hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06340633, orgStudyIdInfo id: SPI-1005-261, briefTitle: SPI-1005 in Adults Receiving Cochlear Implant, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Sound Pharmaceuticals, Incorporated, class: INDUSTRY, collaborators name: Med-El Corporation, descriptionModule briefSummary: The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.The main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might participants experience when taking drug SPI-1005?The clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant.Participants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests.The effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have., conditionsModule conditions: Hearing Loss, conditions: Cochlear Trauma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Ebselen, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of Participants with Treatment Emergent Adverse Events (TEAE), otherOutcomes measure: Effect of SPI-1005 on Residual Low Frequency Hearing, otherOutcomes measure: Effect of SPI-1005 on Word Recognition, otherOutcomes measure: Effect of SPI-1005 on Speech Discrimination, otherOutcomes measure: Effect of SPI-1005 on Tinnitus, otherOutcomes measure: Effect of SPI-1005 on Vertigo, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06340620, orgStudyIdInfo id: 24.017.01, briefTitle: EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Orlando Health, Inc., class: OTHER, descriptionModule briefSummary: This is a randomized trial to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract., conditionsModule conditions: Pancreatic Disease, conditions: Pancreatic Cancer, conditions: Pancreatic Cyst, conditions: Gastrointestinal Tumor, conditions: Bile Duct Diseases, conditions: Bile Duct Cancer, conditions: Lymph Node Disease, conditions: Submucosal Tumor of Gastrointestinal Tract, conditions: Gastrointestinal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: DIAGNOSTIC, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic ultrasound examination, outcomesModule primaryOutcomes measure: Rate of successful completion of the requisite EUS examination, secondaryOutcomes measure: Ease of maneuverability of the device, secondaryOutcomes measure: Quality of EUS imaging, secondaryOutcomes measure: Ease of performing tissue acquisition, secondaryOutcomes measure: Diagnostic adequacy of procured specimen on onsite evaluation, secondaryOutcomes measure: Diagnostic adequacy of procured specimen in cell block, secondaryOutcomes measure: Diagnostic accuracy of procured specimen, secondaryOutcomes measure: Procedure duration, secondaryOutcomes measure: Rate of procedure-related adverse events, secondaryOutcomes measure: Procedure costs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Orlando Health, status: RECRUITING, city: Orlando, state: Florida, zip: 32806, country: United States, contacts name: Ji Young Bang, MD MPH, role: CONTACT, phone: 321-841-2431, email: jiyoung.bang@orlandohealth.com, contacts name: Barbara Broome, role: CONTACT, phone: 321-841-4356, email: barbara.broome@orlandohealth.com, geoPoint lat: 28.53834, lon: -81.37924, hasResults: False
protocolSection identificationModule nctId: NCT06340607, orgStudyIdInfo id: 2023-0561, briefTitle: Neohepatic Albumin-Bilirubin Scores on Renal Outcomes in Living-donor Liver Transplantation Recipients, statusModule overallStatus: COMPLETED, startDateStruct date: 2012-01-05, primaryCompletionDateStruct date: 2020-01-05, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Asan Medical Center, class: OTHER, descriptionModule briefSummary: This study investigates the association between post-reperfusion (neohepatic) ALBI scores and post-LT renal outcomes in living-donor LT (LDLT) recipients., conditionsModule conditions: Acute Kidney Injury, conditions: Chronic Kidney Diseases, conditions: Graft Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3422, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: acute kidney injury, secondaryOutcomes measure: chronic kidney injury, secondaryOutcomes measure: graft failure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Asan Medical Center, city: Seoul, state: Song-pa Gu, zip: 05500, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
protocolSection identificationModule nctId: NCT06340594, orgStudyIdInfo id: RF-2-2024, briefTitle: Single-stage ERCP and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With?, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2024-01-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Chronic calculous cholecystitis is associated with common bile duct (CBD) stones in approximately 12% of patients. These patients need both cholecystectomy and CBD clearance of stones. The standard for cholecystectomy is laparoscopic cholecystectomy (LC) and the mostly common treatment used for CBD clearance is Endoscopic Retrograde Cholangiopancreatography (ERCP). The two interventions can be combined to be done at the same time under single anesthesia session. Studies of single stage ERCP+LC showed confirmed the safety and efficacy of the combined technique. However, some surgeons start with the ERCP while others start with LC.The aim of this study is to compare the start with ERCP followed by LC to the start with LC followed by ERCP when the two techniques are combined at the same session for treatment of chronic calculous cholecystitis associated with CBD stones regarding efficacy and safety of the two approaches., conditionsModule conditions: Choledocholithiasis With Cholecystitis, conditions: Biliary Stones, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 115, type: ACTUAL, armsInterventionsModule interventions name: Laproscopic cholecystectomy (LC), interventions name: Endoscopic Retrograde Cholangiopancreatography (ERCP), outcomesModule primaryOutcomes measure: Operative time operative time, secondaryOutcomes measure: CBD clearance rate, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Mortality rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine-Assiut University -Assiut-Egypt, city: Assiut, state: Asyut, zip: 71515, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False
protocolSection identificationModule nctId: NCT06340568, orgStudyIdInfo id: BNT323-01, secondaryIdInfos id: GOG-3105, type: OTHER, domain: GOG foundation, secondaryIdInfos id: 2023-507525-42-00, type: OTHER, domain: EU CT, secondaryIdInfos id: ENGOT- en25/NSGO-CTU, type: OTHER, domain: European Network for Gynaecological Oncological Trial groups (ENGOT), briefTitle: A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2028-08, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: BioNTech SE, class: INDUSTRY, collaborators name: DualityBio Inc., descriptionModule briefSummary: The goal of this clinical study is to assess the efficacy of BNT323/DB-1303 compared with investigator's choice of chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the endometrial cancer population., conditionsModule conditions: Endometrial Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 468, type: ESTIMATED, armsInterventionsModule interventions name: BNT323/DB-1303, interventions name: Doxorubicin, interventions name: Paclitaxel, outcomesModule primaryOutcomes measure: PFS by BICR in the endometrial cancer population, secondaryOutcomes measure: Overall survival (OS) in the endometrial cancer population, secondaryOutcomes measure: PFS assessed by the investigator in the endometrial cancer population, secondaryOutcomes measure: Objective response rate (ORR) in the endometrial cancer population, secondaryOutcomes measure: Duration of response (DoR) in the endometrial cancer population, secondaryOutcomes measure: Number of patients with occurrence of treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Number of patients with occurrence of dose reduction, delay, and discontinuation of study treatments due to TEAEs, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06340555, orgStudyIdInfo id: PIC-156-22, briefTitle: Intervention to Prevent Mental Health Disorders of Women and Their Partners Who Experienced Pregnancy Loss, acronym: Enzo, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Fundació Sant Joan de Déu, class: OTHER, collaborators name: University of Barcelona, collaborators name: University of Seville, descriptionModule briefSummary: The goal of this clinical trial is to test impact of a multiprofessional intervention in mothers and partners who suffer a pregnancy loss. The main questions it aims to answer are:* impact on mothers and partners mental heatlht status* reasons why mothers do not consent to the interventionParticipants will:* mothers and partners will complete 4 scales* mothers and partners will participate in a interviewResearchers will compare with mothers with standard care to see if the multiprofessional intervention has an impact., conditionsModule conditions: Stillbirth and Fetal Death, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: GUIA ATENCION MULTIDISCIPLINAR SANT BOI, interventions name: USUAL CARE, outcomesModule primaryOutcomes measure: Intensity of grief, secondaryOutcomes measure: Depressive symptoms, secondaryOutcomes measure: Anxiety symptoms, secondaryOutcomes measure: Perinatal postraumatic stress disorder, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Parc Sanitari Sant Joan de Deu, city: Sant Boi De Llobregat, state: Barcelona, zip: 08830, country: Spain, geoPoint lat: 41.34357, lon: 2.03659, hasResults: False
protocolSection identificationModule nctId: NCT06340542, orgStudyIdInfo id: UDhaka, briefTitle: Comparison of Thoracic Mobility Exercise Versus Manual Release Technique in Minimizing Upper Back Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of Dhaka, class: OTHER, descriptionModule briefSummary: Methodology: study aims to evaluate the effectiveness of thoracic mobility exercise and manual release technique in terms of pain intensity, thoracic mobility, muscle strength and improving disability.Study Design: Study was conducted in Service unit of Department of Physiotherapy at university of peradeniya. Undergraduates who are currently having upper back pain for more than seven days was selected as sample. It is a randomized Controlled trail, Double blinded study. Participants allowed randomly to both groups which are experimental group which will receive thoracic mobility exercises and control group which will receive myofascial release and joint mobilization treatment. Total sample size was 60., conditionsModule conditions: Upper Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is a Randomized Control Trial, Double- Blinded study. Participants and accessors was blinded. Participants were allocated randomly in to two groups which are experimental group which will receive thoracic mobility exercises and control group which will receive myofascial release and joint mobilization treatment by using lottery method., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Participants' allocation was concealed by using lottery method whether there are in exercise group or manual therapy group. Accessors was blinded which means they were not aware about the treatment or therapy which was obtained by the participants, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 57, type: ACTUAL, armsInterventionsModule interventions name: Thoracic Mobility exercises, interventions name: Manual Release technique, outcomesModule primaryOutcomes measure: Pain Intensity, primaryOutcomes measure: Range of Motion, primaryOutcomes measure: Muscle strength, primaryOutcomes measure: Disability level - self perception, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 26 Years, stdAges: ADULT, contactsLocationsModule locations facility: Vithursha Sivakumar, city: Jaffna, state: Northern, zip: 40001, country: Sri Lanka, geoPoint lat: 9.66845, lon: 80.00742, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2023-10-09, uploadDate: 2024-03-25T22:35, filename: Prot_SAP_ICF_000.pdf, size: 1324441, hasResults: False
protocolSection identificationModule nctId: NCT06340529, orgStudyIdInfo id: CLS_SIMULATION, briefTitle: Comparison of the Perception of Non-technical Skills, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, descriptionModule briefSummary: Clinical simulation has recently acquired great importance in the health sciences. It is a pedagogical methodology that is increasingly used in health science degrees, since it is very useful for the acquisition of both technical and non-technical skills (leadership, teamwork and effective communication, among others).However, if the investigators focus on physical therapy, the use of clinical simulation is a novel field and therefore requires a great deal of research. Researchers in this field do not yet have the consistency and experience as in other health branches such as medicine or nursing, where the participants have been using high-fidelity simulators for years for the learning of all their students.Clinical simulation allows students to achieve these competencies without the need to practice on real patients. For all these reasons, and because of the situation of need generated in recent years, in which internships in hospitals and clinical centers were completely suppressed, the need for our research is justified., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Clinical Simulation, outcomesModule primaryOutcomes measure: Ottawa Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06340516, orgStudyIdInfo id: HER2BNP, briefTitle: NT-proBNP to Assess Trastuzumab-induced Cardiotoxicity, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2029-03-14, completionDateStruct date: 2029-03-14, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Vastra Gotaland Region, class: OTHER_GOV, descriptionModule briefSummary: Trastuzumab-induced cardiotoxicity (TIC) will be monitored in patients with HER2+ breast cancer undergoing trastuzumab treatment before and after breast cancer surgery. At baseline before start of trastuzumab treatment, echocardiography (ECHO)/multigated Acquisition Scan (MUGA) and measurement of plasma NT-proBNP will be performed. NT-proBNP will be measured again at 6 months and at 12 months of trastuzumab treatment. If elevations in NT-proBNP at 6 months and 12 months occur patients will be referred for ECHO/MUGA. The aim is to assess the sensitivity and specificity to detect TIC with NT-proBNP and whether ECHO/MUGA can be safely replaced by assessment of plasma NT-proBNP levels., conditionsModule conditions: Cardiotoxicity, conditions: Breast Cancer, conditions: Treatment Side Effects, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a national multicentre phase II trial investigating the sensitivity and specificity of NT-proBNP for the diagnose of cardiac toxicity during primary anti-HER2 blockade. NT-proBNP is compared with the todays´ standard (ECHO/MUGA)., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule interventions name: Plasma NT-proBNP, outcomesModule primaryOutcomes measure: Sensitivity and specificity of NT-proBNP to detect trastuzumab-induced cardiotoxicity, secondaryOutcomes measure: Prevalence of trastuzumab-induced cardiotoxicity, secondaryOutcomes measure: Anthracycline-induced change in NT-proBNP, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jubileumskliniken, Sahlgrenska University Hospital, status: RECRUITING, city: Gothenburg, zip: 432 45, country: Sweden, contacts name: Daniel Giglio, Assoc Prof, role: CONTACT, phone: +46(0)31-342 16 06, email: daniel.giglio@pharm.gu.se, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False
protocolSection identificationModule nctId: NCT06340503, orgStudyIdInfo id: IRB00111331, secondaryIdInfos id: WFBCCC 01123, type: OTHER, domain: Atrium Health Wake Forest Baptist Comprehensive Cancer Center, secondaryIdInfos id: P30CA012197, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA012197, briefTitle: Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Wake Forest University Health Sciences, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: The purpose of this research study is to determine whether using the physical activity index screener, exercise coaching, and self-monitoring will increase physical activity and reduce time spent sitting or being inactive in patients who had breast or colon cancer., conditionsModule conditions: Breast Cancer, conditions: Colon Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Research-grade accelerometer, interventions name: National Comprehensive Cancer Network (NCCN) Education Materials, interventions name: Garmin Vivofit activity tracker, interventions name: Exercise Consultation Calls, interventions name: Interview, interventions name: Physical Activity Index Assessment (Intervention Arm), interventions name: Physical Activity Index Assessment (Control Arm), interventions name: Health Surveys, outcomesModule primaryOutcomes measure: Number of Eligible Participants - Participation Rate, primaryOutcomes measure: Percentage of Participants to Complete Exercise Sessions - Adherence, primaryOutcomes measure: Number of Participants Who Complete Study Questionnaires - Retention, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, contacts name: Principal Investigator, role: CONTACT, contacts name: Shirley Bluethmann, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.09986, lon: -80.24422, hasResults: False