hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06268652, orgStudyIdInfo id: B2023-686-01, briefTitle: Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2026-02-15, completionDateStruct date: 2028-01-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: This multicenter, open-label, randomized phase III trial is designed to study the efficacy and safety of organoid-guided personalized treatment （OGPT）versus treatment of physician's choice (TPC) in previously treated refractory breast cancer., conditionsModule conditions: Breast Cancer, conditions: Refractory Breast Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 302, type: ESTIMATED, armsInterventionsModule interventions name: Organoid-guided personalized treatment, interventions name: Gemcitabine, interventions name: Capecitabine, interventions name: Vinorelbine, interventions name: Eribulin, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Incidence of Treatment-related Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yanxia Shi, status: RECRUITING, city: Guangzhou, state: None Selected, zip: 510060, country: China, contacts name: Yanxia Shi, role: CONTACT, phone: 020-87343368, email: shiyx@sysucc.org.cn, geoPoint lat: 23.11667, lon: 113.25, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-12-12, uploadDate: 2024-01-23T03:33, filename: Prot_000.pdf, size: 469389, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-12, uploadDate: 2024-01-23T02:42, filename: ICF_001.pdf, size: 330483, hasResults: False
protocolSection identificationModule nctId: NCT06268600, orgStudyIdInfo id: NPC-Thyroid function, briefTitle: The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-01-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Jiangxi Provincial Cancer Hospital, class: OTHER, descriptionModule briefSummary: This study aimed to reduce radiation-induced thyroid injury without compromising control of the cervical region by optimizing the delineation of the cervical lymph node drainage area., conditionsModule conditions: Nasopharyngeal Carcinoma, conditions: Nasopharyngeal Cancer, conditions: Hypothyroidism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule interventions name: Modified neck target volume delineation, outcomesModule primaryOutcomes measure: Regional Recurrence-free Survival, secondaryOutcomes measure: Radiation-induced hypothyroidism, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Progression-free Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital, status: RECRUITING, city: Nanchang, state: None Selected, zip: 330029, country: China, contacts name: Tianzhu Lu, role: CONTACT, phone: 8615270186250, email: lutianzhu2008@163.com, contacts role: CONTACT, phoneExt: Li, email: lijingao@hotmail.com, contacts name: Jingao Li, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Xiaochang Gong, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 28.68396, lon: 115.85306, hasResults: False
protocolSection identificationModule nctId: NCT06268587, orgStudyIdInfo id: 2023/80, briefTitle: A Before and After Study Studying the Impact of an Analgesia Protocol After Discharge From Outpatient Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-09-01, primaryCompletionDateStruct date: 2022-02-28, completionDateStruct date: 2022-02-28, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Liege, class: OTHER, descriptionModule briefSummary: The goal of this before and after study is to measure the effectiveness of a home analgesia protocol after outpatient surgery in a tertiary hospital. The main question it aims to answer is:- Measure the impact of the protocol on the proportion of patients with a VAS greater than 3/10 on day one and who did not take the analgesics.The participants are divided into two groups. The control group leaves the hospital with instructions and prescriptions. The experimental group leaves the hospital with instructions, analgesics for a maximum of two days with detailed dosages and an explanatory booklet on postoperative pain., conditionsModule conditions: Postoperative Pain, conditions: Outpatient Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1423, type: ACTUAL, armsInterventionsModule interventions name: Measure the impact of the home analgesia protocol on the proportion of patients with a VAS &amp;gt; 3/10 on day one and who did not take analgesics., outcomesModule primaryOutcomes measure: Measure the impact of the protocol on the proportion of patients with a pain greater than 3/10 on a Visual Analogue Scale at day one and who did not take the analgesics., secondaryOutcomes measure: Measure the adequacy of post-op analgesics by measuring the proportion of patients with a Visual Analogue Scale < or = 3/10 on day one for each group, secondaryOutcomes measure: Measure the impact of the protocol on the occurrence of nausea and vomiting on day one, secondaryOutcomes measure: Measure the impact of the protocol on general satisfaction of stay in outpatient surgery on day 7 with a Visual Analogue Scale Satisfaction, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Liège, city: Liège, state: Wallonie, zip: 4000, country: Belgium, geoPoint lat: 50.63373, lon: 5.56749, hasResults: False
protocolSection identificationModule nctId: NCT06268561, orgStudyIdInfo id: IRBN852023/CHUSTE, briefTitle: Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-05, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, descriptionModule briefSummary: OZURDEX endophthalmitis is a rare and potentially very serious pathology. Different treatments can be carried out early and change the functional prognosis of the patient., conditionsModule conditions: Endophthalmitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Visual acuity analysis, interventions name: Intraocular pressure analysis, interventions name: Analysis of optical coherence tomography (OCT) images, interventions name: Analysis of retinograms, outcomesModule primaryOutcomes measure: Visual acuity, secondaryOutcomes measure: IOP measured in mmHg by tonometer and confirmed with Goldman Applanation, secondaryOutcomes measure: Tomography, secondaryOutcomes measure: Resumption of intravitreal therapy, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Saint Etienne, status: RECRUITING, city: Saint-Étienne, zip: 42000, country: France, contacts name: Thibaud GARCIN, MD PhD, role: CONTACT, phone: (0)477829662, phoneExt: +33, email: thibaud.garcin@chu-st-etienne.fr, contacts name: Thibaud GARCIN, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Henri PITEAU, resident, role: SUB_INVESTIGATOR, geoPoint lat: 45.43389, lon: 4.39, hasResults: False
protocolSection identificationModule nctId: NCT06268548, orgStudyIdInfo id: P.T.REC/012/004790, briefTitle: Effect of Manual Diaphragmatic Activation on Diaphragm Function in Patients With Gastroesophageal Reflux Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-15, primaryCompletionDateStruct date: 2024-02-20, completionDateStruct date: 2024-02-27, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study was conducted to investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease, conditionsModule conditions: Diaphragm Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Manual diaphragmatic activation, outcomesModule primaryOutcomes measure: Diaphragm Excursion, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of physical therapy, status: RECRUITING, city: Giza, zip: 12613, country: Egypt, contacts name: Nesreen Ghareb Mohamed, Professor, role: CONTACT, phone: 01002227242, email: nesreen.elnahas@pt.cu.edu.eg, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
protocolSection identificationModule nctId: NCT06268535, orgStudyIdInfo id: CaenUH_DL_1, briefTitle: Identification of Anticancer Drugs Associated With Heart Failure: a WHO Pharmacovigilance Database Analysis, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-01, primaryCompletionDateStruct date: 2022-05-31, completionDateStruct date: 2022-05-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University Hospital, Caen, class: OTHER, descriptionModule briefSummary: Therapeutic advances have significantly improved the survival of patients with cancer. However, these novel therapies are associated with a concomitant increase in the prevalence of toxicity, including cardiovascular complications of cancer therapy.Among these adverse drug reactions, heart failure and, more generally, cancer therapy-related cardiac dysfunction are the most concerning cardiovascular complications of cancer therapy, carrying a high morbidity burden and an elevated risk of death.Patients with both heart failure and cancer have a worse prognosis when compared with heart failure patients with no history of cancer. It is therefore crucial to enhance the identification of patients at a higher risk of cancer therapy-related cardiac dysfunction both before and during treatment, especially when utilizing cancer therapies with known potential cardiovascular adverse drug reactions.The explosion of new anticancer drugs has led to the potential association of these therapies with cardiac dysfunction.Using VigiBase, the World Health Organization's (WHO) global pharmacovigilance database, the investigators aimed to assess the relationship between cancer therapy-related cardiac dysfunction and the administration of anti-cancer drugs., conditionsModule conditions: Heart Failure, conditions: Cancer, Therapy-Related, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3406383, type: ACTUAL, armsInterventionsModule interventions name: Cancer therapy with FDA and/or EMA approval on the 31st March 2022, outcomesModule primaryOutcomes measure: Disproportionality individual case data analysis between heart failure of cardiac dysfunction and cancer therapies, secondaryOutcomes measure: Description of the population of patients having a heart failure of cardiac dysfunction event with cancer therapies, secondaryOutcomes measure: Description of the pathologies (cancer) for which the incriminated drugs have been prescribed, secondaryOutcomes measure: Description of the drug-drug interactions associated with adverse events, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Caen University Hospital, city: Caen, country: France, geoPoint lat: 49.18585, lon: -0.35912, hasResults: False
protocolSection identificationModule nctId: NCT06268522, orgStudyIdInfo id: 2023P001582, briefTitle: Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, descriptionModule briefSummary: This study is a Randomized Controlled Trial exploring the effects of a Mindfulness interventions in reducing pain interference and opioid dose in patients with Chronic Low Back Pain. A total of 200 opioid-using patients with chronic pain, male and female participants will be enrolled, with a need for 160 completers. Patient will be randomly assigned into the Mindfulness-Oriented Recovery Enhancement or the Psychoeducation comparison control group., conditionsModule conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Behavioral, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Mindfulness-Oriented Recovery Enhancement: (MORE) group, interventions name: Psychoeducation, outcomesModule primaryOutcomes measure: Pain Interference, primaryOutcomes measure: Opioid Dose, secondaryOutcomes measure: Pain Intensity, secondaryOutcomes measure: Opioid Misuse, secondaryOutcomes measure: Opioid Withdrawal, secondaryOutcomes measure: Opioid Craving, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, status: RECRUITING, city: Chestnut Hill, state: Massachusetts, zip: 02467, country: United States, contacts name: Marie Curiel, role: CONTACT, phone: 617-732-9578, email: MCURIEL@mgh.harvard.edu, contacts name: Asimina Lazaridou, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Robert Edwards, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 42.33065, lon: -71.16616, hasResults: False
protocolSection identificationModule nctId: NCT06268496, orgStudyIdInfo id: LRP23021-A serum, briefTitle: Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cosmetique Active International, class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo., conditionsModule conditions: Hyperpigmentation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: serum formula 2039125 03, outcomesModule primaryOutcomes measure: IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP), primaryOutcomes measure: modified Melasma Area and Severity Index (mMASI) for patients with melasma, primaryOutcomes measure: Post-Acne Hyperpigmentation Index (PAHPI), primaryOutcomes measure: solar lentigo pigmentation scale, secondaryOutcomes measure: colorimetry measurements, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medcin Instituto da Pele Ltda, city: Osasco, country: Brazil, geoPoint lat: -23.5325, lon: -46.79167, hasResults: False
protocolSection identificationModule nctId: NCT06268470, orgStudyIdInfo id: Chula-ARC 001/18, briefTitle: Antiplatelet Therapy in Chronic Urticaria, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2018-06-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Chulalongkorn University, class: OTHER, descriptionModule briefSummary: This study compares the combination of antiplatelets and antihistamine versus antihistamine alone for the treatment of chronic spontaneous urticaria, conditionsModule conditions: Chronic Urticaria, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients diagnosed with chronic urticaria will be assigned to 2 treatment arms. 1. high dose antihistamine with antiplatelets; and 2. high dose antihistamine alone., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Identical capsules, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Desloratadine plus cilostazol and dipyridamole, interventions name: Desloratadine, outcomesModule primaryOutcomes measure: Weekly urticaria activity score, secondaryOutcomes measure: D-dimer levels, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine, Chulalongkorn University, city: Bangkok, zip: 10330, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
protocolSection identificationModule nctId: NCT06268457, orgStudyIdInfo id: CE-AVEC 789/2023/Oss/IOR, briefTitle: Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis, acronym: Embodesmo, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2028-02-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Istituto Ortopedico Rizzoli, class: OTHER, descriptionModule briefSummary: Desmoid fibromatoses are rare (1-2 cases/million per year) and locally aggressive mesenchymal tumors. For asymptomatic disease, current guidelines suggest an initial period of active surveillance.The current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. Embolization of desmoid tumors alone, without chemotherapy, on the contrary, has been shown to be inefficient. Using Doxorubicin in desmoid fibromatosis is effective but associated with systemic toxicity. Consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing or life-threatening tumors. The intrinsic hypervascularity of desmoid tissue can be exploited as a conduit to achieve local distribution of Doxorubicin by navigation of a catheter endovascular., conditionsModule conditions: Desmoid, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Chemoembolization with Doxorubicin, outcomesModule primaryOutcomes measure: Volume reduction in cm, primaryOutcomes measure: Reduction of pain (VAS score), primaryOutcomes measure: Reduction of antalgic therapy (mg), secondaryOutcomes measure: Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire), secondaryOutcomes measure: Improvement in quality of life (EORTC QLQ - BM22), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Ortopedico Rizzoli, status: RECRUITING, city: Bologna, state: Emilia Romagna, zip: 40136, country: Italy, contacts name: Giancarlo Facchini, MD, role: CONTACT, phone: +39 333 650 0944, email: giancarlo.facchini@ior.it, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False