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1. Assess how and when sex-specific bone developmental trajectories in the leg and arm will differ between children with T1D and control cohorts relative to the critical period of rapid skeletal growth in puberty. It is hypothesized that children with T1D will have inferior bone development, particularly lower gains in bone strength.
2. Assess why bone trajectories differ between T1D and control cohorts by identifying the role of body composition, site-specific muscle force and physical activity on differences in bone properties in female and male children with and without T1D. It is hypothesized that children with T1D will have lower gains in lean mass, muscle force, number of daily bone impacts and minutes of moderate-vigorous physical activity and will be associated with inferior gains in bone development.
3. Assess why T1D may impair sex-specific bone development by exploring the role of disease-related factors (e.g., duration, glucose control, hormones and markers of bone turnover) and fracture history on bone trajectories of children with T1D. It is hypothesized that longer exposure to T1D, poorer glucose control, alterations in hormones, lower bone formation markers and higher history of fracture will be negatively associated with bone trajectories of children with T1D.
Participant's physical growth, bone growth, muscle strength, physical activity and nutrition habits will be assessed and followed up annually for up to 4 years. conditions: Type-1 Diabetes studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 204 type: ESTIMATED measure: Trabecular Thickness (μm) measure: Bone Strength (Failure load) measure: Total, Cortical and Trabecular Bone Area (mm^2) measure: Total, Cortical and Trabecular Bone Density (mg HA/cm^3) measure: Cortical Thickness (μm) measure: Cortical Porosity measure: Trabecular Bone Volume Fraction (%) measure: Trabecular Bone Number (1/mm) measure: Trabecular Bone Separation (μm) measure: Total Body and Hip Bone Mineral Content (g) measure: Total Body and Hip Areal Bone Mineral Density (g/cm^2) measure: Age from Peak Height Velocity (years) measure: Pubertal Development measure: Long Jump (m) measure: Hand Grip (N) measure: Bone Impacts measure: Physical Activity (minutes/day) measure: Food Frequency Questionnaire measure: Health measure: Osteocalcin measure: Procollagen type I N-propeptide (P1NP-N) measure: C-terminal telopepide (CTx) measure: Sclerostin measure: Insulin growth factor-1 measure: Alkaline phosphatase sex: ALL minimumAge: 10 Years maximumAge: 12 Years stdAges: CHILD facility: University of Saskatchewan status: RECRUITING city: Saskatoon state: Saskatchewan zip: S7N5B2 country: Canada name: Saija Kontulainen, PhD role: CONTACT phone: (306)966-1077 email: saija.kontulainen@usask.ca lat: 52.13238 lon: -106.66892 hasResults: False
<\|newrecord\|> nctId: NCT06287827 id: 190224 briefTitle: Treatment of Acute Malnutrition in Outpatient Care Services in Venezuela: a Prospective Cohort Research overallStatus: RECRUITING date: 2024-02-14 date: 2024-06-01 date: 2024-06-01 date: 2024-03-01 date: 2024-03-05 name: UNICEF - Venezuela class: OTHER briefSummary: The goal of this observational study is to compare the effectiveness, safety, and efficiency of the simplified protocol, which includes the following three modifications: a) use of a single treatment product (RUTF), b) reduced dose, c) expanded cut-offs, with the standard protocol based on the 2023 World Health Organization (WHO) guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months, in outpatient care services of the states of Bolívar, Capital District, La Guaira, and Miranda of Venezuela.
The main question it aims to answer is:
What is the effectiveness, safety, and efficiency of the simplified protocol, which includes these three modifications (use of a single treatment product (RUTF), reduced dose, expanded cut-offs) when compared to a standard protocol that is based on the 2023 WHO guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months in the outpatient care services of the states of Bolívar, Capital District, La Guaira, and Miranda of Venezuela? This prospective cohort, longitudinal study will be conducted in 4 states, treating children aged 6-59 months diagnosed with uncomplicated AM, defined as WHZ \<-2 or mid-upper-arm circumference (MUAC) \<125mm or bilateral edema. Children will be prospectively followed for 16 weeks or until their recovery.
Researchers will compare the simplified protocol cohort with the standard protocol cohort to determine which one has the best effectiveness, safety, and efficiency indicators in the Venezuela context.
The effectiveness of the treatment will be measured by the recovery rate, duration of the treatment, and changes in anthropometry (weight, height, and arm circumference). Other treatment effects will also be measured, including how many are admitted to the hospital, death, and relapse rates from the nutritional program. An economic evaluation component will be incorporated. Total costs will be aggregated and presented as costs per child treated and per child recovered. conditions: Acute Malnutrition in Childhood conditions: Wasting conditions: Child Malnutrition studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Simplified protocol name: Standard protocol measure: Recovery rate measure: Weight gain measure: Mid-Upper Arm Circumference (MUAC) gain measure: Duration of the treatment measure: Prevalence of child morbidity measure: Number of RUTF delivered per child measure: Cost per child measure: Prevalence of child stunting sex: ALL minimumAge: 6 Months maximumAge: 59 Months stdAges: CHILD facility: Bolivar State Centers status: RECRUITING city: Puerto Ordaz state: Bolivar zip: 8050 country: Venezuela name: Mary Lares, PhD role: CONTACT phone: +584166203588 email: marylares@hotmail.com name: Mary Lares, PhD role: PRINCIPAL_INVESTIGATOR lat: 8.29829 lon: -62.72198 facility: Ditrict Capital centers status: RECRUITING city: Caracas state: Capital District zip: 1090 country: Venezuela name: Pablo Hernandez, MSc role: CONTACT phone: +584142561345 email: doctuscumliber@gmail.com name: Pablo Hernandez, MSc role: PRINCIPAL_INVESTIGATOR lat: 10.48801 lon: -66.87919 facility: Miranda State Centers status: RECRUITING city: Santa Lucia state: Miranda zip: 1214 country: Venezuela name: Pablo Hernandez, MSc role: CONTACT phone: +584142561345 email: doctuscumliber@gmail.com name: Pablo Hernandez, MSc role: PRINCIPAL_INVESTIGATOR facility: La Guaira State Centers status: RECRUITING city: La Guaira zip: 1160 country: Venezuela name: Claret Mata, MSc role: CONTACT phone: +584142052498 email: clujaym@gmail.com name: Claret Mata, MSc role: PRINCIPAL_INVESTIGATOR lat: 10.59901 lon: -66.9346 hasResults: False
<\|newrecord\|> nctId: NCT06287814 id: RECHMPL23_0299 briefTitle: French Assessment of MRD by Liquid Biopsies in Stage III CRC Patients (FRENCH.MRD.CRC) overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-10-31 date: 2028-10-31 date: 2024-03-01 date: 2024-03-01 name: University Hospital, Montpellier class: OTHER briefSummary: Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for colorectal cancer, the methods used to decide who gets additional post-surgery treatment are suboptimal. Some patients get too much treatment, while others do not get enough.
There is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment after surgery. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points.
The GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient.
FRENCH-MRD-CRC is the French study of the european GUIDE.MRD project. conditions: Colorectal Cancer conditions: Stage III Colon Cancer conditions: Minimal Residual Disease conditions: Liquid Biopsy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 70 type: ESTIMATED name: Blood sample/lliquid biopsy measure: 3-year disease-free survival (DFS) measure: Sensitivity (Se) of the ctDNA diagnostics measure: Specificity (Sp) of the ctDNA diagnostics measure: Positive predictive value of the ctDNA diagnostics measure: Negative predictive value of the ctDNA diagnostics measure: Area under the curve of the ctDNA diagnostics measure: Time to clinical recurrence measure: Overall survival measure: Time to molecular recurrence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06287801 id: 2024P000271 briefTitle: Annual Wellness Visits vs GRACE-augmented Annual Wellness Visits For Older Adults With High Needs - Phase 1 acronym: SPIRE1 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-01-01 date: 2025-06-01 date: 2024-03-01 date: 2024-03-25 name: Massachusetts General Hospital class: OTHER name: Brandeis University name: Patient-Centered Outcomes Research Institute name: Vanderbilt University Medical Center name: Dartmouth-Hitchcock Medical Center name: Indiana University briefSummary: This study consists of three aims focused on examining the feasibility of adding the Geriatric Resources and Assessment for the Care of Elders (GRACE) model to structured Annual Wellness Visits (AWVs) to improve patient and caregiver outcomes and reduce hospitalizations in older adults with complex health needs. The objectives are to:
1. Co-design a community-centric implementation strategy for the AWVs vs AWVs + GRACE -augmented care (AWV GRACE) study arms
2. Develop a referral pathway and algorithm to optimize enrollment of eligible participants
3. Conduct a pilot clinical trial to assess the feasibility of the AWV GRACE intervention. conditions: Healthy Aging conditions: Health Care Utilization conditions: Health-Related Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Feasibility of a clinical comparative effectiveness trial primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The outcomes assessor team will be blinded to the intervention assignments of participants. Due to the nature of the intervention, the participants, the investigator, and the care providers are unable to be blinded to the participant assignments. whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Annual Wellness Visit name: Geriatric Resources and Assessment for the Care of Elders measure: Hospitalizations measure: Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CG-CAHPS) with Patient Centered Medical Home 1.0 supplement (PCMH CAHPS) measure: Net Promotor Score measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - Physical Health (PH) and Mental Health (MH) measure: Caregiver Strain measure: Patient's out-of-pocket costs for up to 180 days after enrollment measure: Caregiver's hours spent caregiving. measure: Pilot ACOs Staffing costs measure: Exploratory Geriatric Outcomes - Number of participants with new ICD-10 diagnosis codes measure: Exploratory Geriatric Outcomes- number of participants that complete advanced care planning documents measure: Exploratory Geriatric Outcomes - number of participants with inappropriate medications measure: Covariate - Demographics measure: Covariate - Medicare Entitlement Status measure: Covariate - Elixhauser comorbidity index measure: Covariate - Area Deprivation Index measure: Covariate - Loneliness measure: Exploratory - Hope measure: Covariate - Activities of daily living (ADL) measure: Exploratory - ED visits measure: Exploratory - Observation visits sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06287788 id: NFEC-2024-068 briefTitle: A Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Radiation-induced Oropharyngeal Mucositis overallStatus: RECRUITING date: 2024-03-01 date: 2026-10-30 date: 2026-12-31 date: 2024-03-01 date: 2024-03-01 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: The performance of the predictive models for severe oropharyngeal mucositis established using current oral mucosal contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance. The aim of this prospective, multicenter, observational study was to further explore the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC. conditions: Radiation-induced Oropharyngeal Mucositis conditions: Swallowing-induced Breakthrough Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 240 type: ESTIMATED measure: The AUC of the predictive model measure: The accuracy, sensitivity, specificity, positive predictive value, negative predictive value and F1 score of the predictive model measure: The important predictors of severe oropharyngeal mucositis in the predictive model sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510515 country: China name: Jian Guan, Ph.D. role: CONTACT phone: 86+13632102247 email: guanjian5461@163.com lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06287775 id: NCI-2024-01398 id: NCI-2024-01398 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 10629 type: OTHER domain: JHU Sidney Kimmel Comprehensive Cancer Center LAO id: 10629 type: OTHER domain: CTEP id: UM1CA186691 type: NIH link: https://reporter.nih.gov/quickSearch/UM1CA186691 briefTitle: Testing the Combination of an Anti-cancer Drug, Iadademstat, With Other Anti-cancer Drugs (Atezolizumab or Durvalumab) at Improving Outcomes for Small Cell Lung Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-24 date: 2026-01-31 date: 2026-01-31 date: 2024-03-01 date: 2024-03-12 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase I/II trial tests the safety, side effects, and best dose of iadademstat when given together with atezolizumab or durvalumab, and studies the effect of the combination in treating patients with small cell lung cancer that has spread outside of the lung in which it began or to other parts of the body (extensive stage) who initially received standard of care chemotherapy and immunotherapy. Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab or durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding iadademstat to either atezolizumab or durvalumab may be able to stabilize cancer for longer than atezolizumab or durvalumab alone in treating patients with extensive stage small cell lung cancer. conditions: Extensive Stage Lung Small Cell Carcinoma conditions: Stage IV Lung Cancer AJCC v8 studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Atezolizumab name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Durvalumab name: Echocardiography name: Iadademstat name: Magnetic Resonance Imaging name: Multigated Acquisition Scan measure: Progression free survival measure: Objective response rate measure: Overall survival measure: Incidence of adverse events measure: Detection of circulating tumor deoxyribonucleic acid (DNA) (ctDNA) minimal residual disease measure: Impact of iadademstat on the correlation of immune checkpoint inhibitors (ICIs) and the presence of cachexia measure: Exposure response relationships of iadademstat in combination with ICIs measure: Changes to small cell lung cancer subtype sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06287762 id: 10001737 id: 001737-NR briefTitle: A Natural History Study of RYR1-Related Disorders overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2031-04-30 date: 2031-12-30 date: 2024-03-01 date: 2024-04-26 name: National Institute of Nursing Research (NINR) class: NIH briefSummary: Background:
Congenital myopathies (CM) are genetic disorders that can cause decreased muscle tone and muscle weakness. Most CMs in the United States are related to the ryanodine receptor 1 (RYR1) gene. Researchers need more natural history data to learn about these CMs in children and adults.
Objective:
To learn more about the signs, symptoms, and course of RYR1-related disorders.
Eligibility:
People aged 7 years and older with an RYR1-related disorder.
Design:
Ambulatory participants will come to the Clinical Center and non-ambulatory participants will visit via telehealth.
Visits will be once a year for 3 or 5 years. Clinical Center visits will take 2 to 3 days.
All participants will undergo tests including:
Photos and videos. These will be taken to document the participant s condition.
Blood and urine tests.
Activity Tracker. Participants will wear a device to record their activity.
Questionnaires. Participants will answer questions about their health, pain, fatigue, stress, quality of life, and other topics.
Participants who visit the Clinical Center will also undergo:
Tests of heart and lung function.
Motor skills and strength tests. Participants will walk, climb stairs, kneel, crawl, stand up, and perform other movements to test their strength and abilities. They will squeeze and pinch a handheld device to test their grip.
Imaging scans.
Skin biopsy. Adult participants may opt to have a sample of skin taken (one time only).
Eye exam conditions: Ryanodine Receptor 1-Related Myopathy conditions: Ryanodine Receptor 1 Related Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: Adverse and disease-related events measure: Medical data review measure: Ophthalmology measure: Patient-reported outcomes measure: Pulmonary function measure: Motor function and performance measure: Characterize phenotype and disease course over an extended (2-year) period (total 5 years).Collect exploratory biomarker data. sex: ALL minimumAge: 7 Years maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health Clinical Center city: Bethesda state: Maryland zip: 20892 country: United States name: Irene Chrismer role: CONTACT phone: 240-591-8884 email: irene.chrismer@nih.gov name: NIH Clinical Center Office of Patient Recruitment (OPR) role: CONTACT phone: (800) 411-1222 phoneExt: TTY dial 711 email: ccopr@nih.gov lat: 38.98067 lon: -77.10026 hasResults: False
<\|newrecord\|> nctId: NCT06287749 id: RECHMPL23_0298 briefTitle: French Assessment of MRD by Liquid Biopsies in PDAC Patients (FRENCH.MRD.PDAC) overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2028-10-31 date: 2028-10-31 date: 2024-03-01 date: 2024-03-01 name: University Hospital, Montpellier class: OTHER briefSummary: The overall objective of this GUIDE.MRD consortium is to confirm that ctDNA detected after curative intended treatment for PDAC is a marker of residual disease and for risk-of-recurrence, and applicable in clinical practice.
Primary objective To confirm that ctDNA analyses performed after PDAC treatment can identify patients with a high risk-of-recurrence.
Specifically, the investigators want to determine the association between disease-free survival (DFS) and ctDNA detection status after
1. curative-intended surgery and
2. adjuvant chemotherapy.
FRENCH.MRD.PDAC is the French study of the european GUIDE.MRD project conditions: Pancreatic Cancer Resectable conditions: Pancreatic Ductal Adenocarcinoma conditions: Minimal Residual Disease conditions: Liquid Biopsy conditions: ctDNA studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 37 type: ESTIMATED name: Blood sample/Liquid Biopsy measure: 3-year Disease-free survival (DFS) measure: Sensitivity (Se) of the ctDNA diagnostics measure: Specificity (Sp) of the ctDNA diagnostics measure: Positive predictive value of the ctDNA diagnostics measure: Negative predictive value of the ctDNA diagnostics measure: Are Under the Curve of the ctDNA diagnostics measure: Time to clinical recurrence measure: Overall survival measure: Time to molecular recurrence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06287736 id: 2023H0386 briefTitle: Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-01 date: 2024-03-01 name: Ohio State University class: OTHER name: Neuright, Inc. briefSummary: This is a prospective randomized control trial. Participants enrolled into the study will be randomized into one of three groups, two of which are treatment groups and the third is a control group. A time course of measurements before and after spinal cord stimulation (SCS) treatment (where applicable) will assess pain, DPN severity, small fiber nerve activity, and metabolic health markers. conditions: Diabetic Peripheral Neuropathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: Spinal Cord Stimulator Implantation (SCS) measure: Change in Pain level measure: Change in Diabetic Peripheral Neuropathy (DPN) Pain using the Neuropathic pain diagnostic questionnaire (DN4) measure: Change in PROMIS quality of life in relation to pain level measure: change in neuropathic symptoms using Michigan Neuropathy Screening instrument sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Ohio State University Wexner Medical Center city: Columbus state: Ohio zip: 43210 country: United States name: Uchechi Okafor role: CONTACT phone: 614-366-3439 email: Uchechi.Okafor@osumc.edu name: Brian Dalm, MD role: PRINCIPAL_INVESTIGATOR name: Kristy Townsend, PhD role: SUB_INVESTIGATOR name: Magdalena Blaszkiewicz, PhD role: SUB_INVESTIGATOR name: Miriam Freimer, MD role: SUB_INVESTIGATOR name: Bakri Elsheikh, MD role: SUB_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False
<\|newrecord\|> nctId: NCT06287723 id: RECHMPL23_0297 briefTitle: French Assessment of MRD by Liquid Biopsies in Colorectal With Liver Metastasis Patients (FRENCH.MRD.CRLM) overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-10-31 date: 2028-10-31 date: 2024-03-01 date: 2024-03-01 name: University Hospital, Montpellier class: OTHER briefSummary: Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for colorectal cancer, the methods used to decide who gets additional post-surgery treatment are suboptimal. Some patients get too much treatment, while others do not get enough.
There is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment after surgery. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points.
The GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient.
FRENCH.MRD.CRLM is the French study and part of the european GUIDE.MRD project. conditions: Colorectal Cancer conditions: Liver Metastases conditions: Stage IV Colorectal Cancer conditions: Minimal Residual Disease conditions: Liquid Biopsy conditions: ctDNA studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Blood sample/Liquid biopsy measure: 3-year disease free survival measure: Sensitivity (Se) of the ctDNA diagnostics measure: Specificity (Sp) of the ctDNA diagnostics measure: Positive predictive value of the ctDNA diagnostics measure: Negative predictive value of the ctDNA diagnostics measure: Area under the curve of the ctDNA diagnostics measure: Time to clinical recurrence measure: Overall survival measure: Time to molecular recurrence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06287710 id: CHUBX 2023/32 briefTitle: Fluid Responsiveness Evaluation by a Non-invasive Method in Children, Extended to PREterm Infants - FRENCH-PREMA acronym: FRENCH-PREMA overallStatus: RECRUITING date: 2024-01-17 date: 2024-11-17 date: 2025-04-17 date: 2024-03-01 date: 2024-03-01 name: University Hospital, Bordeaux class: OTHER briefSummary: In this study, the investigators aim to validate a non-invasive marker of fluid-responsiveness in preterm infants (term below 37 gestational week) with acute circulatory failure based on standardized abdominal compression. This would allow physicians to identify which patient could benefit from a fluid expansion, thus avoiding a potentially useless or even dangerous fluid expansion, leading to fluid overload. To this end, the investigators will evaluate the diagnostic accuracy (sensitivity and specificity) of stroke volume variation induced by standardized abdominal compression for the diagnosis of fluid responsiveness (based on the gold-standard test: significant increase in cardiac index after fluid expansion). conditions: Premature Baby 26 to 32 Weeks conditions: Premature Baby 33 to 36 Weeks studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment). measure: Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness, measure: Diagnostic accuracy of the SAV mean and the ΔPeak for the diagnosis of fluid responsiveness sex: ALL minimumAge: 1 Minute maximumAge: 5 Months stdAges: CHILD facility: Bordeaux Hospital University status: RECRUITING city: Bordeaux zip: 33076 country: France name: Sophie CRAMAREGEAS, MD role: CONTACT phone: 0557821269 name: sophie.cramaregeas@chu-bordeaux.fr role: CONTACT lat: 44.84044 lon: -0.5805 hasResults: False
<\|newrecord\|> nctId: NCT06287697 id: LOA/RAP/2019/20 briefTitle: Energy Expenditure and Body Composition of Infants and Young Children (6-24 Months Old) in Asia overallStatus: ACTIVE_NOT_RECRUITING date: 2020-01-21 date: 2024-11-30 date: 2024-11-30 date: 2024-03-01 date: 2024-03-01 name: Mahidol University class: OTHER name: International Atomic Energy Agency name: National Institute of Nutrition, Vietnam name: Faculty of Medicine, University of Ruhuna, Sri Lanka name: Pakistan Institute of Nuclear Science and Technology (PINSTECH) name: Food and Nutrition Research Institute, Philippines name: FAO briefSummary: This project is a collaboration between International Atomic Energy Agency (IAEA), FAO Regional Office for Asia and The Pacific, and Mahidol University, Thailand to carry out the study on doubly-labeled water for assessment of total energy expenditure and body composition among infants and young children aged 6-23 months old. Thailand conducted a longitudinal study with participation from 4 other countries, namely, Pakistan, Philippines, Sri Lanka and Vietnam, in undertaking the same assessments in a cross-sectional design. conditions: Energy Expenditure conditions: Body Composition conditions: Infants and Young Children conditions: Infant and Young Child Feeding studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 391 type: ACTUAL name: No intervention measure: Total Energy Expenditure measure: Body composition measure: Weight measure: Length measure: Head circumference measure: Mid-upper arm circumference measure: Triceps skinfold thickness measure: Subscapular skinfold thickness measure: Infant and Young Child Feeding (IYCF) measure: Dietary intake sex: ALL minimumAge: 6 Months maximumAge: 24 Months stdAges: CHILD facility: Institute of Nutrition, Mahidol University city: Salaya state: Nakhon Pathom zip: 73170 country: Thailand lat: 13.802 lon: 100.32111 hasResults: False
<\|newrecord\|> nctId: NCT06287684 id: ESICM-22 briefTitle: Molecular Endotype-Specific Dynamics of Lung Endothelial Barrier Integrity in Sepsis acronym: MENDSEP overallStatus: RECRUITING date: 2023-09-13 date: 2025-12-30 date: 2025-12-30 date: 2024-03-01 date: 2024-03-01 name: Mater Dei Hospital, Malta class: OTHER name: European Society of Intensive Care Medicine name: University of Malta briefSummary: Sepsis is a complex syndrome that causes lethal organ dysfunction due to an abnormal host response to infection. No drug specifically targeting sepsis has been approved. The heterogeneity in sepsis pathophysiology hinders the identification of patients who would benefit, or be harmed, from specific therapeutic interventions. Recent clinical genomics studies have shown that sepsis patients can be stratified as molecular endotypes, or subclasses, with important clinical implications. Classifying sepsis patients as molecular endotypes revealed that a poor prognosis endotype was characterized by immunosuppression and septic shock. Against this backdrop, the study hypothesis is that a poor prognosis for sepsis is defined by a molecular endotype reflecting impaired innate immune and endothelial barrier integrity in the primary anatomical site of infection. conditions: Sepsis conditions: Septic Shock conditions: Pneumonia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 132 type: ESTIMATED name: Blood transcriptomics and BAL protein profiling measure: Patient stratification as transcriptomic endotypes measure: Lung endothelial barrier integrity measure: Survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mater Dei hospital, Intensive Care Unit status: RECRUITING city: Imsida zip: MSD2080 country: Malta name: Carmel Abela role: CONTACT phone: +35625450000 email: carmel.c.abela@gov.mt lat: 35.8925 lon: 14.48278 hasResults: False
<\|newrecord\|> nctId: NCT06287671 id: COCO briefTitle: Colorectal Omics and ofCS Proteoglycans acronym: COCO overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-12 date: 2032-12 date: 2024-03-01 date: 2024-03-01 name: Claus Anders Bertelsen, PhD, MD class: OTHER name: Viborg Regional Hospital briefSummary: This observational study aims to test proteomics, metabolomics and proteoglycans as predictors of postoperative complications after colorectal surgery and as biomarkers of colorectal cancer.
The main questions to answer are:
* can these biomarkers predict anastomotic leakages
* can these biomarkers predict recurrence after colorectal cancer
* can these biomarkers be used as diagnostic tests for colorectal cancer
* can these biomarkers be identified in the tumor
Participants will undergo elective colorectal resection or stoma closure. conditions: Colorectal Cancer conditions: Diverticulitis, Colonic conditions: Inflammatory Bowel Diseases conditions: Stoma Colostomy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Colorectal resection or stoma closure measure: Rate of anastomotic leakage diagnosed by CT-scan or reoperation measure: Rate of major postoperative complications measure: Short-term mortality measure: Recurrence after colorectal cancer measure: Diagnostic value of omics and other biomarkers detecting colorectal cancer measure: Correlation between biomarker in plasma and tissue sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nordsjaellands Hospital city: Hillerød zip: 3400 country: Denmark name: Nanna B Hupfeld, MD role: CONTACT phone: +4548292793 email: nanna.baekvang.hupfeld.01@regionh.dk name: Claus A Bertelsen, PhD role: CONTACT phone: +4548295972 email: claus.anders.bertelsen@regionh.dk lat: 55.92791 lon: 12.30081 facility: Regionshospitalet Viborg city: Viborg zip: 8800 country: Denmark name: Uffe S Løwe, PhD role: CONTACT lat: 56.45319 lon: 9.40201 hasResults: False
<\|newrecord\|> nctId: NCT06287658 id: E-57428665-050.04-240046 briefTitle: The Effect of Kegel Exercise and Ba Duan Jin Applications on Premenopausal Women With Urinary Incontinence overallStatus: RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2025-03-01 date: 2024-03-01 date: 2024-04-03 name: Ondokuz Mayıs University class: OTHER briefSummary: This study aimed to determine the effects of Kegel exercise and Ba Duan Jin applications applied to premenopausal women with urinary incontinence on quality of life and psychological well-being. Study Group of the Research: Premenopausal women between the ages of 45-55 who come to the family health center with any complaint and have urinary incontinence. The research will be conducted as a randomized pre-test, post-test and control group intervention study design. The research will be conducted with women aged 45-55 with urinary incontinence who came for examination for any reason to a Family Health Center in Sinop between March 2024 and July 2024. According to the power analysis, the number of participants was calculated to be at least 54 when the type 1 error was taken as 0.05, the power was 0.95 and the effect size was medium (0.25) for the two-group design with two repeated measurements. To prevent possible data loss, the sample size was increased by 10% and the total number of participants was determined as 60. A total of 60 women, 30 experimental and 30 control, coming to the Family Health Center will be randomly included in the study. No information, Kegel exercise program and Ba Duan Jin applications will be given to the women in the experimental group, and no intervention will be given to the control group during the research process. Participants will be assigned to 2 groups: experimental and control. Those who come to FHC on odd days of the month will be included in the experimental group, and those who come on even days of the month will be included in the control group. Each group will be determined as 30 people. After the research is completed, the interventions applied to the experimental group will be applied to the women in the control group. Personal Information Form, Psychological Well-Being Scale and Incontinence Quality of Life Scale will be applied to women in the experimental and control groups as pre-test measurements. As a final test, the same measurements will be made to both the control group and the experimental group 16 weeks after the first measurement. conditions: Urinary Incontinence conditions: Menopause conditions: Wolman Disease conditions: Quality of Life conditions: Psychological Well-Being studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Training on Kegel exercise and Ba Duan Jin applications online name: training on Kegel exercises and Ba Duan Jin applications after the research is completed measure: Psychological Well-Being Scale measure: Incontinence Quality of Life Scale sex: FEMALE minimumAge: 45 Years maximumAge: 55 Years stdAges: ADULT facility: Tuba Yilmaz Bulut status: RECRUITING city: Kocaeli country: Turkey name: TUBA YILMAZ BULUT, Dr. role: CONTACT phone: 05343435109 email: tuba_yilmaz1991@hotmail.com lat: 39.62497 lon: 27.51145 hasResults: False
<\|newrecord\|> nctId: NCT06287645 id: Retinal Images Dataset briefTitle: Color Fundus Photograph With Experts Labelling overallStatus: RECRUITING date: 2022-05-12 date: 2025-12-31 date: 2026-06-30 date: 2024-03-01 date: 2024-03-07 name: Pakistan Council of Scientific and Industrial Research class: OTHER name: Al-Ibrahim Eye Hospital briefSummary: This trial aims to provide a digital retinal image dataset from Pakistan, graded by three specialists according to the severity of Diabetic Retinopathy. The dataset aims to improve research and patient care. conditions: Retinal Disease conditions: Diabetic Retinopathy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 50000 type: ESTIMATED name: Color Fundus Photography/Non-Mydriatic Opthalmic Cameras measure: Grading Diabetic Retinopathy Severity according to International Clinical Diabetic Retinopathy Severity Scale measure: Grading Diabetic Retinopathy Severity according to Early Treatment of Diabetic Retinopathy Scale measure: Finding inter-rater agreement among the graders sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Al Ibrahim Eye Hospital status: RECRUITING city: Karachi country: Pakistan name: Ghulam Mustafa role: CONTACT email: mustafabme@gmail.com lat: 24.8608 lon: 67.0104 hasResults: False
<\|newrecord\|> nctId: NCT06287632 id: 2024P000451 briefTitle: CPAP in Patients With Severe Obesity After Anesthesia overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-11 date: 2026-06 date: 2024-03-01 date: 2024-03-01 name: Massachusetts General Hospital class: OTHER briefSummary: The goal of this study is to compare two continuous positive airway pressure (CPAP) settings on heart and lung function in patients with severe obesity after anesthesia. The main questions it aims to answer are:
1. Does a recruitment maneuver and CPAP set to intrathoracic pressure (ITP) improve cardiopulmonary function compared to standard CPAP settings in patients with severe obesity after anesthesia?
2. Does the location of adipose tissue influence the response to CPAP settings in patients with severe obesity after anesthesia?
Participants will undergo monitoring of their intrathoracic pressure using an esophageal catheter. In the recovery area after anesthesia, participants will receive two CPAP settings, each for 20 minutes.
* Intervention 1: Recruitment maneuver and CPAP will set to the level of intrathoracic pressure
* Intervention 2: CPAP set to home settings (if OSA is present) or between 8-10 cmH20 (if OSA is not present). conditions: Obesity, Abdominal conditions: Anesthesia Morbidity conditions: Apnea, Obstructive Sleep conditions: Atelectases, Postoperative Pulmonary conditions: Ventilator Lung studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Recruitment/ITP-CPAP (Intervention A) name: Standard CPAP (Intervention B) name: Atmospheric Pressure measure: End expiratory lung impedance measure: Regional lung ventilation measure: Right ventricular function measure: Mean pulmonary artery pressure measure: Inspiratory effort measure: Abdominal muscle thickness measure: Respiratory rate measure: Oxygen saturation measure: Systemic blood pressure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06287619 id: 22-5685 briefTitle: Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery acronym: POAM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-06 date: 2024-03-01 date: 2024-03-07 name: University Health Network, Toronto class: OTHER name: Queen's University name: Sunnybrook Health Sciences Centre name: Heart and Stroke Foundation of Canada briefSummary: POAM is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT investigating whether, in patients with chronic iron-deficiency anemia undergoing cardiac surgery, IV iron therapy in the postoperative period (initiated shortly after surgery, and repeated at 42 days after surgery, if needed) improves clinical outcomes (days alive and out of hospital at 90 days after surgery; DAOH-90) relative to placebo. conditions: Chronic Iron Deficiency Anaemia conditions: Cardiac Surgery studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: POAM is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in Canada. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: This is a blinded study, with patients randomized to receive ferric derisomaltose (Monoferric) or placebo. Given that the products have different physical appearances, an unblinded research pharmacist will prepare the IMP then blind the appearance of the IMP for both the intervention group and control group by covering the IV bag and tubing with opaque plastic. All other clinicians, research coordinators, outcome assessors, and patients will remain blinded by using a generic product label in the patient chart and/or the electronic product name (i.e., POAM study drug dose 1 and dose 2, rather than specifying type of product used). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Monoferric Injectable Product name: 0.9% sodium chloride solution measure: Feasibility Outcome 1: Percentage of major protocol deviations measure: Feasibility Outcome 2: Adequate patient enrollment measure: Feasibility Outcome 3: Percentage of patients lost to follow-up at 90 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kingston Health Sciences Centre city: Kingston state: Ontario zip: K7L 3N6 country: Canada lat: 44.22976 lon: -76.48101 facility: Sunnybrook Health Sciences Centre city: Toronto state: Ontario zip: M4N 3M5 country: Canada lat: 43.70011 lon: -79.4163 facility: Toronto General Hospital - University Health Network city: Toronto state: Ontario zip: M5G 2C4 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06287606 id: CTP0302 briefTitle: A Phase 3 Clinical Trials for Bowel Preparation for Colonoscopy overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-29 date: 2024-01-17 date: 2024-05-14 date: 2024-03-01 date: 2024-03-01 name: Taejoon Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy conditions: Bowel Preparation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 161 type: ACTUAL name: CTP0302-A name: CTP0302-B name: Conventional OST measure: Ratio of subjects With successful Bowel Cleansing measure: Each segments ratio of subject with successful Bowel Cleansing measure: Comparison of Acute gastropathy probability score sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taejoon Pharmaceutical Co., Ltd. city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06287593 id: NeoLiq briefTitle: The Feasibility of Dynamic Liquid Biopsy Monitoring During Neoadjuvant Treatment for EGFR-mutated NSCLC overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-12-31 date: 2027-12-31 date: 2024-03-01 date: 2024-04-24 name: Zhejiang University class: OTHER briefSummary: This study aimed to assess the value of dynamic ctDNA monitoring in guiding the development of personalized neoadjuvant treatment strategies for EGFR-mutated NSCLC patients. conditions: EGF-R Positive Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: ctDNA monitoring measure: the rate of major pathological response (MPR) measure: the rate of pathological complete response (pCR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06287580 id: STU-2024-0140 briefTitle: Effects of Antihypertensive Drug Treatment on Brain Blood Flow, Cognition, and Regulation of Nervous System in Older Adults With Hypertension. overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-01-01 date: 2027-01-01 date: 2024-03-01 date: 2024-04-24 name: University of Texas Southwestern Medical Center class: OTHER briefSummary: High blood pressure (BP) is a public health problem worldwide. Nearly three-quarters of older adults (age \~60 years) in the United States have high BP. High BP links to many health problems, like stroke. Drug treatments are typically used in clinics to reduce high BP and the risk of associated health problems. However, these drug treatments may not always benefit brain health. For example, drug treatment may reduce brain blood flow, which may reduce cognitive function in older adults with high BP. Alternatively, reduced brain blood flow may cause high BP due to increased nervous system activity (the so-called "fight or flight response"). Thus, monitoring brain blood flow may help to manage high BP during drug treatment.
It is unknown if brain blood flow and its control will be altered by drug treatment in older high BP patients. Therefore, study team will recruit older adults with high BP, who receive either drug treatment or a placebo for 2 weeks and will assess brain blood flow, cognitive function, and nervous system control before and after treatment.
Results from this study will provide novel and clinically relevant information on the impact of drug treatment for high BP on brain health. Investigators expect these results will suggest that it is crucial to measure brain blood flow, which may be a therapeutic new target for BP control and brain health. conditions: Essential Hypertension conditions: Older Adults studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: chlorthalidone 25 mg name: Placebo measure: Change in Muscle sympathetic nerve activity (MSNA) from baseline at 2 weeks post intervention measure: Change in cognitive performance from baseline at 2 weeks post intervention via Stroop Color and Word Test measure: Change in cognitive performance from baseline at 2 weeks post intervention via NIH Toolbox Cognitive Battery measure: Change in Cerebral blood flow from baseline at 2 weeks post intervention sex: ALL minimumAge: 60 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Exercise and Environmental Medicine city: Dallas state: Texas zip: 75231 country: United States name: Takuro Washio, Ph.D. role: CONTACT phone: 214-345-4852 email: TakuroWashio@texashealth.org lat: 32.78306 lon: -96.80667 hasResults: False
<\|newrecord\|> nctId: NCT06287567 id: IIT2023078-EC-1 briefTitle: Lusutrombopag in the Treatment of Immune Thrombocytopenia (ITP) overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-09-30 date: 2024-11-30 date: 2024-03-01 date: 2024-03-04 name: Institute of Hematology & Blood Diseases Hospital, China class: OTHER briefSummary: This exploratory study is to investigate the efficacy, safety and tolerability of Lusutrombopag in the treatment of primary immune thrombocytopenia in Chinese patients who have failed first-line therapy conditions: Idiopathic Thrombocytopenic Purpura conditions: Immune Thrombocytopenia studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 17 type: ESTIMATED name: Lusutrombopag Oral Tablet measure: Percentage of Participants with a Platelet Response after 4 Weeks (Day 29) measure: Percentage of Participants with a Platelet Response after 12 Weeks (Day 85) measure: Percentage of Participants Who at least once Achieved a Platelet Count of ≥100x10^9/L in the Core Study measure: Change in Platelet Count measure: Percentage of Participants Who at least once Achieved a Platelet Count of≥50x10^9 /L during the Treatment measure: Percentage of Participants Who at least once Achieved a Platelet Count of≥100x10^9 /L during the treatment measure: Time to first Achieve a Platelet Count of ≥ 50x10^9/L measure: Time to first Achieve a Platelet Count of ≥100x10^9 /L measure: Percentage of Participants Who at least once Achieved a Platelet Coun platelet count≥30×10^9/L, a≥2-fold increase from baseline within week 1-4 and week 5-12，respectively. measure: Durable Platelet Response (platelet count ≥50×10^9/L in ≥75% of weeks) Rate measure: Cumulated Number of Weeks of Response（≥50x10^9/L） measure: Percentage of Participants with a Reduction in the use of Concomitant ITP Medications from Baseline measure: The Incidence and Rating of Bleeding Events During the Study measure: Percentage of Participants Who Required Rescue Therapy for Bleeding During the Study measure: Number of Participants With Adverse Events (AEs) measure: Change in Health-related Quality of Life Assessed by FACIT-F Scale from Baseline to Week 16 measure: Change in Health-related Quality of Life Assessed by ITP-PAG Scale from Baseline to Week 16 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Hematology & Blood Diseases Hospital city: Tianjin state: Tianjin zip: 300020 country: China lat: 39.14222 lon: 117.17667 hasResults: False
<\|newrecord\|> nctId: NCT06287554 id: 404/2024 briefTitle: Effect of Early Implementation of Prone Positioning acronym: prone overallStatus: COMPLETED date: 2020-03-04 date: 2022-04-20 date: 2022-04-20 date: 2024-03-01 date: 2024-03-01 name: Zulekha Hospitals class: OTHER name: Al-Azhar University briefSummary: Background and objective: The ramifications of early lung protective measures and prone positioning on the ICU length of stay rates of participants admitted to the ICU with acute respiratory distress syndrome amid the COVID-19 pandemic constitute a pivotal examination. The study aims to identify the effect of early prone positioning on the length of stay, discharge rate, and number of tracheostomized patients in the ICU. conditions: Severe Acute Respiratory Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 70 type: ACTUAL name: PRONE POSITION measure: Number of discharged patients measure: The total length of stay measure: ICU length of stay measure: Patients who underwent tracheostomy procedures sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Al-Azhar faculty of medicine city: Cairo zip: 12546 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06287541 id: 2023-SR-486 briefTitle: The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection overallStatus: RECRUITING date: 2023-07-01 date: 2025-12-01 date: 2027-07-01 date: 2024-03-01 date: 2024-03-01 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The goal of this clinical trial is to evaluate the efficacy of using a urine biomarker test to guide the decision-making process regarding the necessity of reTURBT in NMIBC patients. The main question aims to answer whether patients with negative urine biomarker tests can safely avoid reTURBT without compromising recurrence-free survival. Participants who have completed the initial TURBT and tested negative for the urine biomarker will be enrolled in the study. They will then be randomized 1:2 into two groups:Group A: Participants will not receive reTURBT and Group B: Participants will undergo reTURBT. Researchers will compare the RFS rates between Group A (no reTURBT) and Group B (reTURBT) to determine if the urine biomarker test can safely spare patients from unnecessary reTURBT. conditions: Non Muscle Invasive Bladder Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants who meet the inclusion criteria are randomized 1:2 into two parallel groups. Group A: Participants assigned to this group will not undergo reTURBT. They will receive standard follow-up care as per institutional guidelines.
Group B: Participants assigned to this group will undergo reTURBT as part of their treatment protocol. Following reTURBT, they will also receive standard follow-up care. Outcome measures of recurrence rate and RFS would be compared between the two groups to determine the effectiveness and safety of the urine genetic test-guided approach compared to standard care with reTURBT.Throughout the study period, both groups are followed up simultaneously, allowing for parallel comparisons of outcomes. primaryPurpose: TREATMENT masking: NONE count: 428 type: ESTIMATED name: Urine biomarker -Guided without reTURBT measure: 2-year RFS rate measure: RFS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210029 country: China name: Qiang Lv, Ph.D role: CONTACT email: doctorlvqiang@sina.com lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06287528 id: 23-307 briefTitle: A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL) overallStatus: RECRUITING date: 2024-02-23 date: 2028-02-23 date: 2028-02-23 date: 2024-03-01 date: 2024-04-03 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: Participants will have a sample of their white blood cells, called T cells, collected using a procedure called leukapheresis. The collected T cells will be sent to a laboratory to be changed (modified) to become 19-28z/IL-18, the CAR T-cell therapy that participants will receive during the study. Making the participants' study therapy will take about 2-4 weeks. conditions: Philadelphia-Negative ALL conditions: Philadelphia-Positive ALL conditions: Relapsed ALL, Adult conditions: Refractory Acute Lymphoblastic Leukemia conditions: Refractory Acute Lymphoblastic Leukemia (ALL) conditions: Refractory Acute Lymphoid Leukemia in Relapse studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: 19-28z/IL-18 CAR T cells measure: Toxicity as determined by CTCAE, version 5.0 sex: ALL minimumAge: 17 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Jae Park, MD role: CONTACT phone: 646-608-3743 lat: 40.70621 lon: -74.54932 facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities) status: RECRUITING city: Middletown state: New Jersey zip: 07748 country: United States name: Jae Park, MD role: CONTACT phone: 646-608-3743 lat: 40.39652 lon: -74.09211 facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities) status: RECRUITING city: Montvale state: New Jersey zip: 07645 country: United States name: Jae Park, MD role: CONTACT phone: 646-608-3743 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Cancer Suffolk-Commack (Limited Protocol Activities) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Jae Park, MD role: CONTACT phone: 646-608-3743 lat: 40.84288 lon: -73.29289 facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities) status: RECRUITING city: Harrison state: New York zip: 10604 country: United States name: Jae Park, MD role: CONTACT phone: 646-608-3743 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities) status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Jae Park, MD role: CONTACT phone: 646-608-3743 lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities) status: RECRUITING city: Uniondale state: New York zip: 11553 country: United States name: Jae Park, MD role: CONTACT phone: 646-608-3743 lat: 40.70038 lon: -73.59291 hasResults: False
<\|newrecord\|> nctId: NCT06287515 id: 2023-0940 id: NCI-2024-01986 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Hypophysectomy by Stereotactic Radiosurgery for Cancer-Related Pain overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2025-07-01 date: 2027-07-01 date: 2024-03-01 date: 2024-03-04 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn if hypophysectomy (treatment of the pituitary gland) using a type of radiation treatment called stereotactic radiosurgery (SRS) can help to relieve cancer-related pain. conditions: Hypophysectomy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: Stereotactic Radiosurgery measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Chenyang Wang, MD role: CONTACT phone: 832-710-1570 email: cwang23@mdanderson.org name: Chenyang Wang, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06287502 id: KHRehab_LeungHC_2 briefTitle: Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis overallStatus: ACTIVE_NOT_RECRUITING date: 2022-09-09 date: 2024-04-30 date: 2024-06-30 date: 2024-03-01 date: 2024-03-04 name: Kowloon Hospital, Hong Kong class: OTHER briefSummary: This is a prospective parallel group, double-blinded randomized controlled trial. Subjects are randomized into two groups - the intervention group and waitlist control group. Subjects received resistance, aerobic, flexibility and balance exercise training; and nutritional supplement containing β-hydroxy β-methylbutyrate (HMB). The intervention group would first receive the intervention during the 12-week study period. Meanwhile, the waitlist control group would receive 12 weeks of conventional care. After the study period, they would receive the same intervention. conditions: Sarcopenia conditions: Osteoporosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: β-hydroxy β-methylbutyrate (HMB) name: Resistance, aerobic, flexibility and balance exercise training measure: Grip strength measure: Body weight measure: Body mass index measure: Appendicular skeletal muscle mass index measure: 6-metre walk test measure: 5-time chair stand test measure: Short Physical Performance Battery (SPPB) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Kowloon Hospital city: Kowloon country: Hong Kong lat: 22.31667 lon: 114.18333 hasResults: False
<\|newrecord\|> nctId: NCT06287489 id: No.:2023-08-010ACF briefTitle: Effects of Mediterranean Diet on Subjective Cognitive Decline overallStatus: RECRUITING date: 2023-10-26 date: 2025-10-31 date: 2025-12-31 date: 2024-03-01 date: 2024-03-01 name: Chih-Ping Chung class: OTHER_GOV name: National Yang Ming Chiao Tung University briefSummary: Research Questions:
1. Due to the fact that most participants in past clinical trials on the Mediterranean diet were cognitively healthy individuals, and while the observed effects were significant, they were not particularly substantial, does the Mediterranean diet have similarly significant and more pronounced effects on both physical and cognitive functions in older adults with subjective cognitive decline (SCD)?
2. What is the mechanism behind the effects of the Mediterranean diet on physical or/and cognitive function? Is it through vascular protection or improvements in brain structure/brain network function?
Research Objective:
Conduct a cross-over randomized controlled trial to investigate the effects of a three-month Mediterranean diet on the physical and cognitive functions of older adults with subjective cognitive decline (SCD) in the community. Utilize brain MRI and circulatory biomarkers measurements to elucidate the underlying mechanisms. conditions: Subjective Cognitive Decline studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Mediterranean diet phase X regular diet phase primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Mediterranean diet name: Regular diet measure: Cognitive functional change measure: Physical function 1 - gait speed change measure: Physical function 2 - handgrip strength change measure: Physical function 3 - stand from chair speed change measure: Brain MRI structural change - total and regional voxel-based brain parenchymal features change measure: Brain MRI functional change - total and regional voxel-based brain functional features change measure: Brain MRI neurovascular lesion change - small vessel disease markers measure: Brain MRI neurovascular structural change - microvascular density measure: AD circulatory biomarkers sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Veterans General Hospital status: RECRUITING city: Taipei zip: 11217 country: Taiwan name: Chih-Ping Chung, MD PhD role: CONTACT phone: +886-2-918155976 email: pin324pin324@gmail.com lat: 25.04776 lon: 121.53185 hasResults: False
<\|newrecord\|> nctId: NCT06287476 id: H-23043870 briefTitle: Alveolar-capillary Reserve After Exercise in Chronic Obstructive Pulmonary Disease (COPD) (COP-DTPA) overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-03-15 date: 2025-03-15 date: 2024-03-01 date: 2024-03-01 name: Rigshospitalet, Denmark class: OTHER briefSummary: It is unknown whether individuals with COPD exhibit abnormal alveolar-capillary breaching during exercise, and whether this contributes to exertional dyspnoea. The aim of this study is to investigate whether individuals with COPD exhibit an abnormal increase in alveolar-capillary breaching during exertion, as indicated by an increase alveolar-capillary permeability with a concomitantly exacerbated increase in lung tissue mass. conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 32 type: ESTIMATED name: Acute exercise bout on visit 2 and 3 measure: Rest-to-exercise pulmonary DTPA clearance change after exercise in COPD vs. controls measure: Pulmonary DTPA clearance at rest in COPD vs. controls measure: Pulmonary DTPA clearance after exercise in COPD vs. controls measure: Rest-to-exercise change in lung tissue mass in COPD vs. controls measure: Lung tissue mass at rest in COPD vs. controls measure: Lung tissue mass after exercise in COPD vs. controls measure: Rest-to-exercise pulmonary DTPA clearance and lung tissue mass change according to GOLD measure: Supine pulmonary capillary blood volume after exercise in COPD vs. controls measure: Supine cardiac output after exercise in COPD vs. controls measure: Supine pulmonary capillary blood volume at rest in COPD vs. controls measure: Supine cardiac output at rest in COPD vs. controls measure: Supine pulmonary diffusing capacity to nitric oxide (DLNO) after exercise in COPD vs. controls measure: Supine haemoglobin-corrected pulmonary diffusing capacity to carbon monoxide (DLCOc) after exercise in COPD vs. controls measure: Supine alveolar-capillary membrane diffusing capacity (DM) after exercise in COPD vs. controls measure: Supine pulmonary diffusing capacity to nitric oxide (DLNO) at rest in COPD vs. controls measure: Supine haemoglobin-corrected pulmonary diffusing capacity to carbon monoxide (DLCOc) at rest in COPD vs. controls measure: Supine alveolar-capillary membrane diffusing capacity (DM) at rest in COPD vs. controls sex: ALL minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center For Physical Activity Research, Rigshospitalet city: Copenhagen country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False
<\|newrecord\|> nctId: NCT06287463 id: DCC-3084-01-001 briefTitle: Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-08 date: 2027-08 date: 2024-03-01 date: 2024-04-29 name: Deciphera Pharmaceuticals LLC class: INDUSTRY briefSummary: This is a multicenter, Phase 1/2 clinical trial to evaluate DCC-3084 alone or in combination with other cancer therapies in participants with advanced cancers. Module A will enroll participants with solid tumors. Additional modules exploring other cancers may be added to the master protocol at a later date. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). conditions: Advanced Solid Tumor conditions: RAF Mutation conditions: RAS Mutation conditions: NF1 Mutation conditions: Non-Small Cell Lung Cancer conditions: Pancreatic Ductal Adenocarcinoma conditions: Melanoma conditions: BRAF Gene Mutation conditions: CRAF Gene Mutation studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: DCC-3084 measure: Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1) measure: Objective Response Rate (ORR) (ModA Part 2) measure: ORR (ModA Part 1) measure: Progression-Free Survival (PFS) (ModA Part 1 and 2) measure: Overall Survival (OS) (ModA Part 1 and 2) measure: Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) (ModA Part 1 and 2) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NEXT Oncology city: San Antonio state: Texas zip: 78229 country: United States name: Ildefonso Ismael Rodriguez Rivera, MD role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 facility: NEXT Oncology Virginia city: Fairfax state: Virginia zip: 22031 country: United States name: Alexander Spira, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.84622 lon: -77.30637 hasResults: False
<\|newrecord\|> nctId: NCT06287450 id: IN006001 briefTitle: A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-04 date: 2026-10 date: 2024-03-01 date: 2024-03-01 name: Shenzhen Shenxin Biotechnology Co., Ltd class: INDUSTRY briefSummary: The study will evaluate the safety, tolerability, and immunogenicity of a single injection of up to 4 dose levels of IN006 in younger adults and 3 dose levels of IN006 in older adults; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults. conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Bivalent RSV Vaccine (IN006) name: Placebo measure: Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination measure: Percentage of Participants With Unsolicited Adverse Events (AEs) Through 28 Days After Initial Vaccination measure: Percentage of Participants With Any Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Study Discontinuation Through 12 Months After Initial Vaccination measure: Percentage of Participants With Any Medically Attended AEs (MAAEs) Through 6 Months After Initial Vaccination measure: Geometric Mean Titer (GMT) for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay) measure: Geometric Mean Fold Rise (GMFR) for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay) measure: Vaccine Response Rate for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay) measure: GMC for Pre-F Specific Binding Antibodies Against RSV A and RSV B (Via Enzyme Immunoassay [EIA]) measure: GMFR for Pre-F Specific Binding Antibodies Against RSV A and RSV B (Via Enzyme Immunoassay [EIA]) measure: Vaccine Response Rate for Pre-F Specific Binding Antibodies Against RSV A and RSV B (Via Enzyme Immunoassay [EIA]) measure: Frequency of Pre-F Specific IFN-γ/IL-4 Secreting T cells (Via Enzyme-Linked Immunospot [ELISpot] Assay) measure: Frequency of Pre-F Specific CD4 and CD8 T Cells Expressing Activation Markers (Via Intracellular Cytokine Staining [ICS] Assay) measure: Percentage of Participants (Part 2, Aged 60 to 79 Years) With Solicited Local and Systemic Adverse Reactions Through 14 Days After Revaccination measure: Percentage of Participants (Part 2, Aged 60 to 79 Years) With Unsolicited AEs Through 28 Days After Revaccination measure: Percentage of Participants (Part 2, Aged 60 to 79 Years) With Any MAAEs Through 6 Months After Revaccination measure: Percentage of Participants (Part 2, Aged 60 to 79 Years) With Any SAEs, AESIs, and AEs Leading to Study Discontinuation Through 6 Months After Revaccination sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06287437 id: B2023-335R briefTitle: HRS9531 Controls Weight Regain in Obese Subjects overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2025-06-30 date: 2025-12-31 date: 2024-03-01 date: 2024-03-01 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: This is a single-center, double-blinded, randomized, placebo-controlled phase II study to explore the effectiveness, safety and energy balance mechanism of low-frequency continuous subcutaneous injection of HRS9531 to inhibit weight regain in obese non-diabetic and obese diabetic patients conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: HRS9531 name: HRS9531 placebo measure: Percent Change in Body Weight from 24 weeks measure: Energy intake change from 24 weeks measure: Energy expenditure change from 24 weeks measure: Metabolic adaptation from 24 weeks measure: Systolic blood pressure and diastolic blood pressure change from 24 weeks measure: Body fat rate change from 24 weeks measure: Serum total cholesterol change from 24 weeks measure: Triglyceride change from 24 weeks measure: Nonestesterified fatty acid change from 24 weeks measure: Energy intake at baseline measure: Energy expenditure at baseline measure: Appetite at baseline (assessed by Visual Analogue Scale subjective rating scale) measure: Percent Change in Body Weight at 24 weeks measure: Appetite at 24 weeks (assessed by Visual Analogue Scale subjective rating scale) measure: Energy expenditure at 24 weeks measure: Energy intake at 24 weeks measure: Change of body weight at 24 weeksl from baseline sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Xiaoying Li city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06287424 id: HMO-2O-0536 briefTitle: The Efficacy Of AGE On Periodontitis overallStatus: COMPLETED date: 2021-04-04 date: 2022-09-30 date: 2023-01-01 date: 2024-03-01 date: 2024-03-01 name: Hadassah Medical Organization class: OTHER name: Wakunaga Pharmaceutical Co., Ltd. briefSummary: The objective of this study is to assess the long-term efficacy of "AGE among on deep periodontal pockets by different doses of "AGE" for a period of 18 months. conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 4 Regimen parralel groups primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Eligible subjects will be stratified based on Screening mean PPD (above or below 2mm), mean GBI (above or below 0.44), mean age (above or below 45 years old), gender (male or female) and tobacco use (yes or no). Within strata, subjects will be randomly assigned to one of the treatment groups using an encoded program. This assignment process and the distribution of test products will be conducted in a protected area that will ensure blinding of the examiner to the identity of the test products. whoMasked: PARTICIPANT count: 300 type: ACTUAL name: Aged Garlic Extract name: Placebo measure: Gingival Bleeding Index (GBI) measure: Probing Pocket Depth (PPD) sex: ALL minimumAge: 30 Years maximumAge: 60 Years stdAges: ADULT facility: Hebrew University city: Jerusalem zip: 9112102 country: Israel lat: 31.76904 lon: 35.21633 hasResults: False
<\|newrecord\|> nctId: NCT06287411 id: 202436 briefTitle: Role of FAPI PET/MR Combined With Gadoxetate Disodium in Assessing Hepatic Malignancies overallStatus: RECRUITING date: 2023-12-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-01 date: 2024-03-05 name: Xiao Chen class: OTHER briefSummary: This study aimed to prospectively evaluate the utility of fibroblast activation protein inhibitor (FAPI) positron emission tomography (PET)/magnetic resonance (MR) combined with gadoxetate disodium in patients with clinical suspected hepatic malignancies (lesion diameter ≤ 3.0cm), with histopathological findings obtained from biopsy or resected surgical specimens, or follow-up results as reference standards. conditions: Hepatic Malignancies studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 36 type: ESTIMATED name: FAPI PET/MR combined with gadoxetate disodium measure: Diagnostic performance measure: Quantitative parameters of PET/MR sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400010 country: China name: Xiao Chen, Ph.D role: CONTACT phone: 15922970174 email: xiaochen229@foxmail.com lat: 29.56278 lon: 106.55278 hasResults: False
<\|newrecord\|> nctId: NCT06287398 id: NHL38 briefTitle: Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-11 date: 2031-11 date: 2024-03-01 date: 2024-03-01 name: Australasian Leukaemia and Lymphoma Group class: OTHER briefSummary: The goal of this clinical trial is to evaluate clinical efficacy of incorporating Epcoritamab into the salvage treatment routine for relapsed-refractory aggressive B-cell lymphoma, followed by autologous stem-cell transplantation (ASCT) and consolidation Epcoritamab. The main questions it aims to answer are:
* Will the addition of epcoritamab to intensive salvage chemotherapy be safe and increase the proportion of patients with relapsed or refractory (R/R) large B-cell lymphoma who achieve a complete remission prior to planned transplant?
* Is consolidation epcoritamab after ASCT deliverable and safe?
* Will consolidation epcoritamab will result in improved clearance of molecularly detectable residual disease?
* Will the combination of pre- and post-ASCT epcoritamab lead to higher rates of progression-free survival (PFS) and event free survival (EFS) at 12 months compared to historical estimates in this population.
Participants will undergo three phases in this trial:
1. Epcoritamab-Salvage treatment: consists of 3 cycles of R-DHAOx (rituximab, dexamethasone, cytarabine, oxaliplatin) plus Epcoritamab
2. ASCT: Pre-autograft eligibility assessment for ASCT will be performed according to local practice. ASCT may be administered at local referring centre and will follow local standard operative procedures.

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