hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06281249, orgStudyIdInfo id: 73172, briefTitle: Neuraxial Ultrasound Device Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, collaborators name: Rivanna Medical, Inc., descriptionModule briefSummary: The aim of the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an experimental device (Accuro 3S). Investigators will verify the clinical workflow for utilizing the Accuro 3S during epidural and spinal procedures and validation of needle visualization while using the device as well as anatomical guidance provided by the device during spinal imaging.The underlying bone imaging enhancement algorithms were introduced in the commercially available FDA approved Accuro. The Accuro 3S will be used to establish needle insertion point and trajectory, after which the clinician will use standard of care methods to advance the needle such as the loss of resistance method., conditionsModule conditions: Labor Pain, conditions: Cesarean Delivery Regional Anesthesia Induction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound placement device, outcomesModule primaryOutcomes measure: Incidence of difficult block placement, secondaryOutcomes measure: Incidence of failed block, secondaryOutcomes measure: Incidence of post-dural puncture headache, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanford University, city: Stanford, state: California, zip: 94305, country: United States, geoPoint lat: 37.42411, lon: -122.16608, hasResults: False
protocolSection identificationModule nctId: NCT06281236, orgStudyIdInfo id: SPI-62-CL-1002, briefTitle: A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Sparrow Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited., conditionsModule conditions: Polymyalgia Rheumatica, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Prednisolone, interventions name: SPI-62, outcomesModule primaryOutcomes measure: Erythrocyte sedimentation rate, primaryOutcomes measure: C-reactive protein, primaryOutcomes measure: Plasma fibrinogen, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emovis Gmbh, city: Berlin, country: Germany, contacts name: Anna Wieczorek, role: CONTACT, phone: +49 30 439741221, email: anna.wieczorek@futuremeds.com, contacts name: Frank Zollmann, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Klinische Forschung Hannover Mitte GmbH/Pratia, city: Hannover, zip: 30159, country: Germany, contacts name: Matilde Planer, role: CONTACT, phone: +49 511 169 7650, email: matilde.planer@pratia.com, contacts name: Jan Wagner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37052, lon: 9.73322, locations facility: Klinische Forschung Schwerin GmbH/Pratia, city: Schwerin, zip: 19055, country: Germany, contacts name: Julia Grindel, role: CONTACT, phone: +49 385 557 740, email: julia.grindel@pratia.com, contacts name: Charlotte von Engelhardt, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.62937, lon: 11.41316, hasResults: False
protocolSection identificationModule nctId: NCT06281223, orgStudyIdInfo id: JBR_2023_9, briefTitle: Study of Brain-spinal Cord Neural Connectivity in Spasticity, acronym: MOVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fondation Ophtalmologique Adolphe de Rothschild, class: NETWORK, descriptionModule briefSummary: Little is known about the peripheral and central mechanisms of action of selective dorsal rhizotomy surgery for the treatment of spasticity. A better understanding of these mechanisms will enable us to improve the surgical procedure. This will require cortico-medullo-radiculo-muscular recordings never before performed and published in the literature, and the identification of variations in connectivity correlated with the clinic., conditionsModule conditions: Spasticity, Muscle, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: intraoperative neuroelectrophysiological monitoring, outcomesModule primaryOutcomes measure: variation in "spontaneous/resting" cortico-medullo-radiculo-muscular synchronization before and after selective rhizotomy surgery, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 17 Years, stdAges: CHILD, hasResults: False
protocolSection identificationModule nctId: NCT06281210, orgStudyIdInfo id: IEO 2034, briefTitle: Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery, acronym: BETTY-CRASY, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-11, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT., conditionsModule conditions: Breast Cancer, conditions: Triple Negative Breast Cancer, conditions: HER2-positive Breast Cancer, conditions: Neoadjuvant Chemotherapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 77, type: ESTIMATED, armsInterventionsModule interventions name: Omission of surgical treatment, outcomesModule primaryOutcomes measure: Event-free survival, secondaryOutcomes measure: Positive predictive value of MRI, secondaryOutcomes measure: Contrast-Enhanced Mammography (CEM) positive predictive value, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto di Candiolo IRCCS, status: NOT_YET_RECRUITING, city: Candiolo, state: Turin, zip: 10060, country: Italy, contacts name: Antonio Toesca, MD, role: CONTACT, geoPoint lat: 44.95858, lon: 7.59812, locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, zip: 20141, country: Italy, contacts name: Elisabetta Rossi, MD, role: CONTACT, phone: +390294372191, email: ElisabettaMariaCristina.Rossi@ieo.it, contacts name: Mara Negri, role: CONTACT, email: mara.negri@ieo.it, contacts name: Elisabetta Rossi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06281197, orgStudyIdInfo id: 2021/48, briefTitle: Does Subspinal Le Fort I Osteotomy Affect the Nasal Airway Volume, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-15, primaryCompletionDateStruct date: 2021-08-15, completionDateStruct date: 2022-05-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: After the description of Le Fort fractures, maxillary osteotomies are used to correct dentofacial deformities. The profile changes on nasolabial region resulting from a Le Fort I osteotomy, also that affects nasal airway. The Subspinal Le Fort I osteotomy (SLFIO) describe to prevent undesirable soft tissue changes. In the literature, too many articles have reported the effectiveness of SLFIO in preventing nasal deformation. However, there is no study to evaluate the nasal volume or septum deviation., conditionsModule conditions: Maxillofacial Abnormalities, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: double blind, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: double blind, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 47, type: ACTUAL, armsInterventionsModule interventions name: Conventional, interventions name: Subspinal, outcomesModule primaryOutcomes measure: Evaluation of Septum Deviation, primaryOutcomes measure: Evaluation of Nasal Airway, secondaryOutcomes measure: nasal obstruction scale evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Selin Çelebi, city: Kayseri, state: Meligazi, zip: 38320, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False
protocolSection identificationModule nctId: NCT06281184, orgStudyIdInfo id: DIA2024.1, secondaryIdInfos id: 715758, type: REGISTRY, domain: Regional committee for medical and health research ethics, briefTitle: A Post-trial Follow-up of MERINO Participants to Evaluate Long-term Effects of Methotrexate Treatment in Adults With Erosive Hand OA., acronym: MERINO:2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Diakonhjemmet Hospital, class: OTHER, descriptionModule briefSummary: In response to the high prevalence of synovitis in hand osteoarthritis (OA) and its association with pain, there\&amp;#39;s a compelling rationale for investigating the efficacy of MTX in managing inflammatory erosive hand OA. Recent guidelines highlight the need for large, well-designed trials to assess the effectiveness of MTX. A recent trial (METHODS study) showed promising pain reduction with MTX, but due to pandemic-related protocol changes, the duration of the study was limited to six months. The ongoing MERINO trial randomizes participants to MTX or placebo for one year. After completing the MERINO trial, several participants asked for MTX open label. In the subsequent MERINO:2 study, participants completing the trial will be invited to a structured follow-up after one year, including electronic questionnaires and hand radiographs, providing valuable long-term data on the effects of MTX in hand OA. Together, these trials aim to fill gaps in understanding the long-term impact of MTX in hand OA, particularly on structural progression., conditionsModule conditions: Hand Osteoarthritis, conditions: Erosive Osteoarthritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Methotrexate, interventions name: No treatment, outcomesModule primaryOutcomes measure: Effect of MTX on radiographic progression of erosive hand OA., secondaryOutcomes measure: Effect of MTX on pain, function and life quality, secondaryOutcomes measure: Effect of MTX on radiographic progression of hand OA., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Diakonhjemmet Hospital, city: Oslo, zip: 0319, country: Norway, contacts name: Ida Løchting, role: CONTACT, phone: +4722451500, email: Ida.Lochting@diakonsyk.no, contacts name: Alexander Mathiessen, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.91273, lon: 10.74609, hasResults: False
protocolSection identificationModule nctId: NCT06281171, orgStudyIdInfo id: 90BISB0022, briefTitle: Evaluation of SkillTalk for Autistic Young Adults, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: dfusion Inc, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the effectiveness of using a Microskills video training library for young adults, aged 18-28, with autism spectrum disorder (ASD) to enhance their skills in developing and maintaining healthy relationships.The main questions it aims to answer are:* Does using SkillTalk increase autistic young adults skills in the communications skills that are demonstrated in the video curriculum (skills: resolve conflict, compromise, give feedback)?* Does using SkillTalk increase reported confidence and satisfaction in communication and relationship skills?* Does using SkillTalk increase interpersonal competence?* Does using SkillTalk increase ability to cope with rejection?* Does using SkillTalk improve mental health and wellbeing?Participants will be asked to:* Take a survey at the beginning of the study, after one month the end of the study, and at 3-month follow up* Participate in recorded video calls with projects staff, comprised of 2-3 brief roleplay scenarios of relationship skills at the beginning of the study, after one month the end of the study, and at 3-month follow up* Watch a minimum of 85% of the 60 minutes of video assigned, conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: SkillTalk for Autistic Young Adults, interventions name: Flyer Library, outcomesModule primaryOutcomes measure: Demonstrated Skill Score in communication skills., secondaryOutcomes measure: Participant Confidence & Satisfaction in their communication skills, secondaryOutcomes measure: Interpersonal Competence Score, secondaryOutcomes measure: Coping with Rejection, Jealousy and Relationship Anxiety, secondaryOutcomes measure: Mental Health and Wellbeing, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 28 Years, stdAges: ADULT, contactsLocationsModule locations facility: Virtual Study, city: Santa Cruz, state: California, zip: 95060, country: United States, geoPoint lat: 36.97412, lon: -122.0308, hasResults: False
protocolSection identificationModule nctId: NCT06281158, orgStudyIdInfo id: DNLI-F-0009, briefTitle: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Denali Therapeutics Inc., class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 7, type: ESTIMATED, armsInterventionsModule interventions name: [14C]-DNL343, outcomesModule primaryOutcomes measure: PK Parameter: AUC0-∞, primaryOutcomes measure: PK Parameter: AUC0-tlast, primaryOutcomes measure: PK Parameter: Cmax, primaryOutcomes measure: PK Parameter: Tmax, primaryOutcomes measure: PK Parameter: t1/2, primaryOutcomes measure: Total radioactivity in plasma and whole blood, primaryOutcomes measure: Total radioactivity in blood-to-plasma ratio, primaryOutcomes measure: Extent and rate of recovery of total radioactivity in urine and feces, secondaryOutcomes measure: PK Parameter: AUC0-∞, secondaryOutcomes measure: PK Parameter: AUC0-tlast, secondaryOutcomes measure: PK Parameter: Cmax, secondaryOutcomes measure: PK Parameter: Tmax, secondaryOutcomes measure: PK Parameter: t1/2, secondaryOutcomes measure: DNL343 and a DNL343 metabolite recoveries in urine, secondaryOutcomes measure: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Site, status: RECRUITING, city: Madison, state: Wisconsin, zip: 53704, country: United States, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False
protocolSection identificationModule nctId: NCT06281145, orgStudyIdInfo id: RSV-SK001/UC-SK004/OUSA, briefTitle: Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer, acronym: SRI-BrCa_CRC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-03-15, completionDateStruct date: 2029-03-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Comenius University, class: OTHER, descriptionModule briefSummary: The goal of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in 2 cohorts of patients. Cohort A will evaluate the effect of the addition of HRV BI in patients with breast cancer treated in the neoadjuvant setting (vs. standard of care alone, SOC) followed by local therapy (surgery +/-radiotherapy). Cohort B will evaluate the effect of the addition of HRV BI in patients with colon cancer after surgery in the adjuvant setting (vs. standard of care alone, SOC)., conditionsModule conditions: Breast Cancer, conditions: Colon Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study consists of two cohorts (breasts cancer and colorectal cancer) with two arms SOC + intervention vs SOC alone., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Heart-rate variability biofeedback intervention, outcomesModule primaryOutcomes measure: Primary endpoint - inflammation, primaryOutcomes measure: Primary endpoint - QoL, primaryOutcomes measure: Primary endpoint - executive functions, primaryOutcomes measure: Primary endpoint- salivary cortisol slopes, primaryOutcomes measure: Primary endpoint- sleep quality, primaryOutcomes measure: Primary endpoint - heart rate variability (HRV), primaryOutcomes measure: Primary endpoint - Working memory, secondaryOutcomes measure: Secondary endpoint - Pathologic Complete Response (pCR) and Residual Cancer Burden (RCB) rate in cohort A, secondaryOutcomes measure: Secondary endpoint - Relapse-free Survival (RFS), secondaryOutcomes measure: Secondary endpoint - Overall survival (OS), secondaryOutcomes measure: Secondary endpoint - Serious Adverse Events (SAE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Elizabeth Cancer Institute, status: RECRUITING, city: Bratislava, zip: 81250, country: Slovakia, contacts name: Bela Mrinakova, MD, role: CONTACT, phone: 00421232249111, email: bela.mrinakova@ousa.sk, contacts name: Miriam Hancinova, MD, role: CONTACT, phone: 00421232249111, email: miriam.hancinova@ousa.sk, contacts name: Bela Mrinakova, role: PRINCIPAL_INVESTIGATOR, contacts name: Miriam Hancinova, role: SUB_INVESTIGATOR, geoPoint lat: 48.14816, lon: 17.10674, hasResults: False
protocolSection identificationModule nctId: NCT06281132, orgStudyIdInfo id: A126_03BE2316, briefTitle: Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic After Oral Administration of CKD-341 and D956 in Healthy Adults, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2024-05-07, completionDateStruct date: 2024-05-14, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Chong Kun Dang Pharmaceutical, class: INDUSTRY, descriptionModule briefSummary: The objective was to evaluate and compare the pharmacokinetic profiles and safety after administration of test drug (CKD-341) and reference drugs (D956) in healthy adults., conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: CKD-341, D956, outcomesModule primaryOutcomes measure: area under curve(AUC) of CKD-341, D956, primaryOutcomes measure: Cmax of CKD-341, D956, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Jeonbuk National University Hospital, city: Jeonju, country: Korea, Republic of, geoPoint lat: 35.82194, lon: 127.14889, hasResults: False