hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06304259, orgStudyIdInfo id: 24428, briefTitle: Effect of Different Modalities of Cryotherapy on Post-Operative Pain in Patients With Symptomatic Irreversible Pulpitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: October 6 University, class: OTHER, descriptionModule briefSummary: Problem statement: The post-operative pain after endodontic treatment. aim of study: The study is aiming to compare postoperative pain after submucosal cold saline injection (submucosal cryotherapy) (SMC) versus intra-canal cryotherapy (ICC) in mandibular single rooted premolars with symptomatic irreversible pulpitis with symptomatic apical periodontitis (SAP). The material and methods: Subjects and methods: sixty patients will be randomly divided into three groups: the SMC group, the ICC group, and the control group. The patients' postoperative pain will be recorded at 12, 24, and 48 hours postoperatively by questioning them. Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab., conditionsModule conditions: Endodontic Disease, conditions: Endodontically Treated Teeth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Saline, interventions name: Saline, outcomesModule primaryOutcomes measure: postoperative pain, primaryOutcomes measure: postoperative pain, primaryOutcomes measure: postoperative pain, secondaryOutcomes measure: Substance P level, secondaryOutcomes measure: Substance P level, secondaryOutcomes measure: Substance P level, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, Ain shams University, city: Cairo, zip: 4543070, country: Egypt, contacts name: Yara Adel, BDs, role: CONTACT, phone: 00201000099191, email: yara.adel170496@gmail.com, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06304220, orgStudyIdInfo id: MedroGestrel, briefTitle: Comparison of Two PPOS Models for Pituitary Suppression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: NextFertility, class: INDUSTRY, collaborators name: SINAE SL, descriptionModule briefSummary: The scarcity of evidence regarding the interchangeable use of different progestogens poses challenges, particularly in international egg donation and fertility preservation programs where standardizing protocols is crucial for achieving consistent efficacy, efficiency, and safety outcomes. Consequently, there's a pressing need for clinical studies to assess the effects of various progestogens on clinical outcomes in controlled ovarian hyperstimulation cycles. This study, a pioneering effort, aims to compare the effects of two progestogens on oocyte performance, safety, and efficiency in an egg donation program involving young, healthy, normo-responding patients., conditionsModule conditions: Infertility, Female, conditions: Fertility Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, randomized, and controlled clinical study with two different progestogens: desogestrel 75 mg and medroxyprogesterone acetate 10 mg., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: Cerazet, outcomesModule primaryOutcomes measure: Total number of oocytes retrieved from follicular puncture, primaryOutcomes measure: Number of mature oocytes (MII) retrieved from follicular puncture, secondaryOutcomes measure: Oocyte quality variables, secondaryOutcomes measure: Ovarian sensitivity index (OSI, secondaryOutcomes measure: Follicles, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 34 Years, stdAges: ADULT, contactsLocationsModule locations facility: NextFertility, city: Valencia, state: Comunidad Valenciana, zip: 46009, country: Spain, contacts name: Luis Quintero, role: CONTACT, phone: +34 963160240, email: luis.quintero@next-clinics.com, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
protocolSection identificationModule nctId: NCT06304181, orgStudyIdInfo id: KY-2023-195, briefTitle: Effect of Paracetamol and Mannitol Injection on Postoperative Analgesia in Patients With Thoracoscopic Lobectomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule briefSummary: This study thoroughly evaluates the efficacy of acetaminophen mannitol injection for postoperative analgesia in patients undergoing thoracoscopic lobectomy, by comparing it with a control group., conditionsModule conditions: Postoperative Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Paracetamol and Mannitol Injection, interventions name: Parecoxib, outcomesModule primaryOutcomes measure: NRS scores, primaryOutcomes measure: RASS score, secondaryOutcomes measure: Time of first use of remedial analgesics or analgesic pump, secondaryOutcomes measure: Total analgesic pump drug use, secondaryOutcomes measure: Postoperative liver enzyme level, secondaryOutcomes measure: Postoperative bilirubin level, secondaryOutcomes measure: Postoperative creatinine level, secondaryOutcomes measure: Postoperative cortisol level, secondaryOutcomes measure: Postoperative IL-6 level, secondaryOutcomes measure: Postoperative IL-8 level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06304168, orgStudyIdInfo id: 19-000890, secondaryIdInfos id: NCI-2024-00954, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 19-000890, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-05-13, primaryCompletionDateStruct date: 2028-05-15, completionDateStruct date: 2028-05-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This study explores the potential value of a new blood test approach for early detection of cancer., conditionsModule conditions: Hematopoietic and Lymphatic System Neoplasm, conditions: Malignant Solid Neoplasm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 5850, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Overall cancer (Y/N) - blood test, primaryOutcomes measure: Overall cancer (Y/N) - urine test, primaryOutcomes measure: Cancer specific site prediction - blood samples/MDM, primaryOutcomes measure: Cancer specific site prediction - urine samples/MDM, primaryOutcomes measure: Cancer specific site prediction - blood samples/RNA, primaryOutcomes measure: Cancer specific site prediction - urine samples/RNA, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: John B. Kisiel, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
protocolSection identificationModule nctId: NCT06304142, orgStudyIdInfo id: SGB-reflux, briefTitle: Effect of Lidocaine Block on Gastroesophageal Reflux Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to explore Clinical Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease. The main question it aims to answer is:• Can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Stellate Ganglion Block once a day additionally. The study lasts 10 days for each participant. Researchers will compare the Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, Self-Evaluation Questionnaire for Gastroesophageal Reflux Disease, to see if the Stellate Ganglion Block can help improve the symptom., conditionsModule conditions: Gastroesophageal Reflux Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation therapy, interventions name: Injection, interventions name: Lidocaine hydrochloride, outcomesModule primaryOutcomes measure: Gastroesophageal Reflux Disease Questionnaire, secondaryOutcomes measure: Pressure pain threshold, secondaryOutcomes measure: Modified Mayo Clinic Dysphagia-30 questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06304129, orgStudyIdInfo id: 2023-A00709-36, briefTitle: Diagnostic Performance of Plasma Biomarkers of Alzheimer's Disease Compared With CSF Markers, acronym: PLASM-ALZ, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2026-01-02, completionDateStruct date: 2026-09-02, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, collaborators name: Thérèse Jonveaux, collaborators name: Laure Joly, collaborators name: Lucie Hopes, collaborators name: Maia Simon, collaborators name: Franck Schreiner, descriptionModule briefSummary: .The goal of this interventional study is to estimate the diagnostic performance of plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL), enabling discrimination between patients with and without a pathophysiological AD process. The main questions it aims to answer are:* to define a threshold value for each of the plasma,* to describe the correlations between the plasma biomarkers of interest and the other biological analyses performed as part of care, in particular triglyceridemia, cholesterolemia, glycemia and proteinemia,* to describe biomarker results in relation to comorbidities, in particular dyslipidemia and diabetes* to describe the final diagnosis and results obtained for plasma biomarkers, for patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-) Participants will be selected among patients undergoing lumbar puncture for the differential diagnosis of AD at Nancy University Hospital., conditionsModule conditions: Alzheimer Blood Biomarkers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 189, type: ESTIMATED, armsInterventionsModule interventions name: Blood ponction, outcomesModule primaryOutcomes measure: Aβ40 and Aβ42, P-Tau, Tau and NFL, secondaryOutcomes measure: Sensitivity/specificity, secondaryOutcomes measure: Co-mobidity, secondaryOutcomes measure: Final diagnosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHRU De Nancy, city: Nancy, state: Grand Est, zip: 54500, country: France, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False
protocolSection identificationModule nctId: NCT06304116, orgStudyIdInfo id: SGB-TBI, briefTitle: Effect of Lidocaine Block in Traumatic Brain Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated., conditionsModule conditions: Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation therapy, interventions name: Stellate ganglion block, interventions name: Lidocaine Hydrochloride, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Modified Barthel Index, secondaryOutcomes measure: Swallowing duration, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06304103, orgStudyIdInfo id: AND017-MDS-206, briefTitle: A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Kind Pharmaceuticals LLC, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 2, multicenter, randomized, open-lable study to evaluate the efficacy and safety of luspatercept (ACE-536) for the treatment of anemia due to lower risk Myelodysplastic syndromes (MDS)in patients subjects who are Red blood cell (RBC) non-transfusion dependent (NTD) and low transfusion burden (LTB)., conditionsModule conditions: Myelodysplastic Syndromes, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: AND017, outcomesModule primaryOutcomes measure: Percentage of HI-E/RBC-TI responding subjects, secondaryOutcomes measure: Mean level and change from baseline in untransfused Hb throughout the first 8 weeks of treatment, secondaryOutcomes measure: Mean level and change from baseline in untransfused Hb at each visit throughout the treatment period and, secondaryOutcomes measure: Percentage of visits in which untransfused Hb was maintained in this range after reaching two consecutive increases of ≥1.5 g/dL and ≥1.0 g/dL from baseline, respectively, throughout the treatment period, secondaryOutcomes measure: Mean time required after two consecutive increases in untransfused Hb ≥1.5 g/dL and ≥1.0 g/dL from baseline, respectively, throughout the treatment period, secondaryOutcomes measure: For changes in mean transfusion units throughout the treatment period compared to baseline (mean transfusion units 16 weeks prior to first dose), secondaryOutcomes measure: For LTB cohorts, the average time required to reach first transfusion independence throughout the treatment period, secondaryOutcomes measure: Levels of reticulocyte count at each visit and change from baseline, secondaryOutcomes measure: Levels of hematocrit at each visit and change from baseline, secondaryOutcomes measure: Levels of mean corpuscular volume at each visit and change from baseline, secondaryOutcomes measure: Levels of mean corpuscular hemoglobin at each visit and change from baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06304090, orgStudyIdInfo id: SGB-NT, briefTitle: Efficacy of Lidocaine Block in Children With Cerebral Palsy and Dysphagia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: routine rehabilitation treatment, interventions name: Stellate ganglion block, interventions name: Lidocaine Hydrochloride, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06304064, orgStudyIdInfo id: CAP-1002-DMD-03, briefTitle: Halt cardiomyOPathy progrEssion in Duchenne (HOPE-OLE), acronym: HOPE-OLE, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-06-21, primaryCompletionDateStruct date: 2019-03-06, completionDateStruct date: 2019-03-06, studyFirstPostDateStruct date: 2024-03-12, resultsFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Capricor Inc., class: INDUSTRY, descriptionModule briefSummary: This Phase 2, multi-center, open-label extension trial will provide CAP-1002 to participants who were randomized to the Usual Care treatment group of the HOPE-Duchenne study (NCT02485938) and completed 12 months of follow-up.The trial will assess the safety and efficacy of two intravenous administrations of CAP-1002, each separated by three months., conditionsModule conditions: Duchenne Muscular Dystrophy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ACTUAL, armsInterventionsModule interventions name: Allogeneic Cardiosphere-Derived Cells (CAP-1002), outcomesModule primaryOutcomes measure: Number of Participants Experiencing Acute Respiratory Decompensation, primaryOutcomes measure: Number of Participants With Hypersensitivity Reactions, primaryOutcomes measure: All-cause Mortality, primaryOutcomes measure: Number of Treatment-emergent Adverse Events (TEAEs) Related to Investigational Product or Administration and Serious Adverse Events (SAEs), primaryOutcomes measure: Number of Participants With Immune Sensitization Syndrome, eligibilityModule sex: MALE, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Florida, city: Gainesville, state: Florida, zip: 32610, country: United States, geoPoint lat: 29.65163, lon: -82.32483, locations facility: Cincinnati Children's Medical Center, city: Cincinnati, state: Ohio, zip: 45229, country: United States, geoPoint lat: 39.12713, lon: -84.51435, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2018-02-12, uploadDate: 2024-03-29T13:28, filename: Prot_000.pdf, size: 2102667, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2019-03-26, uploadDate: 2024-03-29T13:25, filename: SAP_001.pdf, size: 741616, hasResults: True