hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06304792, orgStudyIdInfo id: H-22030591, briefTitle: Immediate Versus Postponed Single Blastocyst Transfer in Programmed or Stimulated Cycle Frozen Embryo Transfer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2028-08-01, completionDateStruct date: 2028-08-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: The aim of this randomized controlled trial is to examine whether single blastocyst transfer in the first cycle after oocyte retrieval (immediate) is non-inferior to single blastocyst transfer in a subsequent cycle (postponed) in stimulated or programmed cycle frozen embryo transfer (FET). The primary outcome is live birth rate., conditionsModule conditions: Infertility, conditions: IVF, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 464, type: ESTIMATED, armsInterventionsModule interventions name: Immediate FET in a stimulated or programmed cycle, outcomesModule primaryOutcomes measure: Live birth rate, secondaryOutcomes measure: Live birth rate per blastocyst transfer, secondaryOutcomes measure: Ongoing pregnancy rate, secondaryOutcomes measure: Miscarriage rate, secondaryOutcomes measure: Cancelled cycle rate and reason for cancelled cycles, secondaryOutcomes measure: Endocrinology of the luteal phase, secondaryOutcomes measure: Number of ovarian follicular structures >10 mm, secondaryOutcomes measure: Time-to-pregnancy, secondaryOutcomes measure: Time-to-live-birth, secondaryOutcomes measure: Pregnancy related complications, secondaryOutcomes measure: Neonatal outcomes (weight in kilograms), secondaryOutcomes measure: Neonatal outcomes (length in cm), secondaryOutcomes measure: Neonatal outcomes (apgar score at 1, 5 and 10 minutes postpartum), secondaryOutcomes measure: Quality of life based on the Copenhagen Multicenter Psychosocial Infertility (COMPI) stress scale questionnaires, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fertility Departmen, Rigshospitalet, status: RECRUITING, city: Copenhagen, zip: 2100, country: Denmark, contacts name: Anja B. Pinborg, Prof., DMSC, role: CONTACT, phone: 0045 35 45 64 30, email: anja.bisgaard.pinborg@regionh.dk, contacts name: Clara Colombo, MD, role: CONTACT, email: clara.colombo@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
protocolSection identificationModule nctId: NCT06304779, orgStudyIdInfo id: V3.0.2023.11.29, briefTitle: The Effect of Continuous Intravenous Infusion of Lidocaine on PPCs and Prognosis in Emergency Surgical Patients With IAI, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-31, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, collaborators name: Tianjin Medical University General Hospital, collaborators name: The Affiliated Hospital of Xuzhou Medical University, collaborators name: West China Hospital, descriptionModule briefSummary: The main purpose of this study is to evaluate the impact of continuous 24-hour intravenous infusion of lidocaine on the incidence of PPCs in patients undergoing emergency laparotomy for intra-abdominal infection (IAI).The secondary objectives of this study are to assess the impact of continuous 24-hour intravenous lidocaine infusion on the proportion of patients requiring mechanical ventilation, protection of important organ function during the perioperative period, length of hospital stay, and outcomes within 30 days postoperatively., conditionsModule conditions: Postoperative Pulmonary Complications, conditions: Intra-abdominal Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Lidocaine group: Patients receive a loading dose of 1.5 mg/kg 2% lidocaine at anesthesia induction, followed by continuous intravenous infusion at 1.5 mg/kg/h until 24 hours postoperatively Control group: Patients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 428, type: ESTIMATED, armsInterventionsModule interventions name: Lidocaine, interventions name: Placebo, outcomesModule primaryOutcomes measure: The impact of continuous 24-hour intravenous lidocaine on the incidence of PPCs in patients undergoing emergency laparotomy for IAI., secondaryOutcomes measure: the impact of continuous 24-hour intravenous lidocaine infusion on the proportion of patients requiring mechanical ventilation, protection of important organ function during the perioperative period, otherOutcomes measure: To observe the impact of continuous perioperative lidocaine infusion on the levels of neutrophil extracellular traps (NETs) postoperatively, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Hospital,Fudan university, city: Shanghai, state: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06304766, orgStudyIdInfo id: H-23015954, briefTitle: Open Versus Laparoscopic Ablation of Liver Malignancies, acronym: OPTIMAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: The purpose of this study is to compare laparoscopic ablation to open ablation of liver malignancies regarding complication rates and ablation response as well as quality of life following the surgery., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Cholangiocarcinoma, conditions: Liver Metastases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Approximately 80 patients will be randomized 1:1 between laparoscopic or open ablation after operability assesment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Laparoscopic ablation, interventions name: Open ablation, outcomesModule primaryOutcomes measure: Complications measured by the comprehensive complication index., secondaryOutcomes measure: Tumor ablation completeness., secondaryOutcomes measure: Quality of Recovery score (QoR), secondaryOutcomes measure: Quality of Life score (QoL), secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet, status: RECRUITING, city: Copenhagen, zip: 2100, country: Denmark, contacts name: Hans-Christian Pommergaard, MD DMSc PhD, role: CONTACT, email: hans-christian.pommergaard@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-05-01, uploadDate: 2023-10-06T05:58, filename: Prot_SAP_000.pdf, size: 192543, hasResults: False
protocolSection identificationModule nctId: NCT06304740, orgStudyIdInfo id: IMG-007-102, briefTitle: Safety and Pharmacokinetics of Subcutaneous Dose of IMG-007 in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Inmagene LLC, class: INDUSTRY, descriptionModule briefSummary: This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: IMG-007, interventions name: Placebo, outcomesModule primaryOutcomes measure: Adverse Event Evaluation, secondaryOutcomes measure: Pharmacokinetic Parameters, Cmax, secondaryOutcomes measure: Pharmacokinetic Parameters, Tmax, secondaryOutcomes measure: Pharmacokinetic Parameters, AUC0-t, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Linear Clinical Research, status: RECRUITING, city: Perth, country: Australia, geoPoint lat: -31.95224, lon: 115.8614, hasResults: False
protocolSection identificationModule nctId: NCT06304727, orgStudyIdInfo id: 23-5064, secondaryIdInfos id: Easydore, type: OTHER, domain: 69HCL23_0736, briefTitle: Evaluation of Short Enteral Nutrition in the Emergency Room for Bronchiolitis With Main Nutritional Impairment, acronym: 1TreSBCD, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-21, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: The winter epidemic of bronchiolitis in infants poses insurmountable difficulties for the hospital system for the 2022-2023 season globally. These difficulties are linked to the combination of an unusual epidemic intensity and the loss of medical and paramedical caregivers in the hospital leading to the closure of beds since the Covid-19 pandemic. Bronchiolitis in youngest and most vulnerable infants can lead to severe clinical pictures requiring hospitalization. Among them, some infants present exclusively with inability to eat and only require continuous enteral nutrition during their hospitalization.A service protocol has been put in place in the pediatric emergency room of the Hôpital Femme Mère Enfant for the 2022-2023 season to carry out short enteral nutrition and monitoring before returning home. This outpatient care would aim to reduce the effect of hospital saturation during the winter epidemic of bronchiolitis, increase the comfort and satisfaction of families by allowing less disruption of family life and prevent nosocomial infections.A retrospective evaluation of the feasibility and effectiveness of this protocol is necessary to rely on this first experience of outpatient management., conditionsModule conditions: Bronchiolitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: clinical data review, outcomesModule primaryOutcomes measure: Feasibility of the short enteral feeding protocol, eligibilityModule sex: ALL, minimumAge: 8 Weeks, maximumAge: 1 Year, stdAges: CHILD, contactsLocationsModule locations facility: Hopital Femme Mere Enfant, status: RECRUITING, city: Bron, country: France, contacts name: Dominique PLOIN, MD, role: CONTACT, phone: 0427855642, phoneExt: +33, email: dominique.ploin@chu-lyon.fr, contacts name: Côme HORVAT, MD, role: CONTACT, phone: 0427855634, phoneExt: +33, email: come.horvat@chu-lyon.fr, geoPoint lat: 45.73333, lon: 4.91667, hasResults: False
protocolSection identificationModule nctId: NCT06304675, orgStudyIdInfo id: 905055423985, briefTitle: Manageable Environmental Factors in Migraine, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-30, primaryCompletionDateStruct date: 2024-02-15, completionDateStruct date: 2024-03-04, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Samsun University, class: OTHER, descriptionModule briefSummary: There is limited and insufficient information on the effects of inappropriate living environments, exposure to allergens, electromagnetic fields and stress factors on the chronicity of migraine. The aim of this study is to investigate the frequency of environmental variables/triggers in episodic and chronic migraine patients and their relationship with clinical variables in the chronic migraine group. The results obtained will be shared not only in the scientific community, but also on workplace health and employer-related platforms, including "Wellbeing" groups., conditionsModule conditions: Migraine, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ACTUAL, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: 1. Environmental factors/triggers affecting the chronicity of migraine, secondaryOutcomes measure: 2.Environmental factors/triggers and migraine treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsun University, city: Samsun, zip: 55100, country: Turkey, geoPoint lat: 41.27976, lon: 36.3361, hasResults: False
protocolSection identificationModule nctId: NCT06304662, orgStudyIdInfo id: *University of Jaén, briefTitle: Yoga for Physical and Mental Health, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-13, primaryCompletionDateStruct date: 2024-02-09, completionDateStruct date: 2024-02-19, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Jaén, class: OTHER, descriptionModule briefSummary: In the university environment, where academic pressure and personal exploration are paramount, yoga serves as a sanctuary for students facing stress and seeking self-discovery. Through practices like asanas, pranayama, and meditation, yoga equips students with tools to manage stress, foster inner balance, and enhance emotional well-being. Apart from its emotional benefits, yoga offers physical advantages, improving strength, flexibility, and posture, particularly beneficial for those sedentary due to academic demands. Moreover, yoga enhances concentration and mental clarity through mindfulness practices, aiding students in academic focus and problem-solving.Additionally, yoga provides a space for students to disconnect from external stimuli and recharge, reducing mental and physical fatigue while boosting vitality. By integrating yoga into university life, students can better balance academic pressures with personal care, laying the groundwork for a more harmonious and mindful future., conditionsModule conditions: Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 142, type: ACTUAL, armsInterventionsModule interventions name: Yoga intervention, outcomesModule primaryOutcomes measure: D2 test, primaryOutcomes measure: Mindful Attention Awareness Scale (MAAS), primaryOutcomes measure: Handgrip Strength, primaryOutcomes measure: Anxiety and Depression, primaryOutcomes measure: Sleep quality, primaryOutcomes measure: Stress level, primaryOutcomes measure: The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), primaryOutcomes measure: State Anxiety Inventory (STAI), primaryOutcomes measure: Attentional Control: Shifting and Distraction (AC-S and AC-D), primaryOutcomes measure: Positive and Negative Affect Schedule, primaryOutcomes measure: Difficulties in Emotion Regulation Scale (DERS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Agustín Aibar Almazán, city: Jaén, zip: 23007, country: Spain, geoPoint lat: 37.76922, lon: -3.79028, hasResults: False
protocolSection identificationModule nctId: NCT06304649, orgStudyIdInfo id: Cast21CHLA2023Study1SAP, briefTitle: Clinical Evaluation of Cast21 Short Arm Product During Treatment of Distal Radial or Distal Ulnar Fractures, acronym: Cast21 SAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Cast21, class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients.A secondary objective will be to characterize the clinician and patient experience with the Cast21 Short Arm Product., conditionsModule conditions: Fractures, Closed, conditions: Fractures Bone, conditions: Fracture, conditions: Fractures, conditions: Radius; Fracture, Lower or Distal End, conditions: Ulna Fractures, conditions: Radius Distal Fracture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Cast or brace alternative, outcomesModule primaryOutcomes measure: Clinical determination of healing (standard of care), primaryOutcomes measure: Range of Motion (standard of care), secondaryOutcomes measure: Patient Reported Outcomes - Pain, secondaryOutcomes measure: Patient Reported Outcomes - Satisfaction, secondaryOutcomes measure: Physical Therapy Referral, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06304636, orgStudyIdInfo id: DC15-MM-01, briefTitle: Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma, acronym: DC15-MM-01, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2027-10-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Cartesian Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15, conditionsModule conditions: Refractory Multiple Myeloma, conditions: Relapsed Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Study consists of two parts. Part 1 is a single-arm dose escalation study. Part 2 is a dose-expansion study with 2 arms., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 41, type: ESTIMATED, armsInterventionsModule interventions name: Descartes-15, outcomesModule primaryOutcomes measure: Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM), secondaryOutcomes measure: To assess the anti-myeloma activity of Descartes-15, as measured by IMWG response criteria and progression-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Cancer and Blood Disorders (AON), status: RECRUITING, city: Bethesda, state: Maryland, zip: 20817, country: United States, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False
protocolSection identificationModule nctId: NCT06304623, orgStudyIdInfo id: CIRE.112, briefTitle: SVF for Treating Pulmonary Fibrosis Post COVID-19, acronym: SVFCOVID-19, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-05-05, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Michael H Carstens, class: OTHER, collaborators name: Ministerio de Salud de Nicaragua, collaborators name: Wake Forest University, collaborators name: National Autonomous University of Nicaragua, descriptionModule briefSummary: General description of the studyThis is a prospective, multicenter, expanded access interventional study of subjects recovered from COVID-19 pneumonia to assess their response to intravenous administration of adipose-derived autologous SVF.Primary objectiveThe purpose of this study was to evaluate the safety of single intravenous injections of autologous adipose-derived SVF produced using the GID SVF-2 device system for the treatment of secondary respiratory distress associated with COVID-19.Secondary objectiveTo evaluate the efficacy of the initial treatment with SVF IV., conditionsModule conditions: Pulmonary Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Autologous adipose-derived SVF IV administration, outcomesModule primaryOutcomes measure: Safety of treatment with SVF IV, secondaryOutcomes measure: Efficacy of the initial treatment with SVF IV, otherOutcomes measure: Effectiveness of the initial treatment with SVF IV, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Escuela Oscar Danilo Rosales Arguello (HEODRA), city: León, state: Leon, zip: 21000, country: Nicaragua, geoPoint lat: 12.43787, lon: -86.87804, locations facility: Hospital Escuela Cesar Amador Molina, city: Matagalpa, zip: 61000, country: Nicaragua, geoPoint lat: 12.92559, lon: -85.91747, hasResults: False