hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06339788, orgStudyIdInfo id: HD-MP-106, briefTitle: Pharmacokinetics of HD-P023 and Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Handok Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to compare the pharmacokinetics and safety of HD-P023 and coadministration of Teneligliptin and Empagliflozin in healthy adult volunteers, conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: HD-P023, interventions name: Teneligliptin, interventions name: Empagliflozin, outcomesModule primaryOutcomes measure: Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin, primaryOutcomes measure: Peak Plasma Concentration (Cmax) of Teneligliptin and Empagliflozin, secondaryOutcomes measure: Area under the plasma concentration versus time curve zero to time infinity (AUC∞) of Teneligliptin and Empagliflozin, secondaryOutcomes measure: Ratio of AUCt and AUC∞ (AUCt/AUC∞) of Teneligliptin and Empagliflozin, secondaryOutcomes measure: Time to peak drug concentration (Tmax) of Teneligliptin and Empagliflozin, secondaryOutcomes measure: Volume of distribution (VZ/F) of Teneligliptin and Empagliflozin, secondaryOutcomes measure: Clearance (CL/F) of Teneligliptin and Empagliflozin, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06339775, orgStudyIdInfo id: 2024318, briefTitle: Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Suping ZHANG, class: OTHER, descriptionModule briefSummary: B-ALL patients received regular follow-up after allogeneic hematopoietic stem cell transplantation, and in case of recurrence, they were given Blinatumomab.Anti-treatment was followed by DLI, and the second course was performed 1-2 months after DLI.Patients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment.(MNC infusion is about 5×10\^7/kg\~1×10\^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10\^7/kg\~1×10\^8/kg). Objective To observe and analyze the efficacy and side effects of Blinatumomab followed by donor lymphocyte infusion in patients with relapsed acute B lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation in our hospital., conditionsModule conditions: Acute B-cell Lymphoblastic Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Blinatumomab, outcomesModule primaryOutcomes measure: Overall survival, primaryOutcomes measure: Disease-free survival, secondaryOutcomes measure: incidence of cytokine release syndrome （CRS）, secondaryOutcomes measure: Incidence of acute/chronic graft-versus-host disease （GVHD）, secondaryOutcomes measure: hematological adverse reactions Incidence rate, eligibilityModule sex: ALL, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Zhengzhou University, status: RECRUITING, city: Zhenzhou, state: Henan, zip: 450000, country: China, contacts name: Suping ZHANG, role: CONTACT, phone: +8613523510641, email: zsp198612@163.com, contacts name: Zhilei BIAN, role: CONTACT, phone: 037166862272, geoPoint lat: 32.28034, lon: 119.16999, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-11-15, uploadDate: 2024-03-27T23:22, filename: Prot_000.pdf, size: 167222, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-11-15, uploadDate: 2024-03-19T23:43, filename: ICF_001.pdf, size: 140825, hasResults: False
protocolSection identificationModule nctId: NCT06339762, orgStudyIdInfo id: 2024/03-19, briefTitle: Self-Compassion Training Given to Relatives of Patients in Palliative Care, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2024-03-13, completionDateStruct date: 2024-04-13, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Firat University, class: OTHER, descriptionModule briefSummary: The concept of self-compassion is a concept that has been frequently the subject of research lately and has gained importance along with positive psychology. It is also referred to as self-understanding and self-compassion in the literature. The concept of self-compassion used in our study represents the concept of self-compassion in its original form as used in foreign sources. Compassion is classified according to the source to which it is directed or received. It is suggested that there are three different flows: the feeling of compassion that the individual directs from himself to others, the feeling of compassion he receives from others, and the feeling of compassion that he directs directly to his own self. It means showing oneself the same compassion and understanding one does to others, accepting and being open to one's own pain, and being accepting of oneself without being judgmental. Individuals with self-compassion believe that the difficulties, flaws and shortcomings they experience are normal. At the same time, they are aware that being human has characteristics and that everyone can experience these situations. Individuals may be less compassionate towards themselves than they are towards others. Individuals with self-compassion are as understanding, forgiving and loving towards themselves as they are towards other people., conditionsModule conditions: Self-Compassion Training, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Self-Compassion Training, outcomesModule primaryOutcomes measure: Self-Compassion Scale:, primaryOutcomes measure: Care Burden Scale:, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fırat university, status: RECRUITING, city: Elazığ, state: Center, zip: 25240, country: Turkey, contacts name: Gülcan Bahçecioğlu Turan, role: CONTACT, phone: 506 557 60 86, geoPoint lat: 38.67431, lon: 39.22321, hasResults: False
protocolSection identificationModule nctId: NCT06339749, orgStudyIdInfo id: [2024] Ethics Review NO.040, briefTitle: Pregnancy Outcomes in Normotensive VS stage1 Hypertension: a Prospective Observational Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2026-02-27, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: FANG HE, class: OTHER, descriptionModule briefSummary: In 2017, the American College of Cardiology (ACC) and American Heart Association (AHA) guidelines built on evidence that elevated blood pressure increases cardiovascular mortality in the general population, Reclassification of BP; however, these diagnostic definitions do not include pregnant women, and whether newly diagnosed stage 1 hypertension affects pregnancy complications remains unclear. In this study, the combination of maternal factors, MAP and PLGF was used to comprehensively analyze the risk factors of preeclampsia through the "Bayesian rule" developed by the British Fetal Medicine Foundation (FMF). According to the guidelines and consensus, the pregnant women were considered to be at high risk when the calculated risk was higher than 1% of the population. To compare the pregnancy outcomes of women with normal blood pressure in the first trimester and stage 1 hypertension in different risk groups, and to find out whether screening for preeclampsia can be omitted for women with normal blood pressure in the first trimester, while screening for preeclampsia should still be performed for women with stage 1 hypertension as an independent moderate risk factor, and finally to optimize the screening strategy for preeclampsia., conditionsModule conditions: stage1 Hypertension, conditions: Preeclampsia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 626, type: ESTIMATED, armsInterventionsModule interventions name: blood pressure, interventions name: Clinical protocols for preeclampsia risk screening, outcomesModule primaryOutcomes measure: preeclampsia, secondaryOutcomes measure: premature delivery, secondaryOutcomes measure: fetal intrauterine growth restriction, secondaryOutcomes measure: Severe complications of preeclampsia, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: FANG HE, city: Guangzhou, state: Guangdong, zip: 510150, country: China, contacts name: Fang He, M.D, role: CONTACT, phone: +86 13724831279, email: hefangjnu@126.com, contacts name: Yafei Wang, Master, role: CONTACT, phone: +86 18716442633, email: 542114919@qq.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06339736, orgStudyIdInfo id: 23815, briefTitle: Treatment Outcomes in Patients With Muscular Temporo-mandibular Joint Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-10, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Pisa, class: OTHER, descriptionModule briefSummary: The aim of the present study was to assess the treatment outcomes in patients affected by M-TMDs in terms of pain scores assessed with pressure pain threshold (PPT). The levels of de-pression, anxiety and the Oral-Health Impact profile were also assessed and compared to healthy controls. Patients with a clinical diagnosis of M-TMDs and a control group of healthy subjects were enrolled. At baseline, OHIP-14, PHQ-9 and GAD-7 were administered. PPT was registered at the level of masseter and temporalis muscles. The patients were then treated with oral splints and physio-kinesiotherapy following a standardized treatment protocol. At 6-months follow-up, PPT was registered, and the questionnaires were re-administered to compare treatment outcomes., conditionsModule conditions: TMD, conditions: TMD/Orofacial Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaires administered to all study participants, outcomesModule primaryOutcomes measure: Evaluation of the impact of muscular pain on oral health, primaryOutcomes measure: Evaluation of the impact of muscular pain on anxiety, primaryOutcomes measure: Evaluation of the impact of muscular pain on depression, secondaryOutcomes measure: Changes in muscular pain, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Pisa, status: RECRUITING, city: Pisa, zip: 56126, country: Italy, contacts name: Rossana Izzetti, role: CONTACT, phone: +39050993037, email: rossana.izzetti@unipi.it, contacts name: Rossana Izzetti, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False
protocolSection identificationModule nctId: NCT06339723, orgStudyIdInfo id: 2024/03-17, briefTitle: Pecha Kuka Method About Percutaneous Endoscopic Gastrostomy for Caregivers Who Care for Palliative Care Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2024-03-13, completionDateStruct date: 2024-04-13, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Firat University, class: OTHER, descriptionModule briefSummary: Palliative care; It was started by Dame Cicely Saunders in the 1960s as a hospice for community-based provision. Today, palliative care is defined as care that begins with the patient's diagnosis, symptom management is carried out effectively, and a comprehensive, supportive, humanistic approach is based on the individual and his family. When the literature was examined, no study was found that evaluated the effectiveness of the training given by the Pecha Kuka method to caregivers caring for palliative care patients about percutaneous endoscopic gastrostomy. In addition, it is thought that the results of this research will shed light on identifying problems related to feeding practices in patients fed with PEG tubes and identifying misinformation and practices of caregivers. Determining the knowledge level and initiatives of caregivers regarding percutaneous endoscopic gastrostomy tube feeding practices will contribute to the development of educational activities and effective strategies. Study results may provide important data regarding improving the quality of care given to patients and caregivers after discharge and controlling complication rates., conditionsModule conditions: Pecha Kuka, conditions: Palliative Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Pecha Kucha, outcomesModule primaryOutcomes measure: Evaluation Form for Feeding Practices with Percutaneous Endoscopic Gastrostomy Tube:, primaryOutcomes measure: Visual Analog Scale -Anxiety:, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fırat university, status: RECRUITING, city: Elazığ, state: Center, zip: 25240, country: Turkey, contacts name: Gülcan Bahçecioğlu Turan, role: CONTACT, phone: 506 557 60 86, geoPoint lat: 38.67431, lon: 39.22321, hasResults: False
protocolSection identificationModule nctId: NCT06339697, orgStudyIdInfo id: 2022-KY-233, briefTitle: Short-term Effects of Bowel Preparation on Gut Microbiome in Patients Undergoing Endoscopic Colon Polypectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2023-06-30, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Zhang Yanli, class: OTHER, descriptionModule briefSummary: To investigate the role of different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate) on the composition, evolution and recovery of the gut microbiome of patients with colonic polyps undergoing bowel preparation., conditionsModule conditions: Colon Polyp, conditions: Cathartic Colon, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 194, type: ACTUAL, armsInterventionsModule interventions name: different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate), outcomesModule primaryOutcomes measure: gut microbiome-taxonomy, primaryOutcomes measure: gut microbiome-heatmap, primaryOutcomes measure: gut microbiome-Alpha Diversity, primaryOutcomes measure: gut microbiome-Beta Diversity, primaryOutcomes measure: gut microbiome-Functional predictions, secondaryOutcomes measure: Age, secondaryOutcomes measure: Gender, secondaryOutcomes measure: Height, secondaryOutcomes measure: Weight, secondaryOutcomes measure: BMI, secondaryOutcomes measure: Whether the enrollee is a smoker, secondaryOutcomes measure: Whether the enrollee is a drinker, secondaryOutcomes measure: Evaluation of the effectiveness of intestinal cleansing Evaluation of the effectiveness of intestinal cleansing, secondaryOutcomes measure: Gastrointestinal Symptom Score, secondaryOutcomes measure: adverse event, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: China-Japan Friendship Hospital, city: Beijing, state: Beijing, zip: 100029, country: China, geoPoint lat: 39.9075, lon: 116.39723, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2022-12-01, uploadDate: 2024-03-20T22:22, filename: Prot_SAP_000.pdf, size: 135642, hasResults: False
protocolSection identificationModule nctId: NCT06339684, orgStudyIdInfo id: 2021 0075257, briefTitle: HPV Immunological Markers of Cervical Persistent Infection and Oncogenesis, acronym: HPVImmuno, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-08, primaryCompletionDateStruct date: 2026-03-08, completionDateStruct date: 2026-03-08, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Foundation IRCCS San Matteo Hospital, class: OTHER, descriptionModule briefSummary: The aim of this observational study is to build an immunological assay to quantify an immunoscore system for clinical practice, which could identify HPV lesions with a risk of persistent cervical infection, which represents the main predictive factor of neoplastic evolution. A pattern of host immunological factors and HPV-related parameters, in order to identify an algorithm of risk stratification and tailoring treatment will be identified. Finally, in patients with HPV infection, a virus specific immunity after vaccination will be quantified, in order to highlight those patients who have the most significant risk of infection persistence., conditionsModule conditions: HPV-Related Cervical Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ACTUAL, outcomesModule primaryOutcomes measure: Analysis plan for primary end-point, secondaryOutcomes measure: Analysis plan for secondary end-points, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Policlinico San Matteo, city: Pavia, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
protocolSection identificationModule nctId: NCT06339671, orgStudyIdInfo id: PASSAGE, briefTitle: Post-operative Complications and Smoking Habits in Colorectal Surgery, acronym: PASSAGE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-09-25, completionDateStruct date: 2025-09-25, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: IRCCS Ospedale San Raffaele, class: OTHER, collaborators name: Ospedale San Paolo, collaborators name: Ospedali Riuniti Marche Nord pesaro, descriptionModule briefSummary: PASSAGE is a national multicenter retrospective and prospective observational cohort study in which patients who will undergo colorectal surgery will be enrolled., conditionsModule conditions: Colorectal Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 1527, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Incidence and severity of postoperative complications surgery in three groups, secondaryOutcomes measure: Incidence and severity of postoperative complications surgery in NF (non-smokers) group, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prof. Pierpaolo Sileri, city: Milan, country: Italy, contacts name: Pierpaolo Sileri, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06339658, orgStudyIdInfo id: TAD-ICG, briefTitle: ICG vs Blue Patent as a Tracer in the Performance of TAD in Patients With cN1 Breast Carcinoma After Neoadjuvant Chemotherapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Hospital Universitari de Bellvitge, class: OTHER, descriptionModule briefSummary: To validate the use of ICG as a tracer during TAD in patients with cN1 breast carcinoma after neoadjuvant chemotherapy., conditionsModule conditions: Breast Cancer, conditions: Axillary Metastases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 43, type: ESTIMATED, armsInterventionsModule interventions name: Targeted axillary dissection (TAD) by ICG, interventions name: Targeted axillary dissection (TAD) by Blue patent, outcomesModule primaryOutcomes measure: Detection rate of sentinel lymph node, secondaryOutcomes measure: Detection rate of sentinel lymph node, secondaryOutcomes measure: Adverse effects, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital de Bellvitge, status: RECRUITING, city: Hospitalet de Llobregat, state: Barcelona, zip: 08907, country: Spain, contacts name: Amparo Garcia-Tejedor, MDPhD, role: CONTACT, phone: 0034-660223417, email: agarciat@bellvitgehospital.cat, geoPoint lat: 41.35967, lon: 2.10028, hasResults: False