hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06311357, orgStudyIdInfo id: 100/2566, briefTitle: Percent Weight Change in the Medical Supplement Group of Early Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-12, primaryCompletionDateStruct date: 2024-04-26, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Rajavithi Hospital, class: OTHER_GOV, descriptionModule briefSummary: The goal of this RCT is to compare percent weight change in early breast cancer who takes medical supplement or not, during treatment with chemotherapy (standard AC regimen).The main question is• the change of weight (%) before and after complete treatment of breast cancer therapy.Participants will be randomized into 2 group* intervention group - receive medical supplement daily during chemotherapy treatment.* control group - Nutritional advise during chemotherapy treatment., conditionsModule conditions: Early Stage Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Ensure, outcomesModule primaryOutcomes measure: Percent weight change, secondaryOutcomes measure: EORTC QLQ-C30, secondaryOutcomes measure: Patient interpretation of the Patient-Generated Subjective Global Assessment, secondaryOutcomes measure: EORTC QLQ-BR23, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rajavithi hospital, status: RECRUITING, city: Ratchathewi, state: Bangkok, zip: 10400, country: Thailand, contacts name: Meitinarth Juntong, role: CONTACT, phone: +66654415447, email: juntong.mei@gmail.com, geoPoint lat: 13.759, lon: 100.53358, hasResults: False
protocolSection identificationModule nctId: NCT06311344, orgStudyIdInfo id: 2021-06, briefTitle: Filling Key Research Gaps With Clinical Implications in Mansonellosis and Schistosomiasis: a Network Approach, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-14, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: This is an experimental, multicenter, non-profit study promoted by the Department of Infectious and Tropical Diseases of the IRCCS (Istituto di Ricerca e Cura a carattere scientifico) Sacro Cuore Don Calabria of Negrar which aims to evaluate the presence of endosymbiont Wolbachia in circulating microfilariae obtained from biological samples of individuals infected with M .perstans and the presence of infection with hybrid Schistosoma species in the population of Schistosoma eggs isolated from biological samples of patients with active schistosomiasis., conditionsModule conditions: Schistosoma Mansoni, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Molecular biology analyses, outcomesModule primaryOutcomes measure: Number of M. perstans microfilariae, primaryOutcomes measure: Percentage of M. perstans microfilariae, primaryOutcomes measure: Number of Schistosoma eggs, primaryOutcomes measure: Percentage of Schistosoma eggs, secondaryOutcomes measure: Number of samples positive for Wolbachia, secondaryOutcomes measure: Percentage of samples positive for Wolbachia, secondaryOutcomes measure: Number of samples positive for Schistosoma hybrid species, secondaryOutcomes measure: Percentage of samples positive for Schistosoma hybrid species, secondaryOutcomes measure: Identification of hybrid species of Schistosoma spp., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria hospital, status: RECRUITING, city: Negrar, state: Verona, zip: 37024, country: Italy, contacts name: Elena Pomari, role: CONTACT, phone: +390456013111, email: elena.pomari@sacrocuore.it, contacts name: Elena Pomari, role: PRINCIPAL_INVESTIGATOR, contacts name: Francesca Tamarozzi, role: SUB_INVESTIGATOR, contacts name: Bonnie Webster, role: SUB_INVESTIGATOR, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False
protocolSection identificationModule nctId: NCT06311331, orgStudyIdInfo id: restor3d-007, briefTitle: Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2031-05, completionDateStruct date: 2031-05, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Restor3D, class: INDUSTRY, descriptionModule briefSummary: This is a Humanitarian Device Exemption (HDE) approved device. The purpose of this study is to evaluate the continued safety and probable benefit of the restor3d Total Talus Replacement device in commercial use., conditionsModule conditions: Avascular Necrosis of the Talus, conditions: Talar Osteochondral Defect of Ankle, conditions: Talar Dysfunction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Total Talus Replacement (TTR), outcomesModule primaryOutcomes measure: Proportion of participants who pass a composite of safety and probable benefit outcomes, secondaryOutcomes measure: Change in perceived pain from baseline, secondaryOutcomes measure: Change in Foot and Ankle Outcome Score (FAOS) Composite score from baseline, secondaryOutcomes measure: Change in Foot and Ankle Outcome Score (FAOS) pain subscale score from baseline, secondaryOutcomes measure: Change in Foot and Ankle Outcome Score (FAOS) other symptoms subscale score from baseline, secondaryOutcomes measure: Change in Foot and Ankle Outcome Score (FAOS) activities of daily living (ADL) subscale score from baseline, secondaryOutcomes measure: Change in Foot and Ankle Outcome Score (FAOS) sports/recreation subscale score from baseline, secondaryOutcomes measure: Change in Foot and Ankle Outcome Score (FAOS) quality of life (QOL) subscale score from baseline, secondaryOutcomes measure: Change in ankle range of motion (ROM) from baseline, secondaryOutcomes measure: Proportion of procedure-related Serious Adverse Events, secondaryOutcomes measure: Proportion of Adverse Events, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06311318, orgStudyIdInfo id: Department of surgery MED CMU, briefTitle: Post-operative Lower Eyelid Massage for Prevention of the Lower Eyelid Scare Contracture After Subciliary Approach, acronym: RCT, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-11-01, primaryCompletionDateStruct date: 2019-11-30, completionDateStruct date: 2020-09-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Chiang Mai University, class: OTHER, descriptionModule briefSummary: Patients were randomly allocated to the lower eyelid massage (experimental) or standard care (control) groups. The massage group received post-operative instructions. Data on demographics, injury profiles, lower eyelid scar contracture (graded by GLESCO criteria), eyelid malpositioning, comfort scores, and complications were gathered over a 6-month follow-up., conditionsModule conditions: Zygomatic and Lefort II Fractures, conditions: Infraorbital Rim Fixation, conditions: Subciliary Approach Repair, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized controlled trial enrolled patients with traumatic facial fractures slated for subciliary approach repair. Patients were randomly allocated to the lower eyelid massage (experimental) or standard care (control) groups. The massage group received post-operative instructions. Data on demographics, injury profiles, lower eyelid scar contracture (graded by GLESCO criteria), eyelid malpositioning, comfort scores, and complications were gathered over a 6-month follow-up., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Patients were randomly assigned, using concealed block of four randomization, to either the experimental group receiving lower eyelid massage or the control group receiving standard care. While the authors, acting as massage trainers, were unblinded, an independent plastic surgeon, serving as the assessor, remained blinded to the study interventions., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 59, type: ACTUAL, armsInterventionsModule interventions name: lower eyelid massage, outcomesModule primaryOutcomes measure: Grading of Lower Eyelid Scar Contracture (GLESCO), primaryOutcomes measure: Grading of lower eyelid malpositioning, primaryOutcomes measure: Comfort scores, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06311305, orgStudyIdInfo id: Soh-med-24-03-07MS, briefTitle: Does Early Laparoscopic Cholecystectomy After ERCP Reduce the Risk of Complications, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-20, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Gallstones have been recognised since antiquity and have been found during autopsies of Egyptian mummies. Following the first successful open cholecystectomy in 1882, it was Eric Muhe, a German surgeon, who performed the first laparoscopic cholecystectomy (Lapara, the flank; and skopein, to examine) in 1985.The common mechanism of gallstone formation includes cholesterol hypersecretion, alteration in intestinal bile salt, cholesterol absorption and gall bladder hypokinesia, which leads to bile cholesterol supersaturation and nucleation.Incidence of CBD stones in cases of cholelithiasis is around 3.4%-15%.2 Choledocholithiasis can either be primary or secondary. Secondary Choledocholithiasis being more common occurs due to stones originating in gallbladder and then migrating through cystic duct to CBD. Primary bile duct stones originate from within bile ducts and are more common in Asian populations. These stones are associated with biliary stasis and bacteria., conditionsModule conditions: Cholelithiases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: we aim to assess if the early laparoscopic cholecystectomy after ERCP can reduce the risks or complications, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: NONE (open label single group), enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Early Laparoscopic cholecystectomy, outcomesModule primaryOutcomes measure: bile leakage, primaryOutcomes measure: operative time, primaryOutcomes measure: intraoperative bleeding, primaryOutcomes measure: sepsis, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag University, status: RECRUITING, city: Sohag, zip: 82511, country: Egypt, contacts name: Abdulla M Ahmed, master, role: CONTACT, phone: 01006546957, phoneExt: 002, email: abdallah_mohamed_ex@med.sohag.edu.eg, contacts name: Abdulla M Ahmed, master, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
protocolSection identificationModule nctId: NCT06311292, orgStudyIdInfo id: STUDY22090138, briefTitle: Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Daniel J. Weiner, class: OTHER, descriptionModule briefSummary: This is a small pilot study with the goal of identifying a superior sputum collection method in Cystic Fibrosis patients unable to produce a sputum.Participants will use the Volara System during clinic visit in an attempt to produce sputum., conditionsModule conditions: Cystic Fibrosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: No parties will be prevented from having knowledge of the Volara System use., enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Volara System, outcomesModule primaryOutcomes measure: Sufficient sputum quantity for a pellet, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UPMC Presbyterian Hospital, status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, contacts name: Elizabeth Hartigan, MPH, RN, role: CONTACT, phone: 412-692-7060, email: elizabeth.hartigan@chp.edu, contacts name: Jamie Adams, BS, RRT, role: CONTACT, email: adamsjm2@upmc.edu, contacts name: Daniel Weiner, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False
protocolSection identificationModule nctId: NCT06311279, orgStudyIdInfo id: Soh-Med-24-03-01MD, briefTitle: End to End Versus Side to End Anastomosis After Anterior Resection of Cancer Rectum, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-03-20, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Comparison between end to end and side to end anastomosis after anterior resection of cancer rectum and compare the outcomes of both surgical techniques. The main outcomes were bowel functional outcomes and QoL. Bowel functional outcomes mainly included three indexes: stool frequency, urgency, incomplete defecation, and incontinence. The secondary outcomes were surgical outcomes including operative time, postoperative hospital stay, postoperative complications, reoperation, and mortality., conditionsModule conditions: Rectum Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Comparison between end to end and side to end anastomosis after anterior resection of cancer rectum and compare the outcomes of both surgical techniques. The main outcomes were bowel functional outcomes and QoL. Bowel functional outcomes mainly included three indexes: stool frequency, urgency, incomplete defecation, and incontinence. The secondary outcomes were surgical outcomes including operative time, postoperative hospital stay, postoperative complications, reoperation, and mortality, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: randomized comparative clinical trial, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Anterior resection of Rectal cancer, outcomesModule primaryOutcomes measure: Operative time, primaryOutcomes measure: Anastomotic leakage, primaryOutcomes measure: hospital stay, primaryOutcomes measure: Mortality, primaryOutcomes measure: Anastomotic leak amount, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag university, status: RECRUITING, city: Sohag, zip: 82511, country: Egypt, contacts name: Nabil A Al-Ameer, MD, role: CONTACT, phone: 1118416290, email: Nabil.abdelnaser@med.sohag.edu.eg, contacts name: Ahmed G Hassanein, MD, role: CONTACT, phone: 1552538300, phoneExt: 0020, email: ethics@med.sohag.edu.eg, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
protocolSection identificationModule nctId: NCT06311266, orgStudyIdInfo id: 34-424 ex 21/22, briefTitle: Robotic Endoscopic Neurosurgical Interventions, acronym: RENI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Medical University of Graz, class: OTHER, descriptionModule briefSummary: Endoscopic operations have become increasingly important in the field of neurosurgery over the past decade and require a high degree of precision. Current methods for setting the planned trajectory only offer limited precision due to the manual control, which can lead to complications.The EndoGuide robot is a modular positioning device for controlling endoscopic instruments, which can use radiological data from neuronavigation to align the trajectory in real time with an accuracy of \<0.1mm.The previous model of the robot is currently approved for interventional radiology and positioning of electrodes and catheters in the field of neurosurgery and is now to be tested in endoscopic neurosurgery.The investigators therefore expect not only an increase in the accuracy of endoscopic interventions, but also a reduction in morbidity., conditionsModule conditions: Robot for Endoscopic Neurosurgical Interventions, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: prospective, randomized, single center cohort trial, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: SINGLE, maskingDescription: Due to the surgical workflow (using the robotic guided device or not) the performing surgical team will not be blinded to the allocated group. However, investigators will be blinded to the allocation of the patients., whoMasked: PARTICIPANT, enrollmentInfo count: 19, type: ESTIMATED, armsInterventionsModule interventions name: Robotic endoscopic neurosurgical intervention, outcomesModule primaryOutcomes measure: Target Error (TE), secondaryOutcomes measure: Adverse Effect, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06311253, orgStudyIdInfo id: 2024-LACTOFERRINPREGNANT, briefTitle: Non-surgical Periodontal Treatment With Adjunctive Use of Lactoferrin Contained in Toothpaste and Mouthwash, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, descriptionModule briefSummary: The aim of the study is to assess the effect of lactoferrin in LBC complex can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients., conditionsModule conditions: Periodontal Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Emoform Glic Toothpaste, interventions name: Emoform Glic Mouthwash, outcomesModule primaryOutcomes measure: Change in Recession (R), primaryOutcomes measure: Change in Plaque Index (Silness and Loe, 1964), primaryOutcomes measure: Change in Bleeding on Probing (BoP), primaryOutcomes measure: Change in Probing Pocket Depth (PPD), primaryOutcomes measure: Change in modified Marginal Gingival Index (mMGI), primaryOutcomes measure: Change in Papillary Marginal Gingival Index (PMGI), primaryOutcomes measure: Change in Plaque Control Record (PCR%), primaryOutcomes measure: Change in Clinical Attachment Loss (CAL), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia, city: Pavia, state: Lombardy, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
protocolSection identificationModule nctId: NCT06311227, orgStudyIdInfo id: NCI-2024-01904, secondaryIdInfos id: NCI-2024-01904, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 10637, type: OTHER, domain: National Cancer Institute LAO, secondaryIdInfos id: 10637, type: OTHER, domain: CTEP, briefTitle: Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase II trial tests how well venetoclax works in treating patients with hairy cell leukemia that has come back after a period of improvement (relapsed). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival., conditionsModule conditions: Recurrent Hairy Cell Leukemia, conditions: Recurrent Hairy Cell Leukemia Variant, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Bone Marrow Aspiration, interventions name: Bone Marrow Biopsy, interventions name: Computed Tomography, interventions name: Magnetic Resonance Imaging, interventions name: Venetoclax, outcomesModule primaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Complete remission (CR) rate, secondaryOutcomes measure: Minimal residual disease (MRD)-negative CR rate, secondaryOutcomes measure: MRD negativilty, secondaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Complete response duration, secondaryOutcomes measure: MRD-negative survival, otherOutcomes measure: TP53 mutations and other mutations, otherOutcomes measure: Whole exome sequencing of relapsed HCL/HCLv samples, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False