hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06279130, orgStudyIdInfo id: N23NEO, briefTitle: Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations, acronym: NEOASIS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2029-01-29, completionDateStruct date: 2034-01-29, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: The Netherlands Cancer Institute, class: OTHER, collaborators name: Agenus Inc., descriptionModule briefSummary: In this study, the efficacy of botensilimab and balstilimab in mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) tumors will be assessed., conditionsModule conditions: Resectable MMR-deficient Solid Tumors, conditions: Resectable MMR-proficient Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Basket, open-label, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: botensilimab, interventions name: balstilimab, outcomesModule primaryOutcomes measure: Major pathological response rate, secondaryOutcomes measure: Pathological response rates, secondaryOutcomes measure: Event free survival, secondaryOutcomes measure: Disease free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Radiological response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Netherlands Cancer Institute, status: RECRUITING, city: Amsterdam, state: Noord-Holland, zip: 1066 CX, country: Netherlands, contacts name: Marieke van de Belt, MsC, role: CONTACT, contacts name: Myriam Chalabi, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False
protocolSection identificationModule nctId: NCT06279117, orgStudyIdInfo id: 2023/9/8, briefTitle: The Effect of Therapeutic Touch on Exam Anxiety, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-02-23, completionDateStruct date: 2024-03-10, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Dokuz Eylul University, class: OTHER, descriptionModule briefSummary: Aim: This study was planned to determine the effect of therapeutic touch applied to nursing students on test anxiety.Method: Students who met the inclusion criteria were divided into therapeutic touch and control groups using the randomization method. After the groups were determined, the students filled out the Introductory Information Form and the State Exam Anxiety Scale. 30 minutes before the exam, therapeutic touch was applied to each of the students, who were divided into groups, for 20 minutes. No application was made to the control group, and they were told to wait in the classroom where the group was waiting as they wished.Immediately after the application was completed, the scale was re-applied to both groups., conditionsModule conditions: Test Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised controlled clinical trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: therapeutic touch, outcomesModule primaryOutcomes measure: Text Anxiety, primaryOutcomes measure: Text Anxiety, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Gizem Göktuna, status: RECRUITING, city: İzmir, zip: 35000, country: Turkey, contacts name: Gizem Göktuna, role: CONTACT, phone: +905448303393, email: gizemgoktuna@gmail.com, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
protocolSection identificationModule nctId: NCT06279104, orgStudyIdInfo id: 2023-TJ-OCCC, briefTitle: A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Tongji Hospital, class: OTHER, collaborators name: Wuhan Union Hospital, China, collaborators name: Henan Cancer Hospital, collaborators name: Qilu Hospital of Shandong University, collaborators name: Hubei Cancer Hospital, collaborators name: Anhui Provincial Cancer Hospital, collaborators name: Peking University Cancer Hospital & Institute, collaborators name: Hunan Province Tumor Hospital, collaborators name: First Affiliated Hospital of Suzhou Medical College, collaborators name: Shandong Tumor Hospital, collaborators name: Chongqing University Cancer Hospital, collaborators name: First Affiliated Hospital of Zhongshan Medical University, collaborators name: Peking University Shenzhen Hospital, descriptionModule briefSummary: The goal of this observational study is to learn about the treatment effectiveness of physician's choice of chemotherapy and the immune checkpoint inhibitor (ICI)-based therapy in patients with relapsed/refractory ovarian clear cell carcinoma (OCCC), and compare the treatment response with the phase II, single-arm clinical trial INOVA to investigate the efficacy of combinational therapy of sintilimab plus bevacizumab. The main questions it aims to answer are:* What is the efficacy of physician's choice of chemotherapy in relapsed/refractory OCCC patients in the real world?* Is ICI-based therapy more effective than physician's choice of chemotherapy in real-world for relapsed/refractory OCCC patients?* Dose the combinational regimens of sintilimab plus bevacizumab in Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma (INOVA) trial more effective than physician's choice of chemotherapy?Participants will be respectively retrieved and extracted de-identified, longitudinal electronic health records (EHR)-derived data., conditionsModule conditions: Ovarian Clear Cell Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: physician's choice of chemotherapy, interventions name: immune checkpoint inhibitor based therapy, outcomesModule primaryOutcomes measure: tumor response rate, secondaryOutcomes measure: progression-free survival (PFS), secondaryOutcomes measure: time to response (TTR), secondaryOutcomes measure: duration of response (DOR), secondaryOutcomes measure: disease control rate (DCR), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06279091, orgStudyIdInfo id: A0104023PP, briefTitle: Correlation of Children and Parental Anxiety and Effectiveness of Breathing Exercises on Anxiety Reduction, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-05-23, primaryCompletionDateStruct date: 2023-11-05, completionDateStruct date: 2024-05-23, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: The purpose of this study to evaluate the correlation between children and parental dental anxiety as well as to evaluate the effectiveness of breathing exercises on anxiety reduction., conditionsModule conditions: Dental Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Selected children will be divided randomly into 3 groups:Control group (Group I). Diaphragmatic Breathing group (Group II). Bubble Blower Breathing group (Group III)., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Diaphragmatic Breathing, interventions name: Bubble Blower Breathing, interventions name: Tell Show Do, outcomesModule primaryOutcomes measure: scale of dental anxiety by Corah Dental Anxiety Scale (CDAS), primaryOutcomes measure: scale of dental anxiety by Facial Image Scale (FIS), primaryOutcomes measure: scale of dental anxiety by Venham Clinical Anxiety Scale (VCAS), primaryOutcomes measure: scale of dental anxiety by Pulse Oximeter, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: Mansura University, city: Mansoura, state: Dakahlia, zip: 35511, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
protocolSection identificationModule nctId: NCT06279078, orgStudyIdInfo id: AJOUIRB-DB-2023-446, briefTitle: Long-term Effect of Steroid on Metabolic Diseases in Asthmatics, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-30, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Ajou University School of Medicine, class: OTHER, collaborators name: AstraZeneca, descriptionModule briefSummary: The goal of this retrospective/observational study is to compare the clinical outcomes between the high-cumulative-dose group and the low- cumulative-dose group of oral/inhaled corticosteroid in the long-term management of asthma patients. The main hypothesis are:i. High cumulative dose of corticosteroid is related to the prevalence of osteoporosis/osteoporosis in the long-term management of adult asthma.ii. High cumulative dose of corticosteroid can affect populations that have a high-risk of osteoporosis (females over 50 years of age).iii. High cumulative dose of corticosteroid is related to the prevalence of diabetes mellitus, hypertension, and hyperlipidemia in the long-term management of adult asthma.iv. High cumulative dose of corticosteroid affects bone metabolism-related diagnostic tests and laboratory values and the prescription rate of bone metabolism-related medications., conditionsModule conditions: Asthma, conditions: Osteoporosis, Osteopenia, conditions: Osteoporosis Risk, conditions: Osteoporotic Fractures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20000, type: ESTIMATED, armsInterventionsModule interventions name: Corticosteroid, outcomesModule primaryOutcomes measure: Prevalence of osteoporosis/osteopenia, secondaryOutcomes measure: Bone mineral density (BMD) score, secondaryOutcomes measure: Total alkaline phosphatase, secondaryOutcomes measure: Corrected calcium, secondaryOutcomes measure: Serum phosphate, secondaryOutcomes measure: Serum albumin, secondaryOutcomes measure: prevalence of steroid related comorbidities(Diabetes Mellitus, Hypertension, Hyperlipidemia, etc.), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ajou University Medical Center, status: RECRUITING, city: Suwon, state: Gyeonggi, zip: 16499, country: Korea, Republic of, contacts name: Hyun-Seob Jeon, M.D., role: CONTACT, phone: +82-31-219-4612, email: googlingpenguin@gmail.com, contacts name: Hae-Sim Park, M.D., Ph.D., role: CONTACT, phone: +82-31-219-4779, email: hspark@ajou.ac.kr, geoPoint lat: 37.29111, lon: 127.00889, hasResults: False
protocolSection identificationModule nctId: NCT06279065, orgStudyIdInfo id: 373/23-EP, briefTitle: Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis, acronym: GCA-Biom, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-18, primaryCompletionDateStruct date: 2026-02-18, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of Bonn, class: OTHER, descriptionModule briefSummary: The longitudinal observational study aims to assess the impact of the microbiome especially the gut-microbiome in the emergence and course of giant cell arteritis (GCA) patients. At diagnosis and 6 month follow up we will analyze the oral, blood and gut microbiome from GCA patients and healthy controls. Thereby identified potential candidate commensal will be further analyzed for possible interactions and influence on the immune system., conditionsModule conditions: Giant Cell Arteritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Analysis of blood and microbiome samples (stool, oral lavage), outcomesModule primaryOutcomes measure: Significant differences in the composition of the microbiome, secondaryOutcomes measure: Influence of the microbiome on therapy response e.g. increased probability of recurrence with accumulation of specific microbiome species, secondaryOutcomes measure: potential association of microbiom composition with application of immune modulating drugs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn, status: RECRUITING, city: Bonn, state: North Rhine-Westphalia, zip: 53127, country: Germany, contacts name: Valentin S. Schäfer, Dr. med., role: CONTACT, phone: +49 228 287-17000, email: rheumatologie@ukbonn.de, geoPoint lat: 50.73438, lon: 7.09549, locations facility: University Hospital Bonn, status: RECRUITING, city: Bonn, zip: 53127, country: Germany, contacts name: Valentin Schäfer, MD, role: CONTACT, phone: +28 287 17000, email: rheumatologie@ukbonn.de, contacts name: Maike Adamson, role: CONTACT, phone: +28 287 17000, email: rheumatologie@ukbonn.de, geoPoint lat: 50.73438, lon: 7.09549, hasResults: False
protocolSection identificationModule nctId: NCT06279052, orgStudyIdInfo id: RC31/23/0535, briefTitle: Adolescent Projections During Transition in Prader-Willi Syndrome, acronym: APT-WILL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University Hospital, Toulouse, class: OTHER, descriptionModule briefSummary: Single-center, cross-sectional qualitative study seeking to collect the experience of adolescence and the transition to adulthood of people affected by Prader-Willi syndrome in a population. To do this, the present will carry out a qualitative study with a reflexive thematic analysis of the data collected through semi-structured interviews using an interview guide., conditionsModule conditions: Prader-Willi Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Phone interview, outcomesModule primaryOutcomes measure: Experience of the disease and aspirations regarding the future, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: CHU de Toulouse, city: Toulouse, country: France, contacts name: Grégoire BENVEGNU, role: CONTACT, email: benvegnu.g@chu-toulouse.fr, contacts name: Dalil Benkanoun, role: CONTACT, email: dalil.benkanoun@hotmail.fr, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False
protocolSection identificationModule nctId: NCT06279039, orgStudyIdInfo id: KY20230116-06, briefTitle: Clinical Observation of Exosomes in Patients After Q-switched Laser Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Nanjing First Hospital, Nanjing Medical University, class: OTHER, descriptionModule briefSummary: the goal of this half-face controlled study is to evaluate the effect of exosome-containing liquid dressings on the recovery of patients after Nd:YAG laser 532 treatment., conditionsModule conditions: Exosome, conditions: Skin Regeneration, conditions: Laser, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Exosome liquid dressing, outcomesModule primaryOutcomes measure: Global Aesthetic Improvement Scale score, primaryOutcomes measure: Dermatology Quality of life index, secondaryOutcomes measure: post-inflammatory hyperpigmentation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Jie Dai, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210006, country: China, contacts name: jie dai, role: CONTACT, phone: 02552271117, email: karry_dj@126.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
protocolSection identificationModule nctId: NCT06279026, orgStudyIdInfo id: PG-006-5, briefTitle: UTAA17 Injection in the Treatment of Relapsed/Refractory Multiple Myeloma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: PersonGen BioTherapeutics (Suzhou) Co., Ltd., class: INDUSTRY, collaborators name: Second Affiliated Hospital of Soochow University, descriptionModule briefSummary: The clinical trial was designed as a single-arm, open-label clinical study, with the main purpose of exploring the safety, pharmacokinetics, and best recommended dose (RP2D) of the UTAA17 injection in the treatment of relapsed or refractory multiple myeloma (r/r MM) subjects, and also the efficacy will be observed. Eligible subjects will accept the infusion of UTAA17 injection after pretreatment, and their blood will be collected before and after infusion for evaluation of pharmacokinetics, immunogenicity and safety. This study plans to evaluate efficacy using the revised Evaluation of Efficacy in multiple myeloma -IMWG criteria (2016), which will be evaluated at 4w, 2m, 3m, 6m, and 6 to 24m (at a frequency of Q3m) after cell reinfusion, in addition to the baseline period. Efficacy evaluation continues until one of the following occurs: subject disease progression (PD), acceptance of a new antitumor therapy, death, occurrence of intolerable toxicity, investigator decision, or patient decision to withdraw., conditionsModule conditions: Relapsed/Refractory Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: UTAA17 injection, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: UTAA17 Injection, outcomesModule primaryOutcomes measure: DLT, primaryOutcomes measure: RP2D, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Soochow University, status: RECRUITING, city: Suzhou, state: Jiangsu, zip: 215000, country: China, contacts name: Huimin Meng, doctor, role: CONTACT, phone: +86-18015580390, email: huimin.meng@persongen.com.cn, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False
protocolSection identificationModule nctId: NCT06279000, orgStudyIdInfo id: CTU 22/025, briefTitle: Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery, acronym: COLCAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2027-09-30, completionDateStruct date: 2028-09-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Cantonal Hospital of St. Gallen, class: OTHER, descriptionModule briefSummary: Perioperative myocardial injury/infarction (PMI) and major adverse cardiovascular events (MACE) are common causes of morbidity and mortality in patients at increased cardiovascular risk undergoing non-cardiac surgery.However, research in recent years has yielded limited preventive and therapeutic measures for PMI/MACE. Recent studies in patients with chronic and acute coronary artery disease have shown that colchicine administration can reduce the risk of cardiovascular events.These encouraging results in non-surgical patients ask for a similar investigation in patients undergoing major non-cardiac surgery. The aim of the proposed study is to investigate the effects of perioperative colchicine administration on the incidence of PMI/MACE., conditionsModule conditions: Cardiovascular Diseases, conditions: Cardiovascular Complication, conditions: Perioperative Complication, conditions: Myocardial Infarction, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized, triple-blinded, placebo-controlled, multicenter, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Patients, anaesthesia providers and all other health care workers involved in the treatment and the study personal will be blinded to the group allocation by provision of equal looking study drugs (verum and placebo), which are repacked for blinding., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 880, type: ESTIMATED, armsInterventionsModule interventions name: Colchicine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Perioperative Myocardial Injury/Infarction, primaryOutcomes measure: Major Adverse Cardiovascular Events, secondaryOutcomes measure: New onset Atrial fibrillation, secondaryOutcomes measure: postoperative high sensitive cardiac Troponin T concentrations, secondaryOutcomes measure: long term cardiovascular outcome, otherOutcomes measure: Gastrointestinal adverse events, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False