hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06308796, orgStudyIdInfo id: RADIOCARIES2023, briefTitle: Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy, acronym: RADIOCARIES, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Milan, class: OTHER, descriptionModule briefSummary: One of the long-term side effects of head and neck radiotherapy (RT) is radiation-induced tooth decay. Hyposalivation, associated with radiation therapy, further increases caries susceptibility and caries progression, due to the lack of salivary protective effects and of tooth minerals useful for remineralization processes, especially calcium phosphate (CaP). Dental extractions that could be required in case of severe tooth decay expose the patient to the risk of osteoradionecrosis of the jaws (i.e. the necrosis of the bone tissue following a local trauma, including surgical trauma). This protocol aims at verifying the effectiveness of CaP mousse in the prevention of carious lesions, added to topical fluoride. A randomized controlled clinical trial will be performed comparing CaP + fluoride treatment versus no treatment in head and neck cancer patients, who received radiotherapy. The hypothesis is that CaP, which is lacking in the mouth of these patients due to hyposalivation, can combine with fluoride to promote remineralization, reducing the risk of carious lesions., conditionsModule conditions: Caries,Dental, conditions: Head and Neck Cancer, conditions: Radiotherapy; Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Application of CaP dental mousse, outcomesModule primaryOutcomes measure: Number of new cavitated caries per each patient (incidence of caries), secondaryOutcomes measure: Number of extracted teeth per patient (incidence of extracted teeth), secondaryOutcomes measure: Number of patients with a diagnosis of osteoradionecrosis (incidence of osteoradionecrosis), secondaryOutcomes measure: Number of dental surfaces with caries or filling, and missed teeth, secondaryOutcomes measure: Rate of dentinal hypersensitivity per patient, secondaryOutcomes measure: Rate of dental surface with plaque per patient, secondaryOutcomes measure: Rate of bleeding gingival sites per patient, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Univeristy of Milan, status: RECRUITING, city: Milan, zip: 20142, country: Italy, contacts name: Elena M Varoni, PhD, role: CONTACT, phone: +3950319017, email: elena.varoni@unimi.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06308705, orgStudyIdInfo id: 2022-19, briefTitle: The SsRI/NIE Recombinant Antigen ELISA for the Follow up of Patients Infected by Strongyloides Stercoralis, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-06, primaryCompletionDateStruct date: 2023-10-18, completionDateStruct date: 2023-10-18, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: This is a single-center interventional study with an IVD medical device.The main objective of this study is to evaluate the ELISA SsIR/NIE test for the post-treatment follow-up of patients suffering from strongyloidosis, using well-characterized sera from a previous study.All sera available in the Tropica biobank and coming from the Strong Treat study, for which serum samples collected at baseline and at 12-month follow-up are available, will be eligible for the study.The test The InBios Strongy Detect TM IgG ELISA detects specific IgG antibodies against recombinant Strongyloides NIE and SsIR antigens in serum. It consists of an enzymatically amplified sandwich immunoassay. Positive and negative control samples are provided in the kit. The test will be performed and interpreted according to the manufacturer's instructions. The results are expressed as OD and nOD. Clinical interpretation of the results will be performed by receiver operating characteristic (ROC) curve analysis generated using data from confirmed positive and confirmed negative samples.The laboratory technicians will receive from the PI of the study a list of pseudo-anonymized sera to be tested with SsIR/NIE ELISA, they will check their availability and proceed with the test according to the Manufacturer's instructions. Laboratory personnel performing and reading the tests will be blinded to the results of any previously performed tests (and the classification of the sample in the Strong Treat study). A single run will be performed for each sample, unless the test needs to be repeated due to any technical problem. Both baseline and follow-up sera will be tested. The resulting OD and nOD will be reported in an Excel file by the laboratory technicians performing the tests., conditionsModule conditions: Strongyloides Stercoralis Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ACTUAL, armsInterventionsModule interventions name: InBios Strongy Detect TM IgG ELISA, outcomesModule primaryOutcomes measure: Result of the SsIR/NIE ELISA, secondaryOutcomes measure: Seroconversion, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria hospital, city: Negrar, state: Verona, zip: 37024, country: Italy, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False
protocolSection identificationModule nctId: NCT06308692, orgStudyIdInfo id: 2022-11, briefTitle: Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Real Time PCR-ARES PCR Methods, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-28, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: Experimental study without drug and device, on pseudo-anonymized samples archived at the Tropica Biobank.The objective is to evaluate the performance for the identification of microorganisms in blood samples and rectal swabs of real time PCR assays for the targets: KPC, VIM, IMP, NDM, Acinetobacter OXA, Oxa48, MCR.The evaluations will be carried out taking into consideration the data obtained from the diagnostic routine at the DITM., conditionsModule conditions: Drug Resistant Bacterial Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: ARES PCR, outcomesModule primaryOutcomes measure: PCR results, secondaryOutcomes measure: Gene mutations, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria hospital, status: RECRUITING, city: Negrar, state: Verona, zip: 37024, country: Italy, contacts name: Elena Pomari, role: CONTACT, phone: +390456013111, email: elena.pomari@sacrocuore.it, contacts name: Elena Pomari, role: PRINCIPAL_INVESTIGATOR, contacts name: Pierantonio Orza, role: SUB_INVESTIGATOR, contacts name: Francesca Perandin, role: SUB_INVESTIGATOR, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False
protocolSection identificationModule nctId: NCT06308679, orgStudyIdInfo id: BE 001-24, briefTitle: A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers Under Fasting Conditions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-28, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-06-07, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Pharma Nueva, class: INDUSTRY, descriptionModule briefSummary: Objectives:Primary:to evaluate the bioequivalence of two formulations of Empagliflozin tablets, test formulation and reference innovator formulation, after a single oral dose administration in healthy Thai subjects under fasting conditionsSecondary:To examine the pharmacokinetics and safety of test and reference formulationsStudy Design:A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers under Fasting Conditions, conditionsModule conditions: Healthy Vollunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Empagliflozin 10 mg tablets, interventions name: JARDIANCE®, outcomesModule primaryOutcomes measure: Plasma area Under the Curve (AUC(0-48hr)) for Empagliflozin, primaryOutcomes measure: Peak Plasma Concentration (Cmax) of Empagliflozin, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06308666, orgStudyIdInfo id: 46091, briefTitle: Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who Report Substantial Digital Device Use, acronym: FOX, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-07-18, completionDateStruct date: 2024-07-18, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Waterloo, class: OTHER, collaborators name: Alcon Research, descriptionModule briefSummary: The purpose of this study is to evaluate the performance of DAILIES TOTAL1 daily disposable contact lenses with regards to subjective symptoms (comfort, dryness, vision) in lens wearers who use identify themselves as substantial digital device users (at least eight hours of digital device use per day)., conditionsModule conditions: Myopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Delefilcon A contact lenses, outcomesModule primaryOutcomes measure: Subjective Rating of Comfort After 8 Hours or More of Digital Device Use, primaryOutcomes measure: Subjective Rating of Dryness After 8 Hours or More of Digital Device Use, primaryOutcomes measure: Subjective Rating of Clarity of Vision After 8 Hours or More of Digital Device Use, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Centre for Ocular Research & Education, status: RECRUITING, city: Waterloo, state: Ontario, zip: N2L 3G1, country: Canada, contacts name: Jill Woods, McOptom, role: CONTACT, phone: 519-888-4567, phoneExt: 36743, email: jwoods@uwaterloo.ca, contacts name: Lyndon Jones, PhD, FCoptom, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.4668, lon: -80.51639, hasResults: False
protocolSection identificationModule nctId: NCT06308640, orgStudyIdInfo id: ORTH 11-23 2097, briefTitle: Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-10, primaryCompletionDateStruct date: 2026-01-10, completionDateStruct date: 2026-01-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to to evaluate and compare the skeletal and dental changes of bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander in bilateral distalization of maxillary molars using CBCT in Egyptian people. The main question it aims to answer are: • If bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander will be effective in bilateral distalization of maxillary molarsThe patients will be selected according to the following criteria:1. Patient with full permanent dentition.2. Good oral hygiene.3. None of the patients had received any orthodontic treatment.4. Class II molar relationship.5. Minimal or no crowding in the mandibular arch.6. Non-extraction treatment plan with molar distalization.7. Low angle cases.8. No medical problems or active periodontal disease.Researchers will compare between bone supported Fast Back appliance and bone supported modified Leaf Spring Self-Activated and see if they will be effective in maxillary molars distalization., conditionsModule conditions: Class II Malocclusion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The purpose of this study is to evaluate and compare the treatment effects of two bone supported protocols for bilateral distalization of maxillary molars in patients exhibiting class II pattern using Fast Back appliance and modified Leaf Spring Self-Activated Expander, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Insertion of the device intraorally, outcomesModule primaryOutcomes measure: 3D Dental and skeletal Cephalometric Measurements, primaryOutcomes measure: 2D Dental and skeletal Cephalometric Measurements, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, city: Tanta, state: Gharbia, zip: 6620010, country: Egypt, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False
protocolSection identificationModule nctId: NCT06308627, orgStudyIdInfo id: K2022-03-074, briefTitle: A One-year Trajectory of Depression Status Changes in Elderly Patients With MCI and SD: a Longitudinal Cohort Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Fujian Medical University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the one-year trajectory of changes in depression status in elderly patients with mild cognitive impairment and subthreshold depression, and to explore relevant risk factors for predicting changes in depression status. This one-year prospective longitudinal follow-up study involved 400 (expected) subjects who met the diagnostic criteria for mild cognitive impairment combined with subthreshold depression in the elderly, and their depressive status was assessed using the Geriatric Depression Scale (GDS). Follow up monitoring of depression status at 6 and 12 months. Obtain factors related to changes in depressive status (such as age, gender, education level, cognitive function, anxiety level, sleep status, social support, psychological resilience, social network, etc.). By studying the longitudinal trajectory of depression status in elderly patients with mild cognitive impairment and subthreshold depression, a multi state Markov model with time and state discreteness is constructed, namely: State 1 (normal); State 2 (subliminal depression); State 3 (mild depression); State 4 (moderate depression); State 5 (severe depression). Deeply explore and analyze the impact of certain factors and indicators on the transition between states, and estimate the probability of transition between states., conditionsModule conditions: Mild Cognitive Impairment, conditions: Subthreshold Depression, conditions: Older Adults, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, outcomesModule primaryOutcomes measure: Depressive state, secondaryOutcomes measure: General information of patients, secondaryOutcomes measure: Cognitive, secondaryOutcomes measure: Cognitive, secondaryOutcomes measure: Activity of Daily Living, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Social Function, secondaryOutcomes measure: Social Function, secondaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Resilience, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fujian provincial hospital, status: RECRUITING, city: Fuzhou, state: Fujian, zip: 350000, country: China, contacts name: Hong Li, role: CONTACT, phone: 18120826271, email: leehong99@126.com, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False
protocolSection identificationModule nctId: NCT06308588, orgStudyIdInfo id: 2024-0054, secondaryIdInfos id: NCI-2024-02121, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2029-05, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Novartis Pharmaceuticals, descriptionModule briefSummary: To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL., conditionsModule conditions: Philadelphia Chromosome-Positive, conditions: Acute Lymphoblastic Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Blinatumomab, interventions name: Asciminib, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Nicholas Short, MD, role: CONTACT, phone: 713-563-4485, email: nshort@mdanderson.org, contacts name: Nicholas Short, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
protocolSection identificationModule nctId: NCT06308575, orgStudyIdInfo id: 2023-0771, secondaryIdInfos id: NCI-2024-02155, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: A Phase II Study of Rivoceranib for Patients With Recurrent or Metastatic Olfactory Neuroblastoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2026-11-30, completionDateStruct date: 2028-11-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Elevar Therapeutics, descriptionModule briefSummary: To learn if rivoceranib can help to control olfactory neuroblastoma. The safety of this drug in participants with olfactory neuroblastoma will also be studied., conditionsModule conditions: Metastatic Olfactory Neuroblastoma, conditions: Recurrent Olfactory Neuroblastoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Rivoceranib, outcomesModule primaryOutcomes measure: Safety and Adverse Events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Luana Guimaraes De Sousa, MD, role: CONTACT, phone: 832-728-7849, email: lgsousa@mdanderson.org, contacts name: Luana Guimaraes De Sousa, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
protocolSection identificationModule nctId: NCT06308562, orgStudyIdInfo id: 23-010717, briefTitle: Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The objective of this study is to determine if using Fuzzy Wale compression stockinett can assist in reducing the healing time and decrease costs in trastibial amputation patients as compared to standard of care treatment compression stocking., conditionsModule conditions: Peripheral Arterial Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Fuzzy Wale Compression Stockinet, outcomesModule primaryOutcomes measure: Surgical site infection, primaryOutcomes measure: Wound dehiscence, primaryOutcomes measure: Days on negative pressure wound therapy, primaryOutcomes measure: Pain control, primaryOutcomes measure: Time to prosthetic fitting, secondaryOutcomes measure: Length of hospital stay, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Vascular Research Team, role: CONTACT, phone: 507-538-7425, contacts name: Matthew Melin, M.D., role: CONTACT, phone: (507) 266-6717, email: Melin.Matthew@mayo.edu, contacts name: Matthew Melin, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False