hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06304987, orgStudyIdInfo id: BFH-niCRT-05, briefTitle: Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and PCSK9 Inhibitor for pMMR/MSS Locally Advanced Mid-low Rectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Beijing Friendship Hospital, class: OTHER, collaborators name: Peking Union Medical College Hospital, collaborators name: Peking University Cancer Hospital & Institute, collaborators name: Changhai Hospital, descriptionModule briefSummary: This is a multicenter, prospective, randomized controlled study to evaluate the effectiveness and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor in the treatment of patients with pMMR/MSS locally advanced middle and low rectal cancer., conditionsModule conditions: Locally Advanced Rectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Experimental: Neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor Control: Neoadjuvant chemoradiotherapy combined with PD-1 inhibitor, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitor, interventions name: Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitor, outcomesModule primaryOutcomes measure: CR, primaryOutcomes measure: AE rate, secondaryOutcomes measure: NAR score, secondaryOutcomes measure: OPR, secondaryOutcomes measure: ORR, secondaryOutcomes measure: immune-related adverse event rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, Capital Medical University, city: Beijing, state: Beijing, zip: 100050, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Friendship Hospital, city: Beijing, state: Beijing, zip: 100050, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06304974, orgStudyIdInfo id: BL-B01D1-305, briefTitle: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Sichuan Baili Pharmaceutical Co., Ltd., class: INDUSTRY, collaborators name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd., descriptionModule briefSummary: This study is a registered phase Ill, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic esophageal squamous cell carcinoma after failure of PD-1/PD-L1 monoclonal antibody in combination with platinum-based chemotherapy., conditionsModule conditions: Esophageal Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 488, type: ESTIMATED, armsInterventionsModule interventions name: BL-B01D1, interventions name: Irinotecan, interventions name: paclitaxel, interventions name: docetaxel, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), primaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Treatment Emergent Adverse Event (TEAE), secondaryOutcomes measure: Cmax, secondaryOutcomes measure: T1/2, secondaryOutcomes measure: Anti-drug antibody (ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, contacts name: Lin Shen, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06304961, orgStudyIdInfo id: D9180C00011, briefTitle: A Study to Investigate Relative Bioavailability of Two Different Dosage Forms for Tozorakimab Via Subcutaneous Administration in Healthy Volunteers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-09-05, completionDateStruct date: 2024-09-05, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The study will assess the relative bioavailability between two dosage forms of tozorakimab (test dosage form and reference dosage form) and to assess the pharmacokinetic (PK) profiles of both dosage forms., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Tozorakimab, outcomesModule primaryOutcomes measure: Area under the concentration-time curve from time 0 to infinity (AUCinf), primaryOutcomes measure: Area under the concentration-curve from time 0 to the last quantifiable concentration (AUClast), primaryOutcomes measure: Maximum observed drug concentration (Cmax), secondaryOutcomes measure: Time to reach peak or maximum observed concentration following tozorakimab administration (tmax), secondaryOutcomes measure: Terminal elimination half-life (t1/2), secondaryOutcomes measure: Terminal rate constant (λz), secondaryOutcomes measure: Apparent total body clearance (CL/F), secondaryOutcomes measure: Apparent volume of distribution based on the terminal phase (Vz/F), secondaryOutcomes measure: Number of participants with adverse events (AEs), secondaryOutcomes measure: Number of participants with presence of Anti-Drug Anitbodies (ADAs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Research Site, status: RECRUITING, city: Berlin, zip: 14050, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, hasResults: False
protocolSection identificationModule nctId: NCT06304948, orgStudyIdInfo id: Vitamin D and migraine, briefTitle: The Link Between Human Cytomegalovirus Gene Expression and Glutamate Level in Migraine;Relation to Vitamin D Deficiency, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: 1. To correlate serum 25(OH)-vitamin D level with duration, frequency, and severity of migraine headache attacks2. To evaluate the relationship between the serum level of vitamin D and other indices in patients with migraine.3. To correlate the serum level of glutamate with gene expression of in migraine, conditionsModule conditions: Migraine, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 72, type: ESTIMATED, outcomesModule primaryOutcomes measure: The Link between human cytomegalovirus gene expression and glutamate levels in Migraine :relationship to the Vit D Deficiency, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06304935, orgStudyIdInfo id: IPRF effect post tonsillectomy, briefTitle: Injectable Platelet Rich Fibrin Post Tonsillectomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: To evaluate the effect of injectable Prf on healing, hemostasis and pain post tonsillectomy, conditionsModule conditions: IPRF Post Tonsillectomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Use of injectable platelet rich fibrin after tonsillectomy by injection of IPRF in one tonsillar bed and use of other side as control, outcomesModule primaryOutcomes measure: IPRF effect on healing, primaryOutcomes measure: IPRF effect on post tonsillectomy pain and bleeding, eligibilityModule sex: ALL, minimumAge: 5 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06304922, orgStudyIdInfo id: BRCA 1/2 in cancer ovary, briefTitle: BRCA 1/2 Status as a Predictive Factor to Response to Platinum Based Chemotherapy in Cancer Ovary, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The main objective of this prospective study is to assess the clinical outcomes of platinum based chemotherapy cases either cisplatin or carboplatin according to BRCA status in neoadjuvant and recurrent ovarian cancer., conditionsModule conditions: Ovarian Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Assess the response to platinum-based chemotherapy in correlation to BRCA status in neoadjuvant and recurrent ovarian cancer, outcomesModule primaryOutcomes measure: Objective response rate., primaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall survival and toxicity, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06304909, orgStudyIdInfo id: 2080278, briefTitle: Effect of Intravenous Dexmedetomidine Versus Dexamethasone for Management of Repound Pain After Supraclavicular Brachial Plexus Block, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Effect of intravenous dexmedetomidine versus dexamethasone for management of repound pain after supraclavicular brachial plexus block., conditionsModule conditions: Trauma Injury, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 111, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine injection, outcomesModule primaryOutcomes measure: The incidence of rebound pain., eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06304896, orgStudyIdInfo id: #18240343, briefTitle: Colchicine Versus Beta-blockers, Angiotensin-converting Enzyme Inhibitors, and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy, acronym: BASiC-CIC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Arab Contractors Medical Centre, class: OTHER, descriptionModule briefSummary: BASiC-CIC Trial is a multicenter, double-blinded, randomized, placebo-controlled clinical trial to investigate whether repurposing colchicine or a combination of beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and statins will be effective as a prophylactic treatment for the prevention of chemotherapy-induced cardiomyopathy, reduction of major adverse cardiovascular events, and all-cause mortality., conditionsModule conditions: Chemotherapy Induced Systolic Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Carvedilol, interventions name: Ramipril, interventions name: Rosuvastatin, interventions name: Colchicine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Chemotherapy-induced cardiomyopathy, primaryOutcomes measure: Chemotherapy-induced cardiomyopathy, secondaryOutcomes measure: Major Adverse Cardiovascular Events, secondaryOutcomes measure: All-Cause Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arab Contractors Medical Centre, city: Cairo, country: Egypt, contacts name: Eslam Abbas, MBChB, MSc, role: CONTACT, phone: 01023054574, phoneExt: +2, email: islam.omr@med.au.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06304870, orgStudyIdInfo id: SYB-reflux, briefTitle: Impact of Blocking the Glossopharyngeal Nerve on Gastroesophageal Reflux Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation therapy, interventions name: Lidocaine, interventions name: Injection, outcomesModule primaryOutcomes measure: Rosenbek penetration-aspiration scale, secondaryOutcomes measure: Gastroesophageal Reflux Disease Questionnaire, secondaryOutcomes measure: Pressure pain threshold, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06304844, orgStudyIdInfo id: Soh-Med-24-02-06MD, briefTitle: Risk of CKD in Diabetic Patients With MAFLD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: This cross-sectional study of 300 participants investigates the risk of chronic kidney disease (CKD) in individuals with metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes. By evaluating hepatic measurements and metabolic markers, the study aims to identify key risk factors for CKD in this population, contributing valuable insights to inform targeted interventions., conditionsModule conditions: Type 2 Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: transient elastography (Fibroscan), outcomesModule primaryOutcomes measure: Determine the number of participant with eGFR<60 ml/min/1.73 m2 or albuminuria (urinary albumin-to-creatinine ratio (ACR) ⩾3 mg/mmol) in patients with type 2 DM and MAFLD, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06304818, orgStudyIdInfo id: SCTB14-X101, briefTitle: Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB14 in Adult Patients With Advanced Malignant Solid Tumours., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2028-12-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sinocelltech Ltd., class: INDUSTRY, descriptionModule briefSummary: This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB14 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial., conditionsModule conditions: Advanced Malignant Solid Tumours, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 515, type: ESTIMATED, armsInterventionsModule interventions name: SCTB14, outcomesModule primaryOutcomes measure: Dose-Limiting toxicity(DLT), primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06304805, orgStudyIdInfo id: TGRX-326-1002, briefTitle: TGRX-326 Phase I/II Pharmacokinetic Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-13, primaryCompletionDateStruct date: 2024-01-12, completionDateStruct date: 2024-01-19, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Shenzhen TargetRx, Inc., class: INDUSTRY, collaborators name: First Affiliated Hospital Bengbu Medical College, descriptionModule briefSummary: A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-326 and the effect of different drug specifications on human bioavailability for TGRX-326, a drug indicated for non-small cell lung cancer treatment, conditionsModule conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: This is a PK assessment study, hence only bio-sample analysis personnel were masked for the type of treatment received for each sample to avoid bias in analysis. Other study personnel, including participants, investigators and staffs were not masked for treatment types., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: cycle 1: treatment drug, interventions name: cycle 1: reference drug, interventions name: cycle 1: fasted, interventions name: cycle 1: food, interventions name: cycle 2: treatment drug, interventions name: cycle 2: reference drug, interventions name: cycle 2: fasted, interventions name: cycle 2: food, interventions name: cycle 3: treatment drug, interventions name: cycle 3: reference drug, interventions name: cycle 3: fasted, interventions name: cycle 3: food, outcomesModule primaryOutcomes measure: Plasma Cmax, primaryOutcomes measure: Plasma AUC(0-t), primaryOutcomes measure: Plasma AUC(0-inf), secondaryOutcomes measure: Plasma Tmax, secondaryOutcomes measure: terminal elimination rate constant (lambda-z), secondaryOutcomes measure: Elimination half-life (T1/2-Z), secondaryOutcomes measure: AUC(%Extrap), secondaryOutcomes measure: Plasma volume of distribution (Vz/F), secondaryOutcomes measure: Plasma clearance (CL/F), secondaryOutcomes measure: Adverse events/serious adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: First Affiliated Hospital Bengbu Medical College, city: Bengbu, state: Anhui, zip: 233004, country: China, geoPoint lat: 32.94083, lon: 117.36083, hasResults: False