pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Echocardiography Versus no Echocardiography in S. Aureus Bacteraemia and VIRSTA Score < 3
NCT Number: NCT06457386
Acronym: VIRSTA-VAL
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Staphylococcus Aureus|Bacteremia|Infective Endocarditis
Interventions: PROCEDURE: systematic echocardiography|PROCEDURE: no echocardiography arm
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 700
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-12
Completion Date: 2028-12
Locations: Bichat Claude Bernard Hospital, Paris, 75018, France

Summary:
Staphylococcus aureus is the most frequent cause of both healthcare-associated and community-acquired bloodstream infections worldwide. Infective endocarditis (IE) has been detected in 5-17% of cases and is a determinant of poor prognosis. The investigators developed a score (the VIRSTA score) based on patients' characteristics to rule out IE with high confidence (negative predictive value (NPV) above 99%) in patients with SAB. This score, with a cut-off of 3 has been externally validated by two international studies which have also established its high NPV. The 2023 European society of cardiology (ESC) guidelines state that echocardiography should be considered in all patients with Staphylococcus aureus bacteremia (SAB) using risk scores (including VIRSTA score) to guide the use or not of echocardiography. While recommended, the investigators think that VIRSTA score must be evaluated in terms of patients' outcome.

Primary Outcome Measures: All causes mortality, 90 Days|SAB relapse microbiologically confirmed, Relapse of SAB is defined in patients with bacteriologic success as the isolation of a strain of Staphylococcus aureus with in vitro antibiotic susceptibility pattern similar to that of the Staphylococcus aureus strain isolated at inclusion. Relapse will be confirmed at the end of the study by an independent adjudication committee, 90 Days
Secondary Outcome Measures: Number of definite IE according to ESC 2023 criteria, An independent adjudication committee will classify definite, possible or excluded IE according to the 2023 ESC criteria, the end of hospital stay, up to 90 days|Number of definite IE according to ESC 2023 criteria, 90 Days|Number of IE valvular cardiac surgery and indications (heart failure, uncontrolled infection or prevention of embolism), the end of hospital stay, up to 90 days|Number of IE valvular cardiac surgery and indications (heart failure, uncontrolled infection or prevention of embolism), 90 Days|Length of hospitalization (days), 180 Days|All-causes mortality, 180 Days|Number of SAB relapse, 90 Days|Cost difference between the two strategies, Cost-effectiveness analysis if there is a difference in the number of events in each arm, 90 Days|quality of life measured by EQ5D5L, 180 Days
Comparison of Chitosan, Ankaferd and Tranexamic Acid in Dental Extraction in Liver Pre-Transplant Children
NCT Number: NCT06457360
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Liver Cirrhosis
Interventions: DRUG: tranexamic acid|DRUG: Ankaferd Blood Stopper|DRUG: Chitosan
Sponsor: British University In Egypt
Sex: ALL
Age: CHILD
Enrollment: 39
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-11-15
Completion Date: 2024-05-20
Locations: British University in Egypt, Cairo, Egypt

Summary:
The aim of the present study is:

To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases where the:

• Primary objective: is to evaluate which of the previous materials will be the most effective as a hemostatic agent

Primary Outcome Measures: To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases, evaluation of the previous materials which will be the most effective as a hemostatic agent by measuring blood loss after dental extraction after 30 minutes by the weight difference between the gauze preoperatively and postoperatively using fine electronic measurement weight device, 30 minutes
Secondary Outcome Measures: pain score assessment, Pain scores will be assessed using Visual Analog Scale (VAS) from 0 to 10 pain score for seven days following extraction, 7 days
Effect of Helicobacter Pylori Eradication on Gastroesophageal RefIux Disease (GERD)
NCT Number: NCT06457334
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: GERD
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2025-01-01
Locations: Alrajhi Hospital, Assiut, Egypt

Summary:
Evaluate the effect of H.pylori eradication on Gastroesophageal-reflux disease and symptoms improvement

Primary Outcome Measures: Eradication of Helicobacter pylori after triple therapy, H.pylori eradication will be assessed using the endoscope, 1\2024 to 12\2024|Effect of Helicobacter pylori eradication on Gastroesophageal RefIux disease (GERD) syptomes, Evaluate the effect of H.pylori eradication on Gastroesophageal-reflux disease and correlate with GERD symptoms improvement., 1\2024 to 12\2024
Compare the Agility Exercise and Resistance Exercise on Physical Function and Stability in Osteoporotic Women
NCT Number: NCT06457308
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postmenopausal Osteoporosis|Agility Exercise|Physical Function|Balance Stability|Fall Prevention
Interventions: BIOLOGICAL: Physical training of agility|BIOLOGICAL: Physical training of resistance
Sponsor: Tainan Hospital, Ministry of Health and Welfare
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2021-07-14
Completion Date: 2022-12-31
Locations: Chen, Ying-Chen, Tainan, Taiwan

Summary:
Osteoporosis weakens bones with age, increasing fracture risk. Exercise improves physical function and reduces falls, crucial for preventing osteoporotic fractures, especially with balance, resistance, and multi-component training. Agility exercise, integrating various aspects like aerobic, strength, balance, and cognitive tasks, is promising for fall prevention in older adults, though its effectiveness in osteoporosis is not extensively studied.

This study compares agility and resistance exercise impacts on physical function and balance stability in postmenopausal osteoporosis. Fifty-one women (average age: 68±6.3y, BMI: 22.3±2.7 kg/m2) were divided into agility exercise (AG), resistance exercise (RG), and control groups (CG) through purposive sampling. AG and RG received added intervention training once a week for 2 hours over 12 weeks. Main outcomes included physical function and balance stability measured through various tests.

Primary Outcome Measures: Physical function of upper limb strength, arm curl in 30 secs, after the completed training course, about 12 weeks|Physical function of upper limbs strength, Hand grip, after the completed training course, about 12 weeks|Physical function of lower limbs, Walking speed, after the completed training course, about 12 weeks|Physical function of dynamic balance, Up and go test, after the completed training course, about 12 weeks|Physical function of lower limbs, Sit to stand in 30 secs, after the completed training course, about 12 weeks|Physical function of static balance, One leg stand test, after the completed training course, about 12 weeks|Stability index, Biodex balance system device, after the completed training course, about 12 weeks
Impact of Diabetes Mellitus on Retinal Microvasculature in Patients Without Clinical Retinopathy Using Optical Coherence Tomography Angiography
NCT Number: NCT06457295
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetic Retinopathy, DR
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-10
Completion Date: 2025-03-01

Summary:
the aim of this study is to assess the impact of duration of DM on OCTA parameters in diabetic patients without clinical Diabetic retinopathy.

Primary Outcome Measures: Density of vessels in superficial retinal layer by OCTA, OCTA (Optical Coherence Tomography Angiography) has AI-based technology that allows quantitative analysis of vessel density from baseline. Possible Scores range from 30 (lowest) to 60 (highest), baseline|Density of vessels in deep retinal layer by OCTA, OCTA (Optical Coherence Tomography Angiography) has AI-based technology that allows quantitative analysis of vessel density from baseline. Possible Scores range from 30 (lowest) to 60 (highest), baseline
Studying The Association Between Environmental Exposure to PFAS and Breast Cancer in Assiut Governorate- Egypt
NCT Number: NCT06457282
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer
Sponsor: Assiut University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-08

Summary:
1. Measuring serum level of PFAS in breast cancer female patients and healthy participants.
2. Studying the correlation between serum level of PFAS and breast cancer risk through statistical modeling and analysis.
3. Studying the magnitude of environmental exposure through measuring levels of PFAS in air and water sources of corresponding participants.

Primary Outcome Measures: 1- Measuring serum level of PFAS in breast cancer female patients and healthy participants., Studying the correlation between serum level of PFAS and breast cancer risk through statistical modeling and analysis.

Studying the magnitude of environmental exposure through measuring levels of PFAS in air and water sources of corresponding participants., 2 yrs
Closed-loop cTBS for the Core Clinical Features of Methamphetamine Use Disorder
NCT Number: NCT06457243
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Amphetamine Use Disorders
Interventions: DEVICE: Closed-loop cTBS stimulation based on addiction induced states
Sponsor: Shanghai Mental Health Center
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-08
Locations: Min Zhao, PhD, Shanghai, Shanghai, 200000, China

Summary:
Using specific EEG biomarkers in methamphetamine-dependent individuals, this study systematically probes closed-loop continuous Theta-burst Stimulation (cTBS) based on brain states, assessing dosage, neurologic and behavioral effects, while comparing its efficacy with traditional open-loop cTBS methods.

Primary Outcome Measures: Change of Craving assessed by Visual Analog Scale (VAS), The intensity of psychological craving in MA dependents was assessed using the Visual Analogue Scale (VAS), where individuals rated their cravings on a scale from 0 to 10, with higher scores indicating greater levels of craving. The VAS scores were utilized based on two conditions: during a resting state and when subjected to cue induction involving images associated with methamphetamine, serving as the criteria for evaluation.

individuals rated their cravings on a scale from 0 to 10, with higher scores indicating greater levels of craving. The VAS scores were utilized based on two conditions: during a resting state and when subjected to cue induction involving images associated with methamphetamine, serving as the criteria for evaluation., through study completion, an average of 1 month
Secondary Outcome Measures: Changes of electroencephalogram power spectrum, Resting-state EEG can be used to extract power spectra and electrode functional connectivity; on-task EEG can be used to isolate time-frequency features during non-stimulated trials to extract alpha, beta, theta, and gamma band energy of the parietal and occipital electrodes. Both can be used to assess changes in neural activity before, during, and after their restimulation., through study completion, an average of 1 month|Probabilistic inversion learning task, The matching of symbols and colours was reversed without informing the subjects and their cognitive flexibility in the reversed condition was assessed, through study completion, an average of 1 month|Anxiety, The reduction rate in the Beck Anxiety Inventory (BAI) scores was calculated before and after intervention to assess the rate of decrease in anxiety levels among MA dependents., through study completion, an average of 1 month|Depression, The reduction rate in the Beck Depression Inventory (BDI) scores was calculated before and after the intervention to evaluate the rate of reduction in their levels of depression., through study completion, an average of 1 month|sleep quality, Improvement in subjects' sleep before and after the intervention as assessed by the Pittsburgh Sleep Quality Index scale (PSQI), through study completion, an average of 1 month
Paired-pulse rTMS Treatment for Methamphetamine Use Disorder Based on the Frontopolar-Cerebellum
NCT Number: NCT06457230
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Amphetamine Use Disorders
Interventions: DEVICE: 10Hz rTMS based on cerebellum and FPC|DEVICE: 10Hz rTMS based on cerebellum or FPC
Sponsor: Shanghai Mental Health Center
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12
Locations: Min Zhao, PhD, Shanghai, Shanghai, 200000, China

Summary:
To investigate the mechanism and efficacy of a novel repetitive transcranial magnetic stimulation (rTMS) intervention model with paired frontopolar cortex (FPC) -cerebellar pulses on episodic methamphetamine use in patients on methadone maintenance treatment and to develop a novel physiotherapeutic intervention to optimise the treatment and management of addicted patients.

Primary Outcome Measures: Change of Craving assessed by Visual Analog Scale (VAS), The intensity of psychological craving in MA dependents was assessed using the Visual Analogue Scale (VAS), where individuals rated their cravings on a scale from 0 to 10, with higher scores indicating greater levels of craving. The VAS scores were utilized based on two conditions: during a resting state and when subjected to cue induction involving images associated with methamphetamine, serving as the criteria for evaluation., through study completion, an average of 1 month
Secondary Outcome Measures: Depression, The reduction rate in the Beck Depression Inventory (BDI) scores was calculated before and after the intervention to evaluate the rate of reduction in their levels of depression., through study completion, an average of 1 month|Anxiety, The reduction rate in the Beck Anxiety Inventory (BAI) scores was calculated before and after intervention to assess the rate of decrease in anxiety levels among MA dependents., through study completion, an average of 1 month|Addiction stroop task, By testing reaction time and rate of correct response to detect multiple cognitive abilities such as attention selection, processing speed, executive functions, and cognitive inhibition by testing reaction time and correct response rate., through study completion, an average of 1 month|Changes of electroencephalogram power spectrum, Resting-state EEG can be used to extract power spectra and electrode functional connectivity; on-task EEG can be used to isolate time-frequency features during non-stimulated trials to extract alpha, beta, theta, and gamma band energy of the parietal and occipital electrodes. Both can be used to assess changes in neural activity before, during, and after their restimulation., through study completion, an average of 1 month|Probabilistic inversion learning task, The matching of symbols and colours was reversed without informing the subjects and their cognitive flexibility in the reversed condition was assessed, through study completion, an average of 1 month
MRSI Evaluation for Minor Stroke With Large Vessel Occlusion
NCT Number: NCT06457217
Acronym: MINORITY
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Ischemic Stroke
Interventions: DIAGNOSTIC_TEST: Magnetic resonance spectroscopic imaging
Sponsor: Shanghai 6th People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-15
Completion Date: 2027-12-30

Summary:
The goal of this observational study is to understand acute anterior circulation large artery occluded minor stroke (LVO-MIS) evolution using magnetic resonance spectroscopic imaging evaluation. The main questions it aims to answer are:

1. Neurometabolic predictors of early neurological deterioration and functional outcome;
2. Temporal and spatial dynamic changes of the neurometabolites from the acute stage (within 24 hours), through the subacute stage (5-7 days), to the chronic stage (90 days);
3. Temporal and spatial dynamic changes of the neurotransmitters GABA, glutamate, and glutamine from the acute stage to the chronic stage;
4. Brain regions exhibiting changes in whole-brain metabolic network connectivity.

Primary Outcome Measures: Early neurological deterioration, It is defined as an increase of ≥4 points from baseline NIHSS at hospital arrival, and excluding non-ischemic causes such as hemorrhagic transformation and epilepsy., 24 hours
Secondary Outcome Measures: Neurological functional outcome, Modified Rankin Scale (mRS) score is used to measure the degree of disability in patients who have had a stroke, as follows 0: No symptoms at all

1. No significant disability despite symptoms; able to carry out all usual duties and activities
2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
3. Moderate disability; requiring some help, but able to walk without assistance
4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention
6. Dead, 90 days|Composite Temporal and spatial dynamic changes of the neurometabolites, Signals of NAA, lactate, choline, creatine, and myo-inositol were evaluated using MRSI technology, acute stage (within 24 hours), the subacute stage (5-7 days) and the chronic stage (90 days)|Composite Temporal and spatial dynamic changes of the neurotransmitters, Signal of GABA, glutamate, and glutamine determined by MRSI technology, acute stage (within 24 hours), the subacute stage (5-7 days) and the chronic stage (90 days)|Changes in whole-brain metabolic network connectivity, Changes of metabolic connectivity mapping in whole brain between acute stage and chronic stage of stroke., acute stage (within 24 hours), the subacute stage (5-7 days) and the chronic stage (90 days)
A Study in Healthy People to Compare Two Different Sifrol® Tablets
NCT Number: NCT06457204
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: Pramipexole (from manufacturing site 1)|DRUG: Pramipexole (from manufacturing site 2)
Sponsor: Boehringer Ingelheim
Sex: ALL
Age: ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-27
Completion Date: 2024-08-12
Locations: Humanpharmakologisches Zentrum Biberach, Biberach, 88397, Germany

Summary:
The main objective of this trial is to establish the bioequivalence of Sifrol® tablets manufactured at two different sites.

Primary Outcome Measures: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), up to 3 days|Maximum measured concentration of the analyte in plasma (Cmax), up to 3 days
Secondary Outcome Measures: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), up to 3 days
Roflumilast and TMS Motor Plasticity
NCT Number: NCT06457191
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Other Conditions of Brain
Interventions: DRUG: Roflumilast|DRUG: Placebo|DEVICE: Intermittent theta-burst stimulation transcranial magnetic stimulation|DEVICE: Continuous theta-burst stimulation transcranial magnetic stimulation
Sponsor: University of Calgary
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08
Completion Date: 2026-06
Locations: University of Calgary, Calgary, Alberta, T2N 1N4, Canada

Summary:
Repetitive transcranial magnetic stimulation (rTMS) uses a magnetic field to non-invasively induce electrical function within the brain. Stimulation allows brain cells to change the way that they adapt and communicate with each other, known as 'synaptic plasticity'. It is thought that alterations in these adaptive brain changes underlie the ability of rTMS to treat mental illnesses like depression.

The regulation of synaptic plasticity is complex, and involves multiple interacting factors and redundant systems to ensure that plasticity is carefully regulated. To date, studies attempting to alter impact synaptic plasticity have done so using pharmacological adjuncts that target extracellular contributions to plasticity. Here, we propose the first proof of principle study targeting intracellular regulation of plasticity by using a pharmacological adjunct targeting Phosphodiesterase 4 (PDE4), a key regulator a cyclic AMP gradients in brain cells.

We will pair TMS with electromyography (EMG) to measure activity dependent changes in the motor cortex following rTMS to test the ability of a PDE4 inhibition to enhance synaptic plasticity after rTMS.

Primary Outcome Measures: Motor evoked potential amplitude, Motor evoked potentials will be measured using surface electrodes placed over the first dorsal interosseous muscle of the hand to a single stimulus intensity of 120% of resting motor threshold., -5 minutes, -10minutes, -5 minutes, and immediately prior to theta-burst stimulation, then +5 minutes, +10 minutes, +15 minutes, +20 minutes, +25 minutes, +30 minutes, +45 minutes and +60 minutes after theta-burst stimulation.
Secondary Outcome Measures: Motor evoked potential stimulus response curve, Motor evoked potentials will be measured using surface electrodes placed over the first dorsal interosseous muscle to varying stimulus intensities., Baseline, 30 minutes following theta-burst stimulation, 60 minutes following theta-burst stimulation.|Cortical silent period, Motor evoked potentials will be measured using surface electrodes placed over the first dorsal interosseous muscle while participants maintain a light contracture of the muscle., Baseline, 30 minutes following theta-burst stimulation, 60 minutes following theta-burst stimulation.
The Role of Anthropometric Measurements and Ultrasonograpic Suprasternal Adipose Tissue Thickness
NCT Number: NCT06457165
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Intubation; Difficult or Failed|Obesity|Anesthesia
Interventions: DEVICE: Difficult Intubation|DEVICE: Not Difficult Intubation
Sponsor: Ankara City Hospital Bilkent
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-01-01
Completion Date: 2024-01-01
Locations: Ankara Bilkent City Hospital, Ankara, 06800, Turkey

Summary:
Prediction of difficult preoperative intubation in obese patients and completion of preparations for difficult intubation both reduce the risk of repeated intubation and prevent complications.

In this study, the investigators aimed to evaluate whether anthropometric measurements are superior in defining difficult preoperative airways.

Primary Outcome Measures: Suprasternal Adipose Tissue Thickness, It is predicted that it may indicate difficult intubation., within 10 minutes before going into surgery
Secondary Outcome Measures: Abdominal circumference, Noted for each patient., within 10 minutes before going into surgery|Waist circumference, Noted for each patient., within 10 minutes before going into surgery|Arm circumference, Noted for each patient., within 10 minutes before going into surgery|Distance between incisions, Noted for each patient., within 10 minutes before going into surgery|Thyromental distance measurement, Noted for each patient., within 10 minutes before going into surgery|Sternomental distance measurement, Noted for each patient., within 10 minutes before going into surgery|Mallampati Score, Noted for each patient., within 10 minutes before going into surgery(class 1-4; 1 means good and 4 means bad)|Wilson score, Noted for each patient., within 10 minutes before going into surgery(grade 0-10; 0 means good, 10 means bad)|Cormack-Lehane score, Noted for each patient., 1. minute after intubation(class 1-4; 1 means good and 4 means bad)|Age, Noted for each patient., within 10 minutes before going into surgery|Sex, Noted for each patient., within 10 minutes before going into surgery|ASA, Noted for each patient., within 10 minutes before going into surgery(grades 1-6; 1 means good and 6 means bad)|BMI, Noted for each patient., within 10 minutes before going into surgery
Multi-Center Project: Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure
NCT Number: NCT06457152
Acronym: BETTER CARE-HF
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure
Interventions: OTHER: EHR-Emedded Alert
Sponsor: NYU Langone Health
Collaborators: Massachusetts General Hospital|University of Pennsylvania|OhioHealth
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2025-04-30
Completion Date: 2025-12-31
Locations: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|NYU Langone Health, New York, New York, 10016, United States|OhioHealth, Columbus, Ohio, 43228, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

Summary:
This study will test an automated, electronic health record (EHR-)embedded alert to improve prescribing of guideline-directed medical therapy for patients with heart failure and reduced ejection fraction (HFrEF). The investigators have previously tested and implemented this alert at NYU Langone Health (NYULH), and will now test and implement this alert across three other health systems.

Primary Outcome Measures: Number of Patients with a Prescription for Mineralocorticoid Antagonists (MRA), Measured at the prescription encounter level using patient EHR data., Up to Day 30
Secondary Outcome Measures: Number of Patients with a Prescription for Beta-Blocker (BB), Measured at the prescription encounter level using patient EHR data., Up to Day 30|Number of Patients with a Prescription for ACE-I/ARB/ARNI, Prescription for angiotensin converting enzyme-inhibitors/angiotensin receptor blockers/angiotensin receptor neprilysin inhibitors (ACE-I/ARB/ARNI) measured at the prescription encounter level using patient EHR data., Up to Month 36|Number of Patients with a Prescription for Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i), Measured at the prescription encounter level using patient EHR data., Up to Month 36|Number of Patients with Hyperkalemia, Measured using patient EHR data., Up to Month 36|Number of Patients who are Hospitalized, Measured using patient EHR data., Up to Month 36|Number of Patients who are Hospitalized for Heart Failure (HF), Measured using patient EHR data., Up to Month 36
Preventing T2DM After GDM With Immediate Postpartum Screening and Treatment
NCT Number: NCT06457139
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Gestational Diabetes|Type 2 Diabetes
Interventions: DRUG: Metformin Hydrochloride|OTHER: Active Comparator
Sponsor: University of Massachusetts, Worcester
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-04-01
Completion Date: 2028-12-01
Locations: University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, 01605, United States

Summary:
The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening and subsequent treatment with metformin for postpartum patients with pregnancies affected by GDM.

Primary Outcome Measures: Glycemic Outcomes--Hemoglobin A1c, Serum blood measurement of hemoglobin A1c, 3 months, 6 months and 1 year|Glycemic Outcomes--Fructosamine Levels, Serum blood measurement of fructosamine levels, 3 months, 6 months and 1 year
Secondary Outcome Measures: Patient Satisfaction, Participant satisfaction will be assessed using the validated survey, the Patient Satisfaction Survey. The survey was developed in 1979 and has been used to assess patient satisfaction with research participation based on 8 simple questions. It has not been used in a randomized trial in an obstetric population but has been validated in other clinical populations, At randomization, 3, 6, and 12 months after randomization|Provider Engagement, The investigators will assess provider comfort with a 5-point Likert scale (not at all comfortable, slightly comfortable, neutral, very comfortable, extremely comfortable) with this screening and treatment strategy, identification of abnormal glucose tolerance, and decisions for treatment with metformin., At Randomization|Patient Recruitment, The investigators will examine the ease and feasibility of recruitment by calculating the total number of subjects that were approached and the reasons for ineligibility and non-participation., at Randomization/approach|Patient Retention, The investigators will record reasons for failure to complete in hospital diabetes screening and treatment., Randomization, 3, 6, and 12 months after randomization|Feasibility of Assessment, The investigators will examine the ease by which patient and providers are able to complete in hospital testing and adhere to early treatment intervention with metformin. Ease of use will be assessed by a 5-point Likert scale (categories: very difficult, somewhat difficult, neutral, somewhat easy, very easy). The investigators will assess medication adherence and experienced side effects for all patients., At randomization, 3, 6, and 12 months after randomization
Emotional Attention Bias Modification and Targeted Memory Reactivation in Alcohol Use Disorder
NCT Number: NCT06457113
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alcohol Use Disorder
Interventions: BEHAVIORAL: Emotional Attention Bias Modification and Targeted memory reactivation during REM sleep|BEHAVIORAL: Emotional Attention Bias Modification
Sponsor: Shanghai Mental Health Center
Sex: ALL
Age: ADULT
Enrollment: 74
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2025-06-30

Summary:
Through this protocol, researchers examine whether Targeted Memory Reactivation (TMR), a technique used to enhance memory, can augment the control of craving levels in patients with Alcohol Use Disorder by enhancing positive emotional attention bias modification.

Primary Outcome Measures: Changes in behavioral indicators of positive emotional attention bias towards alcohol-related cues, Positive emotional attention bias is assessed through emotional attention bias under electroencephalogram recording, with the indicator being D scores calculated from the response time (D alcohol=RT (negative) - RT (positive) )/SD negative+positive)., baseline, 1 day after treatment, 2 weeks after treatment
Secondary Outcome Measures: Changes in behavioral indicators of positive emotional attention bias towards healthy activity cues, Positive emotional attention bias is assessed through emotional attention bias under electroencephalogram recording, with the indicator being D scores calculated from the response time (D health=RT (negative) - RT (positive) )/SD negative+positive)., baseline, 1 day after treatment, 2 weeks after treatment|Change of Craving assessed by Visual Analog Scale, evaluate all participants' craving for for methamphetamine assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 10, and higher values represent high level of craving., baseline, 1 day after treatment, 2 weeks after treatment|Change of Craving assessed by Visual Analog Mood Scale, evaluate all participants' mood assessed by Visual Analog Scales (VAS). The scores ranges from 0 to 10, where 0 indicates the absence of the emotion and 10 indicates the emotion is extremely intense., baseline, 1 day after treatment, 2 weeks after treatment
Optical Biopsy for Peripheral Pulmonary Lesions
NCT Number: NCT06457087
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Peripheral Pulmonary Lesions
Sponsor: Shanghai Chest Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06
Completion Date: 2025-06
Locations: Shanghai Chest Hospital, Shanghai, Shanghai, 200030, China

Summary:
The purpose of the study is to describe confocal laser endomicroscopy (CLE) interpretation criteria for different types of peripheral pulmonary lesions (PPLs), with histopathological correlation, and to perform the validation of these criteria.

Primary Outcome Measures: Diagnostic accuracy of CLE in differential diagnosis of benign and malignant PPLs, Diagnostic accuracy is defined as the number of lesions correctly identified as malignant or benign using our proposed CLE interpretation criteria divided by the total number of lesions., 6 months post-procedure
Secondary Outcome Measures: Sensitivity, specificity of CLE in differential diagnosis of benign and malignant PPLs, Sensitivity is defined as the number of lesions correctly identified as malignant using our proposed CLE interpretation criteria divided by the total number of malignant lesions. Specificity is defined as the number of lesions correctly identified as benign using our proposed CLE interpretation criteria divided by the total number of benign lesions., 6 months post-procedure|positive predictive value, and negative predictive value of CLE in differential diagnosis of benign and malignant PPLs, The positive predictive value is the percentage of true malignant lesions among all lesions identified as malignant using our proposed CLE interpretation criteria. The negative predictive value is the percentage of true benign lesions among all lesions identified as benign using our proposed CLE interpretation criteria., 6 months post-procedure|Diagnostic accuracy of CLE in differential diagnosis of different types of PPLs, Different types of PPLs include different types of common malignant PPLs (e.g., adenocarcinoma, squamous cell carcinoma, small cell lung carcinoma, etc.) and different types of common benign PPLs (e.g., inflammation, tuberculosis, fungal infection, etc.). Diagnostic accuracy is defined as the number of lesions correctly identified as a specific disease using our proposed CLE interpretation criteria divided by the total number of lesions., 6 months post-procedure|Incidence of complications, Complications mean a composite of procedure related adverse advents during and after the operation., 1 month post-procedure
Evaluation of Caregiver Burden and Depression Severity in Patients With Hemiplegia
NCT Number: NCT06457061
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Hemiplegia|Caregiver Burden|Depression
Interventions: OTHER: Survey Study
Sponsor: Abant Izzet Baysal University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-01
Completion Date: 2024-05-01
Locations: Abant Izzet Baysal University, Bolu, 14100, Turkey

Summary:
This study aimed to evaluate the caregiving burden and severity of depression in patients with right hemiplegia and left hemiplegia.

Primary Outcome Measures: Beck's Depression Inventory, The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. The score to be received varies between 0-63. A high total score indicates a higher severity of depression., Day 1|Zarit Caregiver Burden, Zarit caregiver burden interview evaluates caregivers' caregiving burden. It consists of 22 questions. A minimum of 0 and a maximum of 88 points can be obtained from the scale. A A high total score indicates a higher severity of caregiver burden, Day 1
Secondary Outcome Measures: Barthel Index for Activities of Daily Living Scale, The Barthel index is used to assess activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs. Scores range from 0-100. A score of 100 represents complete independence, and a score of 0 represents complete dependence., Day 1|Star Cancellation test, The Star Cancellation Test is a screening tool developed to detect the presence of unilateral spatial neglect, Day 1
Development and Validation of a Nomogram for Predicting Surgery in Newly-diagnosed Crohn's Disease: a Retrospective Cohort Study
NCT Number: NCT06457035
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Newly-diagnosed Crohn's Disease
Interventions: DRUG: immunosuppressant
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 490
Study Design: Observational Model: |Time Perspective: p
Start Date: 2005-01-01
Completion Date: 2023-12-01

Summary:
A majority of patients with Crohn's disease undergo surgery during the disease course. We aimed to develop an easily available nomogram to predict the risk of surgery at diagnosis.

Primary Outcome Measures: Requirement of surgery, need for bowel resection at any time, Any time during the follow-up (up to Dec 31, 2022)
Outcome Measures of Modified Constraint Induced Movement Therapy Versus Dual Task Training on Upper Extremity and Cognitive Functions in Patients With Hemiparesis
NCT Number: NCT06457022
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemiparesis
Interventions: OTHER: Modified Constraint Induced Movement therapy|OTHER: Dual task training in the form of cognitive - motor task|OTHER: Conventional physiotherapy rehabilitation program
Sponsor: Ahmed Alshimy
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2024-07-10
Locations: Al Ryada University for Science and Technology, Sadat, Menoufia, Egypt

Summary:
All stroke patients were assessed via isokinetic dynamometer, Montreal cognitive assessment scale (MOCA) and Fugl Myer Upper extremity (FMUE) before and after the treatment program.

Primary Outcome Measures: Biodex isokinetic dynamometer, Used to assess muscle strength and function, 4 weeks|Montreal cognitive assessment, a quick test that is used to examine mild cognitive impairment and early dementia., 4 weeks|Fugl Myer upper extremity, a scale used to measure the functional impairment of stroke, 4 weeks
Frequency of Metabolic Dysfunction Associated Fatty Liver Disease in Patients With Acute Coronary Syndromes
NCT Number: NCT06456970
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Fatty Liver
Interventions: DEVICE: fibroscan
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-07-01

Summary:
Aim of the research is to assess frequency of MAFLD among patients with acute coronary syndromes (ACS).

Primary Outcome Measures: Assess frequency of MAFLD among patients with acute coronary syndromes (ACS)., patients with acute coronary syndrome will be evaluated if they have MAFLD and then we will know frequency of MAFLD among patients with acute coronary syndromes (ACS), baseline
Fetal Abdominal Subcutaneous Tissue Thickness in Prediction of Fetal Weight in Term Pregnant Women
NCT Number: NCT06456957
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ultrasound|Fetal Weight
Sponsor: Assiut University
Sex: FEMALE
Age: ADULT
Enrollment: 240
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2026-07

Summary:
Fetal Abdominal subcutaneous tissue thickness (FASTT) can be easily measured during the routine ultrasound examination of pregnant women. Numerous reports have shown FASTT measurement to be a good way of evaluating subcutaneous fat tissue.

However, to the best of our knowledge, no studies have investigated the association of FASTT with abnormal fetal growth in nondiabetic. For this reason, in this study we evaluated whether FASTT can predict birth weight or diagnose LGA and/or LBW infants in the third trimester.

Primary Outcome Measures: sensitivity of measuring Fetal Abdominal Subcutaneous Tissue Thickness, To evaluate sensitivity of measuring Fetal Abdominal Subcutaneous Tissue Thickness compared to Hadlock formula IV in Prediction of Fetal Weight in Term non-diabetic Pregnant Women in 3rd trimester., 37-40 weeks gestation
Secondary Outcome Measures: Mode of delivery., Vaginal delivery or cesarean section, 37-40 weeks gestation|Gestational age at the time of delivery, detection of gestational age at the time of delivery, 1 week from recruitment|Neonatal Apgar score, Measure Apgar score for the newborn at 1 minute and 5 minutes, at the time of delivery|Neonatal birth weight, Measure of Neonatal weight in grams, at the time of delivery|Neonatal need for NICU, Need for admission of neonate at NICU and Number of days if admitted, at the time of delivery
ValidationTurkishVersionQualityofRecovery-15
NCT Number: NCT06456918
Acronym: ValidQoR-15
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Major Abdominal Surgery|Patient-reported Outcome
Interventions: PROCEDURE: Quality of Recovery 15 questionnaire
Sponsor: Ankara University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 510
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-09-01
Completion Date: 2022-12-01
Locations: Mehmet Ali Koc, Ankara, Altindag, 06230, Turkey

Summary:
The aim of this study was to perform a cross-cultural adaptation and psychometric evaluation of the Quality of Recovery 15 questionnaire in Turkey.

Primary Outcome Measures: To validate the QoR-15, the survey was conducted on the day before the surgery (Pre), and on postoperative days 1 (P1), 7 (P7), and 30 (P30)., September 2019-September 2022
Automated Reinforcement Management Systems, Phase II
NCT Number: NCT06456905
Acronym: ARMS II
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alcohol Use Disorder
Interventions: BEHAVIORAL: Contingency Management
Sponsor: Washington State University
Collaborators: Managed Health Connections
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 125
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-07
Completion Date: 2025-09-01
Locations: Washington State University, Spokane, Washington, 99202, United States

Summary:
The Automated Reinforcement Management Systems Phase II (ARMS II) study is a phase II trial is a randomized controlled, non-medicated assisted trial to determine the effectiveness of Contingency Management (CM) treatment for reducing alcohol drinking among adults who want to quit or reduce their alcohol consumption.

Primary Outcome Measures: Change in days abstinent, Increase in days abstinent as verified through three consecutive negative breathalyzer samples submitted at designated time slots over a period of 12 hours., 45 months
Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen
NCT Number: NCT06456892
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Rhabdomyosarcoma|Pediatric Cancer
Interventions: DRUG: Pucotenlimab
Sponsor: Sun Yat-sen University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 82
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-06
Completion Date: 2026-12-06
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
This study comprises both Phase I and Phase II research. This phase focuses on safety, tolerability, and pharmacokinetics using a "3+3" dose escalation design with three dose groups: 1 mg/kg, 3 mg/kg, and 6 mg/kg. The drug will be administered in combination with the standard regimen for intermediate/high-risk rhabdomyosarcoma once every three weeks (Q3W). In phase II study, all subjects will receive Pucotenlimab combined with the standard regimen for intermediate/high-risk rhabdomyosarcoma for 2-4 cycles of neoadjuvant therapy every 3 weeks (Q3W), followed by surgery.

Primary Outcome Measures: DLT, dose-limiting toxicity, within 28 days of the dose escalation phase.|pCR, pathological complete response rate, from treatment of pucotenlimab to the surgery
Clinical Performance and Convenience of Four Types of Crowns for Primary Molars
NCT Number: NCT06456879
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Crown of Tooth With Poor Contour
Interventions: OTHER: extra-coronal restoration type
Sponsor: Mansoura University
Sex: FEMALE
Age: CHILD
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-02-05
Completion Date: 2024-05-17
Locations: Faculty of Dentistry, Mansoura University, Mansoura, Dakahlia, 002, Egypt|Mansoura university, Mansoura, Dakahlya, 002, Egypt

Summary:
This study will be conducted to assess the clinical performance and convenience of three types of crowns as esthetic alternatives to stainless steel crown for primary molars:

* The prefabricated commercially available zirconia crowns (NuSmile®) (NZC).
* The locally manufactured zirconia crowns created via Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) system (CCZC).
* The locally manufactured hybrid ceramic crowns created via Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) system (CCHC).

Primary Outcome Measures: the gingival index, 0 = normal gingiva

1. = mild inflammation
2. = moderate inflammation
3. = severe inflammation, 12 months|Crown retention, 0 = present.

1 = absent., 12 months|Crown integrity, 0 = intact.

1. = crack present.
2. = fracture present.
3. = crown lost., 12 months|Color stability, 0 = Unchanged.

1. = Minor deviation from original.
2. = Unacceptable discoloration., 12 months|Plaque Index, 0 = no plaque

1= film at the gingival margin and adjacent tooth 2 = moderate accumulation of plaque 3 = abundance of plaque., 12 months
Secondary Outcome Measures: wear of opposing natural teeth., To evaluate the wear of the antagonistic natural enamel of primary molar, the upper arch was scanned using an intraoral scanner immediately, (6 months and 1 year after cementation. Both 3d images were placed in the same position and compared using the CAD software to calculate the amount of linear wear on millimeters., 12 months