text
stringlengths 0
197k
|
|---|
2. Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep? conditions: Autism conditions: Sleep Disturbance studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot, non-blinded intervention trial primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Power Down bedtime manipulation measure: Recruitment rates of participants through the trial measure: Retention rates of participants through the trial measure: Caregiver reported acceptability measure: Treatment adherence measure: Data collection rates- Questionnaires measure: Data collection rates- Daily diaries measure: Data collection rates- Wearing the actigraphy watch measure: Credibility/Expectancy Questionnaire sex: ALL minimumAge: 6 Years maximumAge: 10 Years stdAges: CHILD facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Amy G Hartman, PhD role: CONTACT phone: 614-989-6303 email: [email protected] lat: 40.44062 lon: -79.99589 hasResults: False |
<|newrecord|> nctId: NCT06386016 id: Stethoscope study briefTitle: Detection of Valvular Heart Disease Using Artificial Intelligence-based Stethoscope overallStatus: RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-09-01 date: 2024-04-26 date: 2024-04-26 name: Xiao-dong Zhuang class: OTHER briefSummary: The aim of this study is to develop a deep learning-based application of heart sounds in the diagnosis of valvular heart disease, which can be used to screen patients with valvular heart disease and promote earlier clinical monitoring and intervention. conditions: Valvular Heart Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: artificial intelligence-based stethoscope measure: valvular heart disease sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital, Sun Yat-Sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Xiaodong Zhuang, PhD role: CONTACT phone: +86 13760755035 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06386003 id: 23-230 briefTitle: Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-03 date: 2025-05 date: 2024-04-26 date: 2024-04-26 name: Unity Health Toronto class: OTHER name: Toronto Metropolitan University name: University of Ottawa briefSummary: This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD). conditions: Post Traumatic Stress Disorder conditions: PTSD conditions: Chronic PTSD studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Psilocybin measure: Feasibility and tolerability measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score measure: Posttraumatic stress disorder Checklist-5 (PCL-5) measure: Patient Health Questionnaire-9 (PHQ-9) measure: Generalized Anxiety Disorder Scale, 7-item (GAD-7) measure: Dissociative Experiences Scale II (DES-II) measure: Pittsburgh Sleep Quality Index (PSQI) measure: World Health Organization Well-Being Index, 5-item (WHO-5) measure: Quality of relationships inventory (QRI) measure: Inventory of psychosocial functioning (IPF) measure: Posttraumatic Maladaptive Beliefs Scale (PMBS) measure: Brief Experiential Avoidance Questionnaire (BEAQ) measure: 24-items Multidimensional Psychological Flexibility Inventory (MPFI-24) measure: Working Alliance Inventory- Short Form (WAI-SF) measure: Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) measure: Self-Compassion Scale-Short Form (SCS-SF) measure: Psychological Insight Questionnaire (PIQ) measure: Emotional Breakthrough Inventory (EBI) measure: Altered States of Consciousness Rating Scale (ASC) measure: Acceptance/Avoidance-Promoting Experiences Questionnaire (APEQ) measure: Effect on digital physiological passive data collected through the use of a wearable device sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Michael's Hospital, Unity Health Toronto city: Toronto state: Ontario country: Canada lat: 43.70011 lon: -79.4163 hasResults: False |
<|newrecord|> nctId: NCT06385990 id: 2024ks01 briefTitle: Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy overallStatus: RECRUITING date: 2024-03-29 date: 2025-03-29 date: 2027-03-29 date: 2024-04-26 date: 2024-04-26 name: Hunan Cancer Hospital class: OTHER briefSummary: This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug. |
Solution: UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles. conditions: Triple Negative Breast Neoplasms studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 53 type: ESTIMATED name: UTD1 measure: 2-year disease-free survival (DFS) measure: Overall Survival (OS) measure: Disease Free Survival (DFS) measure: Invasive Disease free survival (iDFS) measure: Distant Disease-free Survival (DDFS) sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Quchang Ouyang status: RECRUITING city: Changsha state: Hunan zip: 410083 country: China name: Quchang Ouyang role: CONTACT phone: 8673189762161 email: [email protected] lat: 28.19874 lon: 112.97087 hasResults: False |
<|newrecord|> nctId: NCT06385977 id: ShaanxiPPH briefTitle: Risk Factors for Chronic Prostatitis Patients in Northwest China overallStatus: RECRUITING date: 2016-01 date: 2024-05 date: 2024-06 date: 2024-04-26 date: 2024-04-26 name: Shaanxi Provincial People's Hospital class: OTHER briefSummary: The goal of this observational study is to learn about the risk factors of lifestyle, medication and sexual habits in adult chronic prostatitis / chronic pelvic pain syndrome patients. The main questions it aims to answer are: |
* Is lifestyle, medication, and sexual habits related to chronic prostatitis / chronic pelvic pain syndrome |
* Is there any medication available to protect men from chronic prostatitis / chronic pelvic pain syndrome. |
Participants will: |
* Independently receive a survey questionnaire on lifestyle, medication, and sexual habits. |
* Symptomatic individuals will undergo additional prostate fluid examination for diagnosis. |
Researchers will compare healthy adult males to see if there are differences on lifestyle, medication and sexual habits between the two groups. conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: lifestyle name: sexual habits name: medication measure: Odds Ratio sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shaanxi Provincial People's Hospital status: RECRUITING city: Xi'an state: Shaanxi zip: 710061 country: China name: Qian Deng, Doctor role: CONTACT phone: 86-029-85251331 phoneExt: 2079 email: [email protected] lat: 34.25833 lon: 108.92861 hasResults: False |
<|newrecord|> nctId: NCT06385964 id: SHR-4597-101 briefTitle: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-4597 Inhalation in Healthy Subjects and Asthmatic Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-01 date: 2024-04-26 date: 2024-04-26 name: Guangdong Hengrui Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: The primary objective of this randomized, double-blind, single/multiple ascending dose, placebo-controlled Phase I clinical trial was to evaluate the safety and tolerability of SHR-4597 in healthy subjects and asthmatic patients. The study consists of two parts: Part 1 involves single ascending inhalation dose in healthy subjects; Part 2 involves multiple ascending inhalation dose in asthmatic patients, further divided into Part 2A: multiple ascending inhalation dose in mild to moderate asthmatic patients, and Part 2B: multiple ascending inhalation dose in moderate to severe asthmatic patients. Subsequent lung pharmacokinetic studies of SHR-4597 inhalation will be conducted based on patients' PKPD data. conditions: Healthy Subjects conditions: Asthmatic Patients studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: SHR-4597 name: Placebo measure: Incidence and severity of inhalant adverse events after 4 days of single inhalation of SHR4597 in healthy subjects measure: Incidence and severity of inhalant adverse events after 16 days of multiple inhalation of SHR4597 in asthmatic patients, sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385951 id: ONZ-2023-0323 briefTitle: Spatial Navigation for the Early Detection of Alzheimer's Disease. acronym: ALLO-task overallStatus: RECRUITING date: 2024-03-05 date: 2028-03-01 date: 2028-10-01 date: 2024-04-26 date: 2024-04-26 name: University Hospital, Ghent class: OTHER briefSummary: Alzheimer's Disease (AD) is the most common form of dementia and may contribute to 60-70 % of all cases. An early, accurate diagnosis of AD will become increasingly important with disease-modifying therapies. Different types of fluid and neuroimaging biomarkers are available for the early detection of AD. However, implementation of routine use of these biomarkers in clinical settings is held back due to the risk of overdiagnosis, increased cost and invasiveness of the assessment method. Therefore, novel biomarkers are needed beyond the amyloid and tau pathologies for the early diagnosis of AD. Neuropsychological paper and pencil tests can detect AD and discriminate between different clinical stages. Since medial temporal lobe structures, including the hippocampus and entorhinal cortex (EC), are involved in spatial navigation and degenerate in the earliest stages of AD, spatial navigation can be considered as an early cognitive biomarker of the disease. Nonetheless, the measurement of spatial navigation needs further improvement since the current paper and pencil tests lack ecological validity. Therefore, the test environment should be set up in immersive Virtual Reality (iVR). Dr. Andrea Castegnaro (Space and Memory Lab of University College of London) developed the Allocentric Spatial Update Task (ALLO task), which is an iVR task measuring egocentric and allocentric spatial abilities. |
Therefore, the main objective of this study is to evaluate whether allocentric and egocentric spatial navigation, measured by the ALLO iVR task can be considered a cognitive biomarker for the early detection of AD. In addition, the investigators want to report on the neuronal correlates of both spatial navigation strategies. |
Through the Department of Neurology of the University Hospital of Ghent, which has a large cognitive disorders clinic, patients with mild cognitive impairment and mild Alzheimer's dementia will be recruited. Participants will undergo standard clinical assessment, including a neuropsychological examination, Magnetic Resonance Imaging, a 18F-fluorodeoxyglucose PET and a Lumbar Puncture. In addition, participants will also be asked to undergo Tau PET imaging, Amyloid PET imaging and complete the ALLO iVR task. Healthy controls will also be recruited and have to undergo the same investigations, except for the amyloid PET and lumbar puncture. conditions: Mild Cognitive Impairment conditions: Alzheimer Disease conditions: Healthy Aging studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 160 type: ESTIMATED name: Procedure for patients name: Procedure for healthy controls measure: Spatial navigation abilities measure: Medial Temporal Lobe atrophy measure: Amount and spreading of amyloid in the brain measure: Amount and spreading of tau in the brain measure: Decreases in cerebral glucose metabolism in the brain measure: Cognitive functioning measure: amyloidB1-42 / 40 ratio, total tau and phosphorylated tau sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Gent status: RECRUITING city: Ghent state: East-Flanders zip: 9000 country: Belgium name: Tineke Van Vrekhem role: CONTACT phone: 093326483 email: [email protected] lat: 51.05 lon: 3.71667 hasResults: False |
<|newrecord|> nctId: NCT06385938 id: 23-012048 briefTitle: Ultrasound Imaging and Quantitative Vibro-Acoustic Assessment of Rickets Under the Age of Ten overallStatus: RECRUITING date: 2024-05 date: 2026-04 date: 2026-04 date: 2024-04-26 date: 2024-04-26 name: Mayo Clinic class: OTHER briefSummary: The goal of this study is to find out if the use of ultrasound pictures of bones can spot changes in the growth areas of children with rickets, a condition that affects how bones harden. Researchers want to see if these ultrasound pictures can help tell the difference between children who have rickets and those who don't. conditions: Rickets studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 45 type: ESTIMATED name: Ultrasound with quantitative vibro-acoustic assessment measure: Relationship of quantitative vibro-acoustic ultrasound and rickets severity score measure: Relationship of ultrasound images with radiographic evidence of rickets measure: Case-control comparison of quantitative vibro-acoustic ultrasound measurements between children with rickets and control subjects measure: Longitudinal changes in vibro-acoustic ultrasound measurements with treatment of rickets sex: ALL maximumAge: 10 Years stdAges: CHILD facility: Mayo Clinic Minnesota status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Mary A Johnson role: CONTACT phone: 507-422-6823 email: [email protected] name: Tom D. Thacher, MD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False |
<|newrecord|> nctId: NCT06385925 id: TSN1611-2023-101 briefTitle: A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation overallStatus: RECRUITING date: 2024-04-30 date: 2026-10-30 date: 2027-04-30 date: 2024-04-26 date: 2024-04-26 name: Tyligand Bioscience (Shanghai) Limited class: INDUSTRY briefSummary: The study is a first-in-human (FIH), open-label, multi-center phase 1/2 study of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors. This study will consist of a phase 1 dose escalation part and phase 2 dose expansion part. conditions: Malignant Neoplasm studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: TSN1611 measure: Dose limiting toxicities (DLTs) in phase 1 part measure: Objective response rate (ORR) in phase 2 part measure: Adverse events measure: Area under the plasma concentration-time curve (AUC) measure: Maximum blood concentrations (Cmax) measure: Time to maximum blood concentration (Tmax) measure: Duration of response (DOR) measure: Time to response (TTR) measure: Disease control rate (DCR) measure: Progression free survival (PFS) measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Siqing Fu, MD, PhD role: CONTACT lat: 29.76328 lon: -95.36327 facility: NEXT Oncology status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: David Sommerhalder, MD, PhD role: CONTACT lat: 29.42412 lon: -98.49363 facility: NEXT Virginia status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States name: Alexander Spira, MD, PhD role: CONTACT lat: 38.84622 lon: -77.30637 hasResults: False |
<|newrecord|> nctId: NCT06385912 id: 2024-TJ-SLIDS briefTitle: Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer overallStatus: COMPLETED date: 2006-07-01 date: 2021-02-10 date: 2021-02-10 date: 2024-04-26 date: 2024-04-26 name: Tongji Hospital class: OTHER briefSummary: The study aims to investigate the prognostic and postoperative complication relevance of lymphadenectomy in advanced epithelial ovarian cancer patients who received neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The main question it aims to answer is: |
Does systematic lymphadenectomy during interval debulking surgery have a significant impact on survival in patients with advanced epithelial ovarian cancer who have received neoadjuvant chemotherapy? |
The progression-free survival (PFS), overall survival (OS), and postoperative complication were compared between the lymphadenectomy and no lymphadenectomy groups to answer the question. conditions: Ovarian Cancer conditions: Postoperative Complications conditions: Neoadjuvant Therapy conditions: Lymph Node Excision studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 1090 type: ACTUAL name: lymphadenectomy measure: Progression free survival (PFS) measure: Overall survival (OS) sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China lat: 30.58333 lon: 114.26667 hasResults: False |
<|newrecord|> nctId: NCT06385899 id: : Poorly controlled T2DM-12 briefTitle: Effect of Intensive Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background overallStatus: COMPLETED date: 2021-08-01 date: 2023-01-01 date: 2023-03-01 date: 2024-04-26 date: 2024-04-26 name: Goztepe Prof Dr Suleyman Yalcın City Hospital class: OTHER briefSummary: In Turkey, only 55% of patients with type 2 diabetes have been diagnosed, and 91% of these patients have been receiving treatment. The rate of patients reaching the treatment target is 50%. The pandemic has also affected diabetic patients. It is aimed to determine the characteristics of patients with type 2 diabetes (HbA1c \>=10) with poor metabolic control and to evaluate the extent to which metabolic control can be achieved in 12 months. conditions: Type 2 Diabetes conditions: Poor Glycemic Control studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 266 type: ACTUAL measure: Changes in HbA1c levels after 12 months treatment measure: percentage of patients who reached the HbA1c target of equal to or below 7% measure: The effect of education on the HbA1c changes measure: The effect of depression on the HbA1c changes measure: The effect of the level of physical activity on the HbA1c changes measure: The effect of weight loss on the HbA1c changes sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06385886 id: 1R01HL158807-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HL158807-01A1 briefTitle: Recruitment and Engagement in Care to Impact Practice Enhancement (RECIPE) for Sickle Cell Disease acronym: RECIPE overallStatus: RECRUITING date: 2023-06-08 date: 2027-10 date: 2027-12 date: 2024-04-26 date: 2024-04-26 name: RTI International class: OTHER briefSummary: The goal of this observational study is to help us understand more about the best ways to help individuals living with Sickle Cell Disease (SCD) get the best care. The main question it aims to answer is: How to find individuals unaffiliated from SCD specialist care use three distinct pathways? Once unaffiliated individuals are found using the pathways, Investigators will employ linkage coordinators (trained staff) to engage these patients in care. Participants will be asked to fill out an assessment survey which will cover areas such as previous and current treatment, clinic and hospital experience, pain, and quality of life. Participants will also be given the option of participation in a 1-hour long interview how they feel about treatment for sickle cell disease including clinic experience, pain, and quality of life? conditions: Sickle Cell Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Linkage Coordinator measure: Identification of unaffiliated patients measure: Affiliation with a Sickle cell disease (SCD)-specific care with SCD specialist measure: Scale Out to Other SCD Centers - Implementation in at least 2 other SCD Center study sites sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama, Birmingham (UAB) status: RECRUITING city: Birmingham state: Alabama zip: 35233 country: United States name: Julie Kanter, MD role: CONTACT phone: 205-934-0435 email: [email protected] lat: 33.52066 lon: -86.80249 facility: University of California, San Francisco (UCSF) status: RECRUITING city: Oakland state: California zip: 94609 country: United States name: Marsha Treadwell, PhD role: CONTACT phone: 510-428-3356 email: [email protected] lat: 37.80437 lon: -122.2708 facility: Augusta University status: RECRUITING city: Augusta state: Georgia zip: 30901 country: United States name: Robert Gibson, PhD role: CONTACT phone: 706-721-1005 email: [email protected] lat: 33.47097 lon: -81.97484 facility: University of Illinois status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Lewis Hsu, MD, PhD role: CONTACT phone: 312-355-5019 email: [email protected] lat: 41.85003 lon: -87.65005 hasResults: False |
<|newrecord|> nctId: NCT06385873 id: 2024-SR-233 briefTitle: RC48 Combined With Adebrelimab and Apatinib and S-1 of the Neoadjuvant Therapy of Locally Advanced Gastric Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2028-05-01 date: 2024-04-26 date: 2024-04-26 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: This study is a prospective, open-label, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. The study drugs include RC48, Adebrelimab, Apatinib and S-1. The purpose is to evaluate the effectiveness and safety of the combined coordinated treatment of multi-mechanism drugs for perioperative treatment of locally advanced gastric cancer with HER2 overexpression. conditions: Gastric Cancer/Gastroesophageal Junction Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: RC48 name: Adebrelimab name: Apatinib name: S-1 measure: Pathological Complete Response Rate (pCR) measure: Major Pathological Response rate (MPR) measure: R0 Resection rate measure: Disease-Free Survival (DFS） measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385860 id: GTMGS0423 briefTitle: Prediction Model for Early Biliary Stasis After Bariatric Surgery acronym: PM-EBS-BS overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-09 date: 2025-04 date: 2024-04-26 date: 2024-04-26 name: China-Japan Friendship Hospital class: OTHER briefSummary: Developing and validating a predictive model to estimate the risk of early biliary stasis following bariatric surgery conditions: Obesity conditions: Diabetes conditions: Gallstones conditions: Biliary Stasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 200 type: ESTIMATED measure: early biliary stasis measure: prediction model sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385847 id: GOMIMP briefTitle: To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer overallStatus: RECRUITING date: 2024-05 date: 2025-05 date: 2025-12 date: 2024-04-26 date: 2024-04-26 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: The GOMIMP will be a Prospective, Randomized, Cross-over Trial to Explore the Patient Preference for Goserelin Microsphere (Zoladex®) Versus Goserelin Implant (LY01005) in Patients of Prostate Cancer conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Prospective, randomized, open-label, cross-over phase II trial primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: Zoladex name: LY01005 measure: Patient preference sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian zip: 361003 country: China name: Xuegang Wang, doctor role: CONTACT phone: 15960263909 email: [email protected] lat: 24.47979 lon: 118.08187 hasResults: False |
<|newrecord|> nctId: NCT06385834 id: LY2014-041-A briefTitle: The Effect of Morning vs Evening Aerobic Exercise Training on Cardiac Remodeling and Function Improvement in Patients After ST Elevation Myocardial Infarction overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2028-04-30 date: 2028-07-30 date: 2024-04-26 date: 2024-04-26 name: RenJi Hospital class: OTHER briefSummary: The aim of the study was to intervene in the Aerobic exercise time of patients with STEMI and to explore the optimal exercise time for STEMI patients conditions: ST-segment Elevation Myocardial Infarction (STEMI) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was divided into three groups: morning intervention group (8:00-9:00AM), evening intervention group (16:00-17:00AM) and control group primaryPurpose: TREATMENT masking: SINGLE maskingDescription: In this study, outcome measurement personnel and intervention personnel were separated during the whole process of the experiment, outcome measurement personnel did not know the grouping status, intervention personnel and rehabilitation therapists did not participate in the outcome measurement work. whoMasked: OUTCOMES_ASSESSOR count: 201 type: ESTIMATED name: Morning aerobic exercise name: Evening aerobic exercise measure: left ventricle ejection fraction measure: Oxygen consumption measure: Endothelial Function measure: Skeletal muscle and fat mass measure: Cardiac structure measure: One year major Adverse Cardiovascular Events measure: VE/VCO2-SLOPE measure: Flow-mediated dilation measure: glucose measure: Blood lipid measure: N-terminal pro-BNP sex: ALL minimumAge: 17 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385821 id: GriQv-ch-III-22 briefTitle: A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus overallStatus: COMPLETED date: 2022-09-21 date: 2023-06-15 date: 2023-10-09 date: 2024-04-26 date: 2024-04-26 name: NPO Petrovax class: INDUSTRY briefSummary: The goal of this clinical study is to prove the no less immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of the "proportion of vaccinated with seroconversion in paired sera of the hemagglutination inhibition reaction obtained before and after vaccination". conditions: Influenza conditions: Influenza A conditions: Influenza, Human conditions: Influenza Type B conditions: Flu conditions: Influenza A H3N2 conditions: Influenza A H1N1 conditions: Influenza Epidemic conditions: Flu, Human conditions: Acute Respiratory Infection conditions: Vaccine Reaction studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 824 type: ACTUAL name: Grippol Quadrivalent name: Grippol Plus measure: To prove non-inferior immunogenicity of the Grippol Quadrivalent vaccine when compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three matching strains of the compared vaccines measure: Geometric mean antibody titers measure: Proportion of those vaccinated with seroconversion and geometric mean titer measure: Multiplicity of the increase in the geometric mean titer measure: Seroprotection measure: Incidence of influenza and acute respiratory infections (ARI) measure: The severity and duration of registered cases of influenza and acute respiratory infections (ARI), the presence of complications measure: To assess the reactogenicity of the vaccine Grippol Quadrivalent and the vaccine Grippol plus measure: Frequency and nature of SAEs measure: Frequency and nature of medically attended AEs sex: ALL minimumAge: 6 Months maximumAge: 5 Years stdAges: CHILD facility: State Autonomous Healthcare Institution of the Sverdlovsk Region "Children's City Clinical Hospital No. 11" city: Ekaterinburg zip: 620028 country: Russian Federation lat: 56.8519 lon: 60.6122 facility: Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V. Petrovsky" city: Moscow zip: 119435 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: State Budgetary Healthcare Institution "Children's City Clinical Hospital No.9 named after G.N. Speransky of Moscow Healthcare Department" city: Moscow zip: 123317 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: State Budgetary Health Institution of the Perm Territory "City Children's Clinical Polyclinic No. 5 city: Perm zip: 614066 country: Russian Federation lat: 58.01046 lon: 56.25017 facility: Limited Liability Company "Clinic USI 4D" city: Pyatigorsk zip: 357502 country: Russian Federation lat: 44.04861 lon: 43.05944 facility: Limited Liability Company Medical technology city: Saint Petersburg zip: 192148 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Health Institution "Children's City Polyclinic No. 45 of the Nevsky District" city: Saint Petersburg zip: 193312 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Limited Liability Company " Energiia Zdoroviya" city: Saint Petersburg zip: 194156 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Limited Liability Company PiterClinica city: Saint Petersburg zip: 196158 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases under the Federal Medical Biological Agency city: Saint Petersburg zip: 197022 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Healthcare Institution City Polyclinic No.106 Children's Polyclinic Department No. 37 city: Saint Petersburg zip: 198328 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: State Budgetary Healthcare Institution of the Samara region "Samara Regional Children's Clinical Hospital named after N.N. Ivanova" city: Samara zip: 443079 country: Russian Federation lat: 53.20007 lon: 50.15 facility: Limited Liability Company Center DNK-issledovaniy city: Saratov zip: 410005 country: Russian Federation lat: 51.54056 lon: 46.00861 facility: Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University" of the Ministry of Healthcare of the Russian Federation city: Tyumen zip: 625023 country: Russian Federation lat: 57.15222 lon: 65.52722 hasResults: False |
<|newrecord|> nctId: NCT06385808 id: XJTU1AF-CRF-2023-XK014 briefTitle: Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R/R AML overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2026-12-31 date: 2024-04-26 date: 2024-04-26 name: First Affiliated Hospital Xi'an Jiaotong University class: OTHER briefSummary: The primary objective of this study was to evaluate the efficacy of MTBF conditioning regimen of salvageable allo-HSCT in patients with relapsed or refractory acute myeloid leukemia. The secondary purpose of the study was to observe the safety of MTBF regimen in these patients. conditions: Relapse Leukemia conditions: Refractory Acute Myeloid Leukemia conditions: Conditioning conditions: Hematopoietic Stem Cell Transplantation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The relapsed or refractory acute myeloid leukemia patients will pretreated with the MTBF regimen prior to salvageable allogeneic hematopoietic stem cells. The one-year recurrence-free survival after transplantation of these patients and the safty of the MTBF regimen will be studied. primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: MTBF regimen measure: Recurrence rate measure: Incidence and Severity of non-hematological adverse events (NCI CTCAE v5.0) measure: Neutrophil recovery time measure: Platelet recovery time measure: OS measure: PFS measure: aGVHD sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385795 id: NOE-PMM-201 briefTitle: A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-04-30 date: 2025-04-30 date: 2024-04-26 date: 2024-04-26 name: Noema Pharma AG class: INDUSTRY briefSummary: The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot flashes) due to menopause in women. conditions: Menopause Syndrome conditions: Menopause conditions: Hot Flashes studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: NOE-115 measure: Withdrawals Due to Adverse Events While on NOE-115 for Any Reason measure: Number of Participants Who Experience at Least One or More Adverse Event and the Severity of the Adverse Events (AEs) measure: Weekly Mean Change in the Severity of Hot Flashes from Baseline to Week 4 measure: Weekly Mean Change in the Frequency (any severity) of Hot Flashes from Baseline to Week 4 measure: Effect of NOE-115 as Assessed by Clinical Global Impression of Severity (CGI-S) from Baseline to Week 4 sex: FEMALE minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06385782 id: 20dz1207200 briefTitle: Exploring HRV in Antarctic Overwintering Members of Asia overallStatus: COMPLETED date: 2021-03-01 date: 2022-04-01 date: 2023-09-01 date: 2024-04-26 date: 2024-04-26 name: Ya-Wei Xu class: OTHER briefSummary: Extreme changes in the Antarctic environment can cause emotional and autonomic dysfunction. In this study, volunteers from the Antarctica stations in China provided scale scores and heart rate variability (HRV) data, which were used to assess the autonomic nervous system. Enroll twenty-two members from Zhongshan Station and the Great Wall Station who are overwintering. Using the Generalized Anxiety Disorder (GAD-7) scale, the Patient Health Questionnaire-9 (PHQ-9) scale, and the SF-36 quality of life scale to evaluate the individual's general physical and mental health. Analyze HRV and other associated parameters. conditions: Heart Rate Variability studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 22 type: ACTUAL name: Antarctic environment measure: changes in HRV sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Tenth People's Hospital city: Shanghai state: Shanghai zip: 200079 country: China lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06385769 id: PamukkaleU.ftr-NYıldız-3 briefTitle: Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-01-31 date: 2026-02-28 date: 2024-04-26 date: 2024-04-26 name: Pamukkale University class: OTHER briefSummary: The investigators conducted a prospective, randomized, double-blind, placebo-controlled study based on the placebo technique to evaluate the efficacy of TTNS versus placebo in patients with OAB after stroke. |
The main questions aimed to be answered are: |
What are the effects of Trans Tibial Nerve Stimulation (TTNS) on incontinence-related clinical parameters and quality of life in patients with overactive bladder (OAB) after stroke compared to the placebo group? Participants (n:22) with post-stroke AAM who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive TTNS (n:11) and the second group will receive placebo TTNS (n:11). Measurements will be performed twice in total, before treatment and at the end of treatment (4th week). conditions: Urinary Bladder, Overactive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: Transcutaneous tibial nerve stimulation (TTNS) name: Sham Transcutaneous tibial nerve stimulation (TTNS) measure: Decreased frequency of increased voiding measure: Frequency of voiding measure: The Quality of Life measure: Barthel Index for Activities of Daily Living (ADL) measure: The Overactive Bladder Symptom Score (OABSS) measure: Treatment Satisfaction Level measure: Cystometric value sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pamukkale University city: Denizli country: Turkey lat: 37.77417 lon: 29.0875 hasResults: False |
<|newrecord|> nctId: NCT06385756 id: TJ-IRB202403020 briefTitle: Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-04-26 date: 2024-04-26 name: Tongji Hospital class: OTHER briefSummary: At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery. |
The main questions it aims to answer are: |
* whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients; |
* whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction. |
Participants will: |
* Induction of anesthesia with the experimental drug or placebo； |
* 5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels； |
* To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded. conditions: Amobarbital Sodium conditions: Hemodynamics Instability studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Amobarbital name: Propofol measure: Mean arterial pressure (MAP) during Induction of anesthesia measure: MAP at different time points measure: Incidence of postoperative nausea and vomiting (ponv) sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06385743 id: yeditepe15 briefTitle: The Effectiveness of Neuromuscular Training-Based Exercise Program overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-17 date: 2024-07-14 date: 2024-12-30 date: 2024-04-26 date: 2024-04-26 name: Yeditepe University class: OTHER briefSummary: This randomised controlled study aimed to investigate the effectiveness of a neuromuscular training-based exercise program on pain, function, risk factors specific to shoulder injuries and performance in overhead athletes with shoulder pain. |
The main hypothesis is; |
H0: There is no difference between the "Thrower's Ten" exercise program and the neuromuscular training-based exercise program applied to overhead athletes with shoulder pain, on pain, function, risk factors specific to shoulder injuries, and performance. |
H1: The effects of a neuromuscular training-based exercise program on pain, function, risk factors specific to shoulder injuries and performance in overhead athletes with shoulder pain are superior to the effects of "Thrower's Ten" exercise program conditions: Pain, Shoulder conditions: Sports Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: Neuromuscular Training-based Exercise Program name: ''Thrower's Ten'' Exercise Program measure: Pain Assessment measure: Disabilities of the Arm, Shoulder and Hand (DASH) measure: Tampa Kinesiophobia Scale measure: Hylyght Injury Prevention and Return to the Sports Screening Program ( measure: Y Balance Test- Upper Quarter measure: Closed Kinetic Chain Extremity Stability Test measure: Single Arm Seated Shot Put Test sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Yeditepe University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06385730 id: SCE2401 briefTitle: Neoadjuvant PD-1 Blockade for Elderly Esophageal Squamous Cell Carcinoma (BLESS) acronym: BLESS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2027-05 date: 2024-04-26 date: 2024-04-26 name: Shanghai Chest Hospital class: OTHER briefSummary: The investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of neoadjuvant PD-1 blockade monotherapy with toripalimab in elderly patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC). conditions: Esophageal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: neoadjuvant anti-PD-1 name: neoadjuvant anti-PD-1 with LDRT measure: MPR rate measure: pCR rate measure: Adverse events and treatment-related adverse events measure: R0 resection rate measure: Objective Response rate measure: Event-free survival (EFS) measure: Overall survival (OS) measure: Correlation between potential biomarkers and tumor response sex: ALL minimumAge: 76 Years stdAges: OLDER_ADULT facility: Shanghai Chest Hospital city: Shanghai state: Shanghai zip: 200030 country: China lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06385717 id: ZhejiangU briefTitle: Multicenter Cohort Study of ESD and Chemo-radiotherapy for High-risk Early-stage Esophageal Cancer acronym: ESCORT overallStatus: RECRUITING date: 2024-05-01 date: 2026-01-31 date: 2029-01-31 date: 2024-04-26 date: 2024-04-26 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: This multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection. conditions: Esophagus Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: chemo-radiation measure: Incidence of toxic events measure: 3-year overall survival measure: 3-year local-regional recurrence free survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Zhejiang University School of Medicine status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China name: Jing Xu, MD role: CONTACT phone: 0086-0571-87783521 email: [email protected] lat: 30.29365 lon: 120.16142 facility: The Second Affiliated Hospital of Zhejiang University, School of Medicine status: NOT_YET_RECRUITING city: Hangzhou country: China name: Jing Xu role: CONTACT phone: 0086-0571-87783521 email: [email protected] lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06385704 id: DMRIBFGM0420 briefTitle: Research on Changes in Intestinal Barrier Function and Gut Microbiome in Patients With Type 2 Diabetes After Duodenal Mucosal Resurfacing (DMR) acronym: DMR-IBF-GM overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-12-01 date: 2024-04-26 date: 2024-04-26 name: Wang Siqi class: OTHER name: China-Japan Friendship Hospital briefSummary: The aim of this study is to demonstrate the effects of duodenal mucosal resurfacing (DMR) on intestinal barrier function and gut microbiota when treating uncontrolled type 2 diabetes. Subjects who underwent DMR and those who did not were enrolled, and potential differences were identified by analyzing urine and fecal samples through microbiomic analysis and High Performance Liquid Chromatography（HPLC）, combined with changes in clinical data. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 100 type: ESTIMATED name: DMR Procedure measure: Microbiome Analysis measure: High Performance Liquid Chromatography sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385691 id: ET22-145 briefTitle: Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer. acronym: MyDIET overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2026-06-30 date: 2026-08-31 date: 2024-04-26 date: 2024-04-26 name: Centre Leon Berard class: OTHER briefSummary: This is a prospective, single-center, single-arm Phase II study evaluating the efficacy of the myDIET software tool in the nutritional management of patients with localized and resectable esogastric junction cancer. conditions: Gastric Cancer conditions: Oesogastric Junction Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a prospective, single-center, single-arm Phase II study. primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: myDIET software tool measure: Proportion of patients starting adjuvant chemotherapy within 2 months measure: Adherence to the tool measure: Number of supportive care and emergency consultations initiated by the caregiver measure: Proportion of patients with malnutrition measure: Evolution of body composition in L3 section (volumes) measure: Evolution of body composition in L3 section (indexes) measure: Evolution of resting energy expenditure measure: Proportion of patient covering theoretical nutritional requirement >= 30kcal/kg/day measure: Comparison between theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetry measure: Weight changes measure: Brachial circumference changes measure: Triceps skin fold changes measure: Initiation time for post-operative chemotherapy measure: Proportion of patient with incomplete scheme of pre operative chemotherapy measure: Proportion of patient with incomplete scheme of post operative chemotherapy measure: Proportion of patients with severe post operative complication measure: Tolerance to perioperative chemotherapy measure: Changes in food intake measure: Changes in SEFI (Easy Food Intake Score) measure: Measurement of quality of life measure: Average lengh of hospital stay measure: Recurrence free survival (RFS) measure: Overall survival (OS) measure: Adherence to the physical activity program measure: Physical activity levels measure: Assessment of muscular function by the 6-min walk test measure: Assessment of muscular function by muscular strength sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Léon Berard city: Lyon zip: 69008 country: France name: Pamela Funk-Debleds, MD role: CONTACT phone: 0469856020 phoneExt: +33 email: [email protected] name: Clélia Coutzac, MD role: CONTACT phone: 0469856020 phoneExt: +33 email: [email protected] lat: 45.74848 lon: 4.84669 hasResults: False |
<|newrecord|> nctId: NCT06385678 id: HRS-4642-201 briefTitle: A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-10 date: 2026-08 date: 2024-04-26 date: 2024-04-26 name: Jiangsu HengRui Medicine Co., Ltd. class: INDUSTRY briefSummary: The study is being conducted to evaluate the safety, tolerability, and efficacy of HRS-4642 in combination with antitumor medicine in patients with advanced solid tumors harboring KRAS G12D mutation. conditions: Advanced KRAS G12D Mutant Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: HRS-4642 name: Adebrelimab name: SHR-A1921 name: Pemetrexed Disodium for Injection、Cisplatin Injection、Carboplatin for Injection measure: Phase IB: Safety endpoints: adverse events (AEs). measure: Phase IB： Maximum tolerated dose (MTD) measure: Phase IB：Recommended phase 2 dose (RP2D) measure: Phase II: Overall response rate (ORR). measure: Efficacy endpoints: Overall response rate (ORR). measure: Efficacy endpoints: Duration of response (DoR). measure: Efficacy endpoints: Disease control rate (DCR). measure: Efficacy endpoints: Progression free survival (PFS). measure: Efficacy endpoints: overall survival (OS). sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai East Hospital city: Shanghai state: Shanghai zip: 200120 country: China name: Caicun Zhou, Doctor role: CONTACT phone: 13301825532 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06385665 id: Xin Peng briefTitle: The Effect of Appropriate Family Companionship on the Physical and Mental Health of Patients With Advanced Breast Cancer overallStatus: RECRUITING date: 2024-04-22 date: 2024-04-22 date: 2024-12-31 date: 2024-04-26 date: 2024-04-26 name: Xin Peng class: OTHER briefSummary: The goal of this clinical trial is to learn about companionship needs in breast cancer patients who are pathologically or cytologically diagnosed as cancer, are alive with the tumor, and have TNM clinical stage IV. The main questions it aims to answer are: |
1. Patients with advanced breast cancer need family companionship |
2. Analyze and study the reasons and factors that affect the physical and mental impact of effective family companionship on patients with advanced breast cancer Participants will be divided into a companion group and a non-accompaniment group. Patients in the companion group are given graded companion intervention methods. A comparison group: Researchers will compare a non-accompaniment group to see if the physical and mental impact of companionship on patients. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 304 type: ESTIMATED name: Graded companionship measure: Change from Baseline meatal state on GAD-7 at Week 48. measure: Change from Baseline physical state on kps at Week 48. sex: FEMALE minimumAge: 21 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan zip: 430022 country: China name: Peng Xin, postgraduate role: CONTACT lat: 30.58333 lon: 114.26667 hasResults: False |
<|newrecord|> nctId: NCT06385652 id: PekingUFH-MM-NB381 briefTitle: PET Imaging Study of 68Ga-NB381 in Multiple Myeloma overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-12-31 date: 2024-04-26 date: 2024-04-26 name: Peking University First Hospital class: OTHER briefSummary: Multiple myeloma (MM) predominantly affects the elderly, often presenting insidiously and with a rising incidence rate. Current diagnostic methods primarily rely on invasive bone marrow biopsies, which can lead to false-negative results if the biopsy site is improperly chosen. CD38 is significantly overexpressed on the surface of malignant plasma cells in MM, making it a characteristic tumor biomarker for this disease. |
Addressing the limitations in specificity and sensitivity of traditional PET imaging agents, this project is dedicated to developing a new type of nanobody PET/CT imaging probe, 68Ga-NB381, which possesses high affinity and targets CD38. This probe, which is an intellectual property of our institution, aims to enhance the accuracy and specificity of early MM diagnosis. In terms of clinical evaluation, the project will implement a comprehensive assessment process including case selection, collection of baseline information, high-precision imaging, expert-level image interpretation, and follow-up studies, comparing directly with traditional 18F-FDG imaging to thoroughly verify the specificity and safety of 68Ga-NB381. This lays the groundwork for the clinical translation of this radiopharmaceutical in China. Furthermore, the project contributes to formulating more effective precision treatment plans based on CD38 expression levels and provides evidence for monitoring the therapeutic effects of daratumumab, a drug also targeting CD38. This makes the project of significant academic value and clinical importance, thus promoting the development of personalized treatment strategies. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: In this sequential assignment clinical trial, we aim to evaluate and compare the diagnostic performance of two PET imaging agents, 68Ga-NB381 and 18F-FDG, in patients diagnosed with multiple myeloma (MM). The study will enroll MM patients who meet the inclusion criteria and are scheduled for routine diagnostic imaging. |
Each participant will undergo PET imaging with 18F-FDG first, followed by a second PET scan using 68Ga-NB381 (or reversed). To minimize potential interference between the two imaging sessions and ensure patient safety, a minimum interval of one day will be maintained between the two scans, with all imaging completed within one week. This sequential imaging approach allows for direct comparison of the imaging agents in the same patient, thus controlling for inter-patient variability and providing a more accurate assessment of the relative merits of each imaging agent in the same metabolic and pathological condition. primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: All PET/CT images are jointly interpreted by at least two imaging and nuclear medicine physicians, each with several years of diagnostic experience and at least at the attending physician level. They compare and record the number of lesions detected and the SUVs (Standard Uptake Values) for both 18F-FDG and 68Ga-NB381 PET/CT scans. After consultation, they provide a unified diagnostic opinion. count: 30 type: ESTIMATED name: 68Ga-NB381 measure: Specificity and Binding Efficiency of 68Ga-NB381 in CD38 Positive Tumors sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Ronghui Yu, Master role: CONTACT phone: +8613466379791 email: [email protected] name: Lei Kang, MD role: PRINCIPAL_INVESTIGATOR name: TIANYAO Wang, PhD role: PRINCIPAL_INVESTIGATOR name: Yongkang Qiu, Master role: SUB_INVESTIGATOR name: Zhenghao Tong, MD role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06385639 id: WK2024005 briefTitle: Efficacy and Safety of Probiotic Products for Digestive Health overallStatus: RECRUITING date: 2024-04-25 date: 2024-05-25 date: 2024-06-25 date: 2024-04-26 date: 2024-04-26 name: Wecare Probiotics Co., Ltd. class: INDUSTRY briefSummary: The objective of this study is to evaluate the efficacy and safety of the probiotic product as an everyday gut health product in supporting digestive environment and homeostasis of gut microbiota. conditions: Healthy Adult studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Probiotic measure: Intestinal health sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: [email protected] status: RECRUITING city: Jakarta state: Pusat zip: 10430 country: Indonesia name: Danang A. Yunaidi, MD role: CONTACT phone: 217515932 phoneExt: +62 email: [email protected] lat: -6.21462 lon: 106.84513 hasResults: False |
<|newrecord|> nctId: NCT06385626 id: UREC: 23_15-Raspberry Leaf Tea briefTitle: The Effects of Raspberry Leaf Tea on Blood Glucose Control acronym: RLT overallStatus: RECRUITING date: 2023-12-18 date: 2024-12-23 date: 2024-12-23 date: 2024-04-26 date: 2024-04-26 name: University of Reading class: OTHER briefSummary: The aim of the present clinical trial is to assess how raspberry leaf polyphenols impact on postprandial glucose and insulin levels in healthy individuals consuming sucrose. |
The questions the project will address: |
* Do raspberry leaf polyphenols lower sucrose-induced increases in plasma glucose in humans? |
* Do these polyphenols mediate these effects by inhibiting digestion of sucrose or the absorption of glucose. |
20 healthy adults will be recruited between the ages of 18-65 years who are non-smokers and not taking certain types of medication (e.g., drugs from a GP for high blood pressure, high blood fats, inflammatory conditions, and depression) or dietary supplements (e.g., cholesterol-lowering spreads, fish oil, probiotics, prebiotics, and natural laxatives), antibiotics in the last three months or if they used any drugs or supplements that could affect their blood glucose or lipid metabolism. No abnormal results for liver function tests, renal function tests, and lipid profile tests. If they have food allergies or consume more than 14 units of alcohol per week (i.e., to help they calculate a alcohol intake, one standard glass of wine (175 ml) or one pint of regular lager is equivalent to just over two units of alcohol), frequently travel for work or are participating in another intervention study, they will not be able to participate. Women who are pregnant or lactating or planning a pregnancy in the next six months will also not be able to take part, not use herbal medicines for at least the previous three months, not be on a weight loss program six months before screening, not involved in clinical trials six months before the screening, and not having severe cardiac, hepatic, or renal function impairment. Not Sufferers of chronic illnesses, not Individuals with food allergies, not people with coeliac disease. |
They will be asked to attend a four-study visit after an eight-hour overnight fast. Volunteers will be asked to consume 50 g of carbohydrate powder (sucrose and glucose) with or without 10 g of raspberry leaf tea, which will be dissolved in 300 mL of warm water during four visits (every month). Blood samples will be taken at intervals for a period of two hours after the consumption of raspberry leaf or control. Blood glucose and insulin levels will be tested 15 minutes before, at 15,30,60,90, and 120 minutes after carbohydrate intake. conditions: Type II Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Volunteers will be asked to consume 50 g of carbohydrate powder (sucrose and glucose) with or without 10 g of raspberry leaf tea, which will be dissolved in 300 mL of warm water during four visits (every month). primaryPurpose: PREVENTION masking: NONE count: 20 type: ESTIMATED name: Raspberry leaf tea measure: Blood Glucose sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hugh Sinclair Unit of Human Nutrition, University of Reading status: RECRUITING city: Reading state: Berkshire zip: RG6 5SG country: United Kingdom lat: 51.45625 lon: -0.97113 hasResults: False |
<|newrecord|> nctId: NCT06385613 id: TDK-2024-13377 briefTitle: The Effect of Mobile-Based Education on Self-Care, Quality of Life and Complications in Patients With Intestinal Stoma overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-04-22 date: 2025-08-22 date: 2024-04-26 date: 2024-04-26 name: Ataturk University class: OTHER briefSummary: Stomas are most commonly used in the gastrointestinal tract as ileostomy or colostomy. Although colorectal cancers are the most important factor causing intestinal stoma opening, intestinal ostomies are also used in cases such as congenital anomalies, obstructive or inflammatory bowel diseases, traumas requiring surgery, large defects caused by colorectal injuries as well as sigmoid colon volvulus and ischemic colitis. In stoma surgery performed to increase the duration and quality of life of individuals, the patient's compliance with the stoma and awareness of possible complications are important. Conditions such as peristomal skin problems, noisy bowel movements, stool leakage and pain make it difficult to adapt to the stoma.In addition, despite all the advances in stoma care products and surgical techniques, individuals are faced with stoma complications. Therefore, individuals with stoma should be closely monitored for complications. Inappropriately selected stoma site or bag/adapter system, lack of knowledge and skills related to stoma care can be listed among the possible causes of complications. Complications such as edema, bleeding, ischemia and mucocutaneous separation may develop in the first days after stoma surgery. In studies evaluating patients in terms of stoma compliance and complications in the literature, it has been observed that mobile-based trainings given to patients increase their stoma compliance and reduce the incidence of complications. With the mobile-based training planned to be used in the study, it is thought to contribute to the ability of individuals to perform stoma care independently. With the decrease in peristomal skin lesions and stoma complications, it is predicted that the quality of life of patients with stoma will increase, self-care competence will be formed, and health expenditures and therefore national health expenditures will decrease. It is thought that this mobile training application will not only provide support to patients with stoma but also guide healthcare professionals. It will also contribute to closing the shortage of stoma and wound care nurses in hospitals. conditions: Intestinal Stoma Site Hemorrhage conditions: Intestinal Stoma Leakage conditions: Life Style, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Groups will be divided into control and intervention. People in the group will be randomly assigned in a simple randomized manner. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Individuals assigned to controls and interventions will not know which group they are in. whoMasked: PARTICIPANT count: 62 type: ESTIMATED name: Mobile-based stoma care education group measure: Adaptation of Quality Life Scale measure: Ostomy Self-Care Index measure: Pittman Ostomy Complication Severity Index measure: Peristomal Skin Tool measure: Ostomy Adjustment Inventory-23 measure: Computer System Usability Questionnaire sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ataturk University Faculty of Nursing city: Erzurum country: Turkey name: Nilgün Söylemez, PhD Student role: CONTACT phone: +905439790424 email: [email protected] lat: 39.90861 lon: 41.27694 hasResults: False |
<|newrecord|> nctId: NCT06385600 id: severe preeclampsia briefTitle: Intravenous Labetalol vs Phentolamine for the Management of Severe Preeclampsia. overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2026-01-20 date: 2026-03-20 date: 2024-04-26 date: 2024-04-26 name: Assiut University class: OTHER briefSummary: The only effective treatment of severe preeclampsia is delivery of the fetus but immediate antihypertensive treatment is given to stabilize the patient and prevent further complications. All antihypertensive medication can potentially cross the placenta. At this time, there are no randomized control trials to base a recommendation for the use of one antihypertensive agent over another. However, certain medications are effective in lowering blood pressure with an acceptable safety profile in pregnancy. The choice of therapy depends on the acuity and severity of hypertension conditions: Severe Pre-eclampsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 200 type: ESTIMATED name: Labetalol name: Phentolamine measure: the effect of Labetalol and Phentolamine on MCA flow velocity by transcranial Doppler monitoring. measure: The effect of labetalol and phentolamine on blood pressure of the patients sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06385587 id: ADH-OL-Study-01-23 briefTitle: Technology-based Symptom Monitoring Intervention for Locally Advanced Head and Neck Cancer Patients acronym: SYMTECH01 overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2024-12-29 date: 2025-09-27 date: 2024-04-26 date: 2024-04-29 name: Aptar Digital Health class: INDUSTRY briefSummary: The goal of this observational study is to assess the satisfaction and usability of an interactive and patient-centered mobile application (app), Oleena™, designed to assist head and neck cancer patients undergoing chemoradiation in managing common and distressing symptoms in real-time, as well as to assess the satisfaction and usability of the related HCP web portal. Additional secondary usage and clinical endpoints that would be used to assess intervention efficacy in future trials will be collected. conditions: Head and Neck Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Oleena measure: Users' satisfaction measure: Feasibility of the technology enabled symptom management solution measure: Usability of the technology enabled symptom management solution measure: Appropriateness of the recommendations measure: Semi-structured exit interviews measure: Symptom burden will be measured using the NIH PRO-CTCAE measurement system, which includes validated scales for individual toxicities measure: Quality of life will be measured using the previously validated FACT-G scale measure: Treatment adherence measure: Health-economic outcome measure: Complaints, alleged deficiencies or malfunctions of the device reported sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385574 id: 2023-088 briefTitle: Technological Based Rehabilitation on Individuals With Rheumatic Disease overallStatus: RECRUITING date: 2024-03-15 date: 2024-05-15 date: 2024-05-20 date: 2024-04-26 date: 2024-04-26 name: Akdeniz University class: OTHER briefSummary: Affects such as pain, swelling, tenderness, deformities, limitations, strength and function losses, skill and coordination deficiencies in the hand joints, which are frequently seen in rheumatism patients with hand involvement, are included in body structure and function disorders within the framework of International Classification of Function System. Leap Motion Controller is used in hand rehabilitation because it is small in size, low-cost, portable, non-contact, easy to use and provides visual and auditory feedback. The aim of our study is to examine the effect of technology-based rehabilitation on joint range of motion, grip strength, functionality and disease activity in adult individuals with rheumatic disease with hand involvement; and also to compare these effects with the effects of the hand rehabilitation program implemented under the guidance of a physiotherapist and the control group that continues its routine life. conditions: Rheumatic Diseases conditions: Hand Rheumatism conditions: Virtual Reality Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are three groups in the study. First group is leap motion interventional group, second group is hand exercises group and the third group is waiting list. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator and outcome assessors do not know which patient is in which group. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Virtual reality therapy measure: Hand grip strength measurement measure: Jebsen Hand Function Test (JHFT) measure: Nine Hole Peg Test (NHPT) measure: Duruoz Hand Index (DHI) measure: Michigan Hand Outcome questionnaire (MHQ) measure: Disease Activity Score 28 (DAS 28) measure: Hand fine grip strength measurement sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Sebahat Yaprak Cetin status: RECRUITING city: Antalya state: Konyaaltı zip: 07100 country: Turkey name: Sebahat Yaprak Cetin, PhD role: CONTACT email: [email protected] lat: 36.90812 lon: 30.69556 hasResults: False |
<|newrecord|> nctId: NCT06385561 id: Tramadol_OIBD id: 2022-500108-23-00 type: CTIS briefTitle: The Influence of Tramadol on Opioid-induced Bowel Dysfunction overallStatus: COMPLETED date: 2022-08-11 date: 2023-05-15 date: 2023-05-15 date: 2024-04-26 date: 2024-04-26 name: Asbjørn Mohr Drewes class: OTHER briefSummary: Tramadol is a weak opioid and widely used to treat moderate to severe pain. Stronger opioids are known to inhibit gastrointestinal motility and secretion, however the effects of tramadol on gastrointestinal function remains less understood. The aim of this study was to determine to what degree tramadol causes opioid-induced bowel dysfunction by using an objective design to explore gastrointestinal transit, motility pattern, secretion, and colonic volume, in a group of healthy male volunteers. conditions: Opioid-Induced Bowel Dysfunction conditions: Constipation studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ACTUAL name: Tramadol name: Placebo measure: Total gastrointestinal transit time measure: Colorectal transit time measure: Constipation symptoms measure: Bowel movement frequency measure: Stool consistency measure: Gastrointestinal symptoms measure: Opioid-induced constipation measure: Diagnostic evaluation of opioid-induced constipation measure: Colonic motility patterns measure: Opiate withdrawal symptoms measure: Colon volume measure: Colonic water content measure: Gastric half emptying time measure: Gastric contraction assessment measure: Gastric contraction assessment measure: Small bowel motility assessment measure: Small bowel water content sex: MALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Aalborg University Hospital city: Aalborg zip: 9000 country: Denmark lat: 57.048 lon: 9.9187 hasResults: False |
<|newrecord|> nctId: NCT06385548 id: VHIO21001 briefTitle: Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - LiDer acronym: LiDer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-04 date: 2026-04 date: 2024-04-26 date: 2024-04-26 name: Vall d'Hebron Institute of Oncology class: OTHER briefSummary: Background: |
Endometrial cancer is a prevalent gynecological malignancy, with a significant number of cases diagnosed at an advanced stage or recurring following initial treatment. Platinum-based chemotherapy represents a standard treatment option for these patients; however, disease progression often occurs, highlighting the need for novel therapeutic approaches. Lurbinectedin, a synthetic analog of marine alkaloid-derived compounds, and dostarlimab, a monoclonal antibody targeting PD-1, have demonstrated promising antitumor activity in various malignancies. This phase I-II clinical trial seeks to evaluate the safety, tolerability, and efficacy of combining lurbinectedin and dostarlimab in patients with advanced or recurrent endometrial cancer who have experienced disease progression following platinum-based chemotherapy. |
Primary Objectives: |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.