hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06324734, orgStudyIdInfo id: D0817R00082, briefTitle: Assessment of Safety of Olaparib in Chinese Patients With Ovarian Cancer in the Real-World Setting, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: Study D0817R00081 is a retrospective study using NCID database to assess the safety of Olaparib in Chinese patients with ovarian cancer by examining the incidence, seriousness, and severity of all AEs, including but not limiting to AESIs and SAEs, AEs related to Olaparib, and AEs leading to dose reduction, interruption or discontinuation of Olaparib. The first Olaparib prescription date will be set as the index date. The baseline period is from the patient's first ovarian cancer diagnosis recorded in the database to the patient's first treatment with Olaparib (as early as the database start date of January 1, 2013) to the index date for derivation of lines of therapy or one year pre-index date for other baseline variables. Patients will be followed until the patient's last medical record in the database, 30 days after the last dose of Olaparib, death, or June 30, 2023, whichever comes first. All patients who meet the inclusion/exclusion criteria will be enrolled., conditionsModule conditions: Using NCID Database to Assess the Safety of Olaparib in Chinese Patients With Ovarian Cancer by Examining the Incidence, Seriousness, and Severity of All AE, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, outcomesModule primaryOutcomes measure: The incidence, seriousness, and severity of all AEs, secondaryOutcomes measure: The number and proportion of patients according to different baseline demographics and characteristics, secondaryOutcomes measure: Overall number and proportion of patients with olaprib combination maintenance therapy in PSR patients, otherOutcomes measure: Overall number and proportion of patients with olap arib combination maintenance therapy in 1L patients 2), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06324708, orgStudyIdInfo id: THA_DXA, briefTitle: Analysis of Defined Elements on DXA in Patients Undergoing Hip Arthroplasty, acronym: THA_DXA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-07, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the role of two-dimensional FEM models obtained from DXA images in the longitudinal assessment of periprosthetic bone, in subjects undergoing hip arthroplasty. Specifically, the study will focus on the joint analysis of changes in the parameters of bone mineral density (BMD) and Bone Strain Index (BSI) at the level of periprosthetic bone of the proximal femur in patients undergoing hip replacement surgery using DXA, evaluating the densitometric variation of these two parameters over time, starting from an immediately postoperative data and checking the change at 6 months to follow the patient through the postoperative course, conditionsModule conditions: Bone Resorption, conditions: Arthroplasty Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 69, type: ESTIMATED, armsInterventionsModule interventions name: DXA, outcomesModule primaryOutcomes measure: Role of two-dimensional FEM models obtained from DXA images in longitudinal evaluation of periprosthetic bone, secondaryOutcomes measure: Role of two-dimensional FEM models of bone resistance to loading, secondaryOutcomes measure: Identification of mechanical stress, secondaryOutcomes measure: Assesment with PROMs: VAS, secondaryOutcomes measure: Assesment with PROMs; HHS, secondaryOutcomes measure: Assesment with PROMs: SF12, secondaryOutcomes measure: Assesment with PROMs: HOOS PS, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio, status: RECRUITING, city: Milan, zip: 20173, country: Italy, contacts name: Laura Mangiavini, role: CONTACT, phone: 0283506790, email: laura.mangiavini@unimi.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06324669, orgStudyIdInfo id: 4765060, briefTitle: The Effect of a Ketone Drink on Blood Glucose Levels in People With Type 2 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-16, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Exeter, class: OTHER, collaborators name: University of British Columbia, collaborators name: Medical Research Council, descriptionModule briefSummary: Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important in the treatment of type 2 diabetes (T2D). The purpose of this research is to determine if a ketone drink can lower blood sugar in people with T2D following a meal. This research will provide new knowledge about the regulation of blood sugar. This may also inform if ketone drinks could be used as a treatment for T2D., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomised cross over trial counterbalanced for trial order, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, maskingDescription: Coded, known only to independent individual, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Ketone supplement, interventions name: Placebo supplement, outcomesModule primaryOutcomes measure: Rate of endogenous glucose production, secondaryOutcomes measure: Total rate of glucose appearance, secondaryOutcomes measure: Exogenous glucose rate of appearance, secondaryOutcomes measure: Total rate of glucose disappearance, secondaryOutcomes measure: Rate of gluconeogenesis, secondaryOutcomes measure: Rate of glycogenolysis, secondaryOutcomes measure: Beta-cell function, secondaryOutcomes measure: Insulin concentration, secondaryOutcomes measure: Glucagon concentration, secondaryOutcomes measure: GLP-1 concentration, secondaryOutcomes measure: GIP concentration, secondaryOutcomes measure: Glycerol concentration, secondaryOutcomes measure: Free fatty acid concentration, secondaryOutcomes measure: Ketone concentration, secondaryOutcomes measure: Energy expenditure, eligibilityModule sex: ALL, minimumAge: 41 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sport & Health Sciences University of Exeter, status: RECRUITING, city: Exeter, state: Devon, zip: EX1 2LU, country: United Kingdom, contacts name: Francis B Stephens, PhD, role: CONTACT, phone: +441392 722157, phoneExt: 2157, email: f.b.stephens@exeter.ac.uk, geoPoint lat: 50.7236, lon: -3.52751, hasResults: False
protocolSection identificationModule nctId: NCT06324656, orgStudyIdInfo id: PRP-PNS, briefTitle: The Efficacy of Combining Platelet-rich Plasma With Crystallized Phenol in Pilonidal Sinus Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-21, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Necmi Kadıoğlu Hospital, class: OTHER, descriptionModule briefSummary: The use of local liquid phenol for pilonidal sinus disease was first introduced by Maurica and Greenwood in 1964. Phenol, also known as carbolic acid, has been proven to be an effective sclerosing agent for treating pilonidal sinus diseas. Its antiseptic and anesthetic qualities make it suitable for application in awake patients under local anesthesia. The treatment of pilonidal sinus diseas in children with crystallized phenol was first published by Ateş et al in 2018. However, the treatment involving only crystallized phenol can require numerous sessions, potentially extending the duration of the treatment. IIn this study, the investigators, investigated whether the application of platelet-rich plasma following crystallized phenol treatment could accelerate the healing process and reach better outcomes. This study evaluates the efficacy of PRP as a treatment modality for pilonidal sinus disease in pediatric patients., conditionsModule conditions: Pilonidal Sinus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: crystallized phenol + platelet rich plasma application, interventions name: crystallized phenol, outcomesModule primaryOutcomes measure: Average time to full daily activities, primaryOutcomes measure: VAS scores, primaryOutcomes measure: Healing time, primaryOutcomes measure: Cosmetic score, primaryOutcomes measure: Success rate, primaryOutcomes measure: Recurrence rate, secondaryOutcomes measure: Bleeding rate, secondaryOutcomes measure: Infection rate, secondaryOutcomes measure: Skin burn rate, secondaryOutcomes measure: Total complication rate, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Mustafa Azizoğlu, status: RECRUITING, city: Istanbul, zip: 34430, country: Turkey, contacts name: Mustafa Azizoğlu, role: CONTACT, phone: +905447448244, email: mdmazizoglu@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06324643, orgStudyIdInfo id: Erb's Palsy, briefTitle: Sensory Motor Integration Training in Erb's Palsy Childern, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Sara Elsayed Ali Abdelnaby Ali, class: OTHER, descriptionModule briefSummary: The aim of the study is to Study effect of sensory motor integration training on ADL activities in children with Erb's palsy., conditionsModule conditions: Sensory Motor Integration and Erb's, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: sensory motor integration training, outcomesModule primaryOutcomes measure: Effect of sensory motor integration training on ADL, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06324604, orgStudyIdInfo id: MT-101-101, briefTitle: Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Mozart Therapeutics Australia Pty Ltd, class: INDUSTRY, descriptionModule briefSummary: First in human study to understand the potential side effects of MTX-101, how long MTX-101 lasts in the human body, and how MTX-101 affects specific human immune cells., conditionsModule conditions: Healthy Volunteers, conditions: Celiac Disease, conditions: Type 1 Diabetes, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Part A will enroll Healthy Adult Volunteers will be randomized, double-blind, placebo-controlled, single ascending dose (SAD), randomized to MTX-101 or placebo in a 1:1 ratio for the first 2 participants (sentinel dosing) and a 3:1 ratio thereafter. Participants in the multiple ascending dose (MAD) will be randomized in a 3:1 ratio and be dosed on Days 1 and 22 for a total of 2 doses.Part B of this study plans to enroll at least 24 (up to 40) participants with Celiac Disease or Type 1 Diabetes, randomized in a 1:1 ratio, in a crossover design, dosed with MTX-101 or placebo on Days 1 and 22 for a total of 2 doses, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: MTX-101, outcomesModule primaryOutcomes measure: Safety of single, ascending dose levels of MTX-101, primaryOutcomes measure: Safety of multiple, ascending dose levels of MTX-101, secondaryOutcomes measure: pharmacokinetics (PK) of MTX-101, secondaryOutcomes measure: pharmacokinetics (PK) of MTX-101, secondaryOutcomes measure: pharmacokinetics (PK) of MTX-101, secondaryOutcomes measure: anti-drug antibody (ADA) formation, otherOutcomes measure: pharmacodynamics (PD) of MTX-101, otherOutcomes measure: Receptor occupancy of MTX-101, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nucleus Network Brisbane, city: Herston, state: Queensland, zip: 4006, country: Australia, contacts name: Gloria Wong, MD, role: CONTACT, phone: 1800243733, email: brisbane@nucleusnetwork.com, contacts name: Gloria Wong, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.44453, lon: 153.01852, hasResults: False
protocolSection identificationModule nctId: NCT06324591, orgStudyIdInfo id: RISKCROHNBIOM, briefTitle: Observational Prospective Study to Identify Intestinal Microbial Profiles in Newly Diagnosed Crohn's Disease Patients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-02-03, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Crohn's disease (CD), a chronic inflammatory disease affecting the intestine, is characterised by a relapsing course. In 25% of cases, the onset of this disease occurs in childhood. Relevant studies have provided evidence of a key role of gut microbial communities (the microbiota) in triggering or maintaining active gut inflammation, pointing to gut dysbiosis as the main event disrupting the balance of microbial communities Recent evidence suggests that, in addition to the bacterial component, the commensal fungal component also plays a crucial role in CD.The purpose of this prospective, longitudinal, study is to characterise the composition of intestinal bacterial and fungal communities in patients 6-18 years newly diagnosed with Crohn Disease in order to identify a possible association of specific faecal microbial profiles with a severe or mild-to-moderate disease course., conditionsModule conditions: Crohn Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Collection biological sample and analysis, outcomesModule primaryOutcomes measure: Modifications in alpha and beta diversity of stool microbiome profile in patients with different phases of disease course (at diagnosis, remission and after one year of mantainance therapy), secondaryOutcomes measure: Differences intestinal alpha and beta diversity, microbiome richness and composition between patients at high risk and patients at low risk, secondaryOutcomes measure: Indentification of different patterns of intestinal microbiome as a potential biomarker for high and low risk stratification, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Medical University of Graz-Educational center for Paediatric Gastroenterology, Hepatology and Nutrition, Department of Paediatrics and adolescence medicine, city: Graz, country: Austria, geoPoint lat: 47.06667, lon: 15.45, locations facility: Ospedale Maggiore-Azienda Usl Di Bologna, city: Bologna, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Meyer Children's Hospital IRCCS, city: Florence, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, hasResults: False
protocolSection identificationModule nctId: NCT06324578, orgStudyIdInfo id: RC 25/2023, briefTitle: Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-25, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: IRCCS Burlo Garofolo, class: OTHER, descriptionModule briefSummary: The main study hypothesis is that Sjögren Disease (SD), usually considered a disorder typical of adult females, may occur not exceptionally in adolescence or even in childhood as a subclinical process. There are several pieces of evidence in favor of this hypothesis, from the incidental detection of asymptomatic SD in pediatric age to biobank-based studies showing that biological signs of SD may precede the disease clinical onset by years or decades. The best scenario to verify this hypothesis could be that of autoimmune thyroiditis, for the following three reasons: 1) subjects with Autoimmune thyroiditis (AT) have a high risk of developing SD (7%); 2) in cases with comorbidity of SD and AT the diagnosis of AT had usually been made before; 3) subjects with AT routinely undergo periodic blood examination and neck ultrasonography (US), which may include Salivary Gland Ultrasound (SGUS) providing contributive data to detect an asymptomatic pre-SD. The knowledge of the real association between AT and pre-SD may impact on several aspects of medicine., conditionsModule conditions: Sjögren, conditions: Autoimmune Thyroid Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: AT Testing, outcomesModule primaryOutcomes measure: Prevalence of pre-SD in pediatric subjects with AT, primaryOutcomes measure: Prevalence of pre-SD in pediatric subjects with AT, primaryOutcomes measure: Prevalence of pre-SD in pediatric subjects with AT, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", status: RECRUITING, city: Trieste, zip: 34137, country: Italy, contacts name: Alberto Tommasini, MD PhD Prof, role: CONTACT, phone: +39.040.785.422, email: alberto.tommasini@burlo.trieste.it, contacts name: Barbara Bonifacio, role: CONTACT, phone: +39.040.3785.422, email: barbara.bonifacio@burlo.trieste.it, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False
protocolSection identificationModule nctId: NCT06324565, orgStudyIdInfo id: RC 24/2021, briefTitle: Role of Preoperative D-dimer Levels in the Diagnosis of Adnexal Torsion, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-13, primaryCompletionDateStruct date: 2024-12-13, completionDateStruct date: 2024-12-13, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: IRCCS Burlo Garofolo, class: OTHER, descriptionModule briefSummary: Adnexal torsion is the fifth most common gynecologic emergency. Thirty percent of all cases of adnexal torsion occur in females younger than 20 years. Approximately 5 of 100,000 females aged 1-20 years are affected, with girls older than 10 years at increased risk because of hormonal influences and gonadal growth that result in an increased frequency of physiologic and pathologic masses. The most common clinical symptom of torsion is sudden-onset abdominal pain that is intermittent, non-radiating, and associated with nausea and vomiting in 62% and 67% of cases respectively. Moreover, abdominal tenderness is a clinical sign which is reported in up to 88% of patients with adnexal torsion. None of the following tests are useful in the diagnosis of adnexal torsion: leukocytosis, pyuria, C-reactive protein, and erythrocyte sedimentation rate. Actually, transabdominal ultrasonography is the imaging modality of choice with a sensitivity of 92% and specificity of 96% in detecting adnexal torsion. A second-line imaging tool in the diagnosis of adnexal torsion is magnetic resonance, which may require a sedation in selected cases. Consequently, there are no clinical or imaging criteria sufficient to confirm the preoperative diagnosis of adnexal torsion to date. Therefore, patients with a clinical suspicion for adnexal torsion should undergo emergent diagnostic laparoscopy., conditionsModule conditions: Adnexal Torsion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: D-Dimer test, outcomesModule primaryOutcomes measure: Diagnostic accuracy of the D-Dimer, eligibilityModule sex: FEMALE, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", status: RECRUITING, city: Trieste, zip: 34137, country: Italy, contacts name: Alessandro Boscarelli, MD, role: CONTACT, phone: +393931757607, email: alessandro.boscarelli@burlo.trieste.it, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False