hackint0sh/New-Dataset huggingface dataset:
Eligible patients will be randomized in a 1:1 ratio into two groups: the observation group and the adjuvant radiotherapy group. The control group consists of patients who receive surgery after neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer, followed by maintenance therapy with PD1/PDL1 inhibitors for up to 1 year or until tumor progression. The adjuvant radiotherapy group receives additional adjuvant radiotherapy on top of the control group's treatment. The specific treatment process involves receiving 2 cycles of neoadjuvant chemotherapy combined with immunotherapy (PD1/PDL1 inhibitors) before potentially curative esophageal cancer surgery. The chemotherapy regimen includes paclitaxel in combination with platinum agents, with a preference for albumin-bound paclitaxel (280mg/m2 on Day 1, or 100mg on Days 1, 8, and 15) in combination with carboplatin (AUC=5). Following surgery, patients start adjuvant radiotherapy 4-6 weeks after the operation, with a radiation dose of 45Gy/25F/5W, completed no later than 8 weeks post-surgery. Two weeks after completing radiotherapy, patients continue with immunotherapy maintenance therapy for up to 1 year or until tumor progression. Subsequently, follow-up visits are scheduled every 3-4 months for the first 3 years, every 6 months for the next 2 years, and annually thereafter. The primary endpoint is 2-year disease-free survival (DFS), and secondary endpoints include overall survival (OS), local recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), recurrence patterns, and safety assessment. Additionally, the study will explore biomarkers predicting treatment efficacy and adverse reactions in subjects, including PD-L1 expression, ctDNA clearance status, infiltrating immune cell types and quantities, cytokine expression, and other tumor biomarkers. This exploration aims to guide stratified precision treatment for patients. conditions: Adjuvant Radiotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 146 type: ESTIMATED name: Adjuvant radiotherapy name: Observation measure: 2-year DFS measure: OS measure: LRFS measure: DMFS measure: HRQoL measure: Adverse effects recorded during radiotherapy and PD1/PDL1 inhibitors maintaince period measure: Incidence of Recurrence sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital city: Hangzhou state: Zhejiang country: China name: YANG YANG, M.D. role: CONTACT phone: +8657188128182 email: yangyang@zjcc.org.cn name: Youhua Jiang role: PRINCIPAL_INVESTIGATOR name: Yongling Ji role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False
nctId: NCT06272201 id: 50620 TPR briefTitle: Incisionless Suture Plications in a POSE2.0 Interventional Randomized Obesity Study acronym: INSPIRO overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2026-08 date: 2026-08 date: 2024-02-22 date: 2024-02-22 name: USGI Medical class: INDUSTRY briefSummary: This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (sutures placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP). conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 186 type: ESTIMATED name: POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors measure: Percentage of total body weight loss (%TBWL) following randomization measure: Responder rate of at least 50% in the POSE2.0 treatment group measure: Safety- Incidence of device and procedure related adverse events through 12 months sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06272188 id: 09.2023.1435 briefTitle: Preconception Care for Couples Planning Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2025-07-15 date: 2025-08-15 date: 2024-02-22 date: 2024-02-22 name: Yuzuncu Yıl University class: OTHER name: Marmara University name: Kocaeli University name: Kastamonu University name: Maltepe University name: Izmir Katip Celebi University briefSummary: Preconception care is to optimize health, address modifiable risk factors, and eliminate or reduce health-threatening factors for the woman, fetus, and newborn by working with couples to achieve a healthy pregnancy. Preconception care is the best way to protect against risks in pregnancy and plan risk management. Preconception care offers women and their partners the opportunity to gain healthy lifestyle behaviors, make conscious choices, and gain awareness of factors that threaten health before, during and after pregnancy. However, the rate of receiving preconception care is only 12.3% in our country.
The randomized controlled experimental study will be conducted between February 1, 2024 and February 1, 2026 in the provinces of Istanbul, Izmir, Kastamonu, Ankara and Van. The population of the research will consist of all couples who applied to the marriage offices in the above provinces between February 1, 2024 and February 1, 2026. In the sample calculation, it was calculated that at least 80 couples (experimental group: 40 couples, control group: 40 couples) should be included in the study. Couples that meet the sampling criteria will be assigned to the experimental or control group according to the random numbers table. Online preconception care counseling will be provided to couples in the experimental group 1 month after their wedding date. Preconception care counseling, consisting of 17 titles, was prepared in line with the relevant literature and standardized by the researchers. After the counseling, the couples will be introduced to the preconception care website, which they can use if they need it, and will be given login information.
Data will be obtained before and in the 3rd month after counseling with the Introductory Information Form (TBF), Preconceptional Period Risk Assessment Form, Preconceptional Care Health Literacy Scale and Preconceptional Period Health Behavior Scale. The data will be transferred to the SPSS 22 program and evaluated by the researchers. Chi-square test, t-test, Mann Whitney-U Test, Wilcoxon test and paired simple t test will be used to analyze the data. conditions: Preconception Care, Preconception Risk studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: We do not use a model primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 160 type: ESTIMATED name: web-based online preconceptional counselling measure: Identifying Information Form measure: Preconceptional Period Risk Assessment Form measure: Preconceptional Care Health Literacy Scale measure: Preconceptional Period Health Behavior Scale sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Van Yuzuncu Yil University city: Van country: Turkey lat: 38.49457 lon: 43.38323 hasResults: False
nctId: NCT06272175 id: 10102023 briefTitle: Immediate Effects of Open and Closed Kinetic Chain Exercises on Upper Extremity in Stroke Patients. overallStatus: RECRUITING date: 2024-03-04 date: 2024-09-30 date: 2024-12-30 date: 2024-02-22 date: 2024-03-07 name: Istinye University class: OTHER briefSummary: Stroke is a sudden disruption of blood flow to the brain, resulting in physical and mental disabilities. It's a global health issue affecting millions each year, often leading to paralysis, altered muscle tone, and loss of motor control and balance. This study aims to examine the immediate effects of open and closed kinetic chain activites on upper extremity spasticity and motor dexterity in hemiplegic patients. This study will be conducted simultaneously at İstinye University Hospital Medical Park Gaziosmanpaşa and İstinye University Physiotherapy and Rehabilitation Application and Research Center (İSÜFİZYOTEM). 50 stroke patients will be included in the study, and all participants will be asked to sign an informed consent form. At the beginning of the session, all participants will be evaluated for their socio-demographic characteristics by a questionnaire created by the researchers, muscle viscoelastic properties by MyotonPRO, upper extremity muscle tone by Modified Ashworth Scale, upper extremity motor dexterity by Box and Block Test, and upper extremity joint range of motion by goniometer and by a phone application named as PhysioMaster. After the assessment, participants will be randomly assigned to two groups: open kinetic chain activity group and closed kinetic chain activity group. After performing the exercises, all evaluations will be conducted again. Thus, the aim is to understand the immediate effects of two different group exercises on the evaluated parameters. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Open Kinetic Chain Activity name: Closed Kinetic Chain Activity measure: MyotonPRO digital palpation device measure: Box and Block Test measure: Modified Ashworth Scale measure: Goniometer measure: PhysioMaster sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istinye University Hospital Medical Park Gaziosmanpasa status: RECRUITING city: Istanbul country: Turkey name: Mehmet Salih Baran, Assist. Prof. role: CONTACT lat: 41.01384 lon: 28.94966 hasResults: False
nctId: NCT06272149 id: VGN-R08b-001 briefTitle: An Exploratory Clinical Trial of VGN-R08b in Patients With Type II Gaucher Disease overallStatus: RECRUITING date: 2023-03-01 date: 2025-01-15 date: 2029-02-28 date: 2024-02-22 date: 2024-02-22 name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine class: OTHER name: Shanghai Vitalgen BioPharma Co., Ltd. briefSummary: This exploratory trial is to prove the tolerability and safety of VGN-R08b to treat infants with type II Gaucher disease. conditions: Type II Gaucher Disease studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: VGN-R08b measure: Number of Adverse Events (AEs), Serious Adverse Events (SAEs) measure: Long-term safety follow-up measure: Survival ratio at age of 24 months measure: Changes in the activity of glucose cerebroside lipase (GCase) measure: Changes in the activity of glucose cerebroside (GC) levels measure: Changes in the activity of glucose sphingosine (Lyso GL1) levels in peripheral blood and CSF after medication measure: Immunogenicity measure: Changes in the genomic level of VGN-R08b vector in peripheral blood after medication sex: ALL minimumAge: 0 Months maximumAge: 24 Months stdAges: CHILD facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine status: RECRUITING city: Shanghai state: Shanghai zip: 200097 country: China name: Zhang Huiwen, Dr. role: CONTACT phone: 18117165075 email: zhanghuiwen@xinhuamed.com.cn lat: 31.22222 lon: 121.45806 hasResults: False
nctId: NCT06272136 id: SPN-007 briefTitle: Spiden Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM) overallStatus: RECRUITING date: 2024-02-23 date: 2024-11-30 date: 2024-12-31 date: 2024-02-22 date: 2024-02-28 name: Spiden AG class: INDUSTRY name: Profil Institut für Stoffwechselforschung GmbH briefSummary: This is a single-centre, multiple sequential-cohort, open study. conditions: Type 1 Diabetes conditions: Type2diabetes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Clinical Demo 2.0 measure: Glucose changes will be measured noninvasively and transcutaneously in dynamic states of glycaemia sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Profil for Stoffwechselforschung GmbH status: RECRUITING city: Neuss state: Nordrhein-Westfallen zip: 41460 country: Germany name: Marc Stoffel, MD role: CONTACT phone: 0049213140180 lat: 51.19807 lon: 6.68504 hasResults: False
nctId: NCT06272123 id: 20D.776 briefTitle: Endotypic Stability in CRS overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-31 date: 2026-01-31 date: 2024-02-22 date: 2024-02-22 name: Thomas Jefferson University class: OTHER name: GlaxoSmithKline briefSummary: A Case control study with 150 cases and 50 controls will be conducted. Immunologic (cytokines measurements in nasal secretions and sinonasal tissues), histopathologic (tissue eosinophilia) and clinical parameters (Lund-Mackay and Lund-Kennedy score, lung function tests), surveys (SNOT- 22, SF-36 quality of life survey) will be compared between different groups of patients conditions: Chronic Sinusitis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 200 type: ESTIMATED name: no intervention measure: Endotypic markers measure: SF-36 measure: SNOT-22 sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thomas Jefferson University Department of Otolaryngology status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19107 country: United States name: Elizabeth Kangas, RN, BSN role: CONTACT phone: 215-955-6784 email: elizabeth.kangas@jefferson.edu lat: 39.95233 lon: -75.16379 hasResults: False
nctId: NCT06272110 id: 22-01303 briefTitle: Promoting Equitable Access to Language Services in Health and Human Services overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-07 date: 2025-08 date: 2024-02-22 date: 2024-02-22 name: NYU Langone Health class: OTHER name: Department of Health and Human Services briefSummary: This is a community-based study that will engage community and health care stakeholders to develop, implement, and evaluate a Health Literacy (HL)-informed, culturally- and linguistically- sensitive approach to improving language access services for patients with limited English proficiency (LEP) to promote health equity and reduce disparities in preventive health services use and health outcomes in New York City (NYC). This study will have a total of 4 phases that include a preparatory work phase (Non-Human Subjects Research), a pre-implementation phase, an implementation phase, and a post-implementation phase.
Findings from the preparatory work and pre-implementation phase and discussions with key partners will inform the co-design of intervention strategies and endpoints for the later phases (implementation and post-implementation phase). conditions: Appropriate Use of Language Across Services studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 17500 type: ESTIMATED name: System level Language Access (LA) intervention measure: Percentage of appropriate interpreter use measure: Percentage of appropriate interpreter use measure: Percentage of patients up to date with preventive screenings and vaccinations measure: Percentage of patients up to date with preventive screenings and vaccinations measure: Percentage of patients with knowledge of federal rights related to LA services measure: Percentage of patients with knowledge of federal rights related to LA services measure: Percentage using untrained interpreters measure: Percentage using untrained interpreters measure: Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back) measure: Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back) measure: Percentage of patients with satisfaction with LA services preventive health services utilization measure: Percentage of patients with satisfaction with LA services preventive health services utilization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health + Hospitals Diagnostic/Treatment Centers city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: NYC Health + Hospitals/Bellevue city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: NYC Health + Hospitals/Woodhull city: New York state: New York zip: 11206 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
nctId: NCT06272097 id: 201328 briefTitle: Postoperative Difficult-to-Heal Wounds of Clinical Trial Registration overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-11-15 date: 2024-02-22 date: 2024-02-22 name: Danni Feng class: OTHER briefSummary: This study aims to investigate the effectiveness of an optimized care management protocol for refractory postoperative wounds based on the TIME CDST tool. Through a randomized controlled trial approach, the investigators will conduct a rigorous comparative analysis of the experimental group and the control group. The intervention group will receive an intervention plan based on the TIME CDST tool led by wound specialist nurses at each dressing change, while the control group receive a routine wound care program of wound cleaning and dressing changes at each dressing change. The main research objective is to evaluate the superiority of the experimental group compared with the control group in terms of wound healing time, healing quality, and patient satisfaction. Through the implementation of this study, the investigators expect to provide an effective optimization scheme for the management of refractory postoperative wounds in clinical practice, thereby improving patient outcomes and quality of life. conditions: Wound Heal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 144 type: ESTIMATED name: Intervention program based on TIME-CDST tool led by wound specialist nurses name: A routine wound care program measure: Wound healing time measure: The wound healing rate measure: The rate of wound area reduction measure: The Pressure Ulcer Scale for Healing (PUSH) measure: The positive rate of bacterial culture measure: The pain intensity measure: Patient comfort score measure: Patient satisfaction score measure: The levels of albumin measure: The number of dressing changes measure: Medical costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06272084 id: CRRT-TPE-01-DE briefTitle: Analysis of TPE Treatments With multiFiltratePRO acronym: TPEopt overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-12 date: 2024-02-22 date: 2024-04-19 name: Fresenius Medical Care Deutschland GmbH class: INDUSTRY name: X-act Cologne Clinical Research GmbH briefSummary: Analysis of therapeutic plasma exchange (TPE) treatments to assess the performance of the TPE mode of multiFiltratePRO based on the successful exchange of plasma from whole blood. The multiFiltratePRO is a device for extracorporeal blood purification treatments. conditions: Autoimmune Diseases studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 60 type: ESTIMATED name: Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO measure: Total amount of exchange plasma (prescribed vs achieved exchange volume) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Klinikum Aschaffenburg-Alzenau city: Aschaffenburg state: Bavaria zip: 63739 country: Germany name: Stefan Büttner, Dr. med. role: CONTACT email: Stefan.buettner@klinikum-ab-alz.de lat: 49.97704 lon: 9.15214 hasResults: False
nctId: NCT06272071 id: 2023YFC2308802-01 briefTitle: A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of Severe Hepatitis (Liver Failure) Complicated With Infection overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-11 date: 2026-11 date: 2024-02-22 date: 2024-03-04 name: Zhejiang University class: OTHER name: Beijing Ditan Hospital name: Beijing YouAn Hospital name: Huashan Hospital name: Qilu Hospital of Shandong University briefSummary: The goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with severe hepatitis (liver failure). The main questions it aims to answer are:
* Constructing early warning predictive models to explore how to give an individualized regimen of integrated immune function. conditions: Liver Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED measure: Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 4 weeks, including site of infection and pathogen of infection. measure: quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks measure: Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 8 weeks, including site of infection and pathogen of infection. measure: Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 12 weeks, including site of infection and pathogen of infection. measure: qSOFA score at 8 weeks measure: qSOFA score at 12 weeks sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06272058 id: 1366-0034 briefTitle: A Study to Test How Avenciguat (BI 685509) is Taken up in the Body of People With and Without Liver Problems overallStatus: RECRUITING date: 2024-03-20 date: 2024-10-01 date: 2024-10-01 date: 2024-02-22 date: 2024-03-25 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to people with and without severe liver problems. People can join the study if they are 18 to 80 years of age and have a body mass index (BMI) between 18.5 and 42 kg/m2.
Participants are in the study for slightly longer than 1 month. Following the screening period of about 4 weeks, they stay at the study site for 4 nights. Afterwards, there are 2 visits to the study site. The site staff measures the amount of Avenciguat (BI 685509) in the blood. The doctors also regularly check participants' health and take note of any unwanted effects. conditions: Healthy conditions: Liver Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Avenciguat (BI 685509) measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) measure: Maximum measured concentration of the analyte in plasma (Cmax) measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) measure: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Orlando Clinical Research Center status: RECRUITING city: Orlando state: Florida zip: 32809 country: United States name: Boehringer Ingelheim role: CONTACT phone: 833-602-2368 email: unitedstates@bitrialsupport.com lat: 28.53834 lon: -81.37924 hasResults: False