hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06327347, orgStudyIdInfo id: 2020-05_C2H, briefTitle: Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg, acronym: C2H, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-17, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-07-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Cristalens Industrie, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to compare the performance of 2 intraocular lenses (IOLs): ARTIS SYMBIOSE (study lenses) vs PANOPTIX (comparator) through binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative by a blinded evaluator.This main objective will be to show superiority of the ARTIS SYMBIOSE system on the primary endpoint.The patient population to be included is patient suffering from cataract who requires cataract surgery procedure that meet the inclusion and non-inclusion criteria and provide written informed consent.Participants will attend a total of 5 study visits: 1 preoperative visit, 1 surgery visit and 3 postoperative visits., conditionsModule conditions: Cataract, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignement, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative is perforemd by a blinded evaluator., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: intraocular lens implantation in cataract surgery, outcomesModule primaryOutcomes measure: Binocular Distance Corrected Intermediate Visual Acuity, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC), status: RECRUITING, city: Heidelberg, country: Germany, contacts name: Raquel Willrich Amroussi, role: CONTACT, phone: +49 6221 56-36849, email: raquel.willrichamroussi@med.uni-heidelberg.de, geoPoint lat: 49.40768, lon: 8.69079, hasResults: False
protocolSection identificationModule nctId: NCT06327295, orgStudyIdInfo id: ATB1651-102, briefTitle: A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2026-01-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: AmtixBio Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis, conditionsModule conditions: Onychomycosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: ATB1651-102- Cohort 1, interventions name: ATB1651-102- Cohort 2, interventions name: ATB1651-102- Cohort 3, interventions name: ATB1651-102- Cohort 4, interventions name: Placebo, outcomesModule primaryOutcomes measure: To evaluate the complete cure rate with topical ATB1651 3% and ATB1651 5% in participants with mild to moderate onychomycosis., secondaryOutcomes measure: To further evaluate the efficacy of topical ATB1651 3% and topical ATB1651 5% in participants with mild to moderate onychomycosis., secondaryOutcomes measure: To assess and collect the percentage and severity of adverse events (AEs)., secondaryOutcomes measure: Maximum plasma concentration (Cmax), secondaryOutcomes measure: Time to maximum plasma concentration (Tmax), secondaryOutcomes measure: Apparent terminal elimination rate constant (λz), secondaryOutcomes measure: Area under curve (AUC), secondaryOutcomes measure: Apparent terminal half-life (t 1/2), secondaryOutcomes measure: Apparent clearance (CL), secondaryOutcomes measure: Apparent terminal volume of distribution (VD), secondaryOutcomes measure: Plasma ATB1651 trough concentrations (Ctrough), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: New Zealand Clinical Research Christchurch, city: Christchurch, zip: 8011, country: New Zealand, contacts name: Corey Sellwood, Dr, role: CONTACT, phone: +64 800 862 278, contacts name: Corey Sellwood, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -43.53333, lon: 172.63333, hasResults: False
protocolSection identificationModule nctId: NCT06327282, orgStudyIdInfo id: ChinaPLAGHPAIN, briefTitle: the Effect of Preoperative Pain Education by Anesthesia Nurses on Postoperative Pain Among Adult Patients Undergoing Abdominal Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-04-04, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Chinese PLA General Hospital, class: OTHER, descriptionModule briefSummary: To explore the effects of preoperative pain education on postoperative pain among patients undergoing abdominal surgery., conditionsModule conditions: Postoperative Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 116, type: ESTIMATED, armsInterventionsModule interventions name: education on pain and related knowledge, outcomesModule primaryOutcomes measure: Occurrence of pain, secondaryOutcomes measure: Mastery of the use of patient-controlled analgesia pump, otherOutcomes measure: Patient satisfaction with postoperative analgesia, otherOutcomes measure: Adverse events of patients using analgesic pump were recorded, otherOutcomes measure: The number of times that the analgesic pump was pressed during each 24h and the amount of analgesic pump remaining at this time were recorded, otherOutcomes measure: The use of rescue analgesics after surgery, otherOutcomes measure: The postoperative sleep status of patients was evaluated, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06327269, orgStudyIdInfo id: MOHW111-TDU-B-221-114009, briefTitle: Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, collaborators name: Ministry of Health and Welfare, Taiwan, descriptionModule briefSummary: The challenge of LDLT to HCC is that tumors with a high risk of recurrence have a high rate of recurrence after liver transplantation, and there is no appropriate treatment to prevent HCC recurrence after transplantation in these patients. Using the advance proton therapy or yttrium 90 as a more aggressive down-staging therapy may contribute to change tumor behavior. It can be used to get a better treatment response and tumor necrosis before LDLT. As a result, it will improve recurrence-free survival and overall survival rate, especially in high-risk groups. In addition, lenvatinib is approved for using in patients with advanced liver cancer because its overall survival rate is not less than sorafenib in clinical trials. A new generation of targeted therapies will be applied to adjuvant therapy after LDLT., conditionsModule conditions: High Risk of Recurrence, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Lenvatinib 10 mg, outcomesModule primaryOutcomes measure: Recurrence-free survival with adjuvant therapy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Surgery, status: RECRUITING, city: Kaohsiung, zip: 833, country: Taiwan, contacts name: Chih-Che Lin, Ph.D, role: CONTACT, phone: +88677317123, phoneExt: 8880, email: chihchelin@cgmh.org.tw, contacts name: I-Hsuan Chen, Ph.D, role: CONTACT, phone: +88677317123, phoneExt: 8582, email: ann0401@cgmh.org.tw, geoPoint lat: 22.61626, lon: 120.31333, hasResults: False
protocolSection identificationModule nctId: NCT06327217, orgStudyIdInfo id: OC-2023-009, briefTitle: Long Term Results After Hip Arthroscopy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Reinier Haga Orthopedisch Centrum, class: OTHER, descriptionModule briefSummary: A common cause of hip joint pain in the young and active population is femoroacetabular impingement (FAI) syndrome. if FAI is left untreated, the changed morphology will have a negative effect on the existing joint and will contribute to the development of osteoarthritis (OA). Hip arthroscopy is the first choice of operative treatment for FAI. While hip arthroscopy improves the patient reported outcome measures (PROMs), the influence of this treatment on the contribution to the development of osteoarthritis after FAI is to the best of our knowledge still unknown., conditionsModule conditions: Femoro Acetabular Impingement, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 451, type: ESTIMATED, armsInterventionsModule interventions name: Bilateral hip x-ray, interventions name: Questionnaires, outcomesModule primaryOutcomes measure: To evaluate the degree of osteoarthritis 5 to 10 years after a hip arthroscopy in comparison with the non-operative side., secondaryOutcomes measure: To evaluate the change in degree of osteoarthritis at 5 to 10 years after a hip arthroscopy in comparison with preoperative/perioperative., secondaryOutcomes measure: To report incidence of total hip replacement within 5 to 10 years after a hip arthroscopy., secondaryOutcomes measure: To determine the functional outcome of patients and, to determine what factors contribute to a good functional outcome 5/10 years after hip arthroscopy., secondaryOutcomes measure: To determine the inter-rater and intra-rater agreement of the Kellgren and Lawrence OA score., secondaryOutcomes measure: To determine patient satisfaction 5-10 years after hip arthroscopy., eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Reinier Haga Orthopedic Center, city: Zoetermeer, zip: 2725 NA, country: Netherlands, geoPoint lat: 52.0575, lon: 4.49306, hasResults: False
protocolSection identificationModule nctId: NCT06327204, orgStudyIdInfo id: Low Level laser 24, briefTitle: Efficacy of Different Low Level Laser Therapy Sessions, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2023-10-01, completionDateStruct date: 2023-12-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: October 6 University, class: OTHER, descriptionModule briefSummary: Myofascial pain dysfunction syndrome is one of the common causes of non-odontogenic pain in the head and neck region. It accounts for 40-60% of the adult population. Different treatment modalities had been reported to release the trigger point within the muscles of mastication in order to reduce pain and allow recovery of the function., conditionsModule conditions: Myofascial Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: 940-nm diode laser / one session, interventions name: 940-nm diode laser / two session, interventions name: 940-nm diode laser/ three session, outcomesModule primaryOutcomes measure: pain score, secondaryOutcomes measure: maximum mouth opening, secondaryOutcomes measure: quality of life questioner, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, October 6 University, city: Cairo, zip: 21523, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06327191, orgStudyIdInfo id: 23-CRFG-21, secondaryIdInfos id: 23-CRFG-21, type: OTHER, domain: Clinical Research Facility Galway (CRFG) study number, briefTitle: EMERGE Mothers and Kids, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: National University of Ireland, Galway, Ireland, class: OTHER, descriptionModule briefSummary: The EMERGE Mothers and Kids study is a follow-up to the EMERGE trial of women with GDM (N=535) that aimed to determine the effect of the addition of metformin compared to placebo on insulin initiation rates, maternal weight gain and perinatal morbidity and mortality.The primary objectives of the EMERGE Mothers and Kids follow up study are:1. to determine whether treatment with metformin leads to a reduction in maternal disorders of glucose, metabolic syndrome, obesity, hypertension and lipids at up to 6 years post the index pregnancy;2. to examine the impact of metformin on maternal anxiety, depression, quality of life and breast feeding duration;3. to examine whether exposure to metformin leads to a reduction in obesity in the offspring at follow up;4. to determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds., conditionsModule conditions: Gestational Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 321, type: ESTIMATED, armsInterventionsModule interventions name: No intervention as the study is observational., outcomesModule primaryOutcomes measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of disorders of glucose metabolism at follow up.., primaryOutcomes measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of metabolic syndrome., primaryOutcomes measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces rates of OW and OB at follow up., primaryOutcomes measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of hypertension., primaryOutcomes measure: To examine the associations of GDM diagnosis, sum of fasting, 1-hour, and 2-hour glucose z-scores after 75-g load, insulin sensitivity, and lipid levels at 24-32 weeks' gestation with lipid levels 3-6 years postpartum., primaryOutcomes measure: To determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06327178, orgStudyIdInfo id: NFEC-2023-520, briefTitle: Abscopal Effects of Stereotactic Body Radiotherapy in Metastatic Clear Renal Cell Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-01-31, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: Prior research has indicated that stereotactic body radiotherapy (SBRT) can effectively trigger systemic anti-tumor immune response. The goal of this observational study is to learn about abscopal effects of stereotactic body radiotherapy in patients of metastatic clear renal cell carcinoma. The primary objective was to assess the objective response rate (ORR) and complete response (CR) in non-irradiated lesions, and incidence of adverse events (AEs)., conditionsModule conditions: Abscopal Effects of Stereotactic Body Radiotherapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, outcomesModule primaryOutcomes measure: Objective Response Rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanfang Hospital, Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510515, country: China, contacts name: Guozhu Xie, role: CONTACT, email: xieguozhu@126.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06327165, orgStudyIdInfo id: 1-2023-0072, briefTitle: Predictability of ANI (Analgesia Nociception Index) for Spinal Hypotension, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Yonsei University, class: OTHER, descriptionModule briefSummary: Spinal anesthesia is widely accepted as the anesthetic method of choice for Cesarean section. However, the incidence of spinal hypotension is 50-70%, and the decrease in blood pressure is often rapid and severe. Heart rate variability is influenced by various factors such as the sympathetic nervous system, parasympathetic nervous system, temperature regulation, baroreflex, and endocrine regulation, but high frequency heart rate variability above 0.15 Hz very specifically reflects the parasympathetic nervous system. The ANI monitor calculates heart rate variability mediated by changes in the parasympathetic nervous system. This study aims to determine whether ANI monitor can predict hypotension in patients undergoing a caesarean section under spinal anaesthesia while applying the preemptive vasopressor phenylephrine infusion protocol., conditionsModule conditions: Cesarean Section, conditions: Spinal Anesthesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: observation, outcomesModule primaryOutcomes measure: predictive value of ANI monitor for spinal hypotension during cesarean delivery, secondaryOutcomes measure: Optimal cutoff value of ANI level for predicting occurrence of hypotension, eligibilityModule sex: FEMALE, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yonsei University Health system, Severance Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Seung Hyun Kim, Associate Professor, role: CONTACT, phone: 82-2-2224-1055, email: anesshkim@yuhs.ac, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
protocolSection identificationModule nctId: NCT06327152, orgStudyIdInfo id: 2659, briefTitle: Caffeine Use in the Management of Preterm Infants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of California, Irvine, class: OTHER, descriptionModule briefSummary: This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster., conditionsModule conditions: Apnea of Prematurity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomized, double-blinded, placebo-controlled trial of 40 preterm infants born at less than or equal to 32 weeks and 0 days gestation. Infants will be randomized to receive either caffeine or placebo for up to maximum of additional four (4) weeks after meeting clinical criteria to come off caffeine., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Families, nurses, therapists, and doctors will be blinded. Only pharmacy will be unblinded and know which subjects are in each treatment arm., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Caffeine, interventions name: Sterile Water Placebo, outcomesModule primaryOutcomes measure: Time to full feeds, secondaryOutcomes measure: Time to discharge, secondaryOutcomes measure: Post menstrual age (PMA) at time of discharge, secondaryOutcomes measure: Number of significant cardiopulmonary events, secondaryOutcomes measure: Weight change, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 40 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: UC Irvine Medical Center, status: RECRUITING, city: Orange, state: California, zip: 92868, country: United States, contacts name: Cherry Uy, MD, role: CONTACT, phone: 714-456-6933, email: ccuy@hs.uci.edu, contacts name: Cherry Uy, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ernest Lai, MD, role: SUB_INVESTIGATOR, contacts name: Muhammad Aslam, MD, role: SUB_INVESTIGATOR, geoPoint lat: 33.78779, lon: -117.85311, hasResults: False