hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06369818, orgStudyIdInfo id: AnIt23-02, briefTitle: Correlation of Cardiac Output Determined by Echocardiography and Indirect Calorimetry in Critically Ill Patients in Cardiogenic Shock on Extracorporeal Circulatory Life Support, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Universität Münster, class: OTHER, descriptionModule briefSummary: This observational study investigates whether the daily measured trend of cardiac output as evaluated by indirect calorimetry correlates with the same evaluated by transthoracic echocardiography., conditionsModule conditions: Cardiogenic Shock, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Correlation of t two methods of determining cardiac output (determined by transthoracic echocardiography and determined by indirect calorimetry, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Münster, city: Münster, zip: 48149, country: Germany, contacts name: Thilo von Groote, MD, role: CONTACT, phone: +49-251-47255, geoPoint lat: 51.96236, lon: 7.62571, hasResults: False
protocolSection identificationModule nctId: NCT06369805, orgStudyIdInfo id: 2021-00731, briefTitle: EVALUATION OF BLOOD BIOMARKER-BASED DIAGNOSTIC AID IN OUTPATIENTS SUFFERING FROM DEPRESSION, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-02, primaryCompletionDateStruct date: 2022-11-17, completionDateStruct date: 2022-11-17, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Les Toises - Psychiatry and Psychotherapy Center, class: OTHER, descriptionModule briefSummary: This is an observational (non-interventional) study, carried out in an outpatient setting, which involves a blood sampling. The primary objective of this study is to confirm the association between the EDIT-B® editing signature and early unipolar or bipolar differentiation. Results of this research may provide an aid to early diagnosis and guide clinical practice towards individualized treatment., conditionsModule conditions: Depressive Disorder, conditions: Bipolar Disorder, conditions: Bipolar Depression, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 307, type: ACTUAL, armsInterventionsModule interventions name: there is no intervention, outcomesModule primaryOutcomes measure: Psychiatric symptomatology, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Les Toises - Psychiatry and Psychotherapy Center, city: Lausanne, zip: 1005, country: Switzerland, geoPoint lat: 46.516, lon: 6.63282, hasResults: False
protocolSection identificationModule nctId: NCT06369792, orgStudyIdInfo id: 2020-00266, briefTitle: PROSPECTIVE EVALUATION OF BLOOD BIOMARKERS AS AN AID TO DIAGNOSTIC AND TREATMENT IN DRUG-NAIVE PATIENTS WITH DEPRESSION, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-10-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Les Toises - Psychiatry and Psychotherapy Center, class: OTHER, descriptionModule briefSummary: This is an observational (non-interventional) prospective study, carried out in drug-naïve outpatients who start a treatment with escitalopram, fluoxetine, sertraline or quetiapine. Five blood samples are collected (i.e. before initiating the drug, and then after 1, 2, 4 and 8 weeks of treatment). It does not affect the choice or the treatment dose. The primary objective of this study is to measure the association between the EDIT-B® editing signature and response to pharmacological treatment in drug-naïve patients. Results of this research could provide an aid to early diagnosis, optimize pharmacological treatment and guide clinical practice towards individualized treatment., conditionsModule conditions: Depressive Disorder, conditions: Bipolar Disorder, conditions: Bipolar Depression, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: psychiatric symptomatology, primaryOutcomes measure: EDIT-B profiling, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Les Toises - Psychiatry and Psychotherapy Center, status: RECRUITING, city: Lausanne, zip: 1005, country: Switzerland, contacts name: Aurélie Reymond-Delacrétaz, PhD, role: CONTACT, phone: +41584580580, email: aurelie.delacretaz@lestoises.ch, geoPoint lat: 46.516, lon: 6.63282, hasResults: False
protocolSection identificationModule nctId: NCT06369779, orgStudyIdInfo id: OTCS 36406866, briefTitle: Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ivoclar Vivadent AG, class: INDUSTRY, descriptionModule briefSummary: The overall objective of this clinical investigation is to evaluate the clinical safety and performance of the new flowable composite TM Flow and the new sculptable composite TM Fill for restoration of class I and class II cavities. The fillings are assessed according to selected FDI criteria at baseline (7-10 days after placement of filling) and after 1, 6, 12, 24, 36 and 60 months., conditionsModule conditions: Class I or II Cavities in Premolars or Molars, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: TM Fill and TM Flow, outcomesModule primaryOutcomes measure: Postoperative hypersensitivity, secondaryOutcomes measure: evaluation of functional (e.g. fracture of the material and retention), biological (e.g. caries at restoration margins) and aesthetic (e.g. color match) properties of the restorations, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06369766, orgStudyIdInfo id: 2023-02144; ko23Papadopoulou4, briefTitle: REtinal Markers In Neuroinflammatory Diseases ("REMIND"), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2029-02, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, collaborators name: University of Basel, descriptionModule briefSummary: The goal of this observational study, including patients with Multiple Sclerosis, patients with other neuroinflammatory diseases and healthy controls, is to determine the predictive value of retinal markers in predicting disease progression. Participants complete a questionnaire and undergo various non-invasive retinal routine clinical examinations., conditionsModule conditions: Multiple Sclerosis, conditions: Neuroinflammatory Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Optical coherence tomography (OCT), interventions name: Static retinal vessel analyzer, interventions name: Dynamic retinal vessel analyzer, interventions name: Laser speckle flowgraphy system, interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Occurence of Progression Independent of Relapse Activity (PIRA), primaryOutcomes measure: Neuroaxonal loss in the retina (as marker of neurodegeneration in the CNS), primaryOutcomes measure: Neuroinflammation in the retina, primaryOutcomes measure: Fixation instability (as marker of global neuronal dysfunction in the CNS), primaryOutcomes measure: Structural changes of the retinal vessels (as marker of systemic microvascular health), primaryOutcomes measure: (For a subgroup of participants) Functional/perfusional changes of the retinal vessels, secondaryOutcomes measure: Relative value of retinal markers for the prediction of PIRA compared to or combined with other biomarkers of neuroaxonal damage, secondaryOutcomes measure: Comparison of the examined retinal markers of Multiple Sclerosis patients with Healthy Controls and with patients with other neuroinflammatory diseases of the CNS, secondaryOutcomes measure: The relationship between neuroaxonal loss, functional deficits and vascular changes in Multiple Sclerosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Basel, Department of Neurology, status: RECRUITING, city: Basel, zip: 4031, country: Switzerland, contacts name: Athina Papadopoulou, PD Dr. med., role: CONTACT, phone: +41 61 32 85704, email: Athina.Papadopoulou@usb.ch, contacts name: Athina Papadopoulou, PD Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False
protocolSection identificationModule nctId: NCT06369753, orgStudyIdInfo id: PR(AG)459/2023B, briefTitle: Visible Abdominal Distension, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Hospital Universitari Vall d'Hebron Research Institute, class: OTHER, descriptionModule briefSummary: Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique. In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical.Aim. To prove the efficacy of a noninstrumental biofeedback technique, transmitted by a standard training program, for the treatment of abdominal distension in different centers.Selection criteria. Episodes of visible abdominal distension. Intervention. Patients will be randomized into biofeedback and placebo groups. Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period.Biofeedback: Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.Placebo: Sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period., conditionsModule conditions: Irritable Bowel Syndrome, conditions: Dyspepsia, conditions: Functional Bloating, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Biofeedback, interventions name: Placebo, outcomesModule primaryOutcomes measure: Visible abdominal distension, secondaryOutcomes measure: Sensation of abdominal pressure/fullness, secondaryOutcomes measure: Sensation of abdominal discomfort/pain, otherOutcomes measure: Follow-up after biofeedback, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitari Vall d'Hebron, city: Barcelona, zip: 08035, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
protocolSection identificationModule nctId: NCT06369740, orgStudyIdInfo id: ENZ20-2024-INDIANAPOLIS, briefTitle: Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia A Monitoring, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-06-04, completionDateStruct date: 2024-06-04, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Enzyre B.V., class: INDUSTRY, collaborators name: Indiana Hemophilia & Thrombosis Center, descriptionModule briefSummary: This observational study consists of two parts.In part one, case scenario focus groups with hemophilia A patients and healthcare providers (HCPs) will be held. This parts aims to identify potential use scenarios of a point of care (POC) in vitro medical for patients with hemophilia A. The main questions it aims to answer are:* How is coagulation lab testing for patients with hemophilia A currently organized?* What is the interest and what are desired alternatives of a POC in-vitro diagnostic medical device for patients with hemophilia A?Part two of the study consists of a use scenario study in which patients with hemophilia A and HCPs will evaluate two types of non-functional mock-ups of a POC in vitro medical device. The main goal of this part is to evaluate the usability of the current prototypes of the POC device., conditionsModule conditions: Hemophilia A, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Case scenarios - questionnaire, interventions name: Case scenarios - Focus groups, interventions name: Use scenarios - Usability test, interventions name: Use scenarios - interview, outcomesModule primaryOutcomes measure: Current management of Hemophilia A coagulation lab testing, primaryOutcomes measure: Potential case scenarios for a point of care in-vitro diagnostic device for hemophilia A, primaryOutcomes measure: Usability issues of the current POC in-vitro diagnostic device prototypes, secondaryOutcomes measure: User preferences for the point of care in-vitro diagnostic device, secondaryOutcomes measure: Problems with current Hemophilia A coagulation monitoring, secondaryOutcomes measure: Potential benefits of a POC device for home use, near-patient use or in clinic use, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Indiana Hemophilia & Thrombosis Center, city: Indianapolis, state: Indiana, zip: 46260, country: United States, geoPoint lat: 39.76838, lon: -86.15804, hasResults: False
protocolSection identificationModule nctId: NCT06369727, orgStudyIdInfo id: MOB015B-VI, briefTitle: Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design, acronym: RIPT, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-10-15, primaryCompletionDateStruct date: 2018-02-15, completionDateStruct date: 2018-02-15, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Moberg Pharma AB, class: INDUSTRY, descriptionModule briefSummary: A Randomized, Controlled Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design To evaluate the sensitization potential, conditionsModule conditions: Erythema, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: NA- Safety study, enrollmentInfo count: 250, type: ACTUAL, armsInterventionsModule interventions name: MOB015B, interventions name: MOB015B vehicle, interventions name: Negative irritant solution of 0.9% saline, outcomesModule primaryOutcomes measure: To determine the potential of MOB015B to induce sensitization by repeated topical application to the healthy skin of humans under controlled conditions., primaryOutcomes measure: To assess safety, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: TKL Research, Inc, city: Fair Lawn, state: New Jersey, zip: 07410, country: United States, geoPoint lat: 40.94038, lon: -74.13181, hasResults: False
protocolSection identificationModule nctId: NCT06369701, orgStudyIdInfo id: C.2024.019, briefTitle: Effects Compressive Tissue Flossing on Lateral Elbow Tendinopathy in US Service Members, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Brooke Army Medical Center, class: FED, descriptionModule briefSummary: The purpose of this research study will be to assess the effects of a compressive tissue flossing (CTF) program on the symptoms of lateral elbow tendinopathy in United States service members. Dependent variables will be the Defense and Veteran's Pain Rating Scale (DVPRS), decrease their Patient-Rated Tennis Elbow Evaluation (PRTEE) score, increase their maximal grip strength in the affected upper extremity (UE). Measurements will be taken at baseline, immediately after the first CTF intervention, and at the 1-week follow-up, for a total of 3 measurements., conditionsModule conditions: Lateral Elbow Tendinopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Within-subjects repeated measures design, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Compressive tissue floss band, outcomesModule primaryOutcomes measure: Patient's report of pain on the Defense and Veteran's Pain Rating Scale, primaryOutcomes measure: Patient-Rated Tennis Elbow Evaluation, primaryOutcomes measure: Maximal grip strength in the affected upper extremity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brooke Army Medical Center, status: RECRUITING, city: Fort Sam Houston, state: Texas, zip: 78234, country: United States, contacts name: Carly R Cooper, PhD, role: CONTACT, phone: 210-808-2240, email: carly.r.cooper2.mil@health.mil, contacts name: Brian T Gregg, PhD, role: CONTACT, phone: (210) 808-2269, email: brian.t.gregg.mil@health.mil, contacts name: John E Elam, DSc Fellow, role: PRINCIPAL_INVESTIGATOR, contacts name: Carly R Cooper, PhD, role: SUB_INVESTIGATOR, contacts name: Katelyn A Culley, DSc Fellow, role: SUB_INVESTIGATOR, contacts name: Tara A Haugen, DSc Fellow, role: SUB_INVESTIGATOR, geoPoint lat: 29.45746, lon: -98.4472, hasResults: False
protocolSection identificationModule nctId: NCT06369675, orgStudyIdInfo id: MOB015B-V, briefTitle: Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design, acronym: CIPT, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-10-19, primaryCompletionDateStruct date: 2017-11-14, completionDateStruct date: 2017-11-14, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Moberg Pharma AB, class: INDUSTRY, descriptionModule briefSummary: A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design To evaluate the irritation potential of MOB015B on normal skin. Single center, randomized, controlled, evaluator blinded, within-subject comparison study, conditionsModule conditions: Erythema, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ACTUAL, armsInterventionsModule interventions name: MOB015B, interventions name: 0.2% SLS, interventions name: 0.9% Saline, interventions name: MOB015B vehicle, outcomesModule primaryOutcomes measure: To determine the potential of MOB015B to cause skin irritation after repeated topical application to the healthy skin of humans under controlled conditions., primaryOutcomes measure: To assess safety, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: TKL Research, Inc, city: Fair Lawn, state: New Jersey, zip: 07410, country: United States, geoPoint lat: 40.94038, lon: -74.13181, hasResults: False
protocolSection identificationModule nctId: NCT06369662, orgStudyIdInfo id: SECI-CD155, secondaryIdInfos id: SECI-IRB-IORG0006563-545, type: OTHER, domain: Scientific Research Unit, briefTitle: CD155 Expression in Acute Myeloid Leukemia, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy. It is the most common form of acute leukemia among adults. In the United States, an estimated 19,940 people will be diagnosed with AML in 2020.CD155 expression was associated with an unfavorable prognosis in solid tumors such as colon cancer, breast cancer, lung adenocarcinoma, pancreatic cancer, melanoma, and glioblastoma, as it correlated with tumor migration, development of metastases, tissue and lymph node invasion, relapse, and poorer survival., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 93, type: ACTUAL, armsInterventionsModule interventions name: Flow cytometric immunophenotyping, interventions name: Complete blood count, interventions name: Bone marrow aspiration, interventions name: Cytogenetic testing, interventions name: FLT3-ITD using High resolution melting curve (HRM) analysis, outcomesModule primaryOutcomes measure: CD155 expression level in AML patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: South Egypt Cancer Institute, Assiut University, city: Assiut, zip: 71111, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False