hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06334510 id: HL-SJLG-2021-Ⅳ-01 briefTitle: Evaluate the Safety and Efficacy of Quadrivalent Influenza in Real-world Situations. overallStatus: COMPLETED date: 2021-11-17 date: 2023-01-20 date: 2023-03-28 date: 2024-03-28 date: 2024-03-28 name: Hualan Biological Bacterin Co. Ltd. class: INDUSTRY briefSummary: To evaluate the inter-batch consistency (CI) of quadrivalent influenza vaccine (split virion) among healthy people aged 18-59 years； Secondly, to evaluate the safety and immunogenicity of quadrivalent influenza vaccine (split virion) in the expanded population aged 3 years and above, in order to observe the rare adverse reaction of 1‰. conditions: GCP studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 4900 type: ACTUAL name: One dose of quadrivalent influenza virus split vaccine was administered measure: To evaluate the safety and immunogenicity of Hualan Biovar quadrivalent influenza vaccine in a larger population in the real world, and to observe rare adverse drug reaction (ADR) of 1‰. measure: To explore the consistency of three consecutive batches of commercial vaccines for vaccination in adults aged 18-59 years. sex: ALL minimumAge: 3 Years maximumAge: 74 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Kou Zengqiang city: Jinan state: Shandong zip: 250000 country: China lat: 36.66833 lon: 116.99722 hasResults: False
nctId: NCT06334497 id: APH220791 id: 2023-506216-40-00 type: OTHER domain: EU CT briefTitle: Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections acronym: LUCY-1 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-03-28 date: 2024-03-28 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The purpose of this study is to evaluate the efficacy and the tolerance of letermovir as part of dual antiviral therapy (in association with valganciclovir) in renal transplant recipients with CMV DNAemia, requiring valganciclovir treatment per investigator's judgment. conditions: Cytomegalovirus Infection studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Letermovir name: Valganciclovir name: Letermovir placebo measure: Virological response to treatment on week-3 measure: Eradication of CMV DNAemia (< 200 IU/ml) before Week-12 measure: Number of days between baseline and first measure of CMV DNAemia < 200 IU/mL measure: Absence of CMV-related symptoms at baseline and each visit measure: Adverse event (AE) occurence measure: Sequencing of whole UL97, UL54, UL56, UL89 and UL51 genes measure: Ganciclovir plasma concentration measure: Letermovir plasma concentration measure: Measure of the CMV specific T-cell immunity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Necker Enfants Malades city: Paris zip: 75015 country: France name: Laurence BUSSIERES, PhD role: CONTACT phone: +33 6 62 08 19 58 email: laurence.bussieres@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
nctId: NCT06334484 id: 6413 briefTitle: Effect of Advanced Hybrid Closed Loop System on Adjunctive Continuous Glucose Monitoring Metrics acronym: TiTR_GR1DM overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2025-09-26 date: 2026-03-26 date: 2024-03-28 date: 2024-03-28 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Type 1 diabetes mellitus (T1DM) is an autoimmune disease characterized by pancreatic beta cells destruction, resulting in insulin secretion deficit (1). Insulin therapy is essential in the therapeutical management of subjects with T1DM (1). The Diabetes Complications and Control Trial (DCCT) has showed that intensive insulin treatment was associated with a reduction in the onset of complications related to diabetes. In recent years, treatment of T1DM evolved rapidly because of the significant improvements in the use of technology (2). With the spread of continuous glucose monitoring (CGM) systems, standardized metrics, summarizing time spent within optimal glucose range (time in range - TIR), time below target glucose range (TBR) and time above target glucose range (TAR), have become commonly used metrics in clinical practice (3,4). Furthermore, glucose management indicator (GMI) estimates glycated haemoglobin from the average glucose level of CGM readings for 14 days and coefficient of variation (CV) evaluates the amplitude of glucose excursions.
Advanced hybrid closed loop (AHCL) systems combine insulin pump infusion and real time CGM (rtCGM) data through an algorithm: they suspend insulin infusion if hypoglycaemia is expected and can administer automatic corrective boluses in case of hyperglycaemia (6). Different algorithms, as Model Predictive Control (MPC) or Proportional-Integral-Derivative (PID), are used by different systems available on the market and are currently used in clinical practice. Overall, AHCL are associated with improvement of glycated hemoglobin (HbA1c) and TIR opening to the possibility to gain even tighter glycemic control.
The primary objective is therefore to evaluate the glycemic improvement expressed through adjunctive CGM metrics in subjects with T1DM 24 months after starting AHCL therapy conditions: Diabetes Mellitus, Type 1 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Advanced hybrid closed loop systems measure: change in time spent in tighter glucose range after 24 months of hybrid closed loop system sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Roma zip: 00168 country: Italy name: DARIO PITOCCO role: CONTACT phone: +390630155701 email: dario.pitocco@policlinicogemelli.it name: DARIO PITOCCO role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False
nctId: NCT06334471 id: INCS_WGS_B-001 briefTitle: Whole Genome Sequencing in Breast Cancer acronym: WGS SIT overallStatus: RECRUITING date: 2022-08-02 date: 2025-08-02 date: 2030-12-31 date: 2024-03-28 date: 2024-04-03 name: Inocras Korea Inc. class: INDUSTRY briefSummary: This study aims to conduct whole genome sequencing in breast cancer patients to elucidate individual genetic characteristics and their correlation with breast cancer subtypes. The primary objective is to establish new treatment guidelines aligned with the paradigm shift in precision medicine. The study will include both prospective and retrospective cohorts totaling 1200 participants. Prospective participants must provide consent and be eligible for tissue collection, while retrospective participants must have histologically confirmed breast cancer and available tissue samples from Samsung Medical Center Biobank. The study period spans 3 years for subject enrollment and 5 years for follow-up observations, with an expected completion date of December 31, 2030. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1200 type: ESTIMATED name: no intervention needed measure: Establishing individual genetic characteristics of breast cancer patients through WGS measure: Analysis of correlation between whole-genome sequencing results and genetic subtypes of breast cancer sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul country: Korea, Republic of name: Yeon Hee Park, MD role: CONTACT name: Yeon Hee Park, MD role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False
nctId: NCT06334458 id: IEO 1910 briefTitle: Epigenomic and Machine Learning Models to Predict Pancreatic Cancer acronym: IMAGene overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-03 date: 2024-02-21 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: European Institute of Oncology class: OTHER briefSummary: The goal of the multicentric and interdisciplinary IMAGene project is to pursue early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups, by developing and validating a comprehensive cancer risk prediction algorithm (CRPA) as a clinical support tool to calculate a personalized risk profile.
The study is a longitudinal, non-randomized exploratory clinical study. A total of 170 asymptomatic first-degree relatives of PC patients. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 170 type: ACTUAL name: Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups measure: Observation of a two or three-fold enrichment in early detection of suspicious pancreatic lesion using the CRPA algorithm measure: Identification of one or more abnormal methylation changes present in blood cells of participants with suspicious lesions versus methylation profiles of participants with no identified lesions measure: Validation of igenetic biomarker testing in liquid biopsy followed by radiological exam as early cancer diagnostic tool sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Toulouse University Hospital city: Toulouse country: France lat: 43.60426 lon: 1.44367 facility: European Institute of Oncology city: Milan country: Italy lat: 45.46427 lon: 9.18951 facility: Oncological Institute "Prof. Dr. Ion Chiricuta" city: Cluj-Napoca country: Romania lat: 46.76667 lon: 23.6 facility: Catalan Institute of Oncology city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 hasResults: False
nctId: NCT06334445 id: IEO 1874 briefTitle: CARDIOCARE Prospective Clinical Study acronym: CARDIOCARE overallStatus: RECRUITING date: 2023-09-14 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: European Institute of Oncology class: OTHER briefSummary: This is a prospective observational study to refine and validate risk stratification algorithms aimed at identifying elderly patients at higher risk of developing cardiotoxicity (us-ing risk factors and potential blood and stool biomarkers) and at assessing whether integrated patient-oriented behavioral and psychological interventions can mitigate, prevent or delay the onset of cardiotoxicity from chemotherapy. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 736 type: ESTIMATED name: Control group name: Intervention group measure: Evaluation of the onset of cardiotoxicity measure: Intra-patient assessment of major adverse cardiac events (MACEs) measure: Intra-patient assessment of plasma Troponin I measure: Intra-patient assessment of plasma Brain natriuretic peptide (BNP) elevation measure: Percentage in the two arm of hospital admission measure: Number of Cardiovascular death in the two arms measure: Number of Non-cardiovascular death in the two arms measure: Evaluation of Health Related Quality of Life in the two arms measure: Cost-effectiveness of provided healthcare pathways determined by costs combined with quality-adjusted life-years (QALYs) in the two arms sex: FEMALE minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Gabriella Pravettoni role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
nctId: NCT06334419 id: 2023-0795 briefTitle: Placebo-Controlled, Single-Dose Challenge Study of Gaboxadol in Adult Males With Fragile X Syndrome (FXS) overallStatus: RECRUITING date: 2024-01-29 date: 2024-09-30 date: 2024-09-30 date: 2024-03-28 date: 2024-03-28 name: Craig Erickson class: OTHER name: Healx Limited briefSummary: This is a single dose, placebo-controlled study. Male subjects aged 18 to 40 years (inclusive) with a diagnosis of FXS. Eligible subjects may enroll in this study comprised of two in home and two in clinic visits each 14 days apart, for a total of four visits. Subjects will be given single dose gaboxadol (10 mg) or matched placebo at each of these visits to take orally. Thus, all enrolled subjects will receive placebo at home and in clinic and receive gaboxadol at home and in clinic in a blinded fashion. conditions: Fragile X Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study was designed as a 2-intervention crossover, with all study participants receiving all possible interventions. These are placebo and Gaboxadol. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Quadruple masking (participant, care provider, investigator and outcomes assessor) count: 10 type: ESTIMATED name: Gaboxadol name: Placebo measure: To evaluate target engagement of gaboxadol treatment on high density EEG recordings measure: To investigate the feasibility of home research visits and procedures in adult males with FXS measure: To investigate the feasibility of high density EEG recording at home in adult males with FXS measure: To potentially explore the pharmacokinetics of gaboxadol treatment in single-dose trial design measure: To investigate the effect of gaboxadol treatment on neuropsychological assessments measure: To investigate the effect of gaboxadol treatment on eye tracking assessments measure: To investigate the effect of gaboxadol treatment on clinician-rated measures measure: To determine whether FMRP levels predict treatment response sex: MALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Cincinnati Children's Hospital Medical Center status: RECRUITING city: Cincinnati state: Ohio zip: 45229 country: United States name: Ashley Dapore role: CONTACT phone: 513-517-1580 email: ashley.dapore@cchmc.org name: Hannah J Sachs, MPA role: CONTACT phone: 513-636-2592 email: hannah.sachs@cchmc.org name: Craig A Erickson, MD role: PRINCIPAL_INVESTIGATOR name: Kelli Dominick, MD, PhD role: SUB_INVESTIGATOR name: Meredith Nelson, PhD role: SUB_INVESTIGATOR name: Ernest Pedapati, MD role: SUB_INVESTIGATOR name: Debra Reisinger, PhD role: SUB_INVESTIGATOR name: Lauren Schmitt, PhD role: SUB_INVESTIGATOR lat: 39.12713 lon: -84.51435 hasResults: False
nctId: NCT06334406 id: 098 DRC 210 ER03 012 briefTitle: Antitumor T Cell Responses in Patients With Bladder Cancer acronym: immunoBLAD overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2026-04-02 date: 2026-04-02 date: 2024-03-28 date: 2024-03-28 name: Centre Hospitalier Universitaire de Besancon class: OTHER briefSummary: The main objective of this study is to evaluate the induction of Th1 anti-TERT responses by treatments in patients with bladder tumor. conditions: Bladder Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 33 type: ESTIMATED name: Biological samples measure: Tumor antigen specific T-cell responses measure: Monitoring of T cells in the blood measure: Monitoring of immune cell death parameters in the blood measure: Monitoring of immune suppressive cells in the blood measure: Overall survival measure: Progression-free survival measure: Local progression-free survival measure: Transcriptomic analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06334393 id: VLA1601-102 briefTitle: Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults overallStatus: RECRUITING date: 2024-03-25 date: 2024-12-31 date: 2025-12-28 date: 2024-03-28 date: 2024-03-28 name: Valneva Austria GmbH class: INDUSTRY briefSummary: This phase 1 clinical trial consists of an initial open-label sentinel run-in (n=25) and a randomized, double-blind, dose-finding (n=125) investigating three antigen dose levels (low, medium and high) of VLA1601 and bedside mixing of the low-dose formulation with one of the two additional adjuvants (CpG1018®, 3M-052-AF/AP 60-702). VLA1601 will be administered according to a two-dose regimen (i.e., on Day 1 and Day 29).
The primary objective of this trial is to assess the safety and tolerability of the vaccine candidate up to 7 days after each vaccination; and to assess the immune response induced by the vaccine candidate 28 days after the second vaccination. Additionally, safety and immune response of the vaccine candidate will be monitored throughout the trial. conditions: Zika conditions: Zika Virus Infection studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: VLA1601 name: CpG 1018® name: 3M-052-AF measure: Solicited Adverse Events measure: Solicited Adverse Events measure: Neutralizing antibodies against ZIKA virus (ZIKV) measure: Solicited Adverse Events measure: Solicited Adverse Events measure: Unsolicited AEs measure: Unsolicited AEs measure: Vaccine-related unsolicited AEs measure: Vaccine-related unsolicited AEs measure: Any AEs measure: Any AEs measure: any vaccine-related AEs measure: Vaccine-related unsolicited AEs measure: Adverse Events of Special Interest (AESI) measure: Adverse Events of Special Interest (AESI) measure: Vaccine-related Adverse Events of Special Interest (AESI) measure: Vaccine-related Adverse Events of Special Interest (AESI) measure: Serious Adverse Events (SAE) measure: Serious Adverse Events (SAE) measure: Vaccine-related Serious Adverse Events (SAE) measure: Vaccine-related Serious Adverse Events (SAE) measure: ZIKV-specific neutralizing antibodies measure: Seroconversion rate (SCR) measure: Geometric Mean Fold Increase (GMFI) sex: ALL minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Flourish Research status: RECRUITING city: Chicago state: Illinois zip: 60640 country: United States name: Rupal Trivedi, MD role: CONTACT lat: 41.85003 lon: -87.65005 facility: Velocity Clinical Research status: RECRUITING city: Omaha state: Nebraska zip: 68134 country: United States name: Frederick Raiser, MD role: CONTACT lat: 41.25626 lon: -95.94043 hasResults: False
nctId: NCT06334380 id: 73688 briefTitle: VR for Surgical Prehabilitation and Rehabilitation acronym: VR-PREP overallStatus: ENROLLING_BY_INVITATION date: 2024-04-15 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-04-25 name: Stanford University class: OTHER briefSummary: This randomized controlled trial aims to determine feasibility and acceptability of of VR-physical therapy modules for surgical patients undergoing breast or axilla surgery in order to prepare for and recover from surgery. conditions: Breast Cancer conditions: Frailty conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants randomized to one of two arms, VR self-paced modules with live PT guidance and VR without live PT guidance. primaryPurpose: OTHER masking: SINGLE maskingDescription: Blinded assessor will conduct adherence calls. whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Virtual Reality Modules Only name: Virtual Reality Modules + Live Physical Therapist Support measure: VR for remote Physical Therapy (PT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford Hospital and Clinics city: Palo Alto state: California zip: 94305 country: United States lat: 37.44188 lon: -122.14302 hasResults: False
nctId: NCT06334367 id: SWYX:NO.2022-1028 briefTitle: Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2026-03-26 date: 2026-03-26 date: 2024-03-28 date: 2024-03-28 name: Wang Xin class: OTHER_GOV briefSummary: The risk of Graft-versus-host Disease(GVHD) is significantly associated with the mortality rate of patients undergoing allogeneic hematopoietic stem cell transplantation. The occurrence of GVHD increases the hospitalization rate and economic burden of patients. In order to explore better methods for controlling GVHD, we designed a clinical trial using CD25 monoclonal antibody for GVHD prevention. Our previous studies have shown that reduced-dose anti-thymocyte globulin(ATG) in the conditioning regimen can achieve the same effect as full-dose ATG. Here, we try to explore the preventive effect of CD25 antibody on acute and chronic GHVD under low-dose ATG pretreatment condition. conditions: GVHD studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: CD25 treatment name: low-dose ATG measure: The incidence of aGVHD measure: The incidence of cGVHD measure: the time of immune reconstitution in haploidentical transplant measure: the time of infection occurrence measure: the time of donor cell engraftment measure: the time of disease relapse measure: the time of death of transplant patient sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong First Medical University city: Jinan state: Shandong zip: 250021 country: China name: Xin Wang, MD, PHD role: CONTACT phone: 86-531-68778331 email: xinw007@126.com name: Xiaosheng Fang, MD, PHD role: CONTACT phone: 8615168889703 email: fxsh_1010@126.com lat: 36.66833 lon: 116.99722 hasResults: False