pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers
NCT Number: NCT06543043
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Not Determined
Interventions: DRUG: Phenytoin|DRUG: Itraconazole|DRUG: sonrotoclax
Sponsor: BeiGene
Collaborators: Quotient Sciences
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-19
Completion Date: 2024-10-04
Locations: Quotient Sciences, Miami, Florida, 33126, United States

Summary:
This is a single-center, open-label, parallel group study designed to investigate the effect of CYP3A induction and inhibition following multiple doses of phenytoin (Part A) and itraconazole (Part B), respectively, on the pharmacokinetics of sonrotoclax in healthy volunteers.

Primary Outcome Measures: Parts A and B: Lag time before observation of quantifiable concentrations in plasma (Tlag) of sonrotoclax, Approximately 21 days for Part A and 11 days for Part B|Parts A and B: Time to maximum observed concentration (Tmax) of sonrotoclax, Approximately 21 days for Part A and 11 days for Part B|Parts A and B: Maximum observed plasma concentration (Cmax) of sonrotoclax, Approximately 21 days for Part A and 11 days for Part B|Parts A and B: Area under the concentration time curve from time zero up to the last quantifiable concentration (AUClast) of sonrotoclax, Approximately 21 days for Part A and 11 days for Part B|Parts A and B: Area under the concentration time curve from time zero extrapolated to infinity (AUCinf) of sonrotoclax, Approximately 21 days for Part A and 11 days for Part B|Parts A and B: Terminal phase elimination rate constant (lambda-z) of sonrotoclax, Approximately 21 days for Part A and 11 days for Part B|Parts A and B: Terminal elimination half life (T1/2) of sonrotoclax, Approximately 21 days for Part A and 11 days for Part B|Parts A and B: Apparent oral clearance (CL/F) of sonrotoclax, Approximately 21 days for Part A and 11 days for Part B|Parts A and B: Apparent volume of distribution (Vz/F) of sonrotoclax, Approximately 21 days for Part A and 11 days for Part B
Secondary Outcome Measures: Parts A and B: Number of Participants with Adverse Events (AEs), Number of participants with AEs and SAEs, including findings from vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory assessments., From time of providing written informed consent until up to 30 days after the final dose of study treatment for each part of the study; approximately 8 weeks for Part A and approximately 7 weeks for Part B
Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma
NCT Number: NCT06543030
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hepatocellular Carcinoma
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-12
Locations: Assiut University hospitals, Assiut, 71515, Egypt

Summary:
Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma

Primary Outcome Measures: To compare transfemoral approach (TFA) and transradial approach (TRA) in patients undergoing hepatic chemoembolization, To compare transfemoral approach (TFA) and transradial approach (TRA) in patients undergoing hepatic chemoembolization in terms of safety, feasibility, and procedural variables, including fluoroscopy time and patient preference., Baseline
Comparison of the Effects of Bio Ceramic and Epoxy Resin-based Sealers on Postoperative Pain After Root Canal Treatment
NCT Number: NCT06543004
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Asymptomatic Apical Periodontitis
Interventions: COMBINATION_PRODUCT: Root canal sealer
Sponsor: Primary Health Care Corporation, Qatar
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-12-31
Locations: Primary Health Corporation, Doha, Qatar

Summary:
This study aims to compare the effect of bio ceramic sealer and resin-based sealer on the intensity and occurrence of post operative pain in single rooted teeth with asymptomatic apical periodontitis.

Primary Outcome Measures: post operative pain questionnaire, The participants of the study groups will be given a questionnaire to record whether they experienced pain following the root canal treatment after applying each type of the study sealers or no, during the Time frame., assessed at 24 hours, 48 hours, and 7 days post-treatment.
Secondary Outcome Measures: Intensity of postoperative pain, The patient will be asked to measure Intensity of their postoperative pain using a Visual Analog Scale. It consist of a straight line, usually 10 centimeters in length, with end point defining the extremes of pain. One end of the line represents no pain(usually marked as 0), while the other end represents' worst imaginable pain' (usually marked as 10) participant mark a point on the line that corresponds to their perceived pain intensity. The distance from the 'no pain' end to the mark is then measured and used to quantify the pain level during Time frame., assessed at 24 hours, 48 hours, and 7 days post-treatment.|Analgesic, Analgesic intake recorded, The participants of the study will be asked to record any analgesic taken and the number of the tables during the Time frame., assessed at 24 hours, 48 hours, and 7 days post-treatment.
An Open-label Study on the Clinical Efficacy of rTMS Intervention in PD
NCT Number: NCT06542991
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Transcranial Magnetic Stimulation|Parkinson Disease|Supplementary Motor Area
Interventions: OTHER: transcranial magnetic stimulation
Sponsor: Anhui Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-03-31
Locations: Cognitive Neuropsychology Lab Anhui Medical University, Hefei, Anhui, China

Summary:
To demonstrate that intervention targeting the supplementary motor area (SMA) using precise navigation positioning can effectively improve motor symptoms in patients with Parkinson's disease.

Primary Outcome Measures: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale Part Ⅲ, The primary outcome was the change in MDS-UPDRS III from baseline to 9 weeks of follow-up. MDS-UPDRS III is a questionnaire used by uniformly trained professionals to evaluate motor symptoms in patients with Parkinson's disease\[21\]. The questionnaire consists of 18 items, which professionals need to score according to the patient's motor symptoms, on a scale of 0-4. Among them, items 3.3-3.8 and 3.15-3.17 can be divided into several sub-items according to the body parts. The results of MDS-UPDRS III are the total of 18 items., baseline; day 8; week 5;week 9;
Secondary Outcome Measures: Hoehn-Yahr(H-Y) stage, It ranges from 1 to 5, and is evaluated based on the range of symptoms involved and whether balance is impaired in PD patients. The higher the score, the more severe the severity., baseline; day 8; week 5;week 9;|The timed up and go test, TUG measures in seconds how long it takes the subject to rise from the chair, walk 3 meters, turn around, walk back to the chair, and sit down. The test is often used to assess walking and balance in older adults. This also applies to evaluating the severity of walking and balance symptoms in patients with Parkinson's disease., baseline; day 8; week 5;week 9;
The Effect of 40Hz Transcranial Stimulation in AICU on Incidence of Postoperative Delirium in Elderly Patients
NCT Number: NCT06542978
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Delirium|Anesthesia|Elderly
Interventions: DEVICE: 40Hz stimulation
Sponsor: Henan Provincial People's Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 98
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-05-01
Completion Date: 2025-03-01
Locations: Henan People's Hospital, Zhengzhou, Henan, China

Summary:
Postoperative delirium is an acute central nervous system dysfunction caused by surgical stress, which is manifested by postoperative acute, non-specific changes in consciousness level, attention, cognitive ability and disturbance of sleep and wake cycles. It is one of the most common surgical complications in the elderly, occurring in more than 75% of patients receiving mechanical ventilation in the intensive care unit(ICU).Exogenous 40 Hz stimulation can improve cognitive functioning.Therefore, the aim of this study was to investigate the effect of exogenous 40Hz stimulation on the incidence of postoperative delirium in elderly patients undergoing elective gastrointestinal surgery in AICU.

Primary Outcome Measures: The incidence of postoperative delirium, Postoperative delirium was assessed using the CAM-ICU scale.The RASS score (The Richmond Agitation-Sedation Scale) was used to assess arousal. When the patient's RASS score is not -4 /-5, delirium evaluation can continue considering the patient's wakefulness status.CAM-ICU scale contains four features (Feature 1, Feature 2, Feature 3, and Feature 4). Delirium can be diagnosed when the patient is positive for features 1, 2, 3, or 4., Day 1, Day 2, Day 3 ,Day 4, Day 5, Day 6,Day 7 after surgery
Secondary Outcome Measures: Blood Markers, Serum Tau proteomic analysis and CRP, IL-6, and TNF-ɑ were recorded, half hour, 6hours, 24hours and 48hours after transfer to aicu|Sleep quality, The Chinese version of the Richards-Campbell Sleep Quality Scale Score (RCSQ) was used to evaluate sleep quality. RCSQ scoring average for five projects, including 0 \~ 25 points on behalf of the poor quality of sleep, on behalf of the sleep quality of 76 \~ 100 points; The higher the score says sleep quality, the better, 8:00 to 10:00 every morning for the first three days after surgery|The incidence of pain, Mark a 0-10cm horizontal line on the paper with a ruler, and determine the score in millimeters (mm). The score range is 0-100mm, and the higher the score, the greater the pain intensity; No pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), severe pain (75-100 mm)., 6hours, 24hours, 48hours after surgery
Bloodstream Infection of Carbapenem-Resistant Proteus Mirabilis
NCT Number: NCT06542965
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Proteus Mirabilis Infection|Bacteremia|Carbapenem Resistant Bacterial Infection
Interventions: OTHER: Non-Interventional Research
Sponsor: Dokuz Eylul University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 67
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-01-01
Completion Date: 2023-01-01
Locations: Dokuz Eylül University, İzmir, 35400, Turkey

Summary:
This study aims to determine the clinical characteristics, risk factors, and resistance mechanisms of patients with carbapenem-resistant P. mirabilis bacteremia.Patients with P. mirabilis growth in blood culture samples sent to bacteriology laboratory between 2018 and 2021 were retrospectively analyzed. Patients meeting the inclusion criteria were divided into carbapenem-resistant and carbapenem- susceptible groups. The investigators recorded demographic data, clinical features, and laboratory findings. Resistance genes were investigated in carbapenem-resistant isolates using PCR.

Primary Outcome Measures: Carbapenem Use, number of patients using carbapenem before P. mirabilis growth in blood cultures, 1 year|Intensive Care Units, number of patients admission in ıntensive care units before P. mirabilis growth in blood cultures, 1 year|Mortality, number of patients who died, 30 days|Length of hospital stay, Length of hospital stay days, 1 year|Presence of chronic disease, number of patients with chronic disease, 1 year
Statistical Analysis of Prevalence, Incidence, Comorbidities and Medical Expense in Epileptic Children in Taiwan Based on National Health Research Insurance Database.
NCT Number: NCT06542952
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Neurologic Disorder|Seizure Disorder
Interventions: OTHER: seizure
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 169026
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-03-09
Completion Date: 2021-02-19
Locations: National Taiwan University Hospital, Tainan, 100, Taiwan|Department of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan

Summary:
Epilepsy is a common disease in pediatric neurology. In recent years, due to the promotion of Taiwan's health insurance and the advancement of related medical treatments and anti-epileptic drugs, the prevalence, incidence, and related comorbidities of childhood epilepsy in Taiwan are expected, as well as the number of epilepsy patients in different regions or different age groups. and medical costs may change. This study aims to collect data from the National Health Insurance Database through the National Institutes of Health, review relevant data on childhood epilepsy patients from 2001 to 2013, and analyze trends to discuss the impact of universal health insurance and medical progress on childhood epilepsy patients. Impact.

Primary Outcome Measures: Statistical Analysis of prevalence, incidence, comorbidities and medical expense medical expense in epileptic children in Taiwan based, in epileptic children in Taiwan based, 2001-2013
NON-COlorectal Liver METastases Undergoing Liver Resection
NCT Number: NCT06542926
Acronym: NONCOLMET
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Liver Metastases
Interventions: PROCEDURE: liver resection
Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-01
Completion Date: 2029-06-30

Summary:
Liver metastases (LM) are common in various types of malignant diseases, either at the diagnosis of the primary tumour or at a later time point. While the resection of colorectal LM (CRLM) is a well-established procedure, with survival rates superior to chemotherapy alone, controversial data still exist on liver resection for non-colorectal LM (NCRLM) (2, 3). These patients comprise a diverse and heterogeneous group usually excluded from surgery due to advanced tumour stage or the presence of concomitant extrahepatic disease. To date, no randomized clinical trial on the surgical treatment of NCRLM has been conducted, and only few retrospective reports are available.The scope of this research project is to develop a large registry of patients undergoing liver surgery for non-colorectal liver metastases.

Primary Outcome Measures: Overall Survival, Overall Survival defined as the time elapsed between the date of resective surgery and the date of death for any reason. Patients who are surviving at the end of observation will be considered "censored" at the date of the last available follow-up., From date of enrollment until the date of death from any cause assessed up to 36 months
Secondary Outcome Measures: Disease-free Survival, Disease-free Survival defined as the time from resective surgery to the date of first relapse or last available follow-up, whichever occurs first, From date of enrollement until the date of first documented progression assessed up to 36 months
Left Lobe Versus Right Lobe in Adult Living Donor Liver Transplantation in Borderline GRWR
NCT Number: NCT06542913
Acronym: LDLT
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Liver Transplant; Complications
Sponsor: Ain Shams University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2026-06-15

Summary:
a prospective cohort study comparing outcomes of left lobe and right lobe adult living donor liver transplantation

Primary Outcome Measures: small for size syndrome, small for size syndrome, 1 year
Secondary Outcome Measures: other complications after LDLT, other complications after LDLT, 1 year
Impact of Physiotherapy on Spasticity, Upper Limb Function, Daily Activities, and Kinesiophobia in Hemiplegic Patients
NCT Number: NCT06542848
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemiplegia|Stroke
Interventions: OTHER: Physiotherapy and Rehabilitation Practices
Sponsor: University of Beykent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2024-07-15
Locations: Beykent University, Istanbul, 34500, Turkey

Summary:
This study investigated the effects of rehabilitation exercises on spasticity levels, upper extremity functions, activities of daily living, and kinesiophobia in patients with hemiplegia following a stroke.

Primary Outcome Measures: Effect of Rehabilitation Program on Spasticity with Modified Ashworth Scale, The primary outcome measure evaluates the changes in spasticity levels. The Modified Ashworth Scale is a measurement system based on manually assessing the resistance of specific muscle groups to passive movement. This scale evaluates the resistance encountered during passive movement of the extremity, scoring it from 0 to 4. As the score increases, it indicates a higher level of spasticity., Baseline (pre-treatment) and 8 weeks (post-treatment)|Effect of Rehabilitation Program on Upper Extremity Motor Function with Fugl-Meyer Assessment of Upper Extremity Motor Function, The Fugl-Meyer Assessment of Upper Extremity Motor Function is a disease-specific, objective motor impairment scale designed to evaluate recovery in hemiplegic patients following a stroke. The highest possible score on this assessment is 66. An increase in the score indicates better motor skills., Baseline (pre-treatment) and 8 weeks (post-treatment)|Effect of Rehabilitation Program on Daily Living Activities with Barthel Index of Activities of Daily Living, The Barthel Index of Activities of Daily Living consists of 10 items related to daily activities and mobility. The highest possible total score is 100, indicating that the individual is completely independent in their physical functions. The lowest score is 0, indicating that the individual is entirely dependent., Baseline (pre-treatment) and 8 weeks (post-treatment)|Effect of Rehabilitation Program on Kinesiophobia with Tampa Scale for Kinesiophobia, The Tampa Scale for Kinesiophobia is a self-report measure developed to assess fear of movement. It consists of 17 items. A high score indicates a high level of fear of movement, while a low score indicates a negligible level of fear of movement. The total score, obtained by summing the individual items, ranges from 17 to 68., Baseline (pre-treatment) and 8 weeks (post-treatment)
Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity
NCT Number: NCT06542835
Acronym: PRIME
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colorectal Cancer
Interventions: BEHAVIORAL: Video text message|BEHAVIORAL: In-clinic CRC screening promotion|BEHAVIORAL: Mailed FIT|BEHAVIORAL: Social needs navigation|BEHAVIORAL: Reminders
Sponsor: University of Arizona
Collaborators: AltaMed Health Services Corporation|Kaiser Permanente|San Diego State University
Sex: ALL
Age: ADULT
Enrollment: 6000
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-08
Completion Date: 2027-01

Summary:
Non-randomized, two-arm stepped-wedge trial of a multi-level colorectal cancer screening intervention.

Primary Outcome Measures: CRC Screening Completion at the Individual Level, Measure the completion rate of colorectal cancer (CRC) screening at the individual level within 6 months of receiving the intervention. This will compare the proportion of participants in the post-intervention group versus the pre-intervention group., 6 months
Secondary Outcome Measures: FIT completion, Measure the completion rate of fecal immunochemical tests (FIT) within 6 months of receiving the intervention. This will compare the proportion of participants who complete FIT in the post-intervention group versus the pre-intervention group., 6 months|Rate of Follow-Up Colonoscopy Completion, Track the completion rate of follow-up colonoscopy within 12 months for participants with abnormal FIT results, comparing the post-intervention versus pre-intervention groups., 12 months|Time to follow-up colonoscopy, Measure the time from abnormal FIT result to the completion of follow-up colonoscopy, comparing the post-intervention versus the pre-intervention groups., Within 12 months post abnormal FIT result
Evaluation of the Propensity of Patients Under rhGH to Envision a Modification of Their Treatment Regimen Toward LAGH
NCT Number: NCT06542809
Acronym: TOWARD-LAGH
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Growth Hormone Deficiency
Interventions: OTHER: Questionnaire
Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators: The Belux Society for Pediatric Endocrinology and Diabetology (BELSPEED)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 500
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-04-15
Completion Date: 2026-03-01
Locations: Cliniques Universitaires Saint-Luc, Bruxelles, Woluwe-saint-lambert, 1200, Belgium

Summary:
Daily subcutaneous injections of rhGH can be burdensome for patients, leading to poor adherence and reduced growth outcomes. This has spurred the development of long-acting GH (LAGH) analogues that allow for weekly, biweekly, or monthly injections. Previous studies on LAGH analogues have demonstrated their non-inferiority compared to daily rhGH in terms of increasing growth velocity and improving body composition in children and adults with growth hormone deficiency (GHD), respectively, without significant and unexpected adverse events. Since 2020, three molecules have received approval from the Food and Drug Administration (FDA) for the treatment of pediatric GHD: lonapegsomatropin, somatrogon, and somapacitan. These LAGH analogues may offer better patient acceptance, improved tolerance, and greater therapeutic flexibility. However, these LAGH analogues could also be associated with potential clinical issues in terms of therapeutic monitoring, incidence and duration of side effects, and long-term safety due to a non-physiological GH profile. The introduction of these new LAGH products will require clinicians to identify optimal candidates for LAGH therapy and gain knowledge on monitoring and adjusting treatment.

Primary Outcome Measures: Evaluate families and patients propensity with a questionnaire to envision a switch from rhGH treatment to LAGH, By distributing a questionnaire designed by the investigators, they are looking to know if patients and families are already aware of these new treatments, likelihood to improve adherence with LAGH or other benefits they might expect from it, potential to increase/decrease risk of treatment-related side effects, concerns they might have in changing the current treatment, what information would they want to receive from their practitioner., Baseline
Secondary Outcome Measures: Evaluate if families/patients response varies according to age, indication of rhGH treatment, any underlying pathology, and/or duration of rhGH treatment., By distributing a questionnaire designed by the investigators., Baseline
Realistic in Generation of HEp-2 Cell Images Using Latent Diffusion Models: a Multi-center Visual Turing Test
NCT Number: NCT06542783
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anti-nuclear Antibody|Visual Turing Tests|Artifical Intelligence
Interventions: BEHAVIORAL: referring to the results of AI model output
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2026-06

Summary:
The objective of this prospective observational study is to rigorously examine the feasibility and efficacy of utilizing latent diffusion models for data augmentation in anti-nuclear antibody (ANA) Hep-2 cell immunofluorescence images. The main question it aims to answer is:

Can the application of such models potentially enhance the data quality, increase sample diversity, or improve the accuracy and efficiency of subsequent analytical processes (like disease diagnosis and classification) when utilized with ANA-related images?

Primary Outcome Measures: The realistic of images synthesized by diffusion models, The investigators conducted a study using the visual Turing test method, measuring through a questionnaire format, and assessed the measurement results using a 5-point Likert Scale.

The 5-point Likert Scale assesses participants' opinions on the quality of images through five response options: Real, Much like, Uncertain, Not quite like, Fake. It calculates scores by assigning numbers (e.g., 5 to 1) to these options, summing up scores for each participant. Results are evaluated by analyzing the distribution of scores, including mean scores, and assessing their reliability and validity.

Additionally, the investigator calculated a range of parameters utilized for internal model assessment, including: including precision, recall, F1 score, and mean average precision (mAP)., Baseline
Secondary Outcome Measures: The impact of the AI model's output on the participants, The investigator evaluated the change in the accuracy rate of participants' interpretations before and after being assisted by AI model, investigators will conduct a comparative analysis. Additionally, the investigator calculate the Kappa coefficient of agreement between human interpretations and the model, and evaluate whether there are differences in accuracy among cytopathologists with varying levels of experience when assisted by AI., Baseline|The time taken of ANA pattern interpretation, The investigator compare the time taken of participant to complete interpretations before and after the AI model's intervention, assessing whether there is a reduction in average interpretation time per case, from X minutes pre-AI assistance to Y minutes post-AI., Baseline
Atrial Anomalies Predict Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Cryptogenic Stroke
NCT Number: NCT06542770
Acronym: CRIPTO-FAST
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Paroxysmal Atrial Fibrillation|Cardiac Rhythm Disorder|Left Atrial Dilatation|Cryptogenic Stroke
Interventions: DEVICE: Early implant of cardiac monitor
Sponsor: Parc de Salut Mar
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2021-01-01
Completion Date: 2024-12
Locations: Hospital del Mar, Barcelona, 08003, Spain

Summary:
Cryptogenic stroke (CS) causes about 30% of admissions to a stroke unit. Silent paroxysmal atrial fibrillation (PAF) is believed to be the underlying cause of a significant proportion of patients. The use of implantable cardiac monitors (ICM) early after the CS has demonstrated benefits in the diagnostic yield, but the indication for ICM in the current guidelines remains unclear. Atrial contraction strain (ACS) evaluated by cardiac ultrasound could be of help to select the patients more prone to suffer from silent PAF.

The purpose of this investigation is to conduct a randomized prospective unicentric study to evaluate the usefulness of ICM for early detection of silent PAF episodes in patients with CS. Clinical and ultrasound predictors of PAF occurrence (ACS) will be studied in order to define patients needing a closer follow-up.

Primary Outcome Measures: Detection atrial fibrilation at follow-up, defined by the presence of a confirmatory 12-leads ECG, or a registration lasting more than 30 seconds in, either the 72h-Holter-Monitoring, or in the ICM recording. In case of AF detection OAC was initiated immediately., Up to 2 years follow-up (ICM and standard care practice)
Secondary Outcome Measures: LA indexed volume, LA indexed volume in ml/m2, Before Day 3 since the Criptogenic Stroke|Maximum Systolic Global Longitudinal Strain (PALs), Maximum Systolic Global Longitudinal Strain (PALs) in %, Before Day 3 since the Criptogenic Stroke|Atrial Contraction Strain (PACs), atrial contraction strain (PACs) in %, Before Day 3 since the Criptogenic Stroke|Atrial Ejection Fraction, Atrial ejection fraction in %, Before Day 3 since the Criptogenic Stroke|stroke recurrences, new neurological events recorded after hospital discharge and validated by a vascular neurologist, Up to 2 years follow-up (ICM and standard care practice)
An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Docetaxel and Ramucirumab as Second-line Therapy in Patients With Advanced or Recurrent Non-small Cell Lung Cancer
NCT Number: NCT06542731
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Non-small Cell Lung Cancer
Interventions: DRUG: ONO-4578|DRUG: ONO-4538|DRUG: Docetaxel|DRUG: Ramucirumab
Sponsor: Ono Pharmaceutical Co. Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-06-01
Completion Date: 2026-12-31
Locations: Saitama Cancer Center, Ina, Saitama, Japan|National Cancer Center Hospital, Chuo Ku, Tokyo, Japan|Juntendo University Hospital, Bunkyo-ku, Japan|Teikyo University Hospital, Itabashi-ku, Japan|Japan Anti-Tuberculosis Association Fukujuji Hospital, Kiyose-shi, Japan|The Cancer Institute Hospital of JFCR, Koto-ku, Japan|Niigata Cancer Center Hospital, Niigata-shi, Japan|Hyogo Medical University Hospital, Nishinomiya-shi, Japan|Osaka Prefectural Hospital Organization Osaka International Cancer Institute, Osaka-shi, Japan|Kitasato University Hospital, Sagamihara-shi, Japan|National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan|Osaka Medical and Pharmaceutical University Hospital, Takatsuki-shi, Japan|Kanagawa Cancer Center, Yokohama-shi, Japan

Summary:
This study is PhaseⅠstudy to evaluate the tolerability and safety of ONO-4578 and ONO-4538 in combination with standard-of-care docetaxel and ramucirumab as second-line therapy in patients with advanced or recurrent NSCLC who were refractory to a combination therapy containing an anti-PD-(L)1 antibody and a platinum-based drug

Primary Outcome Measures: Dose-limiting toxicities（DLT）, 21 days|Adverse event(AE), Up to 28 days after the last dose
Secondary Outcome Measures: Pharmacokinetics（Plasma concentration of ONO-4578）, Up to 28 days after the last dose|Pharmacokinetics（serum concentration of ONO-4538）, Up to 28 days after the last dose|Overall response rate (ORR), Up to 2 years|Disease control rate (DCR), Up to 2 years|Overall survival (OS), Up to 2 years|Progression-free survival (PFS), Up to 2 years|Duration of response (DOR), Up to 2 years|Time to response (TTR), Up to 2 years|Best overall response (BOR), Up to 2 years|Percentage of change in the sum of tumor diameters of target lesions, Up to 2 years|Maximum percentage of change in the sum of tumor diameters of target lesions, Up to 2 years|Changes in tumor markers（CYFRA,CEA,SLX）, Up to 2 years
Studying Phenotypes of Gestational Diabetes Mellitus in an Asian Pregnant Cohort
NCT Number: NCT06542718
Acronym: GDM-CARE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gestational Diabetes|Pregnancy Related|Pregnancy Complications|Birth Weight|Insulin Resistance, Diabetes|Intergenerational Relations
Sponsor: National University Health System, Singapore
Sex: FEMALE
Age: ADULT
Enrollment: 800
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-03
Completion Date: 2025-12-31
Locations: Department of Obstetrics & Gynaecology, Singapore, 117549, Singapore

Summary:
Gestational diabetes mellitus (GDM) is a transient hyperglycemic condition identified during pregnancy in women without a history of chronic diabetes. Evidence indicates that GDM can lead to various adverse health outcomes, including preterm birth, progression to pre-diabetes, and type 2 diabetes after delivery in mothers. Notably, GDM is becoming increasingly prevalent among Asian pregnant women due to rising rates of overweight and obesity, as well as genetic susceptibility. Despite growing recognition of GDM, its treatment efficiency and efficacy remain poor, primarily due to its heterogeneity, which is underpinned by various pathophysiological mechanisms.

Therefore, a better understanding of GDM heterogeneity can aid clinicians in providing more targeted treatment and follow-up strategies for GDM mothers. This study aims to define GDM phenotypes based on in vivo cardio-metabolic profiles and treatment response during pregnancy, utilizing advanced technologies such as continuous glucose profiling and untargeted metabolite profiling. In this proposed 3-year pregnancy cohort study, the investigators will recruit 800 overweight or obese Asian pregnant women in early pregnancy, without a history of diabetes, and follow them through to delivery. The goal of the study is to develop systematic antenatal and postnatal screening, treatment, and intervention guidelines for mothers with GDM.

Primary Outcome Measures: IADPSG (International Association of Diabetes and Pregnancy Study Groups)-defined Gestational Diabetes Mellitus (GDM), Oral Glucose Tolerance Test (OGTT) will be performed during universal screening at 24-28 weeks of gestational age. 0, 1 hour and 2 hour glucose readings will be measured after 8-10 hours of overnight fasting, after a 75 grams glucose drink. Cutoffs are according to The International Association of Diabetes and Pregnancy Study Groups (IADPSG) guidelines., 3 years
Secondary Outcome Measures: Rates of Diet or Insulin-treated gestational diabetes mellitus based on phenotypes, The rates of treatment-specific gestational diabetes phenotypes will be calculated., 3 years
Other Outcome Measures: Rate of large-for-gestational age (LGA) babies based on GDM phenotypes, The numbers and rates of LGA babies according to different GDM phenotypes will be calculated., 3 year
Effect of Whole Body Vibration Therapy on Pain, Muscle Strength, Balance and Quality of Life in Knee Osteoarthritis
NCT Number: NCT06542692
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis, Knee|Osteoarthritis
Interventions: DEVICE: Whole Body Vibration|DEVICE: physical therapy modalities
Sponsor: Burak Çetinkaya
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-08-28
Completion Date: 2023-12-28
Locations: Kocaeli University, Kocaeli, 41000, Turkey

Summary:
The aim of this study is to examine the effects of whole body vibration therapy on knee osteoarthritis. While the participants did static exercise in one group, whole body vibration therapy was applied during static exercise in another group. As a result of 15 sessions of treatment in both groups, the effects on pain, muscle strength, balance and quality of life were compared.

Primary Outcome Measures: visual analog scala, Scale ranging from 0 to 10 points, where 0 points indicate no pain and 10 points indicate maximum pain., 3 weeks|Womac, Western Ontario and McMaster Universities Osteoarthritis Index, 3 weeks|muscle strength, isometric muscle strength measurement(knee extension, flexion), 3 weeks|Biodex, Balance test, 3 weeks|Short Form 36, A test consisting of 36 questions to assess quality of life, 3 weeks
Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion
NCT Number: NCT06542653
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Atheroscleroses
Interventions: PROCEDURE: PCI|DRUG: OMT
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 258
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-17
Completion Date: 2025-09-17
Locations: The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, 210009, China

Summary:
Coronary chronic total occlusions (CTOs) are considered to increase the risk of adverse clinical outcomes. The purpose of this study was to evaluate whether long-term clinical outcomes could be improved by successful percutaneous coronary intervention (PCI) over optimal medical therapy (OMT) in CTO patients.

Primary Outcome Measures: major adverse cardiac cerebrovascular events (MACCE), including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke., January 2011 to December 2023
Secondary Outcome Measures: all-cause death, all-cause death, January 2011 to December 2023
Continuous Glucose Monitoring for Glucose and Weight Management in Prediabetes and Non-severe Type 2 Diabetes: A Prospective Community-based (Workplace) Cohort Study
NCT Number: NCT06542627
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: PreDiabetes|Diabetes Mellitus, Type 2
Interventions: DEVICE: Freestyle Libre
Sponsor: Kangbuk Samsung Hospital
Collaborators: Samsung Electronics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 420
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-22
Completion Date: 2025-12-31
Locations: Kangbuk Samsung Hospital, Seoul, 03181, Korea, Republic of

Summary:
This study aimed to evaluate the effectiveness of use of Continuous Glucose Monitoring (CGM), combined with personalized dietary education and use of smartphone applications in improving glucose control and weight management.

Primary Outcome Measures: HbA1c, HbA1c assessed by blood test after 2-week use of CGM and dietary education, 8weeks after intervention
Secondary Outcome Measures: Fasting blood glucose, Fasting blood glucose, assessed by blood test after 2-week use of CGM and dietary education, 8weeks after intervention|Lipid profiles, Lipid profiles (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride), assessed by blood test after 2-week use of CGM and dietary education, 8weeks after intervention|Body weight, Body weight assessed by blood test after 2-week use of CGM and dietary education, 8weeks after intervention|Pre- and post-intervention questionnaire: Diabetes Treatment Satisfaction Questionnaire (DTSQ), Pre- and post-intervention questionnaires, assessed by self-reported survey. The questionnaire is composed of three parts.

* total satisfaction (minimum 0, maximum 36, higher scores mean a better outcome.)
* perceived hyperglycaemia (minimum 0, maximum 6, higher scores mean a worse outcome.)
* perceived hypoglycaemia (minimum 0, maximum 6, higher scores mean a worse outcome.), 8weeks after intervention|Pre- and post-intervention questionnaire: Summary of Diabetes Self-Care Activities Questionnaire (SDSCAS)., Pre- and post-intervention questionnaires, assessed by self-reported survey. The questionnaire is composed of five parts.

* diet (values: minimum 0, maximum 28, higher scores mean a better outcome.)
* exercise (minimum 0, maximum 14, higher scores mean a better outcome.)
* blood sugar check-up (values: minimum 0, maximum 14, higher scores mean a better outcome.)
* foot care (minimum 0, maximum 14, higher scores mean a better outcome.)
* smoking (minimum 0, maximum 1, higher scores mean a worse outcome.), 8weeks after intervention
Combined Motor and Cognitive Training for Older Adults With Motoric Cognitive Risk Syndrome (CMC-training)
NCT Number: NCT06542601
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Disability Physical|Disabilities Mental|Age Problem
Interventions: DEVICE: Motor cognitive intervention
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 204
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-04
Completion Date: 2025-06-30
Locations: Xuanwu Hospital, Capital Medical University, Beijing, 100053, China

Summary:
To investigate the effects of a combined motor-cognitive intervention on the improvement of motor as well as cognitive function in community residents.

Primary Outcome Measures: Cognitive function changes in the intervention group and the control group, Changes in Montreal Cognitive Assessment Scale (MoCA) scores before and after intervention between the two groups, 12 weeks|Motor function changes in the intervention group and the control group, Changes in Montreal Short Physical performance Battery (SPPB) scores before and after intervention between the two groups, 12 weeks
Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC
NCT Number: NCT06542588
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Rectal Cancer
Interventions: COMBINATION_PRODUCT: HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody)
Sponsor: Wuhan Union Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 29
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-19
Completion Date: 2026-12
Locations: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430022, China|Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China|Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hubei, China

Summary:
The study is a multicenter, open-label, phase II clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR)) of patients with RAS/BRAF wild type locally advanced rectal cancer(LARC) treated with short-term radiotherapy, sequential HLX07, Serplulimab and CAPOX. A total of 29 patients were included in this study.

Primary Outcome Measures: complete response (CR) rate, Defined as pathological complete response (pCR) + Clinical complete response (cCR), an expected average of 12 months
Secondary Outcome Measures: 3-year disease-Free Survival, The time from the first day of disease free (operation date) to local or distant recurrence, or the death event caused by any reason, whichever occurs first, an expected average of 3 years|Overall Survival, The time from the date of randomization to the death caused by any cause, an expected average of 5 years|dverse events (AEs) were graded according to the NCI CTCAE version 5·0, Adverse events and surgical safety, an expected average of 1.5 years
Efficacy of the Integration of Digital Therapeutics and Home-based Cardiac Rehabilitation in High-Risk Post-PCI Patients
NCT Number: NCT06542575
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Artery Disease|Myocardial Infarction
Interventions: OTHER: DTx-guided HBCR
Sponsor: West China Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 366
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2025-12

Summary:
The DTx-HBCR trial will randomize 366 high-risk patients who undergo PCI at the West China Hospital of Sichuan University to either the 6-month DTx-guided HBCR group (intervention group) or the 6-months usual care group (control group) in a parallel-arm randomized controlled trial. The primary outcome is the difference between the intervention group and control group in walk distance on the 6-minute walk test (i.e., functional capacity) at 6 months post randomization. The key secondary outcomes include improvements in cardiovascular risk factor control, quality of life, psychological status, physical activity, major adverse cardiovascular events, and medication adherence. This study aims to evaluate the DTx-guided HBCR, a software-driven, multidisciplinary health intervention as an alternative to traditional in-center CR in patients with high-risk patients following percutaneous coronary intervention (PCI) compared with usual care alone.

Primary Outcome Measures: 6-minute walk distance (i.e., functional capacity) at 6 months post randomization, The change in distance participants walked (i.e., functional capacity) between the intervention and usual care groups, as measured by the 6MWT at 6 months postrandomization., at 6 months post randomization
Secondary Outcome Measures: The change in functional capacity at 3 months postrandomization, The change in distance participants walked (i.e., functional capacity) between the intervention and usual care groups, as measured by the 6MWT at 3 months postrandomization., at 3 months postrandomization
Accuracy of Fully Guided Versus Half Guided Implant
NCT Number: NCT06542562
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Complete Edentulism
Interventions: PROCEDURE: guided implant placement
Sponsor: October University for Modern Sciences and Arts
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2024-12

Summary:
six implants will be placed in edentulous maxilla to rehabilitate patients with implant prosthesis.The primary outcome measure will be the accuracy of implant placement, which will be evaluated using cone-beam computed tomography (CBCT) scans

Primary Outcome Measures: evaluation of accuracy, The spatial relationship between the planned and placed implants will be evaluated using preoperative and postoperative CBCT data of the maxilla bone., day of implant placement
Efficacy and Safety of AK104 (PD-1/CTLA-4 Bispecial Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer
NCT Number: NCT06542549
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Advanced Ovarian Cancer|AK104(PD-1/CTLA-4 Bispecial Antibody)|Chemotherapy|Efficacy|Safety
Interventions: DRUG: AK104
Sponsor: Anhui Provincial Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2030-10-31

Summary:
This is a randomized, controlled, single-center clinical study to evaluate AK104 in FIGO 2018 stage III-IV ovarian cancer subjects who were assessed to be at high perioperative risk and/or unable to achieve R0 resection prior to initial treatment. The efficacy and safety of neoadjuvant therapy with intravenous infusion combined with chemotherapy compared with chemotherapy alone.

Primary Outcome Measures: R0 rate, Rate of complete tumor resection (R0): complete resection of the visible lesion., Up to 6 months
Secondary Outcome Measures: ORR, Objective tumor response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments., 1 year|DCR, Disease control rate (DCR) refers to the percentage of cases with remission and disease stability after treatment in the total number of evaluable cases., 1 year|pCR, Pathological complete response is the breast primary focus and axillary lymph node surgery specimen pathological examination without invasive tumor cell residual., 1 year|PFS, Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress., 1 year|AE, adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0., 1 year