hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06273358, orgStudyIdInfo id: Study Sleep Quality, briefTitle: Preoperative Sleep Quality and Postoperative Delirium, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2023-12-18, completionDateStruct date: 2024-01-27, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Konya City Hospital, class: OTHER, descriptionModule briefSummary: Background: Delirium is a neurocognitive illness that has lately been connected to sleep difficulties. It is a stressful condition. is still not fully understood. A poor sleep burden and its progress were investigated in this study to determine their correlations with the risk of delirium following surgical procedures.Methods: Between August 1st and December 5th, 2023, 124 patients undergoing non-cardiac general anesthesia (mean age 63.68 ± 8.81 years \[SD\]; range 46-82 years) reported on their sleep characteristics. PSQI, 1- sleep duration, 2- sleep disturbance, 3- sleep latency, 4- daytime dysfunction resulting from sleepiness, 5- sleep efficiency, 6- overall sleep quality, and 7- usage of sleep medications were among these sleep characteristics. Seven component scores, ranging from 0 (no difficulty) to 3 (extreme difficulty), are obtained while assessing the PSQI. The global score ranges from 0 to 21 and is calculated by adding the component scores. Higher scores indicate poorer sleep quality. A three-day median follow-up time was used to analyze hospitalization records to gather data on new-onset delirium (n = 26). Approximately 124 people on average, with a mean., conditionsModule conditions: PREOPERATIVE SLEEP QUALITY ON POSTOPERATIVE DELIRIUM, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Sleep quality and delirium index, secondaryOutcomes measure: Preop. and postop. sleep quality index, otherOutcomes measure: Sleep quality and QR 15 score, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yasin Tire, city: Konya, state: Meram, zip: 42140, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
protocolSection identificationModule nctId: NCT06273332, orgStudyIdInfo id: AI surgery protocol, briefTitle: Assessment of the Artifical Intelligence Assisted Registration Versus Conventional Point Based Registration on Cone Beam-computed Tomography (CBCT) With Heavy Metal Artifacts, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2024-01-20, completionDateStruct date: 2024-02-25, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Our study investigates the accuracy and duration needed for 3D model registration using artifical intelligence (AI) assistance compared to conventional point-based registration. Manual segmentation of all cone beam computed tomography (CBCT) scans will be performed before the registration procedure., conditionsModule conditions: Registration Accuracy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: AI-assisted registration, interventions name: Point-based registration, outcomesModule primaryOutcomes measure: Registration accuracy, secondaryOutcomes measure: Duration for registration, eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Private maxillofacial digital lab, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06273319, orgStudyIdInfo id: 010656, briefTitle: The Effect of Oxygen Application With Double Nasal Cannula on Respiratory Complications, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: To compare desaturation and respiratory complications by applying oxygen therapy with double nasal cannula to patients who are planned to undergo gastrointestinal endoscopy., conditionsModule conditions: Gastric Disease, conditions: Gastric Distress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: 2, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: OXYGEN THERAPY, outcomesModule primaryOutcomes measure: Determination of the amount of oxygen to prevent the peripheral oxygen saturation of the patients from falling below 95%, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Inonu universitesi, city: Malatya, zip: 44050, country: Turkey, geoPoint lat: 38.35018, lon: 38.31667, hasResults: False
protocolSection identificationModule nctId: NCT06273306, orgStudyIdInfo id: HULP.PI-4519, secondaryIdInfos id: PI22/00777, type: OTHER_GRANT, domain: Fondo de investigaciones sanitarias.Instituto de Salud Carlos III, briefTitle: Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC), acronym: IMIDOC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Instituto de Investigación Hospital Universitario La Paz, class: OTHER, descriptionModule briefSummary: The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up.This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and Spondylarthritis (SpA) from five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App., conditionsModule conditions: Telemedicine, conditions: Telehealth, conditions: eHealth, conditions: Rheumatic Diseases, conditions: Arthritis, Rheumatoid, conditions: Spondylarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: IMIDOC, outcomesModule primaryOutcomes measure: To assess the primary objective, composite endpoints that consider the viability, adherence and degree of satisfaction of the MAM are included, secondaryOutcomes measure: To identify features associated with adherence to follow-up through the MAM., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06273280, orgStudyIdInfo id: Z-2023025, briefTitle: Renal-based Optimization of QUADruple Therapy in Patients With Heart Failure With Reduced Ejection Fraction., acronym: ReQUAD-HF, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Ziekenhuis Oost-Limburg, class: OTHER, collaborators name: King Baudouin Foundation, descriptionModule briefSummary: The goal of this clinical trial is to evaluate guideline-directed medical therapy (GDMT) up-titration in patients with heart failure with reduced ejection fraction.The main question it aims to answer is the improvement in prescription rate and dose uptitration of quadruple GDMT in patients with HFrEF, assessed by a weighed composite score.Participants will be randomized towards control (standard of care, SOC) or intervention group.Researchers will compare SOC with protocol-based up-titration to see if the protocolized optimization improves prescription rate of GDMT., conditionsModule conditions: Heart Failure, conditions: Heart Failure With Reduced Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a prospective, randomized-controlled trial. Due to the design, the study is open-label, but the endpoint assessment is blinded., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Due to the study design, the study is open-label. In order to reduce bias, a study nurse (blinded for allocation arm) will see or call the patient to register the heart failure medication and dose of loop diuretics at three months and optionally 12months (open-label, endpoint-blinded)., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 345, type: ESTIMATED, armsInterventionsModule interventions name: SOC, interventions name: Protocolized up-titration, outcomesModule primaryOutcomes measure: Weighed composite score of maximal guideline-directed medical therapy, secondaryOutcomes measure: All-cause mortality and heart failure hospitalizations, secondaryOutcomes measure: Change in NTproBNP, secondaryOutcomes measure: Change in renal function, otherOutcomes measure: All-cause mortality, otherOutcomes measure: Number of patients with heart failure hospitalizations, otherOutcomes measure: Change in prescription rate per GDMT class, otherOutcomes measure: Incidence of predefined safety endpoints, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ziekenhuis Oost-Limburg AV, city: Genk, state: Limburg, zip: 3600, country: Belgium, geoPoint lat: 50.965, lon: 5.50082, hasResults: False
protocolSection identificationModule nctId: NCT06273267, orgStudyIdInfo id: APHP231232, briefTitle: Initiating Pediatric Palliative Care in ACT Group 4, acronym: StartSPP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Due to the wide range of diagnoses encountered in pediatric palliative care, the Association for Children's Palliative Care (ACT) and the Royal College of Paediatrics and Child Health (RCPCH) have developed a classification of life-limiting illnesses, based on support models.This classification includes four groups. ACT 4 category is made up of children with a serious incurable non-progressive neurological disease (for example: anoxic ischemia, cerebral palsy, traumatic or infectious brain injuries).Although data relating to specific ACT groups are scarce, experience from clinical practice suggests that the needs and use of Pediatric palliative care resources are different across the four categories.The specific history of ACT-4 patients suggests that pediatric palliative care may be required early on in the history of the disease but effective intervention varies greatly from one patient to another. Tthis study aims to better understand the optimal timing for introducing a PPC team into the care pathway for these children. The study also aims to describe the care trajectory over the first year of PPC intervention., conditionsModule conditions: Encephalopathy, conditions: Cerebral Palsy, conditions: Cerebral Malformation, conditions: Traumatic Head Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Collection of data from the patient's medical file, outcomesModule primaryOutcomes measure: Description of first pediatric palliative care intervention, secondaryOutcomes measure: Description of the patient situation, secondaryOutcomes measure: Timing of pediatric palliative care intervention, eligibilityModule sex: ALL, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hôpital Necker-Enfants Malades, city: Paris, zip: 75015, country: France, contacts name: Ashley RIDLEY, M.D., role: CONTACT, phone: 1 42 19 27 28, phoneExt: +33, email: ashley.ridley@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
protocolSection identificationModule nctId: NCT06273254, orgStudyIdInfo id: SCVL-TFZ-1009, briefTitle: A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Viatris Inc., class: INDUSTRY, descriptionModule briefSummary: Primary objective is to is to evaluate the bioequivalence of two formulations, conditionsModule conditions: Bioequivalence Study, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Sacubitril and Valsartan Tablets 49mg/51mg, interventions name: Entresto® (Sacubitril and Valsartan Tablets 49mg/51mg), outcomesModule primaryOutcomes measure: Cmax, primaryOutcomes measure: AUC, secondaryOutcomes measure: tmax, secondaryOutcomes measure: t1/2, secondaryOutcomes measure: λz, secondaryOutcomes measure: AUC0-t/AUC0-∞, secondaryOutcomes measure: residual area, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Medica Innova Co Ltd, city: Bangkok, zip: 10310, country: Thailand, contacts name: Ariya Khunvichai, Ph.D, role: CONTACT, phone: 666 2428 7178, email: ariya@medicainnova.com, contacts name: Suvimol Niyomnaitham, Assist. Prof., M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
protocolSection identificationModule nctId: NCT06273215, orgStudyIdInfo id: DCTC-IIR202217, briefTitle: Evaluation of the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Diabetic Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-05, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: 1.To explore the functional changes of P-gp, CYP3A4, OATP1B and BCRP in Diabetic patients (including the non-obese T2DM, obese T2DM, elderly T2DM, and T1DM)., conditionsModule conditions: Diabetes, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: The combinations of 10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin were administered to diabetic patients on an empty stomach., outcomesModule primaryOutcomes measure: Pharmacokinetics of study drug, secondaryOutcomes measure: Concentration of endogenous markers of CYP3A and OATP, secondaryOutcomes measure: Genotype of OATP and BCRP, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100191, country: China, contacts name: Yafen Li, role: CONTACT, phone: 18222566785, email: liyafen314159@163.com, contacts name: Dongyang Liu, role: PRINCIPAL_INVESTIGATOR, contacts name: Tianpei Hong, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06273189, orgStudyIdInfo id: 2017/558, briefTitle: Ultrasonic Bone Scalpel in BSSO, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-12-15, primaryCompletionDateStruct date: 2020-12-15, completionDateStruct date: 2021-12-15, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: The conventional saw compared with the piezo surgery in BSSO to evaluate cutting time, surgery duration, amount of bleeding. The purpose of this study was to answers following clinical questions: Is ultrasonic bonescalpel effective osteotomy like conventional bur in BSSO? and 2) Does it reduce operative parameter like bleeding, duration, lingual split pattern? 3) Does it reduce postoperative morbidity after BSSO., conditionsModule conditions: Maxillofacial Abnormalities, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: double blind, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Conventional, interventions name: Bone Scalpel, outcomesModule primaryOutcomes measure: Cutting Time, primaryOutcomes measure: neurosensory disturbance, secondaryOutcomes measure: The length of the procedure, secondaryOutcomes measure: The splitting time, secondaryOutcomes measure: The pattern of the split, secondaryOutcomes measure: postoperative edema, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Selin Çelebi, city: Kayseri, state: Melikgazi, zip: 38039, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False
protocolSection identificationModule nctId: NCT06273137, orgStudyIdInfo id: 2963, briefTitle: Positive Affect Treatment for Adolescents With Early Life Adversity, acronym: PAT4ELA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-03, primaryCompletionDateStruct date: 2026-02-16, completionDateStruct date: 2026-10-16, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of California, Irvine, class: OTHER, descriptionModule briefSummary: Youth exposed to early life adversity (ELA) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. Youth exposed to ELA consistently report symptoms of anhedonia as well as dysregulated positive affect. The present project will test the efficacy of PAT in a sample of ELA-exposed adolescents in order to determine whether PAT increases positive affect, and subsequently symptoms of depression. For this pilot, the investigators will recruit 22 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or a waitlist control condition. At study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia). The results of this study will be used to inform whether PAT has the potential to prevent major depressive episodes among adversity-exposed youth., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants will be randomized 1:1 to either receive PAT upon enrollment or after a waitlist period., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Positive affect treatment, outcomesModule primaryOutcomes measure: Positive affect, secondaryOutcomes measure: depressive symptoms - total, secondaryOutcomes measure: depressive symptoms - anhedonia subscale, secondaryOutcomes measure: Systemic inflammation - C-reactive protein (CRP), secondaryOutcomes measure: Inflammatory gene expression, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of California Irvine, status: RECRUITING, city: Irvine, state: California, zip: 92617, country: United States, contacts name: Kate R Kuhlman, role: CONTACT, phone: 949-824-5574, email: krkuhl@uci.edu, geoPoint lat: 33.66946, lon: -117.82311, hasResults: False