hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06304571, orgStudyIdInfo id: HC006-001, briefTitle: A Study of HC006 in Subjects With Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2026-03-15, completionDateStruct date: 2026-07-16, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: HC Biopharma Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), Immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies. This study is a first-in-human (FIH) study of HC006 in subjects with advanced solid tumors., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: HC006, outcomesModule primaryOutcomes measure: Incidence of Dose Limiting Toxicities(DLTs), primaryOutcomes measure: Incidence of adverse events(AEs), primaryOutcomes measure: Incidence of Serious adverse events(SAEs), primaryOutcomes measure: Clinically Significant changes in safety assessments, secondaryOutcomes measure: Pharmacokinetic (PK) Parameter:Maximum serum concentration (Cmax), secondaryOutcomes measure: PK Parameter:Time to reach Cmax (Tmax), secondaryOutcomes measure: PK Parameter:Area Under the Concentration-time Curve (AUC), secondaryOutcomes measure: Immunogenicity, secondaryOutcomes measure: Objective Response Rate (ORR) per RECIST 1.1, secondaryOutcomes measure: progression-Free Survival (PFS) per RECIST 1.1, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Disease Control Rate (DCR) per RECIST 1.1, secondaryOutcomes measure: Duration of response (DOR) per RECIST 1.1, secondaryOutcomes measure: Time to progression (TTP) per RECIST 1.1, secondaryOutcomes measure: Time To Response (TTR) per RECIST 1.1, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai East Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200120, country: China, contacts name: Ye Guo, MD, role: CONTACT, email: pattrickguo@gmail.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06304558, orgStudyIdInfo id: CI 240228, 2024-480, briefTitle: "Effectiveness of Non-invasive Neuromodulation Treatment for Improving Sexual Satisfaction in Healthy Subjects., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Universidad Europea de Madrid, class: OTHER, descriptionModule briefSummary: The main objectives of the programming with the XSignal device will be to influence the sexual satisfaction of the participants.As secondary objectives, the effectiveness of the XSignal device during a defined treatment period will be analyzed in terms of quality of life, pain, stress, anxiety, sexual function, sleep quality, cortisol, heart rate, blood pressure, respiratory rate, and body temperature of the same subjects, compared with a placebo group, observing the long-term influence of the results., conditionsModule conditions: Sexual Satisfaction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The Placebo group will mimic the Intervention group, but the device will not be connected. With this non-invasive neuromodulation, patiens do not experiment any sensation when the device is connected., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Non-Invasive Neuromodulation (NESA), outcomesModule primaryOutcomes measure: Sexual satisfaction, secondaryOutcomes measure: Stress levels, secondaryOutcomes measure: Blood Pressure (Sistolic and diastolic), secondaryOutcomes measure: Heartbeats per minute, secondaryOutcomes measure: Sleep Quality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06304545, orgStudyIdInfo id: SHR-1210-HLJ-081, briefTitle: Treatment of Rectal Cancer With Long-term Concurrent Chemoradiotherapy Combined With Camrelizumab, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-08-16, completionDateStruct date: 2027-03-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Harbin Medical University, class: OTHER, descriptionModule briefSummary: This is a single-arm, phase II clinical study aim to evaluate the efficacy and safety of long-term concurrent chemoradiotherapy combined with camrelizumab as a neoadjuvant therapy in the treatment of locally advanced/low rectal cancer requiring anus preservation., conditionsModule conditions: Rectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Camrelizumab, interventions name: Chemotherapy, interventions name: Radiotherapy, outcomesModule primaryOutcomes measure: Pathological Complete Response rate, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Anal preservation rate, secondaryOutcomes measure: Disease-free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: AEs, secondaryOutcomes measure: 3-years Overall Survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06304532, orgStudyIdInfo id: HU123, briefTitle: Clinical Efficacy and Safety Assessment of Alsareen Capsule for the Management of H. Pylori Infection, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-15, primaryCompletionDateStruct date: 2024-03-05, completionDateStruct date: 2024-03-06, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Hamdard University, class: OTHER, descriptionModule briefSummary: Helicobacter pylori infection is a major cause of morbidity and mortality worldwide. More than 50% of the global population is estimated to be infected. In 2015, there were approximately 4.4 billion individuals with H pylori infection worldwide. In Pakistan the prevalence of H. pylori infection, highest (63%) in middle age (41-60 years) group while lowest (33%) in teens and pre-teens (\<20 years) group. In young age (20-40) and old age (\>60 years) groups, the prevalence of H. pylori was 55% and 60% respectively.In conventional system of medicine H. pylori infection is treated by triple regimen antibiotic therapy that are amoxicillin, clarithromycin and metronidazole along with acid reducing proton pump inhibitor. Due to recurrence of infection this therapy is repeated multiple times resulting in drug resistance and long term side effects. These side effects \& a long term impact of H. pylori in patient general health necessitates development of a safe and long term effective therapy., conditionsModule conditions: H. Pylori Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 69, type: ACTUAL, outcomesModule primaryOutcomes measure: H. pylori stool for antigen test will screened before and after treatment., eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Shifa Ul Memorial Hospital-Hamdard University, city: Karachi, state: Sindh, country: Pakistan, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False
protocolSection identificationModule nctId: NCT06304519, orgStudyIdInfo id: 1986626-1, briefTitle: Identifying the Optimal Dynamic Ankle-Foot Orthosis Bending Stiffness for Individuals Post-Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University of Delaware, class: OTHER, descriptionModule briefSummary: Ankle braces are commonly prescribed to individuals who have suffered a stroke to help their ankle joints work properly, which allows these individuals to walk better. Currently, there are no standardized guidelines to follow when choosing which brace is best for an individual. Prior work has shown that customizing the level of assistance that these braces provide based on each individual's level of ankle impairment improves the individuals' walking function more than their current brace. The next important step is to fine-tune the customization and work to develop a set of guidelines that can be used by clinicians to help them prescribe the right brace for each patient's needs. The purpose of this study is to test different levels of assistance provided by the brace to determine the optimal customization method. Additionally, this study aims to begin to create a guide to help clinicians choose the best brace for each individuals' needs. To accomplish this goal, individuals will walk with a brace under five different assistance level conditions. The individual's walking function, performance on clinical measures, and response to questionnaires will be examined to determine both the optimal brace for each individual and hopefully identify clinical tools that can be used to guide prescription of the brace. This study is a major step towards developing effective, standardized prescription guidelines that optimize walking of individuals post-stroke., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Dynamic ankle-foot orthosis, outcomesModule primaryOutcomes measure: Mechanical Cost of Transport of the Lower Extremities, primaryOutcomes measure: Sagittal plane ankle moment during stance, primaryOutcomes measure: Sagittal plane ankle angle during stance, primaryOutcomes measure: Self-selected walking speed, primaryOutcomes measure: a candidate set of clinical outcome measures, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Delaware STAR Campus, status: RECRUITING, city: Newark, state: Delaware, zip: 19713, country: United States, contacts name: Elisa Arch, Ph.D., role: CONTACT, phone: 302-831-7268, email: schranke@udel.edu, geoPoint lat: 39.68372, lon: -75.74966, hasResults: False
protocolSection identificationModule nctId: NCT06304506, orgStudyIdInfo id: 514-0894/23-3000, briefTitle: Effect of Obesity on Extracellular Matrix Composition, acronym: EOBECM, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University of Copenhagen, class: OTHER, descriptionModule briefSummary: The experiment is a simple cross-sectional study with three groups (n=10) in each group, young and old healthy men and obese young men. The study will investigate the composition of the adipose tissue extra cellular matrix.The main questions to answer,- is there differences in the adipose tissue extracellular matrix in obese compared to young men is there differences in the adipose tissue extracellular matrix in old compared to young men, conditionsModule conditions: Adipose Tissue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Cross sectional study with three groups, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Cross sectional study, outcomesModule primaryOutcomes measure: The effect of obesity and age on adipose tissue extracellular matrix composition, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xlab, Faculty of Health and Medical Sciences, University of Copenhagen, status: RECRUITING, city: Copenhagen, zip: 2200, country: Denmark, contacts name: Jørn M Helge, PhD, role: CONTACT, phone: +4528757506, email: jhelge@sund.ku.dk, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
protocolSection identificationModule nctId: NCT06304493, orgStudyIdInfo id: 23-2470, briefTitle: REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine if the frequency of use of incentive spirometry during the stay in the Post-Anesthesia Care Unit (PACU) increases with visual and auditory electronic reminders, as compared to not having those reminders., conditionsModule conditions: Postoperative Atelectasis, conditions: Postoperative Hypoxemia, conditions: Postoperative Pneumonia, conditions: Postoperative Pulmonary Complications, conditions: Patient Adherence, conditions: Incentive Spirometry, conditions: Respiratory Therapy, conditions: Respiratory Insufficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a pragmatic single-center cluster study of surgical patients receiving incentive spirometry devices during their PACU stay, with either automatic alarms "ON" or "OFF" in alternating weeks., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Outcome collection and data analysis will be performed by investigators blinded to the patient's cluster allocation (alarms "ON" or "OFF")., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Alarms, outcomesModule primaryOutcomes measure: Rate of adequate IS breaths achieved in PACU, secondaryOutcomes measure: Rate of IS breaths attempted in PACU, secondaryOutcomes measure: Time to first adequate IS breath, secondaryOutcomes measure: Duration of postoperative O2 therapy, secondaryOutcomes measure: Presence of postoperative pulmonary complications, secondaryOutcomes measure: Individual postoperative pulmonary complications, secondaryOutcomes measure: Need for ICU Admission after PACU, secondaryOutcomes measure: PACU Length of Stay, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CU Anschutz, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Emily G Helmer, role: CONTACT, phone: 303-724-2938, email: emily.helmer@cuanschutz.edu, contacts name: Carolyn Gronowski, role: CONTACT, email: carolyn.gronowski@cuanschutz.edu, contacts name: Ana Fernandez-Bustamante, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False
protocolSection identificationModule nctId: NCT06304454, orgStudyIdInfo id: P5_BG, briefTitle: Board Games at Kindergarten (5 Years Old) to Improve Cognitive and Emotional Processes, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Brain In Game scientific-technical service, class: OTHER, descriptionModule briefSummary: Cognitive (i.e. executive functions, memory) and socio-emotional (i.e. affection recognition) processes emerges at first years. These processes have been frequently related to adequate academic performance in the scientific literature (Passolunghi et al, 2015). Current research aimed at training cognitive processes found promising results using board game as a cognitive tool in children (Passolunghi \& Costa, 2016). Considering the growing interest of teachers in this playful and possibly educational, cognitive and socio-emotional resource, a game program for these purposes has been designed to be used in kindergarten classrooms.The main aim of the present study is to test the efficacy of a cognitive and emotional training program in the classroom based on board games in kindergarten students (5 years old). For this, there will be an experimental group that will carry out the cognitive and emotional game program in the classroom implemented by the teachers of the participating centers, and a control group that will be on board games that do not directly activate cognitive and emotional processes. At the end of the interventions, the groups will be compensated by carrying out inversely both board game programs. The classes will be randomly assigned to an experimental group and a passive control group., conditionsModule conditions: Kindergarten Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Cluster RCT, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Double (outcomes assessor and participants), whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 26, type: ACTUAL, armsInterventionsModule interventions name: Board game intervention, outcomesModule primaryOutcomes measure: Visual Memory, primaryOutcomes measure: Processing speed and inhibition, primaryOutcomes measure: Affect recognition, secondaryOutcomes measure: Hollingshead Index (Hollingshead, 1975), secondaryOutcomes measure: CHEXI (Giménez et al. 2022), eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Faculty of Education, Psychology and Social Work; University of Lleida, city: Lleida, zip: 25001, country: Spain, geoPoint lat: 41.61674, lon: 0.62218, hasResults: False
protocolSection identificationModule nctId: NCT06304441, orgStudyIdInfo id: IPVO, briefTitle: Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Guangzhou Medical University, class: OTHER, descriptionModule briefSummary: Intrathecal chemotherapy is one of the mainstay treatment options for leptomeningeal metastases. Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in the treatment of non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. Due to its small molecule properties, it can effectively penetrate the central nervous system barrier and deliver an effective antitumor effect. An international multi-center clinical study published in 2019 confirmed that double-dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R/T790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, whether third-generation small molecule TKI drugs (e.g. 'osimertinib') combined with intrathecal pemetrexed could benefit patients with LM from EGFR- mutant NSCLC remains undetermined., conditionsModule conditions: Leptomeningeal Metastasis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Osimertinib, interventions name: Pemetrexed, outcomesModule primaryOutcomes measure: Clinical response rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Incidence of treatment-related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Third People's Hospital of Huizhou (Huizhou Hospital of Guangzhou Medical University), status: RECRUITING, city: Huizhou, state: Guangdong, country: China, contacts name: Zhenyu Pan, role: CONTACT, phone: +8615804302753, email: dr-zypan@163.com, contacts name: Guozi Yang, role: CONTACT, phone: +8615804302755, email: guoziyang_1982@163.com, geoPoint lat: 23.11147, lon: 114.41523, hasResults: False
protocolSection identificationModule nctId: NCT06304415, orgStudyIdInfo id: CIRB2023/2651, briefTitle: Elevated Lipoprotein(a) in Hospital Staff, acronym: LPACO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2035-12-01, completionDateStruct date: 2036-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Changi General Hospital, class: OTHER, descriptionModule briefSummary: The objective of this study is to investigate the prevalence of elevated Lp(a) in the working general population., conditionsModule conditions: Hypercholesterolemia, conditions: Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia, conditions: Cardiovascular Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2800, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Distribution and prevalence of elevated Lipoprotein(a), secondaryOutcomes measure: Correlation of lipoprotein(a) with cardiovascular outcomes, secondaryOutcomes measure: Genetic variants of lipoprotein(a) and cardiovascular outcomes atherosclerotic events, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Trials & Research Unit, city: Singapore, zip: 529889, country: Singapore, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False