pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Assessing the Accuracy of ChatGPT-4 in Interpreting Arterial Blood Gas Results
NCT Number: NCT06456866
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Blood Gases
Interventions: OTHER: interpretation
Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 398
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-14
Completion Date: 2024-12-02
Locations: Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital, Istanbul, 34303, Turkey

Summary:
Assessment of Acidosis and Alkalosis, Evaluation of Hypoxemia and Hyperoxemia, Evaluation of Hemoglobin Parameters, Assessment of Electrolytes, Evaluation of Metabolic Parameters (Glucose, Lactate, Bilirubin)

Primary Outcome Measures: blood gases sample interpretation, 10 minutes
Comparison of AI-Generated Pain Scoring Visuals With Visual Analog Scale (VAS) for Pain Assessment
NCT Number: NCT06456853
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pain, Postoperative
Interventions: OTHER: Pain assesment
Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 398
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-14
Completion Date: 2024-12-02
Locations: Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital, Istanbul, 34303, Turkey

Summary:
This prospective study will be conducted in surgical wards, assessing postoperative patients. Initially, patients will be evaluated using the VAS method. Subsequently, they will be shown five AI-generated images depicting different pain levels and will select the image that best represents their pain. A follow-up survey will assess the effectiveness of each method.

Using ChatGPT-4/DALL-E, images corresponding to VAS scores of 1-2, 3-4, 5-6, 7-8, and 9-10 will be created. Patients will choose the image that best describes their pain, aiming to determine if AI-supported visuals offer a more accurate alternative to VAS for pain assessment.

Primary Outcome Measures: Pain assesment, The primary outcome for this research is to compare the effectiveness of AI-generated pain assessment visuals with the traditional Visual Analog Scale (VAS) in accurately evaluating and expressing patients' pain levels. This will be measured through patient-reported ease of use, clarity, and usefulness of both methods, as well as patient preference for either method in pain assessment., 10 minutes
Epidemiological Insights Into the Formation, Progression, and Rupture of Intracranial Aneurysms: A Retrospective, Multi-Center Hospital-Based Study in China
NCT Number: NCT06456814
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intracranial Aneurysm|Subarachnoid Hemorrhage, Aneurysmal|Cerebral Aneurysm|Brain Aneurysm
Sponsor: Zhujiang Hospital
Collaborators: Beijing Tiantan Hospital|Guangdong Provincial People's Hospital|First Affiliated Hospital of Chongqing Medical University|The Affiliated Hospital Of Southwest Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2010-01-01
Completion Date: 2026-12-31
Locations: Zhujiang Hospital, Guangzhou, China

Summary:
This is a retrospective, hospital-based and multi-center study aiming at investigating the potential exposures associated with the formation, progression, and rupture of intracranial aneurysms in Chinese population.

Primary Outcome Measures: Intracranial aneurysm, The presence or absence of IAs detected by digital subtractive angiography or by cranial computed tomography angiography / magnetic resonance angiography., 2010.01.01-2024.06.01
Clinical Trial of Anti-PLA2R-IgG Detection Kit (Time-resolved Fluorescence Immunoassay)
NCT Number: NCT06456801
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Nephropathy
Sponsor: Zhejiang University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 219
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-03-01
Completion Date: 2021-10-01
Locations: The First Affiliated hospital Zhejiang University school of medicine, Hangzhou, Zhejiang, 310001, China

Summary:
Conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents.

Primary Outcome Measures: Calculate the correlation between the test reagents and comparison reagents, Calculate the correlation between the test reagents and comparison reagents, 1 year.
Tele-SSM: A Telephone Technology Innovation in the Intervention on Supported Self-management for Depression in Vietnam
NCT Number: NCT06456775
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression
Interventions: BEHAVIORAL: Tele-SSM
Sponsor: Institute for Social Development Studies, Vietnam
Collaborators: National Foundation for Science & Technology Development, Vietnam
Sex: ALL
Age: ADULT
Enrollment: 75
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-02-02
Completion Date: 2023-08-30
Locations: Institute for Social Development Studies, Hanoi, 10000, Vietnam

Summary:
Tele-SSM is a pre-post mixed-method study to investigate the feasibility, acceptability and the preliminary efficacy of the support self-management skills intervention for depression delivered from distance.

The specific objectives of this research include:

* Transform the SSM intervention for depression from face-to-face delivery to delivery from distance.
* Develop an software for intervention management
* Examine knowledge, attitudes and practices of people with depression toward depression
* Examine the feasibility, acceptability and preliminary efficacy of the intervention
* Investigate the cost analysis of Tele-SSM intervention

Primary Outcome Measures: Depression, Measured by PHQ-9 questionnaire, Pre intervention and up to 12 weeks|Acceptability, Measured by questionnaire and in-depth interviews, Up to 12 weeks after pre-intervention survey|Feasiblity, Measured by questionnaire and in-depth interviews, Up to 12 weeks after pre-intervention survey|Cost, Measured by financial reports, Through study completion, an average 6 months
Secondary Outcome Measures: Anxiety, Measure by DASS-21 questionnaire, Pre intervention and up to 12 weeks|Stress, Measured by DASS-21 questionnaire, Pre intervention and up to 12 weeks|Self-esteem, Measured by Rosenberg self - Esteem scale, Pre intervention and up to 12 weeks|Social support, Measured by Multidimensional Scale of Perceived Social Support (MSPSS), Pre intervention and up to 12 weeks|Health related quality of life, Measured by SF-12 and EQ-5D-5L questionnaire, Pre intervention and up to 12 weeks|Knowledge, attitude and practices of people with depression, Measured by in-depth interviews, Pre-intervention
Text-messaging Intervention to Support Parents After Their Child's Psychiatric Emergency
NCT Number: NCT06456762
Acronym: iPEACE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parents|Self Efficacy|Mental Health Literacy|Psychiatric Emergency
Interventions: BEHAVIORAL: iPEACE: Intervention for Parent Education about Care after the ED|BEHAVIORAL: Text Messaging Reminders Only
Sponsor: Vanderbilt University Medical Center
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2025-01-01
Completion Date: 2026-12-30

Summary:
This grant aims to develop and test a text-messaging intervention for parents of children and teens evaluated in the emergency department for a psychiatric emergency and discharged home with outpatient referrals. The intervention for parents will teach parents skills to navigate the mental health services system and build their self-efficacy in managing their child's mental health. This research has the potential to improve services for families seeking emergency psychiatric support, with the goal of facilitating treatment engagement and reducing emergency services utilization using scalable, cost-effective, accessible tools.

Primary Outcome Measures: Child and Adolescent Services Assessment: Outpatient Mental Health Service Utilization, The Child and Adolescent Services Assessment will be used as a parent self-report measure that evaluates the total number of outpatient mental health appointments the participant's child attends during the follow-up period. The outcome will be a total count of the number of outpatient mental health appointments attended., 24 weeks|Child and Adolescent Services Assessment: Emergency Department Services Use, The Child and Adolescent Services Assessment will be used as a parent self-report measure to evaluate the number of psychiatric emergency department visits the participant's child has during the follow-up period. The outcome variable will be a dichotomous variable based on whether the child was readmitted to the emergency department during the follow-up period (yes/no)., 24 weeks
Secondary Outcome Measures: Suicidal Ideation Questionnaire - Jr., Child suicidal thoughts will be assessed using the Suicidal Ideation Questionnaire-Jr. child self-report measure over follow up period. Scores range from 0-90, with higher scores reflecting higher suicidal ideation severity. The clinical cutoff score is 31., 24 weeks|Self-Injurious Thoughts and Behaviors Interview - Revised, Child suicidal thoughts and behaviors will be assessed using an adapted version of the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R); the study will use a child self-report version of the SITBI-R. The SITBI-R will provide outcome scores on the presence or absence of a suicide attempt during the follow up period and the presence or absence of passive and active suicidal ideation during the follow up period., 24 weeks.
Clinical Features and Prognostic Markers in Adult Patients With AE Requiring ICU Treatment
NCT Number: NCT06456736
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Autoimmune Encephalitis
Interventions: OTHER: None, non-interventional study
Sponsor: Central South University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06
Completion Date: 2024-08

Summary:
Autoimmune encephalitis (AE) is a potentially life-threatening inflammation of the central nervous system (CNS) and constitutes 20%-30% of encephalitis cases in adults AE often leads to subacute, severe, and debilitating encephalitis necessitating long-term management in a neurologic intensive care unit (ICU). This study aims to explore the predictive factors for poor clinical outcomes by analyzing the clinical characteristics and prognosis of adult patients with critical AE requiring ICU admission. Prospective observational single center study in neurologic ICU, the second Xiangya hospital, Central South University. All patients admitted to the ICU for probable or confirmed AE (2022 Chinese guidelines for diagnosis and treatment of AE) will be included. Factors associated with a poor prognosis will be identified by multivariate analysis using a logistic regression.

Primary Outcome Measures: Modified Rankin Scale, The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinic. mRS is scored on a scale of 0 to 6. The higher the score, the worse the prognosis, 12 months
Secondary Outcome Measures: Mortality, Rate of death at 12 months, 12 months|Rate of complications, Septic shock, hyponatremia, 12 months
Evaluation of [18F]Fluoroethyl Triazole Labelled [Tyr3]-Octreotate Analogues for the Imaging of Neuroendocrine Tumours.
NCT Number: NCT06456723
Acronym: FETONET
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Neuroendocrine Tumors
Interventions: DRUG: [18F]-FET-βAG-TOCA
Sponsor: Imperial College London
Collaborators: Imperial College Healthcare NHS Trust|Royal Marsden NHS Foundation Trust|University of Manchester|The Christie NHS Foundation Trust|Invicro|Newcastle University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 59
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2014-05-14
Completion Date: 2018-10-17

Summary:
Radiolabelled somatostatin analogs are invaluable in the diagnosis and treatment of neuroendocrine tumours (NET). The most commonly used positron emission tomography (PET) radiotracers used for the visualisation of NET are radiolabelled somatostatin analogs (SSAs) labelled with \[68Ga\]Ga-DOTA-peptides. The \[68Ga\]Ga-DOTA-peptide radiolabelled SSAs have significant limitations in terms of accessibility and low throughput. The team at Imperial College London developed a novel radiotracer, \[18F\]fluoroethyl triazole labelled \[Tyr3\]-Octreotate analogue (\[18F\]-FET-βAG-TOCA), in an attempt to overcome these limitations. Within the FETONET study, two cohorts of patients will undergo PET/CT imaging following an injection of \[18F\]-FET-βAG-TOCA, with the view to compare the clinical utility of this radiotracer with \[68Ga\]Ga-DOTA-peptide PET-CT in patients with NET.

Primary Outcome Measures: To determine the biodistribution of [18F] following single I.V. administration of [18F]-FET-βAG-TOCA injection., Biodistribution of the \[18F\]-FET-βAG-TOCA radiotracer following intravenous administration. Biodistribution assessed through the performance of an \[18F\]-FET-βAG-TOCA dynamic PET-CT scan., -30 to 0 days|To assess tumoural uptake of [18F]-FET-βAG-TOCA., The PET-CT images obtained following injection of the \[18F\]-FET-βAG-TOCA radiotracer will be analysed to determine tumoural uptake. \[18F\]-FET-βAG-TOCA uptake within the tumours identified will be reported as standardised uptake values (SUV)., -30 to 0 days
Secondary Outcome Measures: To assess the efficacy of [18F]-FET-βAG-TOCA-PET/CT in patients with a histological diagnosis of NET and with measurable disease, who have and have not had [68Ga]-DOTA-peptide imaging., To determine the clinical utility of \[18F\]-FET-βAG-TOCA-PET/CT compared with standard of care \[68Ga\]Ga-DOTA-peptide imaging by comparing the number of lesions detected using each radiotracer in patients with histologically-confirmed NET., 0-6 months
Effect of a Psychological Intervention on Stigma: a Randomized Controlled Study
NCT Number: NCT06456710
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Irritable Bowel Syndrome|Stigma|Psychological Intervention
Interventions: BEHAVIORAL: Conventional IBS Health Education|BEHAVIORAL: Based on ACT Theory of Psychological Intervention
Sponsor: Yangzhou University
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-06-01
Completion Date: 2024-01-31
Locations: Yangzhou University, Yangzhou, Jiangsu, 225000, China

Summary:
The purpose of this study was to construct a Stigma intervention program for college students with Irritable Bowel Syndrome (IBS) based on the Acceptance and Commitment Therapy (ACT) theory and to investigate the effectiveness in reducing stigma in IBS patients with the aim of enhancing their mental health and improving their quality of life.

Primary Outcome Measures: Stigma, The Perceived Stigma Scale in IBS (PSS-IBS) was used to assess perceived stigma in terms of disease disclosure, attitude and knowledge about disease, disease efficacy, severity, and blame. The scale has 10 entries with 6 dimensions and is scored on a 5-point Likert scale from 0 to 4, with total scores ranging from 0 to 240, with the higher scores indicating the higher the level of perceived stigma. A score of 1 to 80 indicates mild, a score of 81 to 161 is moderate, and a score of \> 161 is severe., Baseline, 1 and 3 months post-intervention
Secondary Outcome Measures: Psychological flexibility (PF), Acceptance and Action Questionnaire-II (AAQ-II) was used to assess the patients' level of psychological flexibility. The scale consists of 7 entries and is scored on a 7-point Likert scale from 1 to 7, with total scores ranging from 7 to 49. The higher the score, the lower the psychological flexibility, the higher the degree of empirical avoidance., Baseline, 1 and 3 months post-intervention|Self-acceptance (SA), Self-Acceptance Questionnaire (SAQ) consists of two dimensions (self-acceptance and self-evaluation) with a total of 16 entries. The scale is scored on a 4-point Likert scale from 1 to 4, with total scores ranging from 16 to 64. A higher score indicates a higher level of self-acceptance., Baseline, 1 and 3 months post-intervention|Quality of Life (QOL), IBS quality of life (IBS-QOL) consisted of 34 items with 8 dimensions, namely, anxiety, behavior disorder, body ideation, health worry, food avoidance, social function, sexual behavior, and interpersonal relationship. The scale adopts Likert's 5-point scale, with scores ranging from 1-5 from the lowest to the highest. The score of each dimension is converted by the formula to make the value range from 0 to 100. The higher the score, the better the quality of life., Baseline, 1 and 3 months post-intervention
Pipeline Embolization Device for the Treatment of Intracranial Aneurysms on the Long Term Safety and Efficacy
NCT Number: NCT06456697
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Treatment
Sponsor: Xuanwu Hospital, Beijing
Collaborators: Henan Provincial People's Hospital|The First Affiliated Hospital of Zhengzhou University|First Affiliated Hospital of Xinjiang Medical University|Beijing Tiantan Hospital|Qilu Hospital of Shandong University|Nanfang Hospital, Southern Medical University|Second Affiliated Hospital of Nanchang University|The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School|Wuhan Union Hospital, China
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 482
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-12-30
Completion Date: 2024-12-30
Locations: Xuanwu Hospital, Capital Medical University, Beijing, China

Summary:
Since its launch in China in 2014, Pipeline Embolization Device (PED) has been widely used in the treatment of intracranial aneurysms. It is necessary to collect data on the long-term safety and efficacy of the Pipeline Embolization Device (PED) in the treatment of intracranial aneurysms, analyze its long-term effectiveness, and provide guidance for clinical practice.

Primary Outcome Measures: Rate of complete aneurysm occlusion in 5 years, The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Success aneurysm occlusion in which class 1 or 2 is achieved on the Raymond-Roy occlusion classification Scale at the 5 year follow-up angiographic assessments will be evaluated., assessed at 5 years (plus or minus 6 months)after procedure|Rate of parent artery stenosis in 5 years, Severe stenosis is defined as stenosis greater than 50%., assessed at 5 years (plus or minus 6 months)after procedure|Patient prognosis in 5 years, Assessing patient prognosis using Modified Rankin Scale (mRS) scores. mRS is scored on a scale of 0 to 6, with a higher score indicating a more severe condition., assessed at 5 years (plus or minus 6 months)after procedure
Secondary Outcome Measures: Device-related neurologic adverse event in 5 years, This includes but is not limited to shortening, narrowing, and displacement of blood flow devices., assessed at 5 years (plus or minus 6 months)after procedure|Occurrence of major stroke or neurovascular death in 5 years, This includes but is not limited to ruptured aneurysm, intracerebral hemorrhage on the same side, ischemic stroke, symptomatic stenosis of the feeding artery, and other permanent neurological impairments., assessed at 5 years (plus or minus 6 months)after procedure|Brain Vascular Accident Leading to Death in 5 years, Due to other vascular accidents, death occurred., assessed at 5 years (plus or minus 6 months)after procedure
AV133 Longitudinal Imaging Study in Patients With Early and Prdromal Parkinson's Disease
NCT Number: NCT06456684
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Parkinson Disease
Interventions: DIAGNOSTIC_TEST: Fluoro[18F]promethazine
Sponsor: Xuanwu Hospital, Beijing
Collaborators: The Michael J. Fox Foundation for Parkinson's Research|XINGIMAGING LLC|Naming MITRO Pharmaceutical Technology Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 76
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-12
Completion Date: 2026-12-31
Locations: Xuan Wu Hospital, Capital Medical University, Beijing, Beijing, 100053, China

Summary:
A total of 38 patients with early-stage Parkinson's disease and 38 patients with prodromal Parkinson's disease are planned to be enrolled in this study and examined for longitudinal changes in \[18F\]AV-133 through follow-up, thereby informing the design of future therapeutic trials utilizing \[18F\]AV-133 as a marker of disease progression.

Primary Outcome Measures: to assess the mean rate of change and variability of AV133 imaging results, to assess the mean rate of change and variability of AV133 imaging results from baseline at 12 and 24 months follow-up in patients with prodromal and, baseline the 12 months and 24 months
Examining the Generality of Laboratory-based Findings and Their Moderators in the ITC Study
NCT Number: NCT06456671
Acronym: MUSC-R 3a
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cigarette Smoking|Nicotine Vaping
Interventions: OTHER: All nicotine/ tobacco products at market price|OTHER: Nicotine vaping products at 1/2 market price|OTHER: Heated tobacco products at 1/2 market price.|OTHER: Nicotine pouch products at 1/2 market price.
Sponsor: Virginia Polytechnic Institute and State University
Collaborators: Medical University of South Carolina|University of Waterloo|National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 456
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-29
Completion Date: 2024-09-16
Locations: Fralin Biomedical Research Institute, Roanoke, Virginia, 24016, United States

Summary:
This study will investigate the relative appeal (abuse liability) of novel tobacco products, how the appeal is modulated by relative price, user type, and how novel products may substitute for one another.

Primary Outcome Measures: Cigarette demand, Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) prices will be assessed.

To obtain dependent measures of demand, participants' purchasing of the price-manipulated commodity in the ETM task will be fit to a modified exponential equation to quantify the relationship between the price of each commodity and purchasing: Q=Q0\*10k(exp(-αQ0C)-1) where Q is purchasing of the commodity, C is the price, Q0 is the derived initial purchasing without cost constraints (demand intensity), k is the span of the function in logarithmic units, and α is the demand elasticity., 1 day|Nicotine/tobacco products substitution, Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) prices will be assessed.

To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to model the relationship of the price-manipulated product to predict total quantity purchased of the price-constant product., 1 day
Statin Reminders for Improving Prescribing in Primary Care
NCT Number: NCT06456658
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cholesterol, Elevated|Clinical Decision Support|Education
Interventions: OTHER: Interruptive Reminder|OTHER: Non-interruptive Reminder|OTHER: No Reminder
Sponsor: Vanderbilt University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-14
Completion Date: 2026-07
Locations: Vanderbilt University Medical Center, Nashville, Tennessee, 37203, United States

Summary:
Statins reduce cardiovascular events and mortality, but only 30% of eligible primary care patients nationally are on statins. Clinical decision support (CDS) interventions in the electronic health record (EHR) can deliver education to providers and increase adherence to guideline recommendations via many potential forms of delivery. Interruptive alerts are an effective form of CDS but disrupt clinician workflow and increase alert fatigue in an age of clinician burnout and frustration with the EHR. Non-interruptive reminders are proposed as an alternative method of delivering CDS; however, they require active pursuit by the provider, and their effectiveness compared to interruptive alerts has not been rigorously studied. The investigators propose a randomized trial comparing the effect of interruptive vs. non-interruptive reminders displayed to clinicians to increase statin prescribing in primary care clinics.

Primary Outcome Measures: Statin prescription within 24 hours, Statin prescription within 24 hours post-enrollment (either interruptive, non-interruptive, or silent/hidden reminder)., Baseline to 24-hours
Secondary Outcome Measures: Statin prescription within 12 months, Statin prescription within 12 months post-enrollment., Baseline to 12 months|Low density lipoprotein-cholesterol (LDL-C) level, One LDL-C level within 12 months post-enrollment., Baseline to 12 months
Effects of Smoking on Placenta and Lactation
NCT Number: NCT06456645
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Smoking, Tobacco|Placenta Diseases|Breastfeeding|Fetal Conditions
Sponsor: Celal Bayar University
Sex: FEMALE
Age: ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2017-05-01
Completion Date: 2019-11-05
Locations: Manisa Celal Bayar Universitesi, Manisa, Turkey

Summary:
Maternal smoking during pregnancy although it is known to be associated with fetal growth restriction, it's effect on postpartum breastfeeding is not yet clear. The aim of the present study was to examine the impacts of smoking in pregnancy on breastfeeding as well as its impacts on placental immunoreactivity.

Primary Outcome Measures: 100% Patients's placenta with smoking in Pregnancy and 100% Patients's Placenta with from non-smoking in Pregnancy. Placenta Tissues Staining Measured by immunohistochemistry and biochemistry technique., Baseline
Secondary Outcome Measures: Sociodemographic, birth history, and breastfeeding questions were measured by survey technique., Baseline
The Effect of Su Jok Therapy on Postoperative Pain, Anxiety and Patient Satisfaction in Patients With BPH
NCT Number: NCT06456632
Acronym: SuJokTherapy
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Transurethral Resection (TUR) Syndrome
Interventions: OTHER: Intervention Su Jok Therapy
Sponsor: Baskent University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-01
Completion Date: 2025-07-01

Summary:
This study is the first nursing study in the field of urology to examine the effect of Su Jok Therapy on postoperative pain, anxiety and patient satisfaction in patients who underwent Transurethral Resection of the Prostate with a diagnosis of BPH and is thought to make an important contribution to evidence-based nursing practices. In line with the results obtained from the study, it is expected that the anxiety levels of patients planned to apply Su Jok therapy will be reduced, pain levels will be reduced, and patient satisfaction will increase.

Primary Outcome Measures: Patient Pain Assessment, Patient's pain will be assessed. The Visual Analogue Scale (VAS) will be used to assess pain.The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line., From preoperative to 8 hours postoperatively|Anxiety, Patient's anxiety will be assessed. The State Anxiety Inventory (SAI) will be used to assess anxiety. The State Anxiety Inventory (SAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress. its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety., Preoperative and 8th hour after surgery|Patient satisfaction, Patient satisfaction will be assessed. Visual Analog Patient Satisfaction Scale will be used to evaluate patient satisfaction.This scale ranges from 0 (not satisfied at all) to 10 (very satisfied)., 8th hour after surgery
Cardiopulmonary Effects of Prone Position in CARDS
NCT Number: NCT06456606
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: ARDS Due to Disease Caused by SARS Co-V-2|Right Ventricular Dysfunction
Interventions: PROCEDURE: before prone position|PROCEDURE: the first hour of prone position|PROCEDURE: the first hour of returning to the supine position
Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-02-01
Completion Date: 2022-05-30
Locations: Bakirkoy Dr. Sadi Konuk Research Hospital, Istanbul, Bakırköy, 34140, Turkey

Summary:
In coronavirus disease-2019 (COVID-19)-related ARDS (C-ARDS), especially in the severe form, increased shunt rate, impaired ventilation/perfusion ratio (V/Q), hypoxic pulmonary vasoconstriction inhibition, and increased immune microthrombosis may have similar effects on the right ventricle .The cardiopulmonary pathophysiology and outcomes of C-ARDS vary, and this variability requires monitoring to follow the diagnosis and treatment process. This study aimed to increase the treatment success of the prone position in C-ARDS and to provide a prognostic factor for survival by analyzing and monitoring heart-lung interactions. Therefore, we used transesophageal echocardiography (TEE) to evaluate the cardiopulmonary effects of prone position.

Primary Outcome Measures: Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) change during prone position., It was preferred right ventricular recovery evaluation., It was evaluated with transesophageal echocardiography three times: before prone position (T0), the first hour of prone position (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment
Secondary Outcome Measures: Static compliance (C-stat) change with prone position, It was examined in the evaluation of the pulmonary effect of prone position as secondary outcome., It was evaluated with transesophageal echocardiography three times: before prone position (T0), the first hour of prone position (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment
A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)
NCT Number: NCT06456567
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Systemic Lupus Erythematosus
Interventions: BIOLOGICAL: Telitacicept|DRUG: Placebo
Sponsor: RemeGen Co., Ltd.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-04

Summary:
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.

Primary Outcome Measures: SLE Responder Index (SRI-4), Proportion of subjects achieving an SLE Responder Index (SRI-4) response, Week 52
Secondary Outcome Measures: SLE Responder Index (SRI-4), Proportion of subjects achieving an SLE Responder Index (SRI-4) response, Week 24|Achieve and sustain a low dose of corticosteriods, Proportion of subjects achieving the target of corticosteroids reduction., Week 52|SLE Responder Index (SRI-4) and sustaining a low dose of corticosteriods, Proportion of patients achieving an SRI-4 response at Week 52, while achieving and maintaining corticosteroids reduction., Week 52|BILAG-based Combined Lupus Assessment (BICLA) Response, Proportion of patients achieving a BILAG-based Combined Lupus Assessment (BICLA) response at Week 52, Week 52|Time to Flare, Time to flare assessed by SELENA-SLEDAI Flare Index (SFI) from baseline through Week 52, Up to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Proportion of patients achieving clinically meaningful improvement in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52, Week 52
Acellular Dermal Matrix Investigation in Breast Reconstruction
NCT Number: NCT06456554
Acronym: ADMIRE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Reconstruction
Interventions: DEVICE: Acellular Dermal Matrix (Cortiva Tissue Matrix)
Sponsor: RTI Surgical
Collaborators: Bright Research Partners|MCRA
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 467
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-12

Summary:
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.

Primary Outcome Measures: Rate of major adverse events, Surgery-related adverse events requiring rehospitalization or reoperation of the breast under study, 12 months|Health related quality of life, Change from baseline in quality of life as measured by the BREAST-Q Physical Well-Being, 12 months
Secondary Outcome Measures: Change in quality of life, Change from baseline in quality of life as measured by the BREAST-Q, 1 year and 2 years|Procedure related adverse events, Rate of procedure-related adverse events requiring additional treatment, 3 months, 1 year and 2 years|Investigational device related adverse events, Rate of investigational device-related adverse events requiring additional treatment, 3 months, 1 year and 2 years|Histopathology assessment, Histopathology assessment at stage 2 procedure, stage 2 procedure
Infant Formula in Infants and Children With Cow's Milk Allergy
NCT Number: NCT06456541
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cow's Milk Allergy
Interventions: OTHER: Experimental Extensively Hydrolyzed Formula|OTHER: Placebo Extensively Hydrolyzed Formula
Sponsor: Abbott Nutrition
Sex: ALL
Age: CHILD
Enrollment: 61
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-07
Completion Date: 2029-01

Summary:
This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.

Primary Outcome Measures: Food Challenge Reactions, Percent of positive food challenge reactions to the experimental formula, Food Challenge 1 to Food Challenge 2 (within 14 days of the Food Challenge 1)
Secondary Outcome Measures: Volume of Experimental Formula Intake, Parent completed diaries of Intake, Home Feeding Day 1 to Day 7|Food Intake during Study, Parent completed daily food diaries, Home Feeding Day 1 to Day 7|Gastrointestinal Symptoms, Parent completed diaries, Home Feeding Day 1 to Day 7|Medication Use, Parent completed diaries, Home Feeding Day 1 to Day 7|Food Challenge Positive Reactions, Percent of positive food challenge reactions to the experimental formula, Home Feeding Day 1 to Day 7
QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia
NCT Number: NCT06456528
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Cancer Treatment-Induced Thrombocytopenia
Interventions: DRUG: QL0911|DRUG: QL0911 plus Placebo|DRUG: Placebo
Sponsor: Qilu Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 235
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-12

Summary:
To evaluate the efficacy and safety of QL0911 in cancer treatment-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia is a side effect of cancer treatment.

Primary Outcome Measures: The proportion of treatment responders., Randomization up to 80 days
Secondary Outcome Measures: Duration from the commencement of treatment to a platelet count ≥100×109/L, Randomization up to 30 days|Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy, Randomization up to 150 days|Number of adverse events (AEs)/serious adverse events (SAEs), Randomization up to 150 days
Pulse Steroid Injection in Refractory Rheumatoid Arthritis
NCT Number: NCT06456489
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Active Rheumatoid Arthritis
Interventions: DRUG: Solumedrol
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 268
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2024-12-31
Locations: Al-Azhar Univrsity, Cairo, Egypt

Summary:
Remission or low disease activity in active rheumatoid arthritis

Primary Outcome Measures: remission or low disease activity, Outcome measurements for both groups will be done at baseline and every month for 3 months. DAS28, DAS28 ESR ACR20 ACR50 ACR70, 4 months
Patients With Obstructive Jaundice In Sohag University Hospital
NCT Number: NCT06456476
Acronym: Jaundice
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obstructive Jaundice
Interventions: DIAGNOSTIC_TEST: ERCP
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-20
Completion Date: 2024-11-20
Locations: Sohag University Hospital, Sohag, Egypt

Summary:
Study of patients with obstructive jaundice in Sohag university hospital study the clinical, laboratory and imaging charachteristics in patients with obstructive jaundice admitted to sohag university hospital, and to study the available therapeutic options which meight improve patient's quality of life and increase survival rates.

Primary Outcome Measures: Study Of Patients With Obstructive Jaundice In Sohag University Hospital, rate of patients with obstructive jaundice admitted in sohag university hospital, 6 months
Taiwan Severe Asthma Biologic Registry
NCT Number: NCT06456450
Acronym: TARGET
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pulmonary Disease|Asthma
Interventions: BIOLOGICAL: Biological Treatment for severe asthma patients
Sponsor: Taichung Veterans General Hospital
Collaborators: E-DA Hospital|National Cheng-Kung University Hospital|National Yang Ming Chiao Tung University Hospital|Chang Gung Memorial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-11
Completion Date: 2043-02-28
Locations: Taichung Veterans General Hospital, Taichung, 40705, Taiwan

Summary:
This is a prospective multi-centers cohort study for registration adult patients with severe asthma and were reimbursed biologics treatment in Taiwan.

The goal of this observational study is to discover the real-world effectiveness, the impact of initiating, switching of biologics, and the possible prediction factors for selecting the best treatment option for patients.

The main question\[s\] it aims to answer are:

1. Determine risk factors associated with poor asthma control.
2. Support the development of effectiveness and safety of therapeutic principles
3. To discover the real-world effectiveness of different biologics ( Clinical remission)
4. To discover the impact of initiating biologics for severe asthma patients.
5. To evaluate the prevalence of biologics switching and its benefits for patients.
6. To compare the achievement rate of clinical remission among different biologics.

Participants who are treated either with omalizumab, mepolizumab, benralizumab dupilzumab or Tezepelumab after January 1, 2020 will be included in the study.

Primary Outcome Measures: Status of Asthma Control, Mean change in Asthma Control Test score after biologic initiation., 6 months|Status of Asthma exacerbations, Annual frequency of exacerbations after biologic initiation., 6 months|Reduction of daily oral corticosteriod dose, Percentage of daily oral corticosteroids dose reduction after biologic initiation., 6 months|Change of Pre-BD FEV1 (%pred), Measure the change of Pre-BD FEV1 (%pred) after biologic initiation. FVC (L) FEV1(L), 6 months
Secondary Outcome Measures: Disease Prognosis, 1. Describe the Cross-sectional phenotypic or pathophysiological (endotype) characteristics of poor asthma control.
2. Describe the natural history, intervention responsiveness and long-term prognosis of severe asthma., 6 months|Mortality, Define the mortality rate of the study cohort, 6 months
Bacteriophage Therapy for Methicillin-Sensitive Staphylococcus Aureus Prosthetic Joint Infection
NCT Number: NCT06456424
Acronym: PHAGE-2024-01
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Prosthetic Joint Infections of Hip|Staphylococcus Aureus Infection
Interventions: BIOLOGICAL: Phage therapy
Sponsor: University of Calgary
Collaborators: University of Toronto|Precisio Biotix Therapeutics, Inc.
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2025-06

Summary:
This is a single-patient, phase I/II clinical trial that aims to evaluate the potential of a bacteriophage cocktail to treat and prevent the recurrence of a methicillin-susceptible Staphylococcus aureus prosthetic joint infection of the hip. The patient has exhausted all conventional therapies, both surgical and medical, at considerable detriment to his quality of life. The treatment involves a one time, intra-operative injection of bacteriophages into the joint and 14 days of intravenous phage therapy. The goal is to eliminate the infection and prevent further complications, providing a potential new treatment avenue for patients with difficult-to-treat infections.

Primary Outcome Measures: Clinical response, Resolution of the infection, indicated by the absence of clinical symptoms such as wound drainage, swelling, erythema, pain, and fever. This will be determined by a questionnaire and monthly assessments by a Infectious Disease physician., 1 year
Secondary Outcome Measures: Safety of phage therapy, The safety outcome focuses on monitoring and documenting any adverse events (both serious and not) or reactions associated with bacteriophage therapy. Key safety measures include observing for immediate allergic reactions during the first dose, conducting regular clinical assessments, and performing routine blood tests (complete blood counts, lymphocyte subsets, c-reactive protein, liver function tests, serum electrolytes and serum creatinine) to detect any potential organ damage or unexpected side effects., 29 days|Microbiologic response, Bacterial cultures from the infected joint will be sent on an as-needed basis should the patient develop another draining fistula or require a repeat surgical incision and drainage. If there is no need to send bacterial cultures, or if bacteria other than Staphylococcus aureus are isolated, then this would be a good microbiologic response., 1 year|Biochemical response, To monitor for subclinical infection the patient will have serum inflammatory markers (white blood cell count and c-reactive protein) sent on days 0, 2, 4, 8, 11, 15, 29, and then every 30 days afterwards. Should both inflammatory markers decrease to be within the normal limits this would be a good biochemical response., 1 year
Functional Near-Infrared Spectroscopy and Virtual Reality Relaxation Programs for Pain Management in Patients With Cancer
NCT Number: NCT06456411
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Carcinoma|Kidney Carcinoma|Malignant Solid Neoplasm|Malignant Thoracic Neoplasm
Interventions: PROCEDURE: Functional Near-Infrared Spectroscopy|OTHER: Questionnaire Administration|OTHER: Virtual Technology Intervention
Sponsor: Roswell Park Cancer Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-07-12
Completion Date: 2026-07-12
Locations: Roswell Park Cancer Institute, Buffalo, New York, 14263, United States

Summary:
This clinical trial attempts to measure pain severity, location of pain, and feasibility in patients with cancer using functional near-infrared spectroscopy and virtual reality relaxation programs. Functional near-infrared spectroscopy and virtual reality relaxation programs may help relieve pain in patients with cancer who are receiving treatment.

Primary Outcome Measures: Gain knowledge of Brain activity during pain, Computational neuroscience algorithms and graph theories will be used to extract informative patterns of brain activity and diagnose the stimulated brain areas associated with pain and pain severity as well as any relationships between pain severity, functional near-infrared spectroscopy (fNIRS) measures, and visual perception., Up to 4 years
Secondary Outcome Measures: Determine if utilizing virtual reality technologies significantly alleviate pain through distraction, By utilizing virtual reality relaxation program we will analyze brain activity to find out how this distraction is controlled by the brain., Up to 4 years|Reason for pain alleviation caused by virtual reality techniques, Measured by fNIRS and quantified by signal processing and network neuroscience algorithms, to find out the reason for pain alleviation caused by virtual reality techniques. We will also investigate if cognitive distraction can be the main reason., Up to 4 years