hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06319950, orgStudyIdInfo id: 20240229, briefTitle: High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Taizhou Hospital, class: OTHER, descriptionModule briefSummary: The investigators were to explore whether high-dose Furmonertinib, compared with osimertinib, could achieve longer survival in patients with EGFR-mutated NSCLC with CNS metastasis., conditionsModule conditions: Lung Cancer, Nonsmall Cell, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 255, type: ESTIMATED, armsInterventionsModule interventions name: Furmonertinib, interventions name: Osimertinib, outcomesModule primaryOutcomes measure: progression free survival(PFS), secondaryOutcomes measure: objective response rate(ORR), secondaryOutcomes measure: Intracranial objective Response Rate(iORR), secondaryOutcomes measure: Intracranial progression free survival(iPFS), secondaryOutcomes measure: overal survival time(OS), secondaryOutcomes measure: Disease control rate(DCR), secondaryOutcomes measure: Intracranial disease control rate(iDCR), secondaryOutcomes measure: Depth of response (DepOR), secondaryOutcomes measure: Depth of intracranial response(iDepOR), secondaryOutcomes measure: Time to intracranial remission(iTTR), secondaryOutcomes measure: Duration of response(DoR), secondaryOutcomes measure: Duration of intracranial response(iDoR), secondaryOutcomes measure: Rate of improvement in neural function, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Adverse events, otherOutcomes measure: Dynamic changes of ct-DNA, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06319937, orgStudyIdInfo id: OA2023, briefTitle: Muscle Architecture in Knee Osteoarthritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: Background: The aim of this study was to compare the knee and ankle muscle architecture and plantar pressure distribution differences in knee osteoarthritis (OA) women with healthy women.Methods: Fifty women with knee OA (Mean age=52.11±4.96 years, mean BMI=30.94±4.23 kg/m2) and fifty healthy women (Mean age= 50.93±3.78 years, mean BMI=29.06±4.82 kg/m2) were included in the study. Ultrasonography was used to evaluate Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Peroneus Longus (PL), Tibialis Anterior (TA), and Medial Gastrocnemius (MG) muscle thickness, pennation angle, fascicle length, and fat thickness. The plantar pressure distribution was evaluated using the Digital Biometry Scanning System and software (DIASU, Italy)., conditionsModule conditions: Knee Osteoarthritis, conditions: Foot Deformities, conditions: Muscle Weakness, conditions: Kinesiophobia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound, outcomesModule primaryOutcomes measure: Muscle thickness, primaryOutcomes measure: Pennation angle, primaryOutcomes measure: Fat thickness, secondaryOutcomes measure: Stair climbing test, secondaryOutcomes measure: Sit-stand test, eligibilityModule sex: FEMALE, minimumAge: 45 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06319924, orgStudyIdInfo id: XIMEPEG-RL, briefTitle: Fixed Low-dose Simethicone Combined With Macrogol 4000 (PEG) Reduces Colon Bubble Formation in Colonoscopy, acronym: XIMEPEG-RL, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-02-01, primaryCompletionDateStruct date: 2021-05-31, completionDateStruct date: 2022-09-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Hospital St. Joseph, Marseille, France, class: OTHER, descriptionModule briefSummary: Several randomised studies have shown that the addition of low-dose Simethicone to the bowel preparation was sufficient to reduce the presence of bubbles during colonoscopy. The aim of this study was to evaluate the efficacy and safety of a bowel preparation containing low-dose Simethicone on bubble formation.Patients and Methods This prospective, real-life, phase 4 study was conducted from February 2020 to May 2021, in five private endoscopy centres, among adult patients undergoing a colonoscopy. Clinical, endoscopic and histological parameters were collected on e-CRF. The primary endpoint was the measurement of bubble formation in the various colon segments., conditionsModule conditions: Colorectal Cancer, conditions: Colonoscopy, conditions: Bowel Preparation Solution, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 601, type: ACTUAL, armsInterventionsModule interventions name: Simethicone combined with Macrogol 4000 (PEG), outcomesModule primaryOutcomes measure: Assess the quality of the bowel preparation assessed by Bubble scale, primaryOutcomes measure: Assess the quality of the bowel preparation assessed by Boston Bowel Preparation Scale (BBPS), secondaryOutcomes measure: Colonoscope removal time, secondaryOutcomes measure: The frequency of adverse events (AEs), secondaryOutcomes measure: volume of bowel preparation ingested, secondaryOutcomes measure: Caecal intubation rate, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique des Cèdres, Ramsay Santé,, city: Cornebarrieu, zip: 31700, country: France, geoPoint lat: 43.64895, lon: 1.32407, locations facility: Polyclinique Louis Pasteur,, city: Essey-les-Nancy, zip: 54280, country: France, geoPoint lat: 48.70179, lon: 6.22425, locations facility: Saint Joseph Hospital, city: Marseille, zip: 13008, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: 5. Clinique Ambroise Paré, city: Toulouse, zip: 31082, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Pole Santé des Haberges, city: Vesoul, zip: 70000, country: France, geoPoint lat: 47.63333, lon: 6.16667, hasResults: False
protocolSection identificationModule nctId: NCT06319859, orgStudyIdInfo id: N-72-2024, briefTitle: Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study will evaluate the efficacy and safety of intrathecal non-preservative-free morphine and its effect on pain in patients undergoing unilateral inguinal hernia surgeries., conditionsModule conditions: Pain, Postoperative, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Morphine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Time to first analgesic requirement, secondaryOutcomes measure: Nalbuphine consumption, secondaryOutcomes measure: Postoperative pain, secondaryOutcomes measure: The incidence of other adverse effects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kasr Alaini hospital, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06319807, orgStudyIdInfo id: IRB00110194, briefTitle: GrowWell - Responsive Bottle Feeding, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Wake Forest University Health Sciences, class: OTHER, descriptionModule briefSummary: The overall goal of this research is use digital health to augment the clinical encounter with Women, Infants, and Children (WIC) clinicians and prevent rapid infant weight gain among children living in low-income households. Intervening on weight gain during infancy offers an opportunity to influence lifelong obesity risk. Using personalized motivational messages and targeted skills-training resources, the intervention will support parents and caregivers in adopting responsive feeding strategies. Knowledge gained from this project will be used to develop a future, larger grant submission focused on developing healthy feeding and eating habits among mother-infant dyads., conditionsModule conditions: Bottle Feeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Digital Health Intervention, interventions name: Safety Control, outcomesModule primaryOutcomes measure: Engagement - average text message completion rate, secondaryOutcomes measure: Satisfaction Scores - Acceptability, secondaryOutcomes measure: Satisfaction Scores - Frequency, secondaryOutcomes measure: Satisfaction Scores - Timing, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wake Forest University Health Sciences, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, contacts name: Melissa C Kay, PhD, role: CONTACT, phone: 781-249-3062, email: mekay@wakehealth.edu, geoPoint lat: 36.09986, lon: -80.24422, hasResults: False
protocolSection identificationModule nctId: NCT06319794, orgStudyIdInfo id: TQR-BTOP-101, briefTitle: Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: TORQUR, class: INDUSTRY, descriptionModule briefSummary: The aim of the study is to evaluate efficacy and safety of bimiralisib gel treatment for treatment of actinic keratosis (AK) on the face and/or scalp and/or back of hands, conditionsModule conditions: Actinic Keratosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Bimiralisib, interventions name: Bimiralisib, outcomesModule primaryOutcomes measure: Change from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1, secondaryOutcomes measure: Proportion of participants with partial or complete clearance of AK lesions at the End of Treatment Visit (Week 2 or 4 depending on treatment arms), secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Incidence of local skin reactions, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Basel / Department of Dermatology, city: Basel, country: Switzerland, contacts name: Alexander Navarini, role: CONTACT, geoPoint lat: 47.55839, lon: 7.57327, locations facility: CHUV centre hospitalier universitaire vaudois / Department of Dermatology and Venereology, city: Lausanne, country: Switzerland, contacts name: Olivier Gaide, role: CONTACT, geoPoint lat: 46.516, lon: 6.63282, hasResults: False
protocolSection identificationModule nctId: NCT06319755, orgStudyIdInfo id: X23-0230, briefTitle: Characteristics of Intestinal Microbiome Following Pancreatic Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Royal Prince Alfred Hospital, Sydney, Australia, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about intestinal microbiome structure and function in individuals who have undergone a pancreatoduodenectomy and compare to healthy matched controls.The primary objectives of the study are:1. To explore and describe any differences in the gut microbiota especially Shannon diversity index2. To conduct functional profiling by exploring and describing any differences in functional metabolites produced in the gut in people having had pancreatoduodenectomy greater than 6 months ago compared to healthy matched controls.Participants will be asked to complete the following:* Three-day food, bowel and medication diary (see Protocol appendix 5)* Gastrointestinal Symptom Rating Scale (see Protocol appendix 6)* Quality of life questionnaire (see Protocol appendix 7)* Stool sample test using Microba Insight TradeMark (a small swab is taken from soiled toilet paper, sealed in a room-temperature storage capsule and mailed to the testing laboratory), conditionsModule conditions: Pancreatic Cancer, conditions: Microbiota, conditions: Pancreatoduodenectomy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Comparison of microbiota profile between post-surgical participants and healthy controls., secondaryOutcomes measure: Compliance with 3-day food dairies, secondaryOutcomes measure: Pre-paid return rates, secondaryOutcomes measure: Ease of matching, secondaryOutcomes measure: Shannon diversity index, secondaryOutcomes measure: Gastrointestinal symptoms, secondaryOutcomes measure: Protein:fibre ratio of diet, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06319716, orgStudyIdInfo id: 23-01274, briefTitle: Leveraging Videos and Community Health Workers to Address Social Determinants of Health in Immigrants, acronym: LINK-IT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: The overall goal of this study is to examine the efficacy of the video-based Diabetes Self-Management Education and Support (DSMES) (hereafter VIDEO), or the video-based DSMES+community health worker (CHW) intervention (hereafter VIDEO+CHW), compared with a wait-list control group (hereafter CONTROL) to improve glycemic control among Chinese immigrants with uncontrolled Type 2 diabetes in NYC., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 324, type: ESTIMATED, armsInterventionsModule interventions name: Video-Based Diabetes Self-Management Education and Support (DSMES), interventions name: Community Health Worker (CHW) Support, outcomesModule primaryOutcomes measure: Hemoglobin A1c (HbA1c) Levels, primaryOutcomes measure: Hemoglobin A1c (HbA1c) Levels, primaryOutcomes measure: Hemoglobin A1c (HbA1c) Levels, secondaryOutcomes measure: Stanford Self-Efficacy for Diabetes Scale Score, secondaryOutcomes measure: Stanford Self-Efficacy for Diabetes Scale Score, secondaryOutcomes measure: Stanford Self-Efficacy for Diabetes Scale Score, secondaryOutcomes measure: Summary of Diabetes Self-Care Activities (SDSCA) Score, secondaryOutcomes measure: Summary of Diabetes Self-Care Activities (SDSCA) Score, secondaryOutcomes measure: Summary of Diabetes Self-Care Activities (SDSCA) Score, secondaryOutcomes measure: Starting the Conversation (STC) Diet Scale Score, secondaryOutcomes measure: Starting the Conversation (STC) Diet Scale Score, secondaryOutcomes measure: Starting the Conversation (STC) Diet Scale Score, secondaryOutcomes measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score, secondaryOutcomes measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score, secondaryOutcomes measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
protocolSection identificationModule nctId: NCT06319690, orgStudyIdInfo id: REC/RCR&AHS/23/0362, briefTitle: Combined Effects of Lion's Breath Technique With Chest Percussion Therapy in Pneumonia Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-06-05, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: This study will be randomized controlled trial with non-probability convenient sampling. Sample size will be 90,45 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure., conditionsModule conditions: Pneumonia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Control Trial (RCT), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Lion's Breath Technique, interventions name: Chest Percussion Therapy, outcomesModule primaryOutcomes measure: George respiratory questionnaire, primaryOutcomes measure: Forced vital capacity (FVC), primaryOutcomes measure: Borg Dyspnea Scale, primaryOutcomes measure: Forced expiratory volume (FEV1), primaryOutcomes measure: FEV1/FVC Ratio, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jinnah Hospital, status: RECRUITING, city: Lahore, state: Punjab, zip: 42000, country: Pakistan, contacts name: Muhammad Ashraf Jamal, MBBS, role: CONTACT, phone: 03009685981, email: drmajamal@hotmail.com, contacts name: Tania Amjad, DPT, role: SUB_INVESTIGATOR, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
protocolSection identificationModule nctId: NCT06319677, orgStudyIdInfo id: Ivljingjing, briefTitle: PK/PD Study of Anti-Infective Drugs in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation Treatment, acronym: ECMO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: The Third Xiangya Hospital of Central South University, class: OTHER, descriptionModule briefSummary: Extracorporeal membrane pulmonary oxygenation (ECMO) may provide partial or complete support for organ replacement in patients with severe cardiopulmonary failure, buying time for further management of the primary disease. However, ECMO may significantly alter the pharmacokinetic and pharmacodynamic profiles of critically ill patients, affecting the safety and efficacy of drug therapy. This prospective observational study aims to investigate the impact of ECMO treatment on the pharmacokinetics and pharmacodynamics of antimicrobial drugs in critically ill adult patients. Investigators intend to establish a Population Pharmacokinetic (POP PK) and Pharmacokinetic/Pharmacodynamic (PK/PD) model by prospectively collecting blood samples from patients and relevant treatment data. The primary objective is to quantitatively characterize the pharmacokinetic profiles of critically ill patients undergoing ECMO support and provide model-based recommendations for drug regimens tailored to critically ill patients., conditionsModule conditions: Critical Illness, conditions: Extracorporeal Membrane Oxygenation Complication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: ECMO treatment, outcomesModule primaryOutcomes measure: Blood drug concentration, primaryOutcomes measure: Pharmacokinetic parameter, primaryOutcomes measure: Pharmacokinetic parameter, secondaryOutcomes measure: Mortality at 14 and 28 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xiangya Third Hospital, Central South University, city: Changsha, state: Hunan, country: China, contacts name: Jingjing Liu, Doctor, role: CONTACT, phone: +86 0731-88618170, email: ivljingjing@126.com, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False