pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
PTSD Screening in Pregnant Black Women
NCT Number: NCT06522022
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnancy Early|PTSD
Interventions: BEHAVIORAL: Culturally Responsive SBIRT for OB|BEHAVIORAL: Brief Screening for PTSD
Sponsor: Emory University
Collaborators: Patient-Centered Outcomes Research Institute|University of Missouri, Kansas City
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 804
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2025-03
Completion Date: 2029-03
Locations: Grady Health System, Atlanta, Georgia, 30303, United States|Truman Medical Center (TMC) system, Kansas City, Missouri, 64108, United States

Summary:
This study will compare the effectiveness of two active screening interventions in improving post-traumatic stress disorder (PTSD) symptoms, maternal perinatal care utilization, satisfaction utilization of mental healthcare services, and maternal health and birth-related outcomes for Black pregnant women.

Primary Outcome Measures: PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score, Researchers will use the PTSD Checklist for DSM-5 (PCL-5) to measure PTSD symptoms, a well-validated and widely used 21-item measure that assesses the frequency of current PTSD symptoms. Participants report how often they have been bothered by specific symptoms of PTSD on a scale of 0 (not at all) to 4 (extremely). The total symptom severity score ranges from 0 to 80. A provisional PTSD diagnosis can be made and a PCL-5 cut-point score of 33 is recommended., Initial OB visit (weeks 1-13), second trimester (Weeks 14 to 27), third trimester (weeks 28-40), and 6-weeks postpartum
Secondary Outcome Measures: Adequacy of prenatal care utilization (APNCU), OB physicians widely use this measure. The APNCU includes what trimester prenatal care began within the index. APNCU is a standard metric, defined as attending at least 80% of prenatal care visits, adjusting for gestational age. Researchers will use chart abstraction to determine the percent attendance of prenatal care adjusting for gestational age at birth., 6 weeks postpartum
Effect of Time Delay and Syringe Surface Area on Blood Gas Samples Analysis
NCT Number: NCT06522009
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Respiratory Failure
Sponsor: Helwan University
Collaborators: Theodor Bilharz Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-07-30
Completion Date: 2020-07-30
Locations: Theodor Bilharz Research Institute, Cairo, 3357, Egypt

Summary:
To detect the effect of time delay and syringe surface area on the oxygen tension (PaO2), oxyhaemoglobin saturation (SaO2), acidity (pH), and carbon dioxide tension (PaCO2) in both arterial and venous blood gas outcomes.

Primary Outcome Measures: To detect the effect of time delay and syringe surface area on the oxygen tension (PaO2) arterial and venous blood gas outcomes., PaO2 by mmhg arterial and venous samples

To detect the effect of time delay and syringe surface area on SO2 in arterial and venous samples

To detect the effect of time delay and syringe surface area on other parameters of blood gases e.g. PH,CO2, 1 hour
Secondary Outcome Measures: effect of delay on analysis oxyhaemoglobin saturation (SaO2) acidity (pH) carbon dioxide tension (PaCO2), spao2 by mmhg and paco2 by mmhg, 60 minutes
The Effect of Whole Body Vibration on Muscle Elasticity
NCT Number: NCT06521983
Acronym: WBV
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lordosis; Postural|Lordosis|Hyperlordosis
Interventions: OTHER: Whole body vibration
Sponsor: Gaziantep Islam Science and Technology University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-05
Completion Date: 2024-06-28
Locations: Gaziantep Islam Science and Technology University, Gaziantep, Turkey

Summary:
This study examined the effect of whole-body vibration on pain and muscle elasticity in individuals with hyperlordosis and normal lordosis.

Flexible ruler for individuals' spinal curvatures (lumbar lordosis); back-lower back pain levels VAS; muscle elasticity Myoton Pro device; Physical functions will be evaluated with the Modified Oswestry low back pain scale.

Primary Outcome Measures: Muscle viscoelastic properties, muscle stiffness, 6 weeks
Secondary Outcome Measures: Pain level, Visual Analog Scale: between 0 -10 points; 0 (zero) no pain; 5 (five) Moderate pain; 10 (ten) Worst possible Pain, 6 weeks
Dynamic Posture and Head Position in Kyphotic Female and Male
NCT Number: NCT06521970
Acronym: DPHP
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Kyphosis Thoracic|Postural, Thoracic Kyphosis|Postural Kyphosis
Interventions: DIAGNOSTIC_TEST: The kyphosis angle|DIAGNOSTIC_TEST: dynamic postural performance|DIAGNOSTIC_TEST: forward head position
Sponsor: Gaziantep Islam Science and Technology University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 54
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-16
Completion Date: 2024-06-05
Locations: Gaziantep Islam Science and Technology University, Gaziantep, Turkey

Summary:
This study examined the comparison of dynamic posture and head position in kyphotic ındividuals according to gender.

Methods: A total of 54 female and male adolescents (between the ages of 12 and 18) with a thoracic kyphosis (TK) angle of ≥ 50° were divided into two groups according to gender.

The kyphosis angle, dynamic postural performance, and forward head position were measured using a flexible ruler, Mathiass test, and occiput wall distance.

Primary Outcome Measures: Matthias test, Matthias test assesses dynamic postural performance, 1 year
Secondary Outcome Measures: Occiput wall distance, Occiput wall distance is an assessment method to determine forward head posture in clinical settings., 1 year
A Study of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Lymphoma or Solid Tumor Patients
NCT Number: NCT06521931
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Thrombocytopenia
Interventions: DRUG: PN20
Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-12-06
Completion Date: 2024-12-30
Locations: Affiliated Hospital of Hebei University, Baoding, Hebei, 071000, China|The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, 471003, China|Henan Cancer Hospital, Zhengzhou, Henan, 450008, China|Yiyang Central Hospital, Yiyang, Hunan, 413099, China|The Affiliated Hospital of Qingdao University, Qingdao, Shandong, 266057, China|Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China

Summary:
The main aim of this clinical trial is to assess the safety and tolerability of PN20 in adult patients with chemotherapy-induced thrombocytopenia (CID). The main questions it aims to answer are:

* Is PN20 safe in these patients?
* Could these patients potentially benefit from PN20 prevention? Participants will
* Receive subcutaneous injections of PN20 according to weight on the first day of chemotherapy cycle, within 1 hour before the administration of chemotherapy drugs,
* Visit the clinic on Day 1 (D1), D2, D3, D4, D5, D8, D11, D13, D15 and D21 for assessment.

Primary Outcome Measures: AE in single-dose phase, The incidence of adverse events related to PN20 within 21 days after a single dose, Day 1-21 of Cycle 1 (each cycle is 21 days)|The proportion of patients with PLT ≥ 100×10^9/L in multiple-dose phase, The proportion of subjects whose platelet count (PLT) reached ≥ 100 × 10\^9/L at the end of the second chemotherapy cycle., Day 21 of Cycle 2 (each cycle is 21 days)
Combined Artificial Intelligence and Mobile Application for Remote Infant Motor Screening: Development and Validation
NCT Number: NCT06521918
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Motor Disorders
Sponsor: National Taiwan University Hospital
Collaborators: National Health Research Institutes, Taiwan
Sex: ALL
Age: CHILD
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2027-07-31
Locations: National Taiwan University, Taipei, Taiwan, 100, Taiwan

Summary:
The purpose of this three-year study is therefore four-fold: (1) designation of an APP "Baby Go" version 3.0 to include the assessment, referral and education functions for parental use at home, (2) development and validation of the AI algorithm for infant motor screening based on home videos obtained from term and preterm infants, (3) comparison of parental perception and report with AI-driven assessment results, and (4) examination of predictive validity of the AI algorithm for infant motor screening on subsequent outcome.

Primary Outcome Measures: Alberta Infant Motor Scale (AIMS), motor function in supine, prone, sitting and standing position, 3 - 18 months of age|Age of walking attainment, Age of attaining independent walking for at least five steps, 9 - 18 months of age
Clinical Trial on the Treatment of Stent Underexpansion Caused by Calcification Using Intravascular Lithotripsy
NCT Number: NCT06521905
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intravascular Lithotripsy
Interventions: DEVICE: intravascular lithotripsy|DEVICE: high-pressure ballon
Sponsor: China National Center for Cardiovascular Diseases
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 222
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-10-01

Summary:
Our aim is to investigate the efficacy and safety of intravascular lithotripsy(IVL) in the treatment of stent underexpansion caused by calcification through a prospective, multicenter, randomized controlled trial. Patients with inadequate stent expansion due to calcification detected by intravascular ultrasound(IVUS) were randomly divided into two groups. The experimental group received IVL in addition to high-pressure balloon post-dilation, while the control group only received high-pressure balloon post-dilation. Follow up for 1 year is conducted to determine the safety and efficacy of IVL application based on the primary efficacy endpoint, key secondary efficacy endpoint, other secondary efficacy endpoint, and safety endpoint.

Primary Outcome Measures: Satisfaction Rate of Stent Expansion[Effcacy], Satisfied stent expansion is defined as meeting the standard of good expansion after stent implantation through IVUS after PCI, immediately after percutaneous coronary intervention(PCI)
Secondary Outcome Measures: Major Cardiovascular Events[Effcacy], a composite endpoint of cardiovascular death, target vessel myocardial infarction and target vessel revascularization, 1 year after after percutaneous coronary intervention(PCI)|Lumen Obtainment after PCI[Effcacy], changes in lumen area after treatment, immediately after percutaneous coronary intervention(PCI)|Incidence of Treatment-Emergent Complications[Safety], Postoperative complications such as coronary spasm, dissection, acute occlusion, persistent ventricular arrhythmia, etc, immediately after percutaneous coronary intervention(PCI)
Interventions on Non-prescription Dispensing of Antibiotics in Community Pharmacies
NCT Number: NCT06521892
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Non-Prescription Drug Misuse|Acute Respiratory Tract Infection
Interventions: BEHAVIORAL: social surveillance and health education interventions
Sponsor: Huazhong University of Science and Technology
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-25
Completion Date: 2025-07-25
Locations: Hubei Provincial Drug Administration, Wuhan, Hubei, 430071, China

Summary:
This study was a randomized controlled trial conducted in community pharmacies. Empirical data were collected primarily using standardized patient methods. In Hubei Province, 400 community pharmacies were randomly selected and assigned to the intervention group and the control group according to the ratio of 1:1. A one-month intervention was conducted in community pharmacies in the intervention group, which included both social surveillance and health education. First, on-site training was provided to community pharmacy staff. Respiratory physicians and pediatricians were invited to give health education lectures on disease diagnosis and treatment, medication use, etc. Second, signs were posted or hung in the community pharmacies of the intervention group, saying that "antibiotics need to be purchased with a prescription, and you are welcome to call the 12315 hotline to report if you find any sales without a prescription", in order to open up the channels of social supervision and to form a social surveillance intervention. The control group only received the regular drug supervision and management measures in Hubei Province. The primary outcome is to observe the proportion of community pharmacies selling antibiotics without a prescription.

Primary Outcome Measures: Proportion of antibiotics dispensing without a prescription, Proportion of antibiotics dispensing without a prescription measured by standardized patients, baseline, First month after intervention, 3, 6, and 12 months after intervention
Probiotic Use in Oral Iron Replacement Deficiency Anemia Patients Initiating Oral Iron Replacement
NCT Number: NCT06521879
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Iron Deficiency Anemia Treatment|Iron Deficiency Anemia
Interventions: DIETARY_SUPPLEMENT: Lactobacillus plantarum 299v probiotic support
Sponsor: Antalya Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 295
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-09-01
Completion Date: 2023-07-01
Locations: Antalya Training and Research Hospital, Antalya, 07050, Turkey

Summary:
Investigation of gastrointestinal tolerability, treatment compliance and iron status markers in patients with iron deficiency anemia who received oral iron replacement therapy with versus without concomitant probiotic supplementation

Primary Outcome Measures: Gastrointestinal Tolerance and Treatment Compliance in Iron Deficiency Anemia Patients Using Oral Iron with or without Lactobacillus plantarum 299v Probiotic Supplementation, To investigate gastrointestinal tolerability and treatment compliance in patients with iron deficiency anemia who received oral iron replacement therapy with versus without concomitant Lactobacillus plantarum 299v (L. plantarum 299v) probiotic supplementation. Gastrointestinal intolerance symptoms (loss of appetite, nausea, vomiting, abdominal pain, diarrhea, constipation, and bloating) will be assessed using a structured questionnaire with yes or no questions.

Measurement Tool: Structured Questionnaire

Data Collection Points: Baseline, within the first 30 days of iron replacement therapy (IRT), and at any time during the 3-month IRT.

Scale Description: The questionnaire will include yes or no questions to determine the presence of gastrointestinal intolerance symptoms. A "yes" response indicates the presence of a symptom, and a "no" response indicates its absence., 3 months
Toripalimab Combined With Targeted Therapy and Chemotherapy With or Without Radiotherapy as First-Line Treatment for Advanced Colorectal Cancer
NCT Number: NCT06521866
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Advanced Colorectal Carcinoma|Immunotherapy
Interventions: DRUG: Toripalimab|DRUG: Chemotherapy|RADIATION: SABR|DRUG: Targeted therapy
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 208
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-08-01

Summary:
Title: A Prospective, Randomized, Phase II Clinical Study of Toripalimab with Targeted Therapy and Chemotherapy with or without Radiotherapy for Advanced Colorectal Cancer. Objective: To assess the efficacy and safety of combining an immune checkpoint inhibitor with targeted therapy and chemoradiotherapy in patients with locally advanced unresectable or metastatic colorectal cancer. Design: This study involves left-sided wild-type and right-sided or RAS-mutant patients who will receive different combinations of Toripalimab, targeted therapy, chemotherapy, and radiotherapy, with specific treatment regimens for each cohort. The primary endpoints include PFS, ORR, OS, and safety.

Primary Outcome Measures: PFS, Progression Free Survival, 2 year
Secondary Outcome Measures: OS, Overall Survial, 2 year|ORR, Objective Response Rate, 2 year|Incidence of Side Effect, Side Effect, 2 year
Comparison Between PEEK With Autogenous Bone Graft and PEEK With Xenograft in Maxillary Sinus Augmentation
NCT Number: NCT06521853
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Maxillary Sinus
Interventions: OTHER: PEEK With Autogenous Bone Graft|OTHER: PEEK With Xenograft
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2023-06-01
Completion Date: 2024-09-01
Locations: Faculty of dentistry Cairo university, Cairo, 14444, Egypt

Summary:
Comparison Between PEEK With Autogenous Bone Graft and PEEK With Xenograft in Maxillary Sinus Augmentation

Primary Outcome Measures: bone height, using CBCT in mm, after 6 months
Secondary Outcome Measures: bone quality, core biopsy (Histomorphometric evaluation), after 6 months
Non-invasive Point-Of-Care Hemoglobin Testing In An Obstetric Population
NCT Number: NCT06521840
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pregnancy Anemia
Interventions: DEVICE: Masimo RAD 67
Sponsor: Beth Israel Deaconess Medical Center
Sex: FEMALE
Age: ADULT
Enrollment: 125
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2026-08
Locations: Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02115, United States

Summary:
Anemia is common during pregnancy due to increased metabolic rate and normal physiologic changes associated with pregnancy. Anemia during pregnancy has been associated with increased of adverse outcomes during delivery and the postpartum period. Currently, it is recommended to screen for anemia at three pre-specified points during routine prenatal care, typically 3 months apart. This screening method may miss patients who develop anemia between these intervals and lead to a delay in diagnosis and treatment.

MasimoTM has developed a non-invasive device that can detect anemia without a blood draw. This device has not been extensively studied in pregnant patients. The aim of this study is to determine the agreement in hemoglobin readings between the non-invasive device and the standard of care blood draws in pregnant patients.

Primary Outcome Measures: Hemoglobin (g /dL) Accuracy of Masimo RAD 67, Performance will be determined by calculating mean difference and repeatability analysis through the comparison of the hemoglobin values obtained from Masimo RAD67 to the hemoglobin values obtained from a reference phlebotomy sample collected at the same time., At time of phlebotomy
Secondary Outcome Measures: Hemoglobin (g /dL) Accuracy of Masimo RAD 67 stratified by skin tone, Performance will be determined by calculating mean difference and repeatability analysis through the comparison of the hemoglobin values obtained from Masimo RAD67 to the hemoglobin values obtained from a reference phlebotomy sample collected at the same time stratified by skin color using a validated scale. Monk, Ellis. "The monk skin tone scale." (2019)), At time of phlebotomy|Hemoglobin (g /dL) Accuracy of Masimo RAD 67 stratified by gestational age, Performance will be determined by calculating mean difference and repeatability analysis through the comparison of the hemoglobin values obtained from Masimo RAD67 to the hemoglobin values obtained from a reference phlebotomy sample collected at the same time stratified by gestational age., At time of phlebotomy
The Role of Short Course of Palliative Radiation in Metastatic Cancer Rectum
NCT Number: NCT06521827
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metastatic Cancer Rectum
Interventions: RADIATION: short course radiotherapy
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 49
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-12

Summary:
Short-course radiotherapy (SCRT), which allows the delivery of 25 Gy in five daily fractions, has emerged as an attractive strategy for rectal cancer treatment. Surgery can safely be deferred after SCRT, allowing an opportunity to deliver chemotherapy (ChT) preoperatively rather than postoperatively. In cases of metastatic disease, this represents an effective treatment option to improve local control and avoid colostomy in a subset of patients.

Primary Outcome Measures: The role of short course of palliative radiation in metastatic cancer rectum., The role of short course of palliative radiation in metastatic cancer rectum., one year
Globus Reflect Tether - HUD
NCT Number: NCT06521814
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Scoliosis Idiopathic
Interventions: PROCEDURE: REFLECT scoliosis correction system
Sponsor: Medical University of South Carolina
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2033-08-01

Summary:
The purpose of this device is to treat children and adolescents with scoliosis who have growth remaining. In patients with a curvature about the spine, Reflect holds the convexity of the curve in place so that the concavity can grow, thereby harnessing the power of normal spine growth to correct the deformity.

Primary Outcome Measures: Cobb angles, Decrease in cobb angles for patients who are actively still growing, Until patients reach the age of 18
Cardio-Renal Registry
NCT Number: NCT06521801
Acronym: BHCRR
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: End Stage Renal Disease|Cardio-Renal Syndrome|Myocardial Infarction|Cerebrovascular Accident|Percutaneous Coronary Intervention|Dialysis
Interventions: OTHER: Observation
Sponsor: Queen Mary University of London
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2029-06-01
Locations: Barts Health NHS Trust, London, EC1A 7BE, United Kingdom

Summary:
Cardiovascular disease is the leading cause of morbidity and mortality among patients with chronic kidney disease (CKD). Even after adjustment for known cardiovascular risk factors, including diabetes and hypertension, mortality risk progressively increases with worsening CKD. As glomerular filtration rate (GFR) declines the probability of developing coronary artery disease (CAD) increases linearly, and patients with GFR \<60 mL/min/1.73 m2 have 2-3-fold increased CV mortality risk, relative to patients without CKD. Management of CAD is complicated in CKD patients due to the likelihood of comorbid conditions and potential for side effects. Despite their high cardiovascular risk, ACS patients with renal dysfunction are less commonly treated with guideline-based medical therapy and are less frequently referred for coronary revascularisation. This observation, referred to as the "treatment risk paradox," has been well described and may be explained by physicians' concerns regarding possible nonrenal side effects as well as renal toxicities. Furthermore, patients with severe CKD have traditionally been under-represented in most large cardiovascular clinical trials. Therefore, recommendations for both medical and revascularisation of CAD have relied heavily on extrapolation of results from the non-CKD population.

This data will add to that literature by assessing the characteristics and outcomes of patients with CAD and CKD. It will also identify and characterise predictors of outcomes, improve risk stratification and diagnostic evaluation.

Primary Outcome Measures: Mortality, 30 days and 1 year|Re-admission rates, 30 days and 1 year|Major Adverse Cardiac Events, 30 days and 1 year|Major Adverse Kidney Events, 30 days and 1 year
Artificial Intelligence Assisted Breast Ultrasound in Breast Cancer Screening
NCT Number: NCT06521788
Acronym: AIBU
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer|Screening
Interventions: DEVICE: AI-assisted breast ultrasound|DEVICE: Routine breast ultrasound
Sponsor: Fudan University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 21790
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2020-09-01
Completion Date: 2023-12-31
Locations: Maternal and Infant Healthy Centre of Hongkou District, Shanghai, Shanghai, Shanghai, 200086, China|Fudan University Shanghai Cancer Center, Shanghai, China|Shanghai Pudong New Area Healthcare Hospital For Women & Children, Shanghai, China

Summary:
AIBU is a randomized, open-label study assessing the effectiveness of an articificial intelligence-assisted breast ultrasound breast cancer screening strategy compared to standard screening (according to the current local guidelines in each participating area) in detecting late-stage breast cancers.

Primary Outcome Measures: Incidence rate of early breast cancer in each arm, Early cancers should meet any of the following criteria at the time of diagnosis: less than 20 milimeters in diameter, no metastatic lymph nodes in the axilla, no distant metastasis, non-invasive cancers, stage 0, stage I, and stage IIa IIb (T2N1M0) breast cancer according to American Joint Committee on Cancer (AJCC) 8th staging., 4 years
Secondary Outcome Measures: Sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods, A true-positive screening result (sensitivity) was a positive result in a participant who was diagnosed with breast cancer by further diagnostic work-up. A false-positive screening result was a positive result in the absence of breast cancer. A true-negative screening result (specificity) was a negative result in the absence of breast cancer and a false-negative test result was a negative result followed by diagnosis of interval cancer., 4 years
An Investigational Scan (Ga-68 PSMA-11 PET/CT) for the Detection of Therapy Response in Patients With Metastatic Adenoid Cystic Carcinoma
NCT Number: NCT06521775
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Metastatic Adenoid Cystic Carcinoma
Interventions: PROCEDURE: Computed Tomography|OTHER: Electronic Health Record Review|DRUG: Ga-68 PSMA-11|PROCEDURE: Positron Emission Tomography
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-10
Completion Date: 2025-08-10
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
This phase II trial tests whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful for detecting therapy response in patients with adenoid cystic carcinoma (salivary gland cancer) that has spread from where it first started (primary site) to other places in the body (metastatic). The PET scan detects and takes pictures of where the radioactive imaging agent (68Ga PSMA-11) has gone in the body and the CT scan uses x-rays to create images of the bones and internal organs within the body. Combining a PET scan with a CT scan can help make the images easier to interpret. This study may help researchers learn whether GA-68 PSMA-11 PET/CT is useful for detecting treatment response and guiding treatment decisions in patients with metastatic adenoid cystic carcinoma.

Primary Outcome Measures: Treatment response assessment (Feasibility), Data from the prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computerized tomography (CT) exams will be categorized into treatment response categories for each participant using the Response Evaluation Criteria in PSMA PET/CT (RECIP) 1.0 criteria. Tumor volume with PSMA expression on PET/CT will be quantified using MIM Software Version 7.2.7., Up to 20 weeks|Response assessment category and percent change in tumor volume, Will be correlated to percent change in serial PSMA extracellular vesical (EV) from serum measurements from participant data obtained in the MC200708 trial protocol. For continuous measurements (like percent change), scatter plots and simple linear regression will be conducted. Associations of these continuous variables will be done via the Spearman's rank correlation coefficient. For assessment of changes, will use Wilcoxon Signed-Rank test. For any associations of categorical variables, will use the Fisher's Exact test., Up to 20 weeks|Incidence of adverse events, Will be assessed by the number of adverse event incidents reported. Safety will be categorized using the the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., Up to 20 weeks
Secondary Outcome Measures: Percentage change of mean standardized uptake value (SUV) of index lesions, Will be correlated with percentage change in PSMA EVs., Up to 20 weeks|Percentage change of PSMA-avid tumor volume, Will be assessed on PET correlated with percentage change in PSMA EVs., Up to 20 weeks
Universal Stylet Bougie in Patients With Cervical Neck Immobilization.
NCT Number: NCT06521749
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Universal Stylet Bougie
Interventions: DEVICE: USB as a stylet|DEVICE: USB as a bougie
Sponsor: Theodor Bilharz Research Institute
Sex: ALL
Age: ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-03-01
Completion Date: 2024-07-15
Locations: Theodor Bilharz Research Institute, Giza, 02, Egypt

Summary:
In patients with cervical spine injury, securing the airway while adequately immobilizing the cervical spine to avoid secondary neurological damage is very challenging. Although awake fiber-optic intubation is the most reliable method in patients with cervical trauma, it has some limitations such as lack of availability, need for expertise in the use, difficulty with non-cooperative patients, or presence of blood or secretions in the airway. Two devices are commonly used to facilitate tracheal intubation: a stylet or a tracheal tube introducer ("bougie").

Primary Outcome Measures: Time required for intubation., 30 seconds - 2 minutes
Secondary Outcome Measures: number of attempts, 30 seconds to 2 minutes
Effects of Minimal-Flow Sevoflurane and Multimodal Analgesia in Head and Neck Cancer Surgery
NCT Number: NCT06521697
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Head and Neck Cancer|Anesthesia|Renal Protection|Acute Kidney Injury|Multimodal Analgesia
Interventions: DRUG: Multimodal analgesia using dexmedetomidine-ketamine-lidocaine mixture|DEVICE: Minimal flow sevoflurane
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-12

Summary:
This study evaluates the anesthetic-sparing and renal protection effects of minimal-flow sevoflurane anesthesia combined with multimodal analgesia using dexmedetomidine, ketamine, and lidocaine in head and neck cancer patients undergoing free flap microvascular surgery. The 2x2 factorial randomized controlled trial aims to compare sevoflurane usage and renal function changes with different fresh gas flow rates and multimodal analgesia.

Primary Outcome Measures: Sevoflurane usage (mL/h), Volatile anesthetic consumption hourly, Intraoperative period|Renal function, Changes in renal function (serum renin, AVP levels, urine KIM-1, NGAL levels), Perioperative period
Secondary Outcome Measures: Acute kidney injury, Incidence of acute kidney injury, Perioperative period|Hemodynamic stability_1, Hemodynamic stability, present as heart rate fluctuation, Intraoperative period|Hemodynamic stability_2, Hemodynamic stability, present as blood pressure fluctuation, Intraoperative period|Hemodynamic stability_3, Hemodynamic stability, present as vasoactive drug amount of usage, Intraoperative period|Postoperative analgesic effect_1, Postoperative pain scores (VAS), Perioperative period|Postoperative analgesic effect_2, Postoperative analgesic consumption, Perioperative period|Length of hospital stay, Length of hospital stay after surgery, Perioperative period|Cognitive function, Incidence of postoperative cognitive dysfunction using Confusion Assessment Method-Intensive Care Unit (CAM-ICU), Perioperative period
Translational Study of MSS, TP53 Mutation and Chromosome Instability Relationship in Endometrial Carcinoma
NCT Number: NCT06521684
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Endometrial Neoplasms|TP53 Gene Mutation|Chromosomal Instability|Microsatellite Stable Endometrial Carcinoma
Sponsor: Peking Union Medical College Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-06-01

Summary:
The objective is to understand the relationship between TP53 mutation, MSS and chromosome instability in endometrial cancer and the effect on clinical prognosis.We will collect a small amount of tumor tissue samples. NGS panel detection and WGD/AS analysis were performed on the tissue. Paracancer tissue was used as a negative control and relevant information in medical records during the operation. Then we will collect clinical diagnosis and disease information through telephone follow-up after the completion of the operation.

Primary Outcome Measures: microsatellite stability status, microsatellite stability status, 2025-06-30|TP53 mutation, TP53 mutation, 2025-06-30|Chromosomal instability, Chromosomal instability (Whole genome duplication, Aneuploidy), 2025-06-30
Secondary Outcome Measures: recurrence, disease recur, 2026-06-30
Early Migration of Internal Fixation Implants for Femoral Neck Fractures in Young Adults
NCT Number: NCT06521671
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Femoral Neck Fractures|Internal Fixation; Complications|Hip Fractures
Interventions: DEVICE: Dynaloc implant|DEVICE: Cannulated cancellous screws
Sponsor: Odense University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-08

Summary:
The goal of the clinical trial is to assess a novel implant (Dynaloc, Swemac) for internal fixation of femoral neck fractures and compare it to standard treatment with cannulated cancellous screws using AutoRSA (Radiostereometric analysis).

The main question it aims to answer is:

Is internal fixation with the novel implant consisting of three angle stable screws locked together by a plate superior to internal fixation with cancellous screws in young adults under 65 years of age?

Researchers will assess postoperative complications and functional outcomes as well as implant migration using AutoRSA.

The participants will be treated with either Dynaloc or cannulated cancellous screws and followed up at 6 weeks, 12 weeks, 6 months and 12 months.

Primary Outcome Measures: Static fracture migration, Static non-weight bearing fracture migration in a supine set-up, 12 weeks
Secondary Outcome Measures: Static fracture migration, Static non-weight bearing fracture migration in a supine set-up, 6 weeks|New mobility score, Assessment of gait. 0-9 points, Baseline, 6 weeks, 12 weeks|Modified Harris Hip Score, Measure of hip dysfunction. \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent., Baseline, 6 weeks, 12 weeks|EQ-5D-5L, Health related Quality of Life, Baseline, 6 weeks, 12 weeks|Pain VRS, Pain verbal rating scale 0-10, Baseline, 6 weeks, 12 weeks|Reoperation, Any secondary operation, 0-12 weeks|Complication, Any complication (non-union, avascular necrosis of the femoral head, fixation failure), 0-12 weeks|Mortality, Death, 0-12 weeks
Reduction of Pain in Colonoscopy - Loop First Versus Last
NCT Number: NCT06521658
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain
Interventions: PROCEDURE: Timing of retroflexion
Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2025-02

Summary:
Colonoscopy is an endoscopic examination of the colon. Colonoscopy is used to investigate medical gastroenterological diseases, as well as to investigate suspected cancer and to prevent it by identifying and removing premalignant changes - polyps (e.g., as part of the national screening program for colorectal cancer).

As part of a normal endoscopic examination, the tip of the endoscope is bent (retroflexed) to look "backward" into the rectum. This is done to better see the inside of the rectal opening. Performing such a retroflexion of the scope is often associated with discomfort/pain for the patient. It takes 5-10 seconds. There are no guidelines on when such a retroflexion should be done - at the beginning or at the end of the procedure. The aim is to investigate whether the timing of retroflexion makes a difference in the recollection of pain following the procedure. In this way, the pain of colonoscopy might be reduced in the future simply by changing the timing of the retroflexion.

The study is solely about performing this retroflexion either at the beginning or at the end of the examination. Nothing is changed in the diagnostic part of the examination.

The background of the study is a study from 2003 that shows that taking about a one-minute pause in the rectum at the end of the colonoscopy can reduce the overall pain perception of the examination. This was shown without changing the pain during the procedure and despite the fact that the examination itself was prolonged due to the intervention. This relationship is explained by studies showing that the pain experience at the end of a procedure has a greater influence than the pain experience at the beginning of a procedure on the overall pain experience.

Hypothesis: By retroflexing in the rectum first during a colonoscopy versus at the end, patients will perceive the overall procedure as less painful.

Primary Outcome Measures: Remembrance of pain, Visual Analogue Pain (VAS) score of pain. The score is from 0-100 where a smaller score means less pain., 15-60 minutes post colonoscopy
Secondary Outcome Measures: Maximal pain, A simple question on which part of the investigation is remembered as the most painful and how this is rated on a Visual Analogue Pain (VAS) scale. The VAS scale goes from 0-100 where a smaller score means less pains, 15-60 minutes post colonoscopy
Acupoint Stimulation Improves Cognition Under Hypoxia
NCT Number: NCT06521632
Acronym: TREACLE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognition
Interventions: OTHER: transcutaneous electrical acupoint stimulation
Sponsor: Zhihong LU
Sex: MALE
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2025-05-07
Locations: Xijing Hospital, Xi'an, Shaanxi, 710032, China

Summary:
Cognitive impairment is common in people who suffer from hypoxia. Acupuncture and related techniques can be used to improve hypoxia and treat cognitive impairment. In this trial the effect of transcutaneous electrical acupoint stimulation on cognitive impairment in people under hypoxia will be investigated.

Primary Outcome Measures: cognitive function measured by eye-tracking at 1 hour after hypoxia, 1 hour after hypoxia|cognitive function measured by eye-tracking at 2 hours after hypoxia, 2 hours after hypoxia
Secondary Outcome Measures: mean arterial blood pressure, starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes|heart rate, starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes|saturation of pulse oximetry, starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes|Cerebral oxygen saturation, starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes|total sleep time on the first day after hypoxia, the first day after hypoxia, in a total of 24 hours|sleep efficiency(%) on the first day after hypoxia, sleep efficiency=total sleep time/total recording time, the first day after hypoxia, in a total of 24 hours|number of awake on the first day after hypoxia, the first day after hypoxia, in a total of 24 hours|time of awake on the first day after hypoxia, the first day after hypoxia, in a total of 24 hours
Analysis of Postoperative Analgesic of Different Nerve Blocks for Total Knee Replacement Surgery
NCT Number: NCT06521619
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pain|Total Knee Replacement|Motor Function
Interventions: PROCEDURE: Femoral and sciatic nerve blocks
Sponsor: Fu Jen Catholic University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 94
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-26
Completion Date: 2024-12-26
Locations: Fu Jen Catholic University Hospital, New Taipei City, 24300, Taiwan

Summary:
This study is a retrospective analysis using the accumulated clinical database from 2017/09-2023/11 to analyze patients who underwent total knee arthroplasty and received nerve blocks. The aim is to compare the analgesic effects, incidence of nerve injury, and rate of chronic pain under different nerve block techniques.

Primary Outcome Measures: Acute postoperative pain, Acute postoperative pain, Postoperative day 0,1,2
Secondary Outcome Measures: Range of motion, Knee passive range of motion, Postoperative day 0,1,2|Analgesic consumption, PCA dose consumption, Postoperative day 0,1,2
Comparison of Temporary External Fixation and Open Reduction With Internal Fixation for the Management of Pilon Fracture: A Prospective Clinical Trial.
NCT Number: NCT06521606
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pilon Fracture
Interventions: PROCEDURE: Primary open reduction and internal fixation|PROCEDURE: Temporary external fixator
Sponsor: Kasr El Aini Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2021-01-01
Completion Date: 2024-01-01
Locations: Kasr Al Ainy-Cairo University- Faculty of Medicine, Cairo, Manial, 11956, Egypt

Summary:
Pilon fractures are among the difficult injuries to treat in orthopedic surgery. Treatment approaches should consider associated soft tissue injuries. The two main treatment modalities are a two-stage procedure (secondary open reduction internal fixation (ORIF) and primary external fixation) and one-stage ORIF. The latter is widely agreed upon in the literature. In the present study, we contrasted the outcomes of these two approaches.

Primary Outcome Measures: Primary open reduction and internal fixation, The scale includes nine items that can be divided into three subscales (pain, function and alignment). Pain consists of one item with a maximal score of 40 points, indicating no pain. Function consists of seven items with a maximal score of 50 points, indicating full function. Alignment consists of one item with a maximal score of 10 points, indicating good alignment. The maximal score is 100 points, indicating no symptoms or impairments. In the original publication, the AOFAS Ankle-Hindfoot Score was described to be used for ankle replacement, ankle arthrodesis, ankle instability operations, subtalar arthrodesis, subtalar instability operations, talonavicular arthrodesis, calcaneocuboid arthrodesis, calcaneal osteotomy, calcaneus fracture, talus fracture and ankle fractures, 6 months
Tourniquet in Total Knee Replacement Short and Long Duration: A Comparative Study
NCT Number: NCT06521593
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tourniquet Palsy
Interventions: PROCEDURE: Applying a tourniquet for either a short or long time during total knee replacement
Sponsor: Kasr El Aini Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-11-01
Completion Date: 2024-11-01
Locations: Kasr Alainy hospital, Cairo, 11765, Egypt

Summary:
Total knee arthroplasty (TKA) is an effective treatment in severe osteoarthritis. We aim to compare the advantages and disadvantages related to the duration of tourniquet application in TKA surgeries.

Primary Outcome Measures: Blood loss, We measured the intraoperative blood loss by subtracting saline volume used in washing from the whole suction volume which was added to the value resulting from subtracting dry foments weight from the wet foments weight used in managing bleeding., immediately post operative
Outcomes of Patients With Osteopetrosis Weight-bearing Bone Fractures
NCT Number: NCT06521580
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteopetrosis
Interventions: PROCEDURE: Open reduction and internal fixation
Sponsor: Kasr El Aini Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-01-01
Completion Date: 2024-06-24
Locations: Kasr Al Ainy-Cairo University- Faculty of Medicine, Cairo, Manial, 11956, Egypt

Summary:
Osteopetrosis is a rare genetic disorder characterized by the abnormal hardening and density of bones, leading to increased brittleness and susceptibility to fractures. This condition presents significant challenges in fracture management due to the altered bone architecture and compromised healing capacity. Open reduction and internal fixation (ORIF) is a common surgical technique employed to stabilize fractures, but its efficacy and outcomes in patients with osteopetrosis are not well-documented. This study aims to evaluate the clinical and radiological outcomes of ORIF in adult patients with weight-bearing bone fractures due to osteopetrosis, providing insights into the effectiveness and potential complications of this treatment approach.

Primary Outcome Measures: Bone union, We follow up the patients for bone union through radiological examination, 6 months