Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-01-18 @ 1:56 AM
Study NCT ID:
NCT01754350
Status:
COMPLETED
Last Update Posted:
2021-06-02
First Post:
2012-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'j.rieger@uni-tuebingen.de', 'phone': '+4969630187711', 'title': 'Johannes Rieger', 'organization': 'JohannWGUH'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'All, even non-serious adverse events, were monitored at start of treatment until end of intervention at day 12 to assess procedure-specific adverse events. After day 12, the prespecified secondary end point and adverse event "epileptic seizures"), and all serious adverse events were documented until the end of the study of individual patients (until primary end points was reached).', 'description': 'Few minor adverse events are not listed seperately because some of these occured in the same patients.', 'eventGroups': [{'id': 'EG000', 'title': 'Ketogenic Diet and Transient Fasting', 'description': 'Calorie-restricted, ketogenic diet and transient fasting during reirradiation\n\ncalorie-restricted ketogenic diet and transient fasting: On day 1-3 and day 7-9, restriction of carbohydrates to \\< 60 g and of calories to 21-23 kcal/kg per day, on day 4-6 fasting. On day 1-3 and 7-9, restriction of carbohydrates can be supported by the use of drinks provided by "Tavarlin".', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 4, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Nutrition', 'description': 'nutrition according to recommendations of the German society for nutrition during reirradiation\n\nstandard nutrition: nutrition as recommended by the german society for nutrition, 30 kcal/kg per day', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 5, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'epileptic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Others', 'notes': 'headache, nausea or possible epileptic seizures with short lasting aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free-survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketogenic Diet and Transient Fasting', 'description': 'Calorie-restricted, ketogenic diet and transient fasting during reirradiation\n\ncalorie-restricted ketogenic diet and transient fasting: On day 1-3 and day 7-9, restriction of carbohydrates to \\< 60 g and of calories to 21-23 kcal/kg per day, on day 4-6 fasting. On day 1-3 and 7-9, restriction of carbohydrates can be supported by the use of drinks provided by "Tavarlin".'}, {'id': 'OG001', 'title': 'Standard Nutrition', 'description': 'nutrition according to recommendations of the German society for nutrition during reirradiation\n\nstandard nutrition: nutrition as recommended by the german society for nutrition, 30 kcal/kg per day'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Progression-free-survival rates 6 months after reirradiation based on response assessment in neuro-oncology criteria (RANO)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Feasibility Measured as Median Number of Days on Diet Per Patient and Average Calorie and Carbohydrate Intake Per Day During Day 1-9', 'timeFrame': 'day 1-12', 'description': 'Feasibility of the calorie-restricted, ketogenic diet and the transient fasting measured as median number of days on diet per patient and average calorie and carbohydrate intake per day during day 1-9', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability as Defined as Number of Patients With Adverse Events', 'timeFrame': 'day 1-12', 'description': 'Safety and tolerability of the calorie-restricted, ketogenic diet and the transient fasting as defined as number of patients with adverse events', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Progression-free-survival', 'timeFrame': '1 month, 3 months', 'description': 'progression-free-survival rates 1 month and 3 month after reirradiation', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'timeFrame': '12 months', 'description': 'overall survival after the reirradiation', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Frequency of Seizures', 'timeFrame': 'day 1-12', 'description': 'frequency of seizures at day 1-12', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Ketosis', 'timeFrame': 'day 1-12', 'description': 'urine and blood ketosis and metabolic parameters (glucose, insulin, IGF-1) during day 1-12', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Measured by the EORTC Quality of Life Questionnaire', 'timeFrame': 'day 1-12', 'description': 'Quality of life at day 1-12 as measured by the EORTC Quality of Life Questionnaire', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Depression', 'timeFrame': 'day 1-12', 'description': 'depression as measured by SCL-90 at day 1-12', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Attention', 'timeFrame': 'day 1-12', 'description': 'attention as measured by d2-testing at day 1-12', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Response', 'timeFrame': '1 month', 'description': 'response assessment 1 month after reirradiation', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketogenic Diet and Transient Fasting', 'description': 'Calorie-restricted, ketogenic diet and transient fasting during reirradiation\n\ncalorie-restricted ketogenic diet and transient fasting: On day 1-3 and day 7-9, restriction of carbohydrates to \\< 60 g and of calories to 21-23 kcal/kg per day, on day 4-6 fasting. On day 1-3 and 7-9, restriction of carbohydrates can be supported by the use of drinks provided by "Tavarlin".'}, {'id': 'FG001', 'title': 'Standard Nutrition', 'description': 'nutrition according to recommendations of the German society for nutrition during reirradiation\n\nstandard nutrition: nutrition as recommended by the german society for nutrition, 30 kcal/kg per day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketogenic Diet and Transient Fasting', 'description': 'Calorie-restricted, ketogenic diet and transient fasting during reirradiation\n\ncalorie-restricted ketogenic diet and transient fasting: On day 1-3 and day 7-9, restriction of carbohydrates to \\< 60 g and of calories to 21-23 kcal/kg per day, on day 4-6 fasting. On day 1-3 and 7-9, restriction of carbohydrates can be supported by the use of drinks provided by "Tavarlin".'}, {'id': 'BG001', 'title': 'Standard Nutrition', 'description': 'nutrition according to recommendations of the German society for nutrition during reirradiation\n\nstandard nutrition: nutrition as recommended by the german society for nutrition, 30 kcal/kg per day'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '71'}, {'value': '58', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '75'}, {'value': '57', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-21', 'size': 68129, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-02T10:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-30', 'studyFirstSubmitDate': '2012-12-14', 'resultsFirstSubmitDate': '2021-03-28', 'studyFirstSubmitQcDate': '2012-12-18', 'lastUpdatePostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-30', 'studyFirstPostDateStruct': {'date': '2012-12-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free-survival', 'timeFrame': '6 months', 'description': 'Progression-free-survival rates 6 months after reirradiation based on response assessment in neuro-oncology criteria (RANO)'}], 'secondaryOutcomes': [{'measure': 'Feasibility Measured as Median Number of Days on Diet Per Patient and Average Calorie and Carbohydrate Intake Per Day During Day 1-9', 'timeFrame': 'day 1-12', 'description': 'Feasibility of the calorie-restricted, ketogenic diet and the transient fasting measured as median number of days on diet per patient and average calorie and carbohydrate intake per day during day 1-9'}, {'measure': 'Safety and Tolerability as Defined as Number of Patients With Adverse Events', 'timeFrame': 'day 1-12', 'description': 'Safety and tolerability of the calorie-restricted, ketogenic diet and the transient fasting as defined as number of patients with adverse events'}, {'measure': 'Progression-free-survival', 'timeFrame': '1 month, 3 months', 'description': 'progression-free-survival rates 1 month and 3 month after reirradiation'}, {'measure': 'Overall Survival', 'timeFrame': '12 months', 'description': 'overall survival after the reirradiation'}, {'measure': 'Frequency of Seizures', 'timeFrame': 'day 1-12', 'description': 'frequency of seizures at day 1-12'}, {'measure': 'Ketosis', 'timeFrame': 'day 1-12', 'description': 'urine and blood ketosis and metabolic parameters (glucose, insulin, IGF-1) during day 1-12'}, {'measure': 'Quality of Life as Measured by the EORTC Quality of Life Questionnaire', 'timeFrame': 'day 1-12', 'description': 'Quality of life at day 1-12 as measured by the EORTC Quality of Life Questionnaire'}, {'measure': 'Depression', 'timeFrame': 'day 1-12', 'description': 'depression as measured by SCL-90 at day 1-12'}, {'measure': 'Attention', 'timeFrame': 'day 1-12', 'description': 'attention as measured by d2-testing at day 1-12'}, {'measure': 'Response', 'timeFrame': '1 month', 'description': 'response assessment 1 month after reirradiation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ketogenic diet', 'glioma', 'fasting', 'reirradiation', 'nutrition'], 'conditions': ['Recurrent Glioblastoma']}, 'referencesModule': {'references': [{'pmid': '34487222', 'type': 'DERIVED', 'citation': 'Voss M, Wenger KJ, von Mettenheim N, Bojunga J, Vetter M, Diehl B, Franz K, Gerlach R, Ronellenfitsch MW, Harter PN, Hattingen E, Steinbach JP, Rodel C, Rieger J. Short-term fasting in glioma patients: analysis of diet diaries and metabolic parameters of the ERGO2 trial. Eur J Nutr. 2022 Feb;61(1):477-487. doi: 10.1007/s00394-021-02666-1. Epub 2021 Sep 6.'}, {'pmid': '33512717', 'type': 'DERIVED', 'citation': 'Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.'}, {'pmid': '32619561', 'type': 'DERIVED', 'citation': 'Voss M, Wagner M, von Mettenheim N, Harter PN, Wenger KJ, Franz K, Bojunga J, Vetter M, Gerlach R, Glatzel M, Paulsen F, Hattingen E, Baehr O, Ronellenfitsch MW, Fokas E, Imhoff D, Steinbach JP, Rodel C, Rieger J. ERGO2: A Prospective, Randomized Trial of Calorie-Restricted Ketogenic Diet and Fasting in Addition to Reirradiation for Malignant Glioma. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):987-995. doi: 10.1016/j.ijrobp.2020.06.021. Epub 2020 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'Increased glucose metabolism is characteristic for solid tumors. Thereby, glucose is important for the generation of ATP, supply of anabolic substrates and defense against reactive oxygen species in tumor cells. In preclinical models, restricting glucose availability using a ketogenic diet, calorie-restriction or transient fasting inhibits tumor growth.\n\nTherefore, the purpose of the study is to evaluate whether a calorie-restricted, ketogenic diet and transient fasting can enhance the efficacy of reirradiation in patients with recurrent glioblastoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>= 18 years\n* recurrence of a histologically confirmed glioblastoma or gliosarcoma\n* at least 6 months after first surgery\n* at least 6 months after first radiotherapy\n* interdisciplinary recommendation for reirradiation\n* karnofsky performance status \\>= 60, ECOG \\<= 2\n* creatinine \\<= 2,0 mg/dl, urea \\<= 100 mg/dl\n* ALAT, ASAT \\<= 7x upper normal limit\n\nExclusion Criteria:\n\n* bowel obstruction, subileus\n* insulin-dependent diabetes\n* decompensated heart failure (NYHA \\> 2)\n* myocardial infarction within the last 6 months, symptomatic atrial fibrillation\n* severe acute infection\n* malnutrition, cachexia\n* other medical conditions that might increase the risk of the dietary intervention\n* pregnancy\n* uncontrolled thyroid function\n* pancreatic insufficiency\n* dementia or other clinically relevant alterations of the mental status which could impair the ability of the patient to apply to the diet or understand the informed consent of the study'}, 'identificationModule': {'nctId': 'NCT01754350', 'acronym': 'ERGO2', 'briefTitle': 'Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Calorie-restricted, Ketogenic Diet and Transient Fasting vs. Standard Nutrition During Reirradiation for Patients With Recurrent Glioblastoma: the ERGO2 Study', 'orgStudyIdInfo': {'id': 'ERGO2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ketogenic diet and transient fasting', 'description': 'Calorie-restricted, ketogenic diet and transient fasting during reirradiation', 'interventionNames': ['Dietary Supplement: calorie-restricted ketogenic diet and transient fasting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard nutrition', 'description': 'nutrition according to recommendations of the German society for nutrition during reirradiation', 'interventionNames': ['Dietary Supplement: standard nutrition']}], 'interventions': [{'name': 'calorie-restricted ketogenic diet and transient fasting', 'type': 'DIETARY_SUPPLEMENT', 'description': 'On day 1-3 and day 7-9, restriction of carbohydrates to \\< 60 g and of calories to 21-23 kcal/kg per day, on day 4-6 fasting. On day 1-3 and 7-9, restriction of carbohydrates can be supported by the use of drinks provided by "Tavarlin".', 'armGroupLabels': ['ketogenic diet and transient fasting']}, {'name': 'standard nutrition', 'type': 'DIETARY_SUPPLEMENT', 'description': 'nutrition as recommended by the german society for nutrition, 30 kcal/kg per day', 'armGroupLabels': ['standard nutrition']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Dr. Senckenberg Institute of Neurooncology', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'University of Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tavarlin', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'Johannes Rieger', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}