks. Repeated Ultrasound assessment will be done after 1 hour of glucose loaded drink ingestion in Group 1 and after 2 hours in Group 2. Hypothesis of the study is there will be no significant different between ultrasound assessment between this 2 groups.","detailedDescription":"This prospective randomized controlled trial study will be conducted in the Department of Anaesthesiology and Intensive Care UKM for eight months period from November 2018 to June 2019 involving healthy adult volunteers comprising staff members of Department of Anaesthesiology and Intensive Care, after obtaining approval from Research Committee of the Department of Anaesthesiology \\& Intensive Care, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) and the Medical Research \\& Ethics Committee, UKMMC. Written informed consent will be obtained from volunteers who fulfill the inclusion criteria.\n\nAll volunteers will be fasted, a minimum of 8 hours (duration of fasting will be recorded before the study begin) and will undergo baseline ultrasonographic gastric assessment (t0).\n\nAll subjects in Group 1 and group 2 will drink 250 ml of lychee juice (glucose loaded clear fluid containing solution with lychee flavor; 145 kcal in 250 ml) after completion of baseline gastric assessment.\n\nGroup 1 subjects will then continue fasting for one hour until completion of second sonographic antral assessment. Subjects in Group 2 will continue fasting for 2 hours until second sonographic antral assessment scan is completed.\n\nSubjects will be divided into 2 groups via computer randomization which will be allocated by anaesthesia trainee that will not be taking part in the analytical and further write up phases of the study. Ultrasonographic volume assessment will be conducted by a single operator who is an anaesthesia Masters trainee, experienced in diagnostic abdominal ultrasound with more than 20 sonographic gastric volume assessments. The images will be recorded and validated by a consultant radiologist.\n\nUltrasonographic views of antral area will be obtained using a curvilinear array 2- to 5-MHz transducer and a Mindray DC-70 (Shanghai, China) with image compounding technologies. Images will be obtained with the stomach at rest, and between peristaltic contractions. Sonograms of the antral area will be examined in 2 views, cross-section in the supine position, followed by the right lateral decubitus position, at each of the two scanning sessions.\n\nDuring ultrasonography, the antrum will be imaged in a parasagittal plane in the epigastric area using the left lobe of the liver, the inferior vena cava, and the superior mesenteric vein as internal landmarks. The two vessels are usually visualized slightly to the right of the abdominal midline. Once these vessels were identified, the transducer will be rotated slightly clockwise or counterclockwise to best obtain a true cross-sectional view of the antrum. The anteroposterior and craniocaudal diameters will be measured in this view.\n\nCSA of the antral area (a two-dimensional section) will be calculated according to the formula previously used by Bolondi18 using two maximum perpendicular diameters.\n\nThis formula essentially represents the surface area of an ellipse, as follows: CSA (AP x CC x pie/4), where AP is the anteroposterior diameter and CC is the craniocaudal diameter measures in one decimal point.\n\nEstimation of gastric volume will be obtain using this formula:\n\nPredicted gastric volume based on right lateral CSA value : 27 + 14.6 \\* right lat CSA - 1.28\\*age (negative volume value indicates and empty state)."},"conditionsModule":{"conditions":["Healthy Participants"],"keywords":["gastric antrum ultrasonography","Gastric volume estimation","aspiration risk"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"SCREENING","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":254,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1 Hour post intervention","type":"ACTIVE_COMPARATOR","description":"Ultrasound assessment done 1 hour after ingestion of glucose loaded drink","interventionNames":["Other: glucose loaded clear fluid"]},{"label":"2 hours post intervention","type":"PLACEBO_COMPARATOR","description":"Ultrasound assessment done 2 hour after ingestion of glucose loaded drink","interventionNames":["Other: glucose loaded clear fluid"]}],"interventions":[{"type":"OTHER","name":"glucose loaded clear fluid","description":"Ultrasound assessment of gastric antrum is done at different time interval following glucose loaded clear fluid ingestion","armGroupLabels":["1 Hour post intervention","2 hours post intervention"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Gastric volume assessment","description":"Gastric volume can be calculated with gastric antrum measurement","timeFrame":"1 hour after intervention"},{"measure":"Gastric volume assessment","description":"Gastric volume can be calculated with gastric antrum measurement","timeFrame":"2 hours after intervention"}],"otherOutcomes":[{"measure":"Baseline gastric volume","description":"Baseline gastric volume assessed prior to ingestion of glucose loaded clear fluid","timeFrame":"Baseline"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* ASA 1 \\& 2\n\nExclusion Criteria:\n\n* Upper gastrointestinal pathology such as hiatus hernia, oesophageal cancer\n* Prior surgery to upper GI\n* On medication that may affect gastric emptying time\n* Pregnancy","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"60 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Syarifah Noor Nazihah S Masri","affiliation":"PPUKM","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Pusat Perubatan Universiti Kebangsaan Malaysia","city":"Kuala Lumpur","state":"Wp","zip":"5600","country":"Malaysia","geoPoint":{"lat":3.1412,"lon":101.68653}}]},"referencesModule":{"references":[{"pmid":"8424572","type":"RESULT","citation":"Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010."},{"pmid":"1785235","type":"RESULT","citation":"Read MS, Vaughan RS. Allowing pre-operative patients to drink: effects on patients' safety and comfort of unlimited oral water until 2 hours before anaesthesia. Acta Anaesthesiol Scand. 1991 Oct;35(7):591-5. doi: 10.1111/j.1399-6576.1991.tb03354.x."},{"pmid":"21596885","type":"RESULT","citation":"Perlas A, Davis L, Khan M, Mitsakakis N, Chan VW. Gastric sonography in the fasted surgical patient: a prospective descriptive study. Anesth Analg. 2011 Jul;113(1):93-7. doi: 10.1213/ANE.0b013e31821b98c0. Epub 2011 May 19."},{"pmid":"29624530","type":"RESULT","citation":"Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372."}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"IPD will be share on request"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT04434235","orgStudyIdInfo":{"id":"2019-00830"},"organization":{"fullName":"Balgrist University Hospital","class":"OTHER"},"briefTitle":"Effects of Additional Axial Load on Cervical Motor Control","officialTitle":"Effects of Additional Axial Load on Cervical Motor Control","acronym":"Axial"},"statusModule":{"statusVerifiedDate":"2021-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-10-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-07-01","type":"ACTUAL"},"completionDateStruct":{"date":"2020-08-01","type":"ACTUAL"},"studyFirstSubmitDate":"2020-04-28","studyFirstSubmitQcDate":"2020-06-12","studyFirstPostDateStruct":{"date":"2020-06-16","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-01-14","lastUpdatePostDateStruct":{"date":"2021-01-19","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Balgrist University Hospital","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"he objective of this study is to examine the influence of additional axial load abd body position on cervical motor control in young healthy adults.","detailedDescription":"Motor control of the cervical spine is impotent for responsible for maintaining balance during daily living activities and to withstand external loads. Stabilization-aspects of the cervical spine is very complex, passive (ligaments, joint capsule and the skin and active (muscles), and neurological subsystems are involved. Mostly proprioceptive testing and exercises like head and neck position sense testing and re-training have been an integral part of rehabilitation. Another method to evaluate spinal motor control is the assessment of spinal stiffness. The main objective of this study is to explore the effects of additional axial loading on motion control in healthy individuals. Does the motor control of the cervical spine in healthy subjects change with additional axial load or body position? A better understanding of spinal stiffness and neck position sense leads to novel insights into spinal cervical stabilization mechanisms."},"conditionsModule":{"conditions":["Healthy"],"keywords":["cervical spine"]},"designModule":{"studyType":"OBSERVATIONAL","patientRegistry":false,"designInfo":{"observationalModel":"COHORT","timePerspective":"CROSS_SECTIONAL"},"enrollmentInfo":{"count":100,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Dynamic cervical stability","description":"The participant is asked to move the head in 6 directions in a sitting position and 30° leaning backward sitting position; lateral flexion (left / right), flexion, extension, and rotation (left / right). Results are to be taken for each direction and random at each axial load-level (0 kg, 1kg, 2 kg, and 3 kg). In total 24 measurements.\n\nThe duration of all measurement will be 60 minutes.","interventionNames":["Other: axial load"]},{"label":"Cervical Stiffness","description":"The participant is asked to move the head in 4 directions; flexion, extension, and rotation (left / right). Joint-Position Error measurements will be executed in neutral sitting position. Additionally, stiffness will be measured in neutral sitting position and neutral sitting position with 45° cervical flexion. All measurements will be performed with 0 kg and 3 kg axal loading. In total 18 measurements.The duration of all measurement will be 60 minutes.","interventionNames":["Other: axial load"]}],"interventions":[{"type":"OTHER","name":"axial load","description":"With a helmet with Velcro fastener we will add additional weight to produce axial load on the cervical spine","armGroupLabels":["Cervical Stiffness","Dynamic cervical stability"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change of neck joint-position error between differnent weight conditions","description":"Joint-position error will be will be assessed with Sensomove. It consists of the 3D senscoordination sensor, an adjustable headband, and basic software for motion feedback of head movements. The change of Joint-Position Error with and without additional axial load will be assessed.","timeFrame":"20 minutes group cervical stiffness"},{"measure":"Change of neck joint-position error between two sitting positions","description":"Joint-position error will be will be assessed with Sensomove It consists of the 3D senscoordination sensor, an adjustable headband, and basic software for motion feedback of head movements. The change of Joint-Position Error with axial load (3kg) between two sitting positions will be assessed.","timeFrame":"20 minutes group Dynamic cervical stability"},{"measure":"Change of neck range of motion between different weight conditions","description":"Range of motion will be will be assessed with Sensomove It consists of the 3D senscoordination sensor, an adjustable headband, and basic software for motion feedback of head movements. The change of Rage of motion with and without additional axial load will be assessed.","timeFrame":"20 minutes group cervical stiffness"},{"measure":"Change of spinal stiffness between different sitting positions and loading conditions","description":"The device measures tissue compliance according to the concept of impulse-response. A force of exact 20 Newton will be applied from the device to the process spinous. The expected impulse-response (result) will be between 20 Newton and 40 Newton. The change of spinal stiffness due sitting position and loading will be assessed.","timeFrame":"20 minutes group cervical stiffness"}],"secondaryOutcomes":[{"measure":"Pain during measuring","description":"The visual analogue scale will be used to quantify pain, if any of the measurements is painful. The participant is asked to rate his pain intensity on a straight line (100mm) with two endpoints.","timeFrame":"2 minutes"},{"measure":"Self-administered neck mobility","description":"Self-administered neck mobility questionnaire is a self-administered questionnaire that uses visual analog scales to measure pain-free active rage of motion for all neck movements. The patient is asked to place a mark on a 100 mm line (0 mm = \"no movement possible\" and 100 mm = \"as far as possible\"). The total score is the sum of the individual scores (min. score (600) = no restrictions and max. score (0) = total restriction)","timeFrame":"4 minutes"},{"measure":"Neck Disability Index","description":"The Neck Disability Index is a self-report questionnaire with 10-items: pain intensity, personal care, lifting, work, headaches, concentration, sleeping, driving, reading, and recreation. The response to each item is rated on a 6-point scale from 0 (no disability) to 5 (complete disability). The numeric responses for each item are summed for a total score ranging between 0 and 50.","timeFrame":"4 minutes"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nHealthy participant's Signed informed consent after being informed\n\nExclusion Criteria:\n\nAcute pain Chronic neck pain Undergone Neck surgery Neck Disability Index Score \\> 15","healthyVolunteers":true,"sex":"MALE","minimumAge":"18 Years","maximumAge":"30 Years","stdAges":["ADULT"],"studyPopulation":"Young healthy adults","samplingMethod":"NON_PROBABILITY_SAMPLE"},"contactsLocationsModule":{"overallOfficials":[{"name":"Jaap Swanenburg, PhD","affiliation":"Balgrist University Hospital","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Balgrist University Hospital","city":"Zurich","state":"Canton of Zurich","zip":"8008","country":"Switzerland","geoPoint":{"lat":47.36667,"lon":8.55}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"},"interventionBrowseModule":{"meshes":[{"id":"D016474","term":"Weight-Bearing"}],"ancestors":[{"id":"D055595","term":"Mechanical Phenomena"},{"id":"D055585","term":"Physical Phenomena"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT07143435","orgStudyIdInfo":{"id":"EndoscopicFindingsIronDef"},"organization":{"fullName":"National Center for Gastroentestinal and Liver Disease","class":"OTHER"},"briefTitle":"Endoscopic Findings in Iron Deficiency Anemia: A Cross-Sectional Study From Port Sudan","officialTitle":"Endoscopic Findings in Iron Deficiency Anemia: A Cross-Sectional Study From Port Sudan","acronym":"IDA"},"statusModule":{"statusVerifiedDate":"2025-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-02-11","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-04-12","type":"ACTUAL"},"completionDateStruct":{"date":"2021-08-17","type":"ACTUAL"},"studyFirstSubmitDate":"2025-08-09","studyFirstSubmitQcDate":"2025-08-20","studyFirstPostDateStruct":{"date":"2025-08-27","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-08-20","lastUpdatePostDateStruct":{"date":"2025-08-27","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"National Center for Gastroentestinal and Liver Disease","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Background: Iron deficiency anemia (IDA) is a common condition often linked to gastrointestinal blood loss, making endoscopic evaluation essential for identifying underlying causes. This study aimed to assess the endoscopic findings in patients presenting with IDA in Red Sea State, Sudan. Understanding the prevalence and types of gastrointestinal lesions among these patients can aid in early diagnosis and management, reducing associated morbidity and mortality. By focusing on patients undergoing endoscopic evaluation, this study provides valuable insights into the burden of gastrointestinal pathologies contributing to IDA in the region.\n\nMaterials and Methods: This cross-sectional, descriptive study was conducted in the Endoscopy Unit at Alkaleej Medical Complex - Portsudan. Adults aged ≥18 years with IDA undergoing endoscopic evaluation were included, excluding those unwilling participation or with incomplete data. Data were collected via structured questionnaires and medical records, covering demographics, medical history, clinical presentation, and endoscopic findings. SPSS version 26 - 2018, was used for analysis, applying descriptive statistics and chi-square tests to assess associations. Ethical approval was obtained, and informed consent was secured from all participants."},"conditionsModule":{"conditions":["Iron Deficiency Anemia","Endoscopy","Anemia"],"keywords":["Sudan","Gastrointestinal blood loss","Endoscopic findings"]},"designModule":{"studyType":"OBSERVATIONAL","patientRegistry":false,"designInfo":{"observationalModel":"OTHER","timePerspective":"CROSS_SECTIONAL"},"enrollmentInfo":{"count":117,"type":"ACTUAL"}},"outcomesModule":{"primaryOutcomes":[{"measure":"Proportion of patients with endoscopic lesions explaining iron deficiency anemia","description":"Percentage of participants with one or more endoscopic findings potentially accounting for IDA (e.g., gastric/duodenal ulcer, gastritis with bleeding, colonic mass/ulcer, angiodysplasia), confirmed by endoscopy ± biopsy when indicated.","timeFrame":"4 months"}],"secondaryOutcomes":[{"measure":"Proportion of biopsy-proven malignancies","description":"Percentage of participants with histopathology-confirmed gastrointestinal malignancy (e.g., gastric adenocarcinoma, colorectal cancer).","timeFrame":"4 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Adults aged 18 years and above.\n* Patients diagnosed with IDA who underwent endoscopic evaluation.\n\nExclusion Criteria:\n\n* Patients who declined to participate in the study.\n* Patients with incomplete medical records or missing endoscopic findings.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"80 Years","stdAges":["ADULT","OLDER_ADULT"],"studyPopulation":"The study population consisted of all patients presenting with IDA who underwent endoscopic evaluation at the study site during the study period.","samplingMethod":"PROBABILITY_SAMPLE"},"contactsLocationsModule":{"overallOfficials":[{"name":"Mohammed Ganim, Dr.","affiliation":"National Center for Gastrointestinal And Liver Diseases","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Alkhaleej Medical Center","city":"Kassala","zip":"21111","country":"Sudan","geoPoint":{"lat":15.45099,"lon":36.39998}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"},"conditionBrowseModule":{"meshes":[{"id":"D018798","term":"Anemia, Iron-Deficiency"},{"id":"D000740","term":"Anemia"}],"ancestors":[{"id":"D000747","term":"Anemia, Hypochromic"},{"id":"D006402","term":"Hematologic Diseases"},{"id":"D006425","term":"Hemic and Lymphatic Diseases"},{"id":"D000090463","term":"Iron Deficiencies"},{"id":"D019189","term":"Iron Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT00894335","orgStudyIdInfo":{"id":"retroper adrenal"},"organization":{"fullName":"Kliniken Essen-Mitte","class":"OTHER"},"briefTitle":"Anesthesia Management of Retroperitoneal Adrenalectomies","officialTitle":"Anesthesiological Management of Hemodynamics and Gas Exchange for Retroperitoneal Adrenalectomies"},"statusModule":{"statusVerifiedDate":"2009-05","overallStatus":"UNKNOWN","lastKnownStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-05"},"primaryCompletionDateStruct":{"date":"2012-03","type":"ESTIMATED"},"completionDateStruct":{"date":"2012-07","type":"ESTIMATED"},"studyFirstSubmitDate":"2009-05-06","studyFirstSubmitQcDate":"2009-05-06","studyFirstPostDateStruct":{"date":"2009-05-07","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-06-27","lastUpdatePostDateStruct":{"date":"2011-06-28","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Harald Groeben, Prof. Dr.","oldOrganization":"Department of Anesthesiology and CCM , Clinics Essen-Mitte"},"leadSponsor":{"name":"Kliniken Essen-Mitte","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study is a prospective, perioperative evaluation of hemodynamic and respiratory parameters in patients undergoing retroperitoneoscopic adrenalectomies.","detailedDescription":"Due to their underlying disease, patients with adrenal tumors are prone to episodes of hyper- and hypotension. Furthermore, excessive hypercarbia and an increased arterial-alveolar CO2 difference can be seen during these operations."},"conditionsModule":{"conditions":["Adrenal Tumors"],"keywords":["retroperitoneoscopic adrenalectomy","intraoperative arterial-alveolar Carbon dioxide Difference"]},"designModule":{"studyType":"OBSERVATIONAL","designInfo":{"observationalModel":"COHORT","timePerspective":"PROSPECTIVE"},"enrollmentInfo":{"count":500,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"1","description":"Pheochromocytoma"},{"label":"2","description":"Conn-Syndrome"},{"label":"3","description":"Cushing disease"},{"label":"4","description":"Metastasis"},{"label":"5","description":"Non-functional tumor"}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Arterial-alveolar Carbon dioxide Difference","timeFrame":"3 years"}],"secondaryOutcomes":[{"measure":"Perioperative maximal mean arterial pressure","timeFrame":"3 Years"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients with an adrenal tumor\n\nExclusion Criteria:\n\n* Age below 18 years","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"90 Years","stdAges":["ADULT","OLDER_ADULT"],"studyPopulation":"Patients with adrenal tumors scheduled for retroperitoneal adrenalectomies","samplingMethod":"NON_PROBABILITY_SAMPLE"},"contactsLocationsModule":{"centralContacts":[{"name":"Harald Groeben, Prof., M.D.","role":"CONTACT","phone":"##49 201 174","phoneExt":"31109","email":"h.groeben@kliniken-essen-mitte.de"}],"overallOfficials":[{"name":"Harald Groeben, Prof, M.D.","affiliation":"Clinics Essen-Mitte","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Clinics Essen-Mitte","status":"RECRUITING","city":"Essen","zip":"45136","country":"Germany","contacts":[{"name":"Harald Groeben, Prof, M.D.","role":"CONTACT","phone":"##49 201 174","phoneExt":"31109","email":"h.groeben@kliniken-essen-mitte.de"},{"name":"Harald Groeben, Prof, M.D.","role":"CONTACT","phone":"##49 201 174","phoneExt":"31109","email":"h.groeben@klinken-essen-mitte.de"},{"name":"Harald Groeben, Prof., M.D.","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":51.45657,"lon":7.01228}}]},"referencesModule":{"references":[{"pmid":"17188142","type":"BACKGROUND","citation":"Walz MK, Alesina PF, Wenger FA, Deligiannis A, Szuczik E, Petersenn S, Ommer A, Groeben H, Peitgen K, Janssen OE, Philipp T, Neumann HP, Schmid KW, Mann K. Posterior retroperitoneoscopic adrenalectomy--results of 560 procedures in 520 patients. Surgery. 2006 Dec;140(6):943-8; discussion 948-50. doi: 10.1016/j.surg.2006.07.039."}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"},"conditionBrowseModule":{"meshes":[{"id":"D000310","term":"Adrenal Gland Neoplasms"}],"ancestors":[{"id":"D004701","term":"Endocrine Gland Neoplasms"},{"id":"D009371","term":"Neoplasms by Site"},{"id":"D009369","term":"Neoplasms"},{"id":"D000307","term":"Adrenal Gland Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT06873035","orgStudyIdInfo":{"id":"QBGJ398-304"},"organization":{"fullName":"QED Therapeutics, a BridgeBio company","class":"INDUSTRY"},"briefTitle":"An Interventional Study of Infigratinib in Children With Hypochondroplasia","officialTitle":"A Phase 2/3, Multicenter, Open-Label Phase Followed by a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Infigratinib in Children With Hypochondroplasia: ACCEL 2/3","acronym":"HCH"},"statusModule":{"statusVerifiedDate":"2025-03","overallStatus":"ENROLLING_BY_INVITATION","startDateStruct":{"date":"2025-04-22","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2027-01","type":"ESTIMATED"},"completionDateStruct":{"date":"2027-01","type":"ESTIMATED"},"studyFirstSubmitDate":"2025-02-18","studyFirstSubmitQcDate":"2025-03-06","studyFirstPostDateStruct":{"date":"2025-03-12","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-12-09","lastUpdatePostDateStruct":{"date":"2025-12-15","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"QED Therapeutics, a BridgeBio company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"ACCEL2/3 is a Phase 2/3 study. The purpose of the Phase 2 portion of the study (ACCEL2/3) is to evaluate the efficacy and safety, of infigratinib in children with hypochondroplasia (HCH) receiving infigratinib, at one of two doses, of who have completed at least 26 weeks of participation in QED-sponsored ACCEL (QBGJ398-004).","detailedDescription":"ACCEL 2/3 is a Phase 2/3 study that comprises of 2 portions. The Phase 2 portion is an open-label, portion in children with HCH aged 5 to 11 years old followed by a Phase 3 portion which is double-blind, placebo-controlled in children with HCH aged \\>3 years old to \\<18 years old."},"conditionsModule":{"conditions":["Hypochondroplasia"],"keywords":["skeletal dysplasia","endochondral ossification","hypochondroplasia","HCH","shortened proximal limbs","fibroblast growth factor receptor 3","FGFR3","endochondral bone formation","disproportionate short stature","quality of life","dwarfism","bone diseases","musculoskeletal diseases","osteochondrodysplasia","functional abilities","annualized growth velocity","annualized height velocity","growth","genetic diseases","congenital","AHV","AGV","Pathogenic variants"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"This study comprises an open-label Phase 2 portion to evaluate safety and efficacy in participants receiving infigratinib at one of two doses followed by a Phase 3 randomized, double-blind portion of the dose selected from the Phase 2 portion versus placebo.","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":24,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Phase 2 Cohort 1","type":"EXPERIMENTAL","description":"infigratinib (0.128 mg/kg/day)","interventionNames":["Drug: infigratinib 0.128 mg/kg/day"]},{"label":"Phase 2 Cohort 2","type":"EXPERIMENTAL","description":"infigratinib (0.25 mg/kg/day)","interventionNames":["Drug: infigratinib 0.25 mg/kg/day"]}],"interventions":[{"type":"DRUG","name":"infigratinib 0.128 mg/kg/day","description":"Oral infigratinib 0.128 mg/kg/day","armGroupLabels":["Phase 2 Cohort 1"]},{"type":"DRUG","name":"infigratinib 0.25 mg/kg/day","description":"Oral infigratinib 0.25 mg/kg/day","armGroupLabels":["Phase 2 Cohort 2"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change from baseline (BL) in Annualized Height Velocity (AHV; cm/year)","timeFrame":"26 weeks"},{"measure":"Incidence, severity, and seriousness of adverse events (AEs) that require dose reduction or discontinuation","timeFrame":"at least 26 weeks"}],"secondaryOutcomes":[{"measure":"Change from BL in height Z-score (in relation to both HCH and average height tables)","timeFrame":"52 weeks"},{"measure":"Change from BL in upper to lower body segment ratio (cm)","timeFrame":"52 weeks"},{"measure":"Changes in cognitive function (as assessed by age appropriate computerized tests)","timeFrame":"52 weeks"},{"measure":"Pharmacokinetic profile of infigratinib by assessment of maximum concentration (Cmax)","timeFrame":"52 weeks"},{"measure":"Pharmacokinetic profile of infigratinib by assessment of time-to-maximum concentration (Tmax)","timeFrame":"52 weeks"},{"measure":"Change from BL in collagen X marker (CXM) levels","timeFrame":"52 weeks"}],"otherOutcomes":[{"measure":"Change from BL in comorbidities associated with HCH","timeFrame":"52 weeks"},{"measure":"Change from BL in Health-related Quality of Life (HRQoL) (as assessed by Pediatric Quality of Life Inventory [PedsQL tool])","timeFrame":"52 weeks"},{"measure":"Evaluate treatment benefit as assessed by qualitative interviews","timeFrame":"52 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Key Inclusion Criteria:\n\n* Participants must have completed at least 26 weeks and still be on the observational study (QBGJ398-004).\n* Phase 2 portion: Participants 5-11 years of age (inclusive).\n* Phase 3 portion: Participants 3 to \\<18 years of age at screening with growth potential\n* Diagnosis of HCH documented clinically by the presence of disproportionate short stature and confirmed with a molecular test.\n* Participants are able to swallow oral medication.\n* Participants and parent(s), legal guardian(s), or caregiver(s) are willing and able to comply with study visits and study procedures.\n* Participants are ambulatory and able to stand without assistance. Sex and Contraceptive/Barrier Requirements\n* Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche.\n* If sexually active, participants whether male or female, must be willing to use a highly effective method of contraception, as relevant, while taking study drug and for 1 month after the last dose of study drug.\n* Signed informed consent.\n\nKey Exclusion Criteria:\n\n* Participants who have ACH or a short stature condition other than HCH.\n* Significant concurrent disease or condition that, in the view of the investigator and/or sponsor, would confound assessment of efficacy or safety of infigratinib.\n* Current evidence of clinically significant corneal or retinal disorder/keratopathy confirmed by ophthalmic examination.\n* Concurrent circumstance, disease, or condition that, in the view of the investigator and/or sponsor, would interfere with study participation or safety evaluations.\n* History and/or current evidence of extensive ectopic tissue calcification.\n* History of malignancy.\n* Having received or planning to receive treatment with any other investigational or approved product for the treatment of ACH, HCH, or short stature.\n* Regular long-term treatment (≥3 weeks) with supraphysiologic doses of glucocorticoid.\n* Previous limb-lengthening surgery at any time or planned/expected to have limb-lengthening or guided growth surgery while participating in the study.\n* Participants receiving medications which could increase serum phosphorus and/or calcium concentrations\n* Clinically significant abnormality in any laboratory test result at screening.\n* Pregnant or breastfeeding at the screening visit or planning to become pregnant (self or partner) at any time during the study.\n* Allergy to any components of the study drug.\n* Concurrent circumstance, disease, or condition that would interfere with study participation.","healthyVolunteers":false,"sex":"ALL","minimumAge":"3 Years","maximumAge":"18 Years","stdAges":["CHILD","ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"UCSF Benioff Children's Hospital","city":"Oakland","state":"California","zip":"94609","country":"United States","geoPoint":{"lat":37.80437,"lon":-122.2708}},{"facility":"Childrens Hospital Colorado","city":"Aurora","state":"Colorado","zip":"80045","country":"United States","geoPoint":{"lat":39.72943,"lon":-104.83192}},{"facility":"Children's National Hospital","city":"Washington D.C.","state":"District of Columbia","zip":"20010","country":"United States","geoPoint":{"lat":38.89511,"lon":-77.03637}},{"facility":"Johns Hopkins School of Medicine","city":"Baltimore","state":"Maryland","zip":"21287","country":"United States","geoPoint":{"lat":39.29038,"lon":-76.61219}},{"facility":"University of Missouri","city":"Columbia","state":"Missouri","zip":"65201","country":"United States","geoPoint":{"lat":38.95171,"lon":-92.33407}},{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","zip":"37232","country":"United States","geoPoint":{"lat":36.16589,"lon":-86.78444}},{"facility":"University of Wisconsin Madison - Waisman Center Bone Dysplasia Clinic","city":"Madison","state":"Wisconsin","zip":"53705","country":"United States","geoPoint":{"lat":43.07305,"lon":-89.40123}},{"facility":"Murdoch Children's Research Institute","city":"Parkville","state":"Victoria","zip":"3052","country":"Australia","geoPoint":{"lat":-37.78333,"lon":144.95}},{"facility":"London Health Services Center - Children's Hospital of Western Ontario","city":"London","state":"Ontario","zip":"N6C 2R5","country":"Canada","geoPoint":{"lat":42.98339,"lon":-81.23304}},{"facility":"Children's Hospital of Eastern Ontario Research Institute","city":"Ottawa","state":"Ontario","zip":"K1H 8L1","country":"Canada","geoPoint":{"lat":45.41117,"lon":-75.69812}},{"facility":"Université de Montréal - Centre Hospitalier Universitaire Sainte-Justine","city":"Montreal","state":"Quebec","zip":"H3T 1C5","country":"Canada","geoPoint":{"lat":45.50884,"lon":-73.58781}},{"facility":"Hôpital Femme Mère Enfant","city":"Bron","state":"France","zip":"69677","country":"France","geoPoint":{"lat":45.73865,"lon":4.91303}},{"facility":"Hôpital Universitaire Necker-Enfants Malades","city":"Paris","state":"France","zip":"75015","country":"France","geoPoint":{"lat":48.85341,"lon":2.3488}},{"facility":"Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital des Enfants","city":"Toulouse","state":"France","zip":"31059","country":"France","geoPoint":{"lat":43.60426,"lon":1.44367}},{"facility":"Haukeland University Hospital","city":"Bergen","state":"Norway","zip":"5021","country":"Norway","geoPoint":{"lat":60.39299,"lon":5.32415}},{"facility":"Paediatric Clinical Research Unit at Osla University Hospital","city":"Oslo","state":"Norway","zip":"0372","country":"Norway","geoPoint":{"lat":59.91273,"lon":10.74609}},{"facility":"Hospital Pediátrico de Coimbra","city":"Coimbra","state":"Portugal","zip":"3000-602","country":"Portugal","geoPoint":{"lat":40.20686,"lon":-8.41996}},{"facility":"KK Women's and Children's Hospital","city":"Singapore","state":"Singapore","zip":"229899","country":"Singapore","geoPoint":{"lat":1.28967,"lon":103.85007}},{"facility":"Hospital Vithas San Jose","city":"Vitoria-Gasteiz","state":"Spain","zip":"01008","country":"Spain","geoPoint":{"lat":42.84998,"lon":-2.67268}},{"facility":"Astrid Lindgren Children's Hospital","city":"Solna","state":"Sweden","zip":"17164","country":"Sweden","geoPoint":{"lat":59.36004,"lon":18.00086}},{"facility":"Manchester University","city":"Manchester","state":"United Kingdom","zip":"M13 9WL","country":"United Kingdom","geoPoint":{"lat":53.48095,"lon":-2.23743}},{"facility":"Sheffield Children's Hospital","city":"Sheffield","state":"United Kingdom","zip":"S10 2TH","country":"United Kingdom","geoPoint":{"lat":53.38297,"lon":-1.4659}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"},"conditionBrowseModule":{"meshes":[{"id":"C562937","term":"Hypochondroplasia"},{"id":"D009085","term":"Mucopolysaccharidosis IV"},{"id":"D004392","term":"Dwarfism"},{"id":"D001847","term":"Bone Diseases"},{"id":"D009140","term":"Musculoskeletal Diseases"},{"id":"D010009","term":"Osteochondrodysplasias"},{"id":"D030342","term":"Genetic Diseases, Inborn"}],"ancestors":[{"id":"D009083","term":"Mucopolysaccharidoses"},{"id":"D002239","term":"Carbohydrate Metabolism, Inborn Errors"},{"id":"D008661","term":"Metabolism, Inborn Errors"},{"id":"D009358","term":"Congenital, Hereditary, and Neonatal Diseases and Abnormalities"},{"id":"D016464","term":"Lysosomal Storage Diseases"},{"id":"D017520","term":"Mucinoses"},{"id":"D003240","term":"Connective Tissue Diseases"},{"id":"D017437","term":"Skin and Connective Tissue Diseases"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D001848","term":"Bone Diseases, Developmental"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"C568950","term":"infigratinib"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT01983735","orgStudyIdInfo":{"id":"130HT13015"},"organization":{"fullName":"Chong Kun Dang Pharmaceutical","class":"INDUSTRY"},"briefTitle":"Efficacy and Safety of TELMINUVO to Stage 2 Hypertension","officialTitle":"A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Telmisartan and S-Amlodipine(TELMINUVO TAB.) Versus S-Amlodipine Monotherapy in Patients With Stage 2 Hypertension"},"statusModule":{"statusVerifiedDate":"2013-11","overallStatus":"UNKNOWN","lastKnownStatus":"NOT_YET_RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-01"},"primaryCompletionDateStruct":{"date":"2014-08","type":"ESTIMATED"},"completionDateStruct":{"date":"2014-08","type":"ESTIMATED"},"studyFirstSubmitDate":"2013-11-07","studyFirstSubmitQcDate":"2013-11-07","studyFirstPostDateStruct":{"date":"2013-11-14","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-11-07","lastUpdatePostDateStruct":{"date":"2013-11-14","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Chong Kun Dang Pharmaceutical","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The aim of present study is to evaluate the efficacy and safety of two dose combination of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.","detailedDescription":"* In patients with Stage 2 hypertension to determine the efficacy and safety of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) or S-Amlodipine monotherapy (2.5mg and 5mg) during 8 weeks.\n* This study is consist of placebo run-in period(2 weeks\\_single blind) and treatment period(8 weeks\\_double blind)."},"conditionsModule":{"conditions":["Hypertension"],"keywords":["TELMINUVO Tab.","CKD-828","Hypertension","Stage 2 Hypertension","S-Amlodipine","Telmisartan"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":200,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"TELMINUVO Tab. (80/2.5mg, 80/5mg)","type":"EXPERIMENTAL","interventionNames":["Drug: TELMINUVO Tab. (80/2.5mg)","Drug: TELMINUVO Tab. (80/5mg)"]},{"label":"S-Amlodipine 2.5, 5mg","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: S-amlodipine 2.5mg","Drug: S-amlodipine 5mg"]}],"interventions":[{"type":"DRUG","name":"TELMINUVO Tab. (80/2.5mg)","description":"* Fixed dose combination of Telmisartan 80mg and S-amlodipine 2.5mg QD 2 weeks.\n* With the others investigation product placebo 1 tab QD 2 weeks.","armGroupLabels":["TELMINUVO Tab. (80/2.5mg, 80/5mg)"],"otherNames":["TELMINUVO Tab."]},{"type":"DRUG","name":"TELMINUVO Tab. (80/5mg)","description":"* Fixed dose combination of Telmisartan 80mg and S-amlodipine 5mg QD 6 weeks.\n* With the others investigation product placebo 1 tab QD 6 weeks.","armGroupLabels":["TELMINUVO Tab. (80/2.5mg, 80/5mg)"],"otherNames":["TELMINUVO Tab."]},{"type":"DRUG","name":"S-amlodipine 2.5mg","description":"* S-amlodipine 2.5mg QD 2 weeks\n* With the others investigation product placebo 1 tab QD 2 weeks.","armGroupLabels":["S-Amlodipine 2.5, 5mg"],"otherNames":["Anydipine S"]},{"type":"DRUG","name":"S-amlodipine 5mg","description":"* S-amlodipine 5mg QD 6weeks\n* With the others investigation product placebo 1 tab QD 6 weeks.","armGroupLabels":["S-Amlodipine 2.5, 5mg"],"otherNames":["Anydipine S"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Mean Sitting Systolic Blood Pressure (MSSBP)","timeFrame":"After 8 weeks of treatment"}],"secondaryOutcomes":[{"measure":"Mean Sitting Systolic Blood Pressure (MSSBP)","timeFrame":"After 2 weeks and 4 weeks of treatment"},{"measure":"Mean Sitting Diastolic Blood Pressure (MSDBP)","timeFrame":"After 2weeks, 4weeks and 8 weeks of treatment"},{"measure":"Control Rate","description":"Sitting SBP\\<140mmHg, Sitting DBP\\<90mmHg","timeFrame":"After 8 weeks of treatment"},{"measure":"Response Rate","description":"Reduction of Sitting SBP≥20mmHg, Sitting DBP ≥10mmHg","timeFrame":"After 8 weeks of treatment"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* age 18 years or older\n* at the screening visit\n\n  * antihypertensive drugs not taking: 160mmHg ≤ sitSBP \\< 200mmHg\n  * antihypertensive drugs taking: 140mmHg ≤ sitSBP \\< 180mmHg\n* at the randomization visit(160mmHg ≤ sitSBP \\< 200mmHg)\n* willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* mean sitting DBP ≥ 120mmHg or mean sitting SBP ≥ 200mmHg at the screening visit and randomization visit\n* for the past four weeks based on beginning of administration, patients took over four antihypertensive drugs\n* known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)\n* has severe heart disease(Heart failure NYHA functional class 3, 4), ischaemic heart diseases status need to treatment, myocardiopathy, Valve disease, arrhythmia and so on and operated Coronary angioplasty\n* has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months\n* Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) \\> 8%)\n* known severe or malignant retinopathy\n* defined by the following laboratory parameters:\n\n  * hepatic dysfunction(AST/ALT \\> UNL X 3)\n  * renal dysfunction(serum creatinine \\> UNL X 1.5)\n  * hypopotassemia(K \\< 3.0mmol/L) or hyperpotassemia (K\\>5.5 mmol/L)\n* acute or chronic inflammatory status need to treatment\n* need to additional antihypertensive drugs during the study\n* need to concomitant medications known to affect blood pressure during the study\n* history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers\n* known hypersensitivity related to either study drug\n* history of drug or alcohol dependency within 6 months\n* any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, gastric ulcers need to treatment, gastrointestinal/rectal bleeding, impaired pancreatic function such as pancreatitis, obstructions of the urinary tract or difficulty in voiding)\n* administration of other study drugs within 4weeks prior to screening\n* premenopausal women(last menstruation \\> 1year) not using adequate contraception, pregnant or breast-feeding\n* history of malignancy including leukemia and lymphoma within the past 5 years\n* in investigator's judgment","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"centralContacts":[{"name":"Ho-Joong Yoon, Ph.D","role":"CONTACT","phone":"82-2-2258-6029","email":"younhj@catholic.ac.kr"}],"locations":[{"facility":"The catholic university of Korea Seoul St. Mary's hospital","city":"Seoul","country":"South Korea","contacts":[{"name":"Ho-Joong Yoon, Ph.D","role":"CONTACT","phone":"82-2-2258-6029","email":"younhj@catholic.ac.kr"},{"name":"Ho-Joong Yoon, Ph.D","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":37.566,"lon":126.9784}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"},"conditionBrowseModule":{"meshes":[{"id":"D006973","term":"Hypertension"}],"ancestors":[{"id":"D014652","term":"Vascular Diseases"},{"id":"D002318","term":"Cardiovascular Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"C542574","term":"levamlodipine"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT06442735","orgStudyIdInfo":{"id":"A2023-264-01"},"organization":{"fullName":"Third Affiliated Hospital, Sun Yat-Sen University","class":"OTHER"},"briefTitle":"Clinical Application of Intrapartum Ultrasound","officialTitle":"Vaginal Delivery Facilitated by Intrapartum Ultrasound During Labor","acronym":"IPUS"},"statusModule":{"statusVerifiedDate":"2024-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-01-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-12-31","type":"ACTUAL"},"completionDateStruct":{"date":"2023-12-31","type":"ACTUAL"},"studyFirstSubmitDate":"2024-05-18","studyFirstSubmitQcDate":"2024-05-29","studyFirstPostDateStruct":{"date":"2024-06-04","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-05-29","lastUpdatePostDateStruct":{"date":"2024-06-04","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Ping Li","investigatorTitle":"Clinical Professor","investigatorAffiliation":"Third Affiliated Hospital, Sun Yat-Sen University"},"leadSponsor":{"name":"Third Affiliated Hospital, Sun Yat-Sen University","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Intrapartum ultrasound monitoring is to be compared with conventional labor monitoring to clarify the accuracy of this technology, and then provide a basis for later related research.","detailedDescription":"Intrapartum ultrasound monitoring is to be compared with conventional labor monitoring to clarify the accuracy of this technology, and then provide a basis for later related research. All pregnant women intending to have a vaginal delivery were enrolled in the study. After admission, women were randomly assigned to either intrapartum ultrasound (IPUS) or vaginal examination (VE). In IPUS group, the patient was evaluated by ultrasound, including fetal orientation, pelvic and cervical conditions. IPUS and VE were performed every 2 to 4 hours during the first stage of labor and at least hourly during the second stage. The progress of labor, the occurrence of complications and the prediction of the success rate of vaginal delivery were observed. Finally, the investigators compared whether there were any differences in labor and vaginal delivery complications between the two groups."},"conditionsModule":{"conditions":["Abnormal Labor","Complication of Delivery"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"HEALTH_SERVICES_RESEARCH","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":455,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Intrapartum ultrasound","type":"EXPERIMENTAL","description":"IPUS group women were performed pelvic examination at admission and every 2 to 4 hours during the first stage of labor and at least hourly during the second stage by intrapartum ultrasound.","interventionNames":["Other: intrapartum ultrasound"]},{"label":"Vaginal examination","type":"ACTIVE_COMPARATOR","description":"VE group women were performed pelvic examination at admission and every 2 to 4 hours during the first stage of labor and at least hourly during the second stage by vaginal examination.","interventionNames":["Other: vaginal examination"]}],"interventions":[{"type":"OTHER","name":"intrapartum ultrasound","description":"In IPUS group, the patient's labor was observed by intrapartum ultrasound.","armGroupLabels":["Intrapartum ultrasound"]},{"type":"OTHER","name":"vaginal examination","description":"In VE group, the patient's labor was observed by vaginal examination.","armGroupLabels":["Vaginal examination"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Duration of the first stage of labor","description":"Medical record about the length of first stage of labor","timeFrame":"Day 1"},{"measure":"Duration of the second stage of labor","description":"Medical record about the length of second stage of labor","timeFrame":"Day 1"},{"measure":"Number of Participants with fever","description":"physiological parameter about the body temperature when the patient has fever","timeFrame":"Day 3"},{"measure":"Number of Participants with the soft birth canal laceration I, II,III, IV","description":"clinical assessment about the soft birth canal laceration after labor, including I(Perineal skin and vaginal entrance mucosa laceration, little bleeding）, II（The lacerated injury has reached the fascia and muscle layer of the perineum, involved the mucous membrane of the posterior wall of the vagina, extended to the groove on both sides of the posterior wall of the vagina and tore upward, the anatomical structure is not easy to identify, and there is more bleeding）,III（The lacerated wound extends deep into the perineum, the external anal sphincter is broken, and the rectal mucosa is intact）, IV（The anus, rectum and vagina are completely penetrated, the rectointestinal cavity is exposed, the histological tissue is seriously damaged）","timeFrame":"Day 1"},{"measure":"Number of Participants with postpartum hemorrhage","description":"total postpartum blood loss in 24 hours measured by weighing method","timeFrame":"Day 1"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* All pregnant women in the delivery room for vaginal trial labor\n\nExclusion Criteria:\n\n* Those who reject ultrasound","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"18 Years","maximumAge":"45 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Third Affiliated Hospital of Sun Yat-Sen University","city":"Guangzhou","state":"Guangdong","zip":"510630","country":"China","geoPoint":{"lat":23.11667,"lon":113.25}}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"All data generated or analyzed during this study are available from the Central Contact Person on reasonable request."}},"annotationSection":{"annotationModule":{"unpostedAnnotation":{"unpostedResponsibleParty":"Ping Li, Clinical Professor, Third Affiliated Hospital, Sun Yat-Sen University","unpostedEvents":[{"type":"RELEASE","date":"2024-06-06"},{"type":"RESET","date":"2024-09-25"},{"type":"RELEASE","date":"2024-09-27"},{"type":"UNRELEASE","date":"2024-10-12"}]}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12","submissionTracking":{"estimatedResultsFirstSubmitDate":"2024-06-06","submissionInfos":[{"releaseDate":"2024-06-06","resetDate":"2024-09-25"},{"releaseDate":"2024-09-27","unreleaseDate":"2024-10-12"}]}},"conditionBrowseModule":{"meshes":[{"id":"D004420","term":"Dystocia"}],"ancestors":[{"id":"D007744","term":"Obstetric Labor Complications"},{"id":"D011248","term":"Pregnancy Complications"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT04404335","orgStudyIdInfo":{"id":"LL-37PERIOURJC"},"organization":{"fullName":"Universidad Rey Juan Carlos","class":"OTHER"},"briefTitle":"The Role of Anti-inflammatory Cytokines and Antimicrobial Peptide LL-37 Biomarkers in the Treatment of Periodontal Disease.","officialTitle":"The Role of Anti-inflammatory Cytokines and Antimicrobial Peptide LL-37 Biomarkers in the Treatment of Periodontal Disease."},"statusModule":{"statusVerifiedDate":"2022-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-05-17","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-06-30","type":"ACTUAL"},"completionDateStruct":{"date":"2022-07-15","type":"ACTUAL"},"studyFirstSubmitDate":"2020-05-17","studyFirstSubmitQcDate":"2020-05-24","studyFirstPostDateStruct":{"date":"2020-05-27","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-09-27","lastUpdatePostDateStruct":{"date":"2022-09-30","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"David Madruga-Gonzalez","investigatorTitle":"Associate Professor","investigatorAffiliation":"Universidad Rey Juan Carlos"},"leadSponsor":{"name":"Universidad Rey Juan Carlos","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Periodontal disease is an infectious pathology that consists of the destruction of the gums and supporting structures around the teeth. There are several mechanisms involved in this process. In healthy conditions there is a balance between the bacteria present in the gums and the defence mechanisms of the host to fight the disease. One of the substances involved in favouring this protective mechanism is a peptide called LL-37.\n\nThe aim of this study is to find out more about the rol of this peptide during this process by using a non invasive method of analysis consisting of analysing some samples of the fluid existing between the gums and the teeth.\n\nThis clinical study will take place at the University Clinic at the University Rey Juan Carlos, Alcorcon (Madrid), Spain. Patients that attend the clinic suffering from gum disease will be offered the possibility to participate in this study. A full questionnaire indicating the risks and benefits of participating in the study as well as the management of confidential personal data will be discussed with the participants in full detail. Full consent will be sought before commencing the study.\n\nFirstly, all participants will receive a through periodontal (gum) examination to assess if they suffer from periodontal disease and to what extent (severity). Based on this preliminary data, patients will be classified in different categories.\n\nPatients will be divided in two groups:\n\n* 30 Healthy patients (no signs of periodontitis)\n* 30 Periodontal patients (subdivided in 2 groups of 30, depending of the severity of their disease:\n\n  * 15 patients with Stage I-II periodontitis (mild/moderate)\n  * 15 patients with Stage III-IV periodontitis (severe).\n\nThe intervention will consist on taking samples of crevicular fluid (the fluid found in the space between the gum and the root of the tooth) to quantify the presence of LL-37 as well as IL-4, IL-6, IL-10, which seems to be associated with the defence mechanisms (immunity) of the host against periodontal disease. These samples will be analysed in the laboratory by using some specific procedure called ELISA.\n\nAll patients from the test group will receive a basic course of periodontal treatment (root scale and polish), which is intended to remove the bacteria causing the disease from the space between the gums and the roots (periodontal pocket). Samples of crevicular fluid will be obtained before commencing the treatment. After 4-6 weeks, a new periodontal examination will take place to assess if there is an improvement of the condition and also to quantify the levels of LL-37, IL-4, IL-6, IL-10.\n\nThe findings of this study will help to understand the role of this peptide in the defence mechanism of the host against periodontal disease. This could ultimately serve to develop new therapies that could include the use of this peptide in addition to the routine periodontal treatment prescribed to improve the healing conditions of the patient against periodontal disease.","detailedDescription":"'The role of anti-inflammatory cytokines and antimicrobial peptide LL-37 biomarkers in the treatment of periodontal disease.\n\n1. Introduction\n\n   Periodontal disease is an infectious process that consists of the destruction of the supporting anatomical structures of the tooth, as a consequence of the inflammatory response to the periopathogenic activity of the subgingival bacterial plaque, which leads to an innate, inflammatory and adaptative immune response.\n\n   The clinical manifestation of the disease depends of host and environmental factors as well as the specific microbiological agent involved. The interrelation amongst bacteria and the immunodefence mechanisms of the host constitute the base of the immunopathological mechanisms that lead to the disease. In healthy conditions, there is a balance between the activity of the periodontal microbiota and the host immune response.\n\n   In the innate defence system of the oral cavity there are several antimicrobial peptides involved, being one of them, the human cathelicidin LL-37.\n\n   The activity of antimicrobial peptides such as LL-37 in the gingival sulcus is considered one of the greatest defence mechanisms of the periodontum. The gingival epithelium not only constitutes a physical barrier to avoid bacterial invasion. Neutrophils migrate to the junctional epithelium and create a barrier between the bacterial plaque and the underlaying epithelium. They also produce antimicrobial peptides, one of them the 18 kDa (hCAP18). Once the neutrophils are activated in response to the bacterial aggression the release LL-37, with a similar activity to a broad-spectrum antibiotic.\n\n   The total absence of this peptide (LL-37) has been associated to aggressive periodontitis, in particular in patients with a neutrophil deficiency such as those who suffer Morfan Kosmann syndrome\n\n   The nature of this research aims to elucidate the role of LL-37 in periodontal disease by comparing the use of a none invasive technique such as crevicular fluid samples in patients that suffer periodontal disease, before and after receiving a course of basic periodontal treatment (root scaling and planing). In additionto the above, pro and antiinflammatory cytokines (IL-6, IL-4, IL-10 in particular) will also be evaluated before and after periodontal treatment. Samples obtained will be analysed by immunohystochemical analysis (ELISA). The quantification of LL-37 before and after periodontal treatment associated with the clinical findings observed may serve as diagnostic biomarker of the immunopathological response inherent to the periodontal disease.\n2. Justification of research question. Current status\n\n   Over the last years, a great effort by scientific community has been made in order to try to understand the complex immunopathological processes related to periodontal disease and the relationship between the activity of the periodontal microbiota and the host defence mechanisms.\n\n   The relevance of this research may serve to understand in more detail the role of the antimicrobial peptide LL-37 in periodontal disease not only due to their bactericidal effect but in the modulation of the immunological response of the host and its activity before and after periodontal treatment. The lack of studies on this matter reflects the need for further research on this topic.\n\n   Ultimately, the findings of this research may form the basis of a new therapeutic approach based on the use of LL-37 to help modulate the immunological response of the host in combination with conventional periodontal treatment. This may be particularly relevant in patients susceptible to develop periodontal or periimplant diseases or in particular cases that are resistant to conventional treatment alternatives.\n3. Summary of intended research\n\nThe main aim of the study is to investigate the role of LL-37 in the immunopathological response of the periodontum. Subsequent aims are to investigate the possibility of using this microbial peptide to serve as diagnostic, prognostic as well as a therapeutic agent in the treatment of periodontal disease.\n\nResearch hypothesis: There are significant quantitative differences in the levels of LL-37 before and after periodontal treatment, with a significant reduction of LL-37 at re-evaluation (4-6 weeks after a course of basic periodontal treatment -root scaling and planing).\n\nNull hypothesis: There are no significant quantitative differences in the levels of LL-37 before and after periodontal treatment\n\nThe objectives of the present study are:\n\n1. Determine if healthy patients and patients with periodontal disease have different levels of LL-37, IL-6, IL-4 and IL-10 in crevicular fluid at baseline and related them to the stage/severity of periodontal disease.\n2. Evaluate if after a course of basic periodontal treatment these levels of LL-37, IL-6, IL-4 and IL-10 at baseline are similar to the quantified levels on healthy patients at baseline.\n3. With respect to crevicular fluid samples, evaluate if levels of LL-37, IL-6, IL-4 and IL-10 in teeth affected by periodontal disease differ from healthy sites on the same individual or if there are no significant differences in the above before and after a course of periodontal treatment.\n4. Stablish a non-invasive protocol to evaluate the immunological state of the patient before and after periodontal treatment as prognostic factor.\n\n4\\. Material and methods\n\nEthical approval from the Ethical Commite of University Rey Juan Carlos of Madrid (URJC) has been granted. A selection of patients of the \"Master in Advanced Implantology, Tissue Regeneration and Implant supported prosthesis\" of the FCU-URJC that fulfil the inclusion criteria and that consent to be part of the study will be made.\n\nThe criteria for entry were as follows: aged 18 or over, with no previous history of periodontal treatment in the last six months, and no medical or dental history that could contraindicate periodontal treatment. Exclusion criteria included current pregnancy or lactation, immunological disorders, periodontal treatment within the last 6 months, oral contraception and antibiotic usage within the last 3 months, infections (such as HIV, hepatitis, and tuberculosis). In addition, third molar teeth were excluded from GCF sampling for being often impacted or extracted\n\nSmoker patients will not be excluded and will be classified as light smokers (less than 10 cigarettes/day) or heavy smokers (more than 10 cigarettes /day).\n\nDiabetic patients will not be excluded either but will be identified and accounted for.\n\nAll patients included in the study will go through the following stages:\n\n1. Complete periodontal examination (probing depth (PD), clinical attachment level (CAL), plaque index (PI), blood on probing (BOP)).\n2. Patients will be divided in two groups:\n\n   * 30 healthy patients (control)\n   * 30 periodontal patients (test- periodontitis stage I-II (15 patients), periodontitis stage III- IV (15 patients).\n\nDue to lack of in vivo studies, simple sample size calculation was made using a conservative power analysis (G\\*Power 3.1.9.4 program, 2009). The simple size (27 subjects) was based on a two-tailed test with an effective size of 0.05, an alphabetical error probability of 0.05, difference of 50% in mean value, standard deviations to be maxium 80% of the mean values and a power of 0.90.\n\nTaking into account these parameters, a simple sample size between 21-30 patients per group is estimated.\n\nCrevicular fluid samples will also be obtained following the manufacturers protocol using perio papers (Periopaper, Applied Biosystems, Inc, Foster City, CA). Teeth to be examined will be isolated with cotton rolls and air dried. Paper strips will be introduced into the gingival sulcus for approximately 30 seconds. Test group patients' samples will be taken from periodontally pathogenic sites and healthy sites. Heavily contaminated samples with saliva or blood will be discarded.\n\nSamples will be stored at -80 C at the laboratory of Departamento de Ciencias Básicas de la Salud, Edificio Departamental I, Fundación Clínica Universitaria, URJC (Alcorcon). Once all samples are obtained, ELISA analysis of all samples will be performed by using a specific ELISA kit commercially available for human LL-37 (HyCult Biotechnology, Uden, the Netherlands) and commercially available kits for IL-4, IL-4, IL-6 and IL-10 ((Diaclone SAS; Besançon, France; 850.890, 950.035 and 850.880, respectively).\n\nPatients of the test group will receive a course of basic periodontal treatment (root scaling and planing) and oral hygiene instructions after the first sample collection.\n\nA re-evaluation appointment at 4-6 weeks will take place where new crevicular fluid samples of both groups will be obtained (test and control), to evaluate any statistically significant difference with respect to the quantity of LL-37 in relation to the baseline measurements recorded. After that, samples will be scrutinised again by performing ELISA assays following the protocol described above.\n\nOnce all results are obtained, statistical analysis of the samples will be carried out."},"conditionsModule":{"conditions":["Periodontal Diseases","Periodontitis"],"keywords":["Antimicrobial peptides","Defensines","LL-37","Periodontal disease","Crevicular fluid","IL-4","IL-6","IL-10"]},"designModule":{"studyType":"OBSERVATIONAL","patientRegistry":true,"targetDuration":"2 Months","designInfo":{"observationalModel":"COHORT","timePerspective":"PROSPECTIVE"},"bioSpec":{"retention":"SAMPLES_WITHOUT_DNA","description":"Crevicular fluid"},"enrollmentInfo":{"count":60,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Healthy (control group)","description":"This group will include a total of 30 patients free of periodontitis Samples of crevicular fluid to quantity levels of antimicrobial peptide LL-37 will be taken at baseline\n\nELISA analysis of all samples will be performed by using a specific ELISA kit commercially available for human LL-37 and also IL-4, IL-6 and IL-10","interventionNames":["Diagnostic Test: Crevicular fluid analysis by using ELISA testing."]},{"label":"Periodontitis (test group)","description":"30 Periodontal patients (subdivided in 2 groups of 15, depending of the severity of their disease):\n\n* 15 patients with Stage I-II periodontitis (mild/moderate)\n* 15 patients with Stage III-IV periodontitis (severe).\n\nTwo sets of samples of crevicular fluid will be obtained before and after receiving a course of routine basic periodontal treatment (root scaling and planing).\n\nA reevaluation visit to re-assess clinical periodontal parameters will take place at 4-6 weeks after treatment. New samples of crevicular fluid will then be taken at this stage to compare the level of LL-37 before and after the treatment.\n\nELISA analysis of all samples will be performed by using a specific ELISA kit commercially available for human LL-37 (HyCult Biotechnology, Uden, the Netherlands).","interventionNames":["Diagnostic Test: Crevicular fluid analysis by using ELISA testing."]}],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Crevicular fluid analysis by using ELISA testing.","description":"Samples of crevicular fluid (fluid existing in the space between the gums and the roots of the teeth) will be obtained from healthy and periodontal patients. In periodontal patients, samples will be taken before and after receiving a routine course of periodontal treatment (root scale and polish) to assess the levels of a peptide called LL-37 and inflammatory cytokines (IL-4, IL-6, IL-10): Samples will then be analysed using laboratory procedures (ELISA)","armGroupLabels":["Healthy (control group)","Periodontitis (test group)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"LL-37 in crevicular fluid in healthy/periodontal patients.","description":"Crevicular fluid samples will also be obtained following the manufacturers protocol using perio papers (Periopaper, Applied Biosystems, Inc, Foster City, CA). Samples will be stored at -80 C at the laboratory of Departamento de Epidemiología y Salud Pública, Edificio Departamental I, Fundación Clínica Universitaria, URJC (Alcorcon). Once all samples are obtained, appropriate transport will be arranged to the Department of Natural Sciences, Biomedical Sciences, Hendon Campus, Middlesex University of London. There ELISA analysis of all samples will be performed by using a specific ELISA kit commercially available for human LL-37 (HyCult Biotechnology, Uden, the Netherlands).","timeFrame":"At baseline for healthy (control) and periodontal (test) groups and at 4-6 weeks after treatment for test group"}],"secondaryOutcomes":[{"measure":"Periodontal parameters","description":"Probing depth (PD)","timeFrame":"At baseline for healthy (control) and periodontal (test) groups and at 4-6 weeks after treatment for test group"},{"measure":"Probing depth (PD)","description":"Assessment of the depth of the gingival sulcus by inserting a calibrated periodontal probe","timeFrame":"At baseline for healthy (control) and periodontal (test) groups and at 4-6 weeks after treatment for test group"},{"measure":"Clinical attachment level (CAL)","description":"Assessment of the soft tissue from the cemento enamel junction (CEJ) to the gingival margin","timeFrame":"At baseline for healthy (control) and periodontal (test) groups and at 4-6 weeks after treatment for test group"},{"measure":"Plaque index (PI)","description":"By using plaque diclosing tablets to assess levels of plaque/oral hygiene","timeFrame":"At baseline for healthy (control) and periodontal (test) groups and at 4-6 weeks after treatment for test group"},{"measure":"Blood on probing (BOP)","description":"Record of the presence of blood at the time of inserting the periodontal probe into the gingival sulcus","timeFrame":"At baseline for healthy (control) and periodontal (test) groups and at 4-6 weeks after treatment for test group"}]},"eligibilityModule":{"eligibilityCriteria":"The criteria for entry were as follows: aged 18 or over, with no previous history of periodontal treatment in the last six months, and no medical or dental history that could contraindicate periodontal treatment. Exclusion criteria included current pregnancy or lactation, immunological disorders, periodontal treatment within the last 6 months, oral contraception and antibiotic usage within the last 3 months, infections (such as HIV, hepatitis, and tuberculosis). In addition, third molar teeth were excluded from GCF sampling for being often impacted or extracted","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"],"studyPopulation":"This clinical study will take place at the University Clinic at the University Rey Juan Carlos, Alcorcon (Madrid), Spain. Patients that attend the clinic suffering from gum disease will be offered the possibility to participate in this study. A full questionnaire indicating the risks and benefits of participating in the study as well as the management of confidential personal data will be discussed with the participants in full detail. Full consent will be sought before commencing the study.\n\nPatients will be divided in two groups:\n\n* 30 Healthy patients (no signs of periodontitis)\n* 30 Periodontal patients (subdivided in 2 groups of 15, depending of the severity of their disease:\n\n  * 15 patients with Stage I-II periodontitis (mild/moderate)\n  * 15 patients with Stage III-IV periodontitis (severe).","samplingMethod":"NON_PROBABILITY_SAMPLE"},"contactsLocationsModule":{"locations":[{"facility":"Clinica Universitaria Universidad Rey Juan Carlos","city":"Alcorcón","state":"Madrid","zip":"28923","country":"Spain","geoPoint":{"lat":40.34582,"lon":-3.82487}}]},"referencesModule":{"references":[{"pmid":"23778112","type":"BACKGROUND","citation":"Davidopoulou S, Diza E, Sakellari D, Menexes G, Kalfas S. Salivary concentration of free LL-37 in edentulism, chronic periodontitis and healthy periodontium. Arch Oral Biol. 2013 Aug;58(8):930-4. doi: 10.1016/j.archoralbio.2013.01.003. Epub 2013 Feb 8."},{"pmid":"19485828","type":"BACKGROUND","citation":"Turkoglu O, Emingil G, Kutukculer N, Atilla G. Gingival crevicular fluid levels of cathelicidin LL-37 and interleukin-18 in patients with chronic periodontitis. J Periodontol. 2009 Jun;80(6):969-76. doi: 10.1902/jop.2009.080532."},{"pmid":"12387964","type":"BACKGROUND","citation":"Putsep K, Carlsson G, Boman HG, Andersson M. Deficiency of antibacterial peptides in patients with morbus Kostmann: an observation study. Lancet. 2002 Oct 12;360(9340):1144-9. doi: 10.1016/S0140-6736(02)11201-3."},{"pmid":"16926422","type":"BACKGROUND","citation":"de Haar SF, Hiemstra PS, van Steenbergen MT, Everts V, Beertsen W. Role of polymorphonuclear leukocyte-derived serine proteinases in defense against Actinobacillus actinomycetemcomitans. Infect Immun. 2006 Sep;74(9):5284-91. doi: 10.1128/IAI.02016-05."},{"pmid":"26662482","type":"BACKGROUND","citation":"Barros SP, Williams R, Offenbacher S, Morelli T. Gingival crevicular fluid as a source of biomarkers for periodontitis. Periodontol 2000. 2016 Feb;70(1):53-64. doi: 10.1111/prd.12107."},{"pmid":"24303954","type":"BACKGROUND","citation":"Kinney JS, Morelli T, Oh M, Braun TM, Ramseier CA, Sugai JV, Giannobile WV. Crevicular fluid biomarkers and periodontal disease progression. J Clin Periodontol. 2014 Feb;41(2):113-120. doi: 10.1111/jcpe.12194. Epub 2013 Dec 12."},{"pmid":"23952216","type":"BACKGROUND","citation":"McCrudden MT, Orr DF, Yu Y, Coulter WA, Manning G, Irwin CR, Lundy FT. LL-37 in periodontal health and disease and its susceptibility to degradation by proteinases present in gingival crevicular fluid. J Clin Periodontol. 2013 Oct;40(10):933-41. doi: 10.1111/jcpe.12141. Epub 2013 Aug 18."},{"pmid":"23931055","type":"BACKGROUND","citation":"Greer A, Zenobia C, Darveau RP. Defensins and LL-37: a review of function in the gingival epithelium. Periodontol 2000. 2013 Oct;63(1):67-79. doi: 10.1111/prd.12028."},{"pmid":"29551860","type":"BACKGROUND","citation":"Mallapragada S, Wadhwa A, Agrawal P. Antimicrobial peptides: The miraculous biological molecules. J Indian Soc Periodontol. 2017 Nov-Dec;21(6):434-438. doi: 10.4103/jisp.jisp_325_16."},{"pmid":"29206168","type":"BACKGROUND","citation":"Khurshid Z, Naseem M, Yahya I Asiri F, Mali M, Sannam Khan R, Sahibzada HA, Zafar MS, Faraz Moin S, Khan E. Significance and Diagnostic Role of Antimicrobial Cathelicidins (LL-37) Peptides in Oral Health. Biomolecules. 2017 Dec 5;7(4):80. doi: 10.3390/biom7040080."},{"pmid":"37246231","type":"DERIVED","citation":"Madruga D, Garcia MM, Martino L, Hassan H, Elayat G, Ghali L, Ceballos L. Positive correlational shift between crevicular antimicrobial peptide LL-37, pain and periodontal status following non-surgical periodontal therapy. A pilot study. BMC Oral Health. 2023 May 28;23(1):335. doi: 10.1186/s12903-023-03023-w."}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"At present there is no consideration to share this data"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"},"conditionBrowseModule":{"meshes":[{"id":"D010510","term":"Periodontal Diseases"},{"id":"D010518","term":"Periodontitis"}],"ancestors":[{"id":"D009059","term":"Mouth Diseases"},{"id":"D009057","term":"Stomatognathic Diseases"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT05495035","orgStudyIdInfo":{"id":"HQP1351ACE01"},"organization":{"fullName":"Institute of Hematology & Blood Diseases Hospital, China","class":"OTHER"},"briefTitle":"Study for Safety and Efficacy of Olverembatinib Combined With APG-2575 in Children With Relapsed/Refractory Ph + ALL","officialTitle":"Study for Safety and Efficacy Evaluation of Olverembatinib Combined With APG-2575 in Children With Relapsed/Refractory Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (R/R Ph + ALL）"},"statusModule":{"statusVerifiedDate":"2022-08","overallStatus":"UNKNOWN","lastKnownStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-09-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-08-31","type":"ESTIMATED"},"completionDateStruct":{"date":"2024-12-01","type":"ESTIMATED"},"studyFirstSubmitDate":"2022-08-08","studyFirstSubmitQcDate":"2022-08-08","studyFirstPostDateStruct":{"date":"2022-08-10","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-03-01","lastUpdatePostDateStruct":{"date":"2023-03-02","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Institute of Hematology & Blood Diseases Hospital, China","class":"OTHER"}},"oversightModule":{"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is an open-label, multicenter, phase 1b study, which is designed to explore the safety, efficacy and PK of olverembatinib, a third-generation tyrosine kinase inhibitor (TKI) marketed in China, in combination with APG-2575 in treating R/R Ph+ALL children, and to preliminarily establish the recommended dose of olverembatinib and APG-2575 for children based on the above results.","detailedDescription":"Eligible patients will receive a 6-week core treatment after screening, including a 2-week olverembatinib monotherapy and a 4-week combination therapy with olverembatinib, APG-2575 and dexamethasone, and based on the remission of leukemia after 2, 4, and 6 weeks of treatment, these patients will either continue olverembatinib alone/in combination with APG-2575 and dexamethasone as maintenance therapy or switch to other anti-tumor therapy.\n\nToxicities of this study will be graded according to NCI CTCAT (Version 5.0). The investigator will interrupt, reduce or discontinue the dose of the investigational drug according to the correlation and grade of toxicities. The study drug can be resumed when the drug related toxicities resolve to grade 1 or below."},"conditionsModule":{"conditions":["Lymphoblastic Leukemia, Acute, Childhood","Leukemia, Lymphoblastic, Acute, Philadelphia-Positive","Relapsed Leukemia","Refractory Leukemia"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":22,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Olverembatinib + APG-2575 combinational therapy","type":"EXPERIMENTAL","description":"* Period 1: Olverembatinib alone period (2 weeks):\n* Period 2: olverembatinib in combination with APG-2575 and dexamethasone (4 weeks):","interventionNames":["Drug: Olverembatinib, APG-2575, Dexamethasone"]}],"interventions":[{"type":"DRUG","name":"Olverembatinib, APG-2575, Dexamethasone","description":"* Period 1: Subjects will orally take olverembatinib 40mg adult equivalent dose alone QOD from Day 1 to Day 14 (D1 - D14) =. The investigator may start the combination therapy in advance based on medical conditions of the subjects, but not earlier than Day 5/the third dose (D5).\n* Period 2: 1) Subjects will orally take olverembatinib 40mg adult equivalent dose QOD from Day 15 to Day 42 (D15 - D42)).\n\n  2\\) Subjects will orally take APG-2575 at a ramp up 200mg/400mg/600mg adult equivalent dos QD from D13 to D42 at a dose . In addition, a 3-day dose escalation from D13 to D15 will be needed, and the designated reference dose will be reached on D15.\n\n  3\\) Subjects will orally take dexamethasone 6 mg/m2/day, QD from D15 to D42 at 6 mg/m2/day.","armGroupLabels":["Olverembatinib + APG-2575 combinational therapy"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Dose-limiting toxicity (DLT)","description":"DLT evaluation is defined as adverse events or laboratory abnormalities that occur within 6 weeks after investigational drug administration, are unrelated to external causes such as progressive disease, concomitant disease, and concomitant medications, including hematologic and non-hematologic adverse events (grade according to NCI CTCAE 5.0).","timeFrame":"42 days"},{"measure":"Objective Response Rate (ORR)","description":"ORR is defined by Complete Remission (CR)+ CR with incomplete marrow recovery (CRi) + Partial Remission (PR).Response will be evaluated every period till complete treatment and three months after last dose.","timeFrame":"132 days"},{"measure":"Maximum plasma concentration (Cmax)","description":"Maximum plasma concentration (Cmax) will be assessed on all participants of each dose group on the first day of olverembatinib monotherapy in period 1, and on the first and last days of olverembatinib in combination with APG-2575 in period 2 .","timeFrame":"42 days"},{"measure":"Area under the plasma concentration versus time curve (AUC)","description":"Area under the plasma concentration versus time curve (AUC) will be assessed on all participantsof each dose group on the first day of olverembatinib monotherapy in period 1, and on the first and last days of olverembatinib in combination with APG-2575 in period 2 .","timeFrame":"42 days"},{"measure":"R2PD of Olverembatinib and APG-2575","description":"To confirm the recommended doses of olverembatinib and APG-2575 in children with Ph+ ALL","timeFrame":"42 days"}],"secondaryOutcomes":[{"measure":"Minimal Residual Disease (MRD) negative rate","description":"To observe the proportion of subjects with MRD negative status in bone marrow.","timeFrame":"132 days"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Eligible patients must meet all of the following criteria:\n\n  1. Children under 18 years of age on the day of signing the informed consent form, and able to swallow the oral drugs during the study period.\n  2. Subjects who are diagnosed with Ph+ALL, and are resistant or intolerant to at least one TKI. If the subject has BCR-ABL1 T315I mutation, prior use of TKIs will not be considered.\n\n     Drug resistance includes disease recurrence and refractory disease. Relapse: Presence of blasts \\> 5% in peripheral blood or bone marrow or presence of extramedullary disease following CR. Refractory disease: Failure to have CR or incomplete remission (CRi) at the end of induction therapy. Intolerance refers to ≥ grade 3 non-hematological toxicity or ≥ grade 4 hematological toxicity in subjects which is at least possibly related to the last TKI treatment, lasts for \\> 2 weeks, and leads to TKI withdrawal.\n  3. Informed consent of parents or legal guardians should be obtained before any study activities.\n  4. For patients \\>16 years of age, Karnofsky performance status score ≥ 50; for patients ≤ 16 years of age, Lansky performance status score ≥ 50.\n  5. Life expectancy of ≥ 3 months.\n  6. For female patients of childbearing potential, urine β-HCG is negative.\n  7. The following laboratory values must be met (reference ranges based on age and gender of children):\n\n     1. Estimated glomerular filtration rate (eGFR) or radioisotope glomerular filtration rate (GFR) ≥70 mL/min/1.73 m2 based on Schwartz formula, or normal serum creatinine determined based on age and gender\n     2. Serum albumin ≥ 3.0 g/dL\n     3. Total bilirubin \\< 1.5 × upper limit of normal (ULN)\n     4. ALT and AST \\< 5 × ULN\n     5. Serum amylase and lipase ≤ 2 × ULN\n     6. Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN\n     7. Left ventricular ejection fraction of the heart is within the reference range\n  8. Participants must meet the following criteria related to prior or current treatment:\n\n     1. Patients on hydroxycarbamide for lowering cell counts: Discontinue hydroxycarbamide for at least 24 hours before initiating olverembatinib therapy\n     2. Patients who have recurrence during cytotoxic therapy: Olverembatinib must be given at least 14 days after the last dose of chemotherapy with the following exceptions: Intrathecal (IT) chemotherapy and/or maintenance therapy, e.g., vincristine, purinethol, methotrexate, or glucocorticoids. For relapsed patients on maintenance therapy, 24-hour washout period is required.\n     3. Hematopoietic stem cell transplantation (HSCT): Patients who relapse after HSCT are acceptable, provided that they do not have acute or chronic graft versus host disease (GVHD) or receive GVHD prophylaxis or treatment, and use the first dose of olverembatinib at least 90 days after transplantation.\n     4. Biological and targeted drug products: At least a 7-day washout period is required for biological products prior to the first dose of olverembatinib. If a known adverse event (AE) occurs following the discontinuation of biological products, the period must be prolonged to cover the onset time of the known AE. The specific washout period can be comprehensively determined by the investigator.\n     5. Monoclonal antibodies: There must be at least 3 half-lives from the use of monoclonal antibodies to the first dose of olverembatinib.\n     6. Immunotherapy: Prior to the first dose of olverembatinib, there should be at least a 30-day washout period after completing any type of immunotherapies (e.g., tumor vaccine and chimeric antigen receptor T cell \\[CAR-T-cell\\]).\n     7. Immunosuppressive therapy: Prior to the first dose of olverembatinib, there must be at least a 14-day washout period after completing immunosuppressive therapy (including the regimen after stem cell transplantation).\n     8. Radiotherapy: No washout period is needed for the radiotherapy of any extramedullary site excluding the central nervous system (CNS); if subjects have received whole-body irradiation or craniospinal radiation or cranial radiation, the washout period must be more than 90 days.\n     9. Anthracyclines: Prior to the first dose of olverembatinib, a cumulative dose of anthracyclines received by subjects must be less than 400 mg/m2 of adriamycin equivalent.\n     10. Subjects who do not use concomitant medications that may have potential drug-drug interactions with olverembatinib. Or else, at least 5-day washout period is required.\n     11. Subjects who never used olverembatinib.\n\nExclusion Criteria:\n\n* The subject who meets any of the following criteria cannot be enrolled in this study:\n\n  1. Any AEs (excluding alopecia and pigmentation) that are due to other anti-tumor therapies have not recovered to CTCAE v5.0 grade 0 - 1.\n  2. Gastrointestinal dysfunction or gastrointestinal diseases that may significantly alter absorption of study drug.\n  3. Uncontrollable or serious cardiovascular diseases.\n  4. Subjects with symptomatic CNS disorder (e.g., convulsion caused by CNS disorder).\n  5. Patients who have significant bleeding unrelated to Ph+ ALL.\n  6. Patients who are known to have hypersensitivity to any component of the study drug.\n  7. Patients with uncontrolled systemic infection, or there is laboratory or clinical evidence for infection with active human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or SARS-CoV-2.\n  8. Vaccination with attenuated live vaccines within 28 days prior to study treatment.\n  9. Patients who have any conditions that, in the opinion of the investigator, would jeopardize the patient safety or interfere with the evaluation of safety and efficacy of the study drug.","healthyVolunteers":false,"sex":"ALL","minimumAge":"1 Year","maximumAge":"18 Years","stdAges":["CHILD","ADULT"]},"contactsLocationsModule":{"centralContacts":[{"name":"Jingliao Zhang, MD","role":"CONTACT","phone":"+86 22 23909196","email":"zhangjingliao@ihcams.ac.cn"}],"overallOfficials":[{"name":"Xiaofan Zhu, MD","affiliation":"Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"The Second Affiliated Hospital of Anhui Medical University","status":"NOT_YET_RECRUITING","city":"Hefei","state":"Anhui","country":"China","contacts":[{"name":"Ningling Wang, MD","role":"CONTACT","phone":"+86 13721113063"}],"geoPoint":{"lat":31.86389,"lon":117.28083}},{"facility":"Qilu Hospital of Shandong University","status":"NOT_YET_RECRUITING","city":"Jinan","state":"Shandong","country":"China","contacts":[{"name":"Xiuli Ju, MD","role":"CONTACT","phone":"+86 18560086337"}],"geoPoint":{"lat":36.66833,"lon":116.99722}},{"facility":"Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences","status":"RECRUITING","city":"Tianjin","state":"Tianjin Municipality","zip":"300020","country":"China","contacts":[{"name":"Xiaofan Zhu, MD","role":"CONTACT","phone":"86-21-23909001","email":"xfzhu@ihcams.ac.cn"},{"name":"Jingliao Zhang, MD","role":"SUB_INVESTIGATOR"}],"geoPoint":{"lat":39.14222,"lon":117.17667}},{"facility":"Department of Hematology/Oncology, Shanghai Jiaotong University School of Medicine Affiliated Shanghai Children's Medical Center","status":"NOT_YET_RECRUITING","city":"Shanghai","country":"China","contacts":[{"name":"Shuhong Shen, MD","role":"CONTACT","phone":"+86 18930830638"}],"geoPoint":{"lat":31.22222,"lon":121.45806}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"},"conditionBrowseModule":{"meshes":[{"id":"D054198","term":"Precursor Cell Lymphoblastic Leukemia-Lymphoma"},{"id":"D007938","term":"Leukemia"}],"ancestors":[{"id":"D007945","term":"Leukemia, Lymphoid"},{"id":"D009370","term":"Neoplasms by Histologic Type"},{"id":"D009369","term":"Neoplasms"},{"id":"D006402","term":"Hematologic Diseases"},{"id":"D006425","term":"Hemic and Lymphatic Diseases"},{"id":"D008232","term":"Lymphoproliferative Disorders"},{"id":"D008206","term":"Lymphatic Diseases"},{"id":"D007160","term":"Immunoproliferative Disorders"},{"id":"D007154","term":"Immune System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"C579813","term":"olverembatinib"},{"id":"C000726452","term":"Lisaftoclax"},{"id":"D003907","term":"Dexamethasone"}],"ancestors":[{"id":"D011246","term":"Pregnadienetriols"},{"id":"D011245","term":"Pregnadienes"},{"id":"D011278","term":"Pregnanes"},{"id":"D013256","term":"Steroids"},{"id":"D000072473","term":"Fused-Ring Compounds"},{"id":"D011083","term":"Polycyclic Compounds"},{"id":"D013259","term":"Steroids, Fluorinated"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT07386535","orgStudyIdInfo":{"id":"202403128"},"secondaryIdInfos":[{"id":"R01HL168766","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01HL168766"}],"organization":{"fullName":"Washington University School of Medicine","class":"OTHER"},"briefTitle":"Innovative Tools to Expand Music-Inspired Strategies for Blood Pressure and Stroke Prevention","officialTitle":"Innovative Tools to Expand Music-Inspired Strategies for Blood Pressure and Stroke Prevention","acronym":"ITEST-BPStroke"},"statusModule":{"statusVerifiedDate":"2026-03","overallStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2026-02-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2027-10-26","type":"ESTIMATED"},"completionDateStruct":{"date":"2027-10-26","type":"ESTIMATED"},"studyFirstSubmitDate":"2026-01-27","studyFirstSubmitQcDate":"2026-01-27","studyFirstPostDateStruct":{"date":"2026-02-04","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-03-02","lastUpdatePostDateStruct":{"date":"2026-03-04","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Washington University School of Medicine","class":"OTHER"},"collaborators":[{"name":"National Heart, Lung, and Blood Institute (NHLBI)","class":"NIH"},{"name":"Nigerian Institute of Medical Research","class":"OTHER_GOV"},{"name":"University of North Carolina, Chapel Hill","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Expanding evidence-based interventions for hypertension and stroke prevention among youth and their caregivers is crucial for meeting World Health Organization and Nigerian health goals. Innovative strategies are urgently needed to address the burden of hypertension and stroke in Nigeria, aiming to involve local communities, bridge generational gaps, and reduce health disparities. This study aims to determine the effect of a music-inspired intervention and campaign (Music4Health) designed by the community on blood pressure, stroke preparedness and intentions, and uptake of the intervention among youth-caregiver dyads in Nigeria.","detailedDescription":"This study will be a stepped-wedge cluster randomized controlled trial conducted in 30 local government areas in Nigeria. The aim of the study will be to test if the music-inspired intervention reduces blood pressure in caregivers ≥40 years old, maintains blood pressure in youth 14-24 years old, and improves stroke preparedness among youth and caregivers. Sites will be randomly assigned to one of four waves, which will deliver the intervention to a longitudinal cohort of youth-caregiver dyads, spaced one month between each wave. The control period will last three months and include no intervention, and the intervention period will last three months for each wave and will include three music listening sessions (Music4Health Day) spaced one month apart. Participants will be recruited and enrolled in the trial through various methods, including community outreach, referrals, and social media. Participants will be invited to attend three community-based Music4Health Days on predetermined dates (schedule based on randomized intervention waves) and will be asked to return to the intervention site for follow-up data collection, including blood pressure measurements and validated questionnaires. The Music4Health Day intervention will include a listening session of a music video with lyrics designed to improve knowledge and awareness of high blood pressure and stroke preparedness. During Music4Health Day, music ambassadors will also share personal experiences to promote health messages and foster community engagement. Following the intervention period, the investigators will follow the cohort for six months after the intervention period to collect outcome data from each participant."},"conditionsModule":{"conditions":["High Blood Pressure","Stroke"],"keywords":["High blood pressure","Stroke","Hypertension","Young people","Adult caregivers","Prevention"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"NA","interventionModel":"SEQUENTIAL","interventionModelDescription":"Hybrid Type II stepped-wedge cluster randomized trial","primaryPurpose":"PREVENTION","maskingInfo":{"masking":"NONE","maskingDescription":"None (Open Label)"}},"enrollmentInfo":{"count":1412,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Music4Health Intervention","type":"EXPERIMENTAL","description":"Each of the 30 local government areas (LGAs) will be randomly allocated using block randomization to one of the four waves, with 7-8 LGAs allocated to each wave. All waves will begin with a control period with the first wave commencing the intervention period three months following the study start and each subsequent wave commencing one month following the start date of the previous wave's intervention period. Each wave's intervention period will last three months.","interventionNames":["Behavioral: Music4Health Intervention"]}],"interventions":[{"type":"BEHAVIORAL","name":"Music4Health Intervention","description":"The intervention period will include three Music4Health Day community events. Music4Health Day will adapt content from open call submissions and apprenticeships with community-based teams to meet the music preferences of youth and their caregivers. The events will focus on managing blood pressure, preventing strokes, and stroke preparedness through music-inspired strategies, utilizing rhythms and lyrics. Each Music4Health Day event will include a listening session of a music video with lyrics designed to improve knowledge and awareness of high blood pressure and stroke preparedness. Participants will be provided with MP3 files and YouTube video links containing music, videos, visuals, and health messages. Participants will listen to the intervention at the events and also at their convenience on their mobile phones, followed by weekly text reminders. During the events, music ambassadors will also share personal experiences to promote health messages and foster community engagement.","armGroupLabels":["Music4Health Intervention"],"otherNames":["Implementation Phase"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Proportion of youth participants with blood pressure <120/80 mmHg","description":"Systolic and diastolic blood pressure among youth participants will be measured three times at each time point using a digital sphygmomanometer by trained community health extension workers. The mean systolic and diastolic blood pressure from the three measures will be calculated for each time point. We will calculate the proportion of youth participants with a mean systolic and diastolic blood pressure \\<120/80 mmHg for each time point.","timeFrame":"Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14"},{"measure":"Mean change in systolic blood pressure among caregiver participants","description":"Systolic blood pressure among caregiver participants will be measured three times at each time point using a digital sphygmomanometer by trained community health extension workers. The mean systolic blood pressure from the three measures will be calculated for each time point. Change in systolic blood pressure will be calculated as the difference in systolic blood pressure from baseline (month 0) to each endpoint.","timeFrame":"Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14"},{"measure":"Percent accuracy on a stroke knowledge and preparedness assessment","description":"Stroke knowledge and preparedness will be assessed using a self-administered 13-item multiple-choice tool assessing knowledge of stroke symptoms, appropriate responses to stroke symptoms, and the ability to accurately identify a stroke in case examples. This knowledge assessment tool is a modified version of a tool used in the HipHop Stroke Study.","timeFrame":"Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14"},{"measure":"Uptake of music-inspired hypertension/stroke prevention campaign (Music4Health) among youth and caregiver participants","description":"Uptake of the campaign is defined as the absolute number, proportion, and representativeness of participants who participate in the campaign (i.e., attend listening sessions).","timeFrame":"Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14"}],"secondaryOutcomes":[{"measure":"Intervention Acceptability","description":"This will measure the ITEST BP/Stroke campaign. Measured using the Acceptability of Intervention Measure (AIM), Cronbach's alpha = 0.85. The four item measure participants' satisfaction, important implementation outcomes that are often considered a \"leading indicator\" of implementation success. The subscales are rated on a 5-point Likert scale, 1 to 5, with higher scores indicating higher acceptability. This will be measured using a self-administered questionnaire and in-depth interviews facilitated by trained research staff.","timeFrame":"Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14"},{"measure":"Intervention Fidelity","description":"This will measure the evidence that the core ITEST BP/Stroke campaign components were delivered as intended in relation to the study protocol, consistency of implementation across 30 study sites (LGAS). This will be assessed both quantitatively and qualitatively using the following four dimensions: (1) Frequency: number of intervention-related interactions; (2) Duration: length of each component of the intervention; (3) Content: the knowledge or behavioral change the music-inspired intervention seeks to deliver to the youth and caregiver dyads; and (4) Coverage: the number of youth/caregiver dyads who receive the music-inspired intervention as intended over the number of participants who are enrolled. This will be measured using a self-administered questionnaire and in-depth interviews facilitated by trained research staff.","timeFrame":"Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14"},{"measure":"Intervention Reach","description":"The proportion of eligible youth/caregiver dyads reached versus the total target population. Measured as 1) the participation rate among eligible participants; 2) the representativeness of participants based on demographic and health characteristics. The reasons given for declining to participate will also be assessed. This will be measured using a self-administered questionnaire and in-depth interviews facilitated by trained research staff.","timeFrame":"Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14"},{"measure":"Intervention Sustainment","description":"This will measure the maintenance of the BP/Stroke campaign using the Stages of Implementation Completion (SIC), an eight-stage assessment tool will be used to assess the sustainment of the intervention. This tool delineates the start of implementation. This will be measured using a self-administered questionnaire and in-depth interviews facilitated by trained research staff.","timeFrame":"Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nYouth Participants\n\n* Aged 14-24 years\n* Reside in one of the 30 selected LGAs\n* Able to provide informed consent\n* Willing to participate in the M4H campaign\n\nCaregiver Participants\n\n* Aged ≥40 years\n* Identified as a caregiver (biological/surrogate parent, grandparent, or close relative)\n* Reside in the same household or have a caregiving relationship with eligible youth\n* Able to provide informed consent\n\nGeneral Eligibility for Dyads\n\n* Must be a youth-caregiver dyad (one youth and one caregiver)\n* Both members must consent to participate and complete baseline assessments\n* Reside in or be affiliated with the selected study LGAs\n\nExclusion Criteria:\n\nYouth Participants\n\n* Below 14 or above 24 years\n* Inability to provide informed consent\n* Unwilling to participate in intervention activities\n\nCaregiver Participants\n\n* Below 40 years of age\n* Not serving in a caregiver role to eligible youth\n* Inability to provide informed consent\n\nGeneral Eligibility for Dyads\n\n* Either party of the dyad does not meet the inclusion criteria\n* Refusal to participate or complete baseline assessments","healthyVolunteers":true,"sex":"ALL","minimumAge":"14 Years","stdAges":["CHILD","ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"centralContacts":[{"name":"Juliet Iwelunmor, PhD","role":"CONTACT","phone":"2405280123","email":"ijuliet@wustl.edu"},{"name":"Oliver C Ezechi, MD","role":"CONTACT"}],"overallOfficials":[{"name":"Juliet Iwelunmor, PhD","affiliation":"Washington University School of Medicine","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Nigerian Institute of Medical Research","status":"RECRUITING","city":"Yaba","state":"Lagos","country":"Nigeria","contacts":[{"name":"Oliver C Ezechi, MD","role":"CONTACT","phone":"8033065683","email":"oezechi@yahoo.co.uk"},{"name":"Oliver C Ezechi, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":6.51395,"lon":3.37389}}]},"referencesModule":{"references":[{"pmid":"21062776","type":"BACKGROUND","citation":"Trappe HJ. The effects of music on the cardiovascular system and cardiovascular health. Heart. 2010 Dec;96(23):1868-71. doi: 10.1136/hrt.2010.209858."},{"pmid":"21091195","type":"BACKGROUND","citation":"Braveman P, Egerter S, Williams DR. The social determinants of health: coming of age. Annu Rev Public Health. 2011;32:381-98. doi: 10.1146/annurev-publhealth-031210-101218."},{"pmid":"31537347","type":"BACKGROUND","citation":"Bigna JJ, Noubiap JJ. The rising burden of non-communicable diseases in sub-Saharan Africa. Lancet Glob Health. 2019 Oct;7(10):e1295-e1296. doi: 10.1016/S2214-109X(19)30370-5. No abstract available."},{"pmid":"31086621","type":"BACKGROUND","citation":"Ajayi S, Adebiyi A, Kadiri S. Increased urinary sodium excretion is associated with systolic blood pressure in first degree relatives of hypertensive patients in Ibadan, Southwestern Nigeria. Pan Afr Med J. 2018 Nov 9;31:168. doi: 10.11604/pamj.2018.31.168.16611. eCollection 2018."},{"pmid":"34526674","type":"BACKGROUND","citation":"Akinyemi RO, Ovbiagele B, Adeniji OA, Sarfo FS, Abd-Allah F, Adoukonou T, Ogah OS, Naidoo P, Damasceno A, Walker RW, Ogunniyi A, Kalaria RN, Owolabi MO. Stroke in Africa: profile, progress, prospects and priorities. Nat Rev Neurol. 2021 Oct;17(10):634-656. doi: 10.1038/s41582-021-00542-4. Epub 2021 Sep 15."},{"pmid":"29618553","type":"BACKGROUND","citation":"Sarfo FS, Ovbiagele B, Gebregziabher M, Wahab K, Akinyemi R, Akpalu A, Akpa O, Obiako R, Owolabi L, Jenkins C, Owolabi M; SIREN. Stroke Among Young West Africans: Evidence From the SIREN (Stroke Investigative Research and Educational Network) Large Multisite Case-Control Study. Stroke. 2018 May;49(5):1116-1122. doi: 10.1161/STROKEAHA.118.020783. Epub 2018 Apr 4."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"},"conditionBrowseModule":{"meshes":[{"id":"D006973","term":"Hypertension"},{"id":"D020521","term":"Stroke"}],"ancestors":[{"id":"D014652","term":"Vascular Diseases"},{"id":"D002318","term":"Cardiovascular Diseases"},{"id":"D002561","term":"Cerebrovascular Disorders"},{"id":"D001927","term":"Brain Diseases"},{"id":"D002493","term":"Central Nervous System Diseases"},{"id":"D009422","term":"Nervous System Diseases"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT01081535","orgStudyIdInfo":{"id":"4-2009-0107"},"organization":{"fullName":"Yonsei University","class":"OTHER"},"briefTitle":"The Effect of Intravenous (IV) Patient Controlled Analgesic (PCA) With Ketorolac or Fentanyl Combined With Caudal Block for Postoperative Analgesia in Small Children Undergoing Intravesical Ureteroneocystostomy","officialTitle":"The Effect of IV PCA With Ketorolac or Fentanyl Combined With Caudal Block for Postoperative Analgesia in Small Children Undergoing Intravesical Ureteroneocystostomy"},"statusModule":{"statusVerifiedDate":"2010-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-05"},"primaryCompletionDateStruct":{"date":"2010-02","type":"ACTUAL"},"completionDateStruct":{"date":"2010-02","type":"ACTUAL"},"studyFirstSubmitDate":"2010-03-04","studyFirstSubmitQcDate":"2010-03-04","studyFirstPostDateStruct":{"date":"2010-03-05","type":"ESTIMATED"},"lastUpdateSubmitDate":"2010-03-04","lastUpdatePostDateStruct":{"date":"2010-03-05","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Kil Hae Keum/professor","oldOrganization":"Yonsei University, College of Medicine"},"leadSponsor":{"name":"Yonsei University","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The effect of IV PCA with ketorolac or fentanyl combined with caudal block for postoperative analgesia in small children undergoing intravesical ureteroneocystostomy."},"conditionsModule":{"conditions":["Ureteroneocystostomy"],"keywords":["Pediatric patients (6 months-5 years) scheduled elective ureteroneocystostomy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"SUPPORTIVE_CARE","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":50,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"ketorolac","type":"EXPERIMENTAL","interventionNames":["Drug: ketorolac, fentanyl"]},{"label":"fentanyl","type":"EXPERIMENTAL","interventionNames":["Drug: ketorolac, fentanyl"]}],"interventions":[{"type":"DRUG","name":"ketorolac, fentanyl","description":"intravenous PCA","armGroupLabels":["fentanyl","ketorolac"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Children's Hospital of Eastern Ontario Pain Scale, CHEOPS and Faces, Legs, Activity, Cry, and Consolability, FLACC","timeFrame":"postoperative 24 hours, 48hours"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Pediatric patients scheduled for elective ureteroneocystostomy were enrolled.\n\nExclusion Criteria:\n\n* History of allergy to aspirin or NSAIDs\n* Peptic ulcer disease, and renal function impairment.\n* And local infection foci on back, spinal anomalies\n* Infectious diseases\n* Neurologic disorders\n* Seizures and coagulopathies were excluded for sacral epidural block.","healthyVolunteers":false,"sex":"ALL","minimumAge":"6 Months","maximumAge":"5 Years","stdAges":["CHILD"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Hae Keum Kil","affiliation":"Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea","role":"PRINCIPAL_INVESTIGATOR"}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"},"interventionBrowseModule":{"meshes":[{"id":"D020910","term":"Ketorolac"},{"id":"D005283","term":"Fentanyl"}],"ancestors":[{"id":"D007213","term":"Indomethacin"},{"id":"D007211","term":"Indoles"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D010880","term":"Piperidines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT05898035","orgStudyIdInfo":{"id":"KingAbdullahUH"},"organization":{"fullName":"King Abdullah University Hospital","class":"OTHER"},"briefTitle":"Postoperative Symptoms Following Endodontic Microsurgery","officialTitle":"Postoperative Symptoms Following Endodontic Microsurgery Performed by Piezoelectric Osteotomy Versus Conventional Osteotomy: A Randomized Clinical Trial"},"statusModule":{"statusVerifiedDate":"2025-04","overallStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-02-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-12-12","type":"ACTUAL"},"completionDateStruct":{"date":"2025-09","type":"ESTIMATED"},"studyFirstSubmitDate":"2023-03-02","studyFirstSubmitQcDate":"2023-06-07","studyFirstPostDateStruct":{"date":"2023-06-12","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-04-04","lastUpdatePostDateStruct":{"date":"2025-04-08","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Lama Awawdeh","investigatorTitle":"Professor","investigatorAffiliation":"King Abdullah University Hospital"},"leadSponsor":{"name":"King Abdullah University Hospital","class":"OTHER"},"collaborators":[{"name":"Jordan University of Science and Technology","class":"OTHER"}]},"oversightModule":{"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Aims: The purpose of this randomized clinical trial is to assess and compare the post operative pain, swelling and quality of life after endodontic microsurgery using either conventional osteotomy or piezoelectric osteotomy . The PICO question that will be used is Does endodontic microsurgery using piezoelectric osteotomy have similar clinical performance in terms of post operative pain and swelling to that of endodontic microsurgery using conventional hand-piece osteotomy.\n\nMaterial and methods:\n\nbased on solid inclusion criteria , a total of 44 patients in need of endodontic microsurgery will be randomly distributed into two groups (n=22) according to the osteotomy technique: conventional and piezoelectric osteotomy. A standardized microsurgical technique will be employed. After the microsurgery procedure, a pain questionnaire that contain visual analogue scale will be given to each patient to evaluate the pain incidence and intensity at 5 time intervals, 24 hours, 48 hours, 72 hours, 96 hours and 120 hours. The patients will be recalled as well, at days 2 and 7 to evaluate the swelling. Statistical analysis will be performed using chi-square test and linear regression analysis.","detailedDescription":"This randomized prospective clinical study will be conducted at the postgraduate clinics, Department of Conservative Dentistry, at Jordan University of Science and Technology.\n\nEthical approval will be sought from the JUST Institutional ethics and human Research Board (IRB) committee.\n\nSample size and randomization A total of 44 adult patients will be recruited for this clinical trial. Participants will be randomly allocated to one of the two treatment modalities. Randomization will be carried out by sealed envelope online software.\n\nFor the observational part of the study, no randomization or blinding will be applied. Patients will be treated free of charge and their travel expenses will be compensated for all follow up visits.\n\nPreoperative management :\n\nClinical and radiographic assessment :\n\n\\- The patient demographic information, chief complaint and history of the chief complaint, medical and dental history will be registered. A thorough extra-oral and intra-oral examination will be undertaken (an existing swelling , sinus tracts, quality of coronal restoration margins and its history, occlusal relations, gingival biotype , any gingival recession and periodontal assessment ) will be registered .\n\nPercussion and palpating tests will be applied. Pre-operative parallel Digital view will be obtained using film holder showing the entire lesion and at least 2 mm beyond it. Limited view cone beam computed tomography scan of the diseased tooth will be obtained for each patient preoperatively (SFV).\n\nRoot length and axis, Lesion size and features, bone crest level and any radiographic abnormality will be interpreted and registered.\n\nAll patients will receive periodontal scaling a week or two before the surgery. Surgical procedure Prior to surgery , patients will be asked to rinse their mouth with chlorhexidine 0.12% . After which, local anesthesia containing epinephrine will be given. The surgical flap design and procedure will be selected as per case deem , and the flap will be elevated gently and retracted.\n\nThe Root apex will be located and osteotomy will be applied. The resected root will be rinsed , dried and and stained with 1% methylene blue dye after which , it will be inspected carefully under high magnification, to identify possible reasons for the non surgical root canal treatment failure. Subsequently, ultrasonic apical preparation will be performed. After achieving adequate haemostasis with Epinephrine pellets (Gingi-Pak , California state , USA),Biodentine retrograde filling material will be placed. The flap will be re-approximated and interrupted suture using non-absorbable monofilament size 5-0 suture will be applied. Finally, Post-operative parallel Digital view will be obtained using film holder showing the entire lesion and at least 2 mm beyond it.\n\nPost-operative management :\n\nImmediately after the microsurgery the patients will be asked to apply cold ice packs on the surgical site for 20 mins at the clinic, during this time the post-operative instructions will be given ."},"conditionsModule":{"conditions":["Pain Postoperative","Swelling Lips & Face"],"keywords":["Microsurgery, Pain, swelling, Piezo surgery"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"This a randomized prospective clinical study","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","whoMasked":["PARTICIPANT"]}},"enrollmentInfo":{"count":40,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Piezo endodontic surgery","type":"EXPERIMENTAL","description":"The osteotomy will be applied under magnification with a surgical operating microscope (at the apical third of the root .Osteotomy will be done with the Piezosurgery touch","interventionNames":["Procedure: Endodontic Microsurgery"]},{"label":"Conventional endodontic surgery","type":"ACTIVE_COMPARATOR","description":"The osteotomy will be applied under magnification with a surgical operating microscope at the apical third of the root .Osteotomy will be done with air motor high speed hand-piece and round bur with copious irrigation","interventionNames":["Procedure: Endodontic Microsurgery"]}],"interventions":[{"type":"PROCEDURE","name":"Endodontic Microsurgery","description":"Osteotomy will be done either with air motor high speed hand-piece and round bur with copious irrigation or with Piezosurgery touch. After the soft tissue curettage and uncovering the root apex , the last 3 mm of the root apex will be resected perpendicular to the long axis of the tooth at ( 0 - 10) degree bevel , using either conventional dental hand-piece or piezotome (Piezotome Cube by ACTEON ).The resected root will be rinsed , dried and and stained with 1% methylene blue dye after which , it will be inspected carefully under high magnification, to identify possible reasons for the non surgical root canal treatment failure. Subsequently, ultrasonic apical preparation will be performed. After achieving adequate haemostasis with Epinephrine pellets. Biodentine®retrograde filling material will be placed. The flap will be re-approximated and interrupted suture using non-absorbable monofilament size 5-0 suture will be applied. Finally, Post-operative parallel Digital view.","armGroupLabels":["Conventional endodontic surgery","Piezo endodontic surgery"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"changes in pain severity","description":"visual analogue scale that is calibrated between (no discomfort ) and end with (very server pain ),","timeFrame":"to measure changes in the pain severity at 3 hours, 24 hours , 48 hours , 72 hours and 120 hours."},{"measure":"Swelling size changes","description":"Changes in amount of swelling will be measured by measuring distance between fixed points in patient face.","timeFrame":"At the second and seventh days after the microsurgery, patients will be re-called for the determination of edema and swelling"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Non-smokers .\n* Teeth that are periodontally healthy.\n* Age (18-65)\n\nExclusion Criteria:\n\n* Patients with an active systematic diseases that may affect the outcome\n* Medically compromised patients on long term medications.\n* Patients who had received analgesics or antibiotics prior to surgery will be postponed.\n* Cases where orthograde endodontic treatment is feasible\n* Teeth with poor prognosis.\n* Teeth with an active periodontal disease (pocket depth \\> 5 mm).\n* Emotionally distressed patients.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"centralContacts":[{"name":"Lama A Awawdeh, PhD","role":"CONTACT","phone":"+962795412954","email":"lawawdeh@hotmail.com"}],"overallOfficials":[{"name":"Lama A Awawdeh, PhD","affiliation":"Jordan University of Science and Technolgoy","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Jordan University of Science and Technology","status":"RECRUITING","city":"Irbid","zip":"POBOX 3030","country":"Jordan","contacts":[{"name":"Lama A Awawdeh","role":"CONTACT","phone":"0795412954","email":"lawawdeh@hotmail.com"}],"geoPoint":{"lat":32.55556,"lon":35.85}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"},"conditionBrowseModule":{"meshes":[{"id":"D010149","term":"Pain, Postoperative"},{"id":"D019066","term":"Facies"},{"id":"D010146","term":"Pain"}],"ancestors":[{"id":"D011183","term":"Postoperative Complications"},{"id":"D010335","term":"Pathologic Processes"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"},{"id":"D009461","term":"Neurologic Manifestations"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D020969","term":"Disease Attributes"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT04534335","orgStudyIdInfo":{"id":"STUDY00001376"},"organization":{"fullName":"Children's Mercy Hospital Kansas City","class":"OTHER"},"briefTitle":"SNOO Smart Sleeper for Infants With CHD","officialTitle":"The SSSH's: SNOO Smart Sleeper Use in Post-Operative Infants With Congenital Heart","acronym":"SHHH's"},"statusModule":{"statusVerifiedDate":"2022-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-02-04","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-05-28","type":"ACTUAL"},"completionDateStruct":{"date":"2022-09-12","type":"ACTUAL"},"studyFirstSubmitDate":"2020-08-27","studyFirstSubmitQcDate":"2020-08-27","studyFirstPostDateStruct":{"date":"2020-09-01","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-10-04","lastUpdatePostDateStruct":{"date":"2022-10-06","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Lori Erickson","investigatorTitle":"Director, Remote Health Solutions, PhD","investigatorAffiliation":"Children's Mercy Hospital Kansas City"},"leadSponsor":{"name":"Children's Mercy Hospital Kansas City","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":true,"isUsExport":false},"descriptionModule":{"briefSummary":"Study Title The SSSH Study: SNOO Smart Sleeper Use in Post-Operative Infants with Congenital Heart Disease is a single site, cross-sectional, feasibility study of an infant smart sleeper. The Primary Objective is to evaluate the feasibility of collecting and integrating clinical data and SNOO data. The secondary Objective(s) is To assess the feasibility of conducting a future broader trial by evaluating the parents willingness to give parental permission for participation in the use of the SNOO. Research Intervention(s)/ Investigational Agent(s) SNOO Smart Sleeper from Happiest Baby, Inc.There are approximately 300 new infants per year who undergo cardiac surgery at Children's Mercy Kansas City (CMKC) who are 6 months of age and 11kg or less at the time of surgery Sample Size. A maximum of 15 patients will be enrolled for this feasibility study over the study Duration for Individual Participant Length of hospitalization on 4Sutherland, average length of stay for this patient population is 30 days.","detailedDescription":"Infants with congenital heart disease (CHD) are a low frequency but high acuity and stress population in the pediatric hospital setting. There are approximately 300 patients admitted a year that require cardiac surgery and are under the age of 6 months at Children's Mercy. These patients may spend less time in the hospital, but the care they require is often complex resulting in potential hemodynamic changes and pain responses for the infants. Smart technologies are used in CHD populations like single ventricle interstage monitoring at home, CHAMP App, but there are opportunities for baby-parent-nurse in-hospital smart solutions such as the SNOO Smart Sleeper bassinet by Happiest Baby INC . The SNOO Smart Sleeper has been used in more than 20 other hospitals across the country, including The University of Kansas Health System, mainly for infants related to preterm or neonatal abstinence syndrome (NAS). The SNOO utilizes some of the components of the 5 S's (swaddling, side/stomach position, shushing, swinging, and sucking) to aid as physical interventions for infant pain. This has been shown to be effective for pain reduction and less crying time after painful procedures . The calming response for infants has been seen to improve with soothing of the infant through supine mechanical movement, swaddling, and sound . A prospective observational cohort of preterm (32-36 weeks GA) neonates found that intermittent hypoxia and bradycardia significantly declined after use of womb-like soothing sound. The auditory neural pathways have close anatomical connection to the autonomic nervous system and the potential for auditory to parasympathetic response and reduced cardiac and respiratory rates are intriguing for evaluation in the infant population after cardiac surgery. The SNOO has yet to be used in the post-operative pediatric CHD population in the inpatient setting. The success in other fragile infant populations lends to a possible new area for use in the high risk CHD population in the post-operative recovery phase related to pain and hemodynamic changes."},"conditionsModule":{"conditions":["Congenital Heart Disease","Infant Development","Technology"],"keywords":["Congenital Heart disease","Infant Sleep"]},"designModule":{"studyType":"OBSERVATIONAL","patientRegistry":false,"designInfo":{"observationalModel":"COHORT","timePerspective":"CROSS_SECTIONAL"},"enrollmentInfo":{"count":11,"type":"ACTUAL"}},"armsInterventionsModule":{"interventions":[{"type":"DEVICE","name":"SNOO Smart Sleep from Happiest Baby, Inc","description":"Data related to the use of the SNOO itself (collected electronically) such as the amount of movement provided by the SNOO, etc., will be examined with the hemodynamic data obtained during the use of the SNOO. Clinical care data as it relates to the child will also be evaluated as it pertains to the use of the SNOO (this information will focus on the amount and frequency of narcotics administered to the infant). feasibility of use is the device intervention."}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Length of time of utilization of SNOO for each infant","description":"Feasibility of new device for use in the pediatric cardiac surgery infant population","timeFrame":"6 months"}],"secondaryOutcomes":[{"measure":"Number of parents receptive to use of the SNOO","description":"Total number of parents consenting for feasibility trial","timeFrame":"6 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* infants who have recently undergone cardiac surgery or cardiac catheterization for a stent for pulmonary blood flow at Children's Mercy Kansas City\n* less than or equal to 6 months of age and under 11kg .\n\nExclusion Criteria:\n\n* Greater than 6 months of age or over 11kg","healthyVolunteers":false,"sex":"ALL","maximumAge":"6 Months","stdAges":["CHILD"],"studyPopulation":"Only the families of patients that have already undergone a procedure for congenital heart disease will be approached for participation in this study. All female and male infants will qualify.","samplingMethod":"NON_PROBABILITY_SAMPLE"},"contactsLocationsModule":{"overallOfficials":[{"name":"Shannon Lysaught, BSN, MBA","affiliation":"Children's Mercy","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Children's Mercy Kansas City","city":"Kansas City","state":"Missouri","zip":"64108","country":"United States","geoPoint":{"lat":39.09973,"lon":-94.57857}}]},"referencesModule":{"references":[{"pmid":"22508924","type":"BACKGROUND","citation":"Harrington JW, Logan S, Harwell C, Gardner J, Swingle J, McGuire E, Santos R. Effective analgesia using physical interventions for infant immunizations. Pediatrics. 2012 May;129(5):815-22. doi: 10.1542/peds.2011-1607. Epub 2012 Apr 16."},{"pmid":"31017930","type":"BACKGROUND","citation":"Moller EL, de Vente W, Rodenburg R. Infant crying and the calming response: Parental versus mechanical soothing using swaddling, sound, and movement. PLoS One. 2019 Apr 24;14(4):e0214548. doi: 10.1371/journal.pone.0214548. eCollection 2019."},{"pmid":"28587528","type":"BACKGROUND","citation":"Parga JJ, Bhatt RR, Kesavan K, Sim MS, Karp HN, Harper RM, Zeltzer L. A prospective observational cohort study of exposure to womb-like sounds to stabilize breathing and cardiovascular patterns in preterm neonates. J Matern Fetal Neonatal Med. 2018 Sep;31(17):2245-2251. doi: 10.1080/14767058.2017.1339269. Epub 2017 Jun 22."}],"seeAlsoLinks":[{"label":"Happiest Baby, Inc 2020","url":"http://www.happiestbaby.com"}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"},"conditionBrowseModule":{"meshes":[{"id":"D006330","term":"Heart Defects, Congenital"}],"ancestors":[{"id":"D018376","term":"Cardiovascular Abnormalities"},{"id":"D002318","term":"Cardiovascular Diseases"},{"id":"D006331","term":"Heart Diseases"},{"id":"D000013","term":"Congenital Abnormalities"},{"id":"D009358","term":"Congenital, Hereditary, and Neonatal Diseases and Abnormalities"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT06750835","orgStudyIdInfo":{"id":"SPSIP block in breast cancer"},"organization":{"fullName":"Assiut University","class":"OTHER"},"briefTitle":"Efficacy of the Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Breast Cancer Surger.(SPSIP) Block is a Novel Regional Anesthesia Technique Targeting the Dorsal Rami and Intercostal Nerves (T2-T6), Providing Sensory Blockade to Both the Posterior and Lateral Aspect","officialTitle":"Efficacy of the Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Breast Cancer Surgery : A Randomized Comparative Study"},"statusModule":{"statusVerifiedDate":"2024-12","overallStatus":"NOT_YET_RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2025-01","type":"ESTIMATED"},"primaryCompletionDateStruct":{"date":"2026-10","type":"ESTIMATED"},"completionDateStruct":{"date":"2027-10","type":"ESTIMATED"},"studyFirstSubmitDate":"2024-12-20","studyFirstSubmitQcDate":"2024-12-20","studyFirstPostDateStruct":{"date":"2024-12-27","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-12-20","lastUpdatePostDateStruct":{"date":"2024-12-27","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR_INVESTIGATOR","investigatorFullName":"Rehab Adel Ebrahim Okely","investigatorTitle":"Assistant lecturer","investigatorAffiliation":"Assiut University"},"leadSponsor":{"name":"Rehab Adel Ebrahim Okely","class":"OTHER"}},"oversightModule":{"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The Serratus Posterior Superior Intercostal Plane (SPSIP) block is a novel regional anesthesia technique targeting the dorsal rami and intercostal nerves (T2-T6), providing sensory blockade to both the posterior and lateral aspects of the chest wall. By blocking these nerves at a more posterior location, the SPSIP block can potentially offer broader and more comprehensive analgesia for breast surgeries, including the axillary and deeper structures of the breast. This makes it a promising alternative or adjunct to the existing regional techniques used in breast cancer surgeries","detailedDescription":"Breast cancer is the most common malignancy among women worldwide, often requiring surgical intervention such as mastectomy or breast-conserving surgery. Despite advancements in surgical techniques, postoperative pain remains a significant concern, as inadequate pain management can lead to delayed recovery, increased opioid consumption, and a higher incidence of chronic pain conditions such as postmastectomy pain syndrome (PMPS). Effective pain control strategies are, therefore, crucial to enhancing patient recovery, reducing hospital stay, and improving overall quality of life \\[1\\].\n\nRegional anesthesia techniques have gained prominence as an effective method for perioperative pain management in breast surgery \\[2\\]. Traditional blocks such as the Thoracic Paravertebral Block (TPVB) and Serratus Anterior Plane (SAP) Block have been extensively studied and are considered effective options for postoperative analgesia. However, these techniques are not without limitations \\[3\\]. The TPVB, although effective, carries a higher risk of complications such as pneumothorax and hypotension due to its proximity to the pleura. The SAP block, on the other hand, primarily provides analgesia to the lateral thoracic wall and may not adequately cover deeper breast tissues and posterior thoracic areas The current study aims to evaluate the efficacy of the SPSIP block for postoperative analgesia in breast cancer surgeries and to compare its analgesic profile with the SAP block and TPVB. By providing a comprehensive comparison, this study seeks to establish the SPSIP block as a viable and potentially superior option for postoperative pain management in breast cancer surgery.\n\n\\> Patients and methods\n\n• Type of the Study: This is a prospective, randomized controlled cohort study comparing the efficacy of the Serratus Posterior Superior Intercostal Plane (SPSIP) Block, Serratus Anterior Plane (SAP) Block, and Thoracic Paravertebral Block (PVB) for postoperative analgesia in breast cancer surgery.\n\n• Study Setting: The study will be conducted at Assiut University Hospital, a tertiary care center equipped with advanced facilities for breast cancer surgeries and postoperative pain management."},"conditionsModule":{"conditions":["Breast Cancer"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","whoMasked":["OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":90,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"SPSIP block","type":"ACTIVE_COMPARATOR","description":"Serratus posterior superior intercostal plane block","interventionNames":["Procedure: SPSIP block"]},{"label":"SAP block","type":"ACTIVE_COMPARATOR","description":"Serratus anterior plane block","interventionNames":["Procedure: SAP block"]},{"label":"Paravertebral block","type":"ACTIVE_COMPARATOR","description":"Paravertebral block","interventionNames":["Procedure: Paravertebral block"]}],"interventions":[{"type":"PROCEDURE","name":"SPSIP block","description":"Serratus posterior superior intercostal plane block","armGroupLabels":["SPSIP block"]},{"type":"PROCEDURE","name":"SAP block","description":"Serratus anterior plane block","armGroupLabels":["SAP block"]},{"type":"PROCEDURE","name":"Paravertebral block","description":"* The block will be administered under ultrasound guidance at the T2-T5 levels.\n* A total of 15 mL of 0.25% bupivacaine will be injected into the paravertebral space on the side of the surgery.","armGroupLabels":["Paravertebral block"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Post operative pain relief","description":"the level of postoperative pain as assessed by the Numerical Rating Scale (NRS) at rest and during movement at predefined intervals: 1 hour, 6 hours, 12 hours, and 24 hours post-surgery. The NRS is a validated tool that ranges from 0 (no pain) to 10 (worst imaginable pain).","timeFrame":"24 hours"}],"secondaryOutcomes":[{"measure":"Total Opioid Consumption","timeFrame":"24 hours"},{"measure":"Time to First Analgesic Request","timeFrame":"24 hours"},{"measure":"Incidence of Postoperative Nausea and Vomiting (PONV)","timeFrame":"24 hours"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1\\. Female patients aged 18-75 years. 2. Scheduled for elective breast cancer surgery (MRM or BCS). 3. ASA physical status I-II. 4. Able to provide written informed consent.\n\n\\-\n\nExclusion Criteria:\n\n1\\. Chronic pain conditions or long-term opioid use. 2. Coagulation disorders (platelets \\< 100,000/mm³ or INR \\> 1.5). 3. Severe obesity (BMI \\> 35 kg/m²). 4. Allergy to local anesthetics. 5. Anatomical abnormalities affecting block placement. 6. Pregnant or lactating women. 7. Active infection or skin lesions at the injection site.\n\n\\-","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"centralContacts":[{"name":"Rehab Adel Ebrahim","role":"CONTACT","phone":"01099070718","email":"Adelrehab273@gmail.com"}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"},"conditionBrowseModule":{"meshes":[{"id":"D001943","term":"Breast Neoplasms"}],"ancestors":[{"id":"D009371","term":"Neoplasms by Site"},{"id":"D009369","term":"Neoplasms"},{"id":"D001941","term":"Breast Diseases"},{"id":"D012871","term":"Skin Diseases"},{"id":"D017437","term":"Skin and Connective Tissue Diseases"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT07369635","orgStudyIdInfo":{"id":"65/CN-HĐĐĐ"},"organization":{"fullName":"Hanoi Medical University","class":"OTHER"},"briefTitle":"A Phase III Clinical Trial Evaluating the Efficacy and Safety of TriThien Duoc Capsules in Grade II Internal Haemorrhoids Patients With Bleeding Compared to Diosmin.","officialTitle":"A Phase III, Multicenter, Randomized, Open-label, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Trĩ Thiên Dược Capsules in Grade II Internal Haemorrhoids Patients With Bleeding Compared to Diosmin."},"statusModule":{"statusVerifiedDate":"2025-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-07-10","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-09-29","type":"ACTUAL"},"completionDateStruct":{"date":"2020-11-30","type":"ACTUAL"},"studyFirstSubmitDate":"2026-01-18","studyFirstSubmitQcDate":"2026-01-18","studyFirstPostDateStruct":{"date":"2026-01-27","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-01-18","lastUpdatePostDateStruct":{"date":"2026-01-27","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Hanoi Medical University","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"A Phase III, randomized, double-blind, placebo-controlled clinical trial has been conducted to evaluate the efficacy and safety of Trĩ Thiên Dược capsules in people with grade II internal hemorrhoids with bleeding. This study aims to further assess the therapeutic effects and potential adverse effects of Trĩ Thiên Dược, a herbal formulation containing Portulaca Oleracea L. (purslane) and Amaranthus Spinosus L. (spiny amaranth), in comparison to Diosmin (Daflon).Participants will undergo a 5-week study period and will be randomly assigned (1:1 ratio) into one of two groups:Research Group: Participants receiving Trĩ Thiên Dược tablets.Control Group: Participants receiving Daflon (Diosmin).The treatment regimen will last for 28 days, followed by an additional follow-up period extending to day 35 after the initial treatment.","detailedDescription":"Study Design:\n\nThis study is a randomized, open-label, placebo-controlled trial evaluating the efficacy of Diosmin (Daflon) in people with grade II internal hemorrhoids with bleeding. Participants are randomly assigned in a 1:1 ratio to receive either Tri Thien Duoc pills or Diosmin (Daflon).\n\nParticipants:\n\nA total of 172 participants with grade II internal hemorrhoids with bleeding were enrolled in the study and allocated as follows:\n\nIntervention Group: 86 participants received Tri Thien Duoc pills at a dosage of 8 capsules per day for 28 days, with follow-up conducted for 35 days from the initiation of treatment.\n\nControl Group: 86 participants received Diosmin (Daflon) at a dosage of 4 pills per day for 28 days, with follow-up conducted for 35 days from the initiation of treatment.\n\nStudy Procedures:\n\nAll participants in this Phase III study adhered to the dietary and lifestyle recommendations outlined by the American Gastroenterological Association for hemorrhoid management, including:\n\nMaintaining a high-fiber diet rich in vegetables and soft foods. Ensuring adequate hydration (1.5-2 litres of water per day). Engaging in regular physical activity. Avoiding prolonged sitting.\n\nAssessments and Monitoring:\n\nParticipants underwent clinical evaluations and monitoring throughout the study. Key clinical parameters were assessed at four-time points:\n\nBaseline (Day 0, D0) Mid-treatment (Day 14, D14) End of treatment (Day 28, D28) Post-treatment follow-up (Day 35, D35) Laboratory tests, including liver and kidney function assessments, complete blood count, urinalysis, and colonoscopy, were conducted at baseline (D0) and treatment's end (D28)."},"conditionsModule":{"conditions":["Grade II Internal Hemorrhoids With Bleeding"],"keywords":["Tri Thien Duoc","internal hemorrhoids","Portulaca Oleracea L.","Amaranthus Spinosus L."]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"A total of 172 participants with grade II internal hemorrhoids with bleeding were enrolled in the study and allocated as follows:\n\nIntervention Group: 86 participants received Tri Thien Duoc pills at a dosage of 8 capsules per day for 28 days, with follow-up conducted for 35 days from the initiation of treatment.\n\nControl Group: 86 participants received Diosmin (Daflon) at a dosage of 4 pills per day for 28 days, with follow-up conducted for 35 days from the initiation of treatment.\n\nAll participants in this Phase III study adhered to the dietary and lifestyle recommendations outlined by the American Gastroenterological Association for hemorrhoid management, including:\n\nMaintaining a high-fiber diet rich in vegetables and soft foods. Ensuring adequate hydration (1.5-2 litres of water per day). Engaging in regular physical activity. Avoiding prolonged sitting.","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":172,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Tri Thien Duoc capsules","type":"EXPERIMENTAL","description":"Intervention Group: 86 participants with stage II hemorrhoids with bleeding","interventionNames":["Drug: Intervention Group: Tri Thien Duoc Capsules"]},{"label":"Diosmin","type":"ACTIVE_COMPARATOR","description":"Control group: 86 participants with stage II hemorrhoids with bleeding","interventionNames":["Drug: Control group (diosmin)"]}],"interventions":[{"type":"DRUG","name":"Intervention Group: Tri Thien Duoc Capsules","description":"Intervention Group: 86 participants received Tri Thien Duoc pills at a dosage of 8 capsules per day for 28 days, with follow-up conducted for 35 days from the initiation of treatment.","armGroupLabels":["Tri Thien Duoc capsules"]},{"type":"DRUG","name":"Control group (diosmin)","description":"Control group: 86 patients took Daflon, 4 tablets/day for 28 days, monitored for 35 days from the start of treatment.","armGroupLabels":["Diosmin"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Mean duration of rectal bleeding","description":"Mean duration of fresh rectal bleeding episodes: Defined as the mean number of days the patient experiences fresh rectal bleeding.","timeFrame":"Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)"},{"measure":"Rate of cessation of rectal bleeding","description":"Defined as the proportion of patients who achieve complete cessation of fresh rectal bleeding out of the total number of patients","timeFrame":"Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)"},{"measure":"Severity of hemorrhoidal symptoms","description":"the mean symptom score of participants according to the Sodergren scale.","timeFrame":"Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)"}],"secondaryOutcomes":[{"measure":"Pain score during defecation","description":"The average pain level score reported by patients during defecation, measured using the Visual Analog Scale (VAS).","timeFrame":"Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)"},{"measure":"Rate of recurrent bleeding","description":"The number of patients experiencing rebleeding out of the total number of patients in each group.","timeFrame":"During 35 days of follow up"},{"measure":"Degree of defecation disorder","description":"The average Wexner Defecation Disorder Score, which quantifies the severity of defecation dysfunction.","timeFrame":"Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)"},{"measure":"Degree of hemorrhoid prolapse","description":"the proportion of patients classified according to each degree of hemorrhoid severity, as determined by clinical examination and rigid sigmoidoscopy.","timeFrame":"Baseline (Day 0, start of treatment); End of treatment (Day 28, after 28 days of treatment)"},{"measure":"Anal mucosal condition","description":"The percentage of patients classified according to the degree of hemorrhoidal engorgement, as assessed by rigid sigmoidoscopy.","timeFrame":"Baseline (Day 0, start of treatment); End of treatment (Day 28, after 28 days of treatment)"},{"measure":"Adverse Events","description":"the proportion of patients who experienced a drug-related adverse event during the study period in each group.","timeFrame":"During 28 days of treatment"}]},"eligibilityModule":{"eligibilityCriteria":"\\- Inclusion Criteria\n\nPatients must meet all of the following criteria to be eligible for the study:\n\n* Age 18 to 65 years\n* Diagnosis of grade II internal hemorrhoids with bleeding, presenting with the following symptoms:\n\nHemorrhoids prolapse with gentle straining and retract spontaneously Presence of blood in stool Congested and/or bleeding hemorrhoids\n\n* Having symptoms such as anal pain and anal itching\n* Willingness to voluntarily participate in the study - Exclusion Criteria\n\nPatients meeting any of the following criteria will be excluded from the study:\n\n* History of malignancy, including colon cancer and other cancers\n* Anal polyps and proctitis\n* Anal fissures with bleeding\n* Systemic diseases, such as hypertension, liver failure, kidney failure, heart failure, and coagulation disorders.\n* Other severe acute or chronic illnesses\n* Mixed hemorrhoids or conditions requiring immediate surgical intervention, such as hematoma, severe bleeding, or hemorrhoidal infarction\n* Recent use of other hemorrhoid medications (within 7 days prior to study enrollment)\n* Known allergy to any component of the study medications\n* Pregnant or lactating women\n* Patients will be withdrawn from the study if they: Do not adhere to the treatment regimen, including missing medication for more than 3 consecutive days. Or Use other prohibited medications during the study period. Or require routine medical care at the hospital due to non-compliance or other medical reasons.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Hanoi Medical University Hospital","city":"Hanoi","zip":"100000","country":"Vietnam","geoPoint":{"lat":21.0245,"lon":105.84117}}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"All IPD collected throughout the trial","infoTypes":["STUDY_PROTOCOL","SAP","ICF","CSR","ANALYTIC_CODE"],"timeFrame":"Beginning 3 months and ending 3 years after the publication of results","accessCriteria":"* Criteria for Data Sharing:\n\n  * Data will only be shared if it serves a valid scientific purpose (e.g., verifying results, conducting meaningful new analyses).\n  * The statistical methods must be reviewed and approved by experts or an independent committee before use.\n* Mechanism for Data Sharing:\n\n  * Researchers must submit a proposal describing their study and analysis methods.\n  * They must sign a confidentiality and data use agreement.\n  * Once approved, the data will be provided through a secure system"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"},"interventionBrowseModule":{"meshes":[{"id":"D035061","term":"Control Groups"},{"id":"D004145","term":"Diosmin"}],"ancestors":[{"id":"D015340","term":"Epidemiologic Research Design"},{"id":"D004812","term":"Epidemiologic Methods"},{"id":"D008919","term":"Investigative Techniques"},{"id":"D012107","term":"Research Design"},{"id":"D008722","term":"Methods"},{"id":"D047309","term":"Flavones"},{"id":"D005419","term":"Flavonoids"},{"id":"D002867","term":"Chromones"},{"id":"D001578","term":"Benzopyrans"},{"id":"D011714","term":"Pyrans"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT03173235","orgStudyIdInfo":{"id":"Vitamin D"},"organization":{"fullName":"University Hospital Tuebingen","class":"OTHER"},"briefTitle":"Plasma Concentrations of Calcium, Phosphate, FGF23, Klotho, 25 (OH) D3 and 1,25 (OH) 2D3 from Patients Who Wants to Have Children","officialTitle":"Plasma Concentrations of Calcium, Phosphate, FGF23, Klotho, 25 (OH) D3 and 1,25 (OH) 2D3 from Patients Who Wants to Have Children"},"statusModule":{"statusVerifiedDate":"2025-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2015-08-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-12-01","type":"ACTUAL"},"completionDateStruct":{"date":"2021-12-01","type":"ACTUAL"},"studyFirstSubmitDate":"2017-05-30","studyFirstSubmitQcDate":"2017-05-30","studyFirstPostDateStruct":{"date":"2017-06-01","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-01-17","lastUpdatePostDateStruct":{"date":"2025-01-22","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University Hospital Tuebingen","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"1,25-dihydroxy-vitamin D3 (1,25 (OH) 2D3) or calcitriol regulates plasma calcium and phosphate concentrations in the blood by stimulating intestinal absorption and renal reabsorption of calcium and phosphate. 1.25 (OH) 2D3 is formed by the renal 1α25OH vitamin D-hydroxylase (Cyp27b1) and inactivated by the renal 25-hydroxy vitamin D-24-hydroxylase (Cyp24). Unpublished studies in mice revealed an inhibitory effect of 1.25 (OH) 2D3 on embryo implanation. An excess of 1.25 (OH) 2D3 could therefore lead to female infertility. The excess of 1.25 (OH) 2D3 could result from uncritical vitamin D intake with insufficient negative feedback by FGF23 / Klotho. The aim of the study is to identify patients with an excess of 1.25 (OH) 2D3.","detailedDescription":"The physiological institute of the University Tübinge has succeeded in preventing vascular calcification in Klotho-deficient mice by inhibiting osteogenic signal transduction. The animals reach an almost normal life span despite increased 1.25 (OH) 2D3, Ca2 + and phosphate plasma concentrations. The male animals are again fertilized, but not the female animals. However, if the plasma concentrations of 1.25 (OH) 2D3 are normalized by administration of a vitamin-poor diet, the female animals are fertilized within two weeks. Further investigations revealed an inhibitory effect of 1.25 (OH) 2D3 on the implantation of the embryo. In the meantime the 1,25 (OH) 2D3-dependent signal transduction could be revealed, which prevents the implantation of the embryo. The vitamin D receptor and the elements of signal transduction are also expressed in the human endometrium. It is therefore possible that increased 1.25 (OH) 2D3 plasma concentrations also prevent embryo implantation in humans."},"conditionsModule":{"conditions":["Infertility, Female"]},"designModule":{"studyType":"OBSERVATIONAL","patientRegistry":false,"designInfo":{"observationalModel":"CASE_CONTROL","timePerspective":"PROSPECTIVE"},"bioSpec":{"retention":"SAMPLES_WITH_DNA","description":"Blood plasma"},"enrollmentInfo":{"count":80,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Infertile women","description":"Women which desire to have children but are probable infertile between 18 and 45 year old","interventionNames":["Diagnostic Test: Plasma level of vitamin D"]},{"label":"healthy women","description":"Healthy women without systemic diseases in the age of 18 to 45 years","interventionNames":["Diagnostic Test: Plasma level of vitamin D"]}],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Plasma level of vitamin D","description":"messurement of plasma level of vitamin D","armGroupLabels":["Infertile women","healthy women"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Plasma level of 25(OH)D3 and 1,25(OH)2D3","timeFrame":"1 day"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* Known systemic diseases, e.g. Autoimmune disease, scleroderma, malignant disease","healthyVolunteers":true,"sex":"FEMALE","genderBased":true,"minimumAge":"18 Years","maximumAge":"45 Years","stdAges":["ADULT"],"studyPopulation":"Women in the age of 18 to 45 years","samplingMethod":"NON_PROBABILITY_SAMPLE"},"contactsLocationsModule":{"locations":[{"facility":"University Women's Hospital","city":"Tübingen","zip":"72076","country":"Germany","geoPoint":{"lat":48.52266,"lon":9.05222}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"},"conditionBrowseModule":{"meshes":[{"id":"D007247","term":"Infertility, Female"}],"ancestors":[{"id":"D005831","term":"Genital Diseases, Female"},{"id":"D052776","term":"Female Urogenital Diseases"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D000091662","term":"Genital Diseases"},{"id":"D007246","term":"Infertility"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT04068935","orgStudyIdInfo":{"id":"Buddy taping 2019"},"organization":{"fullName":"University Children's Hospital, Zurich","class":"OTHER"},"briefTitle":"Buddy Taping Compared to Splint Immobilization for Displaced Paediatric Finger Fractures","officialTitle":"Buddy Taping Compared to Splint Immobilizations for Reduced Paediatric Finger Fractures"},"statusModule":{"statusVerifiedDate":"2023-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-08-20","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-01-16","type":"ACTUAL"},"completionDateStruct":{"date":"2023-01-16","type":"ACTUAL"},"studyFirstSubmitDate":"2019-08-23","studyFirstSubmitQcDate":"2019-08-23","studyFirstPostDateStruct":{"date":"2019-08-28","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-05-15","lastUpdatePostDateStruct":{"date":"2023-05-16","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University Children's Hospital, Zurich","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Fracture immobilization with Buddy taping is not inferior to Splint immobilization for non-displaced extra-articular paediatric finger fractures. However, whether the same applies for reduced finger fractures is unclear.","detailedDescription":"Displaced fractures will be reduced in the paediatric ED by Emergency physicians. After fracture reduction, fracture immobilization will either be done with a Splint immobilization or a fingertaping. After 4 and 21 days, clinical and radiographic controls will take place at the Hand surgery outpatient clinic."},"conditionsModule":{"conditions":["Fracture Finger"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","whoMasked":["OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":50,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Buddy taping","type":"EXPERIMENTAL","description":"Buddy taping of the fractured finger to ist neighbouring uninjured finger.","interventionNames":["Procedure: fracture immobilization after reduction of displaced finger fractures"]},{"label":"splint immobilization","type":"ACTIVE_COMPARATOR","description":"A forearm-based palmar Hand Splint in an intrinsic plus Position, enclosing all fingers without the thumb.","interventionNames":["Procedure: fracture immobilization after reduction of displaced finger fractures"]}],"interventions":[{"type":"PROCEDURE","name":"fracture immobilization after reduction of displaced finger fractures","description":"After closed reduction of a displaced finger fracture, fracture immobilization with either Buddy taping or Splint immobilization","armGroupLabels":["Buddy taping","splint immobilization"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"secondary fracture displacement","description":"X-ray controls","timeFrame":"5 and 21 days after fracture reduction"}],"secondaryOutcomes":[{"measure":"Patient comfort","description":"visual analog scale (VAS): Smiley scale with a range from 1 to 10, 10 being the highest score possible, indicating that the Patient comfort was very high.","timeFrame":"5 and 21 days after fracture reduction"},{"measure":"Need for analgesic medication","description":"interview with Patient and parents","timeFrame":"5 and 21 days after fracture reduction"},{"measure":"total range of Motion","description":"measurement","timeFrame":"6 month after fracture reduction"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* extraarticular displaced finger fractures of the proximal or middle phalanges\n\nExclusion Criteria:\n\n* fractures of the thumb\n* fractures that are open, instable, pathologic or multifragmented\n* multiple fractures of the Hand\n* phalangeal neck fractures\n* presentation later than 5 days after the injury","healthyVolunteers":false,"sex":"ALL","minimumAge":"4 Years","maximumAge":"16 Years","stdAges":["CHILD"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Michelle Seiler, MD","affiliation":"University Children's Hospital, Zurich","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University Children's Hospital Zurich","city":"Zurich","zip":"8032","country":"Switzerland","geoPoint":{"lat":47.36667,"lon":8.55}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT01433835","orgStudyIdInfo":{"id":"09-001"},"organization":{"fullName":"Microbiotix, Inc.","class":"INDUSTRY"},"briefTitle":"Safety and Pharmacokinetics of Single Oral Doses of MBX-400 in Healthy Volunteers","officialTitle":"Safety and Pharmacokinetics of Single Oral Doses of MBX-400 in Healthy Volunteers"},"statusModule":{"statusVerifiedDate":"2013-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-09"},"primaryCompletionDateStruct":{"date":"2012-08","type":"ACTUAL"},"completionDateStruct":{"date":"2012-09","type":"ACTUAL"},"studyFirstSubmitDate":"2011-09-11","studyFirstSubmitQcDate":"2011-09-12","studyFirstPostDateStruct":{"date":"2011-09-14","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-08-01","lastUpdatePostDateStruct":{"date":"2013-08-02","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Microbiotix, Inc.","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to determine the safety and pharmacokinetics following a single oral dose of MBX-400.","detailedDescription":"Cytomegalovirus (CMV; herpesvirus 5), a member of the betaherpesvirus subgroup, occurs as a benign infection in the majority of humans, with a 90% prevalence in the adult population1. However, CMV infection continues to be a major cause of morbidity and mortality in immunosuppressed patients, particularly recipients of solid organ or bone marrow transplants. CMV is also known for its association with severe blinding retinitis, pneumonia and gastrointestinal inflammation in AIDS patients. However, with the successful introduction of HAART (highly active anti-retroviral therapy), the problem of CMV infection in AIDS patients has decreased substantially. CMV remains the most important cause of congenital viral infection in the United States, and CMV infection of neonates is associated with deafness, mental retardation and mortality. In addition, CMV is a suspected pathogenic agent in cardiovascular disease and can persist in large-vessel endothelial cells and infect all cell types involved in cardiovascular lesions. CMV has been implicated in the restenosis of diseased coronary arteries following angioplasty and has been associated with myocarditis. In severely immunocompromised patients with CMV infection, prolonged antiviral therapy is often necessary, which increases the risk of resistant viruses. Currently available therapy has limitations that preclude their long-term use including toxicity, poor oral bioavailability and the development of drug-resistant strains. MBX-400 is a nucleoside analog that is structurally related to ganciclovir and acyclovir and is being developed for the possible use in the prevention and/or treatment of CMV. MBX-400, has been shown to be a potent inhibitor of viral DNA synthesis and therefore may be useful in treating and/or preventing CMV infection."},"conditionsModule":{"conditions":["Healthy Adult Subjects"],"keywords":["Cytomegalovirus","Antiviral","Safety","Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":48,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Other: Placebo"]},{"label":"MBX-400","type":"EXPERIMENTAL","interventionNames":["Drug: MBX-400"]}],"interventions":[{"type":"DRUG","name":"MBX-400","description":"Capsule(s) for oral administration as a single dose. Planned doses include: 35, 100, 350, 700, 1000 and 1350 mg.","armGroupLabels":["MBX-400"],"otherNames":["ZSM-I-62","NSC D745998","Cyclopropavir (CPV)","(Z)-9-{[2,2-bis-(hydroxymethyl)cyclopropylidene] methyl}guanine"]},{"type":"OTHER","name":"Placebo","description":"Capsule(s) for oral administration as a single dose. Planned doses include: 35, 100, 350, 700, 1000 and 1350 mg.","armGroupLabels":["Placebo"],"otherNames":["microcrystalline cellulose"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Safety","description":"Safety is evaluated by assessing the incidence and severity for 14 days following a single dose of MBX-400 including:\n\n1. Product-related serious and life-threatening adverse events\n2. Adverse events\n3. Laboratory data abnormalities and clinically significant changes\n4. Electrocardiogram abnormalities and clinically significant changes\n5. Physical exam abnormalities and clinically significant changes\n6. Vital signs abnormalities and clinically significant changes","timeFrame":"14 days"},{"measure":"Area under the plasma concentration-time curve (AUC)","description":"The following pharmacokinetic parameters will be evaluated:\n\n1. Maximum plasma concentration (Cmax)\n2. Time of maximum plasma concentration (Tmax)\n3. Area under the plasma concentration-time curve (AUC)\n4. Terminal plasma half-life (t1/2)\n5. Apparent plasma clearance (Cl/F)\n6. Apparent volume of distribution (Vd/F)\n7. Amount excreted in urine (Ae)\n8. Urinary clearance (Clu)","timeFrame":"Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, 84 and 96 hours following dosing"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Male or female 18 to 65 years of age\n2. Females must be surgically-sterilized or post-menopausal (defined as at least 1 year since last menses with follicle stimulating hormone (FSH) level indicating subject is post-menopausal)\n3. Males must have undergone vasectomy\n4. Able to understand study requirements, agrees to participate in the study and willing and able to provide informed consent (using an informed consent form in a language in which the subject is fluent)\n5. Willing and able to stay in a clinical facility for up to 7 days\n6. BMI of 18 to 32 kg/m2\n7. Non-smoker or former smoker or user of nicotine-containing products (defined as someone who smoked or used nicotine-products one or more times a week for at least one month) who has not smoked for at least 3 months and has not used nicotine-containing products for at least 1 month and is willing to abstain from nicotine-containing products during the study\n8. Has adequate venous access\n9. Willing to abstain from alcohol and illicit drugs during the study\n\nExclusion Criteria:\n\n1. Participation in another clinical trial within 3 months of screening\n2. Unwilling to comply with study procedures or cooperate with study personnel.\n3. Donated blood or had significant blood loss (greater than 1 unit) within 3 months of screening\n4. History of any of the following\n\n   * Human immunodeficiency virus (HIV), cytomegalovirus (CMV), hepatitis B or hepatitis C infection\n   * Alcohol or drug abuse\n   * Anemia or bleeding disorders\n   * Gastrointestinal disorders\n   * Chronic illness\n   * Regular medication use (prescription, over-the-counter or herbal; defined as more than once per week; except multivitamins) or use of medication (except multivitamins) within 1 week of screening.\n   * Recent illness requiring treatment within 1 month of screening\n   * History of renal failure or renal insufficiency\n5. Clinically significant abnormal electrocardiogram (e.g., abnormal rhythm, abnormal intervals)\n6. Clinically significant results of hematology, chemistry, coagulation studies or urinalysis, including, but not limited to the following:\n\n   * White blood cell count, red blood cell count or platelet count less than the lower limit of normal or greater than 1.5 times the upper limit of normal\n   * Hemoglobin or hematocrit less than the lower limit of normal or greater than the upper limit of normal\n   * Alanine aminotransferase and aspartate aminotransferase greater than the upper limit of normal\n   * Prothrombin, partial thromboplastin time or international normalized ratio greater than 1.5 times the upper limit of normal\n   * Abnormal electrolyte values (i.e., sodium, potassium, carbon dioxide/bicarbonate, chloride and/or calcium outside of the reference range)\n   * Urinalysis showing presence of red blood cells, protein or microalbumin\n   * Cotinine level indicative of nicotine use\n   * Positive test for any drug of abuse on urine drug screen\n   * Positive serum pregnancy test if female\n   * Positive ethanol test\n7. Clinically significant vital signs\n\n   * Temperature above 100.0 °F\n   * Heart rate \\< 45 or \\> 100 beats per minute\n   * Respiratory rate \\< 12 or \\> 20 breaths per minute\n   * Systolic blood pressure \\< 100 or \\> 140 mm Hg OR diastolic blood pressure \\< 60 or \\> 90 mm Hg\n8. Known hypersensitivity to any ingredients in the MBX-400 capsules or Placebo capsules (e.g., MBX-400, microcrystalline cellulose, gelatin, titanium dioxide).\n9. Scheduled for surgical procedure during the study\n10. Investigator deems that subject has a condition that warrants exclusion from or is not suitable for the study","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Gregory J Tracey, MD","affiliation":"Frontage Clinical Research Center","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Frontage Clinical Research Center","city":"Hackensack","state":"New Jersey","zip":"07601","country":"United States","geoPoint":{"lat":40.88593,"lon":-74.04347}}]},"referencesModule":{"references":[{"pmid":"15561852","type":"BACKGROUND","citation":"Kern ER, Bidanset DJ, Hartline CB, Yan Z, Zemlicka J, Quenelle DC. Oral activity of a methylenecyclopropane analog, cyclopropavir, in animal models for cytomegalovirus infections. Antimicrob Agents Chemother. 2004 Dec;48(12):4745-53. doi: 10.1128/AAC.48.12.4745-4753.2004."},{"pmid":"17454732","type":"BACKGROUND","citation":"Zhou S, Zemlicka J, Kern ER, Drach JC. Fluoroanalogues of anti-cytomegalovirus agent cyclopropavir: synthesis and antiviral activity of (E)- and (Z)-9-[2,2-bis(hydroxymethyl)-3-fluorocyclopropylidene]methyl-adenines and guanines. Nucleosides Nucleotides Nucleic Acids. 2007;26(3):231-43. doi: 10.1080/15257770701257210."},{"pmid":"19410465","type":"BACKGROUND","citation":"Mhaske SB, Ksebati B, Prichard MN, Drach JC, Zemlicka J. Phosphonate analogues of cyclopropavir phosphates and their E-isomers. Synthesis and antiviral activity. Bioorg Med Chem. 2009 Jun 1;17(11):3892-9. doi: 10.1016/j.bmc.2009.04.020. Epub 2009 Apr 17."},{"pmid":"20183619","type":"BACKGROUND","citation":"Li C, Gentry BG, Drach JC, Zemlicka J. Synthesis and enantioselectivity of cyclopropavir phosphates for cellular GMP kinase. Nucleosides Nucleotides Nucleic Acids. 2009 Sep;28(9):795-808. doi: 10.1080/15257770903172720."},{"pmid":"20846508","type":"BACKGROUND","citation":"Gentry BG, Gentry SN, Jackson TL, Zemlicka J, Drach JC. Phosphorylation of antiviral and endogenous nucleotides to di- and triphosphates by guanosine monophosphate kinase. Biochem Pharmacol. 2011 Jan 1;81(1):43-9. doi: 10.1016/j.bcp.2010.09.005. Epub 2010 Sep 22."},{"pmid":"21041510","type":"BACKGROUND","citation":"Chou S, Bowlin TL. Cytomegalovirus UL97 mutations affecting cyclopropavir and ganciclovir susceptibility. Antimicrob Agents Chemother. 2011 Jan;55(1):382-4. doi: 10.1128/AAC.01259-10. Epub 2010 Nov 1."},{"pmid":"21788463","type":"BACKGROUND","citation":"James SH, Hartline CB, Harden EA, Driebe EM, Schupp JM, Engelthaler DM, Keim PS, Bowlin TL, Kern ER, Prichard MN. Cyclopropavir inhibits the normal function of the human cytomegalovirus UL97 kinase. Antimicrob Agents Chemother. 2011 Oct;55(10):4682-91. doi: 10.1128/AAC.00571-11. Epub 2011 Jul 25."}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-06-12"},"interventionBrowseModule":{"meshes":[{"id":"C495219","term":"cyclopropavir"},{"id":"C109691","term":"microcrystalline cellulose"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT01002235","orgStudyIdInfo":{"id":"VMDN-001/G"},"organization":{"fullName":"Helixmith Co., Ltd.","class":"INDUSTRY"},"briefTitle":"Gene Therapy for Painful Diabetic Neuropathy","officialTitle":"A Phase I/II, Open Label, Dose-Escalation Study to Assess the Safety and Tolerability of Engensis (VM202) in Patients With Painful Diabetic Peripheral Neuropathy"},"statusModule":{"statusVerifiedDate":"2025-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-02"},"primaryCompletionDateStruct":{"date":"2011-04","type":"ACTUAL"},"completionDateStruct":{"date":"2012-04","type":"ACTUAL"},"studyFirstSubmitDate":"2009-10-24","studyFirstSubmitQcDate":"2009-10-24","studyFirstPostDateStruct":{"date":"2009-10-27","type":"ESTIMATED"},"resultsFirstSubmitDate":"2025-05-30","resultsFirstSubmitQcDate":"2025-05-30","resultsFirstPostDateStruct":{"date":"2025-06-15","type":"ACTUAL"},"dispFirstSubmitDate":"2015-01-30","dispFirstSubmitQcDate":"2015-01-30","dispFirstPostDateStruct":{"date":"2015-02-09","type":"ESTIMATED"},"lastUpdateSubmitDate":"2025-09-23","lastUpdatePostDateStruct":{"date":"2025-10-06","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Helixmith Co., Ltd.","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this open label, Phase I/II, dose-escalation, 3-cohort, multicenter, 12-month study, is to assess the safety and tolerability of injecting Engensis (VM202) in the leg muscle in patients with painful diabetic peripheral neuropathy (DPN). The study will also assess the potential of VM202 to reduce the pain associated with diabetic peripheral neuropathy.","detailedDescription":"Peripheral neuropathy is a serious complication of diabetes. This form of neuropathy carries a high risk of pain, trophic changes and autonomic dysfunction.\n\nCurrently, there are no approved drugs or interventional strategies known to halt or reverse the progression of painful diabetic peripheral neuropathy (DPN). Treatments target pain reduction, physical function improvement, reduction of psychological distress, and quality of life improvements.\n\nThere is currently no effective treatment for diabetic neuropathy, and good glycemic control is the only way to minimize the risk of occurrence. Clearly, it would be desirable to prevent, impede, or reverse the disrupting and often life-threatening manifestations of peripheral neuropathy by stimulating growth or regeneration of peripheral nerve axons.\n\nThe purpose of this open label, dose-escalation, 3-cohort study is to assess the safety and tolerability of injecting Engensis (VM202) in the leg muscle in patients with painful diabetic peripheral neuropathy. The study will also assess the potential of VM202 to reduce the pain associated with diabetic peripheral neuropathy."},"conditionsModule":{"conditions":["Painful Diabetic Peripheral Neuropathy"],"keywords":["Diabetic","Neuropathy","Peripheral","diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1","PHASE2"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","interventionModelDescription":"Dose Ranging","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":12,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Cohort 1","type":"EXPERIMENTAL","description":"Two divided doses of VM202 injected into the calf muscle on Day 0 and Day 14 for a total dose of 4 mg.","interventionNames":["Biological: VM202"]},{"label":"Cohort 2","type":"EXPERIMENTAL","description":"Two divided doses of VM202 injected into the calf muscle on Day 0 and Day 14 for a total dose of 8mg.","interventionNames":["Biological: VM202"]},{"label":"Cohort 3","type":"EXPERIMENTAL","description":"Two divided doses of VM202 injected into the calf muscle on Day 0 and Day 14 for a total dose of 16mg.","interventionNames":["Biological: VM202"]}],"interventions":[{"type":"BIOLOGICAL","name":"VM202","description":"Intramuscular injections in the calf on Day 0 and Day 14.","armGroupLabels":["Cohort 1","Cohort 2","Cohort 3"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Treatment-emergent Adverse Events for Participants Who Received Engensis 4 mg, 8 mg, or 16 mg","description":"Treatment-emergent adverse events are any adverse events that occurred after the first dose of Engensis (VM202).\n\nThis is a dose escalation study. Cohorts of increasing dose will be enrolled sequentially. Dose escalation decisions (permission to treat at higher doses) will be made by the Data Safety Monitoring Board based on review of adverse events and on the occurrence of dose limiting toxicities in each cohort. The decision to proceed to the next higher dose cohort will be made according to the scheme described in the protocol.","timeFrame":"Day 0 to Day 365"}],"secondaryOutcomes":[{"measure":"Percent Change From Baseline in Visual Analog Scale Pain Scores","description":"Percent change in median Visual Analog Scale Pain Scores from baseline (Day 0). The Visual Analog Scale Pain scoring instrument is a 10-cm line, oriented horizontally, with the left end (0 cm, is 0 Percent) indicating \"no pain\" and the right end (10 cm, is 100 percent) representing \"pain as bad as it can be\".\n\nThe Change from Baseline of the Visual Analog Scale Pain Score is the difference between the Day 0 and the Days 90, 180 and 365 scores.\n\nA negative difference in the Change from Baseline of the Visual Analog Scale Pain Scores, indicates an improvement (reduction of pain severity) of the treated groups Visual Analog Score.","timeFrame":"Days 0, 90, 180, and 365"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Age ≥ 18 years to 75 years\n* Documented history of Type I or II diabetes with current treatment control (glycosylated hemoglobin A1c of ≤ 10.0%)\n* Diagnosis of painful diabetic peripheral neuropathy in both lower extremities\n* The physical examination component of the Michigan Neuropathy Screening Instrument Score (MNSI) is ≥ 3 at Screening\n* Visual analog scale (VAS) score of ≥ 4 cm at Screening (0 cm = no pain - 10 cm worst imaginable pain)\n* Stable treatment of diabetes for at least 3 months with no anticipated changes in medication regimen, and no new symptoms associated with diabetes\n* Lower extremity pain for at least 6 months\n* If female of childbearing potential, negative pregnancy test at screening and using acceptable method of birth control during the study.\n\nExclusion Criteria:\n\n* Peripheral neuropathy caused by condition other than diabetes;\n* Other pain more severe than neuropathic pain;\n* Progressive or degenerative neurological disorder;\n* Myopathy;\n* Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's disease);\n* Active infection;\n* Chronic inflammatory disease (e.g. Crohn's, Rheumatoid Arthritis)\n* Positive HIV or HTLV at Screening\n* Positive Hepatitis B or C as determined by Hepatitis B core antibody (HBcAB), antibody to Hepatitis B antigen (IgG and IgM; HbsAB), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV), at Screening or known immunosuppression or on chronic treatment with immunosuppressive drugs, chemotherapy or radiation therapy\n* Stroke or myocardial infarction within last 6 months;\n* Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination:\n\n  * Cataract surgery within 6 months of trial;\n  * Vascular lesions of the anterior segment of the eye (infection or ulceration of the cornea, rubeotic glaucoma, etc);\n  * Vascular lesions of the posterior segment of the eye or proliferative retinopathy, macular edema, s/p photocoagulation for macular edema or proliferative retinopathy; sickle cell retinopathy, ischemic retinopathy due to retinal venous stasis or carotid artery disease;\n  * Choroidal angiogenesis; and\n  * Large elevated choroidal nevi, choroidal vascular tumors (choroidal hemangioma), or melanomas.\n* Specific laboratory values at Screening including: Hemoglobin \\< 9.0 g/dL, WBC \\< 3,000 cells per microliter, platelet count \\<75,000/mm3, Creatinine \\> 2.0 mg/dL; GFR \\< 50, AST and/or ALT \\> 2 times the upper limit of normal or any other clinically significant lab abnormality which in the opinion of the investigator should be exclusionary;\n* Use of gamma-linolenic acid (GLA), alpha lipoic acid or any other high dose dietary antioxidant supplement for symptomatic relief of DPN;\n* Uncontrolled hypertension as defined as sustained systolic blood pressure (SBP) \\> 200 mmHg or diastolic BP (DBP) \\> 110 mmHg at baseline/screening evaluation;\n* Patients with history of or new screening finding of malignant neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if excised and no evidence of recurrence);\n* Malignant tumors or abnormal screening test suspicious for cancer, or patients in whom screening exams indicate possible occult malignancy unless malignancy has been ruled out. Patients with family history of colon cancer in any first degree relative unless they have undergone a colonoscopy in the last 12 months with negative findings;\n* Elevated PSA unless prostate cancer has been excluded;\n* Subjects requiring \\> 81 mg daily of acetylsalicylic acid; If \\> 81 mg are taken at screening, subjects may be enrolled if willing/able to switch to another medication;\n* Major psychiatric disorder in past 6 months;\n* History of drug or alcohol abuse / dependence in the past 2 years;\n* History of recent tobacco abuse (within past 5 years);\n* BMI \\> 38 kg/m2;\n* Use of an investigational drug or treatment in past 12 months; and\n* Unable or unwilling to give informed consent.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"John Kessler, M.D.","affiliation":"Northwestern Memorial Hospital","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Diablo Clinical Research Hospital","city":"Walnut Creek","state":"California","zip":"94598","country":"United States","geoPoint":{"lat":37.90631,"lon":-122.06496}},{"facility":"Northwestern Memorial Hospital","city":"Chicago","state":"Illinois","zip":"60611","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}}]},"referencesModule":{"references":[{"pmid":"23609019","type":"BACKGROUND","citation":"Ajroud-Driss S, Christiansen M, Allen JA, Kessler JA. Phase 1/2 open-label dose-escalation study of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with painful diabetic peripheral neuropathy. Mol Ther. 2013 Jun;21(6):1279-86. doi: 10.1038/mt.2013.69. Epub 2013 Apr 23."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Engensis 4 mg","description":"Subjects received Intramuscular injections of Engensis to the calf on Days 0 and 14"},{"id":"FG001","title":"Engensis 8 mg","description":"Subjects received Intramuscular injections to the calf on Days 0 and 14"},{"id":"FG002","title":"Engensis 16 mg","description":"Subjects received Intramuscular injections of Engensis on Days 0 and 14"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Intent-to-treat population including any subject who received all assigned dose of Engensis and had evaluable data at a follow-up visit","groups":[{"id":"BG000","title":"Engensis 4 mg","description":"Subjects received Intramuscular injections of Engensis to the calf on Days 0 and 14"},{"id":"BG001","title":"Engensis 8 mg","description":"Subjects received Intramuscular injections to the calf on Days 0 and 14"},{"id":"BG002","title":"Engensis 16 mg","description":"Subjects received Intramuscular injections of Engensis on Days 0 and 14"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"12"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"60.3","spread":"7.0"},{"groupId":"BG001","value":"61.3","spread":"7.1"},{"groupId":"BG002","value":"54.8","spread":"12.4"},{"groupId":"BG003","value":"58.8","spread":"8.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"12"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"11"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Treatment-emergent Adverse Events for Participants Who Received Engensis 4 mg, 8 mg, or 16 mg","description":"Treatment-emergent adverse events are any adverse events that occurred after the first dose of Engensis (VM202).\n\nThis is a dose escalation study. Cohorts of increasing dose will be enrolled sequentially. Dose escalation decisions (permission to treat at higher doses) will be made by the Data Safety Monitoring Board based on review of adverse events and on the occurrence of dose limiting toxicities in each cohort. The decision to proceed to the next higher dose cohort will be made according to the scheme described in the protocol.","populationDescription":"The Safety Population included all participants who received at least one dose of Engensis (VM202) from Day 0 to Day 365","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Day 0 to Day 365","groups":[{"id":"OG000","title":"Engensis 4 mg","description":"Subjects received Intramuscular injections of Engensis (VM202) to the calf on Days 0 and 14"},{"id":"OG001","title":"Engensis 8 mg","description":"Subjects received Intramuscular injections of Engensis (VM202) to the calf on Days 0 and 14"},{"id":"OG002","title":"Engensis 16 mg","description":"Subjects received Intramuscular injections of Engensis (VM202) on Days 0 and 14"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"4"}]}],"classes":[{"title":"Subjects with any TEAEs","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"}]}]},{"title":"Back pain","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Musculoskeletal pain","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Dry eye","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Retinal vascular disorder","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Diarrhoea","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Dry mouth","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Dyspepsia","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Sinusitis","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Viral infection","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Injection site reaction","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Foot fracture","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Benign prostatic hyperplasia","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Ingrowing nail","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Visual Analog Scale Pain Scores","description":"Percent change in median Visual Analog Scale Pain Scores from baseline (Day 0). The Visual Analog Scale Pain scoring instrument is a 10-cm line, oriented horizontally, with the left end (0 cm, is 0 Percent) indicating \"no pain\" and the right end (10 cm, is 100 percent) representing \"pain as bad as it can be\".\n\nThe Change from Baseline of the Visual Analog Scale Pain Score is the difference between the Day 0 and the Days 90, 180 and 365 scores.\n\nA negative difference in the Change from Baseline of the Visual Analog Scale Pain Scores, indicates an improvement (reduction of pain severity) of the treated groups Visual Analog Score.","populationDescription":"Change from Baseline (Day 0) to visits Day 90, Day 180, and Day 365, in the Intent-to-treat (ITT) population participants who received all assigned doses of Engensis and had evaluable data at a follow-up visit","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of Change from Baseline","timeFrame":"Days 0, 90, 180, and 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