pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Vorolanib Combined With Cadonilimab in the Treatment of Untreated Advanced RCC Patients
NCT Number: NCT06577961
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Kidney Cancer|RCC|Renal Cell Carcinoma
Interventions: DRUG: Vorolanib|DRUG: cadonilimab
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 37
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2027-08-31

Summary:
Evaluate the efficacy and safety of vorolanib combined with cadonilimab in the treatment of untreated advanced RCC patients.

Primary Outcome Measures: Objective Response Rate assessed by RECIST 1.1, ORR, per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR)., 12 months
Secondary Outcome Measures: Progression Free Survival assessed by the investigator, PFS, defined as time from study drug administration to progression or death due to any cause.disease progression (PD) or death due to any reason. Imaging assessment is based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)., 24 months|Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0, During the AE reporting period specified in the protocol, collect all AEs (including SAEs) and record them in the CRF form., 24 months|Overall Survival, OS, defined as the time from study drug administration until the date of death due to any cause., 24 months|Disease Control Rate, DCR, defined as proportion of complete response, partial response, and disease stabilization to the proportion of patients with evalueable tumors., 12 months|12 months Progression Free Survival Rate, The progression-free survival rate is evaluated for all enrolled patients from the start of the first treatment to 12 months., 12 months|12 months Overall Survival Rate, Assess the overall survival rate for all enrolled patients from the start of the first treatment to 12 months., 12 months|24 months Overall Survival Rate, Assess the overall survival rate for all enrolled patients from the start of the first treatment to 24 months., 24 months|Health-related quality of life, Use the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) to conduct a questionnaire survey on subjects., 24 months
Other Outcome Measures: Circulating Tumor Cell / circulating tumor DNA, Exploration of biomarkers with potential clinical value for the clearance of circulating tumor cells/DNA, It is anticipated that blood tests will be conducted on patients before medication, 42±3 days after medication, and within 7 days following disease progression.
The P.A.U.S.E.® Spectacle Study
NCT Number: NCT06577948
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myopia
Interventions: DEVICE: Single vision spectacle lens|DEVICE: P.A.U.S.E. spectacle lens 1|DEVICE: P.A.U.S.E. spectacle lens 2
Sponsor: nthalmic Pty Ltd
Collaborators: Brighten Optix Corporation
Sex: ALL
Age: CHILD
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2026-03
Locations: Hai Yen Eye Care, Ho Chi Minh City, Vietnam

Summary:
The goal of this clinical trial is to learn if spectacle lenses using Phase Alteration Utilising Sub Elements (P.A.U.S.E.®) technology works to slow down the rate of myopia progression compared to single vision spectacle lenses in myopic children. The main questions it aims to answer are:

Do spectacle lenses using P.A.U.S.E.® technology slow down the rate of axial length growth? Do spectacle lenses using P.A.U.S.E.® technology slow down the rate of increase in myopic refractive error?

Researchers will compare spectacle lenses using P.A.U.S.E.® technology to a single vision spectacle lens.

Participants will:

Be randomly allocated to wear either spectacle lenses using P.A.U.S.E.® technology or single vision spectacle lenses.

Visit the clinic on five occasions over a 12 month period.

Primary Outcome Measures: Axial Length, Difference in change from dispensing in axial length between each test and control., Dispensing Visit (up to 26 days from Baseline), then 1 month, 6 months, and 12 months after Dispensing Visit
Secondary Outcome Measures: Cycloplegic spherical equivalent autorefraction, Difference in change from Baseline in cycloplegic spherical equivalent autorefraction between each test and control., Baseline, then 6 months, and 12 months after Dispensing Visit (up to 26 days from Baseline).|Visual performance as measured by high contrast visual acuity at 6 m, Difference in visual acuity between each test and control., Dispensing Visit (up to 26 days from Baseline), then 1 month, 6 months, and 12 months after Dispensing Visit|Visual performance as measured by a non validated questionnaire based on a 1-10, Difference in subjective visual performance between each test and control., 1 month, 6 months, and 12 months after Dispensing Visit (up to 26 days from Baseline).
Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy
NCT Number: NCT06577909
Acronym: IVIg
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Immune Thrombocytopenia
Interventions: DRUG: Prednisone|DRUG: IVIg
Sponsor: Peking University People's Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-10-19
Completion Date: 2025-12-31
Locations: Peking University Insititute of Hematology, Peking University People's Hospital, Beijing, Beijing, 100010, China

Summary:
This is a prospective, randomized, open-label, multicenter clinical trial study to compare the efficacy and safety of prednisone plus IVIg to prednisone monotherapy in the treatment of immune thrombocytopenia (ITP) in pregnancy.

Primary Outcome Measures: Overall Response, Achieving a platelet count of≥30×10\^9/L and at least a doubling of the baseline platelet count without administration of any other ITP-specific treatment, and the absence of bleeding, 4 weeks
Secondary Outcome Measures: Complete Response, Platelet count ≥100×10\^9/L measured on 2 occasions at least 7 days apart and the absence of bleeding, 4 weeks|Early response, Platelet count ≥30×10\^9/L and at least doubling baseline at 1 week, 1 week|relapse, After the treatment is effective, the platelet count drops below 30×10\^9/L or drops to less than 2 times the basal value, or bleeding symptoms occur, 1 year|Time to Response, The day achieving OR, 4 weeks|Time to relapse (duration of efficacy), The time from achievement of CR or R to time of relapse, 1 year|Platelet counts at delivery, Platelet counts at delivery, At delivery|Platelet counts of newborns, Platelet counts of d1, 3, and 7 of newborns, extended to d42 if thrombocytopenia occurs, up to 42 days per newborn|Adverse events in parturients, up to 2 years per subject, 2 years
The Study to Evaluate the Safety and Efficacy of the Onyx Family
NCT Number: NCT06577896
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Artery Disease
Interventions: DEVICE: Onyx family
Sponsor: Pusan National University Yangsan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-06-09
Completion Date: 2026-12-31
Locations: Pusan National University Yangsan Hospital, Yangsan, Gyeongsangnam-do, 50611, Korea, Republic of

Summary:
Observation of the safety and efficacy of 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention using Onyx family stents in elderly patients aged 75 years or older

Primary Outcome Measures: MACCE at 12 months after coronary artery intervention, MACCE defined as a composite of all-cause mortality, MI, and cerebrovascular events at 12 months after the index procedure, immediately after the procedure
Secondary Outcome Measures: All-cause mortality, All-cause mortality up to 1 year after the procedure, immediately after the procedure|Cardiac mortality, Cardiac mortality up to 1 year after the procedure, immediately after the procedure|Myocardial infarction (MI), Myocardial infarction (MI) up to 1 year after the procedure, immediately after the procedure|Cerebrovascular events, Cerebrovascular events up to 1 year after the procedure, immediately after the procedure|Target vessel revascularization (TVR), Target vessel revascularization (TVR) up to 1 year after the procedure, immediately after the procedure|Target lesion revascularization (TLR), Target lesion revascularization (TLR) up to 1 year after the procedure, immediately after the procedure|Stent thrombosis (ARC criteria), Stent thrombosis (ARC criteria) up to 1 year after the procedure, immediately after the procedure|Bleeding Academic Research Consortium (BARC) type 2 to 5, Bleeding Academic Research Consortium (BARC) type 2 to 5 up to 1 year after the procedure, immediately after the procedure
Next Generation Chest X-Ray Tomosynthesis for Screening of Lung Cancer
NCT Number: NCT06577883
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer
Interventions: DIAGNOSTIC_TEST: Chest X-ray Tomosynthesis
Sponsor: University of California, San Diego
Collaborators: AIxSCAN, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-02
Completion Date: 2027-06-30
Locations: University of California San Diego, San Diego, California, 92093, United States

Summary:
The goal of this observational clinical trial is to learn if chest tomosynthesis is a potential alternative to computed tomography for the detection of lung cancer. It will also develop artificial intelligence tools to aid in the diagnosis of lung cancer on chest tomosynthesis images. The main questions it aims to answer are:

* What is the accuracy of chest X-ray tomosynthesis in diagnosing lung cancer in a population of individuals undergoing lung cancer screening or evaluation of a suspicious lung nodule?
* Can artificial intelligence help us detect lung cancer on chest tomosynthesis images?

Researchers will compare chest tomosynthesis images to computed tomography scans for each participant to see how they compare in diagnosing lung cancer.

Participants will a chest tomosynthesis scan in addition to their routine clinical computed tomography scan.

Primary Outcome Measures: Chest X-ray tomosynthesis detection of lung cancer, Diagnostic accuracy of chest tomosynthesis in identifying biopsy-proven lung cancer, through 12/31/2026
Secondary Outcome Measures: Chest X-ray tomosynthesis detection of suspicious nodules, Diagnostic accuracy of chest tomosynthesis in identifying pulmonary nodules seen on chest CT at multiple minimum size thresholds: 6-mm, 8-mm, 10-mm, through 12/31/2026
Immersive Sensory Projections for Hospitalized Patients
NCT Number: NCT06577870
Acronym: IHP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hospitalism
Interventions: PROCEDURE: Hospitalization in intensive care or continuing care unit
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 208
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2026-06
Locations: Hôpital Privé Jacques Cartier, Massy, 91300, France

Summary:
The purpose of this study is to assess the impact of adding three sensory elements (visual, auditory, olfactory) on reducing discomfort in patients hospitalized in the intensive care unit/continuing care unit.

Primary Outcome Measures: REAnimation Patient Discomfort Questionnaire, Overall score on the REAnimation Patient Discomfort Questionnaire at the end-of-study visit, 2 months
Inferonasal MIMS® Procedure: Long-Term Follow-Up Extension Study
NCT Number: NCT06577857
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Open Angle Glaucoma
Interventions: DEVICE: Inferonasal Minimally Invasive Micro Sclerostomy
Sponsor: Sanoculis Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 53
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-11-04
Completion Date: 2025-06-30
Locations: S. Malayan Eye Center, Yerevan, Armenia

Summary:
A long-term (24 and 30 months) follow-up extension, prospective, non-interventional, open label study for data collection from subjects who underwent prior MIMS® inferonasal surgery, in continuation of the previous clinical investigation with the MIMS® Device (MMS-EEU-5).

Primary Outcome Measures: Primary Outcome 1, Change in IOP from medicated baseline to 24 months post-MIMS® surgery, Baseline to 24 months post-MIMS® surgery|Primary Outcome 2, Change in IOP from medicated baseline to 30 months post-MIMS® surgery, Baseline to 30 months post-MIMS® surgery|Primary Outcome 3, Change in the number of topical IOP-lowering medications from medicated baseline to 24 months post-MIMS® surgery, Medicated baseline to 24 months post-MIMS® surgery|Primary Outcome 4, Change in the number of topical IOP-lowering medications from medicated baseline to 30 months post-MIMS® surgery, Medicated baseline to 30 months post-MIMS® surgery|Primary Outcome 5, Success rate 24 months post-MIMS® surgery, 24 months post-MIMS® surgery|Primary Outcome 6, Success rate 30 months post-MIMS® surgery, 30 months post-MIMS® surgery
Secondary Outcome Measures: Safety Analysis 1, Late (\>12 months) postoperative interventions, Baseline to 30 months post-MIMS® surgery|Safety Analysis 2, Late (\>12 months) postoperative complications, Baseline to 30 months post-MIMS® surgery
Evaluation of the Contribution of a DEMaterialized VIdeo-pedagogical SUpport in the Care Pathway of Lung Cancer Surgery Patients
NCT Number: NCT06577844
Acronym: SUVIDEM
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer
Interventions: OTHER: video support
Sponsor: Assistance Publique Hopitaux De Marseille
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 226
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-11
Completion Date: 2026-04-11
Locations: Assistance publique Hopitaux de Marseille - Hopital Nord, Marseille, 13015, France

Summary:
Uni-centric, randomized, open-label, prospective interventional-comparative study, with a control arm (patients receiving standard preoperative information) and an experimental arm (patients receiving standard preoperative information and having access to a dematerialized educational video support).

Primary Outcome Measures: Immediate pre-operative anxiety, self-measurement using the HAD Scale, 10 days
Secondary Outcome Measures: Perioperative anxiety (randomization (consultation), immediate postoperative and discharge), based on HAD scale, 90 days|Post-traumatic stress disorder, PCL-5 scale, 90 days|Quality of life evaluation, European Organisation for Research and Treatment of Cancer core health- related quality of life questionnaire (QLQ-C30)., 90 days|Cumulative postoperative morbidity, score CCI, 90 days|Intra-hospital consumption of analgesics, accounting for in-hospital consumption of analgesics, 90 days
Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI
NCT Number: NCT06577831
Acronym: DYNPELVIS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pelvic Deformity
Interventions: DIAGNOSTIC_TEST: dynamic MRI
Sponsor: Assistance Publique Hopitaux De Marseille
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-02-25
Completion Date: 2025-02-25
Locations: Assistance Publique Hopitaux de Marseille _ Hopital de la Timone, Marseille, 13005, France

Summary:
Pelvic floor disorders affect a large population of women and are responsible for a significant impairment in their quality of life, but the pathophysiology of these disorders is still poorly understood.

The project proposes to define new ultra-fast 3D MRI sequences to capture the movements of the main pelvic organs. Visualization of 3D volumes is of great importance to clinicians, but data size hinders clinical use.

This study is the first to propose a dynamic 3D representation of pelvic organs, together with quantitative estimates of the deformations undergone.

The method is based on four steps: dynamic acquisition, organ segmentation, temporal reconstruction, quantification and visualization of deformations.

The D3-Pelvis project responds to the challenge of "technologies for health" with dynamic 3D MRI acquisition and 3D modeling, offering prospects for diagnostic aids and simulators.

Primary Outcome Measures: Develop new three-dimensional analysis tools combining high spatial resolution static MRI with ultra-fast dynamic MRI., a metric for displacement of the anchor points of the targeted pelvic organs will be evaluated, 0 month
Sustained Inflation and Chest Compression vs 3:1 C:V Ratio in Asphyxiated Newborns
NCT Number: NCT06577818
Acronym: SUR1VE-2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiac Arrest
Interventions: PROCEDURE: CC+SI (Chest compression during sustained inflation)|PROCEDURE: 3:1 C:V (3:1 Compression:Ventilation ratio)
Sponsor: University of Alberta
Sex: ALL
Age: CHILD
Enrollment: 792
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-07-01
Completion Date: 2033-07-01
Locations: Royal Alexandra Hospital, Edmonton, Canada

Summary:
Newborn infants who require cardiopulmonary resuscitation at birth receive chest compression using a 3-Compression to 1-Ventilation (3:1 C:V) ratio. However, the optimal chest compression technique during cardiopulmonary resuscitation is uncertain and identified as a critical gap in evidence. The International Consensus Statement advises to use the 3:1 C:V ratio based on animal studies, and states that there are no clinical trials to support this approach and called for more research. There continues to be uncertainty about the optimal chest compression technique during cardiopulmonary resuscitation.

This trial will compare if in newborn infants with cardiac arrest in the delivery room does providing CC+SI (a new chest compression technique) compared to 3:1 C:V decreases the incidence of mortality at hospital discharge.

This will be a multi-centre international cluster randomized trial.

Primary Outcome Measures: Neonatal mortality, Death within the first 28 days after birth, Within the first 28 days after birth
The Outcomes of Living Donor Robotic Assisted Kidney Transplantation
NCT Number: NCT06577805
Acronym: RAKT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Kidney Transplant; Complications|Renal Failure Chronic
Sponsor: West China Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-07-01
Completion Date: 2025-12
Locations: West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, China

Summary:
The technology for robot-assisted kidney transplantation (RAKT) has become increasingly advanced, with numerous studies demonstrating comparable outcomes between RAKT surgery and open surgery. This advancement is particularly noteworthy as it extends its suitability to transplant patients with obesity. It will be important to explore the results of robot-assisted kidney transplantation as compared with open surgery or within cohorts.

Primary Outcome Measures: The graft function of recipients, the graft function of recipients per month after transplant surgery, assessed by the serum creatinine (umol/L) and estimated glomerular function rate (eGFR)., in the follow-up period，about six months to one year
Secondary Outcome Measures: total operative time, The time from the beginning of the procedure to the end of the procedure (minute), about 150 minutes to 300 minutes
A Research Study on How NNC0638-0355, a New Medicine, Works in People Living With Overweight or Obesity
NCT Number: NCT06577766
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Obesity|Overweight
Interventions: DRUG: NNC0638-0355|DRUG: Placebo (NNC0638-0355)
Sponsor: Novo Nordisk A/S
Sex: ALL
Age: ADULT
Enrollment: 88
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-03
Completion Date: 2025-09-18
Locations: ICON, San Antonio, Texas, 78209, United States

Summary:
The study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in your body, and what your body does to the study medicine. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) given as an injection under your skin. Which treatment the participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.

Primary Outcome Measures: Part A: Number of treatment emergent adverse events (TEAE), Measured as Number of events, From NNC0638-0355 administration (day 1) to completion of the end of study visit (6 weeks)|Part B,C,D : Number of treatment emergent adverse events (TEAE), Measured as Number of events, From first NNC0638-0355 administration (day 1) to completion of the end of study visit (20 weeks)
Secondary Outcome Measures: Part A: AUC; area under the NNC0638-0355 plasma concentration-time curve, Measured in hours\*nano mole per litre (h\*nmol/L), From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)|Part A: Cmax; maximum observed NNC0638-0355 plasma concentration, Measured in nano mole per litre (nmol/L), From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)|Part A: t½; terminal half-life of NNC0638-0355, Measured in hours (h), From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)|Part B,C,D: AUC; area under the NNC0638-0355 plasma concentration-time curve, Measured in hour\*nano mole per litre (h\*nmol/L), From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)|Part B,C,D: Cmax; maximum observed NNC0638-0355 plasma concentration, Measured in nano mole per litre (nmol/L), From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)
Group-based and Dual-task Focused Otago Exercises in Geriatric Individuals With Kinesiophobia
NCT Number: NCT06577740
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Geriatric İndividual Health
Interventions: OTHER: Otago Exercise|OTHER: Dual Task Focused Otago Exercise
Sponsor: Istanbul Medipol University Hospital
Collaborators: Istanbul Gedik University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-04-15
Completion Date: 2024-08-08
Locations: Amine Ataç, Istanbul, Turkey

Summary:
The aim of our study was to investigate the effects of group-based and dual-task focused otago exercises on kinesiophobia, musculoskeletal system and psychosocial status in geriatric individuals with kinesiophobia. In the study : 1. Do group-based and dual-task focused otago exercises have an effect on kinesiophobia in geriatric individuals with kinesiophobia? 2. Do group-based and dual-task focused otago exercises have an effect on the musculoskeletal system in geriatric individuals with kinesiophobia? 3. Do group-based and dual-task focused otago exercises have an effect on the psychosocial status of geriatric individuals with kinesiophobia? 4. Do group-based and dual-task focused otago exercises have an effect on cognitive function in geriatric individuals with kinesiophobia? The questions were answered.

Primary Outcome Measures: Tampa Kinesiophobia Scale, It is a 17-question scale measuring fear of movement/re-injury., Duration of change in 4 week|Berg Balance Scale, It is a scale that includes 14 different types of activities aimed at questioning dynamic and static balance., Duration of change in 4 week|Geriatric Depression Scale Short Form, It is a scale consisting of 15 questions that determines the level of depression in geriatric individuals., Duration of change in 4 week|5 times sit and stand test, Used to assess fall risk and lower extremity muscle strength., Duration of change in 4 week|Mini Mental Status Test, It is a scale used to assess cognitive function., Duration of change in 4 week|Montreal Cognitive Assessment Test, It is a scale used to identify individuals with mild cognitive impairment and to distinguish them from healthy geriatric individuals., Duration of change in 4 week|Timed Up and Go Test, It is a scale used to assess mobility in geriatric individuals., Duration of change in 4 week
A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Iron Status of Children
NCT Number: NCT06577727
Acronym: FERROUS 2
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Iron Deficiency
Interventions: OTHER: Gold standard blood test|OTHER: Imaging and videography of anatomical sites
Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Collaborators: KK Women's and Children's Hospital|Srinagarind Hospital, Khon Kaen University
Sex: ALL
Age: CHILD
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-01
Completion Date: 2025-06-30
Locations: KK Women's and Children's Hopsital, Singapore, Singapore|Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand

Summary:
An exploratory study to collect data to build artificial intelligence derived algorithms for estimating iron status in children

Primary Outcome Measures: Accuracy of the Iron AI in a clinic setting, Accuracy of the Iron Ai in a clinic setting, derived from:

1. The Iron AI prediction from images/videos collected
2. The gold standard blood test results, 1 day
Secondary Outcome Measures: Parental acceptability of the Iron AI, Parental acceptability of the Iron AI assessed via the study questionnaire \[Accuracy, Usefulness, Frequency of usage, Data sharing\], 1 day|Investigator's (or delegates) acceptability of Iron AI, Investigators (or delegates) likelihood of using the Iron AI assessed via the study questionnaire \[Ease of taking images/videos, accuracy, frequency of use, recommendation to parents\], 1 day
Other Outcome Measures: Correlation of proposed scoring system for iron status assessment questionnaire against the gold standard blood test result, 1 day
Respiratory Disease Cohort Studies of Chinese Medicine for COPD(RESEARCH-COPD)
NCT Number: NCT06577701
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Obstructive Pulmoriary Disease (COPD)|Preserved Ratio Impaired Spirometry (PRISM)
Interventions: DRUG: traditional Chinese medicine (TCM)
Sponsor: Henan University of Traditional Chinese Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2027-10-30
Locations: The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, China

Summary:
This study will establish a registration research platform, a clinical research database and a biospecimen bank for the prevention and treatment of COPD with Chinese medicine. Based on the COPD registry database, a cohort of Chinese medicine against COPD will be established.

Primary Outcome Measures: Frequencies of acute exacerbations (AEs), The frequencies of acute exacerbations (AEs) will be recorded., Frequency of acute exacerbations at months 3, 6, 9, 12, 15, 18, 21, and 24.|Incidence of COPD, The incidence of COPD will be recorded., 24 months after enrollment.
Secondary Outcome Measures: 6 Six Minute Walk Distance (6MWD), 6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity., 6MWD at months 3, 6, 9, 12, 15, 18, 21, and 24.|Traditional Chinese medicine syndromes, The Traditional Chinese medicine syndromes will be recorded., The Traditional Chinese medicine syndromes at months 3, 6, 9, 12, 15, 18, 21, and 24.|Forced expiratory volume in one second (FEV1), FEV1 will be applied to assess pulmonary function., Change from baseline FEV1 at months 6, 12, 18 and 24.|Forced vital capacity (FVC), FVC will be applied to assess pulmonary function., Change from baseline FVC at months 6, 12, 18 and 24.|FVC as the percentage of the predicted value (FVC%), FVC% will be applied to assess pulmonary function., Change from baseline FVC% at months 6, 12, 18 and 24.|Forced expiratory volume in one second / forced vital capacity (FEV1/FVC), FEV1/FVC will be applied to assess pulmonary function., Change from baseline FEV1/FVC at months 6, 12, 18 and 24.|Diffusing capacity of the lungs for carbon monoxide (DLCO), DLCO will be applied to assess pulmonary function., Change from baseline DLCO at months 6, 12, 18 and 24.|COPD Assessment Test (CAT), CAT will be applied to assess quality of life., At months 6, 12, 18 and 24.
Smartphone Blood Pressure Measurement to Screen for Hypertension
NCT Number: NCT06577688
Acronym: Optiscreen
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Blood Pressure|Blood Pressure Disorders
Interventions: OTHER: Blood pressure measurement
Sponsor: Centre Hospitalier Universitaire Vaudois
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-09-30

Summary:
The goal of this observational study is to assess the feasibility of classifying people whose blood pressures are within hypertensive range using a machine-learning approach based on features derived from smartphone video data recorded at the patient's fingertips. The main question\[s\] it aims to answer are:

Is a smartphone a reliable device for high blood pressure screening ? Is a smartphone a reliable device for blood pressure monitoring ? Participants will record their blood pressure with a smartphone at their fingertips and with an approved cuff device, 3 times in the morning and 3 times in the evening for 7 days. There will be two groups, a volunteer presumed healthy, and a volunteer addressed for a Home Blood pressure monitoring with the diagnosis of hypertension suspected.

Researchers will compare the two groups to see if the smartphone can be reliable in terms of diagnosis and monitoring of the blood pressure comparing to a standard cuff device.

Primary Outcome Measures: Reliability of smartphone's blood pressure measurements, Reliability of smartphone's blood pressure measurements to discriminate values within hypertension range compared to standard cuff device, 7 days
Progression of a Group of Patients Suffering from Emotional Dysregulation but Heterogeneous in Terms of Diagnosis, Benefiting from the DBT Group Programme.
NCT Number: NCT06577675
Acronym: PEAC-TRE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emotion Regulation|Emotional Disorder
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2025-12

Summary:
Human beings experience emotions and have the ability to manage them, but when these abilities are undermined by mental illness, the result is emotional dysregulation. Borderline patients (1 to 4% of the population) suffer from this symptom and can benefit from a specific therapy: DBT (Dialectical Behaviour Therapy; Linehan, 1993). Created specifically for this condition, DBT significantly reduces emotional dysregulation, a dimension at the root of behavioural disorders that is known to be poorly relieved by drug treatments. The DBT group training programme offers patients the opportunity to learn and practise emotional regulation skills. Four types of skills are taught skills: mindfulness, interpersonal skills, emotional regulation and and distress tolerance. This therapy is part of the psychiatric care, in which patients take responsibility in their own care.

There are many studies showing the effectiveness of DBT and its programme with borderline patients. But there are other pathologies concerned by emotional dysregulation: thymic disorders in particular bipolar (1 to 2.5%), addictive disorders (8 to 10%), eating disorders (ADD, 10%), post-traumatic stress disorder (PTSD, 2%).

Primary Outcome Measures: DERS (Difficulties in Emotion Regulation Scale), Measures six dimensions of emotion regulation. The 36 items are scored on a 5-point Likert scale.

The score is between 36 and 180, 36 for no emotional difficulty and 180 for maximum emotional dysregulation. The higher the score, the greater the difficulty the subject has in emotion regulation., Weeks 1, 7, 12 and 16
Secondary Outcome Measures: Quality of life measured by the World Health Organization Quality of Life (WHOQOL-BREF), This scale is a 26-item self-questionnaire exploring four domains (physical health, psychological health, social relationships, environment) and two global factors that assess general life satisfaction and sense of personal well-being. Each response is coded on a 5-point Likert scale. The results for each domain give a raw score which, according to the conversion grid, gives a score ranging from 0 to 100 for each domain, with 100 corresponding to a high quality of life., Weeks 1 and 16.
The Impact of a Colonoscopy Monitoring Program on Endoscopists' Performance
NCT Number: NCT06577610
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adenoma Colon Polyp|Sessile Serrated Adenoma
Interventions: OTHER: Colonoscopy monitoring program
Sponsor: Seoul National University Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-09-01
Completion Date: 2025-09-01

Summary:
The goal of this clinical trial is to learn if colonoscopy monitoring program works to adenoma detection rate in endoscopists. It will also learn about the impact on sessile serrated lesion detection rate, adenomas per colonoscopy, sessile serrated lesions per colonoscopy, advanced adenoma detection rate. The main questions it aims to answer are:

Does colonoscopy monitoring program effect on adenoma detection rate in endoscopists?

Participants will:

Receive result of colonoscopy monitoring program or not every 3 months for 1 year

Primary Outcome Measures: adenoma detection rate, the percentage of patients with at least one histologically proven adenoma, 1 year
Secondary Outcome Measures: sessile serrated lesion detection rate, the percentage of patients with at least one histologically proven sessile serrated lesion, 1 year|adenomas per colonoscopy, the number of detected adenomas divided by the total number of screening colonoscopies, 1 year|sessile serrated lesions per colonoscopy, the number of detected sessile serrated lesions divided by the total number of screening colonoscopies, 1 year|advanced adenoma detection rate, the percentage of patients with at least one histologically proven advanced adenoma, 1 year
Comparison of Diabetes Patients - Care Trajectory Versus Convention
NCT Number: NCT06577584
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Type 2 Diabetes
Interventions: OTHER: Follow-up in the Diabetes Care Trajectory|OTHER: Follow-up in the Diabetes Convention
Sponsor: Universitaire Ziekenhuizen KU Leuven
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12

Summary:
In Belgium, various structures and reimbursement programs are in place for managing Type 2 Diabetes Mellitus (T2DM). The Diabetes Care Trajectory is primarily utilized for patients who require a maximum of two insulin injections per day. In contrast, patients needing multiple daily insulin injections are managed under a diabetes convention program.

The Diabetes Care Trajectory has been operational since 2009. However, unlike patients in the diabetes convention program, where the profile and quality of care are regularly audited, there is limited information available regarding the profile and outcomes of patients within the Care Trajectory. This retrospective study aims to compare the profiles, including complications and quality of care, of T2DM patients across both groups.

Primary Outcome Measures: HbA1c, Glycated haemoglobin A1c, Yearly for the entire study period (2009 - 2024)
Secondary Outcome Measures: Complications of diabetes, Number of diabetes-associated complications such as retinopathy, nephropathy and macroangiopathy., Yearly for the entire study period (2009 - 2024)|Cholesterol profile, Total levels of cholesterol, Yearly for the entire study period (2009 - 2024)|Insulin requirements, The need for insulin (units) on a daily basis, Yearly for the entire study period (2009 - 2024)
Testing Educational Videos on Conservative Kidney Management
NCT Number: NCT06577571
Acronym: CKM-EMPOWER
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Kidney Disease, Chronic
Interventions: OTHER: CKM-EMPOWER
Sponsor: University of Washington
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 126
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08-27
Completion Date: 2025-09-30
Locations: University of Washington, Seattle, Washington, 98108, United States

Summary:
This study aims to test the efficacy of a series of just-in-time educational videos on topics related to CKM (CKM-EMPOWER) in improving nephrology providers ability to provide CKM.

Primary Outcome Measures: Change in CKM knowledge, Number of knowledge questions (total 44) about CKM answered correctly, 2 weeks
Secondary Outcome Measures: Confidence with CKM, Self-rated confidence scores in practice of 11 different clinical topics related to CKM rated from 1-5, 5 being most confident, 2 weeks|Challenges to CKM, Self-reported written qualitative description of challenges face with providing CKM, 2 weeks|CKM practice change, Self-reported written qualitative description of ways in which providers will change the way they provide CKM following receipt of the intervention, 2 weeks
Lifestyle Behavioural Intervention on Breast Cancer Survivors for the Treatment of Overweight/Obesity.
NCT Number: NCT06577545
Acronym: Nutri-Life
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer Female|Overweight and Obesity
Interventions: BEHAVIORAL: Behavioural Lifestyle (BL)
Sponsor: University of Thessaly
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 92
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2026-01
Completion Date: 2026-07
Locations: University of Thessaly, Tríkala, Thessaly, 42132, Greece

Summary:
The goal of this clinical trial is to compare a behavioural lifestyle intervention program (BL) to usual care (UC) in breast cancer survivors. The main questions it aims to answer are:

1. If the participants of the BL group will lose more weight than the UC group.
2. If the participants of the BL group will have more lifestyle benefits than the UC group.

Volunteers will participate in a 24-week behavioural program. This program aims to improve their nutrition and physical activity in order to lose at least 10% of their initial body weight.

Primary Outcome Measures: body weight change, % of the initial body weight change, From enrollment to the end of treatment at 24 weeks
Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Advanced Pancreatic Cancer
NCT Number: NCT06577532
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Pancreatic Neoplasms
Interventions: DRUG: ABO2102|DRUG: Toripalimab
Sponsor: Ruijin Hospital
Collaborators: Suzhou Abogen Biosciences Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-08
Locations: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China

Summary:
The purpose of this study is to evaluate the safety, immunogenicity, pharmacodynamics, as well as preliminary anti-tumor activity of KRAS neoantigen mRNA vaccine (ABO2102) alone and in combination with toripalimab (anti-PD-1 monoclonal antibody) among participants with KRAS-mutated advanced pancreatic cancer. The trial includes dose escalation (Part I) and dose expansion(Part II) parts.

Primary Outcome Measures: Part I: The incidence and nature of dose-limiting toxicity (DLT) for ABO2102 as monotherapy or in combination with toripalilmab., 21 days after the first dose of study treatment|Part I: The incidence and severity of treatment-emergent adverse events (TEAE)s., from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy.|Part I: The incidence and severity of serious TEAEs (TESAE)s., from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy.|Part I: The incidence and severity of TEAEs leading to interruption or early termination of study treatment., from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy.|Part II: Overall Response Rate (ORR) per RECIST version 1.1., from the first dose of study treatment to up to 2 years.
Efficacy and Safety Study of Vicagrel in Patients With Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
NCT Number: NCT06577519
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
Interventions: DRUG: Vicagrel|DRUG: Clopidogrel
Sponsor: Jiangsu vcare pharmaceutical technology co., LTD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2026-12-30
Locations: General Hospital of Northern Theater Command of Chinese PLA, Shenyang, Liaoning, 110015, China

Summary:
This is a multi-center, randomized, double-blind, double-dummy, parallel-controled, phase III trial, aiming to evaluate the effectiveness and safety of long-term continuous administration of Vicagrel capsules in ACS patients undergoing PCI.

Primary Outcome Measures: The incidence of MACE, 6 month
Diabetes Education and Care for Deaf Populations
NCT Number: NCT06577506
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes
Interventions: BEHAVIORAL: Deaf Diabetes Can Together
Sponsor: University of Utah
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-08-17
Completion Date: 2024-11-01
Locations: University of Utah, Salt Lake City, Utah, 84112, United States

Summary:
This study will assess the feasibility and preliminary efficacy of a 10-week intervention called "Deaf Diabetes Can Together".

Primary Outcome Measures: A1C Level, Clinical outcome, 6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
Secondary Outcome Measures: Diabetes Distress Level Using the Screening Scale Questionnaire, Psychosocial outcome, 6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)|Diabetes Self-Care Level using the Self-Care Inventory Revised Questionnaire, Self-management outcome, 6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
A Study of RAY1225 at Different Injection Sites in Participants With Different Body Sizes
NCT Number: NCT06577428
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: RAY1225
Sponsor: Guangdong Raynovent Biotech Co., Ltd
Sex: ALL
Age: ADULT
Enrollment: 48
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-30
Completion Date: 2024-10-29
Locations: Guangdong Hospital of Chinese Medicine, Guanzhou, Guangdong, China

Summary:
The purpose of this study is to compare the amount of RAY1225 that gets into the blood stream and how long it takes the body to get rid of it, when injected under the skin of the upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and females with different body sizes. The tolerability of RAY1225 will be evaluated and information about any side effects experienced will be collected. For each participant, the study will last about 7 weeks, including screening.

Primary Outcome Measures: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of RAY1225 From Time Zero to Infinity (AUC[0-∞]), DAY1~43|PK: Maximum Concentration (Cmax) of RAY1225, DAY1~43
Secondary Outcome Measures: Number of participants with adverse events, DAY1~43
A Study of RAY1225 in Participants With Impaired Liver Function
NCT Number: NCT06577415
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hepatic Impairment
Interventions: DRUG: RAY1225
Sponsor: Guangdong Raynovent Biotech Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-26
Completion Date: 2025-03-15
Locations: Nanfang Hospital,South Medical Hospital, Guangzhou, Guangdong, China

Summary:
The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants.

Primary Outcome Measures: Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of RAY1225, Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC\[0-∞\]) of RAY1225., DAY1~43|PK: Maximum Observed Drug Concentration (Cmax) of RAY1225, PK: Maximum Observed Drug Concentration (Cmax) of RAY1225, DAY1~43
Secondary Outcome Measures: Number of participants with drug-related adverse events as assessed by CTCAE v5.0, DAY1~43
Observational Study on Energy Expenditure and Protein Metabolism Changes in Patients With Severe Brain Injury.
NCT Number: NCT06577402
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Energy Metabolism and Muscle Mass Changes in Patients With Severe Brain Injury
Interventions: DIETARY_SUPPLEMENT: nutritional support
Sponsor: Southeast University, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-15
Completion Date: 2025-12-15
Locations: Zhongda Hospital, Southeast university, Nanjing, Jiangsu, China

Summary:
Evaluation of early energy metabolism and muscle mass changes in patients with severe brain injury, the impact of nutritional therapy on metabolism and muscle mass, and their relationship with patient prognosis, to provide clinical research references for the implementation of individualized nutritional therapy in patients with severe brain injury.

Primary Outcome Measures: Basal Metabolic Rate, first 10 day