hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06262035, orgStudyIdInfo id: 2023-02987-01, briefTitle: Transcriptome, Proteome and Microbiome Profile in Periodontal and Peri-implant Diseases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, descriptionModule briefSummary: 1. To investigate the transcriptomic profile of periodontitis and peri-implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included to investigate the gene expression profile in tissue affected by periodontitis and peri-implantitis. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and the number of teeth. During surgical intervention, tissue biopsies (two specimens per site) will be collected by a periodontist from site with ongoing periodontitis and site from ongoing peri-implantitis.2. To study the microbiome and biomarker profile associated with periodontitis and peri- implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included in this study to determine the bacteria composition, cytokine profile and inflammatory biomarkers profile. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and number of teeth. Peri-implant crevicular fluid (PICF), gingival crevicular fluid (GCF), saliva and submucosal/subgingival plaque will be collected.The presence and composition of periodontal and peri-implant plaque samples are investigated., conditionsModule conditions: Peri-implantitis, conditions: Periodontitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Periodontitis and Peri-implantitis, outcomesModule primaryOutcomes measure: Protein levels in peri-implantitis and periodontitis, primaryOutcomes measure: Microbiome composition in peri-implantitis and periodontitis using 16S-rRNA sequencing method., primaryOutcomes measure: Gene expression profile in peri-implantitis and periodontitis., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06262022, orgStudyIdInfo id: KaramanogluMehmetbeyUFGok, briefTitle: The Effect of Cold Application on Pain Level, Edema and Drainage Amount, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Karamanoğlu Mehmetbey University, class: OTHER, collaborators name: Karaman Training and Research Hospital, descriptionModule briefSummary: In this study, we aimed to investigate the effect of cold application applied for 20 minutes every hour for 8 hours on the first day, second and third days after total hip arthroplasty with gel pads, on the pain level, edema and drainage amount of total hip arthroplasty patients. The main question\[s\]it aims to answer are:* Is there a difference between the pain levels of patients in the control and cold application arms?* Is there a difference between the knee edema of patients in the control and cold application arms?* Is there a difference between the amount of drainage of patients in the control and cold application arms? This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT)., conditionsModule conditions: Cold Therapy, conditions: Pain, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT)., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: cold therapy, outcomesModule primaryOutcomes measure: pain level, secondaryOutcomes measure: edema, secondaryOutcomes measure: amount of drainage, otherOutcomes measure: Analgesic consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karamanoğlu Mehmet bey Üniversitesi, status: RECRUITING, city: Merkez, state: Karaman, zip: 70100, country: Turkey, contacts name: fatma gök, role: CONTACT, phone: 05544906142, email: fatmagok123@gmail.com, hasResults: False
protocolSection identificationModule nctId: NCT06262009, orgStudyIdInfo id: APHP220101, secondaryIdInfos id: 2023-A02282-43, type: OTHER, domain: IDRCB, briefTitle: Dynamics of AMR Spread, Persistence and Evolution Between Humans, Animals and Their Environment, acronym: Dyaspeo, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Humans in contact with animals such as dog owners, may be at risk of antimicrobial resistance (AMR) acquisition. This is the central issue to be investigated in DYASPEO, conditionsModule conditions: Antibiotic Resistant Strain, conditions: Transmission, Close-Contact, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 525, type: ESTIMATED, armsInterventionsModule interventions name: human faecal collection, interventions name: ancillary study, outcomesModule primaryOutcomes measure: generation of a list of priorities for future prevention and control strategies to mitigate antimicrobial resistance (AMR) transmission between companion animals and humans, secondaryOutcomes measure: Rates of AMR acquisitions in one or several housekeepers, secondaryOutcomes measure: A list in nature of changes in dog microbiota, secondaryOutcomes measure: A list in magnitude of changes in dog microbiota, secondaryOutcomes measure: A list in nature of changes in housekeepers microbiota, secondaryOutcomes measure: A list in magnitude of changes in housekeepers microbiota, secondaryOutcomes measure: explore unknown parameters of AMR colonization in dogs under various antibiotic exposures, secondaryOutcomes measure: the generation of a list of sociological factors and potential at-risk practices relevant in the transmission of AMR from dogs to housekeepers, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the National Veterinary School Alfort, city: Maisons-Alfort, zip: 94700, country: France, contacts name: Jean-Yves Madec, PHD, role: CONTACT, phone: 06 85 08 93 30, phoneExt: +33, email: jean-yves.madec@anses.fr, geoPoint lat: 48.81171, lon: 2.43945, hasResults: False
protocolSection identificationModule nctId: NCT06261996, orgStudyIdInfo id: henanFSH, briefTitle: Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Henan Provincial People's Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the safety and efficacy of fospropofol and propofol during sedation in invasively mechanically ventilated patients in the Anesthesia Intensive Care Unit (AICU). Specific objectives include the following:* Evaluate the sedative effects of fospropofol and propofol in invasively mechanically ventilated patients. Compare the sedative effects of the two medications using relevant clinical indicators and scoring tools, such as the Richmond Agitation-Sedation Scale (RASS).* Compare the safety of fospropofol and propofol during sedation. Monitor medication-related adverse reactions, such as respiratory depression, hypotension, arrhythmias, headache, injection site pain, and assess the differences in adverse reaction incidence between the two medications.* Compare the characteristics of recovery from sedation between PPD and propofol. Focus on the time from sedation to emergence from sedation and compare the differences in recovery time between the two medications.Participants will be sedated with fospropofol or propofol during invasive mechanical ventilation., conditionsModule conditions: Invasive Mechanical Ventilation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Fospropofol, outcomesModule primaryOutcomes measure: The patient's Richmond Agitation-Sedation Scale (RASS) score and the incidence of adverse reactions, secondaryOutcomes measure: Incidence of adverse reactions during the follow-up period, secondaryOutcomes measure: Extubation time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06261983, orgStudyIdInfo id: 2019111032, briefTitle: Magnetic Localization of Sentinel Nodes in Squamous Cell Oral Carcinoma., acronym: SentiMag, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-10-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Hospital Donostia, class: OTHER, descriptionModule briefSummary: Sentinel node biopsy has been shown to be a viable alternative to elective neck dissection in the early stages of squamous cell oral carcinoma. The aim of this study was to describe the magnetic localization of sentinel nodes (SN) after peritumoral injection of superparamagnetic iron oxide (SPIO) for treating this type of tumor and to analyze the technique's diagnostic performance in 23 patients. The technique located SNs (with minimal complication) in 95.6 % (22/23) of the patients. Three relapses occurred, one in a patient who had shown negative in magnetic SN location and elective neck dissection. The diagnostic performance of magnetic localization achieved a sensitivity and negative predictive value of 0.80 y 0.94, respectively. Magnetic localization of SNs has been shown to be a reproducible technique that may offer a viable alternative to the conventional technique., conditionsModule conditions: Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Sentinel node biopsy guided by magnetic probe, outcomesModule primaryOutcomes measure: The diagnostic performance of SNB was analyzed in terms of sensitivity (S), specificity (Sp), negative and positive predictive value (NPV and PPV)., eligibilityModule sex: ALL, minimumAge: 29 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Josué Hernando Vázquez, status: RECRUITING, city: Donostia, state: Guipuzkoa, zip: 20011, country: Spain, contacts name: Josué Hernando, PhD, DDS, role: CONTACT, phone: 0034 675825482, email: josue.hernando@gmail.com, geoPoint lat: 43.31283, lon: -1.97499, hasResults: False
protocolSection identificationModule nctId: NCT06261970, orgStudyIdInfo id: 999002684, briefTitle: Increase First-time Mothers' Use of Postpartum Family Planning in Tanzania: The Connect Project, acronym: Connect TZ, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-22, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: George Washington University, class: OTHER, collaborators name: Save the Children, collaborators name: Save the Children International Tanzania, collaborators name: Bill and Melinda Gates Foundation, descriptionModule briefSummary: While a growing body of programs have shown promise to increase use of contraception among first time mothers (FTMs), difficulties remain in scaling beyond small pilot areas and institutionalizing within existing systems. Connect's approach aims to strengthen existing government health systems and community-level health efforts, including those supported through local and international non-governmental organizations, by developing and testing light-touch "enhancements" with the goal of increasing postpartum Family Planning (PPFP) adoption among FTMs. The investigators will evaluate Connect's approach through a cluster randomized control trial., conditionsModule conditions: Contraceptive Usage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 1134, type: ACTUAL, armsInterventionsModule interventions name: Connect, outcomesModule primaryOutcomes measure: Adoption of of Postpartum Family Planning (PPFP):, primaryOutcomes measure: Currently Using PPFP, secondaryOutcomes measure: Adopted or Intention to adopt PPFP, secondaryOutcomes measure: Average Satisfaction with PPFP methods, secondaryOutcomes measure: Contraceptive Preferences, secondaryOutcomes measure: Quality of Family Planning Counseling, secondaryOutcomes measure: Communication and Agency, secondaryOutcomes measure: PPFP Attitudes, secondaryOutcomes measure: PPFP Knowledge, eligibilityModule sex: FEMALE, minimumAge: 14 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: EDI, city: Bahi, state: Dodoma, country: Tanzania, geoPoint lat: -5.98304, lon: 35.3159, locations facility: EDI, city: Kongwa, state: Dodoma, country: Tanzania, geoPoint lat: -6.2, lon: 36.41667, hasResults: False
protocolSection identificationModule nctId: NCT06261944, orgStudyIdInfo id: NIRDM-SXCIP03, briefTitle: A Pivotal Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With Unknown Diabetes Status and Performance Evaluation of the Glyconics SW Package, acronym: ANODE03, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-08-08, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Glyconics Ltd, class: INDUSTRY, descriptionModule briefSummary: The main clinical study objective is to confirm the accuracy of the Glyconics-DS spectrometer when used in its intended medical purpose population, i.e., in individuals with unknown diabetes risk. Additionally, this investigation will serve as a pivotal performance evaluation for the associated software for correct delivery of the algorithm-based analysis of the individual diabetes risk. The study will be considered positive if the backend delivery of the chemometrics output is performed correctly as per the cloud-based analysis and its delivery represents the essential medical software to be evaluated in this investigation. The 'true' diabetes risk will be contrasted against values of an internal biomarker indicative of glycaemia, HbA1c, as measured based on standardised, certified methodology., conditionsModule conditions: Pre-diabetes, conditions: Undiagnosed Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Mass-screening, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 480, type: ESTIMATED, armsInterventionsModule interventions name: Near-infrared (NIR), outcomesModule primaryOutcomes measure: Dichotomised diabetes risk status, secondaryOutcomes measure: Sensitivity and specificity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sant Pau Hospital, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Didac Mauricio, MD, PhD, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
protocolSection identificationModule nctId: NCT06261931, orgStudyIdInfo id: 6313, briefTitle: Severity Over Time of Early Forms of Spondyloarthritis, acronym: STAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2044-02-28, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Spondyloarthritis (SpA) is a group of chronic inflammatory pathologies whose progression over time is poorly defined, and in particular the clinical and instrumental elements that can predispose to a condition of disease severity are not completely known. It would be important to have an idea of what the predisposing factors are, possibly already at baseline, and possibly also at follow up, of severe disease, so as to be able to act early with more aggressive and targeted therapies on these patients, so as to achieve remission., conditionsModule conditions: Spondyloarthritis, conditions: Spondyloarthritis, Axial, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 387, type: ESTIMATED, armsInterventionsModule interventions name: Diagnostic assessment, interventions name: Diagnostic assessment, outcomesModule primaryOutcomes measure: spondyloarthritis severity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, city: Roma, zip: 00168, country: Italy, contacts name: Maria Antonietta D'Agostino, role: CONTACT, phone: +390630155701, email: mariaantonietta.dagostino@policlinicogemelli.it, contacts name: Maria Antonietta D'Agostino, role: PRINCIPAL_INVESTIGATOR, contacts name: Augusta Ortolan, role: SUB_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
protocolSection identificationModule nctId: NCT06261918, orgStudyIdInfo id: 6269, briefTitle: Transcriptional and Epimetabolic Profile of Breast Carcinoma With Luminal or HER2+ or Locally Advanced Triple-negative Histotype in Patients With/Without Previous Clinical History of Metabolic Syndrome, acronym: PROMETA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2026-07-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: This prospective pilot study of biological specimens aims to identify new prognostic and predictive biomarkers of response to standard therapy for local advanced BC, as well as to identify new targets for the development of immuno- therapeutic protocols. First aim is therefore to expand our knowledge to increase the response to preoperative treatment, intensify treatment patterns, and select patients based on clinical parameters. In this regard, it appears imperative to investigate yet under-investigated factors that might impair the response to standard therapy for local advanced BC including association to metabolic syndrome and analysis of tumoral and stromal features supporting a tumor microenvironment impenetrable to both drugs and immune system cells., conditionsModule conditions: Breast Cancer, conditions: Metabolic Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Influence of metabolic syndrome on the achievement of pathological complete response, outcomesModule primaryOutcomes measure: Acheivement of pathological complete response, secondaryOutcomes measure: Event-free survival (EFS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli - IRCCS, status: RECRUITING, city: Roma, country: Italy, contacts name: Alessandra Fabi, role: CONTACT, phone: 0630153773, email: alessandra.fabi@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False