hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06353971, orgStudyIdInfo id: JSP-CP-010, secondaryIdInfos id: 2023-507534-24, type: EUDRACT_NUMBER, briefTitle: A Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment With H1- Antihistamines, acronym: SPOTLIGHT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-04-21, completionDateStruct date: 2025-08-04, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Jasper Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: This is an open-label, single ascending dose Phase 1b/2a trial to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with Cold Urticaria (ColdU) or Symptomatic Dermographism (SD), who remain symptomatic despite treatment with H1 antihistamines. The trial will explore two ascending dose levels which will be tested in two sequential cohorts., conditionsModule conditions: Chronic Inducible Urticaria, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: This is an open-label, single ascending dose, Phase 1b/2a trial.Cohort 1 follows a 3+3 design and will be treated with a single 40mg dose. Cohort 2 will be treated with a single 120mg dose., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Briquilimab, outcomesModule primaryOutcomes measure: Incidence and severity of treatment emergent AEs/SAEs [safety and tolerability] of a single dose of briquilimab in patients with ColdU or SD who remain symptomatic despite the use of H1 antihistamines., secondaryOutcomes measure: Preliminary efficacy of briquilimab, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Charité - University Clinic Berlin, status: RECRUITING, city: Berlin, zip: 12203, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: University Hospital Dresden, status: RECRUITING, city: Dresden, zip: 01307, country: Germany, geoPoint lat: 51.05089, lon: 13.73832, locations facility: Medical University Hannover, status: NOT_YET_RECRUITING, city: Hannover, zip: 30625, country: Germany, geoPoint lat: 52.37052, lon: 9.73322, locations facility: University Clinic Schleswig-Holstein, status: RECRUITING, city: Lübeck, zip: 23538, country: Germany, geoPoint lat: 53.86893, lon: 10.68729, hasResults: False
protocolSection identificationModule nctId: NCT06353958, orgStudyIdInfo id: MiSaver PIIa, briefTitle: MiSaver® Stem Cell Treatment for Acute Myocardial Infarction, acronym: MiSaver®, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Honya Medical Inc, class: INDUSTRY, collaborators name: Chung Shan Medical University, descriptionModule briefSummary: Despite advancements in treatments, cardiovascular diseases, especially acute myocardial infarction (AMI), remain significant health concerns. This study hypothesized that stem cells could improve left ventricular function post-AMI. An open-label trial was initiated to assess the safety and feasibility of intravenous infusion of ABO blood group-matched allogeneic umbilical cord blood stem cells (USC) prefabricated into MiSaver (Myocardial Infarction Saver) in AMI patients.Primary Endpoint:The primary endpoint focused on safety and adverse events over a 12-month observational period. Results showed the treatment was well-tolerated with no AEs attributed to the study product.Secondary Outcomes:Secondary outcomes evaluated changes in left ventricular ejection fraction (LVEF) from baseline to 12 months post-treatment. A retrospective study compared eligible controls with low and middle dosage groups., conditionsModule conditions: Acute Myocardial Infarction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: MiSaver, outcomesModule primaryOutcomes measure: Safety and adverse events events, secondaryOutcomes measure: Efficacy on ventricular ejection fraction (LVEF) improvement, eligibilityModule sex: ALL, minimumAge: 41 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chung Shan Medical University Hospital, city: Taichung, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False
protocolSection identificationModule nctId: NCT06353945, orgStudyIdInfo id: HB062-24, briefTitle: Perceived Effectiveness of the Vaginal Moisturizer Investigational Product Under Normal Conditions of Use., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2024-05-07, completionDateStruct date: 2024-05-15, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Herbarium Laboratorio Botanico Ltda, class: INDUSTRY, descriptionModule briefSummary: The present research project aims to evaluate the perceived effectiveness of the product under investigation under normal conditions of use for 28 days, to defend the claims "High hydration power, relief of discomfort and improvement of vaginal tone.", conditionsModule conditions: Vaginal Atrophy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: vaginal moisturizer, outcomesModule primaryOutcomes measure: evaluate the perceived effectiveness of the investigational product, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06353932, orgStudyIdInfo id: KA-23026, briefTitle: The Effect of Monitoring Endotracheal Tube Cuff Pressure and Keeping it in a Certain Range, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-25, primaryCompletionDateStruct date: 2024-02-25, completionDateStruct date: 2024-02-25, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The main purpose of our prospective, randomized, controlled, double-blind study is to investigate the effect of keeping endotracheal tube cuff pressures within a certain range on the incidence of postoperative sore throat, hoarseness and cough.The secondary aims of our study are to evaluate the effect of intubation duration, smoking, presence of chest disease, presence of blood on the intubation tube after extubation, presence of NG\\OG, and type of surgery on the incidence of sore throat, hoarseness, and cough.The patients were randomly divided into two: a study group with continuous cuff pressure monitoring and a control group without continuous cuff pressure monitoring.The endotracheal cuff pressure of the patients in both groups was measured by a blinded researcher using a cuff manometer after intubation, before extubation, and in long cases, at the 3rd hour after intubation.Patients were evaluated for sore throat, cough, and hoarseness at the 2nd and 24th hours by another researcher blinded to the study groups., conditionsModule conditions: Endotracheal Tube, conditions: Cuff Pressure, conditions: Sore Throat, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 263, type: ACTUAL, armsInterventionsModule interventions name: keeping the endotracheal tube cuff pressure within a certain range, outcomesModule primaryOutcomes measure: Sore throat, primaryOutcomes measure: cough, primaryOutcomes measure: hoarseness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hacettepe University Hospital, city: Ankara, zip: 06100, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
protocolSection identificationModule nctId: NCT06353919, orgStudyIdInfo id: NUNM, briefTitle: Remote Yoga Nidra for Deprescribing BZRAs, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: National University of Natural Medicine, class: OTHER, collaborators name: US Department of Veterans Affairs, descriptionModule briefSummary: The overall goal of this application is to assess feasibility and impact of a remotely delivered guided meditation practice called Yoga Nidra, for reducing or stopping use of Benzodiazepine Receptor Agonists (BZRAs) for insomnia and anxiety in a population of older adults recruited from within the Birmingham VA medical system., conditionsModule conditions: Anxiety, conditions: Insomnia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Yoga Nidra, interventions name: Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education, outcomesModule primaryOutcomes measure: Demand, primaryOutcomes measure: Recruitment Success, primaryOutcomes measure: Implementation practicality, primaryOutcomes measure: Acceptability, primaryOutcomes measure: Retention, primaryOutcomes measure: Adherence to Protocol, secondaryOutcomes measure: Use of Benzodiazepine Receptor Agonist medications, secondaryOutcomes measure: Cessation of Benzodiazepine Receptor Agonist medication, secondaryOutcomes measure: Baseline Urine Benzodiazepine Receptor Agonist Concentration, secondaryOutcomes measure: Close-out Urine Benzodiazepine Receptor Agonist Concentration, otherOutcomes measure: Insomnia Severity Index, otherOutcomes measure: Insomnia Severity Index, otherOutcomes measure: Insomnia Severity Index, otherOutcomes measure: Insomnia Severity Index, otherOutcomes measure: Patient reported outcomes measurement information system 29, otherOutcomes measure: Patient reported outcomes measurement information system 29, otherOutcomes measure: Generalized Anxiety Disorder 7 Questionnaire, otherOutcomes measure: Generalized Anxiety Disorder 7 Questionnaire, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06353906, orgStudyIdInfo id: N22APC, briefTitle: Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer, acronym: PRIAM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-14, primaryCompletionDateStruct date: 2026-10-14, completionDateStruct date: 2028-01-14, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: The Netherlands Cancer Institute, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: This is a single-armed, single-centre, non-blinded phase II trial to assess efficacy of induction chemo-immunotherapy for resectable node-positive squamous cell carcinoma of the penis, conditionsModule conditions: Urologic Neoplasms, conditions: Urogenital Neoplasms, conditions: Male Urogenital Diseases, conditions: Penile Cancer, conditions: Penile Squamous Cell Carcinoma, conditions: Locally Advanced Penile Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: Carboplatin/Paclitaxel, interventions name: Pembrolizumab, interventions name: Partial or total penectomy with inguinal and/or pelvic lymph node dissection, outcomesModule primaryOutcomes measure: Pathological complete response (pCR), secondaryOutcomes measure: Drug toxicity, secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Assessment of correlation between clinical endpoints and tumor characteristics, secondaryOutcomes measure: Tumor tissue HPV status in relation to treatment response, secondaryOutcomes measure: Tumor tissue PD-L1 expression in relation to treatment response, secondaryOutcomes measure: Evaluation of changes in patient reported outcome regarding Quality of Life (QoL), eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06353893, orgStudyIdInfo id: Integrity-001, briefTitle: MRI Evaluation of Integrity Bio-Inductive Implant for Rotator Cuff Tears, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Foundation for Orthopaedic Research and Education, class: OTHER, collaborators name: Anika Therapeutics, Inc., descriptionModule briefSummary: The goal of this observational study is to evaluate the effectiveness and safety of the Integrity bio-inductive implant in treating partial and full thickness rotator cuff tears. The main questions it aims to answer are:* How does the application of the Integrity implant affect patient-reported outcome measures (PROMs) such as ASES, SANE, and PROMIS?* What are the imaging characteristics of the rotator cuff tears at 3 and 6 months postoperatively when using the Integrity implant?Postoperative MRIs will be obtained from 10 consecutive patients who have undergone rotator cuff repair using the Integrity implant at 3 and 6 months after surgery. Participants include those with partial and full thickness tears treated with different surgical techniques involving the implant. They may receive either isolated onlay use of the graft for partial tears or augmentation of a standard single or double row repair with the graft applied to the superior surface of the repair., conditionsModule conditions: Rotator Cuff Tears, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Anika Integrity Implant System, outcomesModule primaryOutcomes measure: MRI Assessment of Adverse Events and Structural Integrity, secondaryOutcomes measure: Effectiveness Evaluation with PROMIS outcome tool, secondaryOutcomes measure: Effectiveness Evaluation with PROMIS tool, secondaryOutcomes measure: Effectiveness Evaluation with SANE score, secondaryOutcomes measure: Effectiveness Evaluation with SANE score, secondaryOutcomes measure: Effectiveness Evaluation with ASES rating scale, secondaryOutcomes measure: Effectiveness Evaluation with ASES rating scale, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Foundation for Orthopaedic Research and Education, city: Tampa, state: Florida, zip: 33607, country: United States, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False
protocolSection identificationModule nctId: NCT06353880, orgStudyIdInfo id: 24K08-001, briefTitle: Obesity With Sperm Quality in Men With Fertility Need, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Yu xiaowei, class: OTHER, descriptionModule briefSummary: This study aims to investigate the impact of different types of obesity on sperm quality. Participants will be divided into three groups: a normal BMI group, an obese group without pudendal fat wrapping the testicles, and an obese group with pudendal fat wrapping the testicles. Sperm quality parameters will be compared among these groups to assess potential differences associated with different types of obesity., conditionsModule conditions: Sperm Quality, conditions: Obesity, conditions: Sex Hormones, conditions: Visceral Fat, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition., outcomesModule primaryOutcomes measure: Investigation of Testicular Fat-Wrapped Testes Incidence and Associated Risk Factors, secondaryOutcomes measure: Comparison of Sperm Quality Across BMI Categories and Testicular Fat-Wrapped Subgroups, secondaryOutcomes measure: Comparison of Sex Hormone Levels Across BMI Categories and Testicular Fat-Wrapped Subgroups, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06353867, orgStudyIdInfo id: 56365223-050.01.04-2023.13754, briefTitle: The Effect of Group Exercise in Children With Special Needs, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-27, primaryCompletionDateStruct date: 2023-04-15, completionDateStruct date: 2023-04-25, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Istanbul Gedik University, class: OTHER, descriptionModule briefSummary: Thirty children with special needs were included in the study. Participants engaged in group exercises twice a week for four weeks, including warm-up and cool-down periods, with the goal of improving balance. The participants' balance was assessed using the Bruininks-Oseretsky Motor Proficiency Test Short Form (Balance Parameters), Pediatric Balance Scale; functional mobility was evaluated using the Timed Up and Go Test, and attention level was assessed using the Stroop Test before and after the intervention., conditionsModule conditions: Developmental Disability, conditions: Child Autism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Group Exercise, outcomesModule primaryOutcomes measure: Bruininks-Oseretsky Motor Competence Test Short Form Balance Subtest (Balance Subtest of BOT 2-KF), primaryOutcomes measure: Paediatric Balance Scale, primaryOutcomes measure: Functional Reach Test, primaryOutcomes measure: Timed Up and Go Test, primaryOutcomes measure: Stroop Test, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Marmara University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06353841, orgStudyIdInfo id: 2023/435, briefTitle: Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-03, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Burdur Mehmet Akif Ersoy University, class: OTHER, descriptionModule briefSummary: The aim of the study is to determine the effect of therapeutic touch on functional constipation in infants and young children., conditionsModule conditions: Functional Constipation, conditions: Therapeutic Touch, conditions: Infants, conditions: Children, conditions: Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: The data analyst will be blinded to the procedure and results of randomization, group allocation, and intervention., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Therapeutic Touch, outcomesModule primaryOutcomes measure: Primary Results Follow-up Form, primaryOutcomes measure: Primary Results Follow-up Form, primaryOutcomes measure: Primary Results Follow-up Form, primaryOutcomes measure: Primary Results Follow-up Form, primaryOutcomes measure: Primary Results Follow-up Form, primaryOutcomes measure: Primary Results Follow-up Form, secondaryOutcomes measure: Bristol Stool Scale, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 24 Months, stdAges: CHILD, contactsLocationsModule locations facility: Burdur Bucak State Hospital, status: RECRUITING, city: Burdur, state: Bucak, zip: 15030, country: Turkey, contacts name: Selda Ateş Beşirik, PhD., role: CONTACT, phone: +905076228189, email: seldaates07@gmail.com, contacts name: Selda Ateş Beşirik, PhD., role: PRINCIPAL_INVESTIGATOR, contacts name: Emine Geçkil, Prof., role: SUB_INVESTIGATOR, geoPoint lat: 37.72028, lon: 30.29083, hasResults: False