hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06298578, orgStudyIdInfo id: Mobile Based Application, briefTitle: The Utility of Mobile Based Application for Patient Reported Outcome Measures In Patients With Acetabular Fractures : A Randomized Clinical Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The primary objective of this study is to validate the feasibility of a remote patient monitoring (RPM) system using Mobile App in terms of the frequency of data interruptions and patient acceptance.The secondary objective is to Improve quality of life and early prediction of the complications., conditionsModule conditions: Acetabular Fracture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: PROSPECTIVE, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: percentage of missed follow up data in both groups postoperatively through assessing the patient-reported outcome measures (PROMS) after surgery for a fracture of the acetabulum using the Arabic validated form of (SF-36), secondaryOutcomes measure: Quality of life scoring (Arabic validated form of (SF-36) and early prediction of the complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06298565, orgStudyIdInfo id: ARGX-113-PASS-2208, briefTitle: A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2034-06, completionDateStruct date: 2034-06, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: argenx, class: INDUSTRY, descriptionModule briefSummary: This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort., conditionsModule conditions: Myasthenia Gravis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 680, type: ESTIMATED, armsInterventionsModule interventions name: efgartigimod, outcomesModule primaryOutcomes measure: The overall long-term safety of efgartigimod including the occurrence of serious infections in generalized myasthenia gravis (gMG) patients treated with efgartigimod compared to gMG patients not exposed to efgartigimod, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06298552, orgStudyIdInfo id: ARGX-113-2308, secondaryIdInfos id: 2024-511796-15-00, type: OTHER, domain: CTIS number, briefTitle: A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis, acronym: ADAPT SERON, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2025-07-25, completionDateStruct date: 2027-07-23, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: argenx, class: INDUSTRY, descriptionModule briefSummary: The primary purpose of this study is to measure the efficacy and safety of efgartigimod intravenously (IV) compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). Other objectives are to assess long-term efficacy, safety, and tolerability of efgartigimod.Study will consist of:* Screening* Part A: participants will be randomized to receive either efgartigimod IV or placebo* Part B: participants completing part A will receive open-label efgartigimod IV, conditionsModule conditions: Generalized Myasthenia Gravis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Efgartigimod IV, interventions name: Placebo IV, outcomesModule primaryOutcomes measure: Myasthenia Gravis Activities of Daily Living (MG-ADL) total score change from baseline, secondaryOutcomes measure: Quantitative myasthenia gravis (QMG) total score change from baseline, secondaryOutcomes measure: Proportion of participants who are both MG-ADL and QMG responders, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Choice Neurology Boca Raton, status: RECRUITING, city: Boca Raton, state: Florida, zip: 33428, country: United States, contacts name: Brian Costell, MD, role: CONTACT, phone: 857-350-4834, email: clinicaltrials@argenx.com, geoPoint lat: 26.3669, lon: -80.13033, hasResults: False
protocolSection identificationModule nctId: NCT06298539, orgStudyIdInfo id: 21C308, briefTitle: Auditory Sensory Attenuation in Obesity, acronym: Ud_SA_OB, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, collaborators name: University of Turin, Italy, descriptionModule briefSummary: The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women with obesity and healthy-weight women. Specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound):i) is observed in obesity ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants.Participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter\&#39;s signal (i.e., interactive context); externally-generated sounds are produced in the opposite way., conditionsModule conditions: Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: point of subjective equality (PSE), secondaryOutcomes measure: cognitive empathy, secondaryOutcomes measure: interpersonal pleasure, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital, city: Piancavallo, state: VCO, zip: 28824, country: Italy, hasResults: False
protocolSection identificationModule nctId: NCT06298526, orgStudyIdInfo id: 21C307, briefTitle: Auditory Sensory Attenuation in Anorexia Nervosa, acronym: UdSA_AN, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women affected by anorexia nervosa and healthy-weight women. Specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound):i) is observed in anorexia nervosa ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants.Participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter\&#39;s signal (i.e., interactive context); externally-generated sounds are produced in the opposite way., conditionsModule conditions: Anorexia Nervosa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: point of subjective equality (PSE), secondaryOutcomes measure: cognitive empathy, secondaryOutcomes measure: interpersonal pleasure, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital, city: Piancavallo, state: VCO, zip: 28824, country: Italy, hasResults: False
protocolSection identificationModule nctId: NCT06298513, orgStudyIdInfo id: 09C338, briefTitle: Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute MI, acronym: RIABILITOMICA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-02, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: Ischemic heart disease remains the leading cause of death in the western world. The beneficial effects of cardiac rehabilitation on the evolution of ischemic heart disease are known, but the effects of rehabilitation on the metabolic processes of the patients are so far poorly understood. Metabolomics is the qualitative/quantitative analysis of the body's metabolic responses to pathophysiological stimuli or genetic alterations. Metabolic changes caused by physical activity have been demonstrated in obese and diabetic patients and in athletes. Aim of the study is to evaluate whether cardiac rehabilitation after a first myocardial infarction induces changes in the metabolic state of patients, and whether these changes may be related with changes in the usual risk factors (i.e. glyco-lipidic profile, natriuretic peptides, homocysteine)., conditionsModule conditions: Acute Myocardial Infarction: Rehabilitation Phase, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Cardiac rehabilitation, outcomesModule primaryOutcomes measure: Changes in purine after rehabilitation, primaryOutcomes measure: Changes in histidine after rehabilitation, primaryOutcomes measure: Changes in galactose after rehabilitation, eligibilityModule sex: MALE, minimumAge: 25 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano, status: RECRUITING, city: Milan, zip: 20149, country: Italy, contacts name: Lia Crotti, MD PhD, role: CONTACT, phone: 39 0261911, phoneExt: 2903, email: lia.crotti@unimib.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06298500, orgStudyIdInfo id: AAG-O-H-2115, briefTitle: Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair, acronym: HISTOLAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Aesculap AG, class: INDUSTRY, collaborators name: B.Braun Surgical SA, descriptionModule briefSummary: The goal of this retrospective study is to identify the incidence of hernia recurrence following the application of Histoacryl® Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery. All adult patients who underwent laparoscopic inguinal hernia repair with Histoacryl® Lapfix - Cannula in the period June 2018 - March 2021 at Hospital San Juan de Dios will be analysed. The investigator team will access electronical medical records for the cohort of patients identified., conditionsModule conditions: Inguinal Hernia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 448, type: ESTIMATED, armsInterventionsModule interventions name: hernia repair surgery, outcomesModule primaryOutcomes measure: Hernia recurrence rate, secondaryOutcomes measure: Delayed tissue adhesive polymerization, secondaryOutcomes measure: Intraoperative bleeding requiring therapeutic measures, secondaryOutcomes measure: Organ injury, secondaryOutcomes measure: Hernia recurrence, secondaryOutcomes measure: Mesh migration, secondaryOutcomes measure: Adhesions, secondaryOutcomes measure: Erosion, secondaryOutcomes measure: Meshoma formation, secondaryOutcomes measure: Tack hernias, secondaryOutcomes measure: Surgical Site Infection (superficial, deep, intraabdominal), secondaryOutcomes measure: Hematoma, secondaryOutcomes measure: Seroma, secondaryOutcomes measure: Hemorrhage, secondaryOutcomes measure: Orchitis, secondaryOutcomes measure: Other Adverse Event, secondaryOutcomes measure: Reintervention, secondaryOutcomes measure: Mesh repositioning or removal, secondaryOutcomes measure: Acute or chronic pain, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital San Juan de Dios, city: Santa Cruz De Tenerife, state: Tenerife, zip: 38001, country: Spain, contacts name: José Miguel Del Pino Monzón, Dr., role: CONTACT, geoPoint lat: 28.46824, lon: -16.25462, hasResults: False
protocolSection identificationModule nctId: NCT06298487, orgStudyIdInfo id: CHRD 1023, briefTitle: Evaluation of the Impact of Therapeutic Education Workshops for COPD Patients in the North-West Val d'Oise Area, acronym: MPSAT-ETP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Hôpital NOVO, class: OTHER, descriptionModule briefSummary: The aim of this study is to assess the impact of the Patient Therapeutic Education (PTE) workshops offered by the Maison de Prévention de la Santé et d'Accompagnement Thérapeutique (MPSAT) on the follow-up and feelings of the COPD patients who take part. These workshops are organised outside the hospital environment and supervised by hospital and town professionals in the NOVO zone., conditionsModule conditions: COPD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Patient questionnaires, outcomesModule primaryOutcomes measure: Evaluation of the overall impact of the PTE workshops offered by the MPSAT on patients' knowledge, skills, attitudes and behaviours with regard to COPD management and care, secondaryOutcomes measure: Measure of the impact of PTE workshops on quality of life (comparison of PTE group versus Control group), secondaryOutcomes measure: Comparison of anxiety/depression levels in patients in the PTE group versus Control group, secondaryOutcomes measure: Comparison of levels of motivation towards physical activity during free time in the PTE group versus Control group, secondaryOutcomes measure: Comparison of the number of hospital admissions for COPD exacerbations in patients in the PTE group versus Control group, secondaryOutcomes measure: Comparison of the perception/feelings of patients in the PTE group versus Control group, concerning PTE workshops organised in a city/hospital setting, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pneumology, respiratory rehabilitation and follow-up and rehabilitation care department - Hôpital NOVO, status: RECRUITING, city: Pontoise, zip: 95300, country: France, contacts name: Dr Bruno PHILIPPE, role: CONTACT, phone: +33 1 30 75 47 75, email: bruno.philippe@ght-novo.fr, contacts name: Mme Anne-Charlotte TAUVERON, role: CONTACT, phone: +33 6 75 08 36 60, email: anne-charlotte.tauveron@valdoise.fr, geoPoint lat: 49.05, lon: 2.1, hasResults: False
protocolSection identificationModule nctId: NCT06298461, orgStudyIdInfo id: BowelPrep, briefTitle: Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University of Manitoba, class: OTHER, collaborators name: Canadian IBD Research Consortium (CIRC), descriptionModule briefSummary: The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy. The aim is to compare oral sulfate solution (OSS) to another laxative called 2L polyethylene glycol (PEG) solution to see which is more effective and more tolerable by individuals with IBD (Crohn's disease or Ulcerative colitis)., conditionsModule conditions: Crohn Disease, conditions: Ulcerative Colitis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 418, type: ESTIMATED, armsInterventionsModule interventions name: KleanLyte, interventions name: Bi-PegLyte, outcomesModule primaryOutcomes measure: Quality of bowel cleanliness, primaryOutcomes measure: Quality of bowel cleanliness, secondaryOutcomes measure: Volume of laxative intake, secondaryOutcomes measure: Endoscopic Outcomes, secondaryOutcomes measure: Endoscopic Outcomes, secondaryOutcomes measure: Endoscopic Outcomes, secondaryOutcomes measure: Endoscopic Outcomes, secondaryOutcomes measure: Patient experience data, secondaryOutcomes measure: Crohn's disease or ulcerative colitis flares after colonoscopy, secondaryOutcomes measure: Endoscopic Outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06298448, orgStudyIdInfo id: NL83176.042.23, briefTitle: eGPA and Local Inflammation Within the Ear, Nose and Throat Area, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, collaborators name: GlaxoSmithKline, descriptionModule briefSummary: Rationale: Eosinophilic Granulomatosis with Polyangiitis (eGPA), eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) are airway diseases where eosinophils and interleukine-5 are involved in the pathogenesis. eGPA differs from the other diseases with respect to involvement of other organs. The investigators hypothesize that nasal microbiome dysbiosis with a central augmenting role for S. Aureus plays an important role in disease expression. The investigators expect that anti-interleukin-5 treatment with mepolizumab restores the changes of the nasal microbiome and immune responses to a healthy control phenotype. To study this, the nasal microbiome, the local and systemic immune response and the effect of mepolizumab treatment will be assessed., conditionsModule conditions: EGPA - Eosinophilic Granulomatosis With Polyangiitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: laboratory experiments before and after mepolizumab treatment, outcomesModule primaryOutcomes measure: The effect mepolizumab treatment has on the nasal microbiome profiles, otherOutcomes measure: Exploratory evaluation of between group differences, otherOutcomes measure: Mepolizumab effect on outcome 2, otherOutcomes measure: s there a correlation between the disease activity, the quality of life and the microbiome and immune parameters?, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UMC Groningen, status: RECRUITING, city: Groningen, zip: 9700RB, country: Netherlands, contacts name: Abraham Rutgers, MD-PhD, role: CONTACT, phone: +31503616161, email: a.rutgers@umcg.nl, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False