hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06303713, orgStudyIdInfo id: 23-693, briefTitle: LuCarbo - a Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-07-19, completionDateStruct date: 2026-07-19, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Dana-Farber Cancer Institute, class: OTHER, collaborators name: Novartis, descriptionModule briefSummary: The purpose of this study is to see whether the combination of a chemotherapy drug, carboplatin, along with the radioligand treatment, 177Lu-PSMA-617, is safe in treating prostate cancer and whether the combination is effective in shrinking or preventing growth of prostate cancer.The names of the study drugs used in this research study are:* Carboplatin (A type of chemotherapy)* 177Lu-PSMA-617 (A type of radioligand therapy), conditionsModule conditions: Prostate Cancer, conditions: Metastatic Prostate Cancer, conditions: Metastatic Castration-resistant Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 37, type: ESTIMATED, armsInterventionsModule interventions name: Carboplatin, interventions name: 177Lu-PSMA-617, outcomesModule primaryOutcomes measure: Maximum tolerated dose (MTD) or the Recommended Phase 2 dose (RP2D) of carboplatin administered in combination with 177Lu-PSMA-617, secondaryOutcomes measure: PSA response rate (PSA reduction by ≥50% from baseline)., secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Radiographic Progression-Free Survival (rPFS), secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beth Israel Deaconess Medical Center, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Daniel Fein, MD, role: CONTACT, phone: 617-667-2100, email: dfein@bidmc.harvard.edu, contacts name: Daniel Fein, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Praful Ravi, MB BCHir, MRCP, role: CONTACT, phone: 617-632-3466, email: Praful_Ravi@DFCI.HARVARD.EDU, contacts name: Praful Ravi, MB BCHir, MRCP, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana-Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Praful Ravi, MB BChir, MRCP, role: CONTACT, phone: 617-632-3466, email: praful_ravi@dfci.harvard.edu, contacts name: Praful Ravi, MB BCHir, MRCP, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
protocolSection identificationModule nctId: NCT06303700, orgStudyIdInfo id: Quality of life, briefTitle: Dyspnea, Risk of Falling and Quality of Life in Adolescents, Youth and Geriatric Groups, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-10, primaryCompletionDateStruct date: 2024-01-31, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Amira Hussin Hussin Mohammed, class: OTHER, descriptionModule briefSummary: To assess the correlation between aspects of the dyspnea scale (indicating poor functionality), the fall efficacy scale (indicating a higher fear of falling), and all aspects of the SF36 (indicating quality of life) in 3 age groups: adolescents, youth, and geriatrics., conditionsModule conditions: Public Health, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 604, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: the severity of dyspnea, primaryOutcomes measure: the level of fear of falling through daily life activities, primaryOutcomes measure: quality of life and public health, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amira Hussin Mohammed, city: Gamasa, zip: 35712, country: Egypt, geoPoint lat: 31.44112, lon: 31.53675, hasResults: False
protocolSection identificationModule nctId: NCT06303687, orgStudyIdInfo id: STUDY00003496, briefTitle: VR-PAT and fNIRS to Identify CNS Biomarkers of Pain, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Nationwide Children's Hospital, class: OTHER, descriptionModule briefSummary: This study aims to use functional near-infrared spectroscopy (fNIRS) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (VR)., conditionsModule conditions: Acute Pain, conditions: Pediatric ALL, conditions: Procedural Pain, conditions: Burns, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants will be randomly assigned to either the intervention (fNIRS and VR-PAT) or the control (fNIRS and standard of care) at the first research dressing change and will then crossover to the alternative group for the second laser procedure., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 4, type: ESTIMATED, armsInterventionsModule interventions name: VR-PAT, outcomesModule primaryOutcomes measure: Change in brain activity, secondaryOutcomes measure: Procedural pain during burn dressing changes, secondaryOutcomes measure: Change in procedural anxiety, secondaryOutcomes measure: Self-reported VR experience, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Nationwide Children's Hospital, city: Columbus, state: Ohio, zip: 43205, country: United States, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
protocolSection identificationModule nctId: NCT06303648, orgStudyIdInfo id: TSND201-PK-101, briefTitle: A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-05-04, completionDateStruct date: 2024-05-11, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Transcend Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects., conditionsModule conditions: Post Traumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Subjects will be enrolled into one of four cohorts. The study will begin enrolling Cohort 1., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Methylone, outcomesModule primaryOutcomes measure: Cmax: Maximum Observed Plasma Concentration for methylone, primaryOutcomes measure: AUC: Area under the plasma concentration-time curve for methylone, secondaryOutcomes measure: Incidence and frequency of adverse events, secondaryOutcomes measure: Change overtime in Visual Analog Scales, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: CMAX Clinical Research, status: RECRUITING, city: Adelaide, state: South Australia, zip: 5000, country: Australia, contacts name: Research Team, role: CONTACT, geoPoint lat: -34.92866, lon: 138.59863, hasResults: False
protocolSection identificationModule nctId: NCT06303635, orgStudyIdInfo id: UFRJvac-1, briefTitle: Safety of UFRJvac, Trivalent COVID-19 Vaccine, acronym: UFRJvac-1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-24, primaryCompletionDateStruct date: 2025-10-16, completionDateStruct date: 2025-11-25, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Azidus Brasil, class: INDUSTRY, collaborators name: Universidade Federal do Rio de Janeiro, descriptionModule briefSummary: Phase I study to evaluate the safety and immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 vaccine., conditionsModule conditions: Healthy People, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 156, type: ESTIMATED, outcomesModule primaryOutcomes measure: Evaluate the safety and reactogenicity of the UFRJvac COVID-19 vaccine booster, secondaryOutcomes measure: Evaluate the safety and reactogenicity of the vaccine booster with the trivalent UFRJvac COVID-19, secondaryOutcomes measure: Evaluate the humoral immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19, secondaryOutcomes measure: Evaluate the humoral immunogenicity of the vaccine booster the trivalent UFRJvac COVID-19, secondaryOutcomes measure: Evaluate the humoral immunogenicity of the vaccine booster with the trivalent UFRJvac, secondaryOutcomes measure: Evaluate the humoral immunogenicity of the vaccine booster trivalent UFRJvac, secondaryOutcomes measure: Evaluate the cellular immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06303622, orgStudyIdInfo id: CRE-2023.610, briefTitle: Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: This study is an international multicentre RCT to compare the linically significant prostate cancer (csPCa) detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 1250, type: ESTIMATED, armsInterventionsModule interventions name: MRI-USG fusion approach, interventions name: Cognitive-guided approach, outcomesModule primaryOutcomes measure: Proportion of men with clinically significant Prostate cancer(csPCa), secondaryOutcomes measure: Proportion of men with a diagnosis of csPCa in MRI lesions with maximal size ≤10mm versus >10mm, secondaryOutcomes measure: Proportion of men with a diagnosis of csPCa in prostate size of ≤50ml vs >50m, secondaryOutcomes measure: The proportion of men with a diagnosis of csPCa only in targeted biopsy, secondaryOutcomes measure: Proportion of men with a diagnosis of csPCa only in systemic biopsy, secondaryOutcomes measure: Proportion of men with a diagnosis of clinically insignificant PCa,, secondaryOutcomes measure: Procedure time, secondaryOutcomes measure: Pain score on a scale of 0-10 taken after biopsy, secondaryOutcomes measure: Proportion of men with post-biopsy adverse events within 30 days after biopsy, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prince of Wales Hospital, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
protocolSection identificationModule nctId: NCT06303609, orgStudyIdInfo id: 61102222.5.0000.5544, briefTitle: Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain Disorder, acronym: Pelvic Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2026-06-20, completionDateStruct date: 2026-07-20, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Centro de Atenção ao Assoalho Pélvico, class: OTHER, descriptionModule briefSummary: The goal of this randomized clinical trial is to verify the response of genito-pelvic pain disorders in women associated with inability to penetrate to the treatment with non-ablative radiofrequency. The main question it aims to answer is: Does non-ablative radiofrequency have a positive effect on the symptoms of genito-pelvic pain disorders associated with inability to penetrate? Before starting the intervention and at one week, one-, three- and six months after the end of the study, participants will be evaluated with 03 questionnaires (Female Sexual Function Index, Sexual Quality of Life and Perceived Stress Scale-10) and will score the visual analogue scale the level of pain with the penetration (from 0 to 10); participants will then undergo digital evaluation of the pelvic floor muscles, using vaginal dilators and electromyographic evaluation. After being randomized, participants will be divided into the Experimental Group and the Sham Group, being submitted to • the use of non-ablative radiofrequency in the anal and urogenital triangles, • the positioning of the vaginal dilator at the end of each session • and participants will be instructed to use the vaginal dilator at home daily. The researchers will compare the groups in relation to the ability to penetrate with reduced vaginal pain, sexual function, quality of sexual life and the correlation between pelvic muscle activity and perceived stress., conditionsModule conditions: Pelvic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: nonablative radiofrequency, interventions name: Vaginal dilator, interventions name: Sham nonablative radiofrequency, outcomesModule primaryOutcomes measure: Penetration capacity with reduced vaginal pain, secondaryOutcomes measure: Sexual function, secondaryOutcomes measure: Quality of sexual life, secondaryOutcomes measure: Stress perception, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06303596, orgStudyIdInfo id: Hippotherapy in Schizophrenia, briefTitle: Hippotherapy in Patients With Schizophrenia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Erzurum Technical University, class: OTHER, descriptionModule briefSummary: This study will determine the efficacy of hippotherapy (horseback-riding) program, as an adjuvant to standard psychiatric treatment, on the outcomes of patients with schizophrenia. A randomized controlled trial is conducted in a Community Mental Health Center. All participants are randomized into two groups (experimental and control groups) using blocked randomization. All participants received the standard psychiatric treatment, while the experimental group is additionally provided with a 16-session hippotherapy program for 8 weeks. All participants will be evaluated using the Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Quality of Life Scale, UCLA Loneliness Scale at both baseline and after the intervention., conditionsModule conditions: Equine-Assisted Therapy, conditions: Schizophrenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: The evaluator who collects the data is blinded to the allocation of groups., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Hippotherapy, interventions name: Standard psychiatric treatment, outcomesModule primaryOutcomes measure: The Positive and Negative Syndrome Scale (PANSS), primaryOutcomes measure: State-Trait Anxiety Inventory (STAI), primaryOutcomes measure: The Quality of Life Scale (QLS), primaryOutcomes measure: UCLA Loneliness Scale, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erzurum Technical University, Erzurum Community Mental Health Center, city: Erzurum, zip: 25010, country: Turkey, contacts name: Musa Eymir, Ph.D., PT, Assist. Prof., role: CONTACT, phone: +904424445388-2733, email: musa.eymir@erzurum.edu.tr, geoPoint lat: 39.90861, lon: 41.27694, hasResults: False
protocolSection identificationModule nctId: NCT06303583, orgStudyIdInfo id: IRB- 2022-213, briefTitle: Neoadjuvant Chemoradiotherapy Followed by Sequential Immunotherapy for Thoracic Esophageal Squamous Cell Carcinoma, acronym: CRIS, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Qiu Guoqin, class: OTHER, descriptionModule briefSummary: The purpose of study is to investigate the safety and efficacy of sequential immunotherapy with neoadjuvant chemoradiotherapy for esophageal cancer, conditionsModule conditions: Esophageal Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: paclitaxel, interventions name: carboplatin, interventions name: tislelizumab, interventions name: radiotherapy, outcomesModule primaryOutcomes measure: Complete pathological response rate, secondaryOutcomes measure: R0 resection rate, secondaryOutcomes measure: 2-year Disease-free survival rate, secondaryOutcomes measure: 2-year overall survival rate, secondaryOutcomes measure: Safety will be analyzed through the incidence of adverse events, serious adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhejiang Cancer Hospital, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
protocolSection identificationModule nctId: NCT06303557, orgStudyIdInfo id: AEŞH-EK1-2023-797, briefTitle: Effect of ESPB on Intraoperative Remifentanil Consumption, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital, class: OTHER, descriptionModule briefSummary: In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Erector spinae plane block (ESPB), is among the regional anesthesia techniques frequently used in lumbar spine surgery.General anesthesia (GA) is the main method of anesthesia for lumbar spine surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as ESPB, lower remifantanil consumption, and more stable hemodynamics are expected by providing preemptive analgesia in patients.As a result of all these; it was aimed to compare the intraoperative remifantanil consumption of patients who underwent preoperative ESPB in patients who will undergo lumbar spine surgery resection under GA with those who underwent postoperative ESPB., conditionsModule conditions: Lumbar Spine Surgery, conditions: Erector Spinae Plane Block, conditions: Remifentanil Consumption, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Preoperative Erector Spinae Plane Block, interventions name: Postperative Erector Spinae Plane Block, outcomesModule primaryOutcomes measure: Intraoperative remifentanil consumption, secondaryOutcomes measure: Mean arterial pressure, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Pain scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Etlik City Hospital, status: RECRUITING, city: Yenimahalle, state: Ankara, zip: 06170, country: Turkey, contacts name: Musa Zengin, Associate Professor, role: CONTACT, phone: 00905307716235, email: musazengin@gmail.com, contacts name: Deniz Çolak, MD, role: CONTACT, phone: 00905386519710, email: doctordenizcolak@outlook.com, hasResults: False