hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06382792, orgStudyIdInfo id: 2024PI059, briefTitle: Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: The gold standard after shoulder resection for tumors is reconstruction by reverse prosthesis and allograft. This is an intervention also performed for more frequent etiologies (revisions of prosthesis, non cancerous humeral bone loss ...).The results in these etiologies are good, and do not find any particular mechanical complications (including no osteolysis of the graft). In the case of reconstruction for cancer, the numbers of patients are lower (rare pathologies) and some studies on small numbers found osteolysis of the allograft. The aim of this study is to analyze the presence or not osteolysis in these patients, and to quantify it precisely by scanner measurement (no data yet in the literature)., conditionsModule conditions: Shoulder Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: proximal humeral resection for tumor and allograft prosthetic composite reconstruction, outcomesModule primaryOutcomes measure: Osteolysis (bone stock in cm3), secondaryOutcomes measure: Constant score, secondaryOutcomes measure: Complications, secondaryOutcomes measure: Revision, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Central Hopital, city: Nancy, zip: 54000, country: France, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False
protocolSection identificationModule nctId: NCT06382779, orgStudyIdInfo id: 2024PI057, briefTitle: Proximal Humerus Reconstruction After Resection for Tumors : Comparison Between Allograft Prosthetic Composite and Cement Sleeve Prosthetic Composite, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: Proximal humerus is a common site for primary bone tumors and metastatic disease. Reconstruction with reverse shoulder arthroplasty (RSA) after resection is a surgical challenge and presented high risk of complication. The options for reconstruction after proximal humerus tumor resection are limited, and depend on the soft tissue conditions and bone loss. The most commonly used techniques include long cemented stem alone (in case of limited resection), allograft prosthetic composite (APC), massive prosthesis. In some cases two step procedure are performed : first step is resection and RSA with cement sleeve, and second step is APC or massive prosthesis., conditionsModule conditions: Shoulder Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: reverse shoulder arthroplasty, outcomesModule primaryOutcomes measure: Constant score, secondaryOutcomes measure: complication, secondaryOutcomes measure: mortality, secondaryOutcomes measure: revision, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHRU - Centre chirurgical emile galle, city: Nancy, zip: 54000, country: France, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False
protocolSection identificationModule nctId: NCT06382766, orgStudyIdInfo id: SMU in malnutrition, briefTitle: Skeletal Muscle Ultrasonography in Detection of Malnutrition, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: * To detect the role of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children.* To assess the accuracy and validity of muscle ultrasonography in assessment of the nutritional status of critically ill child compared with other different nutritional assessment tools ., conditionsModule conditions: Skeletal Muscle Ultrasonography, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Skeletal Muscle Ultrasonography, outcomesModule primaryOutcomes measure: accuracy of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children comared with other traditional nutritional assessment tools ., eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06382753, orgStudyIdInfo id: 20-24-PAR, briefTitle: Impact of Periodontal Supportive Therapy in Patients With Gingivitis and Periodontitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Catania, class: OTHER, descriptionModule briefSummary: The study evaluated the number of sessions of periodontal supportive treatment in patients with gingivitis in order to evaluate the risk of periodontitis development., conditionsModule conditions: Gingivitis, conditions: Periodontitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Gingival inflammation, outcomesModule primaryOutcomes measure: Bleeding on Probing, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AOU Policlinico G. Rodolico, status: RECRUITING, city: Catania, zip: 95124, country: Italy, contacts name: Gaetano Isola, DDS, role: CONTACT, phone: 0953785652, email: gaetano.isola@unict.it, geoPoint lat: 37.49223, lon: 15.07041, hasResults: False
protocolSection identificationModule nctId: NCT06382740, orgStudyIdInfo id: AOP2097, briefTitle: Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years, acronym: Over70-LT, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-10-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera di Padova, class: OTHER, descriptionModule briefSummary: Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several clinical challenges during the selection/evaluation process for LT. Specific algorithms for elderly patient selection for LT are not well established; however, consensus agreement is that elderly LT candidates need a more rigorous selection process.This study proposes a "step by step" algorithm of selection for liver transplant candidates more than 70 years., conditionsModule conditions: End Stage Liver DIsease, conditions: Liver Transplantation, conditions: Old Age, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Liver transplantation, outcomesModule primaryOutcomes measure: 1 year patient survival, secondaryOutcomes measure: 1 year graft survival, secondaryOutcomes measure: 3 months mortality and morbidity, eligibilityModule sex: ALL, minimumAge: 71 Years, maximumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova, status: RECRUITING, city: Padova, zip: 35128, country: Italy, contacts name: Umberto Cillo, MD, role: CONTACT, email: cillo@unipd.it, geoPoint lat: 45.40797, lon: 11.88586, hasResults: False
protocolSection identificationModule nctId: NCT06382701, orgStudyIdInfo id: Kayseri, briefTitle: Effect of Aromatherapy on Pain, Anxiety and Satisfaction in Cannulation, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-09-06, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: The most active members of the healthcare professionals responsible for hemodialysis units are nurses, and they have a key role in pain, anxiety and satisfaction management as they are responsible for cannulation. Therefore, complementary and integrated practices need to be implemented based on evidence to strengthen the independent role of nurses in managing pain and anxiety., conditionsModule conditions: Hemodialysis Patients, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study was designed as a randomized controlled and double-blind study to evaluate the effect of clove oil applied to arterio-venous fistula on pain and anxiety caused by cannulation and to determine the effect of the application on satisfaction., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: Pre-cannulation spray application to the intervention and placebo groups will be provided by an interviewer trained by the researchers. Cannulations will be performed by nurses in the institution where the study is conducted. Data will be collected by the responsible nurses in the institutions.Patients participating in the study, researchers, and the nurse in charge will not know who is in the intervention and placebo groups.The research will be completed in twelve sessions over four weeks., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: aromatherapy, interventions name: placebo, outcomesModule primaryOutcomes measure: Visual Analog Scale (VAS), secondaryOutcomes measure: State and Trait Anxiety Inventory (STAI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erciyes University, city: Melikgazi, state: Kayseri, zip: 38260, country: Turkey, hasResults: False
protocolSection identificationModule nctId: NCT06382688, orgStudyIdInfo id: 23-08-0010, briefTitle: IV Administration of ChromaDex's Niagen® as Compared to NAD+, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-13, primaryCompletionDateStruct date: 2024-03-08, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Franklin Health Research, class: OTHER, descriptionModule briefSummary: This is a 2-part study evaluating the effects of IV administration of NR on healthy adult populations. Study 1 involved all four arms with 37 people. The second study only included the active NR and NAD+ arms to further evaluate tolerability and comfort of the IV., conditionsModule conditions: Healthy Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 53, type: ACTUAL, armsInterventionsModule interventions name: NAD+ (nicotinamide adenine dinucleotide) IV, interventions name: Niagen® (nicotinamide riboside) IV, interventions name: Niagen® (nicotinamide riboside) oral, interventions name: Placebo, outcomesModule primaryOutcomes measure: Blood Pressure, primaryOutcomes measure: Heart rate, primaryOutcomes measure: Total NAD measured through dried blood spot testing, primaryOutcomes measure: Glucose, primaryOutcomes measure: Insulin Levels, primaryOutcomes measure: total NAD measured through blood and plasma, primaryOutcomes measure: Tolerable Infusion Rate, secondaryOutcomes measure: Complete Blood Count, secondaryOutcomes measure: Comprehensive Metabolic Panel, secondaryOutcomes measure: Sleep Scale, secondaryOutcomes measure: Energy Scale, otherOutcomes measure: Subjective Experience, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nutraceuticals Research Institute, city: Franklin, state: Tennessee, zip: 37067, country: United States, geoPoint lat: 35.92506, lon: -86.86889, hasResults: False
protocolSection identificationModule nctId: NCT06382675, orgStudyIdInfo id: TA-PF-01-DE, secondaryIdInfos id: CIV-23-11-044643, type: OTHER, domain: Unique identification number EUDAMED, briefTitle: Clinical Performance of the New Plasma Filter PX2 in TPE Treatments, acronym: plasmaFlux, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Fresenius Medical Care Deutschland GmbH, class: INDUSTRY, collaborators name: KLIFO GmbH, descriptionModule briefSummary: The plasma filter is applied for a single use in extracorporeal blood purification therapy. The intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased concentration of plasma components where a rapid depletion slows down or stops a pathogenic process.The investigation involves the collection of treatment data of the new Plasma Filter PX2 in combination with the multiFiltrate and multiFiltratePRO in therapeutic plasma exchange (TPE) treatments. The multiFiltrate and multiFiltratePRO are devices for extracorporeal blood purification treatments. No further control treatments will be investigated in this one arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the new Plasma Filter PX2. No specific treatment schedule is defined by the study protocol. The TPE treatment is performed with the plasma filter PX2 (investigational device) according to clinical practice established in each of the participating centers and are prescribed at the discretion of the treating physician. The participation in the study will have no influence on the treatment plan. The documentation of the treatment includes the therapy up to the tenth (10th) treatment., conditionsModule conditions: Autoimmune Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Interventional, single arm, multi-centric, open-label, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2, outcomesModule primaryOutcomes measure: Analysis of TPE treatments with the Plama Filter PX2, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Klinikum Aschaffenburg-Alzenau, city: Aschaffenburg, state: Bavaria, zip: 63739, country: Germany, contacts name: Stefan Büttner, Dr. med., role: CONTACT, email: Stefan.buettner@klinikum-ab-alz.de, geoPoint lat: 49.97704, lon: 9.15214, locations facility: Städtisches Klinikum Braunschweig, city: Braunschweig, state: Niedersachsen, zip: 38126, country: Germany, contacts name: Gabriele Eden, Dr. med., role: CONTACT, email: g.eden@skbs.de, geoPoint lat: 52.26594, lon: 10.52673, hasResults: False
protocolSection identificationModule nctId: NCT06382662, orgStudyIdInfo id: PMDAC-01, briefTitle: Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Other Skeletal Muscle Relaxants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2025-04-15, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Primus Pharmaceuticals, class: INDUSTRY, collaborators name: Sun Valley Arthritis Center, descriptionModule briefSummary: Every participant will receive active study drug and (tone) 1 comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be (four) 4 visits., conditionsModule conditions: Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This is a prospective, randomized, single-blind, pilot study to assess degree of drowsiness, cognition, and driving risk following a single dose of oral metaxalone 640 mg (M640) versus metaxalone 800 mg in healthy subjects., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: metaxalone m640, interventions name: Tizanidine, outcomesModule primaryOutcomes measure: Change from baseline, Standard Deviation of Lateral Position, primaryOutcomes measure: Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes, secondaryOutcomes measure: Change from baseline of participants' subjective report of drowsiness on a 10-point scale, secondaryOutcomes measure: Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test), secondaryOutcomes measure: The number of product related adverse events experienced by participants from Visit 1 through Visit 4, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Valley Arthritis Center, status: RECRUITING, city: Peoria, state: Arizona, zip: 85381, country: United States, contacts name: Study Investigator, role: CONTACT, phone: 623-566-3550, email: jtuber@svacltd.com, contacts name: Study Coordinator, role: CONTACT, phone: 623-566-3550, geoPoint lat: 33.5806, lon: -112.23738, hasResults: False
protocolSection identificationModule nctId: NCT06382649, orgStudyIdInfo id: 202403051, briefTitle: Rivastigmine for Antimuscarinic Delirium, acronym: RIVA-AM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, collaborators name: American Academy of Clinical Toxicology, descriptionModule briefSummary: Antimuscarinic delirium (AMD) is a common and dangerous toxicology condition caused by poisoning by medications and other chemicals that block muscarinic receptors. Physostigmine, the standard antidote for AMD, currently has very limited availability in the United States due to an interruption of production.Recent case reports and small observational studies suggest that rivastigmine might be useful in the treatment of AMD, but there is not direct prospective evidence comparing rivastigmine to physostigmine or supportive care. In order to investigate the effectiveness of rivastigmine, the investigators propose a randomized, placebo-controlled clinical trial of rivastigmine for AMD. The investigators hypothesize that patients treated with rivastigmine for antimuscarinic delirium will experience more rapid resolution of agitation and delirium than those treated with placebo., conditionsModule conditions: Anticholinergic Toxicity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Rivastigmine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Time to control of agitation and delirium, secondaryOutcomes measure: Duration of agitation and delirium, secondaryOutcomes measure: Total amount of sedatives administered, secondaryOutcomes measure: Use of sedative infusions, secondaryOutcomes measure: Use of physical restraints, secondaryOutcomes measure: Disposition, secondaryOutcomes measure: Time to medical clearance, secondaryOutcomes measure: Oversedation, secondaryOutcomes measure: Intubation, secondaryOutcomes measure: Seizure, secondaryOutcomes measure: Gastrointestinal upset, secondaryOutcomes measure: Bradycardia, eligibilityModule sex: ALL, minimumAge: 10 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Washington University School of Medicine, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Kevin Baumgartner, role: CONTACT, phone: 314-273-1109, email: baumgartner.k@wustl.edu, geoPoint lat: 38.62727, lon: -90.19789, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-04-10, uploadDate: 2024-04-19T15:42, filename: ICF_000.pdf, size: 1060713, hasResults: False