hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06273826, orgStudyIdInfo id: 01, briefTitle: "Colorectal Leakage App" for Early Detection of Anastomotic Leakage After Colorectal Surgeries, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-19, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: National Research Oncology and Transplantology Center, Kazakhstan, class: OTHER, descriptionModule briefSummary: The aim of this prospective observational study is to evaluate the effectiveness of the mobile application "Colorectal Leakage App" in the early diagnosis of anastomotic leakage after colorectal surgeries at the National Research Oncology Center in Astana, Kazakhstan.Main Questions:1. Development, validation, and implementation of the mobile application "Colorectal Leakage App," based on the Dutch Leakage Score.2. Evaluate the diagnostic effectiveness of the application in detecting anastomotic leakage after colorectal surgeries.3. Determine the frequency of anastomotic leakage after colorectal surgeries performed in the colorectal surgery sector of the National Research Oncology Center in the Astana city.Participants in the study, individuals aged 18 and above undergoing colorectal surgeries, will be monitored by the mobile application "Colorectal Leakage App" in the postoperative period for early identification of anastomotic leakage., conditionsModule conditions: Anastomotic Leak Large Intestine, conditions: Anastomotic Leak Rectum, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: "Colorectal Leakage App", outcomesModule primaryOutcomes measure: Diagnostic effectiveness of "Colorectal Leakage App"., primaryOutcomes measure: Frequency of anastomotic leakage after colorectal surgeries., secondaryOutcomes measure: Mortality within 30 days, secondaryOutcomes measure: Delay in the diagnosis of anastomotic leakage, secondaryOutcomes measure: Duration of hospital stay., secondaryOutcomes measure: Number of days in the ICU., secondaryOutcomes measure: Number of days between surgery and detection of AL., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Research Oncology Center, status: RECRUITING, city: Astana, zip: 010000, country: Kazakhstan, contacts name: Saule Khamzina, MD, role: CONTACT, phone: +77757172961, email: khamzina.saule88@gmail.com, geoPoint lat: 51.1801, lon: 71.44598, hasResults: False
protocolSection identificationModule nctId: NCT06273813, orgStudyIdInfo id: NOV-1776-CL-101, briefTitle: Treatment of Topical Ketorolac Gel in Acute Gouty Flare, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Novilla Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study will be a phase 1, open-label, bioavailability, safety and PK study of topically applied transcutaneous ketorolac tromethamine gel 12.5% (/w) (NOV-1776) versus intravenous administration of approved ketorolac tromethamine injection, USP (15mg/mL) comparator in healthy volunteers, including an evaluation of safety, tolerability, and efficacy in gout participants with flare-up., conditionsModule conditions: Acute Gouty Arthritis, conditions: Acute Pain, conditions: Gout Flare, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: All cohost 1 subjects receive single ketorolac tromethamine injection, followed by escalating doses of ketorolac tromethamine gel Cohort 2 and 3 subjects receive doses of ketorolac tromethamine gel for 5 days, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Ketorolac Tromethamine 15 MG/ML, interventions name: Ketorolac Tromethamine, outcomesModule primaryOutcomes measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0, primaryOutcomes measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of topical ketorolac tromethamine, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Paratus Clinical,, city: Blacktown, zip: 2148, country: Australia, contacts name: Rahul Rahul, role: CONTACT, phone: +61 1300 742 326, email: info@paratusclinical.com, contacts name: Rahul Rahul, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.76667, lon: 150.91667, locations facility: Linear Clinical Research Ltd, city: Nedlands, zip: 6009, country: Australia, contacts name: Jasmine Williams, role: CONTACT, phone: +61 8 6382 5100, geoPoint lat: -31.98184, lon: 115.8073, hasResults: False
protocolSection identificationModule nctId: NCT06273800, orgStudyIdInfo id: M23CMC, briefTitle: Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients, acronym: Chemosense, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2035-07-15, completionDateStruct date: 2036-07-15, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: The Netherlands Cancer Institute, class: OTHER, descriptionModule briefSummary: This study is a prospective, multicenter study in which a serum sample will be collected at the day of starting neo adjuvant treatment in breast cancer patients, conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: collection of serum sample blood at first day of neo adjuvant treatment, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Blood sample, outcomesModule primaryOutcomes measure: pCR rate, secondaryOutcomes measure: Radiological reduction on tumor size, secondaryOutcomes measure: Pathological reduction on tumor size, secondaryOutcomes measure: Residual cancer burden (RCB), secondaryOutcomes measure: Distant recurrence free interval (DRFI), secondaryOutcomes measure: Recurrence-free interval (RFI), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Antoni van Leeuwenhoek, city: Amsterdam, state: Noord-Holland, zip: 1066CX, country: Netherlands, contacts name: Laura Bornes, PhD, role: CONTACT, contacts name: Veerle Geurts, PhD, role: CONTACT, contacts name: Marleen Kok, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False
protocolSection identificationModule nctId: NCT06273787, orgStudyIdInfo id: Mitu, briefTitle: Effect of Diaphragmatic Release in Sleep Quality During Pregnancy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-03-17, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: MTI University, class: OTHER, descriptionModule briefSummary: Sleep disordered breathing (SDB) is very common during pregnancy, and is most likely explained by hormonal, physiological and physical changes. Maternal obesity, one of the major risk factors for SDB, together with physiological changes in pregnancy may predispose women to develop SDB. SDB has been associated with poor maternal and fetal outcomes. Thus, early identification, diagnosis and treatment of SDB are important in pregnancy., conditionsModule conditions: SLEEP APNEA PREGNANCY, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment group a : Diaphragmatic Release in addition to positioning instruction group b: positioning instruction, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: diaphragmatic release, outcomesModule primaryOutcomes measure: pittshurgh sleep quality index, secondaryOutcomes measure: diaphragmatic excursion assessment, eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: MTI, status: RECRUITING, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06273774, orgStudyIdInfo id: 8189-020, secondaryIdInfos id: MK-8189-020, type: OTHER, domain: Merck, briefTitle: A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-09-10, completionDateStruct date: 2024-09-10, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, descriptionModule briefSummary: The goal of this study is to evaluate the safety and tolerability of MK-8189 in participants with stable bipolar I disorder. There will be no hypothesis testing in this study., conditionsModule conditions: Bipolar I Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: MK-8189, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of Participants Who Experience One or More Adverse Events (AEs), primaryOutcomes measure: Number of Participants Who Discontinue Study Treatment Due to an AE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hassman Research Institute Marlton Site ( Site 0006), status: RECRUITING, city: Marlton, state: New Jersey, zip: 08053, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 267-981-8911, geoPoint lat: 39.89122, lon: -74.92183, hasResults: False
protocolSection identificationModule nctId: NCT06273735, orgStudyIdInfo id: 2019-PS-33b, secondaryIdInfos id: PV7350, type: OTHER, domain: Martini-Klinik, briefTitle: Prospective Trial: Myocardial Injury After Noncardiac Surgery (MINS) Following Radical Prostatectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-14, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Martini-Klinik am UKE GmbH, class: OTHER, collaborators name: Universitätsklinikum Hamburg-Eppendorf, descriptionModule briefSummary: The aim of this study is to prospectively analyse the rate of MINS in the standardised radical prostatectomy patient clientele at the Martini-Clinic and to identify risk factors. Pre- and postoperative troponin levels are determined (1st and 2nd postoperative day). The patient's height, weight, age and cardiovascular risk factors (including determination of the Revised Cardiac Risk Index) are recorded in the medical history as well as previous medical and interventional cardiological therapy. Furthermore, the prostate carcinoma-associated tumour and surgical parameters are determined. Clinically significant cardiovascular events during the inpatient stay are also described. Finally, a description of the rate of events, a check for correlation with the Revised Cardiac Risk Index and an identification of risk factors are carried out., conditionsModule conditions: Myocardial Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Pre- and postoperative determination of troponin as part of the study and 24-month FU survey, outcomesModule primaryOutcomes measure: rate of MINS in standardised open and robot-assisted radical prostatectomy, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Martini-Klinik am UKE GmbH, status: RECRUITING, city: Hamburg, zip: 20246, country: Germany, contacts name: Markus Graefen, Professor, role: CONTACT, phone: +4904741051300, email: graefen@uke.de, contacts name: Anke Renter, role: CONTACT, phone: +49407410533115, email: renter@uke.de, geoPoint lat: 53.57532, lon: 10.01534, hasResults: False
protocolSection identificationModule nctId: NCT06273722, orgStudyIdInfo id: 2024-0059, briefTitle: D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: The current gold standard for diagnosing basal cell carcinoma (BCC) is the histopathological examination of biopsy specimen. However, non-invasive imaging modalities such as optical coherence tomography (OCT) may replace biopsy if BCC presence and its subtype can be established with high confidence. Subtype differentiation is crucial; while superficial BCCs (sBCC) can be treated topically, nodular (nBCC) and infiltrative BCCs (iBCC) require excision. Dynamic OCT (D-OCT) is a functionality integrated within the OCT device, enabling the visualization of vascular structures through speckle variance.Descriptive studies have unveiled vascular shapes and patterns associated with BCC and its respective subtypes. These findings suggest that D-OCT could contribute to the accuracy of BCC detection and subtyping. Yet comparative clinical studies between OCT and D-OCT are lacking. In the proposed diagnostic cohort study, we aim to assess whether D-OCT assessment is superior to OCT in terms of accuracy for BCC detection and subtyping., conditionsModule conditions: Basal Cell Carcinoma, conditions: Optical Coherence Tomography, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 424, type: ESTIMATED, armsInterventionsModule interventions name: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner, outcomesModule primaryOutcomes measure: Diagnostic accuracy for BCC detection on D-OCT assessment, secondaryOutcomes measure: Diagnostic accuracy for BCC subtyping on D-OCT assessment, secondaryOutcomes measure: Diagnostic value of vascular structures and patterns, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06273709, orgStudyIdInfo id: 2023-3698, briefTitle: Remote Assessment of OCT Scans for BCC Detection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: Basal cell carcinoma (BCC) is the most common form of cancer and entails approximately 80% of all cutaneous malignancies. This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful, causes procedural scarring and carries a small risk of infection and re-bleeding associated with invasive procedures. Moreover, awaiting the results of the subsequent histopathological examination causes treatment delay and can be stressful for the patient. The drawbacks of biopsy could be overcome by optical coherence tomography (OCT), a non-invasive diagnostic modality that may replace biopsy in up to 66% of patients. However, OCT assessors are scarce which hinders the implementation of OCT. This problem may be addressed by teledermatology in which remote OCT assessment by an assessor facilitates simultaneous assessment for multiple clinics. Remote OCT assessment withholds the OCT assessor from visually inspecting the lesion. But the effect of visual inspection on the diagnostic accuracy remains unknown and the question arises whether visual inspection is necessary for accurate OCT assessment. In this diagnostic case-control study we will determine whether distant OCT assessment without visual information on the lesion is non-inferior to distant OCT assessment with clinical and dermoscopic photographs (CDP-OCT)., conditionsModule conditions: Basal Cell Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner, outcomesModule primaryOutcomes measure: Diagnostic accuracy of high-confidence BCC diagnosis with and without clinical/dermoscopic photographs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06273670, orgStudyIdInfo id: 04-2023-200279, briefTitle: Postpartum Initiation of Long-acting Reversible Contraceptives: Knowledge Attitude and Practice Study (KAP), acronym: KAP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-15, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Comparing Knowledge, attitude and Practice of clients and service providers about the regular (6 weeks) versus earlier initiation of LARC, through a structured questionnaire prepared in English and translated to local language i.e. Arabic., conditionsModule conditions: Contraception, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: screening and data collection, outcomesModule primaryOutcomes measure: Clients' knowledge, secondaryOutcomes measure: Clients' attitude, secondaryOutcomes measure: Clients' practice, secondaryOutcomes measure: Providers' knowledge, secondaryOutcomes measure: Providers' attitude, secondaryOutcomes measure: Providers' practice, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Assiut University, status: RECRUITING, city: Assiut, zip: 71515, country: Egypt, contacts name: mahmoud abdelaleem, Doctorate, role: CONTACT, phone: +201018880201, email: mahmaleem2000@yahoo.co.uk, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False
protocolSection identificationModule nctId: NCT06273631, orgStudyIdInfo id: 2022-SR-481, briefTitle: Effect of Changes in Carbohydrate Intake on Glucose Control in Patients With Type 1 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Yang Tao, class: OTHER, descriptionModule briefSummary: The blood glucose fluctuates greatly in T1DM patients, especially in the middle and late stages of the disease, and carbohydrate (CHO) is the main determinant of postprandial glucose response (PGR). Based on the previous investigation to understand how nutritional habits affect blood glucose control, we will conduct dietary intervention studies in T1DM patients to explore whether the adjustment of dietary pattern is beneficial to blood glucose control, and further explore the relevant mechanism through the detection of related metabolic indicators., conditionsModule conditions: Type 1 Diabetes, conditions: Diet Intervention, conditions: Glucose Control, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: multiple-diverse carbohydrate diet, interventions name: middle carbohydrate diet, outcomesModule primaryOutcomes measure: Change of time in range (TIR), secondaryOutcomes measure: Change of coefficient of variation of blood glucose（CV）, secondaryOutcomes measure: Change of mean amplitude of glycemic excursions（MAGE）, secondaryOutcomes measure: Change in large amplitude of glycemic excursions (LAGE) from baseline, secondaryOutcomes measure: Change in GA（glycosylated albumin）from baseline, secondaryOutcomes measure: Change in HbA1c from baseline, secondaryOutcomes measure: Change in 1,5-anhydroglucitol (1,5-AG) from baseline, secondaryOutcomes measure: Change in time above range(TAR) from baseline, secondaryOutcomes measure: Change in time below range(TBR) from baseline, secondaryOutcomes measure: Change in total insulin dose from baseline, secondaryOutcomes measure: Change in blood lipids from baseline, secondaryOutcomes measure: Change in body weight from baseline, secondaryOutcomes measure: Change in Incidence of hypoglycemic events from baseline, secondaryOutcomes measure: Change in gut microbiota from baseline, secondaryOutcomes measure: Change in metabolomics from baseline, secondaryOutcomes measure: Change in autoimmunity from baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False