hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06341829, orgStudyIdInfo id: PRISM1, briefTitle: Visuospatial and Affective Abilities in Parkinson Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2024-04-18, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: IRCCS Centro Neurolesi "Bonino-Pulejo", class: OTHER, descriptionModule briefSummary: The aim of the study is to investigate whether prismatic adaptation (AP), a non-invasive neuromodulation technique, that involves the use of lenses that deviate the visual field, can modulate alexithyima and performance in visuospatial tasks in patients with Parkinson disease. Furthermore, brain activity during the prismatic adaptation and post-adaptation phases will be recorded using functional near-infrared spectroscopy (fNIRS) and high-density electroencephalography (HD-EEG)., conditionsModule conditions: Parkinson Disease, conditions: Alexithymia, conditions: Visuospatial/Perceptual Abilities, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: Prismatic adaptation, outcomesModule primaryOutcomes measure: Improve visuospatial skills;, primaryOutcomes measure: Modulate alexithymia;, primaryOutcomes measure: Investigation of brain activity;, secondaryOutcomes measure: Improve the quality of life with PDQ-39 questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06341816, orgStudyIdInfo id: VEXUS2, briefTitle: Treatment According to Venous Excess Ultrasound Score in Patients With Heart Failure, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: Heart failure is a syndrome that progresses with symptoms and signs caused by cardiac dysfunction and results in a shortened life expectancy (1). Acute heart failure resulting in hospitalization is a significant cause of morbidity and mortality. With the increase in the severity of the disease and rapid advances in the treatment of heart failure, these patients are frequently hospitalized and monitored in intensive care. (2) Five years after diagnosis, mortality can be up to 67%. Additionally, it is known that patients with heart failure are hospitalized on average once a year after diagnosis. (3) In a multicenter study, it constituted 14% of 3000 cardiac patients admitted to intensive care units. Additionally, due to longer ICU stays, these patients accounted for 33% of total inpatient days. An increasing number of heart failure patients require intensive care due to respiratory failure, regardless of left ventricular ejection fraction. Heart failure accounts for approximately one-third of patient days in intensive care units, and this burden is increasing. This shows that attention should be paid to the quality of care for patients requiring critical care. (2) Multidisciplinary programs have been implemented to deal with the high prevalence. However, the optimal follow-up frequency is unknown. Therefore, some tools are needed to improve patient prognosis (3).Neutrophil gelatinase-associated lipocalin (NGAL) is a biomarker whose values in both urine and plasma have been associated with acute kidney injury (AKI). Although NGAL is an early specific biomarker for AKI, it has not yet come into routine use, but is frequently used in clinical and experimental studies (4).Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion., conditionsModule conditions: Heart Failure, conditions: Acute Kidney Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: VEXUS score, interventions name: NGAL, outcomesModule primaryOutcomes measure: acute kidney injury, primaryOutcomes measure: mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06341738, orgStudyIdInfo id: 421/215/404.102.28/VI/2023, briefTitle: The Efficacy of Digital Educational Interventions on Parental HPV Knowledge and Attitude, and Their Children's Vaccination Rates, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-05, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-29, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Kaohsiung Medical University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to examine in the parental HPV knowledge and attitude, and their children's completion rates in Indonesia. The main question\[s\] it aims to answer are:* Is the digital educational intervention in improving parent's HPV knowledge in the intervention group compared to the control group?* Is the digital educational intervention in improving parent's attitude toward HPV vaccine in the intervention group compared to the control group?* Is the digital educational intervention more effective in increasing children's HPV vaccine completion rates in the intervention group compared to the control group?Participants in intervention group will:* watch a 8 minutes video in front of class at once.* after video education intervention, in 2 weeks, participants received 2 reminder messages before first and second vaccination event, respectively.Participants in control group will:• Receive usual announcement regarding vaccine by staff, conditionsModule conditions: Health Services Research, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 10 units are divided into 2 arms (e.g. intervention and control) by cluster randomisation using the number of units into a sealed envelope. the participants are unaware of which group they were placed in, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 374, type: ACTUAL, armsInterventionsModule interventions name: Video education about HPV and HPV vaccine, interventions name: Electronic reminder messages, interventions name: Usual Information Service, outcomesModule primaryOutcomes measure: Human Papillomavirus Knowledge Scale (HPV-KS), primaryOutcomes measure: Attitude towards HPV vaccine scale by Carolina HPV Immunization Attitudes and Beliefs Scale (CHIAS), primaryOutcomes measure: Vaccine completion rate, eligibilityModule sex: ALL, minimumAge: 17 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Elementary school, city: Ngawi, state: East Java, zip: 63271, country: Indonesia, geoPoint lat: -7.4038, lon: 111.4461, hasResults: False
protocolSection identificationModule nctId: NCT06341725, orgStudyIdInfo id: LinfoK EUS 2016, briefTitle: EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging, statusModule overallStatus: TERMINATED, startDateStruct date: 2018-02-15, primaryCompletionDateStruct date: 2018-02-15, completionDateStruct date: 2018-09-11, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Paolo Giorgio Arcidiacono, MD, class: OTHER, descriptionModule briefSummary: Aim of the study will be to investigate if Endoscopic Ultrasound (EUS) with elastography can be purposed between the routine staging examinations in patients with pancreatic adenocarcinoma without distant metastasis for the staging of lymph nodes status ("N" in TNM classification)* in RESECTABLE pancreatic cancer the investigators will evaluate the concordance with EUS elastography and histological findings of lymph nodes obtained during surgery, in order to assess the sensibility, specificity and the positive and negative predictive value of EUS with elastography, the disease-free survival, the percentage of metastatic patients and the overall survival (in patients with or without metastatic lymph nodes).* in "BORDERLINE resectable" and UNRESECTABLE non-metastatic ("advanced" locally") disease, the investigators will evaluate if the malignant lymph nodes samples during EUS with elastography and fine needle aspiration (FNA) will be related to a decreased survival.Secondary aim will be to register the prognosis (in terms of survival) of the patients with para-aortic and mediastinal pathological lymph nodes (related to a decreases survival in some series in literature), conditionsModule conditions: Pancreatic Adenocarcinoma, conditions: Lymph Node Metastasis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 2, type: ACTUAL, armsInterventionsModule interventions name: malignant lymph nodes, outcomesModule primaryOutcomes measure: CONCORDANCE (PERCENTAGE) of pathological lymph nodes at EUS with elastography and surgical pathology report, primaryOutcomes measure: OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence, primaryOutcomes measure: OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence, secondaryOutcomes measure: OVERALL SURVIVAL (MONTHS), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS San Raffaele Hospital, city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06341699, orgStudyIdInfo id: 05C308, briefTitle: Study of the Steroid Hormone Milieu in Obese Patients, acronym: MiSterO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-16, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, collaborators name: Ministry of Health, Italy, descriptionModule briefSummary: The aim of this observational study is to evaluate the actual secretion of cortisol and testosterone in obese male subjects, together with the receptor sensitivity to these hormones in order to understand whether the hormonal milieu deriving from these parameters is associated with alterations in bone metabolism, lipoprotein concentration and function, and/or the severity and complications of obesity.It will be also investigated if this hormonal milieu is a predictive factor for cardiovascular disease in obese patients.Eligible subjects are male patients (age 18-80 years) with severe obesity and no other known causes of hypercortisolism or hypogonadism.Questionnaires for the evaluation of mood and symptoms will be collected upon enrollment, patient's anamnestic and clinical data relating to disease complications, BMI, previous blood tests, cortisol suppression with dexamethasone 1 mg will be collected, and blood sample will be sent to and analyzed at a centralized laboratory for the study of Steroid hormones, bone metabolism, lipoprotein function, genetics and receptor analysis., conditionsModule conditions: Obesity, Morbid, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 180, type: ESTIMATED, outcomesModule primaryOutcomes measure: Association of androgen milieu with the severity of obesity, primaryOutcomes measure: Association of cortisol milieu with the severity of obesity, primaryOutcomes measure: Algorithm fo CV risk in obesity, secondaryOutcomes measure: Prevalence of hypogonadism in morbid obesity, secondaryOutcomes measure: Prevalence of patients with morbid obesity unresponsive to overnight suppression test, secondaryOutcomes measure: Enrichment in rare HH variants in obese patients with central hypogonadism, secondaryOutcomes measure: Enrichment in rare variants associated with hypercortisolism in obese patients unresponsive to Nugent testing, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo, status: RECRUITING, city: Oggebbio, state: Verbania, zip: 28824, country: Italy, contacts name: Biagio Cangiano, MD, role: CONTACT, phone: 3343177491, email: b.cangiano@auxologico.it, contacts name: Massimo Scacchi, Professor, role: CONTACT, email: massimo.scacchi@unimi.it, geoPoint lat: 45.99088, lon: 8.64663, hasResults: False
protocolSection identificationModule nctId: NCT06341686, orgStudyIdInfo id: 75471023.2.0000.0082, briefTitle: Evaluation of the Prophylactic Use of Letermovir in Kidney Transplant Recipients at Risk of Cytomegalovirus Infection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-05, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Hospital do Rim e Hipertensão, class: OTHER, descriptionModule briefSummary: The two main cytomegalovirus (CMV) prevention strategies are prophylaxis and preemptive therapy. Prophylaxis effectively prevents CMV infection after solid organ transplantation (SOT), but is associated with high rates of neutropenia and late onset of post-prophylactic disease. In contrast, preemptive therapy has the advantage of leading to lower rates of CMV disease and robust humoral and T-cell responses. It is widely used in hematopoietic cell transplant recipients, but is rarely used after solid organ transplant recipients due to logistical considerations., conditionsModule conditions: CMV Infection, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 1. Patients randomized to the prophylaxis group: Letermovir 480mg, 1x/day, from D14 to D98. Letermovir prophylaxis will start on day 14 after the kidney transplant.2. Patients randomized to the preemptive treatment group: Preemptive treatment (PET) will begin on day 21, evaluating CMV DNAnemia weekly until D98.CMV DNAnemia weekly until day 98 (21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91 and 98). The threshold for starting treatment with Ganciclovir is a CMV DNAemiaDNAemia \> 5,000 IU in a single measurement (CMV infection) OR any CMV DNAemia with any signs or symptoms associated with CMV (CMV syndrome or disease).3. In both groups, CMV DNAemia will be monitored weekly until day 98 (21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91 and 98), and after any acute rejection treatment occurring between 3 months and 6 months after kidney transplantation., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Letermovir 480 MG, interventions name: Ganciclovir, outcomesModule primaryOutcomes measure: Incidence of CMV syndrome or disease, secondaryOutcomes measure: Incidence of patients with plasma CMV DNAemia > 200 IU, secondaryOutcomes measure: Incidence of patients with CMV infection/syndrome/disease, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06341660, orgStudyIdInfo id: CROC202313, briefTitle: To Evaluate the Safety and Tolerability of Carbognilumab Combined With Chemotherapy as the First-line Treatment for Patients With KEAP1 Mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer (NSCLC), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-25, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Guangzhou Institute of Respiratory Disease, class: OTHER, descriptionModule briefSummary: To evaluate the safety and tolerability of carbognilumab combined with chemotherapy as first-line treatment in patients with KeAP1-mutated advanced or postoperative recurrent non-small cell lung cancer., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: cadonilimab, outcomesModule primaryOutcomes measure: Safety assessments and ORR, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Guangzhou Medical University, status: RECRUITING, city: Guangdong, state: Guangzhou, zip: 510000, country: China, contacts name: zhou chegnzhi, doctor, role: CONTACT, phone: 13560351186, email: doctorzcz@163.com, hasResults: False
protocolSection identificationModule nctId: NCT06341647, orgStudyIdInfo id: AB-201-01, secondaryIdInfos id: 103300 (HREC 233/23), type: OTHER, domain: TGA (Australia), briefTitle: Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-31, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2029-02, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: GC Cell Corporation, class: INDUSTRY, descriptionModule briefSummary: This clinical trial will enroll subjects with HER2+ solid tumors and is conducted in two phases, which are phase 1a and phase 1b. The primary objective of phase 1 is to determine the safety and tolerability of AB-201 in subjects with advanced HER2+ solid tumors., conditionsModule conditions: Breast Cancer, conditions: Gastric Cancer, conditions: Gastroesophageal Junction Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: * Safety: incidence and severity of AE and SAE \[Time Frame: From the time of consent through End of Study (up to 18 months per patient)\]* Determination of Recommended Phase 2 Dose (RP2D), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: AB-201, interventions name: Cyclophosphamide, interventions name: Fludarabine, outcomesModule primaryOutcomes measure: Incidence, severity, seriousness, and dose relationship of Adverse Events [Safety & Tolerability], primaryOutcomes measure: Determination of Recommended Phase 2 Dose (RP2D), secondaryOutcomes measure: To determine the preliminary efficacy, by the objective response rate (ORR) per the Response Evaluation Criteria for Solid Tumors (RECIST) v1.1, of AB-201 in subjects with advanced HER2+ solid tumors, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peter MacCallum Cancer Centre, city: Melbourne, state: Victoria, zip: 3000, country: Australia, contacts name: Michael Michael, role: CONTACT, phone: +6138559-5000, email: Michael.Michael@petermac.org, geoPoint lat: -37.814, lon: 144.96332, locations facility: The Alfred Hosptial, city: Melbourne, state: Victoria, zip: 3004, country: Australia, contacts name: Mark Voskoboynik, role: CONTACT, phone: +613-9076-3129, email: m.voskoboynik@alfred.org.au, geoPoint lat: -37.814, lon: 144.96332, hasResults: False
protocolSection identificationModule nctId: NCT06341621, orgStudyIdInfo id: SCHBCC-N071, briefTitle: Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib, acronym: Rainbow, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2027-02-25, completionDateStruct date: 2029-01-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in ER+/HER2-endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib, conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Arm 1# endocrine drug plus 3-year abemaciclib without chemotherapy Arm 2# treatment of physician's choice, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1900, type: ESTIMATED, armsInterventionsModule interventions name: 3-year abemaciclib without chemo, interventions name: treatment of physician's choice, outcomesModule primaryOutcomes measure: Invasive disease free survival, secondaryOutcomes measure: disease free survival, secondaryOutcomes measure: distant disease free survival, secondaryOutcomes measure: overall survival, secondaryOutcomes measure: Time Frame: 5 years] 5. adverse effects adverse effects, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhimin Cancer Shao, status: RECRUITING, city: Shanghai, zip: 200032, country: China, contacts name: Zhimin Shao, MD, PhD, role: CONTACT, phone: +8664175590, email: zhimingshao@yahoo.com, contacts name: Yin Liu, MD, role: CONTACT, phone: +8664175590, email: liuyinfudan@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False