pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Research Study Investigating Safety and Concentration in the Blood After One Dose Tablet of the New Medicine Monlunabant in Healthy Weight Japanese and Caucasian Men
NCT Number: NCT06542536
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Obesity
Interventions: DRUG: Monlunabant|DRUG: Placebo (monlunabant)
Sponsor: Novo Nordisk A/S
Sex: MALE
Age: ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-09
Completion Date: 2024-10-25
Locations: Altasciences Clinical LA, Inc., Cypress, California, 90630, United States

Summary:
The study is testing a new study drug in healthy normal weight Japanese and Caucasian participants after a single dose. The aim of this study is to see if the new medicine is safe and how it works in the participants body. Oral monlunabant is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The participant will either get monlunabant or placebo or a combination of both. Which treatment the participant get is decided by chance. The study will last for about 49 days in total.

Primary Outcome Measures: Number of treatment emergent adverse events (TEAEs) after single dose of oral monlunabant, Number of events, From dosing (day 1) to end of study visit (day 21)
Secondary Outcome Measures: AUC0-∞,monlunabant, SD; the area under the monlunabant plasma concentration-time curve from time 0 to infinity after single dose of oral monlunabant, h\*nmol/L, From pre-dose (day 1) to end of study visit (day 21)|Cmax, monlunabant, SD; the maximum plasma concentration of monlunabant after single dose of oral monlunabant, nmol/L, From pre-dose (day 1) to end of study visit (day 21)|tmax,monlunabant, SD; the time of maximum observed plasma concentration of monlunabant single dose of oral monlunabant, h (hours), From pre-dose (day 1) to end of study visit (day 21)|t½,monlunabant,SD; the terminal half-life of monlunabant after single dose of oral monlunabant, h (hours), From pre-dose (day 1) to end of study visit (day 21)
Observational Study Regarding the Necessity of Inclusion of Foot Arch State Together With the Angiosome Theory Within the Wound, Ischemia and Foot Infection Classification (WIfI) to Enhance the Predictability of Wound Healing and Decision Making
NCT Number: NCT06542523
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Limb-Threatening Ischemia|Diabetic Foot|Vascular Diseases
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2025-03
Locations: Ain Shams University, Cairo, Egypt

Summary:
This study aims to assess the complete healing or healing progress of foot ulcer within 1 year Where the patients will be classified according to foot arch state together with the angiosome theory and the WIFI clinical stage to reflect the the necessity of inclusion of foot arch state together with the angiosome theory within the WIFI classification to enhance the predictability of wound healing and decision making

Primary Outcome Measures: Complete Healing, Wound closure with the restoration of tissue integrity and absence of signs of infection., 2,4,6 months|Partial Healing:, significant improvement but not complete closure; may involve change in wound size and improved tissue viability., 2,4,6 months|Worsening, change in wound size or signs of infection which may necessitates performing major amputation. ., 2,4,6 months
Secondary Outcome Measures: Occurrence of Complication, Rates of procedure- and device-related adverse events during revasularization, within 30 days of the procedure
The Impact of Working Night Shifts on Cardiac Autonomic Nervous Regulation During the Six-minute Walk Test in Nurses
NCT Number: NCT06542510
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Autonomic Nervous System Imbalance
Interventions: BEHAVIORAL: working night shift
Sponsor: Nanfang Hospital, Southern Medical University
Sex: FEMALE
Age: ADULT
Enrollment: 35
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-30
Completion Date: 2024-04-30
Locations: Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, 510515, China

Summary:
To evaluate changes in heart rate variability (HRV) after the six-minute walk test (6MWT) in nurses following a night shift and explore the impact of night shift work on the regulation of the autonomic nervous system in the heart.

Thirty-five female nurses, with a mean age of 28.7 years (range 21.0-37.0 years), participated in this study. On the first and second mornings after a night shift, the nurses performed the 6MWT. During the test, electrocardiogram (ECG) signals, blood pressure, and walking distance were recorded simultaneously.

Primary Outcome Measures: Delta HRV during the 6MWT, On the first and second mornings after a night shift, the nurses performed the 6MWT.During the test, electrocardiogram (ECG) signals was recorded simultaneously., 18 minutes
Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia
NCT Number: NCT06542497
Acronym: VEGA-3
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Presbyopia
Interventions: DRUG: 0.75% phentolamine ophthalmic solution|DRUG: Placebo
Sponsor: Ocuphire Pharma, Inc.
Sex: ALL
Age: ADULT
Enrollment: 545
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2026-05
Locations: United States, Phoenix, Arizona, 85028, United States|United States, Scottsdale, Arizona, 85260, United States|United States, Glendale, California, 91204, United States|United States, Newport Beach, California, 92663, United States|United States, Delray Beach, Florida, 33484, United States|United States, Longwood, Florida, 32779, United States|United States, Rochester, New York, 14618, United States|United States, Garner, North Carolina, 27529, United States|United States, Athens, Ohio, 45701, United States|United States, Warwick, Rhode Island, 02888, United States|United States, Goodlettsville, Tennessee, 37072, United States|United States, Memphis, Tennessee, 38119, United States|United States, San Antonio, Texas, 78229, United States

Summary:
Safety and efficacy of POS in participants with presbyopia

Primary Outcome Measures: Primary efficacy endpoint, The primary efficacy endpoint is the percentage of participants with ≥ 15 letters of improvement in binocular DCNVA and with \< 5 letters of loss in binocular BCDVA from baseline comparing POS-treated participants to placebo-treated participants at 12 hours post-dose at Visit 4 (Day 8), Day 8
Plating Versus Nailing in Pediatric BB Forearm Fractures
NCT Number: NCT06542471
Acronym: DINDPL
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intramedullary Nail|Plate Fixation|Forearm Fracture|Randomized Controlled Trial
Interventions: DEVICE: Dual intramedullary nailing|DEVICE: Dual plating
Sponsor: Ain Shams University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-09-01
Locations: Ain Shams University, Cairo, 11655, Egypt

Summary:
A randomized controlled trial to compare between dual intramedullary nailing and dual plating trying to synthesis a high quality evidence study that can solve the conflict between the decisions.

Primary Outcome Measures: Time to union, weeks required to achieve union, 6 months|Elbow range of motion, elbow flexion, extension, pronation and supination in degrees, 6 months|Quick DASH score, Patient reported questionnaire, 6 months|patient satisfaction questionnaire, five points Likert scale, 6 months
Secondary Outcome Measures: Adverse events, Any adverse event will be recorded, 6 months|Re-operation rate, percentage of patients requiring reoperation, 6 months|size of wound scar in millimeters, measuring the size of wound scar in millimeters, 6 months|Deformity (malunion rate), Malunion deformity, 6 months
Under-Represented Communities Diagnosed With SCD or MCI Through Tele-Cog
NCT Number: NCT06542458
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mild Cognitive Impairment|Subjective Cognitive Decline
Interventions: BEHAVIORAL: Assessments|OTHER: Neuroimaging volumetric measures|OTHER: Biofluid samples
Sponsor: Ohio State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-01
Completion Date: 2032-01-01
Locations: The Ohio State University, Columbus, Ohio, 43210, United States

Summary:
Overall, this study's primary aim is to establish a prospective, longitudinal, observational cohort study of older adults at risk for dementia from under-resourced/underrepresented communities. More specifically, older adults diagnosed with subjective cognitive decline (SCD) or Mild Cognitive Impairment (MCI) during clinical care offered via the Tele-Cog clinic would be recruited for more comprehensive data collection to characterize the clinical presentation and course of illness over multiple timepoints spread out longitudinally.

Primary Outcome Measures: Number of adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI) at risk for dementia from under-resourced/underrepresented communities that we longitudinally collect clinical data, neuropsychology, neuroimaging, and biofluids, This study is a longitudinal collection of clinical data, neuroimaging, neuropsychological assessments, and biofluids to establish a cohort of older adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI) at risk for dementia from under-resourced/underrepresented communities from which hypotheses can be generated. Analysis will also include comparing the subject's longitudinal change over time data. Data will be analyzed with one way and repeated measures (ANOVAs) that will control for important covariates. All imaging data will be analyzed using qualitative visual interpretation and quantitative region of interest approach., 5 years
Utility and Effectiveness of Polygenic Risk Scoring (PRS) for Coronary Artery Disease (CAD)
NCT Number: NCT06542432
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Artery Disease|Polygenic Risk Score|Heart Diseases|Coronary Disease|Myocardial Infarction|Cardiovascular Diseases
Interventions: GENETIC: Disclosure of integrate risk score for coronary artery disease
Sponsor: MyOme
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-10-01
Completion Date: 2029-07-01

Summary:
The goal of this study is to assess the benefit to physicians and patients of adding an integrated risk score (IRS) to existing coronary artery risk tools by conducting a randomized prospective study. IRS combines both an individual's coronary artery disease (CAD) polygenic risk score (PRS) and clinical risk factors, like cholesterol levels and age. This study will examine to what extent IRS knowledge impacts physician/provider behavior as well as clinical outcomes including cholesterol levels and incident heart disease.

Primary Outcome Measures: Does receiving an IRS report influence clinical decision making, including the provider's decision to treat with lipid lowering medication or order diagnostic testing?, Aggregating longitudinal clinical data will be collected to compare the incidence of lipid-lowering medication initiation and cardiac diagnostic testing between the intervention arm which received their integrated risk score and the control group., 5 years|Does receiving an IRS report affect patient clinical measurements, including LDL-C levels?, Aggregating longitudinal clinical data will be collected to compare the clinical measurements between the intervention arm which received their integrated risk score and the control group., 5 years
Secondary Outcome Measures: Does the IRS identify those at elevated risk for CAD and future ASCVD events?, Aggregated longitudinal clinical data and patient survey data will be collected to compare patient clinical outcomes in those with a high CAD IRS., 5 years|Does receiving an IRS report affect the incidence of CAD events?, Aggregated longitudinal clinical data will be collected to compare patient clinical outcomes in those with a CAD IRS reported at baseline and the control group., 5 years|Does receiving an IRS report affect participant understanding of their individual CAD risk?, Patient survey data will be collected to assess their understanding of their CAD risk., 5 years
Can Endotracheal Tube Fluctuation With Epigastric Compression Be Used as a Confirmation Method for Endotracheal Intubation?
NCT Number: NCT06542406
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intubation, Intratracheal
Interventions: DEVICE: Endotracheal intubation
Sponsor: Duzce University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2021-02-18
Completion Date: 2023-03-04
Locations: Duzce University, Düzce, Turkey

Summary:
Endotracheal intubation (ETE) may also need to be performed outside the hospital as advanced airway management. In such cases, facilities such as imaging methods, ultrasound or capnography may not be available and only traditional methods such as auscultation of lung sounds, auscultation of the epigastric region without hearing airflow, observation of chest expansion after ventilation, observation of water vapor in the tube may have to be used. Despite all these observational methods and equipment used, it is recommended to keep in mind that there may be errors and to try to provide confirmation with more than one method.

Especially in disaster situations where technological infrastructure is not available and sometimes outside the hospital, the use of traditional methods based on examination may be of vital importance. The traditional methods mentioned above are mostly used to detect tracheal localization and to exclude esophageal localization. In our observations in patients with cardiopulmonary arrest, the investigators noticed that in the case of esophageal placement of the tube, manual compression of the epigastric region produced a fluctuation in the tube and valved balloon caused by airflow. The investigators thought that this could be a method to confirm esophageal placement. The aim of this study was to investigate the usefulness of epigastric manual compression in the confirmation of esophageal placement of the tube.

Primary Outcome Measures: Confirmation with ultrasonography: Successful or Failed, Fluctuation with Epigastric Compression: Yes or No

Failed Successful Failed, 13 months
TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.
NCT Number: NCT06542380
Acronym: TAVI PACER
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pacemaker|TAVI|Risk Score
Interventions: DEVICE: TAVI, pacemaker
Sponsor: German Heart Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-02-07
Completion Date: 2024-06-28
Locations: Deutsches Herzzentrum der Charité, Berlin-Mitte, Berlin, 10117, Germany

Summary:
The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI). This study aimed to develop a novel, two-step risk score to predict PPMI probability after TAVI and to implement it into a user-friendly website. Our risk score addresses the gap in existing data on current prosthesis generations and provides a new and clinically motivated approach to calculating the risk for PPMI.

Primary Outcome Measures: Pacemaker Implantation, Rate of pacemaker implantation up to 30 days after TAVI according to current guidelines, 30 days after TAVI
Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil"
NCT Number: NCT06542367
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tympanic Membrane Perforation
Interventions: PROCEDURE: Tympanoplasty performed under local anesthesia using fat graft and "Tachosil".
Sponsor: HaEmek Medical Center, Israel
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-09-01

Summary:
Eligible participants with chronic tympanic membrane perforation (\>6 month) will be given a detailed description and offered to participate in the study.

the study investigates the efficacy of trans canal tympanoplasty with local anesthesia using fat pad and "Tachosil". Participants will be followed for 1 year after the procedure with otological examination and successive hearing evaluations.

Primary Outcome Measures: closure of tympanic membrane perforation, the effectiveness of the tympanoplasty using far graft and "Tachosil" will be evaluated - whether close of tympanic membrane perforation occured., 1 year following the procedure
Secondary Outcome Measures: Hearing results following tympanoplasty - Speech recognition threshold, SRT (Speech recognition threshold) in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram., 1 year following the procedure|Hearing results following tympanoplasty - Pure Tone Average, PTA air and PTA bone (Pure Tone Average) in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram., 1 year following the procedure|Hearing results following tympanoplasty - air bone gap., Air-bone gap in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram., 1 year following the procedure
Prehabilitation During Neoadjuvant Chemoradiotherapy for Rectal Cancer
NCT Number: NCT06542354
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rectal Cancer
Interventions: BEHAVIORAL: Physical exercise|DIETARY_SUPPLEMENT: Nutrition supplement|BEHAVIORAL: Mental support
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 108
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-12-20
Completion Date: 2024-03-20
Locations: Zhongshan Hospital Fudan University, Shanghai, Shanghai, 200032, China

Summary:
The purpose of this study is determine whether a trimodel prehabilitation program (combined with physical exercise, nutrition supplement and mental support) during neoadjuvant chemoradiotherapy can help patients with rectal cancer to achieve better postoperative outcomes include perioperative complication rate, functional outcomes and quality of life.

Primary Outcome Measures: Functional outcome, Walking capacity measured by 6-minute walking distance (6MWD), at baseline, before surgery, 4 weeks and 8 weeks after surgery
Secondary Outcome Measures: perioperative complication, measured by comprehensive complication index (CCI), recorded from the day of surgery to 30 days after surgery|Nutrition status, measured by BMI and SMI, at baseline, before surgery, 4 and 8 weeks after discharge|Patient-reported outcome measures, using SF-36, at baseline, before surgery and 30days after discharge|immune function markers, specific immnue cells like CD4/CD8, cytokines, peripheral blood test., at baseline, before surgery, 4 and 8 weeks after discharge
Study to Evaluate the Efficacy of the décoLITE LED Device in Treating the Signs of Skin Aging of the décolletage Area
NCT Number: NCT06542341
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Wrinkle
Interventions: DEVICE: decoLITE (TN2037)
Sponsor: Steven Baker
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-09-24
Completion Date: 2021-01-31
Locations: Suite A, Astor House, Sutton Coldfield, B742UG, United Kingdom

Summary:
To assess the efficacy of the décoLITE LED system in reducing the signs of skin aging of the décolletage area one week after a six-week treatment course.

Primary Outcome Measures: Reduction in chest lines at rest, Reduction in chest lines at rest according to the validated Merz aesthetics décolleté grading scale developed by Landau, et al (2016)., 7 weeks after first treatment intervention
Secondary Outcome Measures: Reduction in chest pigmentation, Reduction in chest pigmentation according to the validated Merz aesthetics décolleté grading scale developed by Landau, et al (2016, 7 weeks after first treatment intervention
Pre-market Verification of Portable X Ray Machines for Lung Diseases and Orthopedic Limb Lesions
NCT Number: NCT06542328
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: X-rays; Effects|Chest--Diseases|Orthopedic Disorder
Interventions: DEVICE: ERI CVX-air portable X-ray system|DEVICE: Samsung GM85 (K180543) or MobileDaRt Evolution (K080701)|DEVICE: Samsung GC85A (K160997) or Fujifilm FDR Smart X (K212956)
Sponsor: Energy Resources International Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 228
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-04-01
Completion Date: 2022-08-31
Locations: Changhua Christian Hospital, Changhua City, Changhua County, 500, Taiwan

Summary:
The clinical trial is to evaluate a portable X ray machine (model name: CVXair) for chest and extremities diagnosis, the performance of machine is comparing to the commercial stationary and portable machine both in biological structure way and disease diagnosis way by the image generated.

Currently sold X ray machines in market for hospital are stationary or big size portable, it is not easy for carrying to use and occupied a large space for installation and storage, beside that, CVXair is a small and light machine within 3.2KG and has extremely low dosage. It is the reason we expect to use CVXair as a convenient X ray machine with low radiation dosage for X ray image diagnosis clinically.

This trial has an expected trial period in two years, the accepted patients are limited to thoracic and orthopedics patients no matter out hospital or in hospital. The accepted patients upper limitation number is 123 respectively. The selected patient will be taken X ray shot in same area and position both by CVXair and market sold machine, the images then will be interpreted by 2 qualified radiologist in different biological structure and specified diseases. Then the process will be given by a suitable test score.

The test result will be calculated by defined index for comparing with the market sold X ray machines, and finally we will base on the result to state the machine is equivalent or not by the market sold X ray machines.

Primary Outcome Measures: Comparing the investigational device with the control device using Two Parellel-Sample Mean Test for Non-inferiority, the average scores of image quality at 5 anatomical sites., The average scores (Likert scale，1-4) for image quality at 5 anatomical sites/items generated by the investigational equipment for producing radiographic images of the thorax and limbs in human anatomy, compared to the commercial equipment, were evaluated based on the criteria defined in the study by Cheng Ting Lin et al. (Lin et al., 2020). These scores were assessed for diagnostic utility and level of defects., Only images captured with the trial device and control device within a range of -1 day, 0 day, and 1 day from each other were selected for analysis.
The Effects of Cervical Sensorimotor Control Challenges on Gait Patterns, Cervical Sensorimotor Control During Dynamic Tasks
NCT Number: NCT06542302
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neck Pain|Sensorimotor|Gait
Sponsor: National Cheng Kung University
Collaborators: National Science and Technology Council
Sex: ALL
Age: ADULT
Enrollment: 74
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2027-07-31
Locations: National Cheng Kung University, Tainan, 701, Taiwan

Summary:
To investigate the influence of cervical SMC challenges during gait-related dynamic tasks on all task performance and symptoms in patients with CNP.

Primary Outcome Measures: Spatiotemporal parameter, Gait speed (meter/second), One day|Spatiotemporal parameter, cadence (steps/minute), One day|Spatiotemporal parameter, stride length (meter), One day|Spatiotemporal parameter, stride duration (second), One day|Spatiotemporal parameter, stance duration (second), One day|Spatiotemporal parameter, swing duration (second), One day|Spatiotemporal parameter, stance length (meter), One day|Spatiotemporal parameter, swing length (meter), One day|Spatiotemporal parameter, step width (meter), One day|Head and Cervical Kinematics, Mean, range, maximum, and minimum of the angular displacements (degree), One day|Head and Cervical Kinematics, Mean and peak angular velocity (m/s) and acceleration (m/\^2), One day|Lower Extremity Kinematics and Kinetics, Maximum, minimum, and range angular displacement (degree of joint angle), One day|Lower Extremity Kinematics and Kinetics, Mean and peak angular velocity and acceleration (m/\^2), One day|Enter of Mass and Center of Pressure (COM-COP), A 15-component link-segment model will be used to estimate the location of the total body COM. The center of pressure (COP) data will be derived from the outputs of the AMTI force platform., One day
Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
NCT Number: NCT06542289
Acronym: Paralysis
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bell's Palsy|Ramsay Hunt Syndrome|Lyme Disease|Facial Palsy
Interventions: DEVICE: BlinkER device.
Sponsor: Neurotrigger Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-09-30
Locations: Rand Eye Institute, Deerfield Beach, Florida, 33064, United States

Summary:
Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.

Primary Outcome Measures: The percent of participants who achieve eyelid closure graded by independent, masked graders at a reading center., Eyelid closure is defined as a mean blink score as graded by the independent masked graders using the Mäkelä scale:

5- Complete eye closure 4- Nearly complete eye closure 3- Eyelid covers the pupil 2-Eyelid partially covers the pupil

1-Twitch 0- No movement, 2 weeks
Secondary Outcome Measures: Percent of participants who achieve eyelid closure in the study eye at 1 month., Eyelid closure is defined as a mean blink score as graded by the independent masked graders using the Mäkelä scale:

5- Complete eye closure 4- Nearly complete eye closure 3- Eyelid covers the pupil 2-Eyelid partially covers the pupil

1-Twitch 0- No movement, up to 1 month|Percent of participants who achieve eyelid closure in the study eye at 3 months., Eyelid closure is defined as a mean blink score as graded by the independent masked graders using the Mäkelä scale:

5- Complete eye closure 4- Nearly complete eye closure 3- Eyelid covers the pupil 2-Eyelid partially covers the pupil

1-Twitch 0- No movement, up to 3 months|safety outcome is the rate of adverse events through 3 months., safety measures include IOP, BCVA, slit lamp biomicroscopy and non-mydriatic fundus findings, and VAS pain and discomfort questionnaire evaluated at the follow-up visits., 3 months
Single Lipiflow Treatment to Reduce Pharmacologic Burden in DED
NCT Number: NCT06542276
Acronym: Reduce
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: MGD-Meibomian Gland Dysfunction
Interventions: DEVICE: Thermal Vectored Pulsation
Sponsor: Dunes Eye Consultants
Collaborators: Johnson & Johnson
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-01
Completion Date: 2024-09-01
Locations: Dunes Eye Consultants, Dakota Dunes, South Dakota, 57049, United States

Summary:
Purpose: To evaluate the efficacy of vectored thermal pulsation treatment in subjects with a history of dry eye disease currently using a topical immunomodulator medication.

Primary Outcome Measures: Number of Subjects discontinuing Topical Immunomodulator use, OSDI, TBUT, Tear Osmolarity, Meibomian gland expression quantity, TM, 3 months
Identifying Local Field Potential Biomarkers for Obsessive-compulsive Disorder Treatment With Deep Brain Stimulation
NCT Number: NCT06542224
Acronym: DBS OCD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obsessive-Compulsive Disorder
Interventions: PROCEDURE: Deep Brain stimulation
Sponsor: West China Hospital
Collaborators: Beijing Pins Medical Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-03
Completion Date: 2026-12-03
Locations: West CHina Hospital，Sichuan University, Chengdu, Sichuan, 610041, China|The First People's hospital of Longquanyi District, Chengdu, Sichuan, China|Zigong Fifth People's Hospital, Zigong, Sichuan, China|Zigong Fourth People's Hospital, Zigong, Sichuan, China

Summary:
Obsessive-compulsive disorder (OCD) is a complex and severe mental illness characterized by multiple symptoms and is considered a leading cause of non-fatal health loss. However, nearly 20% of patients do not respond to standard pharmacological or psychological treatments. Currently, we lack objective brain-based biomarkers. To address this issue, we used a novel device for electrophysiology recording and applied deep brain stimulation (DBS) to 16 OCD patients. In this study, we aim to use long-term invasive neural signal collection and machine learning techniques to reveal the complex relationship between these signals and OCD symptoms. By applying advanced machine learning algorithms, our goal is to establish highly accurate prediction models to identify biomarkers associated with the occurrence and progression of OCD. The research will focus on the spatiotemporal features of neural signals and build personalized OCD decoding models based on individual differences through the integration and analysis of large-scale data. By delving into the information contained in neural signals, we hope to provide academic and practical innovations for the development of personalized treatment approaches for OCD.

Primary Outcome Measures: Identifying an electrophysiological biomarker of OCD, Percentage of patients in which an electrophysiological biomarker of OCD can be identified before initial DBS, 30 days
Self-Efficacy Levels of Nurses on Safe Blood and Blood Product Transfusion
NCT Number: NCT06542185
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: To Evaluate the Effect of Online Education on Nurses' Self-efficacy Regarding Blood Transfusion
Interventions: OTHER: online education
Sponsor: Yuksek Ihtisas University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-05-20
Completion Date: 2024-07-30
Locations: Yüksek Ihtisas University, Ankara, Çankaya, Turkey

Summary:
A quasi-experimental study was conducted in a pre-test-post-test design to investigate the self-efficacy levels of nurses working in a cardiovascular surgery Intensive Care Unit regarding safe blood and blood product transfusion and the effects of online training.

Primary Outcome Measures: Personal Information Form, This form, prepared by researchers, includes a total of 13 questions that include nurses' personal and professional characteristics as well as their experiences with blood transfusion (age, gender, professional experience, education, having performed a transfusion, etc.)., 20 minutes
Secondary Outcome Measures: Blood Products Transfusion Self-Efficacy Scale (SBT-SES), Blood and Blood Products Transfusion Self-Efficacy Scale contains 49 items. The 5-point Likert type scal. Behavioral Sub-Factor with 16 items; Cognitive Sub-Factor with 14 items; The Attitudinal Sub-Factor consists of 13 items; The Negative Sub-Factor consists of six items. The six items in the negative sub-dimension are reverse and should be reverse-coded during analysis. The minimum score that can be obtained from the total scale is 49 and the maximum score is 245. As the scores obtained from the entire scale and its sub-dimensions increase, it is evaluated that the self-efficacy of nurses for safe blood and blood product transfusion practices increases., 50 minutes
Impact of Low-fat and Full-fat Milk on Lipids and Cardiac Function in Patients With Coronary Artery Disease
NCT Number: NCT06542172
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Artery Disease
Interventions: DIETARY_SUPPLEMENT: 500 mL/day of full-fat milk from corn-fed cows (fat >3.8%) for 12 weeks|DIETARY_SUPPLEMENT: 500 mL/day of full-fat milk from grass-fed cows (fat >3.8%) for 12 weeks|DIETARY_SUPPLEMENT: 500 mL/day of low-fat milk (fat <1.5%) for 12 weeks
Sponsor: Chinese PLA General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2020-09-03
Completion Date: 2021-03-04
Locations: Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing, China|Chinese PLA General Hospital, Beijing, China|Dongzhimen Hospital, Beijing, China|The Third Military Medical University of the Chinese people's Liberation Army, Chongqing, China|The Second Affiliated Hospital of Kunming Medical University, Kunming, China|Nanjing First Hospital, Nanjing, China|Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China

Summary:
This trial aimed to investigate the effects of low-fat and full-fat milk on patients with coronary artery disease (CAD).

Primary Outcome Measures: differences in lipids, sphingolipids, and cardiac function between the three groups after 12 weeks of intervention, The lipids contain total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), small dense LDL (sd LDL), large buoyant LDL (lb LDL), phospholipids, apolipoprotein A Ⅰ (apoA Ⅰ), apolipoprotein B (apoB), and lipoprotein (a). Sphingomyelins (C16:0, C20:0, C20.1:0, C22:0, C24.1:0) as well as their metabolites such as ceramides (C16:0, C18:0, C18.1:0, C20:0, C20.1:0, C22:0, C24:0, C24.1:0), sphingosine, and sphingosine 1-phosphate, were also measured., after 12 weeks of intervention
Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases
NCT Number: NCT06542159
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Adaptive Radiotherapy|Stereotactic Body Radiotherapy|Non-small Cell Lung Cancer|Lung Oligometastases|Toxicity
Interventions: RADIATION: Online adaptive SBRT|RADIATION: Conventional SBRT
Sponsor: Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-22
Completion Date: 2028-04-21
Locations: Sun yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
This study aims to explore the safety and efficacy of eliminating the PTV (planning target volume) margins based on online adaptive stereotactic radiotherapy for patients with early-stage non-small cell lung cancer (NSCLC) or pulmonary oligometastases.

Primary Outcome Measures: Incidence of grade 2 or higher respiratory toxicity, Incidence of grade 2 or higher respiratory toxicity, 1 year
Secondary Outcome Measures: Objective response rate, Objective Response Rate (ORR) is defined as the proportion of patients whose tumor size decreases to a pre-specified value and is maintained for a certain period of time during cancer treatment. It includes the number of patients with Complete Response (CR) and Partial Response (PR) as a percentage of the total number of evaluable cases., 2 months after radiotherapy|Local control rate, The control of the local lesion after treatment., 2 year
Impact of Dietary Intervention on Children of ADHD at Sohag University Hospital
NCT Number: NCT06542146
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Attention Deficit Hyperactivity Disorder
Interventions: DIETARY_SUPPLEMENT: Mediterranean diet|DIETARY_SUPPLEMENT: Usual diet
Sponsor: Sohag University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-09-01
Locations: Sohag university Hospital, Sohag, Egypt

Summary:
Attention-deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder of persistent impairment of attention, hyperactivity, and impulsivity which worsens daily functioning and quality of life , including social troubles , poor academic achievement and occupational problems .It is one of the most common psychiatric disorders between children . The prevalence of ADHD was 7.2% all over the world in 2015 and this percentage is increasing every year . In Arab countries, A systematic review of studies reported that the prevalence of ADHD ranged from 1.3% to 16%. . ADHD has been treated with medical treatment such as psychostimulants (methylphenidate and amphetamines), noradrenergic treatment as atomoxetine and alpha-2A-adrenergic agonists as guanfacine and clonidine , behavioral treatment and their combination . Due to adverse effects of medical treatments and behavioral therapy limitations, other approaches to augment multimodal ADHD management has been tested . Non medical treatment as Digital therapeutics may improve cognitive functions and attention in ADHD . Physical activity interventions for ADHD may improve cognitive , physical and psychological functions.

Primary Outcome Measures: Severity of ADHD symptoms, WEISS functional impairment rating scale-parent form (WFIRS-P) to assess the severity of ADHD symptoms, 6 months
AVEIR Remote Care System Non-Significant Risk Study
NCT Number: NCT06542133
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiac Pacemaker|Cardiac Rhythm Disorder|Bradycardia
Interventions: DEVICE: AVEIR remote care system
Sponsor: Abbott Medical Devices
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-10
Completion Date: 2024-08-30
Locations: Arrhythmia Research Group, Jonesboro, Arkansas, 72401, United States|Arkansas Heart Hospital, Little Rock, Arkansas, 72211, United States|Premier Cardiology, Inc, Newport Beach, California, 92663, United States

Summary:
The goal of the study is to understand the performance of the AVEIR Remote Care System in an initial patient cohort which will inform the ability to offer a remote follow-up solution to all patients implanted with Aveir LP devices.

Primary Outcome Measures: Successful end-to-end transmission performance metrics, Successful transmission performance metrics of the AVEIR Remote Care System in approximately 32 subjects who have received an Aveir LP implanted system as part of their standard of care., The expected duration of each subject's participation is approximately 30 minutes for an in-clinic visit to complete two transmissions and thereafter an optional at-home transmission (expected duration 10-15 minutes)
Research on Body Voice AI Recognition System for Children's Health Management
NCT Number: NCT06542120
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Congenital Heart Disease|Bronchopneumonia|Abdominal Disease
Interventions: DIAGNOSTIC_TEST: Heart Auscultation and Echocardiography|DIAGNOSTIC_TEST: Chest Auscultation and Chest imaging examinations|DIAGNOSTIC_TEST: Abdominal Auscultation and Abdominal imaging examinations
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-21
Completion Date: 2025-12-30
Locations: Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Hospital), Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430016, China|Human Children's Hospital, Changsha, Hunan, 410007, China|Xinhua Hospital,Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200092, China|Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, 200127, China|Kunming children's Hospital, Kunming, Yunnan, 650028, China

Summary:
The purpose of this research is to develop a body voice artificial intelligence (AI) recognition device, also referred to as an AI-assisted body sound identification device, by utilizing a deep learning-based novel AI algorithm in conjunction with a big body voice model. It could identify normal and abnormal heart, breath, and bowel sounds, and to provide early screening and auxiliary diagnosis of congenital heart disease (CHD), respiratory infections, diarrhea and other common multi-occurring diseases.

Primary Outcome Measures: Sensitivity, Sensitivity in CHD, lung disease and abdominal screening by different artificial intelligence algorithm and auscultation, 1 month|Specificity, Specificity in CHD, lung disease and abdominal screening by different artificial intelligence algorithm and auscultation, 1 month|AUC, AUC in CHD, lung disease and abdominal screening by different artificial intelligence algorithm and auscultation, 1 month
Weaning From Mechanical Ventilation in Patients With Acute Brain Injury
NCT Number: NCT06542107
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ventilator Lung|Acute Brain Injury
Sponsor: Southeast University, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 406
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-05
Completion Date: 2025-09-30
Locations: Ling Liu, Nanjing, Jiangsu, 210009, China

Summary:
Acute brain injury (ABI) patients frequently necessate intubation and invasive mechanical ventilation (IMV). While some ABI patients are capable of breathing spontaneously, which is one of the main criteria of extubation and weaning. However, the rate of extubation failure was significantly higher in ABI patients compared with non-neurological critical care patients. In patients who have failed one or several trials of extubation, tracheostomy is recommend according to the latest ESICM consensus. Tracheostomy can enhance comfort, improve pulmonary hygiene and decrease sedation requirement, which could facilitate the liberation from ventilator.

Numerous studies have explored the causes of weaning failure and provide various predictive models in guiding extubation and tracheostomy. Yet, due to limitations of such as small sample size or a lack of external validation, there is paucity of practical weaning algorithm tailored for ABI patients. The liberation from IMV in ABI patients still remains challenging with poor level of evidence in current guidelines or expert consensus.

We aim to describe the weaning outcomes in ABI patients, and further investigate the potential predictors of weaning success in ABI patients.

Primary Outcome Measures: weaning success, successfully weaned from invasive ventilation according to WIND classification, up to 7-day period (ICU stay)
Secondary Outcome Measures: extubation, Extubation without the need for reintubation or death within a 7-day period, or upon ICU discharge, whichever occurs first, up to 7-day period (ICU stay)
Other Outcome Measures: tracheostomy, tracheostomy during ICU stay, up to 7-day period (ICU stay)
Identifying Local Field Potential Biomarkers for Treatment-Resistant Major Depression With Deep Brain Stimulation
NCT Number: NCT06542094
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Major Depressive Disorder|Treatment Resistant Depression
Interventions: PROCEDURE: Deep Brain stimulation
Sponsor: West China Hospital
Collaborators: Beijing Pins Medical Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-03
Completion Date: 2026-12-03
Locations: West CHina Hospital，Sichuan University, Chengdu, Sichuan, 610041, China

Summary:
Major depressive disorder (MDD) is a complex and severe mental illness, characterized by multiple symptoms, and is a leading cause of non-fatal health loss. Despite this, approximately 30% of patients do not respond to standard pharmacological or psychological treatments. Currently, we lack objective brain-based biomarkers to differentiate between natural mood fluctuations and situations requiring intervention. To address this issue, we employed a novel electrophysiology recording device and applied deep brain stimulation (DBS) to 12 MDD patients. Our study aims to use long-term invasive neural signal collection and machine learning techniques to reveal the complex relationship between these signals and depressive symptoms. By applying advanced machine learning algorithms, our goal is to establish highly accurate prediction models to identify biomarkers associated with the occurrence and progression of depression. The research will focus on the spatiotemporal features of neural signals and build personalized depression decoding models based on individual differences through the integration and analysis of large-scale data. By delving into the information contained in neural signals, we hope to contribute to the development of personalized treatment approaches for depression.

Primary Outcome Measures: Identifying an electrophysiological biomarker of MDD, Percentage of patients in which an electrophysiological biomarker of OCD can be identified before initial DBS, 30 days