{"source":"clinicaltrials","name":"ClinicalTrials.gov","kind":"lookup","result":{"query":{"q":"","status":""},"via":"native","studies":[{"protocolSection":{"identificationModule":{"nctId":"NCT03840135","orgStudyIdInfo":{"id":"PoArvi/PhIII_2017"},"organization":{"fullName":"NPO Petrovax","class":"INDUSTRY"},"briefTitle":"Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged 1-12 Years With ARI","officialTitle":"A Multicenter Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged From 1 to 12 Years With ARI (Acute Respiratory Infection)"},"statusModule":{"statusVerifiedDate":"2020-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-11-07","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-02-26","type":"ACTUAL"},"completionDateStruct":{"date":"2019-12-10","type":"ACTUAL"},"studyFirstSubmitDate":"2018-11-26","studyFirstSubmitQcDate":"2019-02-12","studyFirstPostDateStruct":{"date":"2019-02-15","type":"ACTUAL"},"resultsFirstSubmitDate":"2020-06-05","resultsFirstSubmitQcDate":"2020-06-05","resultsFirstPostDateStruct":{"date":"2020-06-25","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-07-14","lastUpdatePostDateStruct":{"date":"2020-07-29","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"NPO Petrovax","class":"INDUSTRY"}},"oversightModule":{"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is is to demonstrate superiority of Polyoxidonium, nasal and sublingual spray, 6 mg/ml over placebo in children aged from 1 to 12 years with acute respiratory viral infections. This is a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group phase 3 study.","detailedDescription":"This is a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group phase 3 study to evaluate efficacy of Polyoxidonium spray 6 mg/ml on acute respiratory viral infections symptoms in children population. A study will last for 13 days (maximum) for each participant and will include 6 visits: Day 0 (Screening), Day 1, Day 3, Day 5, Day 8 ±1, Day 12 ±1. Express tests will be performed at the screening visit to exclude subjects with influenza or streptococcal infection. All eligible subjects will be treated with Polyoxidonium spray 6 mg/ml or placebo spray for 7 days. Clinical blood and urine tests will be performed at days 0 and 8 ±1. Symptom Assessment Scale (SAS) will be filled in at days 0, 1, 3, 5 and 8 ±1. Integrative Medicine Outcome Scale (IMOS) will be filled in by investigator and a parent/adopter at day 8 ±1. Adverse events information will be collected at days 1, 3, 8 ±1 and 12 ±1."},"conditionsModule":{"conditions":["Acute Respiratory Infection"],"keywords":["ARI, acute respiratory infection"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":172,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Polyoxidonium 6 mg/ml","type":"EXPERIMENTAL","description":"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.","interventionNames":["Drug: Polyoxidonium 6 mg/ml"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo, nasal and sublingual spray - 7 days.","interventionNames":["Other: Placebo"]}],"interventions":[{"type":"DRUG","name":"Polyoxidonium 6 mg/ml","description":"Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:\n\nin children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours).","armGroupLabels":["Polyoxidonium 6 mg/ml"],"otherNames":["Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml"]},{"type":"OTHER","name":"Placebo","description":"Placebo nasal and sublingual spray will be administered for 7 days:\n\nin children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours).","armGroupLabels":["Placebo"],"otherNames":["Placebo, Nasal and Sublingual Spray"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Fever Duration (With a Superiority Cut-off Level δ=-0,52 Days)","description":"Normalization of body temperature (axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning)) will be considered as the end of fever","timeFrame":"Day 8±1"}],"secondaryOutcomes":[{"measure":"Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS)","description":"A total number of patients (NP) without symptoms due to \"General intoxication symptoms\" domain of the Symptom Assessment Scale (SAS) was evaluated.\n\nA total number of patients (NP) with mild symptoms due to \"General intoxication symptoms\" domain of SAS (1 point according SAS) was evaluated.\n\nA total number of patients (NP) with moderate symptoms due to \"General intoxication symptoms\" domain of SAS (2 point according SAS) was be evaluated.\n\nA total number of patients (NP) with severe symptoms due to \"General intoxication symptoms\" domain of SAS (3 point according SAS) was evaluated.\n\nDomain \"General intoxication symptoms\" includes the following symptoms:\n\n* altered/decreased activity;\n* altered appetite;\n* unhealthy appearance;\n* altered or interrupted sleep.\n\nEach symptom may be graded by the following points:\n\n* 0 points - absent;\n* 1 point - mild;\n* 2 points - moderate;\n* 3 points - severe.","timeFrame":"Day 3"},{"measure":"Number of Patients (NP) Without Nasal Discharge Symptom by 3 and 5 Day of Treatment, Number of Patients (NP) With Mild/Moderate/Severe Nasal Discharge Symptom by 3 and 5 Day of Treatment","description":"Each symptom was graded by the following points:\n\n* 0 points - absent;\n* 1 point - mild;\n* 2 points - moderate;\n* 3 points - severe. Number of patients (NP) without nasal discharge symptom by 3 and 5 day of treatment (score on the scale 0 point), Number of patients (NP) with mild nasal discharge symptom by 3 and 5 day of treatment (score on the scale 1 points) Number of patients (NP) with moderate nasal discharge symptom by 3 and 5 day of treatment (score on the scale 2 points) Number of patients (NP) with severe nasal discharge symptom by 3 and 5 day of treatment (score on the scale 3 points)","timeFrame":"Day 3, Day 5"},{"measure":"Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment","description":"Each symptom was graded by the following points:\n\n* 0 points - absent;\n* 1 point - mild;\n* 2 points - moderate;\n* 3 points - severe. The higher scores mean worse outcome. The maximum score is 3 points, the minimum score is 0 points.","timeFrame":"Day 3, Day 5"},{"measure":"Total Score on Symptom Assessment Scale by 3 and 5 Day of Treatment","description":"Symptom Assessment Scale (SAS) consists of 3 domains:\n\n1. Domain \"General intoxication symptoms\" (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);\n2. \"Nose symptoms\" (nasal discharge; nasal congestion/impaired nasal airflow; sneezing);\n3. \"Throat and thoracic symptoms\" (hoarseness; sore throat; cough).\n\nEach symptom may be graded by the following points:\n\n* 0 points - absent;\n* 1 point - mild;\n* 2 points - moderate;\n* 3 points - severe. The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.","timeFrame":"Day 3, Day 5"},{"measure":"Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator","description":"Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition:\n\n0 points - absolute recovery;\n\n1. point - significant improvement;\n2. points - slight to moderate improvement;\n3. points - unchanged;\n4. points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.","timeFrame":"Day 8±1"},{"measure":"Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter","description":"Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition:\n\n0 points - absolute recovery;\n\n1. point - significant improvement;\n2. points - slight to moderate improvement;\n3. points - unchanged;\n4. points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.","timeFrame":"Day 8±1"},{"measure":"Number of Cases of Antifebrile Agents Use","description":"Number of cases of the antipyretic product (paracetamol) consumption for the entire study period","timeFrame":"Day 8±1"},{"measure":"Number of Patients Discontinued From the Study Due to Requirement for Antibacterial Therapy","description":"Number of patients who discontinued from the study due to requirement for antibacterial therapy","timeFrame":"Day 8±1"},{"measure":"Number of Patients With Normalization of Body Temperature by 5 Day of Treatment","description":"Axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning will be considered as normalization of body temperature","timeFrame":"Day 5"},{"measure":"Number of Patients With Clinical Improvement (Symptom Assessment Scale Total Score ≤ 3) by 5 Day of Treatment","description":"Symptom Assessment Scale (SAS) consists of 3 domains:\n\n1. Domain \"General intoxication symptoms\" (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);\n2. \"Nose symptoms\" (nasal discharge; nasal congestion; impaired nasal airflow; sneezing);\n3. \"Throat and thoracic symptoms\" (hoarseness; sore throat; cough). The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.\n\nEach symptom may be graded by the following points:\n\n* 0 points - absent;\n* 1 point - mild;\n* 2 points - moderate;\n* 3 points - severe.","timeFrame":"Day 5"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male and female patients aged 1 to 12 years\n* Diagnosis of acute respiratory viral infection \\[International Classification of Diseases (10-th revision) codes: Acute nasopharyngitis \\[common cold\\], J02 Acute pharyngitis, J02.9 Acute pharyngitis, unspecified, J04 Acute laryngitis and tracheitis, J04.0 Acute laryngitis, J04.1 Acute tracheitis, J04.2 Acute laryngotracheitis, J06 Acute upper respiratory infections of multiple and unspecified sites, J06.0 Acute laryngopharyngitis, J06.9 Acute upper respiratory infection, unspecified\\] confirmed by physical examination: axillary temperature ≥ 37,0°C (measured at the moment of physical examination) and Symptoms Assessment Scale total score ≥5 points (not less than 3 of which should be related to ear, or nose, or throat, or upper respiratory tract affection symptoms).\n* Less than 24 hours from the onset of disease (first respiratory viral infection symptoms)\n* Informed consent signed by parent/adopter, or a child (applicable for children aged \\> 10 years)\n\nExclusion Criteria:\n\n* Suspicion on pneumonia, bacterial infection (including meningitis, sepsis, otitis media, sinusitis, sinusitis, urinary tract infection etc.) or a condition that requires antibacterial therapy from the first day of treatment.\n* Suspicion on other diseases that may simulate acute respiratory viral infection at the moment of onset (other infectious diseases, flu-like syndrome in system collagen and other diseases).\n* Positive express test for influenza or streptococcal infection.\n* Clinical signs of serious acute respiratory viral infection, which requires hospitalization (fever ≥ 40°C, sings of airway obstruction, significant hemodynamic or neurological disorders).\n* History of primary or secondary immunodeficiency.\n* Cancer.\n* Acute infectious and non-infectious diseases (except acute respiratory viral infection), exacerbation or decompensation of chronic diseases (diabetes mellitus, infantile cerebral paralysis, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of upper respiratory tract,ears, nose, or throat) which may affect an ability of patient to participate in study.\n* Saccharase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.\n* History of allergy/hypersensitivity to any component of the study drug (including paracetamol, propacetamol hydrochloride).\n* Use of protocol-prohibited medications within 1 month prior to study.\n* Children, who's parents/adopters may fail to follow the protocol procedures and treatment, in investigator's opinion.\n* Participation in other studies within 3 months to screening.\n* Pregnancy.\n* Any other medical or social condition that may interrupt study participation, in investigator's opinion.","healthyVolunteers":false,"sex":"ALL","minimumAge":"1 Year","maximumAge":"12 Years","stdAges":["CHILD"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Nikolai Dodonov","affiliation":"NPO Petrovax","role":"STUDY_CHAIR"}],"locations":[{"facility":"Medical Center \"Medical Technology\"","city":"Saint Petersburg","state":"Leningradskaya Oblast'","zip":"192148","country":"Russia"},{"facility":"Medical Center \"MedAestheticCentre Laboratory\"","city":"Saint Petersburg","state":"Leningradskaya Oblast'","zip":"192177","country":"Russia"},{"facility":"Medical center \"Curator\"","city":"Saint Petersburg","state":"Leningradskaya Oblast'","zip":"196240","country":"Russia"},{"facility":"Children's City Hospital No. 22","city":"Saint Petersburg","state":"Leningradskaya Oblast'","zip":"196657","country":"Russia"},{"facility":"Medical center \"Korolev Medicine\"","city":"Naro-Fominsk","state":"Moscow Oblast","zip":"143300","country":"Russia","geoPoint":{"lat":55.38752,"lon":36.73307}},{"facility":"City Children's Clinical Clinic №5","city":"Perm","state":"Perm Krai","zip":"614066","country":"Russia","geoPoint":{"lat":58.01046,"lon":56.25017}},{"facility":"Children's City Clinic №4 of the city of Rostov-on-Don","city":"Rostov-on-Don","state":"Rostov Oblast","zip":"344065","country":"Russia","geoPoint":{"lat":47.21997,"lon":39.70769}},{"facility":"Yaroslavl State Medical University","city":"Yaroslavl","state":"Yaroslavl Oblast","zip":"150000","country":"Russia","geoPoint":{"lat":57.62987,"lon":39.87368}},{"facility":"Regional Children's Clinical Hospital","city":"Yaroslavl","state":"Yaroslavl Oblast","zip":"150042","country":"Russia","geoPoint":{"lat":57.62987,"lon":39.87368}},{"facility":"Scientific Clinical Center of Otorhinolaryngology of the Federal Medical and Biological Agency","city":"Moscow","zip":"123182","country":"Russia","geoPoint":{"lat":55.75204,"lon":37.61781}},{"facility":"Federal state budgetary institution \"Research Institute of Influenza\" of Ministry of Health of Russia","city":"Saint Petersburg","zip":"197376","country":"Russia","geoPoint":{"lat":59.93863,"lon":30.31413}}]},"referencesModule":{"references":[{"type":"RESULT","citation":"Garashchenko TI, Karneeva OV, Tarasova GT, Kim IA, Hanferian RA (2020) Efficacy and safety of azoximer bromide (Polyoxidonium) in children aged from 1 to 12 years with ARI: The results of a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group study. Pediatr Dimensions 5: DOI: 10.15761/PD.1000204."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Polyoxidonium 6 mg/ml","description":"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.\n\nPolyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."},{"id":"FG001","title":"Placebo","description":"Placebo, nasal and sublingual spray - 7 days.\n\nPlacebo: Placebo nasal and sublingual spray will be administered for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"86"},{"groupId":"FG001","numSubjects":"86"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"79"},{"groupId":"FG001","numSubjects":"85"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"172 patients were randomized, 8 people dropped out during the trial (due to protocol violations and withdrawal of informed consent). 164 patients completed the study, data from 155 children were accepted for the final analysis (9 patients were excluded from the analysis due to protocol violations).","groups":[{"id":"BG000","title":"Polyoxidonium 6 mg/ml","description":"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.\n\nPolyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:\n\nin children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours)."},{"id":"BG001","title":"Placebo","description":"Placebo, nasal and sublingual spray - 7 days.\n\nPlacebo: Placebo nasal and sublingual spray will be administered for 7 days:\n\nin children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours)."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"76"},{"groupId":"BG001","value":"79"},{"groupId":"BG002","value":"155"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"76"},{"groupId":"BG001","value":"79"},{"groupId":"BG002","value":"155"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6","lowerLimit":"2","upperLimit":"8"},{"groupId":"BG001","value":"5","lowerLimit":"2","upperLimit":"7"},{"groupId":"BG002","value":"5","lowerLimit":"2","upperLimit":"8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"41"},{"groupId":"BG002","value":"74"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"81"}]}]}]},{"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"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"75"},{"groupId":"BG001","value":"78"},{"groupId":"BG002","value":"153"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Russia","categories":[{"measurements":[{"groupId":"BG000","value":"76"},{"groupId":"BG001","value":"79"},{"groupId":"BG002","value":"155"}]}]}]},{"title":"Body Mass","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"20.85","lowerLimit":"14.6","upperLimit":"30"},{"groupId":"BG001","value":"18","lowerLimit":"15","upperLimit":"27"},{"groupId":"BG002","value":"19","lowerLimit":"14.5","upperLimit":"28.05"}]}]}]},{"title":"Body height","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"m","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1.16","lowerLimit":"0.96","upperLimit":"1.33"},{"groupId":"BG001","value":"1.12","lowerLimit":"0.98","upperLimit":"1.29"},{"groupId":"BG002","value":"1.13","lowerLimit":"0.97","upperLimit":"1.305"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Fever Duration (With a Superiority Cut-off Level δ=-0,52 Days)","description":"Normalization of body temperature (axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning)) will be considered as the end of fever","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"day","timeFrame":"Day 8±1","groups":[{"id":"OG000","title":"Polyoxidonium 6 mg/ml","description":"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.\n\nPolyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:\n\nin children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours)."},{"id":"OG001","title":"Placebo","description":"Placebo, nasal and sublingual spray - 7 days.\n\nPlacebo: Placebo nasal and sublingual spray will be administered for 7 days:\n\nin children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"79"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.04","lowerLimit":"1.74","upperLimit":"2.34"},{"groupId":"OG001","value":"2.26","lowerLimit":"2.03","upperLimit":"2.50"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The value of δ = -0.52 days was considered as the boundary of superiority. The end of the fever period is considered to have an axillary body temperature of ≤36.9 ° C in two consecutive measurements (morning-evening / evening-morning).","nonInferiorityType":"SUPERIORITY","pValue":"<0.05","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"-0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.6","ciUpperLimit":"0.16"}]},{"type":"SECONDARY","title":"Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS)","description":"A total number of patients (NP) without symptoms due to \"General intoxication symptoms\" domain of the Symptom Assessment Scale (SAS) was evaluated.\n\nA total number of patients (NP) with mild symptoms due to \"General intoxication symptoms\" domain of SAS (1 point according SAS) was evaluated.\n\nA total number of patients (NP) with moderate symptoms due to \"General intoxication symptoms\" domain of SAS (2 point according SAS) was be evaluated.\n\nA total number of patients (NP) with severe symptoms due to \"General intoxication symptoms\" domain of SAS (3 point according SAS) was evaluated.\n\nDomain \"General intoxication symptoms\" includes the following symptoms:\n\n* altered/decreased activity;\n* altered appetite;\n* unhealthy appearance;\n* altered or interrupted sleep.\n\nEach symptom may be graded by the following points:\n\n* 0 points - absent;\n* 1 point - mild;\n* 2 points - moderate;\n* 3 points - severe.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Day 3","groups":[{"id":"OG000","title":"Polyoxidonium 6 mg/ml","description":"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.\n\nPolyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:\n\nin children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours)."},{"id":"OG001","title":"Placebo","description":"Placebo, nasal and sublingual spray - 7 days.\n\nPlacebo: Placebo nasal and sublingual spray will be administered for 7 days:\n\nin children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"79"}]}],"classes":[{"title":"NP without altered/decreased activity day 0","categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"11"}]}]},{"title":"NP with mild altered/decreased activity day 0","categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"51"}]}]},{"title":"NP with moderate altered/decreased activity day 0","categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"17"}]}]},{"title":"NP with severe altered/decreased activity day 0","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"NP without altered/decreased activity day 3","categories":[{"measurements":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"46"}]}]},{"title":"NP with mild altered/decreased activity day 3","categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"33"}]}]},{"title":"NP with moderate altered/decreased activity day 3","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]},{"title":"NP with severe altered/decreased activity day 3","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"NP without altered appetite day 0","categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"10"}]}]},{"title":"NP with mild altered appetite day 0","categories":[{"measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"44"}]}]},{"title":"NP with moderate altered appetite day 0","categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"25"}]}]},{"title":"NP with severe altered appetite day 0","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]},{"title":"NP without altered appetite day 3","categories":[{"measurements":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"50"}]}]},{"title":"NP with mild altered appetite day 3","categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"27"}]}]},{"title":"NP with moderate altered appetite day 3","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"}]}]},{"title":"NP with severe altered appetite day 3","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"NP without unhealthy appearance day 0","categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"6"}]}]},{"title":"NP with mild unhealthy appearance day 0","categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"56"}]}]},{"title":"NP with moderate unhealthy appearance day 0","categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"17"}]}]},{"title":"NP with severe mild unhealthy appearance day 0","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"NP without unhealthy appearance day 3","categories":[{"measurements":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"49"}]}]},{"title":"NP with mild unhealthy appearance day 3","categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"30"}]}]},{"title":"NP with moderate unhealthy appearance day 3","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]},{"title":"NP with severe unhealthy appearance day 3","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"NP without altered or interrupted sleep day 0","categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"46"}]}]},{"title":"NP with mild altered or interrupted sleep day 0","categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"27"}]}]},{"title":"NP with moderate altered or interrupt. sleep day 0","categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"6"}]}]},{"title":"NP with severe altered or interrupt. sleep day 0","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"NP without altered or interrupted sleep day 3","categories":[{"measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"71"}]}]},{"title":"NP with mild altered or interrupted sleep day 3","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"}]}]},{"title":"NP with moderate altered or interrupt. sleep day 3","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}]},{"title":"NP with severe altered or interrupt. sleep day 3","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.05","statisticalMethod":"χ2 Pearson criterion"}]},{"type":"SECONDARY","title":"Number of Patients (NP) Without Nasal Discharge Symptom by 3 and 5 Day of Treatment, Number of Patients (NP) With Mild/Moderate/Severe Nasal Discharge Symptom by 3 and 5 Day of Treatment","description":"Each symptom was graded by the following points:\n\n* 0 points - absent;\n* 1 point - mild;\n* 2 points - moderate;\n* 3 points - severe. Number of patients (NP) without nasal discharge symptom by 3 and 5 day of treatment (score on the scale 0 point), Number of patients (NP) with mild nasal discharge symptom by 3 and 5 day of treatment (score on the scale 1 points) Number of patients (NP) with moderate nasal discharge symptom by 3 and 5 day of treatment (score on the scale 2 points) Number of patients (NP) with severe nasal discharge symptom by 3 and 5 day of treatment (score on the scale 3 points)","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Day 3, Day 5","groups":[{"id":"OG000","title":"Polyoxidonium 6 mg/ml","description":"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.\n\nPolyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."},{"id":"OG001","title":"Placebo","description":"Placebo, nasal and sublingual spray - 7 days.\n\nPlacebo: Placebo nasal and sublingual spray will be administered for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"79"}]}],"classes":[{"title":"Day 0","categories":[{"title":"NP without nasal discharge symptom","measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"12"}]},{"title":"NP with mild nasal discharge symptom","measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"20"}]},{"title":"NP with moderate nasal discharge symptom","measurements":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"43"}]},{"title":"NP with severe nasal discharge symptom","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"}]}]},{"title":"Day 3","categories":[{"title":"NP without nasal discharge symptom","measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"13"}]},{"title":"NP with mild nasal discharge symptom","measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"37"}]},{"title":"NP with moderate nasal discharge symptom","measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"29"}]},{"title":"NP with severe nasal discharge symptom","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Day 5","categories":[{"title":"NP without nasal discharge symptom","measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"24"}]},{"title":"NP with mild nasal discharge symptom","measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"38"}]},{"title":"NP with moderate nasal discharge symptom","measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"17"}]},{"title":"NP with severe nasal discharge symptom","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.05","statisticalMethod":"χ2 Pearson criterion"}]},{"type":"SECONDARY","title":"Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment","description":"Each symptom was graded by the following points:\n\n* 0 points - absent;\n* 1 point - mild;\n* 2 points - moderate;\n* 3 points - severe. The higher scores mean worse outcome. The maximum score is 3 points, the minimum score is 0 points.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"score on a scale","timeFrame":"Day 3, Day 5","groups":[{"id":"OG000","title":"Polyoxidonium 6 mg/ml","description":"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.\n\nPolyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."},{"id":"OG001","title":"Placebo","description":"Placebo, nasal and sublingual spray - 7 days.\n\nPlacebo: Placebo nasal and sublingual spray will be administered for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"79"}]}],"classes":[{"title":"nasal discharge day 0","categories":[{"measurements":[{"groupId":"OG000","value":"2","lowerLimit":"1","upperLimit":"2"},{"groupId":"OG001","value":"2","lowerLimit":"1","upperLimit":"2"}]}]},{"title":"nasal discharge by day 3","categories":[{"measurements":[{"groupId":"OG000","value":"1","lowerLimit":"0","upperLimit":"2"},{"groupId":"OG001","value":"1","lowerLimit":"1","upperLimit":"2"}]}]},{"title":"nasal discharge by day 5","categories":[{"measurements":[{"groupId":"OG000","value":"0","lowerLimit":"0","upperLimit":"1"},{"groupId":"OG001","value":"1","lowerLimit":"0","upperLimit":"1"}]}]},{"title":"nasal congestion/impaired nasal airflow by day 0","categories":[{"measurements":[{"groupId":"OG000","value":"2","lowerLimit":"2","upperLimit":"2"},{"groupId":"OG001","value":"2","lowerLimit":"1","upperLimit":"2"}]}]},{"title":"nasal congestion/impaired nasal airflow by day 3","categories":[{"measurements":[{"groupId":"OG000","value":"1","lowerLimit":"0","upperLimit":"1"},{"groupId":"OG001","value":"1","lowerLimit":"1","upperLimit":"2"}]}]},{"title":"nasal congestion/impaired nasal airflow by day 5","categories":[{"measurements":[{"groupId":"OG000","value":"0","lowerLimit":"0","upperLimit":"1"},{"groupId":"OG001","value":"1","lowerLimit":"0","upperLimit":"1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.05","statisticalMethod":"χ2 Pearson criterion"}]},{"type":"SECONDARY","title":"Total Score on Symptom Assessment Scale by 3 and 5 Day of Treatment","description":"Symptom Assessment Scale (SAS) consists of 3 domains:\n\n1. Domain \"General intoxication symptoms\" (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);\n2. \"Nose symptoms\" (nasal discharge; nasal congestion/impaired nasal airflow; sneezing);\n3. \"Throat and thoracic symptoms\" (hoarseness; sore throat; cough).\n\nEach symptom may be graded by the following points:\n\n* 0 points - absent;\n* 1 point - mild;\n* 2 points - moderate;\n* 3 points - severe. The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"score on a scale","timeFrame":"Day 3, Day 5","groups":[{"id":"OG000","title":"Polyoxidonium 6 mg/ml","description":"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.\n\nPolyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."},{"id":"OG001","title":"Placebo","description":"Placebo, nasal and sublingual spray - 7 days.\n\nPlacebo: Placebo nasal and sublingual spray will be administered for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"79"}]}],"classes":[{"title":"Day 0","categories":[{"measurements":[{"groupId":"OG000","value":"11","lowerLimit":"8","upperLimit":"14"},{"groupId":"OG001","value":"10","lowerLimit":"8","upperLimit":"13"}]}]},{"title":"Day 3","categories":[{"measurements":[{"groupId":"OG000","value":"4.00","lowerLimit":"2.00","upperLimit":"6.00"},{"groupId":"OG001","value":"5.00","lowerLimit":"3.00","upperLimit":"7.00"}]}]},{"title":"Day 5","categories":[{"measurements":[{"groupId":"OG000","value":"1.00","lowerLimit":"0","upperLimit":"4"},{"groupId":"OG001","value":"3.00","lowerLimit":"1","upperLimit":"5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.05","statisticalMethod":"Wilcoxon (Mann-Whitney)"}]},{"type":"SECONDARY","title":"Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator","description":"Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition:\n\n0 points - absolute recovery;\n\n1. point - significant improvement;\n2. points - slight to moderate improvement;\n3. points - unchanged;\n4. points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Day 8±1","groups":[{"id":"OG000","title":"Polyoxidonium 6 mg/ml","description":"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.\n\nPolyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:\n\nin children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours)."},{"id":"OG001","title":"Placebo","description":"Placebo, nasal and sublingual spray - 7 days.\n\nPlacebo: Placebo nasal and sublingual spray will be administered for 7 days:\n\nin children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"79"}]}],"classes":[{"categories":[{"title":"absolute recovery","measurements":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"60"}]},{"title":"significant improvement","measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"14"}]},{"title":"slight to moderate improvement","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"}]},{"title":"unchanged","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]},{"title":"decline","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.05","statisticalMethod":"χ2 Pearson criterion"}]},{"type":"SECONDARY","title":"Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter","description":"Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition:\n\n0 points - absolute recovery;\n\n1. point - significant improvement;\n2. points - slight to moderate improvement;\n3. points - unchanged;\n4. points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Day 8±1","groups":[{"id":"OG000","title":"Polyoxidonium 6 mg/ml","description":"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.\n\nPolyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."},{"id":"OG001","title":"Placebo","description":"Placebo, nasal and sublingual spray - 7 days.\n\nPlacebo: Placebo nasal and sublingual spray will be administered for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"79"}]}],"classes":[{"categories":[{"title":"absolute recovery","measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"35"}]},{"title":"significant improvement","measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"}]},{"title":"slight to moderate improvement","measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"9"}]},{"title":"unchanged","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"5"}]},{"title":"decline","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.05","statisticalMethod":"χ2 Pearson criterion"}]},{"type":"SECONDARY","title":"Number of Cases of Antifebrile Agents Use","description":"Number of cases of the antipyretic product (paracetamol) consumption for the entire study period","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Day 8±1","groups":[{"id":"OG000","title":"Polyoxidonium 6 mg/ml","description":"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.\n\nPolyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."},{"id":"OG001","title":"Placebo","description":"Placebo, nasal and sublingual spray - 7 days.\n\nPlacebo: Placebo nasal and sublingual spray will be administered for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"79"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"10"}]}]}]},{"type":"SECONDARY","title":"Number of Patients Discontinued From the Study Due to Requirement for Antibacterial Therapy","description":"Number of patients who discontinued from the study due to requirement for antibacterial therapy","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Day 8±1","groups":[{"id":"OG000","title":"Polyoxidonium 6 mg/ml","description":"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.\n\nPolyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."},{"id":"OG001","title":"Placebo","description":"Placebo, nasal and sublingual spray - 7 days.\n\nPlacebo: Placebo nasal and sublingual spray will be administered for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"79"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Patients With Normalization of Body Temperature by 5 Day of Treatment","description":"Axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning will be considered as normalization of body temperature","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Day 5","groups":[{"id":"OG000","title":"Polyoxidonium 6 mg/ml","description":"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.\n\nPolyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."},{"id":"OG001","title":"Placebo","description":"Placebo, nasal and sublingual spray - 7 days.\n\nPlacebo: Placebo nasal and sublingual spray will be administered for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"79"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"76"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.05","statisticalMethod":"Fisher Exact"}]},{"type":"SECONDARY","title":"Number of Patients With Clinical Improvement (Symptom Assessment Scale Total Score ≤ 3) by 5 Day of Treatment","description":"Symptom Assessment Scale (SAS) consists of 3 domains:\n\n1. Domain \"General intoxication symptoms\" (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);\n2. \"Nose symptoms\" (nasal discharge; nasal congestion; impaired nasal airflow; sneezing);\n3. \"Throat and thoracic symptoms\" (hoarseness; sore throat; cough). The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.\n\nEach symptom may be graded by the following points:\n\n* 0 points - absent;\n* 1 point - mild;\n* 2 points - moderate;\n* 3 points - severe.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Day 5","groups":[{"id":"OG000","title":"Polyoxidonium 6 mg/ml","description":"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.\n\nPolyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."},{"id":"OG001","title":"Placebo","description":"Placebo, nasal and sublingual spray - 7 days.\n\nPlacebo: Placebo nasal and sublingual spray will be administered for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"79"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"51"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.05","statisticalMethod":"Chi-squared"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"12±1 days","description":"Among 172 randomized patients, 2 patients did not take the study drug for reasons of non-compliance with inclusion criterion No. 3 and withdrawal of informed consent, respectively. Thus, the safety analysis included data from 170 patients (84 in the study drug group and 86 in the comparison drug group) who were included in the study and took the drug at least once.","eventGroups":[{"id":"EG000","title":"Polyoxidonium 6 mg/ml","description":"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.\n\nPolyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).","deathsNumAffected":0,"deathsNumAtRisk":84,"seriousNumAffected":0,"seriousNumAtRisk":84,"otherNumAffected":1,"otherNumAtRisk":84},{"id":"EG001","title":"Placebo","description":"Placebo, nasal and sublingual spray - 7 days.\n\nPlacebo: Placebo nasal and sublingual spray will be administered for 7 days:\n\nin children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).","deathsNumAffected":0,"deathsNumAtRisk":86,"seriousNumAffected":0,"seriousNumAtRisk":86,"otherNumAffected":6,"otherNumAtRisk":86}],"otherEvents":[{"term":"acute catarrhal otitis media on the left","organSystem":"Ear and labyrinth disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":84},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":86}]},{"term":"acute purulent otitis media on the left","organSystem":"Ear and labyrinth disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":84},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":86}]},{"term":"loose stool","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":84},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":86}]},{"term":"acute otitis media","organSystem":"Ear and labyrinth disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":84},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":86}]},{"term":"nose bleed","organSystem":"Investigations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":84},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":86}]},{"term":"bronchitis","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":84},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":86}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":true},"pointOfContact":{"title":"Nikolay Dodonov, Head of medical department","organization":"NPO Petrovax Pharm, LLC","email":"DodonovNS@petrovax.ru","phone":"+7(495) 730-75-45","phoneExt":"125"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP_ICF","hasProtocol":true,"hasSap":true,"hasIcf":true,"label":"Study Protocol, Statistical Analysis Plan, and Informed Consent Form","date":"2018-05-30","uploadDate":"2019-02-05T04:13","filename":"Prot_SAP_ICF_000.pdf","size":13730309}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"interventionBrowseModule":{"meshes":[{"id":"C540909","term":"azoximer bromide"}]}},"hasResults":true},{"protocolSection":{"identificationModule":{"nctId":"NCT04014335","orgStudyIdInfo":{"id":"ISIS 696844-CS4"},"organization":{"fullName":"Ionis Pharmaceuticals, Inc.","class":"INDUSTRY"},"briefTitle":"A Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Participants With Primary IgA Nephropathy","officialTitle":"An Open-Label Phase 2a Clinical Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Subjects With Primary IgA Nephropathy"},"statusModule":{"statusVerifiedDate":"2025-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-12-04","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-02-08","type":"ACTUAL"},"completionDateStruct":{"date":"2024-04-11","type":"ACTUAL"},"studyFirstSubmitDate":"2019-07-08","studyFirstSubmitQcDate":"2019-07-08","studyFirstPostDateStruct":{"date":"2019-07-10","type":"ACTUAL"},"dispFirstSubmitDate":"2025-01-17","dispFirstPostDateStruct":{"date":"2024-05-14","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-01-17","lastUpdatePostDateStruct":{"date":"2025-01-23","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Ionis Pharmaceuticals, Inc.","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is to evaluate the effectiveness and safety of IONIS-FB-LRx, an antisense inhibitor of complement factor B messenger ribonucleic acid (CFB mRNA), and to evaluate the effect of IONIS-FB-LRx on plasma factor B (FB) levels and serum AH50, CH50 activity in participants with primary immunoglobulin A (IgA) nephropathy.","detailedDescription":"This is a Phase 2, single arm open-label clinical study in up to 25 participants that will consist of a screening period, a 24-week treatment period, an optional treatment extension period of up to an additional 48 weeks, and a 12- week post-treatment follow-up evaluation period."},"conditionsModule":{"conditions":["Primary IgA Nephropathy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":23,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"IONIS-FB-LRx","type":"EXPERIMENTAL","interventionNames":["Drug: IONIS-FB-LRx"]}],"interventions":[{"type":"DRUG","name":"IONIS-FB-LRx","description":"Participants will receive IONIS-FB-LRx, by subcutaneous injection (SC) at Week 1 and every 4 weeks through Week 25. Optional 48-week Extension, with drug dosing continuing every 4 weeks.","armGroupLabels":["IONIS-FB-LRx"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percent Reduction in 24-hour Urine Protein Excretion","timeFrame":"Baseline to Week 29 (If participant discontinues Study Drug prior to Week 25, Baseline and 4 weeks after the last dose of Study Drug will be measured)"}],"secondaryOutcomes":[{"measure":"Absolute Reduction in 24-hour Urine Protein Excretion","timeFrame":"Baseline to Week 29 (If participant discontinues Study Drug prior to Week 25, Baseline and 4 weeks after the last dose of Study Drug will be measured)"},{"measure":"Absolute Reduction in Albuminuria (UACr Ratio)","timeFrame":"Baseline to Week 29"},{"measure":"Absolute Reduction in Proteinuria (UPCr Ratio)","timeFrame":"Baseline to Week 29"},{"measure":"Percent Change from Baseline in Plasma Factor B (FB)","timeFrame":"Up to Week 29"},{"measure":"Percent Change from Baseline in Plasma AH50","timeFrame":"Up to Week 29"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria\n\n* Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal OR use a highly effective method of birth control\n* Biopsy-proven primary immunoglobulin A (IgA) nephropathy\n* Hematuria\n* Proteinuria\n\nExclusion Criteria\n\n* Clinically significant abnormalities in medical history (e.g., dementia, stroke, acute coronary syndrome, thrombocytopenia, or major surgery within 3 months of Screening)\n* Diagnosis of primary or secondary immunodeficiencies of B-lymphocyte function, splenectomy, or history of recurrent meningococcal disease\n* Active infection 30 days prior to study\n* Estimated glomerular filtration rate (eGFR) ≤ 40 milliliters per minute per 1.73 square meters (mL/min/1.73m\\^2) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)\n* Presence of another renal disease including, but not limited to, diabetes and/or diabetic nephropathy, thin basement membrane disease, Alport's disease, IgA Nephritis (Henoch-Schonlein purpura), lupus nephritis, Minimal Change Disease, post-infectious glomerulonephritis or any other cause of proteinuria or secondary IgA nephropathy (including, but not limited to Celiac disease, Crohn's disease, human immunodeficiency virus (HIV), liver cirrhosis)\n* History of renal transplant or another organ transplant\n* Treatment with another investigational drug, biological agent, or device within 6 months of screening, or 5 half-lives of investigational agent, whichever is longer\n* Administration of immunosuppressive/immunomodulatory medication 12 months prior to study drug administration, except for short-term treatments.\n* Other protocol-specified inclusion/exclusion criteria may apply","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"IONIS Investigative Site","city":"Liverpool","state":"New South Wales","zip":"2170","country":"Australia","geoPoint":{"lat":-33.91938,"lon":150.92588}},{"facility":"IONIS Investigative Site","city":"St Leonards","state":"New South Wales","zip":"2065","country":"Australia","geoPoint":{"lat":-33.82344,"lon":151.19836}},{"facility":"IONIS Investigative Site","city":"Parkville","state":"Victoria","zip":"3050","country":"Australia","geoPoint":{"lat":-37.78333,"lon":144.95}},{"facility":"IONIS Investigative Site","city":"Vancouver","state":"British Columbia","zip":"V6Z 1Y6","country":"Canada","geoPoint":{"lat":49.24966,"lon":-123.11934}},{"facility":"IONIS Investigative Site","city":"Toronto","state":"Ontario","zip":"M4G 3E8","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"IONIS Investigative Site","city":"Christchurch","zip":"8011","country":"New Zealand","geoPoint":{"lat":-43.53333,"lon":172.63333}},{"facility":"IONIS Investigative Site","city":"Singapore","zip":"168582","country":"Singapore","geoPoint":{"lat":1.28967,"lon":103.85007}}]},"referencesModule":{"references":[{"pmid":"41443406","type":"DERIVED","citation":"Barbour SJ, Hladunewich MA, McCaleb ML, Robson R, Barrett TD, Yin L, Frazer-Abel A, Garg JP, Geary R, Schneider E, Brice GT. A single-arm phase 2 trial of an investigational RNA therapeutic to complement factor B sefaxersen for treatment of IgA nephropathy. Kidney Int. 2026 Mar;109(3):592-601. doi: 10.1016/j.kint.2025.11.017. Epub 2025 Dec 22."},{"pmid":"39331470","type":"DERIVED","citation":"Tekendo-Ngongang C, Gleeson JG, Mignon L. Treating the Untreatable: Antisense Oligonucleotides as an Individualized Therapy for Rare Genetic Kidney Diseases. J Am Soc Nephrol. 2024 Dec 1;35(12):1774-1777. doi: 10.1681/ASN.0000000532. Epub 2024 Sep 27. No abstract available."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"conditionBrowseModule":{"meshes":[{"id":"D005922","term":"Glomerulonephritis, IGA"}],"ancestors":[{"id":"D005921","term":"Glomerulonephritis"},{"id":"D009393","term":"Nephritis"},{"id":"D007674","term":"Kidney Diseases"},{"id":"D014570","term":"Urologic Diseases"},{"id":"D052776","term":"Female Urogenital Diseases"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D052801","term":"Male Urogenital Diseases"},{"id":"D001327","term":"Autoimmune Diseases"},{"id":"D007154","term":"Immune System Diseases"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT02661035","orgStudyIdInfo":{"id":"2015LS152"},"organization":{"fullName":"Masonic Cancer Center, University of Minnesota","class":"OTHER"},"briefTitle":"Allo HSCT Using RIC for Hematological Diseases","officialTitle":"Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) for the Treatment of Hematological Diseases [MT2015-32]"},"statusModule":{"statusVerifiedDate":"2023-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-03-09","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-04-17","type":"ACTUAL"},"completionDateStruct":{"date":"2023-05-29","type":"ACTUAL"},"studyFirstSubmitDate":"2016-01-19","studyFirstSubmitQcDate":"2016-01-20","studyFirstPostDateStruct":{"date":"2016-01-21","type":"ESTIMATED"},"lastUpdateSubmitDate":"2023-09-19","lastUpdatePostDateStruct":{"date":"2023-09-21","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Masonic Cancer Center, University of Minnesota","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related or unrelated donor stem cell infusion. The primary objective is to evaluate rates of acute graft-versus-host disease (GVHD) grades II-IV and chronic GVHD with an updated GVHD prophylaxis of tacrolimus and mycophenolate mofetil (MMF) with a non-myeloablative preparative regimen in persons with hematologic malignancies."},"conditionsModule":{"conditions":["Acute Myelogenous Leukemia","Acute Lymphocytic Leukemia","Chronic Myelogenous Leukemia","Plasma Cell Leukemia","Myelodysplastic Syndromes","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","B-Cell Lymphoma","Follicular Lymphoma","Lymphoplasmacytic Lymphoma","Mantle-Cell Lymphoma","Prolymphocytic Leukemia","Lymphoblastic Lymphoma","Burkitt's Lymphoma","Non-Hodgkin's Lymphoma","Multiple Myeloma","Myeloproliferative Syndromes","Hematological Diseases"],"keywords":["AML","ALL","CML","MDS","CLL","SLL","NHL"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":156,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Reduced Intensity Conditioning","type":"EXPERIMENTAL","description":"Non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related or unrelated donor stem cell infusion","interventionNames":["Drug: Allopurinol","Drug: Fludarabine","Drug: Cyclophosphamide","Drug: ATG","Radiation: TBI","Drug: Tacrolimus","Drug: MMF","Biological: Peripheral Blood Stem Cells","Biological: Related or Unrelated Bone Marrow Cells"]}],"interventions":[{"type":"DRUG","name":"Allopurinol","description":"300 mg/day (for peds -150 mg/m\\^2/day), day -6 and continue through day 0 or longer if clinically indicated","armGroupLabels":["Reduced Intensity Conditioning"],"otherNames":["Zyloprim"]},{"type":"DRUG","name":"Fludarabine","description":"30 mg/m\\^2 IV over 1 hour, day -6, -5, -4, -3 and -2","armGroupLabels":["Reduced Intensity Conditioning"],"otherNames":["Fludara"]},{"type":"DRUG","name":"Cyclophosphamide","description":"50 mg/kg IV over 2 hours, day -6","armGroupLabels":["Reduced Intensity Conditioning"],"otherNames":["Cytoxan"]},{"type":"DRUG","name":"ATG","description":"Only for patients with an unrelated donor (URD) and NO multi-agent chemotherapy 3 months prior to transplant. ATG will be administered IV every 12 hours for 6 doses on days -6, -5, and -4 according to institutional guidelines. Methylprednisolone 1 mg/kg IV administered immediately prior to each dose of ATG (6 doses).","armGroupLabels":["Reduced Intensity Conditioning"],"otherNames":["Anti-thymocyte globulin"]},{"type":"RADIATION","name":"TBI","description":"All patients who have had previous radiation therapy or TBI will be seen by Radiation Oncology prior to entrance on the protocol for approval for additional 200 cGy of TBI. TBI may be delivered by local guidelines provided the effective dose is equivalent to what is recommended in the TBI Guidelines. The dose of TBI will be 200 cGy given in a single fraction on day -1.","armGroupLabels":["Reduced Intensity Conditioning"],"otherNames":["Total body irradiation"]},{"type":"DRUG","name":"Tacrolimus","description":"All patients will receive tacrolimus therapy beginning on day -3. Initial dosing of tacrolimus will be 0.03 - 0.05 mg/kg/day IV; if the recipient body weight is \\<40 kg, dosing will be 3 times daily, and if ≥ 40 kg, twice daily or per current institutional guidelines.\n\nAn attempt will be made to maintain a trough level of 5-10 ng/mL and subsequent dose modifications will be provided by the pharmacist.\n\nOnce the patient can tolerate oral medications and has a reasonable oral intake, tacrolimus will be converted to an oral form based on the current IV dose providing normal renal and hepatic function and no major drug interactions.\n\nThe timing of the tacrolimus taper will be at the discretion of the treating physician, but in general:\n\n* Taper begins at day +100 +/- 10 days, if the patient is stably engrafted and has no active GVHD.\n* Taper to zero by reducing dose by approximately 10% a week (rounded to nearest pill size), with a goal to discontinue by month 6 post-HCT.","armGroupLabels":["Reduced Intensity Conditioning"],"otherNames":["Prograf"]},{"type":"DRUG","name":"MMF","description":"3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 or 3 doses. In obese patients (\\>125% IBW) 15 mg/kg every 12 hours may be considered. Pediatric patient (\\<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours beginning day -3. MMF dosing will be monitored and altered as clinically appropriate based on institutional guidelines. Patients will be eligible for MMF dosing and pharmacokinetics studies.\n\nMMF will stop at day +30 or 7 days after engraftment, whichever day is later, if no acute GVHD. (Definition of engraftment is 1st day of 3 consecutive days of absolute neutrophil count \\[ANC) ≥ 0.5 x 109 /L\\]). If no donor engraftment, MMF will continue as long as clinically indicated.","armGroupLabels":["Reduced Intensity Conditioning"],"otherNames":["Mycophenolate Mofetil"]},{"type":"BIOLOGICAL","name":"Peripheral Blood Stem Cells","description":"On day 0, patients will receive an allogeneic transplant using PBSC which are CD34+ selected as the donor graft. The graft will be infused over 15-60 minutes after premedication with acetaminophen 650 mg PO and diphenhydramine 25 mg PO/IV with doses adjusted for pediatric patients.","armGroupLabels":["Reduced Intensity Conditioning"]},{"type":"BIOLOGICAL","name":"Related or Unrelated Bone Marrow Cells","description":"On day 0, a target dose of 3 x 10\\^8 nucleated cells/kg recipient weight will be collected. The graft will be infused over 15-60 minutes after premedication with acetaminophen 650 mg PO and diphenhydramine 25 mg PO/IV with doses adjusted for pediatric patients.","armGroupLabels":["Reduced Intensity Conditioning"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Evaluate rates of acute graft-versus-host disease (GVHD) II-IV","description":"Percent of subjects with grade II-IV acute GVHD","timeFrame":"Day 100 post transplant"}],"secondaryOutcomes":[{"measure":"Evaluate rates of chronic GVHD","description":"Percent of subjects with chronic GVHD","timeFrame":"1 year post transplant"},{"measure":"Evaluate neutrophil engraftment without ATG (in siblings)","description":"Percent of subjects with neutrophil engraftment without ATG (in siblings)","timeFrame":"Day 42 post transplant"},{"measure":"Evaluate neutrophil engraftment with ATG (in unrelated donors)","description":"Percent of subjects with neutrophil engraftment with ATG (in unrelated donors)","timeFrame":"Day 42 post transplant"},{"measure":"Evaluate neutrophil engraftment without ATG (in unrelated donors)","description":"Percent of subjects with neutrophil engraftment without ATG (in unrelated donors)","timeFrame":"Day 42 post transplant"},{"measure":"Evaluate relapse without ATG (in siblings) - 1 year","description":"Percent of subjects who relapsed without ATG (in siblings)","timeFrame":"1 year post transplant"},{"measure":"Evaluate relapse without ATG (in siblings) - 2 years","description":"Percent of subjects who relapsed without ATG (in siblings)","timeFrame":"2 years post transplant"},{"measure":"Evaluate relapse with ATG (in unrelated donors) - 1 year","description":"Percent of subjects who relapsed with ATG (in unrelated donors)","timeFrame":"1 year post transplant"},{"measure":"Evaluate relapse with ATG (in unrelated donors) - 2 years","description":"Percent of subjects who relapsed with ATG (in unrelated donors)","timeFrame":"2 years post transplant"},{"measure":"Evaluate relapse without ATG (in unrelated donors) - 1 year","description":"Percent of subjects who relapsed without ATG (in unrelated donors)","timeFrame":"1 year post transplant"},{"measure":"Evaluate relapse without ATG (in unrelated donors) - 2 years","description":"Percent of subjects who relapsed without ATG (in unrelated donors)","timeFrame":"2 years post transplant"},{"measure":"Overall survival","description":"Percent of surviving subjects","timeFrame":"Day 100 post transplant"},{"measure":"Overall survival","description":"Percent of surviving subjects","timeFrame":"1 year post transplant"},{"measure":"Overall survival","description":"Percent of surviving subjects","timeFrame":"3 years post transplant"},{"measure":"Transplant related mortality (TRM)","description":"Percent of subjects with TRM","timeFrame":"Day 100 post transplant"},{"measure":"Transplant related mortality (TRM)","description":"Percent of subjects with TRM","timeFrame":"1 year post transplant"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Age, Performance Status, and Graft Criteria\n\n  * Age 0 to 70 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (\\< 16 years)\n  * Patients ≥ 70 and ≤ 75 years of age may be eligible if they have a HCT-CI Co-Morbidity score ≤ 2\n  * Must be ≥ 3 months after prior myeloablative transplant, if applicable\n  * 5/6 or 6/6 related donor match or a 7-8/8 HLA-A,B,C,DRB1 allele matched unrelated donor marrow and/or PBSC donor match per current institutional guidelines Related donors will be evaluated and collected per MT2012-14C; Unrelated donors will be identified and collected per usual procedures\n* Eligible Diseases\n\n  * Acute Myeloid Leukemia (AML): high risk CR1 (as evidenced by preceding MDS, high risk cytogenetics, ≥ 2 cycles to obtain CR, erythroblastic or megakaryocytic leukemia, FLT-3 ITD +; CR2+. All patients must be in CR as defined by hematological recovery, AND \\<5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%.\n  * Very high risk pediatric patients with AML: Patients \\<21 years, however, are eligible with (M2 marrow) with \\< 25% blasts in marrow after having failed one or more cycles of chemotherapy.\n  * Acute Lymphocytic Leukemia (ALL): factor that define high risk CR1 include but are not limited to cytogenetics demonstrating t(9;22), t (1:19), t(4;11), other MLL rearrangements, hypodiploidy, or IKZF1 abnormalities), DNA index \\< 0.81, \\> 1 cycle to obtain CR or presence minimal residual disease (MRD). Patients in CR2+ are eligible. All patients must be in CR as defined by hematological recovery, AND \\<5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%.\n  * Very high risk pediatric patients with ALL: patients \\<21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieved a complete remission.\n  * Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to imatinib mesylate.\n  * Plasma Cell Leukemia after initial therapy, who achieved at least a partial remission\n  * Myelodysplasia (MDS) requiring transplant as defined as: IPSS INT-2 or High Risk; R-IPSS High or Very High; WHO classification: RAEB-1, RAEB-2; Severe Cytopenias: ANC \\< 0.8, Anemia or thrombocytopenia requiring transfusion; Poor or very poor risk cytogenetics based on IPSS or R-IPSS definitions; therapy-related MDS. Blasts must be \\< 5% by bone marrow aspirate morphology.\n  * Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression/relapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for de-bulking chemotherapy before transplant.\n  * Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia, NK cell malignancies are eligible after initial therapy in CR1+ or PR1+.\n  * Large Cell NHL \\> CR2/\\> PR2: Patients in CR2/PR2 with initial short remission (\\<6 months) are eligible.\n  * Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III/IV in CR1/PR1 or after progression if stage I/II \\< 1 year.\n  * Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin \\> 3 mg/L, may be considered for this protocol after initial therapy.\n  * Myeloproliferative Syndromes\n* Organ Function Criteria Adequate organ function is defined as:\n\n  * Liver: AST and ALT \\< 5 x upper limit of normal and bilirubin \\< 3 x upper limit of normal\n  * Renal: Creatinine ≤ 2.0 mg/dl (adults) and estimated glomerular filtration rate (GFR) ≥ 40 mL/min (pediatrics). Adults with a creatinine \\> 1.2 mg/dl or a history of renal dysfunction must have estimated glomerular filtration rate (GFR) \\> 40 mL/min.\n  * Albumin \\> 2.5 g/dL\n  * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 35%.\n  * Pulmonary: DLCOcorr ≥ 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with or without exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note.\n* If recent mold infection (e.g. aspergillus) must have minimum of 30 days of therapy and responsive disease and be cleared by Infectious Disease\n* Females of child bearing potential and sexually active males must agree to use adequate birth control during study treatment\n* Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate)\n\nExclusion Criteria:\n\n* Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.\n* Untreated active infection\n* Active CNS disease\n* Active HIV infection or known HIV positive serology\n* Congenital bone marrow failure syndrome\n* Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of TBI\n* CML in refractory blast crisis\n* Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.\n* Multiple myeloma progressive on salvage chemotherapy","healthyVolunteers":false,"sex":"ALL","maximumAge":"75 Years","stdAges":["CHILD","ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Erica Warlick, MD","affiliation":"Masonic Cancer Center, University of Minnesota","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Masonic Cancer Center at University of Minnesota","city":"Minneapolis","state":"Minnesota","zip":"55455","country":"United States","geoPoint":{"lat":44.97997,"lon":-93.26384}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"conditionBrowseModule":{"meshes":[{"id":"D015470","term":"Leukemia, Myeloid, Acute"},{"id":"D054198","term":"Precursor Cell Lymphoblastic Leukemia-Lymphoma"},{"id":"D015464","term":"Leukemia, Myelogenous, Chronic, BCR-ABL Positive"},{"id":"D007952","term":"Leukemia, Plasma Cell"},{"id":"D009190","term":"Myelodysplastic Syndromes"},{"id":"D015451","term":"Leukemia, Lymphocytic, Chronic, B-Cell"},{"id":"D016393","term":"Lymphoma, B-Cell"},{"id":"D008224","term":"Lymphoma, Follicular"},{"id":"D018442","term":"Lymphoma, B-Cell, Marginal Zone"},{"id":"D020522","term":"Lymphoma, Mantle-Cell"},{"id":"D015463","term":"Leukemia, Prolymphocytic"},{"id":"D002051","term":"Burkitt Lymphoma"},{"id":"D008228","term":"Lymphoma, Non-Hodgkin"},{"id":"D009101","term":"Multiple Myeloma"},{"id":"D006402","term":"Hematologic Diseases"}],"ancestors":[{"id":"D007951","term":"Leukemia, Myeloid"},{"id":"D007938","term":"Leukemia"},{"id":"D009370","term":"Neoplasms by Histologic Type"},{"id":"D009369","term":"Neoplasms"},{"id":"D006425","term":"Hemic and Lymphatic Diseases"},{"id":"D007945","term":"Leukemia, Lymphoid"},{"id":"D008232","term":"Lymphoproliferative Disorders"},{"id":"D008206","term":"Lymphatic Diseases"},{"id":"D007160","term":"Immunoproliferative Disorders"},{"id":"D007154","term":"Immune System Diseases"},{"id":"D009196","term":"Myeloproliferative Disorders"},{"id":"D001855","term":"Bone Marrow Diseases"},{"id":"D002908","term":"Chronic Disease"},{"id":"D020969","term":"Disease Attributes"},{"id":"D010335","term":"Pathologic Processes"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"},{"id":"D054219","term":"Neoplasms, Plasma Cell"},{"id":"D015448","term":"Leukemia, B-Cell"},{"id":"D008223","term":"Lymphoma"},{"id":"D020031","term":"Epstein-Barr Virus Infections"},{"id":"D006566","term":"Herpesviridae Infections"},{"id":"D004266","term":"DNA Virus Infections"},{"id":"D014777","term":"Virus Diseases"},{"id":"D007239","term":"Infections"},{"id":"D014412","term":"Tumor Virus Infections"},{"id":"D020141","term":"Hemostatic Disorders"},{"id":"D014652","term":"Vascular Diseases"},{"id":"D002318","term":"Cardiovascular Diseases"},{"id":"D010265","term":"Paraproteinemias"},{"id":"D001796","term":"Blood Protein Disorders"},{"id":"D006474","term":"Hemorrhagic Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D000493","term":"Allopurinol"},{"id":"C024352","term":"fludarabine"},{"id":"C042382","term":"fludarabine phosphate"},{"id":"D003520","term":"Cyclophosphamide"},{"id":"D000961","term":"Antilymphocyte Serum"},{"id":"D014916","term":"Whole-Body Irradiation"},{"id":"D016559","term":"Tacrolimus"},{"id":"D009173","term":"Mycophenolic Acid"},{"id":"D001244","term":"Association"}],"ancestors":[{"id":"D011687","term":"Purines"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D010752","term":"Phosphoramide Mustards"},{"id":"D009588","term":"Nitrogen Mustard Compounds"},{"id":"D009150","term":"Mustard Compounds"},{"id":"D006846","term":"Hydrocarbons, Halogenated"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D063088","term":"Phosphoramides"},{"id":"D009943","term":"Organophosphorus Compounds"},{"id":"D007106","term":"Immune Sera"},{"id":"D000906","term":"Antibodies"},{"id":"D007136","term":"Immunoglobulins"},{"id":"D007162","term":"Immunoproteins"},{"id":"D001798","term":"Blood Proteins"},{"id":"D011506","term":"Proteins"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D012712","term":"Serum Globulins"},{"id":"D005916","term":"Globulins"},{"id":"D001688","term":"Biological Products"},{"id":"D045424","term":"Complex Mixtures"},{"id":"D011878","term":"Radiotherapy"},{"id":"D013812","term":"Therapeutics"},{"id":"D008919","term":"Investigative Techniques"},{"id":"D018942","term":"Macrolides"},{"id":"D007783","term":"Lactones"},{"id":"D002208","term":"Caproates"},{"id":"D000144","term":"Acids, Acyclic"},{"id":"D002264","term":"Carboxylic Acids"},{"id":"D005227","term":"Fatty Acids"},{"id":"D008055","term":"Lipids"},{"id":"D013811","term":"Psychotherapeutic Processes"},{"id":"D011613","term":"Psychotherapy"},{"id":"D004191","term":"Behavioral Disciplines and Activities"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT00022035","orgStudyIdInfo":{"id":"RP 99-12"},"secondaryIdInfos":[{"id":"RPCI-RP-9912"},{"id":"NCI-G01-1990"}],"organization":{"fullName":"Roswell Park Cancer Institute","class":"OTHER"},"briefTitle":"Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia","officialTitle":"Influenza Vaccine Immunogenicity in Children During and After Therapy for Acute Lymphoblastic Leukemia"},"statusModule":{"statusVerifiedDate":"2013-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2000-08"},"primaryCompletionDateStruct":{"date":"2002-11","type":"ACTUAL"},"studyFirstSubmitDate":"2001-08-10","studyFirstSubmitQcDate":"2003-01-26","studyFirstPostDateStruct":{"date":"2003-01-27","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-01-30","lastUpdatePostDateStruct":{"date":"2013-01-31","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"leadSponsor":{"name":"Roswell Park Cancer Institute","class":"OTHER"},"collaborators":[{"name":"National Cancer Institute (NCI)","class":"NIH"}]},"descriptionModule":{"briefSummary":"RATIONALE: Flu vaccine may help the body build an immune response and decrease the occurrence of flu in children who are receiving chemotherapy for acute lymphoblastic leukemia.\n\nPURPOSE: Clinical trial to study the effectiveness of vaccine therapy in preventing flu in children who have acute lymphoblastic leukemia.","detailedDescription":"OBJECTIVES:\n\n* Determine the immune response, in terms of the formation of protective antibody titers to influenza, in children with acute lymphoblastic leukemia treated with split-virus trivalent influenza vaccine.\n* Correlate the formation of protective antibody titers following immunization with the absolute neutrophil counts and absolute lymphocyte counts in these patients at the time of vaccination.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to current treatment for acute lymphoblastic leukemia (consolidation chemotherapy vs maintenance chemotherapy vs off therapy for the past 6 months).\n\nPatients receive split-virus trivalent influenza vaccine intramuscularly once or twice at 4 weeks apart for 2 doses.\n\nPatients are followed at week 5. Patients receiving 2 doses of vaccine are also followed at week 9.\n\nPROJECTED ACCRUAL: A total of 175 patients (50 receiving consolidation therapy, 75 receiving maintenance therapy, and 50 off therapy) will be accrued for this study within 2 years."},"conditionsModule":{"conditions":["Infection","Leukemia"],"keywords":["childhood acute lymphoblastic leukemia in remission","infection"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"primaryPurpose":"SUPPORTIVE_CARE"}},"armsInterventionsModule":{"interventions":[{"type":"BIOLOGICAL","name":"trivalent influenza vaccine"}]},"eligibilityModule":{"eligibilityCriteria":"DISEASE CHARACTERISTICS:\n\n* Diagnosis of acute lymphoblastic leukemia\n\n  * In first remission after completion of induction chemotherapy\n  * Currently on active treatment OR\n  * Completed treatment within the past 6 months\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 1 to 20 at time of diagnosis\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nPulmonary:\n\n* No acute respiratory distress\n\nOther:\n\n* No history of Guillain-Barre syndrome\n* No history of hypersensitivity to chicken eggs, egg products, or components of influenza virus vaccine, including thimerosal\n* No febrile illness with fever over 100.4 degrees F\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* At least 7 days since prior antibiotic or antiviral therapy except prophylactic antibiotics","healthyVolunteers":false,"sex":"ALL","minimumAge":"1 Year","maximumAge":"20 Years","stdAges":["CHILD","ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Martin L. Brecher, MD","affiliation":"Roswell Park Cancer Institute","role":"STUDY_CHAIR"}],"locations":[{"facility":"Hackensack University Medical Center","city":"Hackensack","state":"New Jersey","zip":"07601","country":"United States","geoPoint":{"lat":40.88593,"lon":-74.04347}},{"facility":"Roswell Park Cancer Institute","city":"Buffalo","state":"New York","zip":"14263-0001","country":"United States","geoPoint":{"lat":42.88645,"lon":-78.87837}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"conditionBrowseModule":{"meshes":[{"id":"D007239","term":"Infections"},{"id":"D007938","term":"Leukemia"}],"ancestors":[{"id":"D009370","term":"Neoplasms by Histologic Type"},{"id":"D009369","term":"Neoplasms"},{"id":"D006402","term":"Hematologic Diseases"},{"id":"D006425","term":"Hemic and Lymphatic Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D007252","term":"Influenza Vaccines"}],"ancestors":[{"id":"D014765","term":"Viral Vaccines"},{"id":"D014612","term":"Vaccines"},{"id":"D001688","term":"Biological Products"},{"id":"D045424","term":"Complex Mixtures"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT03546335","orgStudyIdInfo":{"id":"17-23566"},"organization":{"fullName":"University of California, San Francisco","class":"OTHER"},"briefTitle":"Zr-89 Cimzia PET Imaging Rheumatoid Arthritis","officialTitle":"Zirconium-89 Certolizumab PET Imaging in Patients With Rheumatoid Arthritis"},"statusModule":{"statusVerifiedDate":"2026-04","overallStatus":"SUSPENDED","whyStopped":"Lapse in study funding.","startDateStruct":{"date":"2018-10-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2029-03-31","type":"ESTIMATED"},"completionDateStruct":{"date":"2029-03-31","type":"ESTIMATED"},"studyFirstSubmitDate":"2018-04-30","studyFirstSubmitQcDate":"2018-05-22","studyFirstPostDateStruct":{"date":"2018-06-06","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-04-28","lastUpdatePostDateStruct":{"date":"2026-05-04","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR_INVESTIGATOR","investigatorFullName":"Robert Flavell, MD, PhD","investigatorTitle":"Assistant Professor in Residence","investigatorAffiliation":"University of California, San Francisco"},"leadSponsor":{"name":"Robert Flavell, MD, PhD","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is a single center exploratory imaging study investigating the initial application of zirconium-89 Deferoxamine B Certolizumab pegol (89Zr-DFO-CZP) PET in patients with rheumatoid arthritis. Patients with active symptoms of RA or signs on physical exam will be invited to participate for PET imaging.","detailedDescription":"This is a single center exploratory imaging study investigating the initial application of 89Zr-DFO-CZP PET in patients with rheumatoid arthritis. Patients with active symptoms of rheumatoid arthritis (RA) or signs on physical exam will be invited to participate for PET imaging. Study 1 is a dose finding study that will involve a single 89Zr-DFO-CZP PET scan acquired \\~24 hours following a single administration of the radiopharmaceutical. The first 2 patients will receive 1 millicurie (mCi) of 89Zr-DFO-CZP. Subsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose. After receiving the dose, participants will undergo 4 serial whole body PET scans between 2 hours and 120 hours after dose administration. Several blood samples will also be collected over this time period, for dosimetry analysis."},"conditionsModule":{"conditions":["Rheumatoid Arthritis"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"The first 2 patients will receive 1 mCi of 89Zr-DFO-CZP. Subsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose.","primaryPurpose":"DIAGNOSTIC","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":10,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"1 mCi injection of 89Zr-DFO-CZP","type":"EXPERIMENTAL","description":"The first 2 patients will receive 1 mCi of 89Zr-DFO-CZP.","interventionNames":["Drug: 89Zr-DFO-CZP"]},{"label":"0.5 mCi injection of 89Zr-DFO-CZP","type":"EXPERIMENTAL","description":"Subsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose.","interventionNames":["Drug: 89Zr-DFO-CZP"]},{"label":"1.5 mCi injection of 89Zr-DFO-CZP","type":"EXPERIMENTAL","description":"Subsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose.","interventionNames":["Drug: 89Zr-DFO-CZP"]},{"label":"2 mCi injection of 89Zr-DFO-CZP","type":"EXPERIMENTAL","description":"Subsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose.","interventionNames":["Drug: 89Zr-DFO-CZP"]}],"interventions":[{"type":"DRUG","name":"89Zr-DFO-CZP","description":"89Zr-DFO-Certolizumab pegol (89Zr-DFO-CZP) is a radiopharmaceutical imaging agent that will be produced under Current Good Manufacturing Practice (CGMP) regulations in the Department of Radiology and Biomedical Imaging Radiopharmaceutical Facility at University of California, San Francisco (UCSF).","armGroupLabels":["0.5 mCi injection of 89Zr-DFO-CZP","1 mCi injection of 89Zr-DFO-CZP","1.5 mCi injection of 89Zr-DFO-CZP","2 mCi injection of 89Zr-DFO-CZP"],"otherNames":["89Zr-Cimzia"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Uptake of 89Zr-DFO-CZP taken up in symptomatic versus asymptomatic joints of patients with rheumatoid arthritis (RA).","description":"Investigators will be evaluating whether 89Zr-DFO-CZP is taken up in symptomatic versus asymptomatic joints of patients with rheumatoid arthritis (RA).","timeFrame":"2 years"}],"secondaryOutcomes":[{"measure":"Uptake of 89Zr-DFO-CZP in symptomatic joints of patients with rheumatoid arthritis after administration of a Tumour Necrosis Factor alpha (TNF-alpha) inhibitor therapeutic.","description":"Investigators will be evaluating the uptake of 89Zr-DFO-CZP in symptomatic joints of patients with rheumatoid arthritis after administration of a TNF-alpha inhibitor therapeutic.","timeFrame":"2 years"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Age \\> 18 years old.\n2. Ability to read and understand written informed consent document.\n3. Patients with clinical diagnosis of rheumatoid arthritis.\n\nExclusion Criteria:\n\n1. For patients planning to be imaged on PET (positron emission tomography) / MRI (magnetic resonance imaging) (PET/MR) scanner, exclusion criteria will include any contra-indication to MRI, including permanent pacemaker, implantable metallic device/ prosthetic, aneurysm clip, non-removable piercing, or severe claustrophobia.\n2. Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator.\n3. Patients who have had a study involving radiation within one year of enrolling in this study.\n4. Patients who are pregnant (female patients of childbearing age will be tested prior to injection of imaging agent - positive test will exclude from participating in the study).\n5. Patients who are breastfeeding.\n6. Patients who cannot confirm that they will use reliable contraceptive methods for 90 days.\n7. Patients treated with TNF-alpha inhibitor therapy.\n8. Females of child-bearing age (\\<50 years old), until data from the dose-finding study has been reviewed by the UCSF Radiation Safety Committee and explicit written permission has been provided by the UCSF Radiation Safety Committee to open the window of potential female participants to ages 18 years and older.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Robert Flavell, MD, PhD","affiliation":"University of California, San Francisco","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","zip":"94143","country":"United States","geoPoint":{"lat":37.77493,"lon":-122.41942}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"conditionBrowseModule":{"meshes":[{"id":"D001172","term":"Arthritis, Rheumatoid"}],"ancestors":[{"id":"D001168","term":"Arthritis"},{"id":"D007592","term":"Joint Diseases"},{"id":"D009140","term":"Musculoskeletal Diseases"},{"id":"D012216","term":"Rheumatic Diseases"},{"id":"D003240","term":"Connective Tissue Diseases"},{"id":"D017437","term":"Skin and Connective Tissue Diseases"},{"id":"D001327","term":"Autoimmune Diseases"},{"id":"D007154","term":"Immune System Diseases"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT00467935","orgStudyIdInfo":{"id":"FVF3933"},"organization":{"fullName":"Retina Research Foundation","class":"OTHER"},"briefTitle":"Scotoma Reduction in AMD Patients Treated With Ranibizumab","officialTitle":"A Phase I/II Study to Evaluate Scotoma Reduction in And Limited Visual Acuity in aGe Related Macular Degeneration Patients Treated With Intravitreal Lucentis","acronym":"SALVAGE"},"statusModule":{"statusVerifiedDate":"2011-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-03"},"primaryCompletionDateStruct":{"date":"2007-11","type":"ACTUAL"},"completionDateStruct":{"date":"2007-11","type":"ACTUAL"},"studyFirstSubmitDate":"2007-04-29","studyFirstSubmitQcDate":"2007-04-30","studyFirstPostDateStruct":{"date":"2007-05-01","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-07-28","lastUpdatePostDateStruct":{"date":"2011-07-29","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Paul Beer, MD","oldOrganization":"Retina Consultants, PLLC"},"leadSponsor":{"name":"Retina Research Foundation","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This is a trial aimed at patients with advanced wet macular degeneration and macular scarring treated wiht intravitreal injections of Lucentis.","detailedDescription":"Patients with severe wet macular degeneration and scarring in the center of the retina may benefit from treatment if the size of the blind spot is reduced wiht injections of Lucentis."},"conditionsModule":{"conditions":["Macular Degeneration"],"keywords":["amd","disciform","fibrosis","Lucentis","scotoma"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1","PHASE2"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":20,"type":"ESTIMATED"}},"armsInterventionsModule":{"interventions":[{"type":"DRUG","name":"intravitreal injection Lucentis (ranibizumab)","description":"intravitreal injection Lucentis (ranibizumab)"}]},"outcomesModule":{"primaryOutcomes":[{"measure":"scotoma reduction","timeFrame":"12 months"}],"secondaryOutcomes":[{"measure":"improved visual function","timeFrame":"12 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* BCVA \\< 20/320\n* Disciform macular degeneration wiht exudation\n\nExclusion Criteria:\n\n* Non-amd CNV","healthyVolunteers":false,"sex":"ALL","minimumAge":"50 Years","maximumAge":"90 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Paul M Beer, MD","affiliation":"Retina Research Foundation","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Retina Research Center","city":"Slingerlands","state":"New York","zip":"12159","country":"United States","geoPoint":{"lat":42.62925,"lon":-73.86457}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Sponsor","url":"http://www.retinaresearchfoundation.org"},{"label":"sponsor","url":"http://retinaconsultants.org"}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"conditionBrowseModule":{"meshes":[{"id":"D008268","term":"Macular Degeneration"},{"id":"D006009","term":"Glycogen Storage Disease Type 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Metabolic Diseases"},{"id":"D010335","term":"Pathologic Processes"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"},{"id":"D014786","term":"Vision Disorders"},{"id":"D012678","term":"Sensation Disorders"},{"id":"D009461","term":"Neurologic Manifestations"},{"id":"D012816","term":"Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D000069579","term":"Ranibizumab"}],"ancestors":[{"id":"D061067","term":"Antibodies, Monoclonal, Humanized"},{"id":"D000911","term":"Antibodies, Monoclonal"},{"id":"D000906","term":"Antibodies"},{"id":"D007136","term":"Immunoglobulins"},{"id":"D007162","term":"Immunoproteins"},{"id":"D001798","term":"Blood Proteins"},{"id":"D011506","term":"Proteins"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D012712","term":"Serum Globulins"},{"id":"D005916","term":"Globulins"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT00441935","orgStudyIdInfo":{"id":"2004-073"},"organization":{"fullName":"Corewell Health East","class":"OTHER"},"briefTitle":"InterStim Prospective Database","officialTitle":"InterStim Prospective Database for Outcomes Research"},"statusModule":{"statusVerifiedDate":"2017-12","overallStatus":"TERMINATED","whyStopped":"Shift in department's research interest","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2004-04"},"primaryCompletionDateStruct":{"date":"2016-12-16","type":"ACTUAL"},"completionDateStruct":{"date":"2016-12-16","type":"ACTUAL"},"studyFirstSubmitDate":"2007-02-28","studyFirstSubmitQcDate":"2007-02-28","studyFirstPostDateStruct":{"date":"2007-03-01","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-12-21","lastUpdatePostDateStruct":{"date":"2017-12-26","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR_INVESTIGATOR","investigatorFullName":"Kenneth Peters, MD","investigatorTitle":"Principal Investigator","investigatorAffiliation":"Corewell Health East"},"leadSponsor":{"name":"Kenneth Peters, MD","class":"OTHER"},"collaborators":[{"name":"Corewell Health East","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The study is to collect information from patient charts and patient questionnaires to evaluate the effects of nerve stimulation therapy on urinary dysfunction.","detailedDescription":"Men and women with urinary incontinence (leakage of urine), frequency, and bladder pain experience embarrassment, inconvenience, and a significant negative impact on their quality of life. Although traditional treatments such as medications, diet modification, and bladder training provide relief for some people, others do not experience improvement with these treatments. Recently, mechanical devices much like a heart pacemaker have been developed to stimulate the nerves (sacral and pudendal) responsible for controlling bladder function. During a two stage operation, a permanent electrical wire is implanted in the lower back and connected to a mechanical box (stimulator) implanted under the patients skin in the hip area.\n\nParticipants will be asked to complete a set of questionnaires (Intake Form, Urinary Incontinence Treatment Network (UITN) Sexual Activity Questionnaire, Interstitial Cystitis Symptom Index and Problem Index, voiding diary) within 60 days prior to the procedure. Preoperative clinical information such as primary diagnosis, history of failed therapies, and medical history will be collected from the physician office record, and operative information will be collected from the inpatient hospital record. After the two stage operation (3, 6, and 12 months, then yearly thereafter as long as the device is in place) participants will be sent questionnaires. Upon completion and return to the study site"},"conditionsModule":{"conditions":["Urinary Retention","Urinary Incontinence","Pelvic Pain"],"keywords":["Urinary Retention","Urinary Incontinence","Pelvic Pain"]},"designModule":{"studyType":"OBSERVATIONAL","designInfo":{"observationalModel":"OTHER","timePerspective":"PROSPECTIVE"},"enrollmentInfo":{"count":736,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Interstim Neuromodulation","description":"Subjects undergoing implantation of an Interstim device for neuromodulation.","interventionNames":["Device: Interstim Neuromodulation"]}],"interventions":[{"type":"DEVICE","name":"Interstim Neuromodulation","description":"Two stage procedure to implant an interstim device for neuromodulation.","armGroupLabels":["Interstim Neuromodulation"]}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* All patients at least 18 years of age scheduled for sacral nerve stimulator implantation at William Beaumont Hospital, Royal Oak, Michigan who give informed consent to participate in the project.\n\nExclusion Criteria:\n\n* None","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"],"studyPopulation":"patients at least 18 years of age scheduled for sacral nerve stimulator implantation at William Beaumont Hospital, Royal Oak","samplingMethod":"NON_PROBABILITY_SAMPLE"},"contactsLocationsModule":{"overallOfficials":[{"name":"Kenneth Peters, MD","affiliation":"Corewell Health East","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"William Beaumont Hospital","city":"Royal Oak","state":"Michigan","zip":"48073","country":"United States","geoPoint":{"lat":42.48948,"lon":-83.14465}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"conditionBrowseModule":{"meshes":[{"id":"D016055","term":"Urinary Retention"},{"id":"D014549","term":"Urinary Incontinence"},{"id":"D017699","term":"Pelvic Pain"}],"ancestors":[{"id":"D014555","term":"Urination Disorders"},{"id":"D014570","term":"Urologic Diseases"},{"id":"D052776","term":"Female Urogenital Diseases"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D052801","term":"Male Urogenital Diseases"},{"id":"D059411","term":"Lower Urinary Tract Symptoms"},{"id":"D020924","term":"Urological Manifestations"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"},{"id":"D010146","term":"Pain"},{"id":"D009461","term":"Neurologic Manifestations"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT07343635","orgStudyIdInfo":{"id":"KY-2025-274"},"organization":{"fullName":"The Fourth Affiliated Hospital of Zhejiang University School of Medicine","class":"OTHER"},"briefTitle":"The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined With Tofacitinib and Doxycycline in Chinese Adult Patients With Mild to Moderate Erythematous Telangiectatic Rosacea","officialTitle":"The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined With Tofacitinib and Doxycycline in Chinese Adult Patients With Mild to Moderate Erythematous Telangiectatic Rosacea: A Prospective Parallel Controlled Single-blind Cohort Study"},"statusModule":{"statusVerifiedDate":"2026-03","overallStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2026-02-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2027-07-01","type":"ESTIMATED"},"completionDateStruct":{"date":"2027-07-01","type":"ESTIMATED"},"studyFirstSubmitDate":"2025-12-04","studyFirstSubmitQcDate":"2026-01-07","studyFirstPostDateStruct":{"date":"2026-01-15","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-03-20","lastUpdatePostDateStruct":{"date":"2026-03-24","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"The Fourth Affiliated Hospital of Zhejiang University School of Medicine","class":"OTHER"}},"oversightModule":{"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The efficacy and safety of anti-inflammation treatment (Hirudoid introduction followed by yellow light therapy) combined with tofacitinib and doxycycline in Chinese adult patients with mild to moderate erythematous telangiectatic rosacea: A prospective parallel controlled single-blind cohort study"},"conditionsModule":{"conditions":["Erythematotelangiectatic Rosacea"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":186,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Control group","type":"ACTIVE_COMPARATOR","description":"Participants receive doxycycline combined with hydroxychloroquine.","interventionNames":["Drug: Doxycycline","Drug: Hydroxychloroquine"]},{"label":"Tofacitinib group","type":"ACTIVE_COMPARATOR","description":"Participants receive doxycycline combined with tofacitinib.","interventionNames":["Drug: Doxycycline","Drug: Tofacitinib"]},{"label":"Anti-inflammation Treatment and Tofacitinib group","type":"EXPERIMENTAL","description":"Participants receive doxycycline and tofacitinib combined with anti-inflammatory treatment.","interventionNames":["Drug: Doxycycline","Drug: Tofacitinib","Device: Anti-inflammatory Treatment (Hirudoid Introduction Followed by Yellow Light Therapy)"]}],"interventions":[{"type":"DRUG","name":"Doxycycline","description":"Doxycycline 100 mg orally once daily","armGroupLabels":["Anti-inflammation Treatment and Tofacitinib group","Control group","Tofacitinib group"]},{"type":"DRUG","name":"Hydroxychloroquine","description":"Hydroxychloroquine 200 mg orally twice daily.","armGroupLabels":["Control group"]},{"type":"DRUG","name":"Tofacitinib","description":"Tofacitinib 5mg orally twice daily.","armGroupLabels":["Anti-inflammation Treatment and Tofacitinib group","Tofacitinib group"]},{"type":"DEVICE","name":"Anti-inflammatory Treatment (Hirudoid Introduction Followed by Yellow Light Therapy)","description":"Topical application of Hirudoid followed by yellow light therapy (wavelength 590 nm, duration 20 minutes per session, once weekly)","armGroupLabels":["Anti-inflammation Treatment and Tofacitinib group"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Achievement of IGA treatment success at Week 12","description":"Achievement of IGA treatment success(IGA = 0 or 1, and the proportion of subjects with an improvement of ≥2 grades from baseline) at Week 12","timeFrame":"0 week、12 week"}],"secondaryOutcomes":[{"measure":"The proportion of subjects achieving successful IGA treatment","description":"The proportion of subjects achieving successful IGA treatment (IGA = 0 or 1, and the proportion of subjects with an improvement of ≥2 grades from baseline)","timeFrame":"From baseline to weeks 4, 8, and 12"},{"measure":"Dermatology Life Quality Index（DLQI）","description":"Patient questionnaire, score is calculated between 0 (worst score possible) and 30 (best score possible)","timeFrame":"Baseline, week 12"},{"measure":"Change in facial erythema severity assessed by VISIA imaging system","description":"Facial erythema severity will be quantitatively assessed using the VISIA imaging system. Standardized facial photographs will be obtained at each visit, and changes in erythema severity from baseline will be evaluated using VISIA-derived analysis.","timeFrame":"From baseline to weeks 4, 8, and 12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* The subjects are male or female, aged 18 to 70 years (inclusive); they voluntarily participate in this study and sign the informed consent form.\n* They are diagnosed with erythematous telangiectatic rosacea, meeting the diagnostic criteria in the \"Chinese Guidelines for the Diagnosis and Treatment of Rosacea (2021)\".\n* At screening and baseline, the IGA score is 2 (mild) or 3 (moderate).\n* The subjects agree not to use any other rosacea treatment drugs (prescription or over-the-counter) during the study period.\n* The subjects are willing to minimize external factors that may trigger rosacea (such as spicy food, alcoholic beverages, prolonged sun exposure, etc.).\n* The subjects (including their partners) agree that they have no plans to conceive within 3 months after signing the informed consent form until the end of the last treatment and are willing to take effective contraceptive measures voluntarily.\n\nExclusion Criteria:\n\n* Diagnosed as papulopustular, hypertrophic, ocular rosacea or other special types of rosacea\n* Other facial skin diseases that were active during the screening period or baseline may interfere with the efficacy/safety assessment of erythematous vasodilating rosacea, including but not limited to perioral dermatitis, facial keratosis, seborrheic dermatitis, and acne vulgaris. If the above-mentioned skin diseases were in clinical remission both during the screening period and at baseline, and the investigators determined that they would not affect the assessment of this study, they could be included.\n* Subjects who have underlying known diseases or medical conditions, or who have undergone major surgeries within the six months prior to screening, where, based on the researcher's judgment, the subjects are at risk (such as cancer, leukemia or cachexia in the blood system);\n* During the screening period or at baseline, researchers evaluate abnormal laboratory test results with significant clinical significance;\n* Those who have received LED light therapy for their faces in the past two weeks;\n* Those who have received laser, intense pulsed light (IPL), fractional microneedle radiofrequency treatment, CO2 exfoliating fractional laser treatment, electrocoagulation, dermabrasion, chemical peels, or any facial procedures (such as Thermage, etc.) for facial treatment in the past 6 weeks;\n* Facial active infections who are currently receiving or require systemic treatment (systemic antibiotics, antifungal, antiviral drugs) - including bacterial pustules, fungal folliculitis, herpeder-like skin lesions and massive proliferation of Demodex mites;\n* Local/systemic treatment that did not complete an adequate elution period before baseline, including: Glucocorticoids (corticosteroids), calcineurin inhibitors (such as tacrolimus, pimecrolimus), Janus kinase inhibitors, epidermal growth factors (such as commercially available repair dressings containing recombinant human EGF), acne treatment drugs (such as azelaic acid, retinoids, benzoyl peroxide, traditional Chinese medicine/Chinese patent medicine treatment), Such as tanshinone, metronidazole tablets, etc.), immunomodulators, topical astringents/exfoliating products, antibiotics (such as macrolides, metronidazole), high-concentration vitamin A (10,000 units per day), anti-pruritus drugs (such as antihistamines), etc.\n* Use drugs that cause acne-like rashes simultaneously (such as azathioprine, haloperidol, halogens, lithium, systemic corticosteroids, phenytoin sodium, phenobarbital, testosterone, anabolic steroids, isoniazid);\n* Those who have used astringents/exfoliating products (cleansing or exfoliating products containing salicylic acid or alcohol) within the past 2 days or are planned to use them during the study period;\n* The subject has a history of alcohol abuse (drinking more than 14 units) within the past 2 years or a history of drug abuse within the past 5 years;\n* Individuals infected with human immunodeficiency virus (HIV), those in the active stage of hepatitis C virus (HCV) infection (positive for anti-HCV), or those in the active stage of hepatitis B virus (HBV) infection (HBV-DNA \\> 2000IU/mL or 104 copies /ml), or those with positive Treponema pallidum antibodies showing an active stage of infection;\n* Female subjects who plan to become pregnant or breastfeed during the study period;\n* Those who are sensitive to light or use photosensitive drugs;\n* People who are allergic to Hirudoid, tofacitinib, doxycycline, hydroxychloroquine or their ingredients.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"centralContacts":[{"name":"Liu","role":"CONTACT","phone":"0579-89979999","email":"2197055@zju.edu.cn"}],"locations":[{"facility":"The Fourth Affiliated Hospital of Zhejiang University School of Medicine","status":"RECRUITING","city":"Yiwu","state":"Zhejiang","zip":"322000","country":"China","contacts":[{"name":"Liu","role":"CONTACT","phone":"0579-89979999","email":"2197055@zju.edu.cn"}],"geoPoint":{"lat":29.31506,"lon":120.07676}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"conditionBrowseModule":{"meshes":[{"id":"D012393","term":"Rosacea"}],"ancestors":[{"id":"D012871","term":"Skin Diseases"},{"id":"D017437","term":"Skin and Connective Tissue Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D004318","term":"Doxycycline"},{"id":"D006886","term":"Hydroxychloroquine"},{"id":"C479163","term":"tofacitinib"}],"ancestors":[{"id":"D013754","term":"Tetracyclines"},{"id":"D009279","term":"Naphthacenes"},{"id":"D011084","term":"Polycyclic Aromatic Hydrocarbons"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D011083","term":"Polycyclic Compounds"},{"id":"D002738","term":"Chloroquine"},{"id":"D000634","term":"Aminoquinolines"},{"id":"D011804","term":"Quinolines"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT00555035","orgStudyIdInfo":{"id":"ING111207"},"organization":{"fullName":"GlaxoSmithKline","class":"INDUSTRY"},"briefTitle":"GSK1349572 First Time in Human Study","officialTitle":"A Double-Blind, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK1349572 in Healthy Subjects"},"statusModule":{"statusVerifiedDate":"2010-10","overallStatus":"COMPLETED","startDateStruct":{"date":"2007-11"},"primaryCompletionDateStruct":{"date":"2008-02","type":"ACTUAL"},"completionDateStruct":{"date":"2008-02","type":"ACTUAL"},"studyFirstSubmitDate":"2007-11-05","studyFirstSubmitQcDate":"2007-11-05","studyFirstPostDateStruct":{"date":"2007-11-07","type":"ESTIMATED"},"dispFirstSubmitDate":"2010-10-13","dispFirstSubmitQcDate":"2010-10-13","dispFirstPostDateStruct":{"date":"2010-10-15","type":"ESTIMATED"},"lastUpdateSubmitDate":"2010-10-13","lastUpdatePostDateStruct":{"date":"2010-10-15","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Study Director","oldOrganization":"GSK"},"leadSponsor":{"name":"GlaxoSmithKline","class":"INDUSTRY"}},"descriptionModule":{"briefSummary":"To determine safety, tolerability and pharmacokinetics of GSK1349572"},"conditionsModule":{"conditions":["Healthy Subjects"],"keywords":["GSK1349572,","healthy volunteers"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE"}},"enrollmentInfo":{"count":20,"type":"ACTUAL"}},"armsInterventionsModule":{"interventions":[{"type":"DRUG","name":"GSK1349572"}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Blood levels of drug over 72 hours. Laboratory test results over 72 hours Vital signs, ECG results over 72 hours","timeFrame":"72 hours."}],"secondaryOutcomes":[{"measure":"Dose proportionality over 72 hours","timeFrame":"72 hours."},{"measure":"GSK1349572 PK parameters: absorption lag time (tlag), and apparent clearance (CL/F) following single dose administration."},{"measure":"AUC(0-¥), AUC(0-t), Cmax, and C24 following single dose administration at different doses for the assessment of dose proportionality."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion criteria:\n\n* The subject is healthy.\n* Healthy as judged by a responsible physician with no clinically significant abnormality identified on the medical or laboratory evaluation, including 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.\n* The subject is ≥18 and ≤55 years of age.\n* The subject is male or female.\n* A female is eligible to enter and participate in this study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:\n\n  * Has had a hysterectomy or\n  * Has had a bilateral oophorectomy (removal of the ovaries) or\n  * Has had a bilateral tubal ligation or\n  * Is post-menopausal (a demonstration of total cessation of menses for ≥ 1 year from the date of screening visit). A follicle stimulating hormone (FSH) level will be performed to confirm a post-menopausal state. For this study FSH levels ≥ 40mIU/mL are consistent with menopause. If a subject is on estrogen replacement and menopausal status is questionable, estrogen replacement should be discontinued for 2 weeks and then the subject rescreened, as estrogen replacement can suppress FSH.\n* A male is eligible to enter and participate in the study if he is surgically sterile OR if he either agrees to abstain from sexual intercourse with a female partner or agrees to use a condom/spermicide, in addition to having his female partner use another form of contraception, such as an intrauterine device (IUD), occlusive cap (diaphragm or cervical/vault cap) with spermicide, oral contraceptives, injectable progesterone, subdermal implants, female condom, contraceptive patch, or contraceptive vaginal ring, or has had a tubal ligation or hysterectomy. These criteria must be followed from the time of the first dose of study medication until 14 days after the last dose of study medication.\n* Body weight ≥ 50 kg (110 lbs.) for men and ≥ 45 kg (99 lbs.) for women and body mass index (BMI) between 18.5-29.9 kg/m2 inclusive.\n* A signed and dated written informed consent is obtained from the subject prior to screening.\n* The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned.\n\nExclusion criteria:\n\n* As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study.\n* The subject's systolic blood pressure is outside the range of 90-140mmHg, or diastolic blood pressure is outside the range of 45-90mmHg or heart rate is outside the range of 50-100bpm for female subjects or 45-100 bpm for male subjects.\n* History/evidence of symptomatic or asymptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.\n* History/evidence of clinically significant pulmonary disease.\n* Has a positive pre-study Hepatitis B surface antigen; positive hepatitis C (HCV) antibody or detectable HCV ribonucleic acid (RNA); or positive HIV-1 antibody result.\n* Has a history of regular alcohol consumption averaging \\>7 drinks/week for women or \\>14 drinks/week for men (1 drink (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits) within 6 months of the screening visit.\n* Unwilling to abstain from alcohol for 48 hours prior to the start of dosing until collection of the final pharmacokinetic sample during each treatment period.\n* Has a history of regular use of tobacco- or nicotine-containing products within 3 months of the screening visit.\n* The subject has a positive pre-study drug and/or alcohol screen.\n* Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.\n* The subject has received an investigational drug or participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.\n* Participation in the study would result in donation of blood in excess of 500 mL within a 56 day period.\n* History or presence of allergy or intolerance to the study drug or its components or drugs of its class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.\n* Use of prescription or non-prescription drugs, including antacids, vitamins, herbal and dietary supplements (including St John's Wort and iron supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, or serum creatinine values greater than the upper limit of normal. A single repeat is allowed for eligibility determination.\n* Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Subjects with a history of cholecystectomy should be excluded.\n* History of significant renal or hepatic diseases.\n* History of Gilbert's syndrome.\n* Exclusion Criteria for 24-Hour Screening Holter:\n\n  * Any symptomatic arrhythmia (except isolated extra systoles).\n  * Sustained cardiac arrhythmias (such as atrial fibrillation or flutter, supraventricular tachycardia (≥10 consecutive beats), complete heart block).\n  * Non-sustained or sustained ventricular tachycardia (defined as ≥ 3 consecutive ventricular ectopic beats).\n  * Any conduction abnormality (including but not specific to left or right incomplete or complete bundle branch block, atrioventricular (AV) block \\[2nd degree or higher\\], WPW syndrome etc.).\n  * Sinus Pauses \\> 3 seconds.\n  * 300 or more supraventricular ectopic beats in 24 hours.\n  * 250 or more ventricular ectopic beats in 24 hours.\n* Evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization).\n* Any conduction abnormality (including but not specific to left or right incomplete or complete bundle branch block, AV block \\[2nd degree or higher\\], WPW syndrome).\n* Sinus Pauses \\> 3 seconds.\n* Any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety for the individual subject.\n* Non-sustained or sustained ventricular tachycardia (≥3 consecutive ventricular ectopic beats)","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"55 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"GSK Clinical Trials, MD","affiliation":"GlaxoSmithKline","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"GSK Investigational Site","city":"Evansville","state":"Indiana","zip":"47714","country":"United States","geoPoint":{"lat":37.97476,"lon":-87.55585}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"interventionBrowseModule":{"meshes":[{"id":"C562325","term":"dolutegravir"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT00561535","orgStudyIdInfo":{"id":"AEFD 2007-01"},"organization":{"fullName":"Assistance Publique - Hôpitaux de Paris","class":"OTHER"},"briefTitle":"Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS Patients","officialTitle":"Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS"},"statusModule":{"statusVerifiedDate":"2011-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-10"},"primaryCompletionDateStruct":{"date":"2010-05","type":"ACTUAL"},"completionDateStruct":{"date":"2010-06","type":"ACTUAL"},"studyFirstSubmitDate":"2007-11-20","studyFirstSubmitQcDate":"2007-11-20","studyFirstPostDateStruct":{"date":"2007-11-21","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-01-26","lastUpdatePostDateStruct":{"date":"2011-01-27","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"COFFIN","oldOrganization":"Association pour l'Etude des Fonctions Digestives"},"leadSponsor":{"name":"Assistance Publique - Hôpitaux de Paris","class":"OTHER"},"collaborators":[{"name":"Association pour l'Etude des Fonctions Digestives","class":"UNKNOWN"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"Probiotics may improve symptoms in IBS patients. The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.","detailedDescription":"The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria."},"conditionsModule":{"conditions":["Irritable Bowel Syndrome"],"keywords":["IBS","Diarrhea","Rome III"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":60,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"A","type":"EXPERIMENTAL","description":"Lactobacillus FARCIMINIS","interventionNames":["Dietary Supplement: Lactobacillus FARCIMINIS"]},{"label":"B","type":"PLACEBO_COMPARATOR","description":"Placebo","interventionNames":["Dietary Supplement: placebo (starch)"]}],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Lactobacillus FARCIMINIS","description":"10.10 UFC of lactobacillus FARCIMINIS","armGroupLabels":["A"],"otherNames":["10.10 UFC of lactobacillus FARCIMINIS"]},{"type":"DIETARY_SUPPLEMENT","name":"placebo (starch)","description":"Once daily","armGroupLabels":["B"],"otherNames":["Once daily"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Overall subject's assessment","timeFrame":"4 weeks"}],"secondaryOutcomes":[{"measure":"Decrease in abdominal pain, stool form and consistency, modifications in intestinal permeability, modification in fecal serine protease activity, modifications in interleukin seric concentrations","timeFrame":"4 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diarrhea predominant IBS\n* Less than 5-year duration\n* Pain intensity between 2 and 7 on VAS\n\nExclusion Criteria:\n\n* Celiac disease\n* Antibiotic treatment within the 1-month period preceding inclusion\n* Digestive organic disease\n* Any severe non digestive organic disease","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Benoit Coffin, Prof","affiliation":"Assistance Publique - Hôpitaux de Paris","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Yoram Bouhnik, Prof","affiliation":"Assistance Publique - Hôpitaux de Paris","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Hopital Louis Mourier, GI Unit","city":"Colombes","state":"Île-de-France Region","zip":"92700","country":"France","geoPoint":{"lat":48.91882,"lon":2.25404}}]},"referencesModule":{"references":[{"pmid":"18848833","type":"BACKGROUND","citation":"Camilleri M, Chang L. Challenges to the therapeutic pipeline for irritable bowel syndrome: end points and regulatory hurdles. Gastroenterology. 2008 Dec;135(6):1877-91. doi: 10.1053/j.gastro.2008.09.005. Epub 2008 Oct 9."}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"conditionBrowseModule":{"meshes":[{"id":"D043183","term":"Irritable Bowel Syndrome"},{"id":"D003967","term":"Diarrhea"}],"ancestors":[{"id":"D003109","term":"Colonic Diseases, Functional"},{"id":"D003108","term":"Colonic Diseases"},{"id":"D007410","term":"Intestinal Diseases"},{"id":"D005767","term":"Gastrointestinal Diseases"},{"id":"D004066","term":"Digestive System Diseases"},{"id":"D012817","term":"Signs and Symptoms, Digestive"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT01504035","orgStudyIdInfo":{"id":"ORG 001"},"organization":{"fullName":"University Hospital, Basel, Switzerland","class":"OTHER"},"briefTitle":"Analgetic Effectiveness of a Lidocaine Loaded Hemostatic, Bioresorbable Putty","officialTitle":"Effectiveness of the Addition of Lidocaine to a Hemostatic, Bioresorbable Putty in the Treatment of Iliac Crest Donor Site Pain"},"statusModule":{"statusVerifiedDate":"2012-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-05"},"primaryCompletionDateStruct":{"date":"2008-07","type":"ACTUAL"},"completionDateStruct":{"date":"2008-11","type":"ACTUAL"},"studyFirstSubmitDate":"2012-01-02","studyFirstSubmitQcDate":"2012-01-03","studyFirstPostDateStruct":{"date":"2012-01-04","type":"ESTIMATED"},"lastUpdateSubmitDate":"2012-02-08","lastUpdatePostDateStruct":{"date":"2012-02-09","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University Hospital, Basel, Switzerland","class":"OTHER"},"collaborators":[{"name":"Orthocon, Inc.","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The goal of this study was to test the efficacy of local analgesic (lidocaine) loaded hemostatic putty in reducing donor site pain following the harvest of pelvic bone grafts. In 14 patients undergoing harvest of a pelvic bone graft during foot surgery, the bone defect at the pelvis was either filled with a lidocaine loaded hemostatic putty (Orthostat-L) or the same putty without lidocaine (Orthostat, currently marketed as Hemabsorb). Postoperatively, foot pain was eliminated with a peripheral nerve block, while pelvis pain was quantified with two commonly used pain rating scales (VAS and Wong Baker). Blood samples were collected at regular time intervals to measure lidocaine levels. Patients which received the lidocaine loaded putty experienced significantly less pain during the first 12 hours after surgery as compared to those patients who received the lidocaine deficient putty. Blood lidocaine levels always stayed below the toxic threshold.","detailedDescription":"The harvest of iliac crest bone grafts (ICBG) is associated with relevant donor site pain, but may be lowered by the local application of a biodegradable, hemostatic putty loaded with Lidocaine (=Orthostat-L ™) for sustained local analgesic release. The primary goal of this double-blind controlled trial was to assess the efficacy of the addition of Lidocaine to a hemostatic putty in reducing donor site pain following ICBG in foot and ankle procedures.\n\nIn 14 patients undergoing ICBG harvest during a foot and ankle procedure, the bone defect at the iliac crest was either filled with Orthostat-L™ (n=7) or with the same hemostatic putty without Lidocaine (Orthostat ™, n=7; currently marketed as HemasorbTM). Postoperatively, donor site pain was managed by patient controlled morphine delivery while surgical site pain was eliminated by a peripheral nerve block. During the first 72 postoperative hours, donor site pain was quantified every 4 hours using a Visual Analog Scale (VAS) and the Wong Baker FACES pain rating scale. In addition, cumulated morphine doses required by the patients and serum Lidocaine levels were registered. Pain scores were plotted over time to calculate the area under the curve (AUC) as a representative of the overall pain experienced within specific time points.\n\nThere were no significant differences in bone graft size, putty amount and cumulated morphine use between the two groups. Orthostat-L™ provided a significant overall harvest site pain reduction over the first 12 hours postoperatively as evidenced by a significant decrease of the AUC in both VAS and Wong Baker FACES pain score plots (p=0.0366 and p = 0.0024, respectively). After 12 hours, pain scores rapidly returned to baseline levels in both groups. Serum Lidocaine consistently remained below the level of toxicity of 6mg/l.\n\nIn conclusion, the addition of Lidocaine to a hemostatic putty offers a significant ICBG harvest site pain reduction over the first 12 postoperative hours and appears to be safe in clinical use."},"conditionsModule":{"conditions":["Pain"],"keywords":["Donor site pain","Iliac crest","Bone graft","Hemostatic putty","lidocaine","Donor site pain following harvest of iliac crest bone grafts"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":14,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Hemostatic putty plus Lidocaine (Orthostat-L)","type":"EXPERIMENTAL","interventionNames":["Device: Orthostat-L"]},{"label":"Hemostatic putty (Orthostat)","type":"ACTIVE_COMPARATOR","interventionNames":["Device: Orthostat"]}],"interventions":[{"type":"DEVICE","name":"Orthostat-L","description":"Application of nx2g Lidocaine loaded hemostatic putty, i.e. Orthostat-L at the iliac crest bone graft harvest site","armGroupLabels":["Hemostatic putty plus Lidocaine (Orthostat-L)"],"otherNames":["Xybrex"]},{"type":"DEVICE","name":"Orthostat","description":"Application of nx2g hemostatic putty, i.e. Orthostat at the iliac crest bone graft harvest site","armGroupLabels":["Hemostatic putty (Orthostat)"],"otherNames":["Hemabsorb"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pelvic Donor Site Pain quantified by the VAS and Wong Baker Pain Rating Scale","description":"Pain scores were plotted over time to either quantify pain at specific time points or to calculate the area under the curve in between two time points as a representative of the overall pain experienced in a specific time intervall.","timeFrame":"72 hours after putty administration"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patient scheduled for a foot and ankle procedure that requires harvest of an iliac crest bone graft\n* Written informed consent\n* No child bearing potential\n\nExclusion Criteria:\n\n* History of iliac crest bone graft removal\n* Liver failure\n* Heart failure\n* Mental condition impeding cooperation in the study ( e.g. dementia)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"71 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Valderrabano Victor, MD PhD","affiliation":"Orthopedic Department, University Hospital Basel, Switzerland","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University Hospital Basel","city":"Basel","state":"Canton of Basel-City","zip":"4031","country":"Switzerland","geoPoint":{"lat":47.55839,"lon":7.57327}}]},"referencesModule":{"references":[{"pmid":"19224820","type":"BACKGROUND","citation":"Wang CF, Djalali AG, Gandhi A, Knaack D, De Girolami U, Strichartz G, Gerner P. An absorbable local anesthetic matrix provides several days of functional sciatic nerve blockade. Anesth Analg. 2009 Mar;108(3):1027-33. doi: 10.1213/ane.0b013e318193596a."},{"pmid":"21169797","type":"BACKGROUND","citation":"Wang CF, Pancaro C, Gerner P, Strichartz G. Prolonged suppression of postincisional pain by a slow-release formulation of lidocaine. Anesthesiology. 2011 Jan;114(1):135-49. doi: 10.1097/ALN.0b013e3182001996."},{"pmid":"25482244","type":"DERIVED","citation":"Muller MA, Mehrkens A, Zurcher R, Vavken P, Valderrabano V. Effectiveness of the addition of Lidocaine to a hemostatic, bioresorbable putty in the treatment of iliac crest donor site pain. BMC Musculoskelet Disord. 2014 Dec 8;15:415. doi: 10.1186/1471-2474-15-415."}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"conditionBrowseModule":{"meshes":[{"id":"D010146","term":"Pain"}],"ancestors":[{"id":"D009461","term":"Neurologic Manifestations"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT05277935","orgStudyIdInfo":{"id":"WEFITTER"},"organization":{"fullName":"Beneficência Portuguesa de São Paulo","class":"OTHER"},"briefTitle":"Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib","officialTitle":"Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib","acronym":"WEFITTER"},"statusModule":{"statusVerifiedDate":"2024-08","overallStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-04-22","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-03-01","type":"ESTIMATED"},"completionDateStruct":{"date":"2025-03-01","type":"ESTIMATED"},"studyFirstSubmitDate":"2022-01-12","studyFirstSubmitQcDate":"2022-03-03","studyFirstPostDateStruct":{"date":"2022-03-14","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-08-23","lastUpdatePostDateStruct":{"date":"2024-08-26","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Graziela Zibetti Dal Molin","investigatorTitle":"MD","investigatorAffiliation":"Beneficência Portuguesa de São Paulo"},"leadSponsor":{"name":"Beneficência Portuguesa de São Paulo","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Combining a fitness tracker technology with real-time patient-reported outcome monitoring associated with interventions through a health care app is a novel strategy to evaluate metastatic breast cancer patients using Palbociclib and endocrine treatment.","detailedDescription":"Measure the quality of life of patients with metastatic breast cancer treated with Palbociclib and endocrine therapy using the Functional Assessment of Cancer Therapy - Breast and EuroQol -5D - European quality of life in five dimensions and compare the group using the Wecancer digital health app with the group using Wecancer and the physical activity monitoring smartwatch."},"conditionsModule":{"conditions":["Breast Neoplasm Female","Quality of Life"],"keywords":["Quality of life","Metastatic breast cancer","Metastasis","Exercise","Palbociclib"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"OTHER","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":68,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Use of the WeCancer app combined with the smartwatch","type":"ACTIVE_COMPARATOR","description":"The Wecancer app will be used in a way, combined with a smartwatch, similar to those used in professional fitness programs, with active measures, which may include, for example: notifications with personalized advice (via chat), feedback to the patient in the comments made, guidance on physical and eating exercises, reception and support from the Wecancer multidisciplinary team, consisting of a navigator nurse, psychologist, nutritionist and physiotherapist. During the survey period, participants should report their symptoms on the Wecancer app whenever possible, preferably daily.","interventionNames":["Device: Use of the WeCancer app combined with the smartwatch."]},{"label":"Using the WeCancer app","type":"NO_INTERVENTION","description":"The Wecancer application similar to those used in professional fitness programs, with active measures, which may include, for example: notifications with personalized advice (via chat), patient feedback on the comments made, guidance on physical and dietary exercises, reception and support of the Multidisciplinary cancer team composed of a navigator nurse, a psychologist, nutritionist and physiotherapist. During the research period, participants must report your symptoms in the Wecancer app whenever possible, preferably daily."}],"interventions":[{"type":"DEVICE","name":"Use of the WeCancer app combined with the smartwatch.","description":"To evaluate if a fitness tracker added to eHealth technology will improve quality of life compared to the use of eHealth technology alone in metastasis breast cancer patients treated with palbociclib and endocrine therapy","armGroupLabels":["Use of the WeCancer app combined with the smartwatch"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast","description":"Measure the Quality of life of patients with metastatic breast cancer treated with Palbociclib and endocrine therapy using the Functional Assessment of Cancer Therapy - Breast and compare the group using the Wecancer digital health app with the group using Wecancer and the physical activity monitoring smartwatch.\n\nThe comparison of the two groups in relation to quality of life, measured by the general score of the Functional Assessment of Cancer Therapy - Breast and its sub-items, over time will be made using a linear model withmixed effects, that is, fixed effects and random effects. Time and group fixed effects will be considered, the patient will be considered random effect. The effects of time, group and interaction between them will be tested.","timeFrame":"Baseline"},{"measure":"Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast","description":"Measure the Quality of life of patients with metastatic breast cancer treated with Palbociclib and endocrine therapy using the Functional Assessment of Cancer Therapy - Breast and compare the group using the Wecancer digital health app with the group using Wecancer and the physical activity monitoring smartwatch.\n\nThe comparison of the two groups in relation to quality of life, measured by the general score of the Functional Assessment of Cancer Therapy - Breast and its sub-items, over time will be made using a linear model withmixed effects, that is, fixed effects and random effects. Time and group fixed effects will be considered, the patient will be considered random effect. The effects of time, group and interaction between them will be tested.","timeFrame":"Follow up 2 month"},{"measure":"Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast","description":"Measure the Quality of life of patients with metastatic breast cancer treated with Palbociclib and endocrine therapy using the Functional Assessment of Cancer Therapy - Breast and compare the group using the Wecancer digital health app with the group using Wecancer and the physical activity monitoring smartwatch.\n\nThe comparison of the two groups in relation to quality of life, measured by the general score of the Functional Assessment of Cancer Therapy - Breast and its sub-items, over time will be made using a linear model withmixed effects, that is, fixed effects and random effects. Time and group fixed effects will be considered, the patient will be considered random effect. The effects of time, group and interaction between them will be tested.","timeFrame":"Follow up 4 month"},{"measure":"Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast","description":"Measure the Quality of life of patients with metastatic breast cancer treated with Palbociclib and endocrine therapy using the Functional Assessment of Cancer Therapy - Breast and compare the group using the Wecancer digital health app with the group using Wecancer and the physical activity monitoring smartwatch.\n\nThe comparison of the two groups in relation to quality of life, measured by the general score of the Functional Assessment of Cancer Therapy - Breast and its sub-items, over time will be made using a linear model withmixed effects, that is, fixed effects and random effects. Time and group fixed effects will be considered, the patient will be considered random effect. The effects of time, group and interaction between them will be tested.","timeFrame":"Follow up 6 month"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Female patients ≥ 18 years of age diagnosed with hormone receptor-positive/ human epidermal growth factor receptor 2- negative metastatic breast cancer undergoing treatment with Palbociclib combined with aromatase inhibitors (letrozole, exemestane or anastrozole) or fulvestrant as first-line therapy, or in treatment with Palbociclib and fulvestrant as second-line or posterior-line therapy in the metastatic setting; may be using ovarian suppression if the patient is premenopausal.\n* The patient must be on treatment for at least three (3) months with Palbociclib and endocrine therapy.\n* Evidence of a signed and dated informed consent document, physically or digitally, indicating that the research participant was informed about all relevant aspects of the study;\n* The patient agrees not to participate in another study with drug intervention while on treatment.\n* Have performance status according to the Eastern Cooperative Oncology Group\n* Have access to a compatible smartphone and 3G or 4G internet connection\n\nExclusion Criteria:\n\n* Patients considered to be at poor medical risk due to uncontrolled serious medical disorder, non-malignant systemic disease, or active uncontrolled infection. Examples: uncontrolled ventricular arrhythmia, recent myocardial infarction (within 6 months), stroke, gastrointestinal bleeding, or any psychiatric disorder that precludes informed consent; between others.\n* Patients who have a life expectancy of \\< 3 months.\n* Treatment with any product under investigation during the last 28 days;\n* Another acute or chronic medical or psychiatric condition or severe laboratory abnormality that could increase the risk associated with participation in the study or that Page 10 de 21 Version 6.0 could interfere with the interpretation of the study results and, in the investigator's judgment, would make the research participant unsuitable for inclusion in the study. study.\n* Illiterate patients or those with a low level of education that may prevent the correct use of the Wecancer application and/or the watch with monitoring of physical activity.","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"centralContacts":[{"name":"Bianca Verboski","role":"CONTACT","phone":"11-35052639","phoneExt":"55","email":"naipe@bp.org.br"},{"name":"Bianca Verboski","role":"CONTACT","phone":"11-35052639","phoneExt":"55","email":"bianca.verboski@bp.org.br"}],"overallOfficials":[{"name":"Graziela Dal Molin, MD","affiliation":"Beneficência Portuguesa de São Paulo","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Oncoclínicas","status":"RECRUITING","city":"Rio de Janeiro","country":"Brazil","contacts":[{"name":"Mayara Pinto","role":"CONTACT","phone":"+55 11 97144-5373","email":"mayara.pinto@oncoclinicas.com"},{"name":"Aline Gonçalves, MD","role":"SUB_INVESTIGATOR"}],"geoPoint":{"lat":-22.90642,"lon":-43.18223}},{"facility":"A Beneficência Portuguesa de São Paulo","status":"RECRUITING","city":"São Paulo","country":"Brazil","contacts":[{"name":"Bianca Verboski","role":"CONTACT","phone":"+551135055031","email":"bianca.verboski@bp.org.br"},{"name":"Jessica Borges","role":"CONTACT","phone":"+551135055722","email":"naipe@bp.org.br"},{"name":"Graziela Dal Molin, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":-23.5475,"lon":-46.63611}},{"facility":"A.C.Camargo Cancer Center","status":"RECRUITING","city":"São Paulo","country":"Brazil","contacts":[{"name":"Marcelle Goldner Cesca, MD","role":"CONTACT","phone":"+55 11 93148-9664","email":"marcelle.goldner@gmail.com"},{"name":"Solange Moraes Sanches, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":-23.5475,"lon":-46.63611}},{"facility":"Centro Paulista de Oncologia","status":"RECRUITING","city":"São Paulo","country":"Brazil","contacts":[{"name":"Mayara Batista","role":"CONTACT","phone":"+55 11 2678-5800","phoneExt":"5433","email":"mayara.pinto@oncoclinicas.com"},{"name":"Larissa Gomes, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":-23.5475,"lon":-46.63611}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"conditionBrowseModule":{"meshes":[{"id":"D001943","term":"Breast Neoplasms"},{"id":"D009362","term":"Neoplasm Metastasis"},{"id":"D009043","term":"Motor Activity"}],"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"},{"id":"D009385","term":"Neoplastic Processes"},{"id":"D010335","term":"Pathologic Processes"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"},{"id":"D001519","term":"Behavior"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT01497535","orgStudyIdInfo":{"id":"NN304-1438"},"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Within-subject Variability of Insulin Detemir in Healthy Volunteers","officialTitle":"A Single-centre, Parallel-group, Randomised, Double Blind Trial in Healthy Japanese Subjects Comparing the Within-subject Variability of Insulin Detemir and Insulin Glargine With Respect to Pharmacodynamic and Pharmacokinetic Properties"},"statusModule":{"statusVerifiedDate":"2017-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2004-05-27","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2004-10-31","type":"ACTUAL"},"completionDateStruct":{"date":"2004-10-31","type":"ACTUAL"},"studyFirstSubmitDate":"2011-12-20","studyFirstSubmitQcDate":"2011-12-20","studyFirstPostDateStruct":{"date":"2011-12-22","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-02-22","lastUpdatePostDateStruct":{"date":"2017-02-24","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers."},"conditionsModule":{"conditions":["Diabetes","Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":40,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Insulin detemir","type":"EXPERIMENTAL","interventionNames":["Drug: insulin detemir"]},{"label":"Insulin glargine","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: insulin glargine"]}],"interventions":[{"type":"DRUG","name":"insulin detemir","description":"On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)","armGroupLabels":["Insulin detemir"]},{"type":"DRUG","name":"insulin glargine","description":"On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)","armGroupLabels":["Insulin glargine"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Maximum glucose infusion rate (GIRmax)"}],"secondaryOutcomes":[{"measure":"Area under the glucose infusion rate curve (AUCGIR)"},{"measure":"Time to maximum glucose infusion rate (tGIRmax)"},{"measure":"Area under the insulin concentration curve (AUC)"},{"measure":"Maximum insulin concentration (Cmax)"},{"measure":"Adverse events"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Healthy Japanese men or women\n* Holding a Japanese pass-port and Japanese-born parents\n* Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator\n* Body Mass Index (BMI) between 18 and 30 kg/m\\^2, incl.\n* Fasting blood glucose maximum 6 mmol/L\n\nExclusion Criteria:\n\n* Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator\n* Any serious systemic infectious disease that occurred during the four weeks prior to the first dose of the trial product, as judged by the Investigator\n* Subject with history of alcohol or drug dependence","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Global Clinical Registry (GCR, 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Neuss","zip":"41460","country":"Germany","geoPoint":{"lat":51.19807,"lon":6.68504}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"conditionBrowseModule":{"meshes":[{"id":"D003920","term":"Diabetes Mellitus"}],"ancestors":[{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000069057","term":"Insulin Detemir"},{"id":"D000069036","term":"Insulin Glargine"}],"ancestors":[{"id":"D049528","term":"Insulin, Long-Acting"},{"id":"D061385","term":"Insulins"},{"id":"D010187","term":"Pancreatic Hormones"},{"id":"D036361","term":"Peptide Hormones"},{"id":"D006728","term":"Hormones"},{"id":"D006730","term":"Hormones, Hormone Substitutes, and Hormone Antagonists"},{"id":"D010455","term":"Peptides"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT00317135","orgStudyIdInfo":{"id":"759346/004"},"organization":{"fullName":"GlaxoSmithKline","class":"INDUSTRY"},"briefTitle":"Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.","officialTitle":"Assess Reactogenicity and Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Compared to Tritanrix™-HepB/Hiberix™ (Control) in Healthy Infants (2,4,6 Months Age), After a Hepatitis B Birth Dose"},"statusModule":{"statusVerifiedDate":"2018-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2003-12-11"},"primaryCompletionDateStruct":{"date":"2004-10-23","type":"ACTUAL"},"completionDateStruct":{"date":"2004-10-23","type":"ACTUAL"},"studyFirstSubmitDate":"2006-02-15","studyFirstSubmitQcDate":"2006-04-20","studyFirstPostDateStruct":{"date":"2006-04-24","type":"ESTIMATED"},"lastUpdateSubmitDate":"2018-08-13","lastUpdatePostDateStruct":{"date":"2018-08-15","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"GlaxoSmithKline","class":"INDUSTRY"}},"descriptionModule":{"briefSummary":"The purpose of this study is to compare the reactogenicity \\& safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.","detailedDescription":"Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth:\n\n\\- One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups) - GSK Biologicals' Tritanrix™-HepB/Hiberix™"},"conditionsModule":{"conditions":["Diphtheria","Hepatitis B","Whole Cell Pertussis","Haemophilus Influenzae Type b","Tetanus"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"PREVENTION"},"enrollmentInfo":{"count":500,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Hib-MenAC Lot 1 Group","type":"EXPERIMENTAL","description":"Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 1 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.","interventionNames":["Biological: Tritanrix-HepB/Meningitec conjugate vaccine"]},{"label":"Hib-MenAC Lot 2 Group","type":"EXPERIMENTAL","description":"Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 2 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.","interventionNames":["Biological: Tritanrix-HepB/Meningitec conjugate vaccine"]},{"label":"Hib-MenAC Lot 3 Group","type":"EXPERIMENTAL","description":"Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 3 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.","interventionNames":["Biological: Tritanrix-HepB/Meningitec conjugate vaccine"]},{"label":"Hiberix Group","type":"ACTIVE_COMPARATOR","description":"Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB vaccine mixed extemporaneously with conjugate vaccine Hiberix at 2, 4 and 6 months of age as intramuscular injection in the anterolateral part of the thigh.","interventionNames":["Biological: Tritanrix/Hiberix vaccine"]}],"interventions":[{"type":"BIOLOGICAL","name":"Tritanrix-HepB/Meningitec conjugate vaccine","description":"The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection","armGroupLabels":["Hib-MenAC Lot 1 Group","Hib-MenAC Lot 2 Group","Hib-MenAC Lot 3 Group"],"otherNames":["DTPw-HBV/Hib-MenAc conjugate vaccine"]},{"type":"BIOLOGICAL","name":"Tritanrix/Hiberix vaccine","description":"The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection.","armGroupLabels":["Hiberix Group"],"otherNames":["DTPw-HBV/Hib vaccine"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1","timeFrame":"Days 0-3 post dose 1"},{"measure":"Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2","timeFrame":"Days 0-3 post dose 2"},{"measure":"Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3","timeFrame":"Days 0-3 post dose 3"}],"secondaryOutcomes":[{"measure":"Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose","timeFrame":"Days 0-3 after each dose"},{"measure":"Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose","timeFrame":"Day 0-30 after each dose"},{"measure":"Occurrence of serious adverse events during the entire study period","timeFrame":"Day 0 up to Month 5"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion criteria at study entry:\n\n* Healthy infants aged less than or equal to 3 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.\n\nExclusion criteria at study entry:\n\n* Any confirmed immunodeficient condition, based on medical history \\& physical examination.\n* A family history of congenital or hereditary immunodeficiency.\n* Major congenital defects or serious chronic illness.\n* History of any neurologic disorders or seizures.\n* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.\n* Acute disease at the time of enrolment.","healthyVolunteers":true,"sex":"ALL","maximumAge":"3 Days","stdAges":["CHILD"]},"contactsLocationsModule":{"overallOfficials":[{"name":"GSK Clinical Trials","affiliation":"GlaxoSmithKline","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"GSK Investigational Site","city":"City of Muntinlupa","zip":"1781","country":"Philippines","geoPoint":{"lat":14.39028,"lon":121.0475}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"conditionBrowseModule":{"meshes":[{"id":"D004165","term":"Diphtheria"},{"id":"D006509","term":"Hepatitis B"},{"id":"D006192","term":"Haemophilus Infections"},{"id":"D013742","term":"Tetanus"}],"ancestors":[{"id":"D003354","term":"Corynebacterium Infections"},{"id":"D000193","term":"Actinomycetales Infections"},{"id":"D016908","term":"Gram-Positive Bacterial Infections"},{"id":"D001424","term":"Bacterial Infections"},{"id":"D001423","term":"Bacterial Infections and Mycoses"},{"id":"D007239","term":"Infections"},{"id":"D000086982","term":"Blood-Borne Infections"},{"id":"D003141","term":"Communicable Diseases"},{"id":"D018347","term":"Hepadnaviridae Infections"},{"id":"D004266","term":"DNA Virus Infections"},{"id":"D014777","term":"Virus Diseases"},{"id":"D006525","term":"Hepatitis, Viral, Human"},{"id":"D006505","term":"Hepatitis"},{"id":"D008107","term":"Liver Diseases"},{"id":"D004066","term":"Digestive System Diseases"},{"id":"D016871","term":"Pasteurellaceae Infections"},{"id":"D016905","term":"Gram-Negative Bacterial Infections"},{"id":"D003015","term":"Clostridium Infections"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT00880035","orgStudyIdInfo":{"id":"08-105-R2"},"secondaryIdInfos":[{"id":"CRC-PAFI-09"}],"organization":{"fullName":"Université de Sherbrooke","class":"OTHER"},"briefTitle":"Efficacy of Music on Reduction of Sedative Drugs in Mechanically Ventilated Intensive Care Unit Patients","officialTitle":"M.U.S.I.C (MUSicotherapy in the Intensive Care) Interventional, Pilot, Cross-Over, in Mechanically-Ventilated Patients on ICU Ward","acronym":"MUSIC"},"statusModule":{"statusVerifiedDate":"2009-04","overallStatus":"UNKNOWN","lastKnownStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-12"},"primaryCompletionDateStruct":{"date":"2010-07","type":"ESTIMATED"},"completionDateStruct":{"date":"2010-12","type":"ESTIMATED"},"studyFirstSubmitDate":"2009-04-10","studyFirstSubmitQcDate":"2009-04-10","studyFirstPostDateStruct":{"date":"2009-04-13","type":"ESTIMATED"},"lastUpdateSubmitDate":"2009-04-20","lastUpdatePostDateStruct":{"date":"2009-04-22","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Olivier Lesur (PI) (Catherine St-Pierre co-PI)","oldOrganization":"CRC-CHUS"},"leadSponsor":{"name":"Université de Sherbrooke","class":"OTHER"},"collaborators":[{"name":"Centre de Recherche Clinique CHUS","class":"UNKNOWN"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"Major objective: a three-days interventional cross-over trial \\[one day music on, one day wash-out, one day music off\\]\\[two periods of listening/day\\], to evaluate:\n\n1. Impact on sedative drug consumption.\n2. Alteration of stress neuropeptide blood concentrations.\n\nPopulation: mechanically-ventilated ICU patients\n\nThe investigators hypothesize the music will decrease the need of sedative drugs and reduce the concentration of neuropeptides in circulation.","detailedDescription":"The study will imply patients mechanically ventilated for more than 3 days, that require sedation with benzodiazepine and narcotics.\n\nThere will be two groups both of exposed to music and placebo (headphones without music). The study will be simple blind.\n\nSedation scale will be followed regularly. Vitals signs and adjustment of sedation will be recorded by the nurse on the ward. Blood test will be taken before and after placement of headphones in the morning. We will measure IL-6, cortisol, copeptin, prolactin, CRP.\n\nWe will analyse the total reduction dose of sedation and analgesia on a daily basis. We will consider a fall of 20% of medication to be significative."},"conditionsModule":{"conditions":["Sedative Drug Consumption","Mechanically Ventilated ICU Patients"],"keywords":["sedative drug","stress","music","mechanical ventilation","IL-6","cortisol","prolactin","CRP","copeptin"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","whoMasked":["INVESTIGATOR"]}},"enrollmentInfo":{"count":50,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Group A","type":"EXPERIMENTAL","description":"Group A: day 1 = music, day 2 = washout, day 3 = headphone without music","interventionNames":["Device: MP3 music program listening"]},{"label":"Group B","type":"EXPERIMENTAL","description":"Group B: day 1 = headphone without music, day 2 = washout, day 3 = music","interventionNames":["Device: MP3 music program listening"]}],"interventions":[{"type":"DEVICE","name":"MP3 music program listening","description":"3 days with two 1 hour periods of headset music listening (1 day on, 1 day wash-out, 1 day off)","armGroupLabels":["Group A","Group B"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"sedative drug consumption in mechanically ventilated ICU patients","timeFrame":"3 days"}],"secondaryOutcomes":[{"measure":"stress neuropeptide blood content evolution with MUSIC listening","timeFrame":"3 days"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* adults older than 18 years old\n* expected time of mechanical ventilation of more than 72 hours\n* sedation needs for a scale of Sedation-Agitation Scale (SAS) more than 1\n\nExclusion Criteria:\n\n* hearing impairment\n* pregnancy\n* needs of vasopressin\n* needs of curarisation","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"centralContacts":[{"name":"Olivier Lesur, MD","role":"CONTACT","phone":"(819)346-1110","email":"olivier.lesur@usherbrooke.ca"},{"name":"Catherine St-Pierre, MD","role":"CONTACT","phone":"(819)346-1110","email":"catherine.st-pierre@usherbrooke.ca"}],"overallOfficials":[{"name":"Olivier Lesur, MD","affiliation":"CHUS and Université de Sherbrooke","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"CHUS","status":"RECRUITING","city":"Sherbrooke","state":"Quebec","zip":"J1H 5N4","country":"Canada","geoPoint":{"lat":45.40008,"lon":-71.89908}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"conditionBrowseModule":{"meshes":[{"id":"D003919","term":"Diabetes Insipidus"}],"ancestors":[{"id":"D007674","term":"Kidney Diseases"},{"id":"D014570","term":"Urologic Diseases"},{"id":"D052776","term":"Female Urogenital Diseases"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D052801","term":"Male Urogenital Diseases"},{"id":"D010900","term":"Pituitary Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT04007835","orgStudyIdInfo":{"id":"CTONG1803"},"organization":{"fullName":"Guangdong Association of Clinical Trials","class":"OTHER"},"briefTitle":"Anlotinib Hydrochloride Combined With EGFR-Tyrosine Kinase Inhibitor (TKI) in Treating Advanced NSCLC Patients With Acquired Resistance to EGFR-TKI","officialTitle":"Safety and Efficacy of Anlotinib Hydrochloride Combined With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR TKIs) in Treating Advanced Non-small-cell Lung Cancer (NSCLC) Patients With Acquired Resistance to EGFR TKIs"},"statusModule":{"statusVerifiedDate":"2019-07","overallStatus":"UNKNOWN","lastKnownStatus":"NOT_YET_RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-07","type":"ESTIMATED"},"primaryCompletionDateStruct":{"date":"2021-07","type":"ESTIMATED"},"completionDateStruct":{"date":"2021-12","type":"ESTIMATED"},"studyFirstSubmitDate":"2019-06-25","studyFirstSubmitQcDate":"2019-07-02","studyFirstPostDateStruct":{"date":"2019-07-05","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-07-02","lastUpdatePostDateStruct":{"date":"2019-07-05","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Guangdong Association of Clinical Trials","class":"OTHER"},"collaborators":[{"name":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","class":"INDUSTRY"}]},"oversightModule":{"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The Single-arm, multicenter study evaluate the safety and efficacy of Anlotinib Hydrochloride combined with EGFR TKIs in treating Advanced NSCLC With acquired Resistance to EGFR TKIs","detailedDescription":"EGFR TKI have been approved as first-line treatment in NSCLC patients harboring EGFR mutation. However, the acquired resistance of EGFR-TKI occurs almost constantly. Anlotinib is a novel oral multitarget tyrosine kinase inhibitor and primary targeted to Vascular Endothelial Growth Factor Receptor (VEGFR), fibroblast growth factor receptor (FGFR) , platelet-derived growth factor receptor (PDGFR) and c-Kit. The ALTER-0303 trial showed that patients with advanced non-small cell lung cancer (NSCLC) who received anlotinib as third-line or further therapy had more survival benefit. The Single-arm, multicenter study evaluate the safety and efficacy of Anlotinib Hydrochloride combined with EGFR TKIs in treating Advanced NSCLC With acquired Resistance to EGFR TKIs"},"conditionsModule":{"conditions":["NSCLC"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":120,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Anlotinib Hydrochloride combined with EGFR-TKI","type":"EXPERIMENTAL","description":"Patients receive anlotinib (12 mg orally daily for 14 days every 21 days cycle) combined with one of following EGFR-TKIs: Gefitinib is administered 250 mg once per day. Erlotinib is administered 150 mg once per day , or Icotinib is administered 125 mg three times per day, until disease progression or untolerated toxicity.","interventionNames":["Drug: Anlotinib Hydrochloride"]}],"interventions":[{"type":"DRUG","name":"Anlotinib Hydrochloride","description":"anlotinib (12 mg orally daily for 14 days every 21 days cycle) combined with one of EGFR-TKIs","armGroupLabels":["Anlotinib Hydrochloride combined with EGFR-TKI"],"otherNames":["Gefitinib Tablets","Erlotinib Hydrochloride Tablets","Icotinib Hydrochloride Tablets"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Progression free survival（PFS）","timeFrame":"From randomization to the first occurrence of disease progression or death from any cause, whichever occurs earlier, assessed up to 1 year"}],"secondaryOutcomes":[{"measure":"6 months and 12 months progression-free survival (PFS) Rate","timeFrame":"Up to 1 year"},{"measure":"objective response rate (ORR)","timeFrame":"Up to 1 year"},{"measure":"Disease Control Rate(DCR)","timeFrame":"Up to 1 year"},{"measure":"Overall survival (OS)","timeFrame":"From the date of randomization to the date of death from any cause，assessed up to 2 year"},{"measure":"Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]","description":"Adverse Events","timeFrame":"Up to 21 days post-the last treatment"},{"measure":"progression-free survival (PFS) for different types of EGFR mutation","timeFrame":"Up to 1 year"},{"measure":"Overall survival (OS) for different types of EGFR mutation","timeFrame":"Up to 2 year"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients voluntarily participate in this study, signed and dated informed consent with good compliance and follow-up;\n* Males or females aged 18 Years to 75 Years\n* The patients should be confirmed with EGFR mutation \\[e.g., T 790 M , exon 19 deletion, L 858 R, etc\\],\n* Cytologically or histologically confirmed locally advanced and / or metastatic non-small cell lung cancer (NSCLC).\n* Patients should be using the EGFR TKI monotherapy as the first line treatment and meet the following criteria:\n\n  1. Patients who showed objective clinical benefit from treatment with an EGFR\n\n     TKI as defined by either:\n     * Patients who showed complete (CR) or partial response (PR) ≥ 4 months, or\n     * Patients who maintained stable disease (SD) status ≥ 6 months\n  2. Patients who showed 1. risk of recurrence and progression, 2. gradual progression or local progression while on continuous treatment with EGFR TKI within the last 28 days prior to enrollment.( For recurrent diseases, patients can be accepted with adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant chemotherapy in the past, and 3. relapse occurs 6 months after the end of treatment).\n\n     1. CEA≥10ng/ml；\n     2. Gradual progression: Disease control lasting ≥6 months with EGFR-TKI treatment, Compared with the previous assessment, no significant increment of tumor burden and progressive involvement of non-target lesions with a score less than 2, and Symptom scored ≤1. Local progression: Disease control lasting more than 3 months with EGFR-TKI treatment, Progressive disease (PD) due to solitary extracranial lesion or limitation in intracranial lesions (covered by a radiation field),and symptom scored ≤1\n     3. Evidence of imaging or clinical progression is required if progression of disease occurs during the treatment or after the last treatment.\n* At least one measurable lesion meet the requirements of the standard Response Evaluation Criteria In Solid Tumors（RESCIST）version 1.1\n* Life expectancy is at least 3 months;\n* Eastern Cooperative Oncology Group（ECOG）Performance Status（PS）:0-2.;\n* The main organs function meet following criteria:\n\n  * Blood routine examination criteria (no blood transfusion and blood products within 14 days, no correction by Granulocyte Colony-Stimulating Factor (G-CSF) and other hematopoietic stimuli): i) hemoglobin (HB) ≥90g/L ii) Absolute neutrophils count (ANC) ≥1.5×109/L iii) platelet (PLT) ≥80×109/L\n  * Biochemical tests meet the following criteria i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; iii) serum creatinine (Cr) ≤1.25 ULN or creatinine clearance (CCr)≥45 mL/min\n* Female patients of childbearing age agree that contraceptive measures must be used within the study period and within 8 weeks after the end of the study drug treatment. The serum or urine test indicates nonpregnant woman within 7 days prior to the study. Male patients agree to have contraceptive use during the study period and within 8 weeks after the end of the study period or have had surgical sterilization.\n\nExclusion Criteria:\n\n* Small cell lung cancer (including Small cell lung cancer mixed with non-small cell lung cancer);\n* Imaging (CT or MRI) showed that the distance between the lesion and the large vessels was less than 5 mm, or there were central tumors invading the local large vessels, or there were obvious pulmonary cavity or necrotic tumors.\n* Patients with active brain metastasis, cancerous meningitis, spinal cord compression, or with brain or pia mater diseases detected by CT or MRI at screening time (patients with stable symptoms and complete treatment 14 days before enrollment may be admitted to the group, but no symptoms of cerebral hemorrhage should be confirmed by craniocerebral MRI, CT or venography evaluation).\n* Uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥ 90 mmHg, despite using the optimal medical treatment;\n* Patients are participating in other clinical studies, or there are less than four weeks before the end of the previous clinical study.\n* Other active malignant tumors requiring concurrent treatment;\n* The patient has a history of malignant tumors. Patients with basal cell carcinoma of skin, superficial bladder cancer, squamous cell carcinoma of skin or carcinoma of cervix in situ who had undergone possible curative treatment and had no disease recurrence within 5 years after the initiation of curative treatment are permitted.\n* Patients had treatment related adverse reactions after previous systemic anti-tumour therapy (except hair loss), but did not recover to NCI-CTCAE ≤ 1 grade.\n* The patient has the coagulation disorders (INR \\> 1.5 or prothrombin time (PT) \\> ULN + 4 seconds or activated partial thromboplastin time (APTT) \\> 1.5 ULN), or bleeding tendency, or undergoing thrombolysis or anticoagulation therapy; Note: On the premise that the International Standardized Ratio of Prothrombin Time (INR) is less than 1.5, low doses of heparin (0.6 million to 12,000 U per day for adults) or aspirin (less than 100 mg per day) are allowed for preventive purposes.\n* Renal insufficiency: Urinary routine indicated that urinary protein ≥ ++ or confirmed 24-hour urinary protein ≥ 1.0 g;\n* Subjects who had undergone major surgery or had severe trauma had less than 14 days before enrollment.\n* Severe acute or chronic infections requiring systemic treatment\n* Severe cardiovascular diseases: grade II or above myocardial ischemia or myocardial infarction and poor control arrhythmias (including corrected QT interval (QTc) interval ≥ 450 ms for males and ≥ 470 ms for females); cardiac insufficiency of grade III to IV according to New York Heart Association (NYHA) criteria, or left ventricular ejection fraction (LVEF) \\< 50% by color Doppler echocardiography;\n* ≥ CTCAE grade 2 peripheral neuropathy, except for trauma.\n* Respiratory syndrome (≥ CTCAE grade 2 dyspnea), serous effusion (including pleural effusion, ascites, pericardial effusion) requiring surgical treatment;\n* Long-term unhealed wound or fracture;\n* Decompensated diabetes mellitus or other contraindications of high-dose glucocorticoid therapy;\n* There are obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction;\n* Three months prior to enrollment, significant hemoptysis (more than 50 ml per day) occurred, or significant clinical hemorrhage symptoms or defined bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or above, or suffering from vasculitis.\n* Arteriovenous thrombosis events occurred within 12 months before enrollment, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism.\n* Patients participated in clinical trials of other antineoplastic drugs within four weeks prior to enrollment, or planned systemic anti-tumor therapy within four weeks prior to enrollment or during the period of the study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or use of mitomycin C within six weeks prior to the treatment of the experimental drugs). Over-extended-field radiotherapy (EF-RT) was performed within four weeks prior to grouping or limited-field radiotherapy to evaluate the tumor lesions was performed within two weeks prior to grouping;\n* Physical and laboratory findings Untreated active hepatitis (hepatitis B: HBsAg positive and hepatitis B virus (HBV) DNA ≥ 500 IU/mL; hepatitis C: hepatitis C virus (HCV) RNA positive and abnormal liver function); co-infection of hepatitis B and hepatitis C;\n* According to the researcher's judgment, patients may have other factors that may lead to the forced termination of the study, such as other serious diseases or serious abnormal laboratory examinations or other factors that may affect the safety of the subjects, or family or social factors such as test data and sample collection.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"centralContacts":[{"name":"HUAJUN CHEN, MD","role":"CONTACT","phone":"0086-13710581145","email":"chjdoctor@163.com"}],"overallOfficials":[{"name":"Yi-Long Wu, MD","affiliation":"Guangdong General Hospital (GGH)& Guangdong Academy of Medical Sciences","role":"STUDY_CHAIR"},{"name":"HUAJUN CHEN, MD","affiliation":"Guangdong Provincial People's Hospital","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Guangdong General Hospital","city":"Guangzhou","state":"Guangdong","zip":"510080","country":"China","contacts":[{"name":"HUAJUN CHEN, MD","role":"CONTACT"},{"name":"HUAJUN CHEN, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":23.11667,"lon":113.25}}]},"referencesModule":{"references":[{"pmid":"39757186","type":"DERIVED","citation":"Chen HJ, Tu HY, Hu Y, Fan Y, Wu G, Cang S, Yang Y, Yang N, Ma R, Jin G, Xu X, Liu A, Tang S, Cheng Y, Yu Y, Xu CR, Zhou Q, Wu YL. A phase II trial of anlotinib plus EGFR-TKIs in advanced non-small cell lung cancer with gradual, oligo, or potential progression after EGFR-TKIs treatment (CTONG-1803/ALTER-L001). J Hematol Oncol. 2025 Jan 5;18(1):3. doi: 10.1186/s13045-024-01656-0."}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"interventionBrowseModule":{"meshes":[{"id":"D000077156","term":"Gefitinib"},{"id":"D000069347","term":"Erlotinib Hydrochloride"}],"ancestors":[{"id":"D011799","term":"Quinazolines"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT01565135","orgStudyIdInfo":{"id":"11-1149"},"secondaryIdInfos":[{"id":"U01IP000501","type":"NIH","link":"https://reporter.nih.gov/quickSearch/U01IP000501"}],"organization":{"fullName":"University of Colorado, Denver","class":"OTHER"},"briefTitle":"Immunization Delivery in Obstetrics and Gynecology Settings","officialTitle":"Immunization Delivery in Obstetrics and Gynecology Settings"},"statusModule":{"statusVerifiedDate":"2019-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2012-09","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2015-10","type":"ACTUAL"},"completionDateStruct":{"date":"2015-10","type":"ACTUAL"},"studyFirstSubmitDate":"2012-03-26","studyFirstSubmitQcDate":"2012-03-26","studyFirstPostDateStruct":{"date":"2012-03-28","type":"ESTIMATED"},"lastUpdateSubmitDate":"2019-06-20","lastUpdatePostDateStruct":{"date":"2019-06-24","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Colorado, Denver","class":"OTHER"},"collaborators":[{"name":"Centers for Disease Control and Prevention","class":"FED"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to determine if a multimodal immunization program carried out in obstetrics and gynecology (ob/gyn) practices would be more effective in improving ob/gyn patients' immunization rates, specifically for Tdap (Tetanus, Diphtheria, Pertussis), HPV (Human papilloma virus), and influenza vaccines, than the usual care provided to patients in ob/gyn practices."},"conditionsModule":{"conditions":["Immunization Status Among Obstetrics and Gynecology Patients"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"HEALTH_SERVICES_RESEARCH","maskingInfo":{"masking":"SINGLE","whoMasked":["PARTICIPANT"]}},"enrollmentInfo":{"count":97087,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Intervention Practices","type":"EXPERIMENTAL","description":"Intervention offices will adopt a multimodal vaccine program to increase their patients' vaccine rates.","interventionNames":["Behavioral: Multimodal Vaccine Program"]},{"label":"Control Practices","type":"NO_INTERVENTION","description":"Control offices will offer usual health care related to immunizations throughout the duration of the study."}],"interventions":[{"type":"BEHAVIORAL","name":"Multimodal Vaccine Program","description":"Efforts will be made to collaborate with private ob/gyn offices to develop a multimodal intervention to improve patients'immunization rates. As part of the overall intervention, intervention practices will agree to 1) purchase, stock, and administer influenza, HPV, and Tdap vaccines, if not already doing so and 2) track patients' vaccination status. In addition, intervention strategies adopted by intervention settings to improve immunization rates may include:\n\n* Patient education regarding the importance of vaccination, including encouragement of vaccination for family members\n* Practice-based reminder/recall\n* Seek to decrease missed opportunities for immunization by using either or both of the following: provider prompts and/or provider education and feedback","armGroupLabels":["Intervention Practices"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in the percent of women vaccinated with one or more Tdap vaccines (among eligible patients) in intervention settings compared to control settings.","description":"The percent of eligible patients presenting for care who receive Tdap vaccine will be assessed one year prior to the intervention and 12 and 21 months after the intervention. This assessment will occur in both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.","timeFrame":"1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)"},{"measure":"Change in the percent of women vaccinated with influenza vaccine (among eligible patients) in intervention settings compared to control settings.","description":"The percent of eligible patients presenting for care who receive influenza vaccine will be assessed one year prior to the intervention and at 12 and 21 months after the intervention. This will be assessed in both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.","timeFrame":"1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)"},{"measure":"Change in the percent of women who have initiated the HPV vaccine series (among eligible patients) in intervention settings compared to control settings.","description":"The percent of eligible patients presenting for care who have received one or more HPV vaccines will be assessed one year prior to the intervention and at 12 and 21 months after the intervention. This number will be assess in both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.","timeFrame":"1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)"},{"measure":"Change in the percent of women who have received one or more needed vaccines (eligible patients who receive HPV, influenza, and/or Tdap vaccines) in intervention settings compared to control settings.","description":"The percent of eligible patients presenting for care who have received one or more needed vaccines (HPV, Tdap, and/or influenza vaccines) will be assessed one year prior to the intervention and at 12 and 21 months after the intervention. This number will be assess in both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.","timeFrame":"1 year (administrative data) & 2 months (survey data) prior to intervention & at 12 and 21 months after intervention (administrative and survey data)"}],"secondaryOutcomes":[{"measure":"Change in the percent of women who have completed the HPV vaccine series (among eligible patients) in intervention settings compared to control settings.","description":"The percent of eligible patients presenting for care who have completed the HPV vaccine series will be assessed one year prior to the intervention and at 12 and 21 months after the intervention. This number will be assess for both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.","timeFrame":"1 year (administrative data) & 2 months (survey data) prior to intervention & at 12 and 21 months after intervention (administrative and survey data)"},{"measure":"Change in the percent of women who report Tdap vaccine uptake among individuals in frequent contact with their infant in intervention offices compared to control offices","description":"The percent of patients who report one or more individuals who are/will be in frequent contact with their infant having received Tdap vaccine will be assessed during Feb/March 2013 and Feb/March 2014. These data will be collected in patients of both intervention and control settings via on-line survey and be administered to patients who volunteer to take the survey.","timeFrame":"Feb/March 2013 & Feb/March 2014"},{"measure":"Change in the percent of women who report influenza vaccine uptake among individuals in frequent contact with their infant in intervention offices. compared to control offices","description":"The percent of patients who report one or more individuals who are/will be in frequent contact with their infant having received influenza vaccine will be assessed during Feb/March 2013 and Feb/March 2014. These data will be collected in patients of both intervention and control settings via on-line survey and be administered to patients who volunteer to take the survey.","timeFrame":"Feb/March 2013 & Feb/March 2014"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. 15 years of age or older when presenting for care\n2. Patients who present for care one year prior to the start of the intervention and up to 21 months after the start of the intervention\n\nExclusion Criteria:\n\n1. less than 15 years of age when presenting for care\n2. patient is not eligible for any immunizations","healthyVolunteers":true,"sex":"FEMALE","minimumAge":"15 Years","stdAges":["CHILD","ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Sean O'Leary, MD, MPH","affiliation":"University of Colorado Denver, Children's Hospital Colorado","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Amanda Dempsey, MD, PhD, MPH","affiliation":"University of Colorado, Children's Hospital Colorado","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Colorado Denver","city":"Aurora","state":"Colorado","zip":"80045","country":"United States","geoPoint":{"lat":39.72943,"lon":-104.83192}}]},"referencesModule":{"references":[{"pmid":"31103367","type":"DERIVED","citation":"O'Leary ST, Pyrzanowski J, Brewer SE, Sevick C, Miriam Dickinson L, Dempsey AF. Effectiveness of a multimodal intervention to increase vaccination in obstetrics/gynecology settings. Vaccine. 2019 Jun 6;37(26):3409-3418. doi: 10.1016/j.vaccine.2019.05.034. Epub 2019 May 15."}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT07589335","orgStudyIdInfo":{"id":"2025-05-07"},"secondaryIdInfos":[{"id":"1R43MD018555-01A1","type":"NIH","link":"https://reporter.nih.gov/quickSearch/1R43MD018555-01A1"}],"organization":{"fullName":"KDH Research & Communication","class":"INDUSTRY"},"briefTitle":"Supplying Useful Perimenopause Through Post-menopause Online Resources and Tools","officialTitle":"Supplying Useful Perimenopause Through Post-menopause Online Resources and Tools","acronym":"SUPPORT"},"statusModule":{"statusVerifiedDate":"2026-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2026-03-06","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2026-04-02","type":"ACTUAL"},"completionDateStruct":{"date":"2026-05-31","type":"ACTUAL"},"studyFirstSubmitDate":"2026-04-17","studyFirstSubmitQcDate":"2026-05-11","studyFirstPostDateStruct":{"date":"2026-05-15","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-07-07","lastUpdatePostDateStruct":{"date":"2026-07-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"KDH Research & Communication","class":"INDUSTRY"},"collaborators":[{"name":"National Institute on Minority Health and Health Disparities (NIMHD)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The goal of the study is to examine the extent to which exposure to the SUPPORT prototype increases community health workers' (CHWs) knowledge, skills, and self-efficacy to conduct effective outreach to minority women experiencing the menopausal transition. The investigators will collect quantitative, pretest and posttest survey data from adult CHWs.","detailedDescription":"The investigators will use a randomized, two-group, pretest/posttest design to develop and evaluate the Supplying Useful Perimenopause through Post-menopause Online Resources and Tools (SUPPORT) course and explore the following research question: To what extent does exposure to the SUPPORT prototype increase community health workers' (CHWs) knowledge, skills, and self-efficacy to conduct mental health outreach to minority women experiencing the menopausal transition?\n\nThe SUPPORT prototype will have four lessons with text, video vignettes, handouts, and artificial intelligence (AI) avatar simulations. CHWs assigned to the treatment group will be exposed to SUPPORT prototype before completing the posttest while CHWs assigned to the control group will be exposed to the SUPPORT prototype after completing the posttest.\n\nResearchers worked with subject matter experts and the intended audience to ensure the SUPPORT course includes accurate material and reflects the specific needs of CHWs providing outreach to women experiencing the menopausal transition.\n\nCo-Principal Investigators Morgan Fleming (KDH Research \\& Communication), with input from Co-PI Mary Dolan (Emory University) and the subject matter experts, developed necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials. Co-PI Fleming also outlined the appropriate statistical analysis methods. All procedure documents will be reviewed by the KDH Research \\& Communication (KDHRC) Institutional Review Board before the evaluation launch.\n\nInvestigators will recruit participants by sharing the opportunity through the KDHRC CHW panel, which notifies more than 700 subscribed CHWs about research opportunities. Notifications and flyers will provide information about the goal of the study, participant eligibility, and a link to an eligibility form. Once a potential participant completes the eligibility form and s/he is eligible for the study, they will receive a link to a consent form located on a secure online platform.\n\nThe study will include up to 160 CHWs nationwide (80 treatment group, 80 control group). KDHRC will remind participants that participation in the study is completely voluntary.\n\nInvestigators will confirm consent for each participant and after confirming consent, will send participants the link to complete the pretest survey. Once the investigators receive the pretest survey, they will randomize each participant into the treatment group or control group using a 1:1 randomization. Investigators will alternate assigning each participant with completed pretest to the treatment groups or the control groups. Then, investigators will provide each participant with group-specific information. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers.\n\nThe investigators will download and export the data from the online survey platform into encrypted Excel files and import the raw data into STATA. The investigators will match the pretest and posttest using the non-personal identifiers and conduct analyses to test for the effect of SUPPORT course exposure on changes in CHWs' knowledge, skills, and self-efficacy.\n\nThe initial evaluation criterion is: Statistically significant (p\\<0.05) and positive relationship between exposure to SUPPORT course and increased knowledge among the treatment group in comparison to the control group."},"conditionsModule":{"conditions":["Women","Community Health Workers","Health","Menopause","Hispanic or Latino","African Americans"],"keywords":["Community Health Workers","Menopause","Women"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"OTHER","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":160,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Treatment: SUPPORT course","type":"EXPERIMENTAL","description":"Lessons 1-4 of professional development training course for CHWs on menopausal transition (SUPPORT)","interventionNames":["Other: Lessons 1-4 for SUPPORT course"]},{"label":"Control: No SUPPORT course","type":"NO_INTERVENTION","description":"No intervention"}],"interventions":[{"type":"OTHER","name":"Lessons 1-4 for SUPPORT course","description":"Multi-module SUPPORT online training","armGroupLabels":["Treatment: SUPPORT course"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Declarative Knowledge Pretest Score","description":"Investigators will ask participants multiple-choice knowledge questions related to the menopausal transition, which the investigators will sum to create a composite knowledge score ranging from 0 to 7. A score of 0 means a participant got zero questions correct, while a score of 7 means a participant got all 7 questions correct. Then, the investigators will create the composite knowledge average by dividing the participant's composite score by the total number of questions (7) and multiplying by 100. The higher the score, the more questions a participant answered correctly.","timeFrame":"Baseline"},{"measure":"Declarative Knowledge Posttest Score","description":"Investigators will ask participants multiple-choice knowledge questions related to the menopausal transition, which the investigators will sum to create a composite knowledge score ranging from 0 to 7. A score of 0 means a participant got zero questions correct, while a score of 7 means a participant got all 7 questions correct. Then, the investigators will create the composite knowledge average by dividing the participant's composite score by the total number of questions (7) and multiplying by 100. The higher the score, the more questions a participant answered correctly.","timeFrame":"Upon study completion, average 15 days"},{"measure":"Procedural Knowledge Pretest Score","description":"Investigators will ask participants multiple-choice procedural knowledge questions related to the menopausal transition, which the investigators will sum to create a composite procedural knowledge score ranging from 0 to 5. A score of 0 means a participant got zero questions correct, while a score of 5 means a participant got all 5 questions correct. Then, investigators will create the composite procedural knowledge average by dividing the participant's composite score by the total number of questions (5) and multiplying by 100. The higher the score, the more questions a participant answered correctly.","timeFrame":"Baseline"},{"measure":"Procedural Knowledge Posttest Score","description":"Investigators will ask participants multiple-choice procedural knowledge questions related to the menopausal transition, which investigators will sum to create a composite procedural knowledge score ranging from 0 to 5. A score of 0 means a participant got zero questions correct, while a score of 5 means a participant got all 5 questions correct. Then, investigators will create the composite procedural knowledge average by dividing the participant's composite score by the total number of questions (5) and multiplying by 100. The higher the score, the more questions a participant answered correctly.","timeFrame":"Upon study completion, average 15 days"},{"measure":"Skills Pretest Score","description":"Investigators will ask all participants Likert-type scale questions about skills to conduct menopausal transition outreach. Each answer choice rating will range from 1 to 10, with higher ratings representing more outreach experience. Investigators will create the composite skills score by summing the scores from the participant's 15 skill items with a range of 15 to 150. Then, investigators will create the composite skills average by dividing the participant's composite score by the total number of questions (15), and the composite score will range from 1 to 10. The higher the score, the more experience a participant indicates.","timeFrame":"Baseline"},{"measure":"Skills Posttest Score","description":"Investigators will ask all participants Likert-type scale questions about skills to conduct menopausal transition outreach. Each answer choice rating will range from 1 to 10, with higher ratings representing more outreach experience. Investigators will create the composite skills score by summing the scores from the participant's 15 skill items with a range of 5 to 150. Then, Investigators will create the composite skills average by dividing the participant's composite score by the total number of questions (15), and the composite score will range from 1 to 10. The higher the score, the more experience a participant indicates.","timeFrame":"Upon study completion, average 15 days"},{"measure":"Self-efficacy Pretest Score","description":"Investigators will ask all participants Likert-type scale questions related to perceived self-efficacy with conducting menopausal transition outreach. Each rating will range from 1 to 10, with higher ratings representing higher perceptions of confidence in providing outreach. Investigators will create the composite self-efficacy score by summing the scores from the participant's 5 self-efficacy items with a range of 5 to 50. Then, investigators will create the composite self-efficacy average by dividing the participant's composite score by the number of self-efficacy items (5). The composite will range from 1 to 10.","timeFrame":"Baseline"},{"measure":"Self-efficacy Posttest Score","description":"Investigators will ask all participants Likert-type scale questions related to perceived self-efficacy with conducting menopausal transition outreach. Each rating will range from 1 to 10, with higher ratings representing higher perceptions of confidence in providing outreach. Investigators will create the composite self-efficacy score by summing the scores from the participant's 5 self-efficacy items with a range of 5 to 50. Then, investigators will create the composite self-efficacy average by dividing the participant's composite score by the number of self-efficacy items (5). The composite average will range from 1 to 10.","timeFrame":"Upon study completion, average 15 days"},{"measure":"Intentions Pretest Score","description":"Investigators will ask all participants Likert-type scale questions related to intentions of conducting menopausal transition outreach. Each rating will range from 1 to 10, with higher ratings representing higher intentions to provide outreach. Investigators will create the composite intention score by summing the scores from the participant's 4 intention items with a range of 4 to 40. Then, investigators will create the composite intentions average by dividing the participant's composite score by the number of intention items (4). The composite average will range from 1 to 10.","timeFrame":"Baseline"},{"measure":"Intentions Posttest Score","description":"Investigators will ask all participants Likert-type scale questions related to intentions of conducting menopausal transition outreach. Each rating will range from 1 to 10, with higher ratings representing higher intentions to provide outreach. Investigators will create the composite intention score by summing the scores from the participant's 4 intentions items with a range of 4 to 40. Then, investigators will create the composite intention average by dividing the participant's composite score by the number of intention items (4). The composite average will range from 1 to 10.","timeFrame":"Upon study completion, average 15 days"}],"secondaryOutcomes":[{"measure":"Satisfaction at posttest","description":"Investigators will ask only the treatment group participants Likert-type scale questions related to their satisfaction with the SUPPORT course. Each rating will range from 1 to 10, with higher scores representing higher satisfaction with the SUPPORT prototype. Investigators will sum the scores from the participant's 4 satisfaction items for a satisfaction composite score ranging from 4 to 40. Investigators will then create the satisfaction composite average by dividing by the total number of satisfaction items (4). Scores range from 1 to 10, with higher scores meaning better satisfaction/outcome.","timeFrame":"Upon study completion, average 15 days"}],"otherOutcomes":[{"measure":"Change in Declarative Knowledge Scores From Pretest to Posttest","description":"At both pretest and posttest, investigators created a composite knowledge score for each participant ranging from 0 to 100. A score of 0 means a participant got zero questions correct while a score of 100 means a participant got all questions correct. Investigators will then subtract pretest composite from posttest composite. Higher scores mean higher gains from baseline to posttest.","timeFrame":"From baseline through study completion, average 15 days"},{"measure":"Change in Procedural Knowledge Scores From Pretest to Posttest","description":"At both pretest and posttest, investigators created a composite procedural knowledge score for each participant ranging from 0 to 100. A score of 0 means a participant got zero questions correct while a score of 100 means a participant got all questions correct. Investigators will then subtract pretest composite from posttest composite. Higher scores mean higher gains from baseline to posttest.","timeFrame":"From baseline through study completion, average 15 days"},{"measure":"Change in Skills Scores From Pretest to Posttest","description":"At both pretest and posttest, investigators created a composite skills score for each participant ranging from 1 to 10. Higher ratings represent higher perceived experience. Investigators will then subtract pretest composite from posttest composite. Higher scores mean higher gains from baseline to posttest.","timeFrame":"From baseline through study completion, average 15 days"},{"measure":"Change in Self-efficacy Scores From Pretest to Posttest","description":"At both pretest and posttest, investigators created a composite self-efficacy score for each participant ranging from 1 to 10. Higher ratings represent high perceptions of confidence in providing outreach. Investigators will then subtract pretest composite from posttest composite. Higher scores mean higher gains from baseline to posttest.","timeFrame":"From baseline through study completion, average 15 days"},{"measure":"Change in Intentions Scores From Pretest to Posttest","description":"At both pretest and posttest, investigators created a composite intentions score for each participant ranging from 1 to 10. Higher ratings represent high intentions in providing outreach. Investigators will then subtract pretest composite from posttest composite. Higher scores mean higher gains from baseline to posttest.","timeFrame":"From baseline through study completion, average 15 days"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Must be at least 18 years old.\n* Must self-identify as a community health worker (CHW).\n* Must live in the United States.\n* Must conduct outreach to minority women.\n* Must have six months of field experience. KDHRC defines \"field experience\" as conducting outreach activities in their community, for example, working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events.\n* Must be an active CHW. KDHRC defines \"active\" as conducting outreach activities, such as working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events, in the last six months.\n* Must have Internet access either at home or at work to access the materials and/or online surveys\n\nExclusion Criteria:\n\n* none","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"99 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Morgan Fleming, MPH","affiliation":"KDH Research & Communication","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"KDH Research & Communication","city":"Atlanta","state":"Georgia","zip":"30309","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT00521235","orgStudyIdInfo":{"id":"ZPII-2007-10"},"organization":{"fullName":"University of Erlangen-Nürnberg Medical School","class":"OTHER"},"briefTitle":"Effect of Different Working Conditions on Risk Factors in Dentists Versus Trainers","officialTitle":"Effects of Different Working Condition on Risk Factors in Dentists Versus Trainers. A Combined Crosssectional and Longitudinal Trial With Student and Senior Employees."},"statusModule":{"statusVerifiedDate":"2020-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2012-06","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2014-01","type":"ACTUAL"},"completionDateStruct":{"date":"2014-01","type":"ACTUAL"},"studyFirstSubmitDate":"2007-08-24","studyFirstSubmitQcDate":"2007-08-24","studyFirstPostDateStruct":{"date":"2007-08-27","type":"ESTIMATED"},"lastUpdateSubmitDate":"2020-12-10","lastUpdatePostDateStruct":{"date":"2020-12-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Erlangen-Nürnberg Medical School","class":"OTHER"},"collaborators":[{"name":"University of Erlangen-Nürnberg","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The aim of the study is to validate the sanitary consequences of dental studies respectively the longtime executed profession. In comparison to this cohort we will also check a collective of subjects with an optimum of physical activity."},"conditionsModule":{"conditions":["Healthy"],"keywords":["risk factors","metabolic syndrome","dentists","trainers","Healthy subjects","students","seniors"]},"designModule":{"studyType":"OBSERVATIONAL","designInfo":{"observationalModel":"COHORT","timePerspective":"PROSPECTIVE"},"enrollmentInfo":{"count":300,"type":"ESTIMATED"}},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Healthy\n* Age 19-30 years(longitudinal)\n* 55-60 years (crosssectional)\n* Dentists\n* Trainers\n\nExclusion Criteria:\n\n* Pregnant\n* CVD\n* Medication; and\n* Diseases affecting body composition","healthyVolunteers":true,"sex":"ALL","minimumAge":"19 Years","maximumAge":"60 Years","stdAges":["ADULT"],"studyPopulation":"male and female students of dentistry male and female students of sports male dentists male teachers of physical education","samplingMethod":"NON_PROBABILITY_SAMPLE"},"contactsLocationsModule":{"overallOfficials":[{"name":"Julia S Bauer, DMD","affiliation":"Zahn-, Mund- und Kieferklinik, University of Erlangen-Nurnberg","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Stefan Eitner, DMD, PhD","affiliation":"Zahn-, Mund- und Kieferklinik, University of Erlangen","role":"STUDY_DIRECTOR"},{"name":"Wolfgang K Kemmler, PhD","affiliation":"University of Erlangen-Nürnberg Medical School","role":"STUDY_CHAIR"},{"name":"Simon O von Stengel, PhD","affiliation":"University of Erlangen-Nürnberg Medical School","role":"STUDY_CHAIR"},{"name":"Jürgen Weineck, PhD, MD","affiliation":"University of Erlangen-Nürnberg Medical School","role":"STUDY_CHAIR"},{"name":"Manfred Wichmann, DMD, PhD","affiliation":"Zahn-, Mund- und Kieferklinik, University of Erlangen","role":"STUDY_CHAIR"}],"locations":[{"facility":"Zahn-, Mund- und Kieferklinik, University of Erlangen-Nurnberg","city":"Erlangen","state":"Bavaria","zip":"91054","country":"Germany","geoPoint":{"lat":49.59099,"lon":11.00783}}]},"referencesModule":{"references":[{"pmid":"26787116","type":"DERIVED","citation":"Kemmler W, von Stengel S, Kohl M, Bauer J. Impact of exercise changes on body composition during the college years--a five year randomized controlled study. BMC Public Health. 2016 Jan 19;16:50. doi: 10.1186/s12889-016-2692-y."}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"conditionBrowseModule":{"meshes":[{"id":"D024821","term":"Metabolic Syndrome"}],"ancestors":[{"id":"D007333","term":"Insulin Resistance"},{"id":"D006946","term":"Hyperinsulinism"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT06730035","orgStudyIdInfo":{"id":"PROPER"},"secondaryIdInfos":[{"id":"Ricerca Corrente 2022-2024","type":"OTHER_GRANT","domain":"Italian Ministry of Health"}],"organization":{"fullName":"IRCCS Azienda Ospedaliero-Universitaria di Bologna","class":"OTHER"},"briefTitle":"PRediction of Outcomes and PERsonalized Radiotherapy by Biomarkers and Functional Imaging","officialTitle":"PRediction of Outcomes and PERsonalized Radiotherapy by Biomarkers and Functional Imaging"},"statusModule":{"statusVerifiedDate":"2024-12","overallStatus":"ACTIVE_NOT_RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2024-10-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2028-05-31","type":"ESTIMATED"},"completionDateStruct":{"date":"2028-05-31","type":"ESTIMATED"},"studyFirstSubmitDate":"2024-12-01","studyFirstSubmitQcDate":"2024-12-10","studyFirstPostDateStruct":{"date":"2024-12-12","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-12-10","lastUpdatePostDateStruct":{"date":"2024-12-12","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"IRCCS Azienda Ospedaliero-Universitaria di Bologna","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is a study focused on analyses of peripheral blood (tissue study). The aim of the trial is to determine whether it is possible to predict early clinical and/or pathological responses after radiotherapy in the setting of neoadjuvant treatment for locally advanced rectal carcinomas, through qualitative and quantitative assessment of circulating extracellular vesicles in plasma and the microRNA (miRNA) contained within them. Extracellular vesicles are \"clean-up\" structures that collect various elements circulating in the blood, including fragments of DNA and RNA from tumor cells. Observing how these structures and their contents change with radiotherapy could provide early indications of the tumor's response to treatment. The trial seeks to answer the question: \"Can the quantity of CD69+ vesicles in patients undergoing neoadjuvant radiotherapy predict their response early?\"\n\nThe trial is monocentric and plans to enroll approximately 30 patients. Participation in this trial does not offer direct benefits, as it involves only laboratory investigations without modifications to the usual diagnostic-therapeutic process for the condition considered.\n\nThe collection of information is aimed at improving knowledge regarding extracellular vesicles. These vesicles could provide early insights into the response to neoadjuvant radiotherapy for locally advanced rectal tumors. In this way, subsequent therapeutic strategies can be personalized based on this response.","detailedDescription":"This is a monocentric, exploratory experimental study on tissues (peripheral blood), which is why the enrollment of a limited number of patients has been planned. The results obtained from the study should not be considered conclusive but rather as generators of research hypotheses for potential subsequent studies to be conducted on larger populations. The qualitative and quantitative characteristics of the vesicles and their miRNA content will be analyzed descriptively.\n\nThe primary objective will be considered achieved if values of CD69+ vesicles \\> 349 absolute units correctly predict the response to radiotherapy in at least 80% of patients. Subsequently, the investigators aim to verify if CD86+ vesicles \\> 10 absolute units and CD3+ \\> 4 absolute units correctly predict the response to radiotherapy in at least 80% of cases. Additionally, the association between the values of the three indicated vesicles (both original and dichotomized as above or below the specified cut-offs, derived from preliminary results of our research group) and the time to disease recurrence at two years will be tested.\n\nPatients will be treated according to clinical practice in accordance with the physician's judgment and the information provided in the Technical Data Sheet of each individual product of any concomitant therapies administered as per clinical practice. The diagnostic-therapeutic pathway of the patients will not be influenced in any way by the results of tissue tests conducted for the study.\n\nThe TC-PET investigations, as part of the normal diagnostic-therapeutic process, will be performed at the Nuclear Medicine Unit of the IRCCS University Hospital of Bologna. Molecular investigations will be carried out at the laboratory of the Immunogenetics and Transplant Biology Unit (IBT) affiliated with the IRCCS University Hospital of Bologna, S. Orsola Polyclinic. The study is aimed at patients undergoing neoadjuvant RT for locally advanced rectal tumors within one year. The study is expected to begin on 01/05/2023, and in any case, only after approval from the Ethics Committee and the subsequent release of the company's authorization.\n\nPatients will be enrolled during the first visit at the Radiotherapy Unit of the IRCCS University Hospital of Bologna, prior to any sampling necessary for the specific study analyses. It should be noted that investigations on the total quantification of DNA and epigenetic changes (methylation and miRNA expression) do not involve genome sequencing. The DNA molecules will be examined without considering individual specificity; therefore, the individual's genetic code remains unknown after the examination. A sample of 10 ml of venous blood will be collected using a vacutainer with EDTA from each patient, and plasma will be collected for each experimental point. Biological samples will be pseudonymized and labeled with the progressive number RT/NEO/00N. All samples will be stored in specially marked RT containers in a locked freezer located in the IBT laboratory until their use. Transport will be carried out using a sealed and temperature-controlled dedicated container by the personnel involved in the project.\n\nThree samples will be analyzed per patient: 1st sample: 1-5 days before the start of RT, 2nd sample: at the end of the 3rd week of RT, 3rd sample: on the last day of RT. Therefore, a total of 90 samples are expected to be analyzed.\n\nIsolation of Nanovesicles: plasma samples will be processed for the separation of extracellular vesicles through column gel ultrafiltration with sterilized and buffered CL-B4 resin. The nanovesicles will then be processed for phenotypic analysis using the Miltenyi MACSPEX kit and processed for DNA/RNA extraction using the Nucleo Spin Tissue kit (Macherey Nagel, M-Medical, Milan, Italy). The procedure will be carried out at the IBT laboratory of the IRCCS University Hospital of Bologna.\n\nEpigenetic Analysis:\n\n* MicroRNA Analysis The RNA samples extracted from the extracellular vesicles will be analyzed for microRNA content using Droplet Digital PCR at the IBT laboratory.\n* Methylation Analysis The DNA methylation profile analysis of nucleated blood cells will be conducted using mass spectrometry performed on the Sequenom platform and the EpiTyper protocol (Sequenom) at the IBT laboratory of the IRCCS University Hospital of Bologna. All statistical analyses will be performed at the IBT unit.\n\nVisits, assessments, and systemic and local treatments will be carried out according to clinical practice and will not be altered for this study. The aliquots of peripheral blood required for the specific study analyses will be collected in addition to routine samples taken during patient treatments and follow-ups, using the same venous access. Specifically, the samples will be taken at the start of radiotherapy, three weeks after the start, and at the end, within the context of exams and visits scheduled by normal clinical practice.\n\nDuring the first visit, according to clinical practice, information related to the patient's clinical history (oncological history, remote pathological history, pharmacological history, family history) will be collected. A general physical examination will be performed, and the radiotherapy pathway will be planned. The patient's eligibility for the PROPER study will be assessed, and if affirmative, informed consents will be obtained.\n\nAnalysis Methodology:\n\nThe demographic and clinical characteristics of the patients will be described using median and interquartile range (for continuous variables) and absolute frequencies and percentages (for categorical variables).\n\nThe evaluation of the predictive capability of the vesicles will be performed through sensitivity and specificity analysis of the predefined cutoffs (CD69+ \\> 349 absolute units; CD86+ \\> 10 absolute units; CD3+ \\> 4 absolute units) to verify that all have a positive predictive value (PPV) \\> 80%. ROC analysis using the original values of the vesicles will also be conducted to identify any alternative cutoff values that may better discriminate regarding the outcome.\n\nThe analysis of disease-free survival at two years from the start of therapy will be conducted descriptively using Kaplan-Meier curves and the log-rank test. Patients who died due to fatal complications will be censored at the date of death. Given the small size of the study population, Cox regressions may be performed, including the indicator of whether the vesicular cutoff was exceeded as a risk factor, along with a maximum of one confounder, provided that the number of events (disease recurrences) is adequate for the analysis."},"conditionsModule":{"conditions":["Rectal Cancer, Radiotherapy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":30,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Experimental analysis on tissues","type":"EXPERIMENTAL","description":"The results obtained from the study should not be considered conclusive but rather as generators of research hypotheses for potential subsequent studies to be conducted on larger populations.","interventionNames":["Other: Blood analysis"]}],"interventions":[{"type":"OTHER","name":"Blood analysis","description":"This is an experimental analysis on tissues (peripheral blood) and exploratory, which is why the enrollment of a limited number of patients has been planned. The results obtained from the study should not be considered conclusive but rather as generators of research hypotheses for potential subsequent studies to be conducted on larger populations. The qualitative and quantitative characteristics of the vesicles and their miRNA content will be analyzed descriptively.","armGroupLabels":["Experimental analysis on tissues"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pathological response","description":"The response to therapy will be assessed as a complete pathological response, defined as present/absent according to the staging criteria commonly used in clinical practice.","timeFrame":"through study completion, an average of 1 year"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients candidates for neoadjuvant RT, administered with hypofractionated-accelerated treatment, for locally advanced rectal tumors;\n* Age ≥ 18 years\n* Obtaining informed consent\n\nExclusion Criteria:\n\n* Contraindications to MRI, uncontrolled chronic intestinal diseases or pelvic infections\n* Pregnancy and breastfeeding\n* Unwillingness to participate in follow-up","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Alessio Giuseppe Morganti, MD","affiliation":"IRCCS Azienda Ospedaliero-Universitaria di Bologna","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"IRCCS Azienda Ospedaliero - Universitaria di Bologna","city":"Bologna","zip":"40138","country":"Italy","geoPoint":{"lat":44.49381,"lon":11.33875}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-16"},"conditionBrowseModule":{"meshes":[{"id":"D012004","term":"Rectal Neoplasms"}],"ancestors":[{"id":"D015179","term":"Colorectal Neoplasms"},{"id":"D007414","term":"Intestinal Neoplasms"},{"id":"D005770","term":"Gastrointestinal Neoplasms"},{"id":"D004067","term":"Digestive System Neoplasms"},{"id":"D009371","term":"Neoplasms by Site"},{"id":"D009369","term":"Neoplasms"},{"id":"D004066","term":"Digestive System Diseases"},{"id":"D005767","term":"Gastrointestinal Diseases"},{"id":"D007410","term":"Intestinal Diseases"},{"id":"D012002","term":"Rectal Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D006403","term":"Hematologic Tests"}],"ancestors":[{"id":"D019411","term":"Clinical Laboratory Techniques"},{"id":"D019937","term":"Diagnostic Techniques and Procedures"},{"id":"D003933","term":"Diagnosis"},{"id":"D008919","term":"Investigative Techniques"}]}},"hasResults":false}],"nextPageToken":"ZVNj7o2Elu8o3lp3Utj4srbumo6Qe5RsYfKm2fg","fetched_at":"2026-07-17T07:00:57.545Z"},"via":"native","generated_at":"2026-07-17T07:00:57.554Z"}