hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06370728, orgStudyIdInfo id: 18621, secondaryIdInfos id: J2A-MC-GZPJ, type: OTHER, domain: Eli Lilly and Company, briefTitle: A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-03, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-07-15, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to assess the effect of carbamazepine on the amount of orforglipron in the bloodstream and how long it takes the body to get rid of orforglipron when given orally in healthy study participants. The safety and tolerability of orforglipron and carbamazepine when given separately or together will also be evaluated. The study may last up to approximately 77 days for each participant., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Orforglipron, interventions name: Carbamazepine, outcomesModule primaryOutcomes measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-∞]) of Orforglipron, primaryOutcomes measure: PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron, primaryOutcomes measure: PK: Maximum Observed Concentration (Cmax) of Orforglipron, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ICON Early Phase Services, city: San Antonio, state: Texas, zip: 78209, country: United States, contacts role: CONTACT, phone: 210-255-5437, contacts name: Robert Bass, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False
protocolSection identificationModule nctId: NCT06370702, orgStudyIdInfo id: 23-054, briefTitle: Evaluating the Use of Grip Exercises to Decrease Deep Vein Thrombosis in Adult Patients With PICC Lines, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-06, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: TriHealth Inc., class: OTHER, descriptionModule briefSummary: Patients who have a peripherally-inserted central catheter (PICC) placed are at a risk of developing a deep vein thrombosis (DVT). At TriHealth, approximately 2-4 patients per month who have a PICC placed experience a subsequent DVT. One innovative way to possibly mitigate the risk of DVTs is hand grip exercises. The current study will be the first study to evaluate hand grip exercises for the prevention of DVTs in adult patients hospitalized in the United States., conditionsModule conditions: Deep Vein Thrombosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 2500, type: ESTIMATED, armsInterventionsModule interventions name: Handgrip Exercises, outcomesModule primaryOutcomes measure: Deep vein thrombosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Good Samaritan Hospital, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45220, country: United States, contacts name: Rachel Baker, PhD, RN, role: CONTACT, phone: 513-569-6191, email: Rachel_Baker2@trihealth.com, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Bethesda North Hospital, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45242, country: United States, contacts name: Rachel Baker, PhD, RN, role: CONTACT, phone: 513-569-6191, email: Rachel_Baker2@trihealth.com, geoPoint lat: 39.12713, lon: -84.51435, hasResults: False
protocolSection identificationModule nctId: NCT06370676, orgStudyIdInfo id: ESO-TIP, briefTitle: Accuracy of Core Body Temperature Measurement Depending on Oesophageal Probe Tip Location, acronym: ESO-TIP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-23, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Institute of Mountain Emergency Medicine, class: OTHER, descriptionModule briefSummary: Background An accurate measurement of the core body temperature (CBT) is of pivotal importance in the management of severely hypothermic patients. For instance, triage decisions for or against extracorporeal rewarming of hypothermic patients in cardiac arrest strongly depend on CBT. CBT measurement with an oesophageal probe is currently considered the gold standard in hypothermic patients with a secured airway in the prehospital setting, with the tip of the probe placed into the distal third of the oesophagus (i.e., posteriorly to the heart and distal to the tracheal bifurcation). However, the correct placement of the probe tip cannot be verified in the prehospital setting, and it is unknown how incorrect placement affects temperature readings.Hypothesis and aim The investigators hypothesise that an incorrect placement of the oesophageal temperature probe tip could lead to inaccurate measurements (i.e., temperature readings not reflecting the real CBT). Particularly, a tip location too high in the oesophagus in close proximity to the trachea could lead to falsely low temperature readings, especially when the patient is ventilated with cold air. The aim of the proposed study is to investigate the influence of oesophageal temperature probe tip location on CBT measurement.Methods Experimental, interventional study on 16 healthy volunteers. During the test oesophageal temperature is measured while participants are breathing ambient air first at 20°C (baseline) followed by cold (-20°C) ambient air in supine position for 20 minutes each test in an environmental simulator (terraXcube). Each participant repeats the 20-min test two times with the oesophageal temperature probe tip placed either in the lower third of the oesophagus (i.e., correct position) or too high in the oesophagus, i.e. behind the trachea., conditionsModule conditions: Emergencies, conditions: Hypothermia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: The participant is blinded for the location of the oesophageal temperature probe tip., whoMasked: PARTICIPANT, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Oesophageal temperature measurement, outcomesModule primaryOutcomes measure: Difference in core body temperature between the two tip positions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06370663, orgStudyIdInfo id: SDZLEC2023-109-01, briefTitle: First-line Treatment for Unresectable Locally Advanced Distal Cholangiocarcinoma Combining Radiotherapy and HAIC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Shandong Cancer Hospital and Institute, class: OTHER, descriptionModule briefSummary: The median survival of intrahepatic cholangiocarcinoma remains less than one year, highlighting the need for new treatments. Hepatic arterial infusion chemotherapy (HAIC), especially with fluoropyrimidine-based regimens, has shown promise in ICC treatment due to increased local drug concentration and reduced systemic toxicity. A combined approach of radiotherapy and HAIC with gemcitabine infusion may offer a hopeful strategy for locally advanced cholangiocarcinoma. However, clinical research on this combination is lacking as first-line therapy for unresectable ICC. Therefore, a single-center, single-arm study aims to assess this treatment approach's safety, efficacy, and molecular predictors. Improved HAIC delivery through modified percutaneous implantation provides a reliable pathway for effective treatment. In conclusion, exploring the synergistic effects of radiotherapy and HAIC in ICC could pave the way for more effective and personalized treatment strategies for this challenging cancer type., conditionsModule conditions: Intrahepatic Cholangiocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Combining radiotherapy with Hepatic Arterial Infusion Chemotherapy, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Radiotherapy, interventions name: HAIC (GEMOX), interventions name: Chemotherapy, outcomesModule primaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Progression-Free Survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jinbo Yue, status: RECRUITING, city: Jinan, state: Shandong, zip: 250000, country: China, contacts name: Jin Bo Yue, Doctor, role: CONTACT, phone: 0531-67626929, email: Len.Xu@hotmail.com, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
protocolSection identificationModule nctId: NCT06370650, orgStudyIdInfo id: soh-med-24-1-9, briefTitle: Effect of Platelet Rich Plasma on Outcome of Narrow Band UVB in Treatment of Vitiligo; Clinical and Histopathological Study, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-08, primaryCompletionDateStruct date: 2024-01-25, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: For each patient, one side of body will be treated with NB-UVB alone while the other side will be treated with NB-UVB therapy in addition to intradermal injection of PRP every 2 weeks. Patients will be photographed at the first visit, in the middle and at the end of therapy. Each patient will sign a written consent form to be included in the study and to be photographed., conditionsModule conditions: Management of Stable Vitiligo, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: platelet rich plasma, narrow band UVB, outcomesModule primaryOutcomes measure: Improvement of vitiligo, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Medicine, Sohag University, city: Sohag, zip: 82515, country: Egypt, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
protocolSection identificationModule nctId: NCT06370624, orgStudyIdInfo id: 2022/03OCT/360, briefTitle: PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment., acronym: PEDI-REAVASC, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-17, primaryCompletionDateStruct date: 2025-09-15, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain, class: OTHER, descriptionModule briefSummary: This study is a prospective, observational, single-center study to assess the correlation between rs-fMRI measures and clinical measures of standard MRI, NIRS, EEG and clinical scores.The target population was neonates with HIE referred to MRI after hypothermia treatment, which was initiated within 6 hours of birth, continued for 72 hours and followed by a slow rewarming period of 6-12 hours.A one-year clinical and imaging follow-up is planned. As the aim of the present study is to assess the predictiveness of the outcome one year after the HIE event, no follow-up is planned., conditionsModule conditions: Encephalopathy, Hypoxic-Ischemic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: One group will be followed - with both the standard of care continuous EEG monitoring and near infrared spectroscopy (NIRS) \& the MRI-scan performed at the same time., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: MRI-scan, outcomesModule primaryOutcomes measure: quantifying cerebrovascular reactivity (CVR) by resting-state functional MRI (r-fMRI) in infants with moderate to severe hypoxic-ischaemic encephalopathy (HIE), eligibilityModule sex: ALL, minimumAge: 1 Hour, maximumAge: 14 Months, stdAges: CHILD, contactsLocationsModule locations facility: Cliniques Universitaires Saint Luc, city: Brussels, zip: 1200, country: Belgium, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False
protocolSection identificationModule nctId: NCT06370598, orgStudyIdInfo id: TP-122, briefTitle: Phase 1/2a to Assess the Safety and Tolerability of TP-122A for the Treatment of Ventilator-Associated Pneumonia, acronym: RECOVER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Technophage, SA, class: INDUSTRY, collaborators name: VectorB2B, descriptionModule briefSummary: Given the challenges of treating complex cases of VAP caused by P. aeruginosa and K. pneumoniae, TechnoPhage developed a bacteriophage cocktail (TP-122) against those pathogens, aiming to provide a hospital-based add-on therapy to the SoC including antibiotic therapy, administered by nebulization. TP-122 is a bacteriophage cocktail divided in two different components: TP-122A is comprised of three bacteriophages against infections caused by Pseudomonas aeruginosa and TP-122B includes three bacteriophages against K. pneumoniae . For this study, an effective sample of 15 subjects will be randomly allocated into two arms, in a 3:2 ratio, with 9 subjects receiving TP-122A, in addition to SoC, and 6 subjects receiving the SoC alone., conditionsModule conditions: Pneumonia, Ventilator-Associated, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: TP-122A, outcomesModule primaryOutcomes measure: Evaluate safety and tolerability following nebulization of multiple doses of TP-122A, secondaryOutcomes measure: Proportion of subjects achieving "Clinical Cure" CR, secondaryOutcomes measure: Time to achieve "Clinical Cure" CR, secondaryOutcomes measure: Proportion of subjects achieving "Eradication" or "Presumed Eradication" MR of TP-122A target bacteria, secondaryOutcomes measure: Time to achieve "Eradication" or "Presumed Eradication" MR, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CH Nantes, city: Nantes, country: France, contacts name: Antoine Roquilly, MD, role: CONTACT, contacts name: Antoine Roquilly, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.21725, lon: -1.55336, hasResults: False
protocolSection identificationModule nctId: NCT06370585, orgStudyIdInfo id: SOPH229-0823/I, briefTitle: Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Laboratorios Sophia S.A de C.V., class: INDUSTRY, descriptionModule briefSummary: This is a phase I study evaluating safety and tolerability of PRO-229 ophthalmic solution through he incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), incidence of chemosis, and changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance (SICCA) Ocular Staining Score (OSS) scale compared to Lagricel® Ofteno PF in clinically healthy subjects., conditionsModule conditions: Dry Eye Disease, conditions: Ocular Surface Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase I, controlled, comparative, double-masked, single-center, randomized, controlled clinical trial., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: PRO-229, interventions name: Lagricel® Ofteno PF, outcomesModule primaryOutcomes measure: Incidence Unexpected Related Adverse Reactions, secondaryOutcomes measure: Changes in Best Corrected Visual Acuity (BCVA), secondaryOutcomes measure: Changes in ocular surface staining using SICCA ocular staining score scale, secondaryOutcomes measure: Incidence of chemosis, secondaryOutcomes measure: Incidence of grade 3 or 4 conjunctival hyperemia., secondaryOutcomes measure: Adherence to treatment (adherence), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06370572, orgStudyIdInfo id: CIRB23-1162, secondaryIdInfos id: U54AG063546, type: NIH, link: https://reporter.nih.gov/quickSearch/U54AG063546, briefTitle: Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, collaborators name: National Institute on Aging (NIA), collaborators name: University of North Carolina, Chapel Hill, descriptionModule briefSummary: The purpose of this study is to learn if the Pain in Advanced Dementia (PAINAD) scale can improve emergency pain care in persons living with dementia (PLWD). It is hypothesized that a PAINAD electronic health record (EHR) prompt that appears to emergency department (ED) staff will enable them to accurately assess pain levels and lead to better pain treatment for PLWD., conditionsModule conditions: Dementia, conditions: Hip Pain, conditions: Emergency Department Patient, conditions: Pain in Advanced Dementia Scale, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This is a interrupted time series intervention, which allows a pre- and post-intervention assessment of the effect of PAINAD scale., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1899, type: ESTIMATED, armsInterventionsModule interventions name: PAINAD EHR Prompt, outcomesModule primaryOutcomes measure: Percentage of eligible patients receiving a PAINAD assessment upon ED arrival, secondaryOutcomes measure: Change in time to administration of first analgesic medication, secondaryOutcomes measure: Change in pain score for patients receiving a repeat PAINAD assessment, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Chicago, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: Teresita M Hogan, MD, role: CONTACT, phone: 773-702-9500, contacts name: Teresita M Hogan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: University of North Carolina at Chapel Hill, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Michelle Meyer, PhD, MPH, CPH, role: CONTACT, phone: (919) 966-6442, contacts name: Michelle Meyer, PhD, MPH, CPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False
protocolSection identificationModule nctId: NCT06370559, orgStudyIdInfo id: 339042, briefTitle: Relationship Between Repetitive Negative Thinking and CBT Outcomes, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: South London and Maudsley NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the role of repetitive negative thinking (measured by the RTQ) in adult populations from an anxiety disorders and trauma clinic.The main questions it aims to answer are:* Whether the repetitive negative thinking can be used to predict i. initial symptom severity, and ii. therapy outcome (measured by change in scores on disorder specific measures).* Whether change in RTQ mediates change in outcome Participants are sent weekly questionnaires that measure their progress. Within these questionnaires are the RTQ and other disorder-specific measures that we will be analysing.Researchers may also compare clients with different disorders to see the accuracy the RTQ can predict treatment outcomes for each disorder., conditionsModule conditions: Anxiety Disorders, conditions: Obsessive-Compulsive Disorder, conditions: Post-traumatic Stress Disorder, conditions: Social Anxiety Disorder, conditions: Specific Phobia, conditions: Panic Disorder, conditions: Body Dysmorphic Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 320, type: ACTUAL, outcomesModule primaryOutcomes measure: Change in Repetitive Ruminative Thinking Questionnaire score, primaryOutcomes measure: Change in disorder-specific measure score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre for Anxiety Disorders and Trauma, city: London, zip: SE5 8AZ, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False