hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06356584 id: SDZLEC2024-078-01 briefTitle: Sintilimab Combined With Fruquintinib/Regorafenib ± Radiotherapy for Third-line Treatment of Advanced Metastatic Colorectal Cancer overallStatus: RECRUITING date: 2024-04-01 date: 2026-10-01 date: 2026-10-01 date: 2024-04-10 date: 2024-04-10 name: Shandong Cancer Hospital and Institute class: OTHER briefSummary: Colorectal cancer (CRC) is a significant cause of morbidity and mortality worldwide. Its early clinical manifestations are often subtle, leading to late-stage diagnosis in about 30% of cases with distant metastases. Liver metastases are widespread and associated with poor prognosis, especially in terms of response to immunotherapy. Despite advancements in first- and second-line treatments, third-line therapies for advanced CRC remain limited, emphasizing the need for novel strategies. This prospective study evaluates the efficacy of combined therapy involving Sintilimab, Fruquintinib/Regorafenib, and radiotherapy in advanced CRC. The study cohort comprises patients with non-liver metastatic advanced CRC and those with liver metastases, each receiving tailored treatment protocols. The primary objectives are to assess progression-free survival (PFS), overall survival (OS), and treatment response rates. Subgroup analyses will focus on liver metastases to delineate their impact on treatment outcomes. The rationale for this study stems from the intricate interplay between immunotherapy, targeted therapy, and radiotherapy in CRC management. Previous data suggest a negative correlation between liver metastases and immunotherapy efficacy, necessitating a comprehensive approach integrating multiple treatment modalities. Radiotherapy, particularly stereotactic body radiation therapy (SBRT), has shown promise in controlling liver tumors and modulating the tumor microenvironment, potentially enhancing immunotherapy responses. This study aims to provide valuable insights into optimizing third-line and subsequent therapies for advanced CRC by elucidating the efficacy and safety of this combined treatment approach. The findings may pave the way for personalized treatment strategies tailored to individual patient characteristics, ultimately improving clinical outcomes in this challenging disease setting. conditions: Colorectal Cancer conditions: Immunotherapy conditions: Radiotherapy conditions: Targeted Therapy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 141 type: ESTIMATED name: Sintilimab measure: Progression-free survival (PFS) measure: Overall response rate (ORR) measure: Disease control rate (DCR) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jinbo Yue status: RECRUITING city: Jinan state: Shandong zip: 250000 country: China name: Jin Bo Yue role: CONTACT phone: 0531-67626442 phoneExt: 0531-67626442 email: Len.Xu@hotmail.com lat: 36.66833 lon: 116.99722 hasResults: False
nctId: NCT06356571 id: LPS18183 id: U1111-1298-7348 type: OTHER domain: WHO ICTRP briefTitle: A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma acronym: SubQSA overallStatus: NOT_YET_RECRUITING date: 2024-06-11 date: 2027-01-08 date: 2027-07-15 date: 2024-04-10 date: 2024-04-17 name: Sanofi class: INDUSTRY briefSummary: The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy. conditions: Plasma Cell Myeloma Refractory studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Isatuximab SC-OBDS name: Montelukast name: Dexamethasone name: Acetaminophen name: Diphenhydramine name: Methylprednisolone name: Carfilzomib measure: Overall response rate (ORR) measure: Number of participants with infusion reactions (IRs) measure: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities (per NCI-CTCAE grade or PCSA if NCI-CTCAE scale is not applicable) measure: Number of participants with injection site reactions (ISRs) measure: CR or better measure: VGPR or better measure: Duration of response (DOR) measure: Time to first response (TT1R) measure: Time to best response (TTBR) measure: Patient experience and Satisfaction Questionnaire v2 (PESQ v2) measure: Positivity titer of anti-drug antibodies (ADA) in a subset of 15 participants measure: Maximum observed concentration (Cmax) of isatuximab in a subset of 15 participants measure: Cumulative area under the curve over the first 4 weeks of isatuximab treatment (AUC4 weeks) in a subset of 15 participants sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06356558 id: IRB-300010279 id: R01CA271303 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA271303 briefTitle: Adapting Enhanced Recovery Programs for Low Health Literacy Patients overallStatus: NOT_YET_RECRUITING date: 2026-05 date: 2027-08 date: 2028-05 date: 2024-04-10 date: 2024-04-10 name: University of Alabama at Birmingham class: OTHER name: National Cancer Institute (NCI) briefSummary: Low health literacy patients are a vulnerable population at high-risk for surgical disparities including longer hospital stays, more complications, and more readmissions. This study will adapt enhanced recovery programs (ERPs) to low health literacy patients with a multilevel, health literacy-based implementation strategy (called VISACT - VISuAl aids, Coach providers in communication, and Train organizations in health literacy) to improve ERP fidelity and thereby outcomes. In the final aim of this project (Specific Aim 3), the VISACT intervention will be tested in a pilot trial. Findings from this study will lay the foundation for a multi-institutional stepped-wedge trial and establish key principles for adapting interventions to eliminate disparities. conditions: Surgery conditions: Health Knowledge, Attitudes, Practice conditions: Colorectal Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This pilot study will be a pre-post trial of the intervention (VISACT - VISuAl aids, Coach providers in communication, and Train organizations in health literacy) at 2 sites. This design was selected because the intervention is an implementation strategy and it will not be possible to randomize patients to a non-intervention arm once the VISACT is delivered to a facility. All patients, providers, and organizational units will be subject to downstream effects of VISACT once implemented. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1050 type: ESTIMATED name: Educational intervention (VISACT) measure: Reach - the primary outcome will be to assess the reach of the intervention (VISACT) on patients and providers. measure: Efficacy - Length-of-stay of index surgical hospitalization measure: Adoption - Completion rate of the intervention (VISACT) by participants per month measure: Implementation - Fidelity rate of patients with components of the Enhanced Recovery Program measure: Maintenance - Long-term adoption rate of the intervention (VISACT) per year measure: Efficacy - Readmission rate measure: Efficacy - Complications rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06356545 id: OMICS_CODE_01 briefTitle: Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-10 date: 2024-04-10 date: 2024-04-10 name: Children's Hospital of Fudan University class: OTHER briefSummary: This study will establish a clinical cohort of children with congenital diarrhea and enteropathy (CODE), mine biomarkers of CODE through multi-omics technology and construct a clinical risk prediction model. conditions: Diarrhea Infantile studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Clinical phenotype of congenital diarrhea and enteropathy in China measure: Biomarkers of congenital diarrhea and enteropathy with diagnostic value through microbiome, metabolome and proteome features measure: Cinical risk prediction model for congenital diarrhea and enteropathy built by artificial intelligence and machine learning sex: ALL minimumAge: 1 Month maximumAge: 3 Years stdAges: CHILD hasResults: False
nctId: NCT06356532 id: 202312197544 briefTitle: the Intensive Care Unit Diary for Liver Transplant Recipients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-10 date: 2024-04-10 name: Chang Gung Memorial Hospital class: OTHER briefSummary: the purpose of this study is to assess the effectiveness of the intensive care unit diary for intensive care unit liver transplant recipients. conditions: Liver Transplant Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants in the control group received the routine care including communication and companionship provided by the nurses of the intensive care unit.
The participants in the intervention group received the intensive care unit diary writing and reading. Participants are required to write at least one sentence daily. The primary writers will be the patients themselves, and in cases where patients are unable to write, their family members will write on their behalf. After completion, the diary will be handed over to the patients to review its contents for at least 10 minutes before bedtime, allowing them to write down their immediate reflections and thoughts on when they read. This process will continue until the 14th day post-operation. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Outcomes Assessor is blinded to the group assignments of the patients. She is tasked with collecting the measured outcomes from the patients. Data collection will be conducted by co-principal investigator of the research team. She will distribute the questionnaires at enrollment, and on the 7th and 14th days post-operation. Once notified by the researchers, data collector will distribute and collect the questionnaires. Upon completion, the questionnaires will be sealed in envelopes by the data collectors. whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: intensive care unit diary measure: change from baseline in depression on the Depression-Anxiety-Stress scale at post operation day 7 and day 14 measure: change from baseline in anxiety on the Depression-Anxiety-Stress scale at post operation day 7 and day 14 measure: change from baseline in stress on the Depression-Anxiety-Stress scale at post operation day 7 and day 14 measure: change from baseline in sense of coherence on the Sense of Coherence Scale at post operation day 7 and day 14 measure: change from baseline in emotional stress on the Brief Symptom Rating Scale at post operation day 7 and day 14 measure: change from baseline in delirium on the intensive care delirium screening checklist at post operation day 1 and day 14 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06356519 id: YOUNGBC-29 briefTitle: Real-world Effectiveness and Safety Study of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-04-10 date: 2024-04-10 name: Fudan University class: OTHER briefSummary: The aim of this trial is to explore the real-world effectiveness and poteintial predictors of Sacituzumab Govitecan in Chinese metastatic breast cancer patients. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: Sacituzumab Govitecan measure: PFS measure: ORR measure: OS measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Biyun Wang role: CONTACT phone: 18017312387 email: pro_wangbiyun@163.com lat: 31.22222 lon: 121.45806 hasResults: False
nctId: NCT06356506 id: 2022-P2-338-01 briefTitle: A Study on Factors of Biochemical Response in Autoimmune Hepatitis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2034-05-01 date: 2034-05-01 date: 2024-04-10 date: 2024-04-19 name: Beijing Friendship Hospital class: OTHER briefSummary: The goal of this observational study is to clarify the clinical characteristics of autoimmune hepatitis (AIH) in China. The main questions it aims to answer are:
Human leukocyte antigen (HLA) gene susceptibility in Chinese AIH patients prognostic factors associated with AIH Participants will provide liver tests results and details of treatment during follow-up. conditions: Autoimmune Hepatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 630 type: ESTIMATED measure: Alanine aminotransferase (ALT) recovery measure: Aspartate transaminase (AST) recovery measure: Immunoglobulin G (IgG) recovery measure: Death measure: Liver transplantaiton measure: Progression to hepatocellular carcinoma (HCC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital, Capital Medical University city: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 hasResults: False
nctId: NCT06356493 id: OBIIA CMNT briefTitle: Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for PASD overallStatus: COMPLETED date: 2020-01-02 date: 2022-12-31 date: 2022-12-31 date: 2024-04-10 date: 2024-04-10 name: Tunis University class: OTHER briefSummary: The placenta accreta spectrum is a heterogeneous disorder due to abnormal placental invasion into the uterine wall putting at risk the lives of the patients by causing a massive hemorrhage. Its incidence is increasing due to the rise of the cesarean section. The management of this spectrum is multidisciplinary but not yet codified. Hysterectomy-caesarean, though hemostatic surgery, remains the standard Gold. Several adjuvant treatments have emerged in recent years to minimize the risk of bleeding and morbidity of these disorders including the internal-iliac prophylactic occlusion balloons.
The aim of the study is to demonstrate the effect of prophylactic occlusion balloons in both uterine iliac arteries in the management of placental accreta spectrum disorders. conditions: Hemorrhage conditions: Placenta Accreta Spectrum conditions: Cesarean Section Complications studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 38 type: ACTUAL name: caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries name: caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries measure: calculated blood loss measure: Transfusion peroperatively measure: Duration of surgery measure: Postoperative hospital stay measure: Postoperative transfer to the intensive care unit measure: Morbidity sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Haithem Aloui city: Manouba state: Nabeul zip: 2010 country: Tunisia lat: 36.80803 lon: 10.09721 facility: Haithem Aloui city: Tunis state: Nabeul zip: 2010 country: Tunisia lat: 36.81897 lon: 10.16579 hasResults: False
nctId: NCT06356480 id: 266 briefTitle: 1% Acetic Acid vs Normal Saline Dressing inManagement of Diabetic Foot overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-01 date: 2024-04 date: 2024-04 date: 2024-04-10 date: 2024-04-10 name: Dr. Muhammad Naeem class: OTHER briefSummary: Chronic diabetic wounds are those wounds that are persistent and do not respond to any sort of treatment. The concept of using topical antiseptics on open wounds is to prevent and treat infections. They also help to shorten the time taken to heal the wounds. The use of topical agents on wounds to prevent infection is a minimal ability to develop resistance to the microorganisms. Pseudomonas aeruginosa is a Gram-negative opportunistic pathogen with innate resistance to many antibiotics. In places that are economically backward, these problems get compounded by the inability of patients to afford newer expensive drugs. Topically applied dilute acetic acid, which is cheap and easily available, has been found to be effective in such chronic diabetic wounds conditions: Granulation of Chronic Diabetic Wounds conditions: Diabetic Wounds studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 74 type: ACTUAL name: 1% Acetic acid dressing measure: Early epithelialization and granulation sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pak Emirates military hospital city: Rawalpindi state: Punjab country: Pakistan lat: 33.6007 lon: 73.0679 hasResults: False
nctId: NCT06356467 id: FARINET briefTitle: Influence of Tumour and Patient's Related Factors on the Response to Medical Treatments in Well Differentiated GEP-NENs acronym: FARINET overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-21 date: 2024-12-31 date: 2024-12-31 date: 2024-04-10 date: 2024-04-12 name: IRCCS San Raffaele class: OTHER briefSummary: Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) represent the most common NeuroEndocrin Neoplasms (NEN) site, comprising 55-70% of all NENs, and they are extremely heterogeneous diseases in terms of clinical presentation and aggressiveness. In recent years there has been a significant increase in the incidence of such neoplasms, partially due to incidental findings of small indolent lesions. However, the behavior of GEP- NEN is variable and mainly dictated by some factors as age, sex, histologic grade, primary site, and stage at diagnosis1. As for grade which is defined by the proliferative activity as measured by mitotic count or ki67 staining, some 75% of neoplasms fall into the G1 grading category, 15% into the G2 category, and 10% into the G3 category. The probability of developing metastases is directly correlated with grading. In addition, the grading of GEP-NENs is also correlated with the type of differentiation of the neoplasm (well differentiated or poorly differentiated). Managing the complexity of this type of neoplasm has made it necessary to stratify patients into progression risk classes. The therapeutic approach is accordingly defined, and may include different treatments (surgery, loco-regional, targeted therapies, chemotherapies,...). Among treatments, the most widely used for patients with well-differentiated NENs are somatostatin analogs (SSAs), targeted therapies, and the combination of oral capecitabine and temozolomide. Systemic intravenous chemotherapy is instead employed in a subset of G3 neoplasms, especially if poorly differentiated. conditions: Neuroendocrine Tumors conditions: GEP-NET studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 450 type: ESTIMATED measure: Global Progression Free Survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS OSpedale San Raffaele city: Milan zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
nctId: NCT06356454 id: KAPCON-CR briefTitle: Knowledge, Attitudes and Practices of Paediatric Cardiologists About Cardiac Rehabilitation in Children With Congenital Heart Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-02 date: 2025-06-02 date: 2025-12-02 date: 2024-04-10 date: 2024-04-15 name: Karamanoğlu Mehmetbey University class: OTHER briefSummary: Despite significant clinical benefits and recommendations of clinical practice guidelines to refer patients for exercise and physical activity counselling in the capacity of cardiac rehabilitation (CR), CR is largely underutilised and not implemented effectively. Studies have reported that the reasons for the low implementation of CR are multifactorial at the healthcare system, physician and patient levels. Therefore, the aim of this study was to investigate the knowledge, attitudes and practical applications of paediatric cardiologists regarding cardiac rehabilitation and specifically exercise and physical activity in children with congenital heart disease (CHD). conditions: Physician's Role studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Questionnaire on knowledge, attitudes and practices of paediatric cardiologists about cardiac rehabilitation in children with congenital heart disease measure: The score of Questionnaire on knowledge, attitudes and practices of paediatric cardiologists about cardiac rehabilitation in children with congenital heart disease sex: ALL minimumAge: 32 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06356441 id: B2024-039-01 briefTitle: Artificial Intelligence-supported Reading Versus Standard Double Reading for the Interpretation of Magnetic Resonance Imaging in the Detection of Local Recurrence for Nasopharyngeal Carcinoma: a Randomised Controlled Multicenter Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-10 date: 2024-04-10 name: Sun Yat-sen University class: OTHER briefSummary: The aim of this randomized controlled study is to investigate whether the previously developed artificial intelligence model can triage post-radiotherapy magnetic resonance images of patients with nasopharyngeal carcinoma and assist radiologists in their interpretation. conditions: Artificial Intelligence Supported Image Reviewing studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10400 type: ESTIMATED name: AI measure: sensitivity measure: specificity measure: positive predictive value measure: negative predictive value measure: total time of interpretation for all the MR images measure: the rate of discussion with a third radiologist measure: the detection rate of local recurrence in the AI-supported reading group measure: the sensitivity in the subgroups of different rT-stage measure: the incidence of cases whose recurrent risks and contours cannot be provided by the AI model sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen University Cancer Center city: Guangzhou state: Guangdong zip: 510060 country: China name: Fang-Yun Xie role: CONTACT phone: +8602087342926 email: xiefy@sysucc.org.cn name: Pu-Yun OuYang role: CONTACT phone: +8602087342926 email: ouyangpy@sysucc.org.cn name: Fang-Yun Xie role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False