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The dataset generation failed
Error code: DatasetGenerationError
Exception: TypeError
Message: Couldn't cast array of type
struct<unpostedAnnotation: struct<unpostedEvents: list<item: struct<date: string, dateUnknown: bool, type: string>>, unpostedResponsibleParty: string>>
to
{'unpostedAnnotation': {'unpostedEvents': [{'date': Value(dtype='string', id=None), 'dateUnknown': Value(dtype='bool', id=None), 'type': Value(dtype='string', id=None)}], 'unpostedResponsibleParty': Value(dtype='string', id=None)}, 'violationAnnotation': {'violationEvents': [{'creationDate': Value(dtype='string', id=None), 'description': Value(dtype='string', id=None), 'issuedDate': Value(dtype='string', id=None), 'postedDate': Value(dtype='string', id=None), 'releaseDate': Value(dtype='string', id=None), 'type': Value(dtype='string', id=None)}]}}
Traceback: Traceback (most recent call last):
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/builder.py", line 2011, in _prepare_split_single
writer.write_table(table)
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/arrow_writer.py", line 585, in write_table
pa_table = table_cast(pa_table, self._schema)
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/table.py", line 2302, in table_cast
return cast_table_to_schema(table, schema)
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/table.py", line 2261, in cast_table_to_schema
arrays = [cast_array_to_feature(table[name], feature) for name, feature in features.items()]
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/table.py", line 2261, in <listcomp>
arrays = [cast_array_to_feature(table[name], feature) for name, feature in features.items()]
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/table.py", line 1802, in wrapper
return pa.chunked_array([func(chunk, *args, **kwargs) for chunk in array.chunks])
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/table.py", line 1802, in <listcomp>
return pa.chunked_array([func(chunk, *args, **kwargs) for chunk in array.chunks])
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/table.py", line 2020, in cast_array_to_feature
arrays = [_c(array.field(name), subfeature) for name, subfeature in feature.items()]
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/table.py", line 2020, in <listcomp>
arrays = [_c(array.field(name), subfeature) for name, subfeature in feature.items()]
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/table.py", line 1804, in wrapper
return func(array, *args, **kwargs)
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/table.py", line 2122, in cast_array_to_feature
raise TypeError(f"Couldn't cast array of type\n{_short_str(array.type)}\nto\n{_short_str(feature)}")
TypeError: Couldn't cast array of type
struct<unpostedAnnotation: struct<unpostedEvents: list<item: struct<date: string, dateUnknown: bool, type: string>>, unpostedResponsibleParty: string>>
to
{'unpostedAnnotation': {'unpostedEvents': [{'date': Value(dtype='string', id=None), 'dateUnknown': Value(dtype='bool', id=None), 'type': Value(dtype='string', id=None)}], 'unpostedResponsibleParty': Value(dtype='string', id=None)}, 'violationAnnotation': {'violationEvents': [{'creationDate': Value(dtype='string', id=None), 'description': Value(dtype='string', id=None), 'issuedDate': Value(dtype='string', id=None), 'postedDate': Value(dtype='string', id=None), 'releaseDate': Value(dtype='string', id=None), 'type': Value(dtype='string', id=None)}]}}
The above exception was the direct cause of the following exception:
Traceback (most recent call last):
File "/src/services/worker/src/worker/job_runners/config/parquet_and_info.py", line 1524, in compute_config_parquet_and_info_response
parquet_operations, partial, estimated_dataset_info = stream_convert_to_parquet(
File "/src/services/worker/src/worker/job_runners/config/parquet_and_info.py", line 1099, in stream_convert_to_parquet
builder._prepare_split(
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/builder.py", line 1882, in _prepare_split
for job_id, done, content in self._prepare_split_single(
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/builder.py", line 2038, in _prepare_split_single
raise DatasetGenerationError("An error occurred while generating the dataset") from e
datasets.exceptions.DatasetGenerationError: An error occurred while generating the datasetNeed help to make the dataset viewer work? Make sure to review how to configure the dataset viewer, and open a discussion for direct support.
protocolSection
dict | resultsSection
null | hasResults
bool | documentSection
null | derivedSection
dict | annotationSection
null |
|---|---|---|---|---|---|
{
"armsInterventionsModule": {
"armGroups": [
{
"description": "Kinesio(R)Tape for edema management applied to a randomly selected lower extremity plus standard inpatient rehabilitation after bilateral total knee arthroplasty",
"interventionNames": [
"Device: Kinesio(R)Tape for edema control"
],
"label": "Kinesiotape leg plus standard rehabilitation",
"type": "EXPERIMENTAL"
},
{
"description": "Control leg receiving standard inpatient rehabilitation alone.",
"interventionNames": null,
"label": "Control leg with standard rehabilitation alone",
"type": "NO_INTERVENTION"
}
],
"interventions": [
{
"armGroupLabels": [
"Kinesiotape leg plus standard rehabilitation"
],
"description": "Kinesio(R)Tape is an elastic, cotton tape with an adhesive backing. When applied for edema management, strips of Kinesio(R)Tape are applied to the lower leg in a criss-cross fashion by a physical therapist who is a Certified Kinesiotape Practitioner.",
"name": "Kinesio(R)Tape for edema control",
"otherNames": [
"kinesiotaping or kinesiological taping"
],
"type": "DEVICE"
}
]
},
"conditionsModule": {
"conditions": [
"Arthroplasty Complications",
"Arthroplasty, Replacement, Knee"
],
"keywords": [
"edema",
"arthroplasty, knee, bilateral",
"kinesiotaping"
]
},
"contactsLocationsModule": {
"centralContacts": null,
"locations": [
{
"city": "White Plains",
"contacts": null,
"country": "United States",
"facility": "Burke Rehabilitation Hospital",
"geoPoint": {
"lat": 41.03399,
"lon": -73.76291
},
"state": "New York",
"status": null,
"zip": "10605"
}
],
"overallOfficials": [
{
"affiliation": "Burke Rehabilitation Hospital",
"name": "Suzanne Babyar, PT, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to determine if kinesiotaping for edema management will decrease post-operative edema in patients with bilateral total knee arthroplasty. The leg receiving kinesiotaping during inpatient rehabilitation may have decreased edema and pain and improved movement and function when compared to the leg not receiving kinesiotape.",
"detailedDescription": "After being informed about the study and potential risk, all patients undergoing inpatient rehabilitation after bilateral total knee arthroplasty will have Kinesio(R)Tape applied to one randomly selected leg while the other leg serves as a control. Measurement of bilateral leg circumference, knee range of motion, numerical rating scale for pain, and selected questions from the Knee Injury and Osteoarthritis Outcome Score will occur at regular intervals throughout the rehabilitation stay. Patients will receive standard rehabilitation."
},
"designModule": {
"bioSpec": null,
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Repeated measures with two within-subjects factors: time and taped/untaped leg",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 65,
"type": "ACTUAL"
},
"expandedAccessTypes": null,
"nPtrsToThisExpAccNctId": null,
"patientRegistry": null,
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL",
"targetDuration": null
},
"eligibilityModule": {
"eligibilityCriteria": "Inclusion Criteria:\n\n* admitted to Burke Rehabilitation Hospital for inpatient rehabilitation within 5 days after same-day or staged bilateral total knee arthroplasty;\n* 50-85 years of age;\n* able to read and understand English or a hospital-provided translator when consenting for the study;\n* free from contraindications for kinesiotaping (see below); and,\n* able to tolerate an active rehabilitation program.\n\nExclusion Criteria:\n\n* stage III or IV heart failure, stage III or IV renal failure;\n* fragile, very hairy or sensitive skin;\n* anesthesia or paraesthesia of any area of the lower extremity, except the surgical sites\n* active skin rashes or infections or skin lesions in the lower extremity;\n* prior history of allergic reactions to skin taping, bandaids, surgical tape; athletic tape or other skin-adhering electrode adhesives;\n* prior history of lower extremity lymphedema;3\n* prior history of lower extremity venous or arterial disease;\n* post-operative complications in the surgical sites;4\n* partial joint arthroplasty or revision arthroplasty of one or both knees;1,5\n* inability to give informed consent offered in English or through a hospital-provided translator\n* age less than 50 years or over 85 years;\n* inability to tolerate an active rehabilitation program.",
"genderBased": null,
"genderDescription": null,
"healthyVolunteers": false,
"maximumAge": "85 Years",
"minimumAge": "50 Years",
"samplingMethod": null,
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
],
"studyPopulation": null
},
"identificationModule": {
"acronym": null,
"briefTitle": "Kinesiotape for Edema After Bilateral Total Knee Arthroplasty",
"nctId": "NCT05013879",
"nctIdAliases": null,
"officialTitle": "Effect of Kinesiotaping on Edema Management, Pain and Function on Patients With Bilateral Total Knee Arthroplasty",
"orgStudyIdInfo": {
"id": "2021-13203",
"link": null,
"type": null
},
"organization": {
"class": "OTHER",
"fullName": "Montefiore Medical Center"
},
"secondaryIdInfos": null
},
"ipdSharingStatementModule": {
"accessCriteria": null,
"description": null,
"infoTypes": null,
"ipdSharing": "NO",
"timeFrame": null,
"url": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"description": "Bilateral circumferences, in centimeters, at the following points: 10 cm above the superior pole of the patella; middle of the knee joint; calf circumference at the broadest part of the calf and at 3 inches below the fibular head landmark; figure of eight method for foot and ankle circumference - a measurement from the lateral malleolus to the navicular tuberosity, under the plantar aspect of the foot towards the tuberosity of the fifth metatarsal, around to the medial malleolus, and posterior to the leg to return to the lateral malleolus.",
"measure": "Change from baseline and during 1-2-day time intervals of circumferences of both knees and lower extremities",
"timeFrame": "During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8"
}
],
"secondaryOutcomes": [
{
"description": "Patient self-report: Pain rating for each leg on a integer scale of 0 (no pain) to 10 (worst pain imaginable)",
"measure": "Change from baseline and day-to-day changes of bilateral knee pain on numerical pain rating scale",
"timeFrame": "During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8"
},
{
"description": "Physical therapist's measurement of active and active assistive knee range of motion (degrees) for flexion and extension using a standard goniometer",
"measure": "Change from baseline and during 1-2-day time intervals for bilateral knee range of motion",
"timeFrame": "During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8"
},
{
"description": "Patient self-report using the KOOS sections relating to pain, stiffness, activities of daily living",
"measure": "Change from baseline to Day 4 to Discharge Day for selected parts of the Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report",
"timeFrame": "At start of study, 4 days after start of study, and day 8"
},
{
"description": "Time (sec) to rise from a seated position, walk 10 m, turn, walk back to seat, and sit down. Patient will use appropriate assistive device and have appropriate guarding by a physical therapist.",
"measure": "Change from baseline and during 1-2-day time intervals for Timed Up-and-Go Test",
"timeFrame": "During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8"
}
]
},
"oversightModule": {
"fdaaa801Violation": null,
"isFdaRegulatedDevice": false,
"isFdaRegulatedDrug": false,
"isPpsd": null,
"isUnapprovedDevice": null,
"isUsExport": null,
"oversightHasDmc": false
},
"referencesModule": {
"availIpds": null,
"references": [
{
"citation": "Tornatore L, De Luca ML, Ciccarello M, Benedetti MG. Effects of combining manual lymphatic drainage and Kinesiotaping on pain, edema, and range of motion in patients with total knee replacement: a randomized clinical trial. Int J Rehabil Res. 2020 Sep;43(3):240-246. doi: 10.1097/MRR.0000000000000417.",
"pmid": "32459670",
"retractions": null,
"type": "BACKGROUND"
},
{
"citation": "Guney Deniz H, Kinikli GI, Onal S, Sevinc C, Caglar O, Yuksei I. Comparison of Kinesio Tape application and manual lymphatic drainage on lower extremity oedema and functions after total knee arthroplasty. [Abstract]. Ann Rheum Dis. 2018; 77: 1791.",
"pmid": null,
"retractions": null,
"type": "BACKGROUND"
},
{
"citation": "Donec V, Krisciunas A. The effectiveness of Kinesio Taping(R) after total knee replacement in early postoperative rehabilitation period. A randomized controlled trial. Eur J Phys Rehabil Med. 2014 Aug;50(4):363-71. Epub 2014 May 13.",
"pmid": "24819349",
"retractions": null,
"type": "BACKGROUND"
},
{
"citation": "Sulman M, Riaz S, Khan RR, Faisal Z, Rajput R, Noor M. Effectiveness of Kinesio Taping on pain and function after total knee arthroplasty. Pak J Med Health Sci. 2020;14:1267-1270.",
"pmid": null,
"retractions": null,
"type": "BACKGROUND"
},
{
"citation": "Oktas B, Vergili O. The effect of intensive exercise program and kinesiotaping following total knee arthroplasty on functional recovery of patients. J Orthop Surg Res. 2018 Sep 12;13(1):233. doi: 10.1186/s13018-018-0924-9.",
"pmid": "30208939",
"retractions": null,
"type": "BACKGROUND"
},
{
"citation": "Alghadir A, Anwer S, Brismee JM. The reliability and minimal detectable change of Timed Up and Go test in individuals with grade 1-3 knee osteoarthritis. BMC Musculoskelet Disord. 2015 Jul 30;16:174. doi: 10.1186/s12891-015-0637-8.",
"pmid": "26223312",
"retractions": null,
"type": "BACKGROUND"
},
{
"citation": "Hancock GE, Hepworth T, Wembridge K. Accuracy and reliability of knee goniometry methods. J Exp Orthop. 2018 Oct 19;5(1):46. doi: 10.1186/s40634-018-0161-5.",
"pmid": "30341552",
"retractions": null,
"type": "BACKGROUND"
},
{
"citation": "Unver B, Ertekin O, Karatosun V. Pain, fear of falling and stair climbing ability in patients with knee osteoarthritis before and after knee replacement: 6 month follow-up study. J Back Musculoskelet Rehabil. 2014;27(1):77-84. doi: 10.3233/BMR-130422.",
"pmid": "23948839",
"retractions": null,
"type": "BACKGROUND"
},
{
"citation": "Bakar Y, Ozdemir OC, Sevim S, Duygu E, Tugral A, Surmeli M. Intra-observer and inter-observer reliability of leg circumference measurement among six observers: a single blinded randomized trial. J Med Life. 2017 Jul-Sep;10(3):176-181.",
"pmid": "29075347",
"retractions": null,
"type": "BACKGROUND"
},
{
"citation": "Collins NJ, Roos EM. Patient-reported outcomes for total hip and knee arthroplasty: commonly used instruments and attributes of a \"good\" measure. Clin Geriatr Med. 2012 Aug;28(3):367-94. doi: 10.1016/j.cger.2012.05.007. Epub 2012 Jun 22.",
"pmid": "22840304",
"retractions": null,
"type": "BACKGROUND"
}
],
"seeAlsoLinks": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"class": "OTHER",
"name": "Burke Rehabilitation Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Montefiore Medical Center"
},
"responsibleParty": {
"investigatorAffiliation": null,
"investigatorFullName": null,
"investigatorTitle": null,
"oldNameTitle": null,
"oldOrganization": null,
"type": "SPONSOR"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-11-24",
"type": "ACTUAL"
},
"delayedPosting": null,
"dispFirstPostDateStruct": null,
"dispFirstSubmitDate": null,
"dispFirstSubmitQcDate": null,
"expandedAccessInfo": {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
},
"lastKnownStatus": null,
"lastUpdatePostDateStruct": {
"date": "2024-02-23",
"type": "ACTUAL"
},
"lastUpdateSubmitDate": "2024-02-21",
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-11-24",
"type": "ACTUAL"
},
"resultsFirstPostDateStruct": null,
"resultsFirstSubmitDate": null,
"resultsFirstSubmitQcDate": null,
"startDateStruct": {
"date": "2021-10-18",
"type": "ACTUAL"
},
"statusVerifiedDate": "2024-02",
"studyFirstPostDateStruct": {
"date": "2021-08-19",
"type": "ACTUAL"
},
"studyFirstSubmitDate": "2021-08-02",
"studyFirstSubmitQcDate": "2021-08-18",
"whyStopped": null
}
}
| null | false
| null |
{
"conditionBrowseModule": {
"ancestors": null,
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M13066",
"name": "Pain",
"relevance": "LOW"
},
{
"asFound": "Edema",
"id": "M7657",
"name": "Edema",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D000004487",
"term": "Edema"
}
]
},
"interventionBrowseModule": null,
"miscInfoModule": {
"removedCountries": null,
"submissionTracking": null,
"versionHolder": "2024-05-24"
}
}
| null |
{
"armsInterventionsModule": {
"armGroups": [
{
"description": "open label single arm trial",
"interventionNames": [
"Drug: Ramipril"
],
"label": "ramipril",
"type": "ACTIVE_COMPARATOR"
}
],
"interventions": [
{
"armGroupLabels": [
"ramipril"
],
"description": "ramipril 2.5mg twice a day",
"name": "Ramipril",
"otherNames": null,
"type": "DRUG"
}
]
},
"conditionsModule": {
"conditions": [
"Migraine With Hypertension"
],
"keywords": [
"migraine,",
"ramipril,",
"hypertension"
]
},
"contactsLocationsModule": {
"centralContacts": null,
"locations": [
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Seoul National University Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": null,
"zip": "110-744"
}
],
"overallOfficials": null
},
"descriptionModule": {
"briefSummary": "Physiology of migraine involving renin-angiotensin systems (RAS) has been implicated. Ramipril is a broadly-used angiotensin-converting enzyme inhibitor. The investigators attempt to test the efficacy of ramipril on the prophylaxis of migraine attacks.",
"detailedDescription": null
},
"designModule": {
"bioSpec": null,
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ACTUAL"
},
"expandedAccessTypes": null,
"nPtrsToThisExpAccNctId": null,
"patientRegistry": null,
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL",
"targetDuration": null
},
"eligibilityModule": {
"eligibilityCriteria": "Inclusion Criteria:\n\n* Patients with chronic migraine are included in this study. Migraineurs should be aged 20 to 70 years old with the ability to read and understand the self-report scales, including the headache diary, used in this study.\n\nExclusion Criteria:\n\n1. Medication overuse headache are excluded in this study.\n2. Treatment with other ACEI or medication that may affect ARS\n3. Treatment with migraine prophylactic medications or anti-hypertensive agents including β adrenergic receptor or calcium channel blockers\n4. Past history of hepatic or renal dysfunction; an abnormal electrocardiography; a psychiatric disorder; a history of substance abuse; pregnancy or lactation; use of anti-psychotics, antidepressants, or anti-anxiety drugs.",
"genderBased": null,
"genderDescription": null,
"healthyVolunteers": null,
"maximumAge": "70 Years",
"minimumAge": "20 Years",
"samplingMethod": null,
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
],
"studyPopulation": null
},
"identificationModule": {
"acronym": null,
"briefTitle": "An Open-labeled Trial of Ramipril in Patients With Migraine",
"nctId": "NCT01402479",
"nctIdAliases": null,
"officialTitle": "An Open-labeled Trial of Ramipril in Patients With Migraine",
"orgStudyIdInfo": {
"id": "0408-131-005",
"link": null,
"type": null
},
"organization": {
"class": "OTHER",
"fullName": "Seoul National University Hospital"
},
"secondaryIdInfos": null
},
"ipdSharingStatementModule": null,
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"description": "headache days",
"measure": "headache frequency",
"timeFrame": "12 week"
}
],
"secondaryOutcomes": null
},
"oversightModule": {
"fdaaa801Violation": null,
"isFdaRegulatedDevice": null,
"isFdaRegulatedDrug": null,
"isPpsd": null,
"isUnapprovedDevice": null,
"isUsExport": null,
"oversightHasDmc": false
},
"referencesModule": null,
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Seoul National University Hospital"
},
"responsibleParty": {
"investigatorAffiliation": null,
"investigatorFullName": null,
"investigatorTitle": null,
"oldNameTitle": "Manho Kim, MD, PhD",
"oldOrganization": "Department of Neurology, Seoul National University Hospital",
"type": null
}
},
"statusModule": {
"completionDateStruct": {
"date": "2005-07",
"type": "ACTUAL"
},
"delayedPosting": null,
"dispFirstPostDateStruct": null,
"dispFirstSubmitDate": null,
"dispFirstSubmitQcDate": null,
"expandedAccessInfo": {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
},
"lastKnownStatus": null,
"lastUpdatePostDateStruct": {
"date": "2011-08-08",
"type": "ESTIMATED"
},
"lastUpdateSubmitDate": "2011-08-05",
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2005-07",
"type": "ACTUAL"
},
"resultsFirstPostDateStruct": null,
"resultsFirstSubmitDate": null,
"resultsFirstSubmitQcDate": null,
"startDateStruct": {
"date": "2004-10",
"type": null
},
"statusVerifiedDate": "2011-07",
"studyFirstPostDateStruct": {
"date": "2011-07-26",
"type": "ESTIMATED"
},
"studyFirstSubmitDate": "2011-07-24",
"studyFirstSubmitQcDate": "2011-07-24",
"whyStopped": null
}
}
| null | false
| null |
{
"conditionBrowseModule": {
"ancestors": [
{
"id": "D000014652",
"term": "Vascular Diseases"
},
{
"id": "D000002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D000051270",
"term": "Headache Disorders, Primary"
},
{
"id": "D000020773",
"term": "Headache Disorders"
},
{
"id": "D000001927",
"term": "Brain Diseases"
},
{
"id": "D000002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D000009422",
"term": "Nervous System Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
{
"asFound": "Hypertension",
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{
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],
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"id": "D000082082",
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{
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{
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],
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],
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{
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{
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},
{
"description": "length of hospitalized stays CU days, expire",
"measure": "Post-op complication: hospitalized days",
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},
{
"description": "length of ICU stays",
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{
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| null |
{
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{
"abbrev": "Ot",
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],
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{
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{
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]
},
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"affiliation": "University of Pennsylvania",
"name": "James D Lewis, MD, MSCE",
"role": "PRINCIPAL_INVESTIGATOR"
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"descriptionModule": {
"briefSummary": "This protocol is designed to compare the effectiveness of two dietary interventions for patients with Crohn's disease (CD): the Specific Carbohydrate Diet (SCD) and a Mediterranean style diet (MSD) that has been demonstrated to have numerous other health benefits. The two diets will be compared in terms of their ability to resolve both the symptoms and bowel inflammation that characterize this debilitating disease.",
"detailedDescription": "This study tested whether the SCD is superior to a MSD for managing symptoms and reducing inflammatory markers in patients with CD.\n\nThe study was designed to include 194 patients with CD who have 1) active symptoms defined by a short Crohn's Disease Activity Index (sCDAI) score \\>175. Although the initial plan was to also require that all patients have active inflammation documented by a fecal calprotectin (FCP) concentration \\>250mcg/g or high sensitivity C-reactive protein (CRP) \\>7 mg/L or ulceration of the small bowel and/or colon consistent with an SES-CD score \\>4 as documented in routine clinical practice within 4 weeks of screening, a decision was made early in the recruitment period to enroll all patients with CD with sCDAI\\>175 regardless of the results of the tests for inflammatory markers and to perform subgroup analyses of those with and without evidence of inflammation.\n\nEligible participants were randomly assigned to follow one of the diets in a 1:1 ratio. Participants were provided with 3 meals and 2 snacks each day for a period of 6 weeks. The meals and snacks were prepared by the food vendor, Healthy Chef Creations, and were delivered directly to the participant's home once per week. Participants in both groups were also provided with instructions on how to follow the diets on their own. Participants reported their symptoms through an electronic diary and provided stool samples for FCP measurement and blood for CRP measurement at weeks 0, 6 and 12. The primary and secondary outcomes were assessed at week 6. Following week 6, participants were able to pay out of pocket to purchase food from Healthy Chef Creations and/or could attempt to follow their assigned diet completely on their own. At week 12, in addition to the primary and secondary outcomes assessed again"
},
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},
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"primaryPurpose": "TREATMENT",
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},
"enrollmentInfo": {
"count": 197,
"type": "ACTUAL"
},
"expandedAccessTypes": null,
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"phases": [
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],
"studyType": "INTERVENTIONAL",
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},
"eligibilityModule": {
"eligibilityCriteria": "Inclusion Criteria\n\n1. Age ≥18\n2. Documented diagnosis of Crohn's disease\n3. sCDAI score \\>175\n4. Documentation of receipt of a baseline stool sample by the data coordinating center and hsCRP.\n5. Access to a computer with internet and the ability to complete daily online surveys\n6. Capable of providing consent to participate\n7. Able to receive weekly food shipments delivered every Friday for 6 weeks\n\nExclusion Criteria\n\n1. Pregnancy\n2. sCDAI \\>400\n3. Hospitalized patients\n4. Anticipated need for surgery within 6 weeks of randomization\n5. Use of the Specific Carbohydrate Diet within 4 weeks of screening\n6. Start or change\\*\\*\\* dose of thiopurines (azathioprine and 6-MP), methotrexate, natalizumab, or vedolizumab within 12 weeks prior to screening\n7. Start or change\\*\\*\\* dose of anti-tumor necrosis factor (TNF) agents (including infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia), golimumab (Simponi) or ustekinumab within 8 weeks prior to screening.\n8. Start or change in dose of any 5-aminosalicylic acid (5-ASA) medications within 2 weeks of screening.\n9. Start or change dose of corticosteroids within 1 week of screening or a dose \\>20mg/day prednisone or equivalent\\*\n10. Use of antibiotics (other than topical formulations) for any reason within 2 weeks prior to screening\n11. Known symptomatic intestinal stricture.\n12. Presence of an ostomy\n13. Baseline stool frequency \\>4 bowel movements/day when well\n14. BMI \\<16\n15. BMI ≥40\n16. Celiac disease\n17. Documented C difficile colitis within four weeks of screening\n18. Diabetes Mellitus requiring medication\n19. Albumin\\<2.0mg/dl, within 4 weeks of screening (if tested as part of routine clinical care)\n20. Known allergy to tree nuts or peanuts\n21. Other conditions that would be a contraindication to any of the study diets or preclude the participant from completing the study.\n22. Currently participating in another clinical trial of a drug to treat Inflammatory Bowel Disease (IBD) or a dietary therapy for any indication.\n\n * Patients may continue these medications at stable dose for the first six weeks and budesonide may be used at any dose. After the 6th week in the study, patients may taper their steroid dose. The study will provide a recommended taper schedule.\n\n * Loading/induction doses of biologic type medication will be considered a stable doses. \\*\\*\\*Exception for treatment failures: if a subject is determined to fail on any of the following standard lines of treatment at the treating investigator's discretion, subjects may screen for study intervention based upon the following wash out periods: 4 weeks for thiopurine and methotrexate and 8 weeks for natalizumab, vedolizumab, anti-TNF, or ustekinumab.",
"genderBased": null,
"genderDescription": null,
"healthyVolunteers": false,
"maximumAge": null,
"minimumAge": "18 Years",
"samplingMethod": null,
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
],
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},
"identificationModule": {
"acronym": "DINE-CD",
"briefTitle": "Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease",
"nctId": "NCT03058679",
"nctIdAliases": null,
"officialTitle": "Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease",
"orgStudyIdInfo": {
"id": "825907",
"link": null,
"type": null
},
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"class": "OTHER",
"fullName": "University of Pennsylvania"
},
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},
"ipdSharingStatementModule": {
"accessCriteria": null,
"description": null,
"infoTypes": null,
"ipdSharing": "NO",
"timeFrame": null,
"url": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"description": "Assessed by Short Crohn's Disease Activity Index (sCDAI) - diarrhea, abdominal pain and general well being; sCDAI \\<150 in the absence of initiation or increase of any CD medications",
"measure": "Percentage of Participants That Achieved Symptomatic Remission at Week 6",
"timeFrame": "6 weeks"
},
{
"description": "reduction of calprotectin to less than 250 μg/g and by greater than 50% from screening among those with screening FC \\>250 μg/g",
"measure": "Reduction in Bowel Inflammation Among Those Whose Screening Fecal Calprotectin (FC) Was Greater Than 250μg/g at Baseline and Who Had an FC Results at Both Baseline and Week 6",
"timeFrame": "6 weeks"
}
],
"secondaryOutcomes": [
{
"description": "Assessed by the CDAI - CDAI \\<150",
"measure": "Percentage of Participants That Reached Clinical Remission at Week 6",
"timeFrame": "6 weeks"
},
{
"description": "reduction in high-sensitivity CRP (hsCRP) to \\<5 mg/L and \\>50% reduction from screening among those with screening hsCRP \\>5mg/L",
"measure": "Percentage of Participants With a Reduction in Systemic Inflammation at Week 6",
"timeFrame": "6 weeks"
}
]
},
"oversightModule": {
"fdaaa801Violation": null,
"isFdaRegulatedDevice": false,
"isFdaRegulatedDrug": false,
"isPpsd": null,
"isUnapprovedDevice": null,
"isUsExport": null,
"oversightHasDmc": true
},
"referencesModule": {
"availIpds": null,
"references": [
{
"citation": "Lewis JD, Sandler RS, Brotherton C, Brensinger C, Li H, Kappelman MD, Daniel SG, Bittinger K, Albenberg L, Valentine JF, Hanson JS, Suskind DL, Meyer A, Compher CW, Bewtra M, Saxena A, Dobes A, Cohen BL, Flynn AD, Fischer M, Saha S, Swaminath A, Yacyshyn B, Scherl E, Horst S, Curtis JR, Braly K, Nessel L, McCauley M, McKeever L, Herfarth H; DINE-CD Study Group. A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults With Crohn's Disease. Gastroenterology. 2021 Sep;161(3):837-852.e9. doi: 10.1053/j.gastro.2021.05.047. Epub 2021 May 27. Erratum In: Gastroenterology. 2022 Nov;163(5):1473.",
"pmid": "34052278",
"retractions": null,
"type": "DERIVED"
}
],
"seeAlsoLinks": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"class": "OTHER",
"name": "Patient-Centered Outcomes Research Institute"
},
{
"class": "OTHER",
"name": "Crohn's and Colitis Foundation"
},
{
"class": "OTHER",
"name": "University of North Carolina, Chapel Hill"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Pennsylvania"
},
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"investigatorFullName": null,
"investigatorTitle": null,
"oldNameTitle": null,
"oldOrganization": null,
"type": "SPONSOR"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2020-03-01",
"type": "ACTUAL"
},
"delayedPosting": null,
"dispFirstPostDateStruct": null,
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"expandedAccessInfo": {
"hasExpandedAccess": false,
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"statusForNctId": null
},
"lastKnownStatus": null,
"lastUpdatePostDateStruct": {
"date": "2021-07-21",
"type": "ACTUAL"
},
"lastUpdateSubmitDate": "2021-06-30",
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2020-03-01",
"type": "ACTUAL"
},
"resultsFirstPostDateStruct": {
"date": "2021-07-21",
"type": "ACTUAL"
},
"resultsFirstSubmitDate": "2021-03-26",
"resultsFirstSubmitQcDate": "2021-06-30",
"startDateStruct": {
"date": "2017-09-29",
"type": "ACTUAL"
},
"statusVerifiedDate": "2021-06",
"studyFirstPostDateStruct": {
"date": "2017-02-23",
"type": "ACTUAL"
},
"studyFirstSubmitDate": "2017-02-16",
"studyFirstSubmitQcDate": "2017-02-16",
"whyStopped": null
}
}
| null | true
| null |
{
"conditionBrowseModule": {
"ancestors": [
{
"id": "D000015212",
"term": "Inflammatory Bowel Diseases"
},
{
"id": "D000005759",
"term": "Gastroenteritis"
},
{
"id": "D000005767",
"term": "Gastrointestinal Diseases"
},
{
"id": "D000004066",
"term": "Digestive System Diseases"
},
{
"id": "D000007410",
"term": "Intestinal Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC06",
"name": "Digestive System Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": "Crohn's Disease",
"id": "M6638",
"name": "Crohn Disease",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M10444",
"name": "Intestinal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17917",
"name": "Inflammatory Bowel Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8875",
"name": "Gastroenteritis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7255",
"name": "Digestive System Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8883",
"name": "Gastrointestinal Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000003424",
"term": "Crohn Disease"
}
]
},
"interventionBrowseModule": null,
"miscInfoModule": {
"removedCountries": null,
"submissionTracking": null,
"versionHolder": "2024-05-24"
}
}
| null |
{
"armsInterventionsModule": {
"armGroups": [
{
"description": null,
"interventionNames": [
"Drug: Caudal dexamedatomidine analgesia"
],
"label": "• Group A will take Caudal Levob 0. 125%+ DEXM 0.5µg/k",
"type": "ACTIVE_COMPARATOR"
},
{
"description": null,
"interventionNames": [
"Drug: Caudal dexamedatomidine analgesia"
],
"label": "• Group B will take Caudal Levob 0.125%+ DEXM 1µg/kg.",
"type": "ACTIVE_COMPARATOR"
},
{
"description": null,
"interventionNames": [
"Drug: Caudal dexamedatomidine analgesia"
],
"label": "• Group C will take Caudal Levob 0. 125%+ DEXM 1.5 µg/",
"type": "ACTIVE_COMPARATOR"
},
{
"description": null,
"interventionNames": [
"Drug: Caudal dexamedatomidine analgesia"
],
"label": "• Group D will take Caudal Levob 0. 125%+ DEXM 2µg/kg.",
"type": "ACTIVE_COMPARATOR"
}
],
"interventions": [
{
"armGroupLabels": [
"• Group A will take Caudal Levob 0. 125%+ DEXM 0.5µg/k",
"• Group B will take Caudal Levob 0.125%+ DEXM 1µg/kg.",
"• Group C will take Caudal Levob 0. 125%+ DEXM 1.5 µg/",
"• Group D will take Caudal Levob 0. 125%+ DEXM 2µg/kg."
],
"description": "Technique performance (Caudal block): classical technique; palpation, identification and puncture with the patients in the lateral position (permits easy access to the airway under general anesthesia) using a 22-G short-beveled needle under sterile conditions advancing needle pierces the sacrococcygeal ligament.\n\nAfter needle insertion, pre-calculated volume of Levob plus DEXM bolus was injected as follow; Group A Caudal Levob 0.125%+ DEXM 0.5µg/kg. Group B Caudal Levob 0.125%+ DEXM 1µg/kg. Group C Caudal Levob 0.125%+ DEXM 1. 5 µg/kg. Group D Caudal Levob 0.125%+ DEXM 2µg/kg.",
"name": "Caudal dexamedatomidine analgesia",
"otherNames": null,
"type": "DRUG"
}
]
},
"conditionsModule": {
"conditions": [
"164 Boys for Hypospadias Surgery Under General Anesthesia With Caudal Block"
],
"keywords": [
"Caudal",
"Dexmedetomidine",
"Levobupivacaine",
"hypospadias"
]
},
"contactsLocationsModule": {
"centralContacts": null,
"locations": [
{
"city": "Mansoura",
"contacts": null,
"country": "Egypt",
"facility": "Anesthesia department,Faculty of medicine, Mansoura univerisety",
"geoPoint": {
"lat": 31.03637,
"lon": 31.38069
},
"state": null,
"status": null,
"zip": null
}
],
"overallOfficials": [
{
"affiliation": "Mansoura Univeristy",
"name": "mohamed A Ghanem, A professor",
"role": "STUDY_CHAIR"
}
]
},
"descriptionModule": {
"briefSummary": "Dexmedetomidine (DEXM) is a highly selective α2-adrenoceptor agonist that has been used increasingly in pediatric anesthesia. This prospective double blinded randomized comparative study is designed to evaluate the analgesic effect of caudal increasing doses of DEXM 0.5 , 1 , 1.5 , 2µg/kg combined with Levobupivacaine (Levob) 0.125% (ED95% =125%=least effective concentration) in providing pain relief over a 24-h period and lowest surgical stress peak. Study hypothesis: Levobupivacaine 0.125 %( ED95) combined with different increasing doses of dexamedatomedine \\>1 µg/kg could not add more analgesic \\& stress response obtundation outcome, but increase side effects (sedation and hemodynamic depression). The peak cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour. Aim of the Study: To detect the optimal analgesic and safe caudal adjuvant DEXM dose associated with the least side effects\\& stress response modulation, guided by PO Cortisol peak difference in between the study groups during pediatric hypospadias surgery.",
"detailedDescription": "Background: Dexmedetomidine (DEXM) is a highly selective α2-adrenoceptor agonist that has been used increasingly in pediatric anesthesia. This prospective double blinded randomized comparative study is designed to evaluate the analgesic effect of caudal increasing doses of DEXM 0.5 , 1 , 1.5 , 2µg/kg combined with Levobupivacaine (Levob) 0.125% (ED95% =125%=least effective concentration) in providing pain relief over a 24-h period and lowest surgical stress peak. Study hypothesis: Levobupivacaine 0.125 %( ED95) combined with different increasing doses of dexamedatomedine \\>1 µg/kg could not add more analgesic \\& stress response obtundation outcome, but increase side effects (sedation and hemodynamic depression).The peak cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour. Aim of the Study: To detect the optimal analgesic and safe caudal adjuvant DEXM dose associated with the least side effects\\& stress response modulation, guided by PO Cortisol peak difference in between the study groups during pediatric hypospadias surgery.\n\nOptimal effective dose defined as; the least caudal DEXM dose which produce the best analgesic outcome \\[least time to 1st analgesic request and lowest rescue analgesic dose (24Hs)\\] associated with the least stress response (cortisol PO. first One hour peak), least PO sedation, and hemodynamic stability IO. \\&PO. HR \\& MAP. The peak cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour.\n\n. Material \\& Methods A prospective randomized double blinded (drug injector and PO assessor) comparative study will be conducted in Mansoura university hospital after obtaining ethics committee approval and written informed parental consent 164 boys (age 1-6 years, ASA I) scheduled for hypospadias surgery. Exclusion criteria; (Operative time exceeding 3 hours, bodyweight \\>25kg, bleeding diathesis, infection at the site of block, pre-existing neurological or spinal disease or abnormalities of the sacrum, inability to palpate the sacral hiatus by anatomic landmark palpation technique) or those with a history of allergic reactions to local anesthetics were excluded from the study. Patients will fast for solids 6h and water and 2 hours before surgery. After Patient Preoperative preparation, General anesthesia induction, caudal block and caudal drug injection (Levob plus DEXM) bolus will be injected according to each group as follow;\n\n* Group A will take Caudal Levob 0. 125%+ DEXM 0.5µg/kg.\n* Group B will take Caudal Levob 0.125%+ DEXM 1µg/kg.\n* Group C will take Caudal Levob 0. 125%+ DEXM 1.5 µg/kg.\n* Group D will take Caudal Levob 0. 125%+ DEXM 2µg/kg.\n\nThe study outcomes recording:\n\n1ry outcome: Time to (1st analgesic request OPS \\>4). Secondary outcome: Total 24hours PO. Rescue analgesic dose IM pethidine 0.5mg/kg \\[2,3\\] based on local policy and protocol, Patients demographic data \\[age, weight, end tidal Sevoflurane (volume %) prior starting skin closure, intraoperative fentanyl total dose, recovery time (time from discontinuation of anesthesia to spontaneous eye opening)\\], Serum Cortisol level at basal before anesthesia and 1hour postoperative in between groups \\[1\\] , Apnea incidence (NO\\&%), and desaturation (NO\\&%), Objective pain score, Sedation score, Behavioral score for Agitation assessment, and Modified bromage score (residual Lower limb muscle weakness) recorded every 15 minutes for 1st hour then every 30 minutes for next 3 PO hours then at next 6th, 12th, 18th, 24th PO hours, hemodynamics, HR\\&SBP the incidence of bradycardia and hypotension per 50% percentile. Recorded every 10 minutes IO for maximum operative time 3 hours and every 30 min PO for next 2h in the recovery room until the child was discharged to the ward."
},
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"designInfo": {
"allocation": "RANDOMIZED",
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},
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"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
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"type": "ACTUAL"
},
"expandedAccessTypes": null,
"nPtrsToThisExpAccNctId": null,
"patientRegistry": null,
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL",
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