hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06318286, orgStudyIdInfo id: MK3475-IIT-60977, briefTitle: Study of Pembrolizumab Plus Chemotherapy With Lenvatinib for Malignant Pleural Mesothelioma, acronym: PENINSULA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-10-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Hyogo Medical University, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: In this Phase-II study, the investigators will investigate the efficacy and safety of lenvatinib in combination with pembrolizumab and chemotherapy in patients with malignant pleural mesothelioma., conditionsModule conditions: Malignant Pleural Mesothelioma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a single-arm, open-label study to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab and chemotherapy in patients with malignant pleural mesothelioma. Patients 18 years of age or older will be eligible for enrollment if they had histologically confirmed unresectable malignant pleural mesothelioma., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Lenvatinib, interventions name: Pemetrexed, interventions name: Cisplatin/Carboplatin, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Tumor shrinkage (response rate) (Physician Judgment by Medical Institution, Modified RECIST [Response Evaluation Criteria in Solid Tumors] criteria), secondaryOutcomes measure: Progression-Free survival (PFS) (Physician Judgment by Medical Institution, Modified RECIST criteria), secondaryOutcomes measure: Overall survival time (OS), secondaryOutcomes measure: Tumor shrinkage (disease control rate) (Physician Judgment by Medical Institution, Modified RECIST criteria), secondaryOutcomes measure: Duration of response (Physician Judgment by Medical Institution, Modified RECIST criteria), secondaryOutcomes measure: Best overall response (Physician Judgment by Medical Institution, Modified RECIST criteria), secondaryOutcomes measure: Incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hyogo Medical University Hospital, city: Nishinomiya, state: Hyogo, zip: 6638501, country: Japan, contacts name: Kozo Kuribayashi, MD, PhD, role: CONTACT, phone: +81-798-45-6596, email: kuririn@hyo-med.ac.jp, contacts name: Tetsuya Takagawa, MD, PhD, role: CONTACT, phone: +81- 798-45-6265, email: takagawa@hyo-med.ac.jp, contacts name: Nobukazu Fujimoto, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Keisuke Aoe, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.71562, lon: 135.33199, hasResults: False
protocolSection identificationModule nctId: NCT06318260, orgStudyIdInfo id: 2023-508298-10-00, briefTitle: Haemodynamic Effects of Dobutamine in Patients With Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt), acronym: DobATTR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Steen Hvitfeldt Poulsen, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the effects of the inotropic drug named dobutamine, in patients with wild-type Transthyretin Amyoid Cardiomyopathy (ATTRwt). The main questions it aims to answer are:* What are the effects of increasing dosages of dobutamine infusion on cardiac output and filling pressures in patients with symptomatic ATTRwt.* Safety of dobutamine infusion in this patient population.Participants will be given increasing dosages of dobutamine infusion, and its effect on cardiac output and filling pressures will be assessed non-invasively by echocardiography, and invasively by right heart catheterization, simultaneously., conditionsModule conditions: ATTR Amyloidosis Wild Type, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, single-centre, one arm clinical explorative study, with consecutive enrolment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Dobutrex, outcomesModule primaryOutcomes measure: Cardiac output, secondaryOutcomes measure: Increase in invasively measured SVI by ≥ 20%., secondaryOutcomes measure: Reduction in mean PAWP and/or mPAP by 10 %., secondaryOutcomes measure: Increase in LVEF and LV-global longitudinal strain (LV-GLS) of absolute 10 %., secondaryOutcomes measure: Correlation between echo- and invasive measured SVI, and CO., secondaryOutcomes measure: Rate of complications (i.e. Systolic blood pressure drop < 90 mmHg, arrhythmias)/symptomatic side effects., eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Cardiology, Aarhus University Hospital, status: RECRUITING, city: Aarhus, zip: 8200, country: Denmark, contacts name: Ali Hussein Jaber Mejren, MD, role: CONTACT, phone: 0045 91 65 18 48, email: alimej@clin.au.dk, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False
protocolSection identificationModule nctId: NCT06318247, orgStudyIdInfo id: 2022-134(R), briefTitle: Using Xenograft Combined With Barrier Membrane to Improve the Formation of Deep Periodontal Pockets, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: The Dental Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule briefSummary: To evaluate the clinical effect of site preservation after third molars extraction by using tooth extraction of third molars with site preservation using bio-oss and bio-guide in preventing the formation of deep periodontal pockets in the distal of second molars., conditionsModule conditions: Periodontal Pocket, conditions: Periodontal Bone Loss, conditions: Impacted Third Molar Tooth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: site preservation, outcomesModule primaryOutcomes measure: Probing pocket depths (PPD), primaryOutcomes measure: Distal bone wall defect (DBWD), primaryOutcomes measure: Clinical attachment lose (CAL), primaryOutcomes measure: Bleeding on probing (BOP), secondaryOutcomes measure: Pain score, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Gingival index (GI), eligibilityModule sex: ALL, minimumAge: 26 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Stomatology Hospital, Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, contacts name: Jue Shi, Doctor, role: CONTACT, phone: +86 13757171359, email: dentistsj@zju.edu.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
protocolSection identificationModule nctId: NCT06318234, orgStudyIdInfo id: 202435, briefTitle: PET/MR Evaluation of Regression Grading After Neoadjuvant Therapy for Rectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Xiao Chen, class: OTHER, descriptionModule briefSummary: This project aims to evaluate the role of 18F-FAPI combined with 18F-FDG PET/MRI imaging in quantitatively and accurately evaluating the grading of rectal cancer after SCRT neoadjuvant therapy in patients with advanced rectal cancer as the research object, with postoperative histopathological analysis as the reference index, and to assess the ability of patients to achieve pCR. A diagnostic model and evaluation system will also be constructed., conditionsModule conditions: Rectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: 18F-FAPI，18F-FDG, outcomesModule primaryOutcomes measure: Evaluation efficacy of tumor regression level, secondaryOutcomes measure: expression of FAP, secondaryOutcomes measure: expression of GLUT1, secondaryOutcomes measure: SUV, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University, status: RECRUITING, city: Chongqing, country: China, contacts name: Xiao Chen, Ph.D, role: CONTACT, phone: +8615922970174, email: xiaochen229@foxmail.com, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False
protocolSection identificationModule nctId: NCT06318221, orgStudyIdInfo id: 06156930, briefTitle: Effects of Perioperative Immunonutrition in Patients With Head and Neck Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-05-01, primaryCompletionDateStruct date: 2021-02-01, completionDateStruct date: 2021-02-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: A prospective randomized controlled study compared the effects of perioperative immunonutrition and standard enteral nutrition (EN) on postoperative short-term outcomes of patients with head and neck (HNC).Five days before surgery and the postoperative day 10, immunonutrition support was given to the intervention group (n=17), and standard EN support was given to the control group (n=17). Body analyses were made, food consumption records were taken, NRS-2002 and quality of life scales were applied, and biochemical parameters were recorded., conditionsModule conditions: Head and Neck Cancer, conditions: Nutrition, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients were classified according to tumor location (oral cavity, oropharynx, larynx or hypopharynx) and body weight loss, approximately equally in both groups. Accordingly, patients were randomly assigned (by computer) into either the immunonutrition (intervention group) or standard EN (control group) groups., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: Experimental (Immunonutrition) Group, interventions name: Active Comparator Group ( Standard enteral nutrition), outcomesModule primaryOutcomes measure: Body weight, primaryOutcomes measure: Body weight loss, primaryOutcomes measure: Body mass index, primaryOutcomes measure: Resting metabolic rate, primaryOutcomes measure: Nutrition Risk Screening 2002, primaryOutcomes measure: The EORTC Core Quality of Life questionnaire-30 (EORTC QLQ-C30), primaryOutcomes measure: The EORTC Quality of life - Head and Neck Cancer Module (EORTC QLQ-H & N35), primaryOutcomes measure: Albumin, primaryOutcomes measure: C-reactive protein, primaryOutcomes measure: Prealbumin, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Complication development status, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erciyes University, city: Talas, state: Kayseri, zip: 38280, country: Turkey, geoPoint lat: 38.6908, lon: 35.5538, hasResults: False
protocolSection identificationModule nctId: NCT06318208, orgStudyIdInfo id: C-LCI, briefTitle: Pulmonary Function in Non-hospitalized Adults and Children After Mild COVID-19, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-04-20, primaryCompletionDateStruct date: 2022-01-03, completionDateStruct date: 2022-01-03, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Rostock, class: OTHER, descriptionModule briefSummary: The study investigates whether patients with mild SARS-CoV-2 infection, who stayed at home during their infection and weren't hospitalized, have any persisting sequelae in pulmonary function.Therefore, 110 patients, aged 6-60 years, were recruited by telephone 4-12 weeks after laboratory-confirmed positive PCR and invited for a lung function testing. Every patient with abnormalities in pulmonary function was invited to a follow-up 3 months after the first appointment to assess changes in lung function values.Patients with a pre-existing lung disease and smokers within the last five years were excluded beforehand.Additionally to lung function testing we did a throat swab at each appointment to analyse via Multiplex PCR whether the patients had any other respiratory infection at the time of the pulmonary function testing., conditionsModule conditions: SARS-CoV-2 Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 110, type: ACTUAL, armsInterventionsModule interventions name: lung function testing, outcomesModule primaryOutcomes measure: Pulmonary function, secondaryOutcomes measure: Changes in pulmonary function, secondaryOutcomes measure: Sociodemographic factors, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Kinder- und Jugendklinik Universitätsmedizin Rostock, city: Rostock, zip: 18057, country: Germany, geoPoint lat: 54.0887, lon: 12.14049, hasResults: False
protocolSection identificationModule nctId: NCT06318156, orgStudyIdInfo id: ZSLL-KY-2024-056-03, briefTitle: Exploring the Distribution Patterns and Infrared Characteristics of Force-sensitive Acupoints in Different Lumbar Nerve Segments in Patients With LDH Based on "Press Quickly" Theory, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Zhou Xingchen, class: OTHER, descriptionModule briefSummary: Utilizing the "responsive acupoint palpation" technique and infrared thermography, we investigated the distribution patterns of pressure-sensitive acupoints across different lumbar spinal segments in patients with lumbar disc herniation (LDH). Methodology: The Finger TPS tactile pressure measurement system was employed to conduct sensitivity examinations on the acupoints of the L1\~L5 lumbar spine in 80 LDH patients (Group 1) and 80 healthy individuals (Group 2), applying a standardized force of 60N. When a sensation of comfort was elicited, the points were marked on a human cutaneous nerve segment map. We then utilized infrared thermography to collect and compare the temperature differences of the top 10 most frequently responsive acupoint areas in the experimental group against those in the control group., conditionsModule conditions: Lumbar Disc Herniation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Infrared thermal imaging, outcomesModule primaryOutcomes measure: skin temperature, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310053, country: China, contacts name: Xingchen Zhou, Dr, role: CONTACT, phone: +86-18370133761, email: zhouxingchen0210@163.com, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
protocolSection identificationModule nctId: NCT06318130, orgStudyIdInfo id: LEAD-LBP, briefTitle: Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes, acronym: LEAD-LBP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: National University Hospital, Singapore, class: OTHER, descriptionModule briefSummary: This trial seeks to evaluate the performance of the extendable helix, stylet-driven pacing lead (EHL) compared to the fixed helix, lumenless pacing lead (FHL) during left bundle branch pacing (LBBP), with respect to enduring left bundle branch capture on follow-up, incidence of acute lead failure, pacing characteristics including QRS duration, pacing thresholds, R-wave amplitudes and lead impedance, and finally, safety profile during LBBP implantation. These data will guide future lead selection during LBBP implantation in achieving improved procedural success and optimal lead performance., conditionsModule conditions: Pacemaker DDD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A target of 210 participants will be enrolled in this study consisting of two groups and randomised in a 1:1 fashion to either of two groups.Group 1: Fixed helix, lumenless pacing lead (FHL) Group 2: Extendable helix, stylet driven pacing lead (EHL), primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Subjects will be blinded to the type of pacing lead received. Operators will not be blinded as they will be performing the procedure. Post-procedure, investigators and outcomes assessors will be blinded to the treatment arm during adjudication of outcomes., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: Fixed helix, lumenless pacing lead., interventions name: Extendable helix, stylet-driven pacing lead., outcomesModule primaryOutcomes measure: Incidence of loss of left bundle branch capture, secondaryOutcomes measure: Incidence of acute lead failure, secondaryOutcomes measure: Serial changes in pacing thresholds (V), secondaryOutcomes measure: Serial changes in R-wave amplitude (mV), secondaryOutcomes measure: Serial changes in lead impedance (ohm), secondaryOutcomes measure: Serial changes in QRS duration (ms), secondaryOutcomes measure: Incidence of peri-procedural complications, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National University Heart Centre Singapore, status: RECRUITING, city: Singapore, country: Singapore, contacts name: Eugene Tan, MBBS, role: CONTACT, phone: +6567795555, email: esjtan@nus.edu.sg, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False
protocolSection identificationModule nctId: NCT06318117, orgStudyIdInfo id: 3398-1, briefTitle: Reason for Prescribing Rice Infant Formula, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Mead Johnson Nutrition, class: INDUSTRY, collaborators name: BioFortis, descriptionModule briefSummary: The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest., conditionsModule conditions: Infant Formula, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Rice infant formula, outcomesModule primaryOutcomes measure: Questionnaire - reason for prescribing a RIF during the 1st year of life., secondaryOutcomes measure: Questionnaire - Reason for prescribing a RIF in first 6 months of life, secondaryOutcomes measure: Questionnaire - Diet characteristics, secondaryOutcomes measure: Growth z-scores body mass index (BMI)-for-age, secondaryOutcomes measure: Growth z-score, secondaryOutcomes measure: Growth z-score, secondaryOutcomes measure: Growth z-score, secondaryOutcomes measure: Growth z-score, secondaryOutcomes measure: Questionnaire - Evolution of digestive and allergic symptoms, secondaryOutcomes measure: Socio-demographic characteristics, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 11 Months, stdAges: CHILD, contactsLocationsModule locations facility: Dr Christine REGIMBART - Private Practice, city: Bécon-les-Granits, state: Becon-les-Granits, zip: 49026, country: France, contacts name: Christine Regimbart, MD, role: CONTACT, geoPoint lat: 47.50134, lon: -0.8, locations facility: Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department, city: Auxerre, zip: 89011, country: France, contacts name: Bertrand Soto, MD, role: CONTACT, geoPoint lat: 47.8, lon: 3.56667, locations facility: Centre Hospitalier Universitaire de Nantes - Pediatric emergency department, city: Nantes, zip: 44093, country: France, contacts name: Hugues Piloquet, MD, role: CONTACT, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Hôpital NOVO - Pediatric department, city: Pontoise, zip: 95300, country: France, contacts name: Mariana Englender, MD, role: CONTACT, geoPoint lat: 49.05, lon: 2.1, hasResults: False