hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06284668, orgStudyIdInfo id: GWang027, briefTitle: Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-07-10, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University General Hospital, class: OTHER, descriptionModule briefSummary: To explore and compare the effects of esketamine and remimazolam on postoperative sleep disturbance in patients undergoing oocyte retrieval, conditionsModule conditions: Sleep Disturbance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: normal Saline, interventions name: Esketamine, interventions name: Remimazolam, outcomesModule primaryOutcomes measure: The incidence of postoperative sleep disturbance on the first night after surgery, secondaryOutcomes measure: The incidence of sleep disturbance one day before surgery, secondaryOutcomes measure: The incidence of postoperative sleep disturbance on the second and third postoperative nights, secondaryOutcomes measure: Postoperative anxiety, secondaryOutcomes measure: Postoperative depression, secondaryOutcomes measure: Pain Score (NRS), secondaryOutcomes measure: Mean intraoperative blood pressure, secondaryOutcomes measure: Oxygen saturation, secondaryOutcomes measure: Somatokinetic reaction, secondaryOutcomes measure: Operation time, secondaryOutcomes measure: Duration of anesthesia, secondaryOutcomes measure: Time to walking down, secondaryOutcomes measure: Adverse event, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Tianjin Medical University General Hospital, status: RECRUITING, city: Tianjin, zip: 300052, country: China, contacts name: Guolin Wang, role: CONTACT, phone: +8618604755166, email: wangguolinghad@hotmail.com, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
protocolSection identificationModule nctId: NCT06284616, orgStudyIdInfo id: K2019-0392, briefTitle: JASP-1 for Children Recently Diagnosed and Their Parents, acronym: JASP-1, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-08-15, primaryCompletionDateStruct date: 2023-04-15, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Region Stockholm, class: OTHER_GOV, descriptionModule briefSummary: To implement and evaluate a patient-and family-centered Juvenile Arthritis Support Program during one year (JASP-1) for children recently diagnosed with JIA and their parents and after 12 months compare satistaction with care and health outcomes with a control group receiving standard care., conditionsModule conditions: JIA, conditions: Support Program, conditions: Patient Satisfaction, conditions: Patient Outcome Assessment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is a non-randomized intervention study with 2 groups receiving either a Support program (JASP-1) or standard care, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: All patient receiving a JIA diagnose was offered to participate in JASP-1. The controls had received diagnose before the start of the study., enrollmentInfo count: 82, type: ACTUAL, armsInterventionsModule interventions name: JASP-1, outcomesModule primaryOutcomes measure: Rate of Patient Reported Experienced Measures (PREM), secondaryOutcomes measure: Rate of Overall perceived health, secondaryOutcomes measure: Rate of Child Health Activity Questionnaire (CHAQ), secondaryOutcomes measure: Number of active joints, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Astrid Lindgren Children´s Hospital, city: Stockholm, state: Region Stockholm, zip: 17176, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
protocolSection identificationModule nctId: NCT06284603, orgStudyIdInfo id: AWF_LA_HBOT, briefTitle: Effectiveness of Hyperbaric Oxygen Therapy in Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2023-12-20, completionDateStruct date: 2023-12-20, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Poznan University of Physical Education, class: OTHER, descriptionModule briefSummary: The goal of this controlled, experimental study is to learn about the effects of 10 sessions of hyperbaric oxygen therapy on physical performance, vascular circulation, biochemical parameters, and composition of the intestinal microbiota in young healthy men depending on the frequency of single treatments.The main questions it aims to answer are:1. Do 10 treatments of hyperbaric oxygen therapy induce significant changes in physical performance levels, vascular circulation, and concentrations of biochemical parameters in young, healthy men?2. Does the body's response to 10 treatments of hyperbaric oxygen therapy differ depending on the frequency of treatments?3. Does a series of hyperbaric oxygen therapy treatments induce significant changes in the composition of the intestinal microbiota, metabolome, and functional status of the intestines?Participants are exposed to hyperoxia under hyperbaric conditions or form a control group with no treatment., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two study groups (dependent on frequency of HBOT treatments) and control group, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Hyperbaric Oxygen Therapy - HBOT, outcomesModule primaryOutcomes measure: Volume of oxygen and carbon dioxide, primaryOutcomes measure: Heart rate, primaryOutcomes measure: Vascular circulation measures, secondaryOutcomes measure: Body composition (body mass, fat mass, lean body mass, muscle mass), secondaryOutcomes measure: Inflammatory cytokine profile, secondaryOutcomes measure: Oxidative stress indicators, secondaryOutcomes measure: F2-Isoprostanes (F2-IsoP), secondaryOutcomes measure: Brain-derived neurotrophic factor concentration (BDNF), secondaryOutcomes measure: Nicotinamide (NAD) metabolites, secondaryOutcomes measure: Gut microbiome and metabolome, secondaryOutcomes measure: Indicators of intestinal inflammation (fecal calprotectin, claudin, occludin, zonulin, sIgA), secondaryOutcomes measure: endothelial nitric oxide synthase (eNOS), secondaryOutcomes measure: Vascular endothelial growth factor (VEGF), secondaryOutcomes measure: Hypoxia inducible factor-1 (HIF-1alfa), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Poznan University of Physical Education, city: Poznan, state: Wielkopolska, zip: 61-871, country: Poland, geoPoint lat: 52.40692, lon: 16.92993, hasResults: False
protocolSection identificationModule nctId: NCT06284577, orgStudyIdInfo id: 677186, briefTitle: Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Oslo University Hospital, class: OTHER, descriptionModule briefSummary: The aim of the present study is to investigate the effect of probiotic supplementation on GI related quality of life, through a randomised placebo-controlled clinical trial. Moreover, the invetigators wish to study CF microbiota and intestinal inflammation in the setting of probiotic supplementation and newly started treatment with a highly effective CF-specific treatment, elexacaftor-tezacaftor-ivacaftor (ETI). The proposed project has the potential to increase QoL and decrease GI morbidity in children with CF. If successful, the results of this study can contribute to alter the care of CF patients by including supplementation of probiotics in routine CF care. Morever, the study can provide much needed insights to GI microbiota and inflammation in pediatric CF patients., conditionsModule conditions: Cystic Fibrosis in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Multistrain Probiotic, interventions name: Placebo - maltodextrin, outcomesModule primaryOutcomes measure: Changes in GI related QoL using the questionnaire PedsQL GI, secondaryOutcomes measure: Changes in microbiota, secondaryOutcomes measure: Changes in intestinal inflammation, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Oslo University Hospital, status: RECRUITING, city: Oslo, country: Norway, contacts name: Magnhild P Kolsgaard, PhD, role: CONTACT, phone: 0047 41514045, email: uxpoma@ous-hf.no, contacts name: Camilla Styffe Sæland, Master, role: CONTACT, phone: 004793257798, email: casael@ous-hf.no, contacts name: Magnhild P Kolsgaard, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Camilla Styffe Sæland, Master, role: SUB_INVESTIGATOR, contacts name: Linh Dieu Ngo, Master, role: SUB_INVESTIGATOR, geoPoint lat: 59.91273, lon: 10.74609, hasResults: False
protocolSection identificationModule nctId: NCT06284564, orgStudyIdInfo id: 2023-0538, secondaryIdInfos id: NCI-2024-03604, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Bristol-Myers Squibb, collaborators name: Cancer Prevention Research Institute of Texas, collaborators name: United States Department of Defense, descriptionModule briefSummary: To learn if evolocumab and nivolumab can control metastatic and refractory renal cell carcinoma. The safety of this drug combination will also be studied., conditionsModule conditions: Metastatic Renal Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Evolocumab, interventions name: Nivolumab, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Eric Jonasch, MD, role: CONTACT, phone: 713-563-7232, email: ejonasch@mdanderson.org, contacts name: Eric Jonasch, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
protocolSection identificationModule nctId: NCT06284551, orgStudyIdInfo id: 202111069RINB, briefTitle: The Relationship Between Internet-use Behavior and Mental Health in Youth, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-02-08, primaryCompletionDateStruct date: 2024-02-15, completionDateStruct date: 2025-01-27, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: Introduction: WHO defines youth as 15-24 years age group. At this stage, the brain is still under development, with high impulsiveness, being fond of stimulation and yearning for peer life. Compared with traditional interpersonal interaction, modern youths use the Internet as a main interpersonal interaction platform and conduct lots of leisure activities on the Internet. Poor cognitive emotion regulation strategies and personal traits may extend to new types of mental health issues; and are associated with depression, anxiety, suicidal/self-injurious behaviors, and cyberbullying.Objectives: (1) To investigate whether emotion regulation strategies while facing stressful events are highly related to with cyberbullying, social media, and internet gaming disorder. (2) To investigate the relation between cyberbullying and depression, anxiety, suicide/self-injury among Taiwanese youths. (3) To investigate the probability of cyberbullying, social media addiction, and internet gaming disorder occurring at the same time.Method: This cross-sectional study recruits cases of youths from 15 to 24 years old and collects data through questionnaires survey. In addition to collection of basic data, Internet using habits, and medical history, self-rated questionnaires include Suicide/Self-Injury Ideation Questionnaire, The Beck Depression Inventory 2nd Edition, Multidimensional Anxiety Scale for Children-Taiwan version, Cognitive Emotion Regulation Questionnaire, Cyberbullying Questionnaire, and Internet Gaming Disorder Scale-Short Form., conditionsModule conditions: Mental Health Issue, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Cyberbullying Questionnaire, secondaryOutcomes measure: Beck's Depression Inventory (BDI-II), eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: National Taiwan University Hospital, city: Taipei, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
protocolSection identificationModule nctId: NCT06284538, orgStudyIdInfo id: NA-01-23, briefTitle: Study to Evaluate the Effectiveness of a Medical Device Based on Hyaluronic Acid in Wounds, acronym: WOUND-H, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Nova Argentia S.r.l., class: INDUSTRY, descriptionModule briefSummary: The primary objective of the study is to evaluate the safety and performance of a Class IIB medical device based on linear hyaluronic acid used in the treatment of post-surgical wounds. The outcomes of the study are the improvement of wound healing assessed through the Clinical Healing score (score from 0 to 5), which includes the evaluation of: redness, edema, suppuration, healthy granulation tissue and signs of re-epithelialization; the percentage of patients with completely healed wounds at day 30 post-treatment; the pain perceived by the patient when changing the dressing; the frequency of adverse events., conditionsModule conditions: Wound Healing Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: NOVA.EMOSTOP RE-EPITHELIZING, outcomesModule primaryOutcomes measure: improvement in Clinical Healing score at visit 3, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Casa di cura riabilitativa Villa Sofia, status: RECRUITING, city: Acireale, state: Catania, zip: 95024, country: Italy, contacts name: Marco Daniele, PI, role: CONTACT, phone: 0957631997, email: marcodaniele@email.it, contacts name: Salvatore Balsamo, role: SUB_INVESTIGATOR, geoPoint lat: 37.60886, lon: 15.16577, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-06-26, uploadDate: 2024-02-13T04:55, filename: Prot_SAP_000.pdf, size: 2091803, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-04-02, uploadDate: 2024-02-21T04:35, filename: ICF_001.pdf, size: 95177, hasResults: False
protocolSection identificationModule nctId: NCT06284525, orgStudyIdInfo id: 2137420, briefTitle: Ankle Assistance and Resistance in Older Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Northern Arizona University, class: OTHER, descriptionModule briefSummary: The goal of this research protocol is to improve mobility in older individuals through advances in wearable assistive devices by focusing on two specific aims. The first aim is to study if targeted ankle resistance gait training improves walking performance in older individuals. The second aim is to evaluate the potential of wearable assistance at the ankle, knee, and/or hip joints to increase walking performance in older individuals., conditionsModule conditions: Sarcopenia, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Ankle resistance and biofeedback, outcomesModule primaryOutcomes measure: 6MWT, primaryOutcomes measure: Metabolic power, primaryOutcomes measure: Plantar flexor strength, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 85 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northern Arizona University, status: RECRUITING, city: Flagstaff, state: Arizona, zip: 86011, country: United States, contacts name: Zach Lerner, PhD, role: CONTACT, phone: 928-523-1787, email: zachary.lerner@nau.edu, geoPoint lat: 35.19807, lon: -111.65127, hasResults: False
protocolSection identificationModule nctId: NCT06284512, orgStudyIdInfo id: Uveal Melanoma 1942/2022, briefTitle: Uveal Melanoma - Comparative Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Medical University of Vienna, class: OTHER, descriptionModule briefSummary: The progress of uveal melanoma is typically monitored with sonography by experienced onco-ophthalmologists. However, there is evidence that twodimensional measurements in color fundus photography match precisely with sonography measurements. This study aims to compare sonography and color fundus photography measurements in order to evaluate the feasibility of monitoring of uveal melanoma with color fundus photography., conditionsModule conditions: Uveal Melanoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Sonography, color fundus photography, outcomesModule primaryOutcomes measure: Largest Basal Diameter, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Vienna, Department of Ophthalmology and Optometry, status: RECRUITING, city: Vienna, zip: 1090, country: Austria, contacts name: Judith Kreminger, MD, role: CONTACT, phone: +4314040048470, email: judith.kreminger@meduniwien.ac.at, contacts name: Reinhard Told, MD, PhD, Priv.-Doz., role: CONTACT, phone: +434040079690, email: reinhard.told@meduniwien.ac.at, contacts name: Adrian Reumueller, MD, Priv.-Doz, role: SUB_INVESTIGATOR, contacts name: Roman Dunavölgyi, Assoc.-Prof. Priv.-Doz. Dr., role: SUB_INVESTIGATOR, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
protocolSection identificationModule nctId: NCT06284499, orgStudyIdInfo id: 26308819120, briefTitle: Effect of Different Fixed Lingual Retainers on Tooth Stability, statusModule overallStatus: WITHDRAWN, startDateStruct date: 2020-01-16, primaryCompletionDateStruct date: 2023-01-15, completionDateStruct date: 2023-10-13, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Mustafa Kemal University, class: OTHER, descriptionModule briefSummary: Objective: The aim of this study was to compare the effect of different fixed lingual retainers (LRs) on tooth stability after orthodontic treatment using a Periotest® device.Materials and methods: A total of 82 patients (43 females and 39 males; mean age = 18.61 ± 3.71 years) with no missing teeth in the lower inter-canine region were treated with fixed orthodontic mechanics. At the completion of the orthodontic treatment, each patient was fitted with either Ortho FlexTech (Reliance; Group I), dead soft 8-braided (Bond-A-Braid, Reliance; Group II), or 5-stranded (PentaOne, Masel; Group III) LR wire. A control group consisting of people with a healthy periodontal condition and no bone loss was included (Control; Group C). The mobility of the lower anterior teeth on the right and left sides was measured using a Periotest® device before (T0), immediately after (T1), and 10 months after (T2) the application of the LR. Statistical analyses were performed using one-way ANOVA followed by post hoc LSD, repeated ANOVA with Bonferroni post hoc test, and Pearson χ2 tests., conditionsModule conditions: Effect of Lingual Retainers on Tooth Stability, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 0, type: ACTUAL, armsInterventionsModule interventions name: measuring tooth stability after orthodontic treatment using a Periotest® device., outcomesModule primaryOutcomes measure: Assessment of tooth stability after orthodontic lingual retainer wire application using periotest device, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hatay Mustafa Kemal University, Faculty of Dentistry, city: Hatay, zip: 31060, country: Turkey, geoPoint lat: 38.40227, lon: 27.10486, hasResults: False