hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06313528, orgStudyIdInfo id: 18726, secondaryIdInfos id: J1I-MC-GZBW, type: OTHER, domain: Eli Lilly and Company, briefTitle: A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of the study is to look at the effect of the study drug compared to placebo on calorie intake, energy metabolism, and appetite. The study will last up to 6 months and may include up to 20 visits., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Sponsor-blind, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: LY3437943, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined), secondaryOutcomes measure: Change from Baseline in Sleep Metabolic Rate (SMR), secondaryOutcomes measure: Change from Baseline in SMR, secondaryOutcomes measure: Change from Baseline in 24-hour Energy Expenditure (EE), secondaryOutcomes measure: Change from Baseline in 24-hour EE, secondaryOutcomes measure: Change from Baseline in Total Calorie Intake at Lunch, secondaryOutcomes measure: Change from Baseline in Total Calorie Intake at Dinner, secondaryOutcomes measure: Change from Baseline in Fasting Appetite Visual Analog Score (VAS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: AdventHealth Orlando, status: RECRUITING, city: Orlando, state: Florida, zip: 32804, country: United States, contacts role: CONTACT, phone: 407-303-7100, contacts name: Steven Smith, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Pennington Biomedical Research Center, status: RECRUITING, city: Baton Rouge, state: Louisiana, zip: 70808, country: United States, contacts role: CONTACT, phone: 225-763-3000, contacts name: Eric Ravussin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.45075, lon: -91.15455, locations facility: Columbia University Medical Center, status: RECRUITING, city: New York, state: New York, zip: 10032, country: United States, contacts role: CONTACT, phone: 212-305-9949, contacts name: Michael Rosenbaum, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
protocolSection identificationModule nctId: NCT06313502, orgStudyIdInfo id: 274271, briefTitle: High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Arkansas, class: OTHER, collaborators name: University of Iowa, descriptionModule briefSummary: The purpose of this research is to evaluate whether HDAA in combination with a single dose of 100 mg/m2 IV melphalan followed by autologous stem cell transplantation (ASCT) is safe and effective for subjects with relapsed refractory multiple myeloma. The proposed melphalan dose is 50% of the current standard myeloablative dose (200 mg/m2). Based on our preclinical data, the investigator hypothesize that the combination of reduced dose melphalan with IV HDAA will have high efficacy and tolerabilityPrimary Objective To determine tumor response using International Myeloma Working Group (IMWG) criteria (see Appendix B).Secondary ObjectivesObjectives:1. Determine the safety and tolerability of HDAA in combination with reduced dose melphalan conditioning and autologous stem cell transplantation (ASCT) in relapsed refractory multiple myeloma subjects.2. Determine the rate of Minimal Residual Disease (MRD) negativity at time point of response assessment using 8 color flow cytometry on BM sample. Functional imaging, such as positron emission tomography (PET) scan and magnetic resonance imaging (MRI), will also be performed to assess the disease status.3. Categorize and quantify adverse events compared to historical control.4. Determine quality of life parameters using standardized health-related quality of life measures5. Determine oxidative stress parameters in plasma during treatment., conditionsModule conditions: Plasma Cell Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: 75gm HDAA, interventions name: 100gm HDAA, interventions name: 125gm HDAA, outcomesModule primaryOutcomes measure: Tumor Response measured by IMWG criteria, secondaryOutcomes measure: Safety and Tolerability of HDAA with reduced dose melphalan measured using number and severity of AEs, secondaryOutcomes measure: Rate of Minimal Residual Disease (MRD) negativity using 8 color flow cytometry, secondaryOutcomes measure: Determine quality of life parameter using QLQ-C30, secondaryOutcomes measure: Determine quality of life parameter using EQ-5D-5L, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06313476, orgStudyIdInfo id: SYSKY-2024-030-01, briefTitle: AMH Predicts Postchemotherapy Menopause in Premenopausal Breast Cancer Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: To determine the accuracy of AMH postchemotherapy in predicting permanent menopause after chemotherapy in breast cancer patients who did not use OFS before menopause, conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 153, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Anti-Mullerian Hormone, secondaryOutcomes measure: Estradiol, secondaryOutcomes measure: Follicle Stimulating Hormone, secondaryOutcomes measure: Menstruation, eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 59 Years, stdAges: ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06313450, orgStudyIdInfo id: B2023-110-X02, briefTitle: De-escalated Radiotherapy for Primary Tumor After Neoadjuvant Therapy With Toripalimab Plus Chemotherapy for Nasopharyngeal Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2028-02-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: In the IMRT era, patients with stage II-III (AJCC8th) nasopharyngeal carcinoma achieve high local control. However, survivors are increasingly experiencing late radiation-induced toxicities. A previous study found that reducing the radiation dose to the primary site to 60Gy for patients who achieved partial or complete response to induction chemotherapy resulted in a lower rate of late toxicities and an inferior local control rate. The investigators aim to reduce the radiation dose to the primary site for patients after immunochemotherapy, given the potential of neoadjuvant chemotherapy and immunotherapy to increase response rates and long-term survival. The protocol includes participants with stage II-III (AJCC8th), except T2N0M0, to receive three courses of neoadjuvant gemcitabine plus cisplatin and Toripalimab. If the primary tumour regresses by over 75%, de-escalated radiotherapy with 60Gy will be administered, and participants will receive two cycles of cisplatin and three cycles of Toripalimab during the radiotherapy course. Otherwise, participants will receive conventional radiotherapy and concurrent chemotherapy with cisplatin for two cycles as usual. The aim of this study is to investigate the 3-year local control rate and toxicities of de-escalated radiotherapy., conditionsModule conditions: Nasopharyngeal Carcinoma, conditions: Radiotherapy; Complications, conditions: IMMUNOTHERAPY, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: de-escalated radiotherapy, interventions name: conventional radiotherapy, outcomesModule primaryOutcomes measure: local recurrence rate(LRR), secondaryOutcomes measure: primary tumor volume regression≥75% rate, secondaryOutcomes measure: 3-year overall survival, secondaryOutcomes measure: acute and late radiation-induced toxicities, secondaryOutcomes measure: complete response rate of primary tumor, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-Sen University Cancer Center, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Puyun Ouyang, role: CONTACT, phone: +8602087342926, email: ouyangpy@sysucc.org.cn, contacts name: Fangyun Xie, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06313424, orgStudyIdInfo id: 9029, briefTitle: Arthroscopic Treatment of Meniscal Lesions on Healthy Meniscus in Children and Adolescents, acronym: ATML, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-29, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04-29, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University Hospital, Strasbourg, France, class: OTHER, descriptionModule briefSummary: Meniscal lesions are common in pediatrics and mainly affect adolescents. These lesions can jeopardize the functional prognosis of the knee in the short, medium or long term if they are not well managed.More precisely, it is a question of determining whether arthroscopic repair of isolated meniscal lesions in children gives good results and what factors influence them, with the aim of improving the care of children suffering from meniscal lesions.The treatment of meniscal lesions comes down to either conservative or restorative treatment or non-conservative treatment by meniscectomy. For most authors, the treatment of meniscal lesions must remain restorative through meniscal suture, leaving no room for meniscectomy. The open approach has given way to the arthroscopic approach which, according to the literature, is the gold standard. Meniscal lesions are varied and therefore there are numerous therapeutic procedures. Therapeutic indications are precise but the results of the treatments remain differently assessed depending on the studies; studies evaluating the results of treatment in the pediatric population are few in number.Based on this observation, the present study aims to describe the results of repairs of meniscal lesions in pediatric traumatology., conditionsModule conditions: Knee Injuries, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, outcomesModule primaryOutcomes measure: description of the results of repairs of meniscal lesions in pediatric traumatology, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Service de Chirurgie Pédiatrique - CHU de Strasbourg - France, status: RECRUITING, city: Strasbourg, zip: 67091, country: France, contacts name: Philippe GICQUEL, MD, PhD, role: CONTACT, phone: 33 3 88 12 82 65, email: Philippe.Gicquel@chru-strasbourg.fr, contacts name: Philippe GICQUEL, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Saïd Nahl Oumar GANAME, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, hasResults: False
protocolSection identificationModule nctId: NCT06313411, orgStudyIdInfo id: 8778, briefTitle: How do I Perform a Laparoscopic Removal of a Pelvic Retroperitoneal Schwannoma, acronym: PRS, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-23, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University Hospital, Strasbourg, France, class: OTHER, descriptionModule briefSummary: Schwannomas are mainly benign tumors, which develop mainly in the skull or in the cervical region. Retroperitoneal location is rare, since it represents between 0.5 and 5% of scwhanomas. The malignant retroperitoneal form is, however, more common than in other locations.Retroperitoneal schwannoma is often discovered during the exploration of unexplained lumbo-pelvic pain, or in the face of compression of nearby organs. Abdominopelvic CT and magnetic resonance imaging are essential to characterize the mass and verify its extension. The precise diagnosis is based on the pathological examination of the part, and complete surgical excision is the standard treatment.Acquiring the surgical techniques and skills necessary to carry out these types of procedures is essential to providing optimal patient care., conditionsModule conditions: Endometriosis Pelvic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1, type: ESTIMATED, outcomesModule primaryOutcomes measure: laparoscopic removal of a retroperitoneal pelvic schwannoma, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Service de Gynécologie Obstétrique - CHU de Strasbourg - France, status: RECRUITING, city: Strasbourg, zip: 67091, country: France, contacts name: Emilie FALLER, MD, role: CONTACT, phone: 33 3 88 12 63 87, email: emilie.faller@chru-strasbourg.fr, contacts name: Alexandre PIFFER, MD, role: CONTACT, phone: 33 6 71 47 38 61, email: Alexandre.piffer@yahoo.fr, contacts name: Emilie FALLER, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Alexandre PIFFER, MD, role: SUB_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, hasResults: False
protocolSection identificationModule nctId: NCT06313359, orgStudyIdInfo id: FY2024-125, briefTitle: Fall Risk and Quality of Life: in Individuals With Cancer Treatment Related Peripheral Neuropathy., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Texas Woman's University, class: OTHER, descriptionModule briefSummary: The purpose of this research is to examine the impact of peripheral neuropathy on fall risk and quality of life in people who had cancer. Specifically, we are interested to find out if you have any difficulty with thinking, feeling, balancing, or moving around that will contribute to risk for falls or quality of life. We are also interested to see if you have any difficulty with doing two activities at the same time, such as walking and texting., conditionsModule conditions: Peripheral Neuropathy Due to Chemotherapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Fall risk, primaryOutcomes measure: Quality of life- in cancer patients, secondaryOutcomes measure: Trail Making Test (TMT) Parts A & B, secondaryOutcomes measure: Single Task- Working Memory, secondaryOutcomes measure: Single Task- Visual Attention Cognitive Task, secondaryOutcomes measure: Protective Sensation, secondaryOutcomes measure: Grip Strength, secondaryOutcomes measure: LE strength assessment- HHD, secondaryOutcomes measure: Dynamic Balance, secondaryOutcomes measure: Single Task- Gait Speed, secondaryOutcomes measure: Dual Task- Working Memory & Gait Speed - Composite measure, secondaryOutcomes measure: Dual Task- Visual Attention Cognitive Task & Gait Speed - Composite measure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06313333, orgStudyIdInfo id: SID01, briefTitle: National Register of Moderate and Severe Adult Atopic Dermatitis, acronym: ATOPYREG, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-06-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2030-06-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse, class: OTHER, descriptionModule briefSummary: Collect clinical history and treatment data of AD in adulthood;, conditionsModule conditions: Atopic Dermatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Epidemiological data, primaryOutcomes measure: Identification of factors for specific treatment, primaryOutcomes measure: clinical and therapeutic data, primaryOutcomes measure: characterization of diagnostic criteria, primaryOutcomes measure: Assessment of possible conditioning factors, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ASST Spedali Civili di Brescia, status: RECRUITING, city: Brescia, zip: 25123, country: Italy, contacts name: Piergiacomo MD Calzavara Pinton, role: CONTACT, phone: 0303995305, email: piergiacomo.calzavarapinton@unibs.it, geoPoint lat: 45.53558, lon: 10.21472, hasResults: False
protocolSection identificationModule nctId: NCT06313320, orgStudyIdInfo id: OAIC1344-23, briefTitle: Intraoperative Electroencephalographic Biomarkers of Postoperative Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Chile, class: OTHER, descriptionModule briefSummary: The goal of this study is to explore whether specific intraoperative EEG signals (brain waves or neuronal electrical activity) are associated with the severity of acute postoperative pain., conditionsModule conditions: Pain Postoperative, conditions: Nociceptive Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, outcomesModule primaryOutcomes measure: Maximum Pain in PACU, secondaryOutcomes measure: Opioid Consumption in PACU, secondaryOutcomes measure: Maximum Pain at 24h, secondaryOutcomes measure: Presence of surgical related pain at day 7, secondaryOutcomes measure: Presence of surgical related pain at day 30, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hospital Clinico de la Universidad de Chile, city: Santiago, state: RM, zip: 7563215, country: Chile, contacts name: Rodrigo Gutierrez, MD, PhD, role: CONTACT, phone: +56995993665, email: rodrgutierrez@uchile.cl, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Centro de Investigacion Clinica Avanzada, city: Santiago, country: Chile, geoPoint lat: -33.45694, lon: -70.64827, hasResults: False
protocolSection identificationModule nctId: NCT06313294, orgStudyIdInfo id: 230929002, briefTitle: Postoperative Follow-up Via Text Messages Automated Versus Telephone in Patients With Continuous Regional Anesthesia, acronym: txt-RA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Pontificia Universidad Catolica de Chile, class: OTHER, descriptionModule briefSummary: Monitoring performed by a trained operator has proven to be useful and valued by patients after the use of continuous regional anesthesia. A health professional calls each patient to gather information about their recovery. However, this direct communication strategy requires time and resources, especially if many patients are involved.A modern and convenient approach involves the use of immediate communication technology for follow-up after a procedure. They may contain specific questions that patients can easily answer from their mobile devices.Automated text messages could be associated with greater convenience and ease for patients with response rates at least like the traditional method. Phone calls, on the other hand, may be less scalable and require more human resources.The objective of the project is to evaluate the feasibility of monitoring through automated electronic messaging by evaluating its usability using a validated scale in Spanish. response rate on the first day and adherence rate compared to that of the traditional method. Secondarily, adherence and differences in satisfaction will be compared., conditionsModule conditions: Anesthesia, conditions: Regional Anesthesia, conditions: Nerve Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will are assigned to one of two groups in parallel for the duration of the study, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: The research patients will be blind to the proposed intervention., whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Tracking application app, interventions name: Telephone interview, outcomesModule primaryOutcomes measure: Usability level of the tracking application, secondaryOutcomes measure: Patient satisfaction with Perception of Quality in Anesthesia, secondaryOutcomes measure: Patient adherence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pontificia Universidad Catolica de Chile, city: Santiago, state: Metropolitana, zip: 450881, country: Chile, contacts name: Victor Contreras, MSN, role: CONTACT, phone: 223549217, email: vecontre@uc.cl, contacts name: Erick Strange, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.45694, lon: -70.64827, hasResults: False