hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06278597, orgStudyIdInfo id: GLC02-22, briefTitle: Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-05, primaryCompletionDateStruct date: 2024-01-20, completionDateStruct date: 2025-01-24, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Fondazione G.B. Bietti, IRCCS, class: OTHER, descriptionModule briefSummary: The aim of the study is to evaluate an objective, non-invasive optical device able to quantify, without eye contact, the width of the irido-corneal angle and to better identify cases of narrow angle or angle closure that may be prevented with relatively simple treatments., conditionsModule conditions: Glaucoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: NACA Estimator, outcomesModule primaryOutcomes measure: Agreement between the automatic Narrow Anterior Chamber Angle Estimator grading of peripheral anterior chamber width with clinical grading as performed by Van Herick (VH) test at slit lamp, primaryOutcomes measure: Agreement between the automatic Narrow Anterior Chamber Angle Estimator grading of peripheral anterior chamber width with clinical grading as performed by gonioscopy., secondaryOutcomes measure: Reproducibility (intra-session) and repeatability (inter-session) of the peripheral anterior chamber width (PACW) evaluation by the Narrow Anterior Chamber Angle Estimator, secondaryOutcomes measure: Sensitivity and specificity of NACA Estimator grading of PACW in detecting primary angle closure suspects as classified by clinical gonioscopy., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Fondazione GB Bietti, status: RECRUITING, city: Roma, zip: 00184, country: Italy, contacts name: Carmela Carnevale, MD, role: CONTACT, phone: +390677052834, email: carmela.carnevale@fondazionebietti.it, contacts name: Francesco Oddone, PhD, role: CONTACT, phone: +390677052834, email: francesco.oddone@fondazionebietti.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
protocolSection identificationModule nctId: NCT06278584, orgStudyIdInfo id: 2020001-00, briefTitle: iLux Treatment for Meibomian Gland Dysfunction, acronym: MGD, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-10-15, primaryCompletionDateStruct date: 2021-02-01, completionDateStruct date: 2022-02-28, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Clínica de Oftalmología de Cali S.A, class: OTHER, descriptionModule briefSummary: Summary:Purpose: To compare the safety and efficacy of eyelid treatment with the ILux®-MGD Treatment System in one session versus five sessions of mechanical meibomian gland expression (MMGE) in patients with moderate to severe meibomian gland dysfunction (MGD).Methods: Prospective, randomized, open-label, controlled clinical trial comparing one session of the ILux® MGD Treatment System versus five sessions of MMGE in both eyes of 130 patients aged ≥18 years with OSDI scores ≥13, total MGS of 15 in the lower lid of each eye and NI-TBUT \&lt;10 s, who were randomized 1:1 to ILux® or MMGE., conditionsModule conditions: Meibomian Gland Dysfunction, conditions: Eyes Dry Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ACTUAL, armsInterventionsModule interventions name: iLUX Treatment System, outcomesModule primaryOutcomes measure: Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Non Invasive Tear break-up time (NI-TBUT) in seconds., primaryOutcomes measure: Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Meibomian gland scores (MGS)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clínica de Oftalmología de Cali S.A, city: Cali, state: Valle Del Cauca, zip: 760036, country: Colombia, geoPoint lat: 3.43722, lon: -76.5225, hasResults: False
protocolSection identificationModule nctId: NCT06278558, orgStudyIdInfo id: 2023-02-01, briefTitle: Psychological Factors Influencing Cancer Post-traumatic Growth, acronym: CEMA-P, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-10, primaryCompletionDateStruct date: 2026-11-10, completionDateStruct date: 2027-11-10, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier de Valenciennes, class: NETWORK, collaborators name: Ligue contre le cancer, France, collaborators name: Centre Oscar Lambret, collaborators name: Centre de Cancérologie Les Dentellières, collaborators name: Clinique Teissier, descriptionModule briefSummary: The study focuses on post-traumatic growth (positive changes linked to appreciation of life, personal strengths, social relationships...) in the context of different types of cancer and with a longitudinal approach to the care pathway. The aim of the study is to better understand whether psychological variables (emotional competence, psychological flexibility, psychological distress) and patients' care satisfaction, assessed at the start of the cancer treatment pathway, can influence their post-traumatic growth at the end of the chemotherapy protocol and 6 months later., conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 289, type: ESTIMATED, armsInterventionsModule interventions name: Interviews with a psychologist/psychiatrist, outcomesModule primaryOutcomes measure: Post-traumatic growth, primaryOutcomes measure: Post-traumatic growth, primaryOutcomes measure: Post-traumatic growth, secondaryOutcomes measure: Satisfaction of supportive care needs, secondaryOutcomes measure: Satisfaction of supportive care needs, secondaryOutcomes measure: Satisfaction of supportive care needs, secondaryOutcomes measure: Emotional competence, secondaryOutcomes measure: Emotional competence, secondaryOutcomes measure: Emotional competence, secondaryOutcomes measure: Anxiety and depression symptoms, secondaryOutcomes measure: Anxiety and depression symptoms, secondaryOutcomes measure: Anxiety and depression symptoms, secondaryOutcomes measure: Psychological flexibility, secondaryOutcomes measure: Psychological flexibility, secondaryOutcomes measure: Psychological flexibility, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier de Valenciennes, status: RECRUITING, city: Valenciennes, zip: 59300, country: France, contacts name: FODIL Hanane, role: CONTACT, phone: 0327140665, email: fodil-h@ch-valenciennes.fr, contacts name: Anne Sophie Baudry, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.35, lon: 3.53333, hasResults: False
protocolSection identificationModule nctId: NCT06278545, orgStudyIdInfo id: MANFREDI PHRCK 2022, briefTitle: Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma, acronym: FOLFORINOX SBA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2029-02, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire Dijon, class: OTHER, descriptionModule briefSummary: Randomized, non-comparative, open-label, multi-centre Phase II study to evaluate modified FOLFIRINOX and modified FOLFOX in the locally advenced or metastatic small bowel adenocarcinoma.The primary objective is to assess the percentage of patients alive without prograssion at 8 months., conditionsModule conditions: Locally Advanced or Metastatic Small Bowel Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: modified FOLFORINOX, interventions name: Modified FOLFOX, outcomesModule primaryOutcomes measure: Assess the percentage of patients alive without progression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu Dijon Bourgogne, status: RECRUITING, city: Dijon, zip: 21000, country: France, contacts name: Sylvain MANFREDI, role: CONTACT, phone: +33 03 80 29 37 50, email: sylvain.manfredi@chu-dijon.fr, geoPoint lat: 47.31667, lon: 5.01667, hasResults: False
protocolSection identificationModule nctId: NCT06278506, orgStudyIdInfo id: 4612, briefTitle: Resection or Ablation of Small Kidney Tumors, acronym: RESTART, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2037-12, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Karolinska University Hospital, class: OTHER, descriptionModule briefSummary: Ablative treatments are believed to have a lower rate of complications, shorter hospital stays, and fewer interventions with benign PAD compared to partial nephrectomies in small kidney cancer lesions. The purpose of the study is to compare complications, the frequency of residual tumors, impact on kidney function, differences in quality of life, and health economic factors in a randomised study. We will also compare the oncological outcomes, including survival and recurrence of kidney cancer., conditionsModule conditions: Kidney Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: RCT, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Ablation, interventions name: Surgery, outcomesModule primaryOutcomes measure: Number of participants with surgical complications according to Clavien-Dindo grade 2-5, primaryOutcomes measure: Radiological signs of a residual tumor at the 6-month follow-up, primaryOutcomes measure: Number of postoperative hospitalization days (LOS), secondaryOutcomes measure: Cancer-specific survival (CSS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Change in eGFR one year after treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska University Hospital, status: RECRUITING, city: Stockholm, zip: 14186, country: Sweden, contacts name: Anders Kjellman, MD, PhD, role: CONTACT, phone: +46736995258, email: anders.kjellman@regionstockholm.se, contacts name: Per-Olof Lundgren, MD, PhD, role: CONTACT, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
protocolSection identificationModule nctId: NCT06278493, orgStudyIdInfo id: AL2846-I-0002, briefTitle: A Clinical Study of AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-08-23, primaryCompletionDateStruct date: 2021-10-25, completionDateStruct date: 2023-05-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a clinical study to observe the tolerance and primary efficacy of AL2846 capsules combined with Gemzar injection in patients with pancreatic cancer, and to determine the recommended dosage and administration method for subsequent clinical studies., conditionsModule conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: AL2846 capsules, interventions name: Gemzar, outcomesModule primaryOutcomes measure: Dose limiting toxicity (DLT), primaryOutcomes measure: Maximum tolerated dose (MTD), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Medical University Cancer Hospital, city: Tianjin, state: Tianjin, zip: 300181, country: China, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
protocolSection identificationModule nctId: NCT06278480, orgStudyIdInfo id: LNC-MECA-003, briefTitle: Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-06-23, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-02-29, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: L&C Bio, class: INDUSTRY, descriptionModule briefSummary: The MegaCarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent high tibial osteotomy(HTO) were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery., conditionsModule conditions: Osteoarthritis, Knee, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: MegaCarti®, interventions name: microfracture, outcomesModule primaryOutcomes measure: Comparison of the ICRS-Cartilage Repair Assessment grade-Overall repair assessment, primaryOutcomes measure: Comparison of macroscopic status of regenerated cartilage, secondaryOutcomes measure: Comparison of IKDC score, secondaryOutcomes measure: Comparison of VAS score, secondaryOutcomes measure: Comparison of KOOS score, secondaryOutcomes measure: Comparison of WOMAC score, secondaryOutcomes measure: Comparison of Kellgren-Lawrence grade, secondaryOutcomes measure: Comparison of HKA angle, Posterior Tibial slope, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yonsei University Health System, Gangnam Severance Hospital, city: Seoul, zip: 06273, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
protocolSection identificationModule nctId: NCT06278467, orgStudyIdInfo id: KonyaBeyhekimTRH2023, briefTitle: Frequency of Cognitive Dysfunction in Patients With Chronic Low Back Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2023-12-15, completionDateStruct date: 2024-02-12, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Konya Beyhekim Training and Research Hospital, class: OTHER_GOV, descriptionModule briefSummary: This study evaluates cognitive dysfunction status and related factors in patients with chronic low back pain over the age of 60., conditionsModule conditions: Cognitive Dysfunction, conditions: Low Back Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 107, type: ACTUAL, armsInterventionsModule interventions name: visual pain scale (VASpain/fatigue), Beck depression index (BDI),, interventions name: Pain catastrophizing scale, sleep quality with a single Likert type question in the Pittsburgh questionnaire, interventions name: Roland Morris Disability Questionnaire, quality of life with Short Form-36 ( SF-36),, interventions name: Montreal Cognitive Assessment Scale (MOCA); Standard Mini mental test (SMMT), outcomesModule primaryOutcomes measure: Montreal Cognitive Assessment Scale (MOCA), primaryOutcomes measure: Standard Mini mental test (SMMT), primaryOutcomes measure: Short Form-36 ( SF-36), primaryOutcomes measure: Beck depression scale (BDI), primaryOutcomes measure: Roland Morris Disability Questionnaire, primaryOutcomes measure: A single Likert type question in the Pittsburgh questionnaire (Sleep quality), primaryOutcomes measure: VAS pain and VAS fatigue, primaryOutcomes measure: Pain catastrophizing scale, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Konya Beyhekim Training and Research Hospital, city: Konya, state: Selçuklu, zip: 42060, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, locations facility: University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation, city: Konya, zip: 42060, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
protocolSection identificationModule nctId: NCT06278441, orgStudyIdInfo id: Zila Özlem KIRBAŞ, briefTitle: The Effect of White Noise and Kangaroo Care Practices on Stress Parameters in Newborns With Heel Lancing, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2024-02-10, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Karadeniz Technical University, class: OTHER, descriptionModule briefSummary: Aim: It is an examination of the effects of white noise and kangaroo care on some physiological parameters (pulse, saturation, crying duration) and stress markers (cortisol and glucose-regulated protein 78 (GRP78)) in heel lancing in newborns.Methods: In this parallel-group, randomized controlled study, healthy newborns with a gestational age of ≥37 weeks, birth weight of \>2500 g, and an Apgar score of ≥8 at the 1st minute and 5th minute were included. White noise and kangaroo care were applied to newborns in the intervention groups for heel lancing.Results: Ninety newborns were randomized into three groups (30 in each group). A statistically significant difference was determined between the median values of total crying time according to groups (p\<0.001). A statistically significant difference was determined between the median values of pulse measurements according to the interaction of group and time (p\<0.001). A statistically significant difference was determined between the median values of saturation measurements according to groups (p=0.001). A statistically significant difference was determined between the mean values of cortisol and GRP78 measurements according to the group and time interaction (p\<0.001).Conclusion: It was concluded that white noise and kangaroo care help reduce newborns' stress in the case of heel lancing., conditionsModule conditions: Healthy Newborns, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is parallel-group, randomized controlled., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Due to the nature of the intervention, blinding could not be done for the participants, and the two researchers who collected the data, but the statistician and two other researchers who analyzed the results were unaware of group allocation., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: Kangaroo care and White noise, outcomesModule primaryOutcomes measure: Ninety newborns were randomized into three groups (30 in each group)., eligibilityModule sex: ALL, minimumAge: 32 Hours, maximumAge: 72 Hours, stdAges: CHILD, contactsLocationsModule locations facility: Bayburt University, city: Bayburt, zip: 69100, country: Turkey, geoPoint lat: 40.25631, lon: 40.22289, hasResults: False
protocolSection identificationModule nctId: NCT06278428, orgStudyIdInfo id: DEE UMC, briefTitle: Genotype, Phenotype, and Disease Progression of Developmental Epileptic Encephalopathy With Onset Before 2 Years of Age, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2028-11-01, completionDateStruct date: 2028-11-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Number 2 Children's Hospital, Ho Chi Minh City, class: OTHER, descriptionModule briefSummary: According to estimates by the World Health Organization in 2019, more than 50 million people around the world have epilepsy. Nearly 80% of patients with epilepsy live in developing countries. Among them, children under 2 years old are the group with the highest incidence of epilepsy, and at the same time, the most dangerous epilepsy groups are also likely to start at these ages. World medical literature on epileptic encephalopathy and early-onset development before 2 years of age records that 71% of children have severe intellectual disability and 60% of children show signs of autism spectrum disorder, of which Children with epileptic and developmental encephalopathy due to genetic causes are at higher risk of developing neurodevelopmental disorders than children with epileptic and developmental encephalopathy due to other causes. However, in Vietnam, there is no research on this topic.The question is what are the phenotypes, genotypes, and progression after 2 years of follow-up of Vietnamese children with epileptic and developmental encephalopathy with onset before 2 years of age?, conditionsModule conditions: Epilepsy; Seizure, conditions: Child Development, conditions: Gene Abnormality, conditions: Early Onset Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Genotye of early-onset developmental epileptic encephalopathy, otherOutcomes measure: Phenotye of early-onset developmental epileptic encephalopathy, otherOutcomes measure: Progression of epileptic encephalopathy and early onset developmental epileptic encephalopathy, eligibilityModule sex: ALL, maximumAge: 23 Months, stdAges: CHILD, contactsLocationsModule locations facility: Children hospital number 2, status: RECRUITING, city: Ho Chi Minh, zip: 700000, country: Vietnam, contacts name: Thuy-Minh-Thu LT NGUYEN, MD, role: CONTACT, phone: +84983966371, email: dr.thu.nguyen.neurology@gmail.com, geoPoint lat: 10.82302, lon: 106.62965, hasResults: False