hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06291142, orgStudyIdInfo id: R129030, secondaryIdInfos id: IRAS 315004, type: OTHER, domain: IRAS, briefTitle: Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-11-22, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Manchester, class: OTHER, collaborators name: National Institute for Health Research, United Kingdom, collaborators name: Royal Bolton Hospital NHS Foundation Trust, collaborators name: Alder Hey Children's NHS Foundation Trust, collaborators name: University Hospitals of Morecambe Bay NHS Trust, collaborators name: Stockport NHS Foundation Trust, collaborators name: Medway NHS Foundation Trust, collaborators name: Northern Care Alliance NHS Foundation Trust, collaborators name: Royal Free Hospital NHS Foundation Trust, descriptionModule briefSummary: The goal of this observational pilot data acquisition study is to establish if target users can obtain diagnostic quality images in the clinic, from participants with Systemic Sclerosis (SSc), and SSc spectrum conditions. The main questions it aims to answer are:* Can a range of healthcare professionals, including non-specialists, use the capillaroscopy image acquisition system to take high quality images that can be used to create a clinical report?* Can the investigators collect user and patient feedback on the usability of the capillaroscopy system, to help develop the software and to develop the clinical report* Which microscope light source, from four different light wavelengths is better to see the blood vessels in skin with more melanin content.Participants will be asked to attend a single clinic visit where they will undergo a brief, non-invasive nailfold capillaroscopy examination, using the software-guided capillaroscopy system.Participants and rheumatology healthcare professionals will be invited to take part in one or more focus groups and interviews, to collect feedback and to contribute to the development of the image acquisition software and the clinical report., conditionsModule conditions: Systemic Sclerosis, conditions: Raynaud Phenomenon, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: Observation - Nailfold capillaroscopy, outcomesModule primaryOutcomes measure: Pilot Image Acquisition, secondaryOutcomes measure: Qualitative Feedback, secondaryOutcomes measure: Skin tone sub-study data set, eligibilityModule sex: ALL, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northern Care Alliance NHS Foundation Trust, city: Salford, zip: M6 8HD, country: United Kingdom, geoPoint lat: 53.48771, lon: -2.29042, hasResults: False
protocolSection identificationModule nctId: NCT06291129, orgStudyIdInfo id: CAAE: 61347422.4.0000.5626, briefTitle: Gingival Health and Malocclusion Among Type 1 Diabetic Children and Adolescents, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-10-30, primaryCompletionDateStruct date: 2023-10-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Universidade Federal Fluminense, class: OTHER, descriptionModule briefSummary: Introduction: This study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes. Methods: The sample consisted of 36 children, who were distributed into two groups: DM; n=18 and NDM; n=18. Periodontal parameters considered were plaque Index (PI), gingival Index (GI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL). Gingival biotype clinical parameters: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars. Malocclusion were evaluated by the Dental Aesthetic Index (DAI) and the Angle's Classification. The statistical analyses were Shapiro Wilk test and T test., conditionsModule conditions: Gingivitis, conditions: Periodontal Diseases, conditions: Diabetes, conditions: Diabetes Mellitus, Type 1, conditions: Malocclusion, conditions: Malocclusion in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Periodontal therapy, outcomesModule primaryOutcomes measure: Bleeding on probing, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Universidade Federal Fluminense, city: Nova Friburgo, state: Rio De Janeiro, zip: 28625650, country: Brazil, geoPoint lat: -22.28194, lon: -42.53111, hasResults: False
protocolSection identificationModule nctId: NCT06291116, orgStudyIdInfo id: 2022/0345/HP, briefTitle: Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease, acronym: ETERNAL-PKD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-01, primaryCompletionDateStruct date: 2029-05-01, completionDateStruct date: 2029-05-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease linked to mutation of the PKD1 or PKD2 genes encoding polycystins 1 and 2. Patients develop renal cysts with progressive impairment of renal function leading to renal failure. terminal renal failure for 1/3 of them. These patients also present early with high blood pressure and cardiovascular complications, notably intracerebral aneurysms. This phenotype is linked to abnormal polycystins on the cilia of renal epithelial and vascular endothelial cells which no longer ensure the mechanotransduction of shear forces linked to urinary and blood flow leading to the modification of numerous cellular functions.Experimental results suggested that stimulation of dopamine receptor type 5 (DR5) could restore the mechanosensitivity of endothelial cells, a hypothesis supported by our first results showing that local administration of dopamine improves endothelial function in patients with ADPKD. through restoration of endothelial NO release upon increased blood flow. Similar positive results on endothelial function and hemodynamics were recently obtained in the IMPROVE-PKD study with rotigotine, a dopamine agonist administered via transdermal patches for 2 months at a low dose (4 mg/24h).Dopaminergic stimulation could also prevent abnormalities linked to polycystin deficiency at the renal level and we therefore hypothesize that rotigotine could slow the progression of ADPKD both at the renal and cardiovascular levels.This phase 2 study aims to ensure the good long-term tolerance of rotigotine in patients with ADPKD and to collect preliminary data on its renal impact., conditionsModule conditions: Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: standard care + rotigotine at 4 mg/24h for 24 months., interventions name: standard care for 24 months., outcomesModule primaryOutcomes measure: Evaluate the safety and tolerability of rotigotine administered at a dose of 4 mg/24h for 24 months in patients with ADPKD, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06291090, orgStudyIdInfo id: 22-0789, secondaryIdInfos id: K08DA049905, type: NIH, link: https://reporter.nih.gov/quickSearch/K08DA049905, briefTitle: A Multi-site Intervention to Expand Hospital Based OUD Treatment Provision, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-18, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD., conditionsModule conditions: Opioid Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This intervention will be implemented across 12 hospitals, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: OUD treatment intervention, outcomesModule primaryOutcomes measure: Change in buprenorphine prescribing at hospital discharge, secondaryOutcomes measure: Change in rates of methadone prescribing during hospitalization, otherOutcomes measure: Change in average (mean) COWS score over time, otherOutcomes measure: Change in naloxone prescribing at hospital discharge, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado Anschutz Medicl Campus, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Susan L Calcaterra, MD, role: CONTACT, phone: 248-703-5947, email: susan.calcaterra@cuanschutz.edu, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False
protocolSection identificationModule nctId: NCT06291077, orgStudyIdInfo id: 2021/0391/HP, briefTitle: Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO>, acronym: BELAFENDO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-01, primaryCompletionDateStruct date: 2028-01-01, completionDateStruct date: 2028-01-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: Kidney transplantation is the standard treatment for patients with end-stage renal failure.However, anticalcineurin inhibitors, the most widely used immunosuppressants, are involved in the occurrence of cardiovascular events, a major cause of premature death in these patients. They play an important role in the occurrence of endothelial dysfunction and increased arterial stiffness by decreasing the synthesis of nitric oxide (NO), promoting intrarenal arterial vasoconstriction and stimulating the production of pro-inflammatory cytokines. leading to the development of hypertension and chronic graft dysfunction.Belatacept, a more recently developed immunosuppressant and co-stimulation signal inhibitor, has shown an anti-rejection effect similar to cyclosporine with a better cardiovascular tolerance profile. Preliminary studies are contradictory on the influence of Belatacept on arterial stiffness. Furthermore, to date, no study has evaluated the impact of Belatacept on vasomotor endothelial function in humans, an indicator of NO bioavailability. The interest of this study is to demonstrate that patients taking Belatacept have an improvement in vascular function compared to patients taking anticalcineurins in order to consider an earlier change in immunosuppressive strategy in the event of vascular damage., conditionsModule conditions: Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Belatacept, interventions name: anticalcineurins, outcomesModule primaryOutcomes measure: Replacement of anticalcineurins with Belatacept in kidney transplant patients allows an improvement in the endothelium-dependent dilation of peripheral conductance arteries, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06291064, orgStudyIdInfo id: IRB23-0678, briefTitle: Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer, acronym: TARMAC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2029-06, completionDateStruct date: 2032-06, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, descriptionModule briefSummary: The primary purpose of this study is to determine what proportion of participants will achieve complete pathological response with epirubicin+ cyclophosphamide followed by docetaxel +carboplatin. This will also examine the potential of using signals in the blood (biomarkers) to identify resistance to chemotherapy in Nigerian women with triple negative breast cancer (TNBC).All enrollment to this trial will occur at sites in Nigeria. University of Chicago is serving as coordinating center and will be involved in data analysis., conditionsModule conditions: Triple Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: Cyclophosphamide, interventions name: Epirubicin, interventions name: Docetaxel, interventions name: Carboplatin, interventions name: Breast Surgery, interventions name: Capecitabine, outcomesModule primaryOutcomes measure: Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Breast), primaryOutcomes measure: Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Lymph Nodes), primaryOutcomes measure: Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (By Stage), secondaryOutcomes measure: Side Effects of the Study Pre-surgery Chemotherapy Regimen, secondaryOutcomes measure: Clinical Response, secondaryOutcomes measure: Progressive Disease, secondaryOutcomes measure: Invasive Disease Free Survival (iDFS), secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Heart Related Side Effects of the Pre-Surgery Chemotherapy Regimen, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06291038, orgStudyIdInfo id: 2021/0381/HP, briefTitle: Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel Syndrome With Impaired Intestinal Permeability, acronym: MISSISIIPI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2029-03-01, completionDateStruct date: 2029-03-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: Irritable bowel syndrome (IBS) affects approximately 5% of the general population and remains a daily problem in the practice of clinicians with inconsistent effectiveness of treatments while patients' expectations are high.One of the functional abnormalities described during IBS is increased intestinal permeability. This increase in intestinal permeability is primarily present in the diarrheal subtype (IBS-D) and can be measured using the lactulose/mannitol test.Glutamine is a non-essential amino acid which regulates numerous metabolic pathways, and which plays a key role in the intestine because it is the preferential substrate of enterocytes and immune cells. Ex vivo, glutamine is able to restore the expression of tight junction proteins in patients suffering from IBS-D. On the other hand, glutamine supplementation is capable of reducing abdominal pain and restoring intestinal permeability disorders in a subgroup of patients with intestinal permeability disorder (post-infectious IBS-D).Our working hypothesis would be that all patients suffering from IBS with permeability disorder, measured by the lactulose/mannitol test, could benefit from oral glutamine supplementation., conditionsModule conditions: Irritable Bowel Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicentric; prospective; randomized; double blind; interregional, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: double blind, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks, interventions name: • Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks., outcomesModule primaryOutcomes measure: Evaluate the symptomatic effectiveness of glutamine supplementation in patients suffering from IBS-D with increased intestinal permeability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06291012, orgStudyIdInfo id: RECHMPL22_0399, secondaryIdInfos id: 2024-512236-30-00, type: REGISTRY, domain: EUCT Number, briefTitle: Stopping Pneumonia Antibiotherapy Regimen Early, acronym: SPARE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-09-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, collaborators name: Direction Générale de l'Offre de Soins, descriptionModule briefSummary: The hypothesis for this trial is that an antibiotic strategy for the management of non-severe community-acquired alveolar pneumonia in children aged 3 to 59 months, including amoxicillin 80-100 mg/kg/day for at least 3 days in case of rapid response and 5 days in case of delayed response, would not be inferior to current French recommendations (antibiotic therapy for 5 days in case of rapid response and 7 days in case of delayed response) in terms of treatment of failure rate at 7 days., conditionsModule conditions: Community-acquired Pneumonia, conditions: Child, Only, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The randomization will be carried out by minimization with stratification on the investigating center and age (\< 1 year and ≥ 1 year), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: CARE_PROVIDER, enrollmentInfo count: 1100, type: ESTIMATED, armsInterventionsModule interventions name: Quick response: Amoxicillin for 3 days, interventions name: Delayed response: Amoxicillin for 5 days, interventions name: Quick response: Amoxicillin for 5 days, interventions name: Delayed response: Amoxicillin for 7 days, outcomesModule primaryOutcomes measure: Therapeutic failure rate D7, secondaryOutcomes measure: Therapeutic failure rate on D30, secondaryOutcomes measure: Adverse effects, secondaryOutcomes measure: Compliance, secondaryOutcomes measure: Duration of antibiotic therapy, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 59 Months, stdAges: CHILD, contactsLocationsModule locations facility: CHU de Montpellier, city: Montpellier, zip: 34295, country: France, contacts name: Sarah DUTRON, MD, role: CONTACT, contacts name: Sarah DUTRON, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Eric JEZIORSKI, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False
protocolSection identificationModule nctId: NCT06290999, orgStudyIdInfo id: CHUBX 2023/80, briefTitle: Study of Multifrequential Impedancemetry in Pulsatile Tinnitus, acronym: MADMAN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-09-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University Hospital, Bordeaux, class: OTHER, descriptionModule briefSummary: This study intended to search for a relationship between the multifrequential admittancemetry and the pulsatile tinnitus., conditionsModule conditions: Pulsatile Tinnitus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: multifrequential admittancemetry, outcomesModule primaryOutcomes measure: Multifrequency admittancemetry, secondaryOutcomes measure: compression maneuvers, secondaryOutcomes measure: Evaluation of the effect of interventional radiology, secondaryOutcomes measure: success of radiointerventional treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bordeaux University Hospital, city: Bordeaux, zip: 33000, country: France, contacts name: Balthazar CROC, role: CONTACT, email: balthazar.croc@chu-bordeaux.fr, contacts name: Valérie FRANCO-VIDAL, Pr, role: CONTACT, phone: 0556795609, email: valerie.vidal@chu-bordeaux.fr, geoPoint lat: 44.84044, lon: -0.5805, hasResults: False