pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Breathing Therapy for Patients With Medically Unexplained Physical Symptoms and Dysfunctional Breathing: A Pilot and Feasibility Study
NCT Number: NCT06575920
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mind-Body Therapies
Interventions: BEHAVIORAL: Breathing excercizes
Sponsor: University of Agder
Collaborators: UiT The Arctic University of Norway|The University of New South Wales
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-10-11
Completion Date: 2024-02-14
Locations: University of Agder, Arendal, Agder, Norway

Summary:
Medically unexplained physical symptoms (MUPS) capture conditions characterized by symptoms without corresponding objective findings, such as asthenia, low back pain, fibromyalgia, irritable bowel syndrome, or chronic fatigue syndrome. In order to establish the grounds for a RCT. this pilot study aims to investigate the effectiveness and feasibility of a 5-week breathing retraining programme on patients who meet the criteria for MUPS.

Primary Outcome Measures: The 'Nijmegen Questionnaire, To detect dysfunctional breathing, Base line, end of intervention, and 3 months post-interventions|Subjective Health Complaints Inventory, Measures 29 subjective health problems., Base line, end of intervention, and 3 months post-interventions|Measure Yourself Medical Outcome Profile', measures one or two symptoms (physical or psychological), Base line, end of intervention, and 3 months post-interventions|Carbon dioxide levels, Measured through a nasal cannula with a capnograph, Base line, end of intervention, and 3 months post-interventions|Heart rate variability, Measured through Hearth Math, Base line, end of intervention, and 3 months post-interventions
Secondary Outcome Measures: Patient adherence and attrition rates, Number of patients, Base line, end of intervention, and 3 months post-interventions
Implementing Mental Health Programs Across Communities in Iowa & Indiana for Transformation
NCT Number: NCT06575894
Acronym: IMPACT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health Disorder
Interventions: BEHAVIORAL: Adapted Facilitation|BEHAVIORAL: Standard Implementation
Sponsor: Elissa Faro
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1750
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2025-07-01
Completion Date: 2029-05-01

Summary:
Depression and anxiety during and after pregnancy are common medical complications contributing to a rising maternal mortality rate. Home visiting programs can offer evidence-based interventions to improve mental health outcomes for a vulnerable pregnant population; however, barriers remain to achieving the full potential of these interventions. Our work will explore the impact of context on the implementation of a mental health intervention to provide action-based and impactful data that focuses on the lived experiences of the diverse populations served by home visiting programs in Iowa and Indiana.

Primary Outcome Measures: Adoption, Percent of home visitors who deliver Mothers and Babies intervention to program recipients, From date of recruitment assessed up to 12 months (3 months postpartum)|Fidelity, Percent of home visitors who deliver all 9 sessions of Mothers and Babies to program recipients, From date of recruitment assessed up to 12 months (3 months postpartum)
Secondary Outcome Measures: Depressive Symptoms, Program recipient scores on the Edinburgh Postnatal Depression Scale (Scores range from 0-30; a score of more than 10 suggests minor or major depression may be present.), From date of recruitment assessed up to 12 months (3 months postpartum)|Perceived Stress, Program recipient scores on the Perceived Stress Scale (Scores range from 0-40. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.), From date of recruitment assessed up to 12 months (3 months postpartum)
Defining the Risk of Ventricular Tachycardia in Genetic Cardiomyopathies
NCT Number: NCT06575881
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation|Ventricular Tachycardia|Premature Ventricular Contraction
Sponsor: Vanderbilt University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-13
Completion Date: 2029-12
Locations: Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States

Summary:
The goal of this observational study is to determine if electrophysiologic mapping and cardiac MRI can help identify patients that have genetic forms of cardiomyopathy that are at high risk for development of dangerous ventricular arrhythmias.

We aim to study:

1. the prevalence and mechanism of inducible ventricular tachycardia
2. pace-mapping to define the site of origin of ventricular arrhythmias
3. voltage mapping to define low voltage scar substrate in the basal LV to determine the risk of development of ventricular arrhythmias in patients with genetic forms of cardiomyopathy.

Participants will undergo cardiac MRI before their scheduled procedure and voltage mapping during their scheduled procedure as part of data collection.

Primary Outcome Measures: Ventricular Tachycardia Inducibility, Patients will undergo an electrophysiology study (EP study) as part of the research or clinical protocol for the procedure. Inducible VT (yes/no) with the EP study will be the primary outcome measure., During procedure
Secondary Outcome Measures: Site and Substrate of Ventricular Ectopy, Localization of ventricular ectopy or arrhythmia will be evaluated during the procedure by electoanatomic mapping, and the assessment of scar burden in this area (by voltage mapping) will be secondary outcomes for Aims 1B and 1C., During procedure
Myo-inositol During Pregnancy to Prevent Gestational Diabetes
NCT Number: NCT06575868
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnancy Related
Interventions: DIETARY_SUPPLEMENT: Myo-inositol|DIETARY_SUPPLEMENT: Myo-inositol placebo
Sponsor: Tufts Medical Center
Sex: FEMALE
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2025-01-01
Completion Date: 2027-06-30

Summary:
Myoinositol is an insulin-like compound that is present in both plant and animal cells. Humans synthesize it naturally, but it is also obtained in our diet. It works through an intracellular signaling pathway to increase insulin sensitivity. Myoinositol has been used as an over-the-counter (OTC) supplement in the management of polycystic ovarian syndrome due to this effect. Myoinositol has also been shown to improve glycemic profiles in pregnant euglycemic women and well as improve insulin sensitivity in pregnant patients with gestational diabetes mellitus (GDM).

This is a double blind RCT offering myo-inositol or placebo to those who are eligible and enrolled.

Primary Outcome Measures: Eligibility, proportion of screened women who were eligible, 1 year|Glucose levels, Average glucose levels during CGM monitoring period for those enrolled, 1 year
Comparative Effectivenes of IASTM and MET on Post Operative Elbow Stiffness
NCT Number: NCT06575855
Acronym: IASTM
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Elbow Stiffness
Interventions: OTHER: IASTM|OTHER: METS
Sponsor: University of Faisalabad
Collaborators: University of Sargodha
Sex: ALL
Age: ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-02-17
Completion Date: 2024-06-17
Locations: Nayyab Goher, Faisalābad, Punjab, Pakistan

Summary:
This study is basically for the evaluation of comparative effectiveness of instrument assisted soft tissue mobilization IASTM and muscle energy technique MET on Post operative , Randomized clinical trial .

Primary Outcome Measures: VAS and goniometer, Visual analog scaleThe Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain) and universal goniometer to measure the range of motion, an instrument that measures angle motion at a joint., 4 months
Secondary Outcome Measures: DASH questionaire, The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100, 4 months
Accuracy of Continuous Glucose Monitors During the Perioperative Period in Youth With Type 1 Diabetes
NCT Number: NCT06575842
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Type 1 Diabetes
Sponsor: University of Colorado, Denver
Sex: ALL
Age: CHILD, ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-21
Completion Date: 2025-09-01

Summary:
This study is assessing the accuracy of continuous glucose monitors during surgical procedures requiring anesthesia.

Primary Outcome Measures: Accuracy of CGM compared to blood glucose using standard statistical methods including mean absolute relative difference (MARD)., Accuracy assessment will be completed comparing CGM glucose values to blood glucose values using standard statistical assessments., Perioperatively
Effect of Augmented Reality on Pain, Anxiety, and Fear in Children During Blood Collection
NCT Number: NCT06575816
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain|Fear|Anxiety
Interventions: BEHAVIORAL: Augmented Reality Video Intervention
Sponsor: Dokuz Eylul University
Sex: ALL
Age: CHILD
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-03-30
Completion Date: 2024-09-02
Locations: Emine Zahide Özdemir, İzmir, 35340, Turkey

Summary:
In recent years, technological advances have enabled the development of innovative intervention methods in healthcare. This study aims to examine the effect of augmented reality (AR) technology on pain, anxiety and fear in children during pediatric blood collection procedures. The study is based on a randomized controlled design. Participants were randomized into two groups, the group receiving AR intervention and the control group receiving standard care. Pain, anxiety and fear levels will be assessed with pre and post intervention measurements.

Primary Outcome Measures: Pain Level, Children's pain levels will be measured using a standardized pain scale, such as the Wong-Baker Pain Rating Scale, immediately after the blood collection procedure.The scale can be scored from a minimum of 0 to a maximum of 10. As the score increases, pain increases., Five minutes before and 5 minutes after blood collection
Secondary Outcome Measures: Fear Level, Children's fear levels will be evaluated using a fear assessment tool, such as the Children's Fear Scale, before and after the blood collection procedure.

The scale can be scored from a minimum of 0 to a maximum of 4. As the score increases, fear increases., Five minutes before and 5 minutes after blood collection
Other Outcome Measures: Anxiety Level, Children's anxiety levels will be assessed using the State-Trait Anxiety Inventory for Children before, during, and after the blood collection procedure.The scale can be scored from a minimum of 1 to a maximum of 10. As the score increases, Anxiety increases., Five minutes before and 5 minutes after blood collection
Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems
NCT Number: NCT06575790
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 1 Diabetes
Interventions: BEHAVIORAL: Simple Meal Bolusing|BEHAVIORAL: Carbohydrate counting
Sponsor: University of Colorado, Denver
Sex: ALL
Age: CHILD, ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-09-30

Summary:
The goal of this trial is to evaluate blood sugar control in patients with type 1 diabetes when using a simple meal bolus strategy (small, medium, large meals) compared to carbohydrate counting when on a hybrid closed loop system. The main question it aims to answer are:

What is the blood sugar time in range when using simple meal boluses versus carbohydrate counting?

Participants will:

Use the simple meal bolus plan for 4 weeks. Do precise carbohydrate counting for 4 weeks. Provide their continuous glucose monitor and pump data Take surveys about the experience of meal bolusing during the study

Primary Outcome Measures: Time in Range, % of time sensor glucose values are between 70-180 mg/dL, Measured during the duration of the study period, up to 12 weeks
Secondary Outcome Measures: Hypoglycemia, Percentage of time with BG \<70 mg/dL and \<54 mg/dL as reported by CGM, Measured during the duration of the study period, up to 12 weeks|Hyperglycemia, Percentage of time with BG \>250 mg/dL as reported by CGM, Measured during the duration of the study period, up to 12 weeks|Feasibility, acceptability, and self-reported mealtime insulin bolus burden, Survey completed by participants to report on feasibility, acceptability, and self-reported mealtime insulin bolus burden using the different mealtime bolus strategies, Given 3 times during the duration of the study period, up to 12 weeks
The Heart Priority Programme for Cardiac Patients at Risk of Dropout From Cardiac Rehabilitation
NCT Number: NCT06575764
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Coronary Syndrome
Interventions: OTHER: The Heart Priority Programme
Sponsor: Defactum, Central Denmark Region
Collaborators: University of Aarhus|Aarhus Municipality, Denmark|Viborg Municipality, Denmark|Ringkøbing-Skjern municipality, Denmark
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 260
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-01-08
Completion Date: 2025-01-31
Locations: Aarhus Municipality, Aarhus, 8000, Denmark|Ringkøbing-Skjern Municipality, Ringkøbing, Denmark|Viborg Municipality, Viborg, Denmark

Summary:
The goal of this study is to develop The Heart Priority programme, a supplement to standardised cardiac rehabilitation (CR) aimed at identifying and supporting cardiac patients at risk of dropout due to being in a vulnerable situation. Additionally, the study aims to test the programme through a feasibility study.

The programme comprises two main parts: 1) an evidence-based identification form to identify patients at risk of dropout from CR due to being in a vulnerable situation and 2) an add-on intervention targeted these patients.

The study will be guided by the Medical Research Council's framework for developing and evaluating complex interventions (MRC). The development follows an iterative three-stage process guided by the framework for co-producing and prototyping of healthcare interventions. Stage 1 is preparation by considering the knowledgebase. Building on this knowledge, stage 2 and 3 includes a co-production and prototyping process, aiming to develop, field test and adapt the programme, deemed ready for feasibility testing.

The feasibility study will be designed as a single-arm follow-up study conducted in two community health care centres in Denmark. Process data will be collected continuously over a six-months period and at the study's conclusion, focussing on three dimensions: implementation (reach and fidelity), acceptability, and mechanism of impact.

Primary Outcome Measures: Implementation (reach and fidelity), Evaluate: 1)The extent to which the target group encounters the programme (reach) and 2) Whether the programme was delivered as intended (fidelity), Six months
Secondary Outcome Measures: Acceptability, Evaluate the CR teams' view on the programme, Six months|Mechanisms of impact, Evaluate how the CR teams respond to and interact with the programme, Six months
Rectus Sheath Block for Analgesia After Gynecological Laparotomy
NCT Number: NCT06575699
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Gynecologic Surgical Procedures
Interventions: PROCEDURE: Rectus sheath block|PROCEDURE: Thoracic Epidural Analgesia|DRUG: Liposomal bupivacaine|DRUG: Bupivacaine Hydrochloride|DRUG: Bupivacaine-Hydromorphone Cassette
Sponsor: Duke University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2025-12

Summary:
Thirty subjects undergoing laparotomy for Gynecologic oncology surgery will be prospectively enrolled and will receive a bilateral rectus sheath block (RSB) under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side. Cases will be matched in a 1:2 ratio by age, race, insurance status and duration of surgery with historical controls who received postoperative analgesia using thoracic epidural analgesia.

Primary Outcome Measures: Postoperative opioid consumption 0- 72 hours after surgery, 0-72 hours after time 0 (end of surgery)
Secondary Outcome Measures: Total postsurgical opioid consumption at 0-24, 24-48, and 48-72 hours, 0-24 hours, 24-48 hours and 48-72 hours after time 0 (end of surgery)|Number of patients with intraoperative hypotension, Intraoperative|Number of patients with postoperative hypotension, 0-72 hours after time 0 (end of surgery)|Number of patients receiving rescue antiemetics, 0-72 hours after time 0 (end of surgery)|Number of patients receiving rescue antipruritics, 0-72 hours after time 0 (end of surgery)|Number of patients developing ileus or constipation, 0-72 hours after time 0 (end of surgery)|Number of patients with respiratory Depression, 0-72 hours after time 0 (end of surgery)|Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores through 72 hours (AUC0-72), Visual analog scores 0-10 (0=no pain, 10=worst possible pain), 0-72 hours after time 0 (end of surgery)|Maximum pain scores reported, Visual analog scores 0-10 (0=no pain, 10=worst possible pain), 0-72 hours after time 0 (end of surgery)|Time to mobilization, 0-72 hours after time 0 (end of surgery)|Time to urinary catheter removal, 0-72 hours after time 0 (end of surgery)|Duration of post anesthesia care unit (PACU) stay, 0-6 hours after time 0 (end of surgery)|Duration of hospital stay, 0-10 days after surgery|Number of patients receiving intraoperative vasopressors, Intraoperative
Other Outcome Measures: Complications related to rectus sheath block or epidural analgesia, Inadvertent dural puncture, postdural puncture headache, need to discontinue epidural due to hypotension, epidural hematoma., 0-72 hours after time 0 (end of surgery)
Exercise Therapy on Rheological Functions of Erythrocyte in Hemodialysis
NCT Number: NCT06575634
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemodialysis Complication
Interventions: BEHAVIORAL: Supervised exercise training
Sponsor: Chang Gung Memorial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-08-01
Completion Date: 2025-07-31
Locations: Chang Gung University, Taoyuan, 333, Taiwan

Summary:
To improve aerobic capacity, muscular function, and health-related quality of life in patients with end-stage renal disease (ESRD), regular exercise is recommended. Supervised intradialytic exercise at moderate intensity is a viable approach to ensure patient safety, maintain compliance, and effectively enhance physiological adaptations. However, the impact of exercise training on erythrocyte rheological properties in ESRD patients, such as red blood cell deformability, aggregation, and oxygen transport capacity, remains unclear.

Method: ESRD patients (anticipated n=180) will undergo supervised exercise training therapy three times per week for six months in the hospital, followed by three months at home. Cardiopulmonary exercise tests will be conducted before and after the intervention. Erythrocyte deformability and aggregation will be assessed using a laser-assisted optical rotational cell analyzer (LORCA), while additional protein levels and reactive oxygen species (ROS) status will be measured using a flow cytometer. This will help determine how exercise affects the rheological properties of red blood cells in this population.

Primary Outcome Measures: Deformability of erythrocytes, Red blood cells (RBCs) deformability refers to the cells' ability to adapt their shape to the dynamically changing flow conditions so as to minimize their resistance to flow., 9 months|Aggregation of erythrocytes, Erythrocyte aggregation is the reversible clumping of red blood cells (RBCs) under low shear forces or at stasis., 9 months
Secondary Outcome Measures: Cardiopulmonary fitness, ESRD patients performed cardiopulmonary exercise testing (CPET) to assess their aerobic capacity. CPET composed of continuous workload increment of 10 W/min until exhaustion (usually within 8-12 minutes). Oxygen consumption, carbon dioxide production, ventilation, respiratory rate would be recorded., 9 months|Quality of life in ESRD patients, The investigators would use a qusionnaire, The Kidney Disease Quality of Life 36-item short form survey (KDQOL-36), to record and scale the qulaity of life in ESRD patients. The KDQOL-36 (Kidney Disease Quality of Life 36-Item Short Form Survey) measures the quality of life in kidney disease patients. It uses a score range from 0 to 100, where higher scores indicate better quality of life and lower scores indicate worse outcomes. Ensure to note this when reporting results to clarify that higher scores reflect fewer symptoms and better overall well-being., 9 months
Estimation of VO2Max Using Smartphone Application
NCT Number: NCT06575608
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Assessmet of VO2max in Elderly
Sponsor: Cairo University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 52
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-12
Completion Date: 2025-04

Summary:
The aim of this observational study Is to examine the validity of the Smartphone application (VO2max calculator) in calculating VO2max in elderly population.

Research hypotheses:

this study will test the following null hypothesis: (Vo2max calculator) application will not have criterion validity in estimating VO2max values in the elderly population.

Research question:

Is the Smartphone application (VO2max calculator) considered a valid tool for estimating accurate values of VO2max in the elderly population in comparison to the golden standard method?

Primary Outcome Measures: maximum oxygen consumption (VO2MAX), The greatest amount of oxygen a person can take in from inspired air while performing dynamic exercise involving a large part of total muscle mass., at the peak of exercise (peak VO2) over the final 30 seconds of exercise
Secondary Outcome Measures: Heart rate (HR), the number of times your heart beats per minute., at baseline one shot|The Borg rating of perceived exertion (RPE) scale, It is a subjective scale for estimating effort and exertion, breathlessness, and fatigue during physical work., at baseline one shot
Effect of HIIT on Cardiopulmonary Function After PCI in Patients With Coronary Heart Disease
NCT Number: NCT06575569
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Heart Disease
Interventions: BEHAVIORAL: high-intensity interval training|BEHAVIORAL: Moderate-intensity continuous training
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-06-17
Completion Date: 2025-04-17
Locations: Department of Cardiology ,the First Affiliated Hospital of Nanjing Medical University, Nanjing, China

Summary:
Both the gut microbiome and exercise are closely related to human health, but the understanding of the effect of high-intensity interval training (HIIT) on cardiopulmonary function and human intestinal flora is still further study.

Primary Outcome Measures: Gut microbiome, Fecal DNA isolation was performed using the QIA amp Fast DNA Stool Mini Kit. After DNA extraction, fecal DNA was used for library preparation, and whole-genome shotgun sequencing was performed on the Illumina NovaSeq-6000 plat- form. From the raw metagenomic sequencing data, low-quality reads were discarded by the sequencing facility, and reads belonging to human contaminations were removed by mapping the data to the reference genomes using Bowtie2 (RRID:SCR _ 016368 ; v2.4.5). After filtering, on average, 54.8 million (SD = 14.7 million) paired reads per sample were obtained for subsequent analysis., 12 weeks|Plasma metabolite Traumatic acid, Plasma, 12 weeks|6MWT, 6-minute walk test, 12 weeks|VO2peak, CPET, 12 weeks
Validation of MRI Instead of CT to Follow-up Ross Procedure With Loose Jacket Technique
NCT Number: NCT06575556
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiac Imaging
Interventions: DIAGNOSTIC_TEST: Cardiac CT and MRI
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2025-07
Locations: Aswan Heart Centre (Magdi Yacoub Foundation), Aswan, 1242770, Egypt

Summary:
Patients who underwent Ross procedure with loose jacket technique will be enrolled in this study and undergo CT and MRI follow-up to compare between both modalities.

Primary Outcome Measures: Accuracy of MRI measurements in comparison to CT using statistical analysis., We will use bland altman plots to visualize the degree of agreement between the two raters and identify any systematic bias. The closer the difference to zero, the better., 1 year
Secondary Outcome Measures: The largest diameters of each aortic structure, The largest diameters of each aortic structure will be re-calculated as z-scores. In our study, "significant dilatation of the aortic structures" is defined as 95% confidence interval (z-score≥2) in diameter of each aortic structures., 1 year
CT Evaluation of ACL Anatomical Reconstruction
NCT Number: NCT06575543
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: ACL Tear
Interventions: RADIATION: CT
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 72
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-10
Locations: Assiut University, Assiut, Egypt

Summary:
Our research is to evaluate the position and length of femoral tunnel, and to examine whether knee stability and clinical functional outcomes are better while using two-portal or three-portal technique .

Primary Outcome Measures: Ct evaluation, 3D CT scan have been used to evaluate the tunnels location after ACL reconstruction, as they can provide excellent perspective of the tunnel aperture, good visualization of bony structure and shape of the intercondylar notch, that preclude the use of a conventional 2-dimensional CT scan for measurement of the ACL tunnels location, 1 day after surgery
Secondary Outcome Measures: Clinical Examination &amp;amp; Functional scores, - KOOS ( Knee Injury \&amp;amp; Osteoarthritis Outcome ) The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved., at least 2 years after surgery
A Multifaceted Intervention to Improve Bleeding Management Among Patients Using Oral Anticoagulants (IMPACT-BLEEDING)
NCT Number: NCT06575517
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bleeding
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 168
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2025-09-30

Summary:
Prospective, cluster randomized trial including expected 168 patients with chronic use of oral anticoagulation (OAC) suffering major bleeding. Randomization will be performed stratified by geographic region (Southern/Southeastern Brazil versus other Brazilian regions).

Primary Outcome Measures: Proportion of patients adherent to a predefined checklist for optimal bleeding management strategies, This checklist will involve proper use of blood products; proper use of reversal agents; proper dose adjusting and timing of restart of anticoagulation., 2 months
Ultrasonographical of Suprarenal Gland in High Risk Neonates
NCT Number: NCT06575504
Acronym: USSGneonates
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Insuffeciency of the Suprarenal Gland
Interventions: DIAGNOSTIC_TEST: Ultrasonographical examination
Sponsor: Al-Azhar University
Sex: ALL
Age: CHILD
Enrollment: 105
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-15
Completion Date: 2024-08-15
Locations: Faculty of medicine for girls, Cairo, Pediatrics/neonatology, 11351, Egypt

Summary:
Observation study The aim is to study the suprarenal blood flow among high-risk neonates and its relation to the risk factors

Primary Outcome Measures: Adrenocortical insufficiency, Blood flow velocity RI ED TMAX, 12 months
Ultrasound Guided Supraclavicular and Infraclavicular Subclavian vs Catheterization in Pediatric
NCT Number: NCT06575491
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ultrasound Guided|Supraclavicular|Infraclavicular|Subclavian|Venous Catheterization|Pediatric
Interventions: DEVICE: Ultrasound-guided supraclavicular approach|DEVICE: Ultrasound-guided infraclavicular approach
Sponsor: Al-Azhar University
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2023-09-01
Completion Date: 2024-06-01
Locations: Al-Azhar University, Cairo, 11796, Egypt

Summary:
The aim of this study was to compare between ultrasound-guided supraclavicular and infraclavicular approaches for subclavian venous catheterization in pediatric to get clinical practice of rapid, accurate central venous catheter, insertion and less Complications.

Primary Outcome Measures: Puncture time, Puncture time was recorded., Interoperatively
Secondary Outcome Measures: Total access time, Total access time was recorded, Interoperatively|First attempt success rate, First attempt success rate was recorded, Interoperatively|Quality of needle visualization, Quality of needle visualization was recorded, Interoperatively|Incidence of complication, Incidence of complication was recorded such as complication rates.failure rate haematoma, pneumothorax, 24 hours postoperatively
Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Drug Naive Type 2 Diabetes Patients
NCT Number: NCT06575478
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diabetes Mellitus, Type 2|Diabetes|Type2diabetes
Interventions: DRUG: Fuling Yunhua Granules|DRUG: Fuling Yunhua Granules matched placebo|DRUG: Dihuang Baoyuan Granules|DRUG: Dihuang Baoyuan Granules matched placebo
Sponsor: Beijing Supreme Life Pharmaceutical Technology Co., Ltd.
Collaborators: Peking University People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2025-01-30
Locations: Peking University People's Hospital, Beijing, China

Summary:
The goal of this investigator-initiated clinical trial is to investigate the efficacy and safety of sequential therapy of Fuling Yunhua Granules (prescription A) and Dihuang Baoyuan Granule (prescription B) in the treatment of type 2 diabetes patients with poor glycemic control after diet and exercise intervention.

Primary Outcome Measures: Change in HbA1c concentrations (%) from baseline, Change in HbA1c concentrations (%) from baseline, 12 weeks
Secondary Outcome Measures: Change in FPG (mmol/L) from baseline, Change in FPG (mmol/L) from baseline, 12 weeks|The proportion of participants who achieved HbA1c target, The proportion of participants who achieved HbA1c target (HbA1c\<7.0% and \<6.5% Patient percentage), 12 weeks|Changes in TIR from baseline, Changes in TIR from baseline, 7 days|Changes in TBR from baseline, Changes in TBR from baseline, 7 days|Changes in TAR from baseline, Changes in TAR from baseline, 7 days|Changes in MAGE from baseline, Changes in MAGE from baseline, 7 days|Changes in fasting lipid profiles, Changes in fasting lipid profiles from baseline(mmol/L), 12 weeks|Change in weight, Change in weight from baseline(kg), 12 weeks
An Observational Study of Predictors and Outcomes of Lung Cancer in Never-smokers in the UK
NCT Number: NCT06575439
Acronym: OLIVE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer
Sponsor: University College London Hospitals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 225
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2029-09

Summary:
The goal of this observational study is to improve the early detection of lung cancer in adults who have smoked less than 100 tobacco cigarettes ("never-smokers") in the United Kingdom. The main questions it aims to answer are:

* To describe characteristics such as demographics, co-morbidities and environmental exposures
* To describe participant pathways including presentation mode and symptoms to understand if earlier diagnosis would be possible
* To describe participant outcomes such as cancer stage, treatment and mortality
* To quantitatively or qualitatively measure modifiable and non-modifiable factors that may be associated with LCINS including environmental measures, blood tests and genomic data.

Participants will currently have no change to their usual care.

Primary Outcome Measures: Demographics, comorbidities and environmental exposures of participants, From review of electronic health records, Comorbidities and environmental exposures at diagnosis (approximately up to 156 weeks prior to diagnosis)|Participant pathways including presentation mode and symptoms, From review of electronic health records, Presentation mode and symptoms at time of diagnosis (approximately up to 52 weeks prior to diagnosis)
Secondary Outcome Measures: Participant outcomes such as cancer stage, treatment, mortality, From review of electronic health records, Cancer stage at time of diagnosis, treatment and mortality through study completion (likely 5 years)|Measurement of modifiable and non-modifiable factors associated with LCINS, To be determined, Through study completion (likely 5 years)
Investigating the Role and Electrophysiological Characteristics of the Human Claustrum Based on SEEG
NCT Number: NCT06575413
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Refractory Epilepsy|Consciousness, Loss of
Interventions: OTHER: Direct Electrical Stimulation
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-27
Completion Date: 2025-05-01
Locations: Xuanwu Hospital,Capital Medical University, Beijing, Beijing, 100053, China

Summary:
This single-center prospective study aims to investigate the electrophysiological characteristics and functions of the human claustrum by analyzing clinical, imaging, and electrophysiological data from 14\~65-year-old patients with drug-resistant epilepsy.

Primary Outcome Measures: Patients Clinical responses Rating, Researchers categorized patients' clinical responses as normal, mild, moderate, or severe based on their subjective clinical response., During the trial(up to 3 hours for each subject)|EEG power in spectral frequency bands, Using SEEG-implanted electrodes, the investigators applied electrical stimulation of varying intensities to the CLA while observing and recording EEG power changes across six spectral frequency bands during the pre-stimulation, stimulation, and post-stimulation periods.

EEG Frequency Bands

* delta (1-4 Hz)
* theta (5-8 Hz)
* alpha (9-12 Hz)
* beta (13-30 Hz)
* low gamma (31-70 Hz)
* high gamma (71-150 Hz), During the trial(up to 3 hours for each subject)|The root mean square (RMS) value of Claustrum-Cortical Evoked Potentials, All cortical-evoked responses were averaged by time-locking the recordings to the onset of each electrical stimulus (zero) off-line, within a time window of -200 to +400 mses, to quantify the morphology.

The N1 peak, identified as the first negative deflection distinguishable from the stimulus artifact, was the primary focus due to its clear visibility and reproducibility across different stimulations.

The root mean square (RMS) value will be calculated for different cortical locations during time windows that encompass both the N1 peak(early response time time window) and the baseline.

A paired one-sample t-test will be used to compare the RMS values in the early response time window across different cortical sites with the RMS values in the baseline., During the trial(up to 3 hours for each subject)
A Study to Test How Well Different Doses of BI 3804379 Are Tolerated by Healthy People
NCT Number: NCT06575400
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: BI 3804379|DRUG: Placebo matching BI 3804379
Sponsor: Boehringer Ingelheim
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 106
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-10
Completion Date: 2025-10-09

Summary:
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PKs) of BI 3804379 in healthy male and female subjects following administration of single rising doses and administration of multiple rising doses.

Primary Outcome Measures: SRD part and MRD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator, Up to Day 84 for SRD part and up to Day 168 for MRD part.
Secondary Outcome Measures: SRD part: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity), Up to Day 84.|SRD part: Cmax (maximum measured concentration of the analyte in plasma), Up to Day 84.|MRD part: AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ), Up to Day 168.|MRD part: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ), Up to Day 168.
The Utility of Partogram in Management
NCT Number: NCT06575387
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Labor Onset
Interventions: PROCEDURE: Partogram
Sponsor: Egymedicalpedia
Collaborators: Al-Azhar University
Sex: FEMALE
Age: ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-09-01
Completion Date: 2024-09-10
Locations: Al-Azhar University hospitals, Assiut, Egypt

Summary:
The partograph serves as "early warning system" and it has shown to be effective in preventing prolonged labour, in reducing operative interventions and in improving the neonatal outcome.

"A picture is worth a thousand words". A partograph review if well recorded provides rapid and comprehensive information about progress of labour when compared with a review of detailed handwritten case sheets. Partograph is a Latin/Greek hybrid word synonymous with parturition recorded in a graphic form.

Primary Outcome Measures: Mode of Delivery, The mode of delivery was assessed by the condition of the mother and the fetus by BISHOP score (The Bishop score is a cervical assessment system used to predict the success of labor induction. This scoring system evaluates several clinical parameters of the cervix, including dilation, effacement, position, consistency, and the fetal head's station in the pelvis)., 24 hours
Open Label Single Arm Pilot Trial of Letermovir for Cytomegalovirus Prophylaxis After Axicabtagene Ciloleucel Therapy
NCT Number: NCT06575374
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cell Therapy
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-31
Completion Date: 2027-08-01

Summary:
The goal of this clinical research study is to learn if a drug called Letermovir can help to prevent CMV reactivation.

Primary Outcome Measures: Safety and Adverse Events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year
Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis
NCT Number: NCT06575361
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostate Cancer
Interventions: DIAGNOSTIC_TEST: Combination of targeted biopsy and systematic biopsy
Sponsor: Peking University First Hospital
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-01-01
Completion Date: 2025-05-01
Locations: Peking University First Hospital, Beijing, Beijing, 100034, China

Summary:
The goal of this real-world prospective diagnostic study is to comprehensively evaluate the value of MRI artificial intelligence (MRI-AI) in assisting the diagnosis of prostate cancer (PCa). The main questions it aims to answer are:

Does MRI-AI promote the accurate diagnosis and treatment of prostate cancer? What's the capability of prostate MRI-AI in calculating the prostate volumn? What's the value of prostate MRI-AI assistant diagnosis system in detecting the suspicious lesions on MRI and guiding prostate targeted biopsy? What's the value of prostate MRI-AI assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? Researchers will compare the cancer detection rates of suspicious lesions detected by MRI-AI and senior radiologists.

Participants will:

Receive combination of systematic biopsy and targeted biopsy.

Primary Outcome Measures: The clinically significant prostate cancer (csPCa) detection rate for suspicious lesions found by MRI-AI and urogenital radiologists, csPCa was defined as PCa with a grade group \> 2 or GS ≥ 7. The reference standard was the pathological results of targeted biopsies for the suspicious lesions., One month after the biopsy procedure.
Secondary Outcome Measures: The PCa detection rate, The PCa detection rate for the suspicious lesions found by MRI-AI and urogenital radiologists., One month after the biopsy procedure.|The Gleason score (GS) of the biopsy sample, The Gleason score was reported by senior uropathologists according to the Standards of Reporting for MRI Targeted Biopsy Studies (START) criteria and interpreted according to the recommendations of the International Society of Urological Pathology (ISUP) Grade Group., One month after the biopsy procedure.|The GS of radical prostatectomy (RP) specimens, The overall grade was assigned based on the part with the highest Gleason score according to the recommendations of the ISUP., One month after the biopsy procedure.
Triphala Tooth Wipes in Reduction of Streptococcus Mutans Colonies
NCT Number: NCT06575335
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Plaque Control
Interventions: OTHER: Triphala Tooth Wipe|OTHER: Chlorhexidine Tooth Wipe
Sponsor: Dow University of Health Sciences
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2025-10

Summary:
This double-blind randomized clinical trial will be conducted among differently abled institutionalized children. Sixty participants aged 6-12 years with mild intellectual disability (ID) will be enrolled in the study and divided into two treatment groups. The participants will be allocated in either of the two treatment arms through Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) by the principal investigator. One group will receive triphala tooth wipes and the other will be given chlorhexidine tooth wipes, both for 7 days twice a day. Supragingival plaque sample will be collected from the buccal surface of the permanent maxillary first molar and will be subjected to microbial analysis for Streptococcus mutans (S. mutans) colonies using colony-forming units per millilitre (CFU/ml).

The tooth wipes will be prepared by the principal investigator under supervision of Pharmacognosist at Department of Pharmaceutics and Pharmacognosy, University of Karachi, Pakistan.

Primary Outcome Measures: Streptococcus mutans (S. mutans) count, Colony Forming Unit per millilitre (CFU/ml) classified as Class 0 (none), Class 1 (\<102), Class 2 (103-104) and Class 3 (10≥5) CFU/ml showing negligible, low, moderate and high caries susceptibility, The S. mutans count will be assessed at baseline and at day 8 of the intervention.
Secondary Outcome Measures: Plaque Index, Silness and Loe Plaque Index: The score will range from 0 to 3; 0 (excellent), 0.1-0.9 (good), 1.0-1.9 (fair), and 2.0-3.0 (poor) oral hygiene., These counts will be assessed at baseline and at day 8 of the intervention.