pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
The Effectiveness of Audiovisual Intervention
NCT Number: NCT06525142
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parent-Child Relations|Premature; Infant, Light-for-dates|Premature Infant Disease
Interventions: BEHAVIORAL: Audiovisual Intervention
Sponsor: Chang Gung Memorial Hospital
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 99
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07
Completion Date: 2026-06-05

Summary:
The objective of this clinical study is to understand the current status of parent-child bond, parenting role perception and well-being of fathers of preterm infants, and to explore the effect of audio-visual interventions on parent-child bonding, parenting role perception and well-being of fathers of preterm infants. The main questions it aims to answer are:

* After intervention, whether the parent-child connection between fathers and preterm infants in the audio-visual group is higher than that in the audio-visual group and the control group
* After the intervention, whether the father's perception of parenting role in the audio-visual group is higher than that of the vocal group and the control group
* After intervention, whether the father's happiness in the audio-visual group is higher than that in the audio-visual group and the control group The investigators will compare the pre- and post-test methods bwtween the experimental groups and the control group. The fathers of enrolled preterm infants will fill in the structured questionnaires at the time before the intervention (Baseline data) and one month later after the intervention.

Primary Outcome Measures: Postpartum Bonding Questionnaire, This questionnaire was designed by Brockington et al and published in 2001. The scale is a 5-point Likert's score. The higher score means a better parent-child bounding., one month|Paternal Role Significance Questionnaire, This questionnaire was designed by Bruce et al and published in 1999. The scale is a 4-point Likert's score. The higher score means a better significance of paternal role., one month|Satisfaction With Life Scale, This questionnaire was designed by Diener et al and published in 1985. The scale is a 7-point Likert's score. The higher score means a better satisfaction with life., one month|Positive and Negative Affect Schedule (PANAS), This questionnaire was designed by Diener et al and published in 1995. The scale is a 7-point Likert's score. The higher score means more perceived happiness in life., one month
MRD Detection by NGS in Pediatric T-ALL
NCT Number: NCT06525116
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Acute Lymphoblastic Leukemia, Pediatric
Interventions: OTHER: MRD
Sponsor: The Children's Hospital of Zhejiang University School of Medicine
Sex: ALL
Age: CHILD, ADULT
Enrollment: 69
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-02-01
Completion Date: 2022-12-31
Locations: The Children's Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310003, China

Summary:
This retrospective analysis aims to investigate pediatric patients with T cell acute lymphoblastic leukemia who were detected for minimal residual disease (MRD) using next-generation sequencing (NGS). The study will utilize second-generation sequencing technology to analyze the rearrangement of the T cell receptor (TCR) genes in these patients. Patients will be stratified based on NGS-MRD levels, and the relationship between NGS MRD and Event-Free Survival (EFS) will be evaluated.

Primary Outcome Measures: event-free survival, The EFS time was calculated from the date of diagnosis to the last date of follow-up or the first event., Between February 2018 and December 2022
PEMT Versus WBV on Quadriceps Strength Post Burn
NCT Number: NCT06525103
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Burns of Thigh
Interventions: DEVICE: electromagnitic field therapy|DEVICE: whole body vibration
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2024-12

Summary:
The purpose of the study is to evaluate which is more effective pulsed electromagnetic field therapy or whole-body vibration on quadriceps strength after chronic burn.

Primary Outcome Measures: measure the strengh of quadriceps, evaluate which is more effective pulsed electromagnetic field therapy or whole-body vibration on quadriceps strength after chronic burn, basline
Turkish Version of Child-Friendly Oral Health Questionnaire
NCT Number: NCT06525090
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Tooth Diseases|Oral Disease
Interventions: OTHER: no intervention-child-administered questionnaires
Sponsor: Muğla Sıtkı Koçman University
Collaborators: recep kara|özgül Cartı Dörterler|gülay manav
Sex: ALL
Age: CHILD
Enrollment: 298
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-05-01
Completion Date: 2021-12-31
Locations: 12 Primary Schools, Fethiye, Turkey

Summary:
Oral problems are a common occurrence among school-age children. In order to develop effective oral health interventions and services, it is essential to determine children's oral health behaviours using an internationally accepted standardised instrument that is child-friendly. However, no instrument currently exists to measure oral health according to the Theory of Planned Behaviour (TPB) in Turkish school-aged children. The aim of this study was to investigate the psychometric properties of the Oral Health Questionnaire, which includes the components of the theory of planned behavior such as attitude toward children's oral health, subjective norm, perceived behavioral control, and self-efficacy, for the Turkish population

Primary Outcome Measures: reliability, To measure stability of the test over time by Turkish Version of Child-Friendly Oral Health Questionnaire. Turkish Version of Child-Friendly Oral Health Questionnaireis filled with two week interval., 2 months|validity, To test in order to establish the correlation among the proposed instrument and instruments that had already been translated and validated. factor analysis was done., 6 months
Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)
NCT Number: NCT06525077
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Idiopathic Hypersomnia
Interventions: DRUG: FT218|OTHER: Placebo
Sponsor: Avadel
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-09
Locations: Alpine Clinical Research Center, Boulder, Colorado, 80301, United States|Florida Pediatric Institute, Winter Park, Florida, 32789, United States|Clinical Research Institute, Stockbridge, Georgia, 30281, United States|Clinical Neurophysiology Services PC, Sterling Heights, Michigan, 48314, United States|Advanced Respiratory and Sleep Medicine, Huntersville, North Carolina, 28078, United States|Bogan Sleep Consultants, Columbia, South Carolina, 29201, United States

Summary:
This is a double-blind, placebo-controlled, randomized withdrawal, multicenter study of the efficacy and safety of FT218 with an open-label safety extension period. FT218 drug product is a once-nightly formulation of sodium oxybate for extended-release oral suspension. The study will enroll subjects who are diagnosed with idiopathic hypersomnia. Subjects will be eligible to enroll regardless of current treatment with oxybate therapy or stimulants/alerting agents at study entry. The estimated total duration of study for each subject is approximately 42 weeks, including the open-label safety extension period.

Primary Outcome Measures: Epworth Sleepiness Scale (ESS), Change in total ESS score, End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]
Secondary Outcome Measures: Patient Global Impression of change (PGI-C), Worsening of idiopathic hypersomnia symptoms as assessed by subject, End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]|Idiopathic Hypersomnia Severity Scale (IHSS), Change in total IHSS score, End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]|Clinical Global Impression of change (CGI-C), Worsening of idiopathic hypersomnia symptoms as assessed by clinician, End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]|Functional Outcomes of Sleep Questionnaire (FOSQ-10), Change in total FOSQ-10 score, End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]
Health-E You Efficacy Trial for Male Adolescents
NCT Number: NCT06525064
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sexually Transmitted Diseases|Sexual Health|Reproductive Health
Interventions: OTHER: Health-E You app
Sponsor: Johns Hopkins University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sex: MALE
Age: CHILD, ADULT
Enrollment: 1866
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2025-01
Completion Date: 2027-12
Locations: Johns Hopkins University, Baltimore, Maryland, 21287, United States

Summary:
This study will involve evaluating Health-E You/Salud ìTu™, a web-based, pre-visit mobile app designed to support adolescent male youth and his clinicians in discussing sexual and reproductive health (SRH) topics and care. It will test its efficacy among male patients in clinical settings using a stepped wedge cluster randomized controlled trial design.

Primary Outcome Measures: Correct Condom Use Self-Efficacy Scale, Higher score indicates greater self-efficacy for correct use of male condoms. This measure is scaled with range from 1 (very difficult) to 5 (very easy); range 7-35., Baseline, 24 hours after visit, 2-month follow-up|Perceived efficacy in patient-physician interactions (PEPPI), Higher score indicates greater efficacy in patient-physician interaction about sexual and reproductive health. This measure is scaled with range from 1 (not at all confident) to 5 (very confident); range 5-25., Baseline, 24 hours after visit, 2-month follow-up|Frequency condom use, Measures frequency condom use with main \& non-main partners in past year and last 2 months, Baseline, 2-month follow-up|Sexual and reproductive care receipt, Measures receipt of the recommended sexual and reproductive care package, based on national guidelines outlined by the Centers for Disease Control and Prevention (CDC) Office of Population Affairs (OPA) Quality Family Planning guidance \& American Academy of Pediatrics' Bright Futures, Baseline, 24 hours after visit, 2-month follow-up
Effect of Tiotropium on Eye Findings in the Treatment of Chronic Obstructive Pulmonary Disease
NCT Number: NCT06525051
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Chronic Obstructive Pulmonary Disease|Glaucoma, Angle-Closure
Interventions: DRUG: Tiotropium
Sponsor: Giresun University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 108
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-23
Completion Date: 2024-04-30
Locations: Giresun Training and Research Hospital, Giresun, Gi̇resun, 28100, Turkey

Summary:
This study aimed to examine the effect of Tiotropium, which is used in the treatment of COPD, on eye symptoms.The study was conducted prospectively. Patients were examined in three groups. Thirty-six patients were included in each group in the study. Anterior chamber parameters, intraocular pressure values, and photopic-mesopic pupil diameters were measured at the initial visit for Group 1 and Group 2 patients, and at the third month of treatment for Group 3 patients.

Primary Outcome Measures: Tiotropium causes narrowing of the eye angles and an increase in intraocular pressure and pupil diameters., Tiotropium 18 mcg is a long-acting anticholinergic drug used in the treatment of COPD. In patients diagnosed with COPD who do not receive any steroid treatment and who are not diagnosed with hypertension, glaucoma, diabetes mellitus, cataract and who have not undergone eye surgery and using only handhaler Tiotropium 18 microgram, a narrowing of the eye angles, an increase in photopic-mesopic pupil diameters and intraocular pressure were detected in the third month of treatment., Measurements were made in the third month of Tiotropium treatment.
Secondary Outcome Measures: Tiotropium did not cause acute angle-closure glaucoma in COPD patients., Tiotropium 18 mcg is a long-acting anticholinergic drug used in the treatment of COPD. In patients diagnosed with COPD ( who do not receive any steroid treatment and who are not diagnosed with hypertension, glaucoma, diabetes mellitus, cataract and who have not undergone eye surgery ) using only handhaler Tiotropium 18 microgram, open angle-closure glaucoma was not observed., Measurements were made in the third month of Tiotropium treatment.
PRISMA 7 and SARC-F in Predicting Emergency Department Readmission and Mortality
NCT Number: NCT06525038
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Frailty|Sarcopenia|Morality
Interventions: OTHER: All groups were observed for clinical end-points described in the study protocol
Sponsor: Firat University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2023-09-30
Locations: Firat University School of Medicine, Elazig, 23119, Turkey

Summary:
Frailty scores can predict hospitalization and other related adversities. Thus, the frailty status determination is useful in clinical decisions regarding elderly patients. This study aimed to evaluate the potential of PRISMA-7 and SARC-F scores in predicting hospitalization following emergency department (ED) admission, readmission at 1, 3, and 6 months, and mortality within a 6-month follow-up period.

Primary Outcome Measures: Mortality, up to 6 months|Readmission to the Emergency Department, up to 6 months
Building a Traditional Chinese Medicine Clinical Diagnosis and Treatment Database
NCT Number: NCT06525025
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Medicine, Chinese Traditional|Artificial Intelligence
Interventions: OTHER: Observational study, non intervention
Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-08-15

Summary:
Collecting Traditional Chinese Medicine (TCM) clinical diagnosis and treatment data, including doctor-patient dialogues, tongue diagnosis, facial diagnosis, and TCM constitution information, to construct databases for tongue diagnosis, TCM constitution, and doctor-patient dialogues. Based on artificial intelligence technology, engage in research related to the standardization and intelligentization of TCM.

Primary Outcome Measures: Development of a tongue image-based machine learning tool, 1. It is anticipated to enroll 50,000 samples to establish a Traditional Chinese Medicine (TCM) tongue appearance database.
2. The tongue images will undergo quality selection and preprocessing.
3. The tongue images will be manually annotated, with 40% allocated to the training group and 60% to the testing group.
4. For the training group: A TCM tongue appearance model will be constructed based on the manually annotated tongue images.
5. For the testing group: The TCM tongue appearance model will be used to interpret the tongue images.
6. Analyze the consistency between the tongue appearance interpretations by the model built from the training group and the readings by TCM physicians for the testing group's tongue images., 20 months
Secondary Outcome Measures: TCM Constitution Multimodal Model, 1. It is projected to include 20,000 samples to construct a Traditional Chinese Medicine (TCM) constitution database.
2. Of these, 15,000 samples will complete the TCM constitution survey questionnaire and have their tongue and facial diagnosis data collected.
3. Based on the data from step 2, a multimodal TCM constitution assessment model will be constructed.
4. An additional 5,000 samples will be tested, first by completing the multimodal TCM constitution assessment model, and then the TCM constitution survey questionnaire.
5. Analyze the consistency between the readings of the TCM constitution assessment model and the results from the TCM constitution survey questionnaire generation, and treatment plan recommendations, prepare in advance for optimizing interactive large-scale TCM models., 20 months
Other Outcome Measures: Traditional Chinese Medicine (TCM) Doctor-Patient Dialogue Database, 1. It is anticipated to include 10,000 samples to construct a Traditional Chinese Medicine (TCM) doctor-patient dialogue database.
2. Optimize the TCM large model, which mainly includes the following aspects: a Q\&A system, assistance in medical record generation, and recommendation of diagnosis and treatment plans., 20 months
Observational Study on Mortality and Outcome of Patients Hospitalized for Subarachnoid Hemorrhage of Aneurysmal Origin in Martinique Between 2013 and 2021
NCT Number: NCT06525012
Acronym: HSA Rankin
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Subarachnoid Hemorrhage of Aneurysmal Cause
Interventions: OTHER: Usual patient care for patients hospitalized for subarachnoid hemorrhage of aneurysmal origin
Sponsor: University Hospital Center of Martinique
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 122
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-19
Completion Date: 2025-03-01
Locations: University Hospital Center of Martinique, Fort-de-France, 97261, Martinique

Summary:
The aim of our study is to analyze mortality and sequelae of subarachnoid hemorrhage of aneurysmal origin in hospitalized patients in Martinique. Predictive factors of poor prognosis will also be analyzed.

Primary Outcome Measures: Evaluate mortality in patients hospitalized for subarachnoid hemorrhage of aneurysmal origin over a 9-year period (2013-2021) in Martinique., Mortality of subarachnoid hemorrhage of aneurysmal origin., 6 months
Secondary Outcome Measures: Evaluate the clinical outcome of these patients., Patient's clinical outcome (mortality, impairment of patient autonomy, impairment of patient's level of dependece), assessed with the modified Rankin score at discharge and at a distance from hospitalization (minimum delay: 2.5 years)., 6 months|Analyze the factors associated with a significant impairment of autonomy and/or dependence., Predictive factors associated with significant impairment of patient autonomy and/or dependence (modified Rankin score = 4 or 5): age, degree of consciousness at the time of treatment (WFNS score), amount of blood in the meningeal spaces (Fisher score), aneurysm size, 6 months|Analyze the factors associated with death., Predictive factors associated with death (modified Rankin score = 6): age, degree of consciousness at the time of treatment (WFNS score), amount of blood in the meningeal spaces (Fisher score), aneurysm size., 6 months|Analyze the factors associated with a poor prognosis (death AND/OR significant impairment of autonomy/dependence)., Predictive factors associated with a poor prognosis (modified Rankin score ≥ 4: death AND/OR impaired patient autonomy and/or dependence): age, degree of consciousness at the time of treatment (WFNS score), amount of blood in the meningeal spaces (Fisher score), aneurysm size., 6 months
The Effect of Self-Efficacy Promoting Program Using Computer Game on Proteinuria in Thai Children With Nephrotic Syndrome
NCT Number: NCT06524986
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nephrotic Syndrome in Children
Interventions: BEHAVIORAL: Self-efficacy promoting program using computer game|BEHAVIORAL: Standard nursing care
Sponsor: Chulalongkorn University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-03-01
Completion Date: 2023-07-30
Locations: Faculty of Nursing, Chulalongkorn University, Pathum Wan, Bangkok, 10330, Thailand

Summary:
Nephrotic syndrome is a medical condition where the kidneys release substantial amounts of protein into the urine, resulting in various issues such as tissue swelling and an increased susceptibility to infections. Emphasizing the importance of adequate nutrition and symptom monitoring is crucial in managing urine protein levels and mitigating associated complications.

The purpose of this study was to boost self-efficacy through a computer game-based program, aiding pediatric patients with Nephrotic syndrome in the adoption of healthy eating habits and efficient management of urine protein levels.

Primary Outcome Measures: Protein levels in the urine, Urine dipstick test assessments with COMBI-SCREEN® GP test strips, Change from Baseline Protein levels in the urine at 5 weeks, followed by three days of consecutive follow-up calls
Biodentine Pulpotomy vs Metapex Pulpectomy in Primary Molars: Clinical & Radiographic Comparison of Outcomes in Irreversible Pulpitis Cases
NCT Number: NCT06524921
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Caries
Interventions: PROCEDURE: dental pulpectomy using metapex|PROCEDURE: dental pulpectomy using biodentine
Sponsor: Mohamed Ahmed Hamdi Abo El Yamin
Sex: ALL
Age: CHILD
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-09-15

Summary:
Irreversible pulpitis is defined as a clinical diagnostic based on subjective and objective findings suggesting that the vital inflamed pulp is incapable of healing in the American Association of Endodontists (AAE) Consensus Conference Recommended Diagnostic Terminology. Other characteristics include persistent heat discomfort, transferred pain, spontaneous pain, or no clinical symptoms but caries-induced inflammation, caries excavation, and trauma.".

Dental caries is one of the most frequently occurring diseases affecting human beings that becomes a challenge for dentists as the disease progresses. The ultimate goal of operative and endodontic treatment is to preserve and maintain the vitality of pulp to allow continued development of odontogenic apparatus.

Primary Outcome Measures: Radiographic, Radiographic Furcation involvement: Furcation involvement will be assessed radiographically using DIGORA software, with visual interpretation assigning scores based on radiolucency levels: 0 for no radiolucency; 1 for radiolucency affecting up to ¼ of the furcation area extending towards the periapical region; 2 for radiolucency involving between ¼ and ½ of the furcation area extending towards the periapical region; and 3 for radiolucency affecting more than ½ of the furcation area extending towards the periapical region., Twelve Months
Secondary Outcome Measures: Clinical, The presence of postoperative pain:The Wong-Baker FACES Pain Rating Scale, a self-report tool for acute pain, will be used to assess spontaneous pain and pain on biting. This scale ranges from 0 to 10, with six illustrated faces representing pain levels from "no hurt" to "hurts worst.", Twelve Months
Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
NCT Number: NCT06524882
Acronym: ATS24
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Amblyopia
Interventions: DEVICE: Vivid Vision|DEVICE: Luminopia|DEVICE: Optical Correction
Sponsor: Jaeb Center for Health Research
Collaborators: National Eye Institute (NEI)|Pediatric Eye Disease Investigator Group
Sex: ALL
Age: CHILD
Enrollment: 252
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-07-01

Summary:
Participants eligible for the study will be randomly allocated (1:1:1) to receive either Luminopia dichoptic treatment while wearing optical correction if needed, Vivid Vision dichoptic treatment while wearing optical correction if needed, or continued optical correction alone if needed, with clinical assessments at 9- and 18-weeks post-randomization.

At the 18-week primary outcome visit, participants who were randomly assigned to receive optical correction alone if needed with an IOD of 1 logMAR line (5 letters) or more, will be offered randomization to Luminopia or Vivid Vision dichoptic therapy and if they accept, followed forward with visits at 27- and 36-weeks post-randomization.

The study will end for all other participants at 18 weeks.

Primary Outcome Measures: Change in amblyopic eye logMAR distance VA, between randomization and 18 weeks, 18 Weeks
Secondary Outcome Measures: Functional Vision, Social, and Frustration/Worry quality of life domains as measured by the Pediatric Eye Questionnaire (PedEyeQ)., Questionnaire outcome, 18 Weeks
Association Between Neuromuscular Parameters and Functional Assessment After ACL Reconstruction
NCT Number: NCT06524869
Acronym: KASTLAB
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: ACL Injury
Interventions: DIAGNOSTIC_TEST: Isokinetic neuromuscular assessment
Sponsor: University Hospital, Caen
Sex: ALL
Age: ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-10
Completion Date: 2024-08-30
Locations: CHU Caen Normandie, Caen, 14000, France

Summary:
The anterior cruciate ligament (ACL) injury is common in athletes aged 18 to 35. ACL reconstruction (ACLR) aims to restore knee stability in the process of returning to sports. Post-surgical rehabilitation focuses on optimizing biomechanical parameters, with neuromuscular and functional tests assessing muscle strength, proprioception, and dynamic stability. Isokinetic allows the measurement of muscle strength symmetry and proprioception, while the single-leg hop and landing tasks assess functional stability and are predictive of sports resumption and injury prevention. Despite progress, concerns remain about neuromuscular factors impacting knee stability, especially during landings, which can increase the risk of secondary ACL injuries.

This study proposes examining knee strength and proprioception using isokinetic dynamometry, alongside biomechanical assessments from functional tests, to explore their relationship to biomechanical features during landings, at 6-to-12 months post-ACL reconstruction. The hypothesis is that better muscle strength and proprioception correlate with improved knee control during landing tasks.

Primary Outcome Measures: Passive proprioceptive evaluation, Measurement of knee proprioception by the passive repositioning technique (JPS, in degrees) on isokinetic dynamometer., One measurement during the visit at 6 to 12 months after surgery|Strength, Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer., One measurement during the visit at 6 to 12 months after surgery|Single Hop test, Measurement of knee position during landing from a single leg hop task, One measurement during the visit at 6 to 12 months after surgery|Single-leg landing task, Measurement of knee position during landing from a 30-cm box, One measurement during the visit at 6 to 12 months after surgery
Secondary Outcome Measures: Single Hop for Distance, The total distance is recorded (in cm), One measurement during the visit at 6 to 12 months after surgery|ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury), The ACL-RSI measures the patient's understanding of his knee. It comprises 12 questions with a score of 1 to 10 for each, One measurement during the visit at 6 to 12 months after surgery|Landing Error Scoring System (LESS), The LESS (Landing Error Scoring System) scale is a 13-item tool used to assess landing technique during a hop task., One measurement during the visit at 6 to 12 months after surgery
The Increase of Lung Capacity Using the Lung Master (Pulmonary Exerciser)
NCT Number: NCT06524856
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dyspnea|Chronic Obstructive Pulmonary Disease|Asthma
Interventions: DEVICE: Lung Master (Pulmonary Exerciser)
Sponsor: University of Nebraska
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08
Completion Date: 2025-03
Locations: Biomechanics Research Building, Omaha, Nebraska, 68182, United States

Summary:
Investigators are studying how a device called The Lung Master device can help people breathe better. The investigational device increases the amount of air our lungs can hold, which is important for overall lung health. The Lung Master is not approved by the FDA.

The study has two visits approximately one month apart. In the first visit participants will take a spirometry test, particularly forced vital capacity (FVC), to measure volume change in the lungs. Participants will take the investigational device home to use daily, either in the morning or evening. Use will be recorded in a diary. After one month, participants will return for another spirometry test. Each study visit will take about one to two hours to complete.

Primary Outcome Measures: Inspiratory Capacity, After reaching the end of a normal, quiet expiration, the maximum volume of air that can be inspired will be measured., baseline and after one month of device use|Tidal Volume, The amount of air that moves in or out of the lungs with each respiratory cycle will be measured., baseline and after one month of device use
Fracture Risk Evaluation of Bone Metastases Derived From Carcinoma
NCT Number: NCT06524843
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bone Metastases
Interventions: OTHER: Analysis
Sponsor: Costantino Errani
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-10
Locations: IRCCS Istituto Ortopedico Rizzoli, Bologna, Emilia-Romagna, 40134, Italy

Summary:
From the archives of the Rizzoli institute all patients (approximately 750) treated for bone metastases from 01/01/2010 to 31/12/2022.

A review will be made from the medical records, radiological imaging, and histological data of these patients

Primary Outcome Measures: Creation a dataset of clinical data and diagnostic images, Creation a dataset of clinical data and diagnostic images, called RAW, relating to patients suffering from metastatic bone cancer that will be used by the unit UNICH to create innovative models for fracture risk prediction and of life expectancy based on various patient clinical parameters., At baseline (Day 0)
A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression
NCT Number: NCT06524830
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Treatment Resistant Depression
Interventions: DRUG: VLS-01-203 BU|DRUG: VLS-01-BU Placebo
Sponsor: atai Therapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 142
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-31
Completion Date: 2026-03-30

Summary:
This Phase 2 study (protocol number VLS-01-203) will determine the efficacy, safety, and tolerability of short-term VLS-01-BU treatment in patients with TRD and will characterize the onset and durability of antidepressant effects of VLS-01-BU versus placebo.

Primary Outcome Measures: Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score, Baseline to Day 29
Secondary Outcome Measures: Change from Baseline in MADRS total score, Baseline to Day 43
Other Outcome Measures: Incidence and severity of adverse events, adverse events of special interest and serious adverse events, Baseline to Day 113|Incidence of clinically significant abnormalities in physical examinations, vital signs, electrocardiogram parameters, and safety laboratory results, Baseline to Day 113|Columbia-Suicide Severity Rating Scale (C- SSRS) scores, Baseline to Day 113
Prevalence of Faecal Bacteriophage in Patients With Digestive Symptoms
NCT Number: NCT06524791
Acronym: PREPHAGE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastroenteritis
Interventions: OTHER: bacteriophage detection
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-15
Completion Date: 2025-11-15
Locations: CHRU Nancy, Nancy, 54000, France

Summary:
Define the prevalence of fecal phage carriage in individuals with digestive symptoms (i) Determine the concentrations of infectious fecal phages in the stools of individuals with digestive symptoms (detection by culture)

(ii) Determine fecal phage genome concentrations in the stools of individuals with digestive symptoms (PCR detection)

(iii) Explore factors that could impact fecal phage carriage (patients with digestive symptoms vs. healthy individuals, immunocompromised patients vs. immunocompetent patients)

Primary Outcome Measures: prevalence of faecal phage carriage, define the prevalence of faecal phage (coliphage) carriage in individuals presenting with digestive symptoms., baseline
Secondary Outcome Measures: concentrations of infectious fecal phages, Determine the concentrations of infectious fecal phages in the stools of individuals with digestive symptoms (detection by culture), baseline|fecal phage genome concentrations, determine fecal phage genome concentrations in the stools of individuals with digestive symptoms (PCR detection), baseline
Single High-dose Brachytherapy for Giant Osteosarcoma Masses
NCT Number: NCT06524778
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Osteosarcoma
Interventions: RADIATION: brachytherapy
Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2027-06-30

Summary:
This study is a prospective, single-arm, phase II, single-center study. Patients with locally unresectable giant osteosarcoma masses who meet the criteria are enrolled in the experimental group, and all patients receive a single dose of 10Gy of implantable brachytherapy. Record treatment-related acute events during and after treatment. Follow up on survival and local control after treatment ends, marking the end of the trial treatment.

Primary Outcome Measures: progression-free survival, 6 months of progression-free survival, 6 months
Secondary Outcome Measures: progression-free survival, 12 months progression-free survival, 12 months|progression-free survival, 12 months of progression-free survival, 12 months|OS, 12 months of OS, 12 months|Adverse reactions related to radiotherapy, Adverse reactions, 12 months
Intestinal Microbiota and Their Antibiotic Resistance Genes of ICU Health Care Workers
NCT Number: NCT06524765
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intensive Care Unit
Interventions: OTHER: Living conditions
Sponsor: Wuhan Union Hospital, China
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2024-09-30

Summary:
In this study, metagenomic sequencing (10G) results of stool samples from health care workers in ICU and non-medical professionals were compared to observe whether there are significant differences in community diversity, structure and function of intestinal microbiota and whether there are drug resistance genes carried by intestinal microbes, so as to determine whether long-term exposure to multi-pathogen environment in ICU has an impact on intestinal microbiota.

Primary Outcome Measures: Differences of antibiotic resistance genes-within the gut microbiota, Metagenomic sequencing (10G) will be performed on three days after inclusion, to compare the differences of antibiotic resistance genes-within the gut microbiota between ICU health care workers and non-medical professionals., Within three days after inclusion.
Secondary Outcome Measures: Patient Health Questionnaire (PHQ-9) score., Correlation analysis of the relationship between the antibiotic resistance genes and the PHQ-9 score in ICU health care workers and non-medical professionals., Within three days after inclusion.|Symptom checklist 90 (SCL-90) score, Correlation analysis of the relationship between the antibiotic resistance genes and the SCL-90 score in ICU health care workers and non-medical professionals., Within three days after inclusion.|Perceived Stress Scale (PSS) score, Correlation analysis of the relationship between the antibiotic resistance genes and the PSS score in ICU health care workers and non-medical professionals., Within three days after inclusion.|International Physical Activity Questionnaire (IPAQ) score, Correlation analysis of the relationship between the antibiotic resistance genes and the IPAQ score in ICU health care workers and non-medical professionals., Within three days after inclusion.|Pittsburgh sleep quality indexs (PSQI) score, Correlation analysis of the relationship between the antibiotic resistance genes and the PSQI score in ICU health care workers and non-medical professionals., Within three days after inclusion.
Risk Factors for PONV in Patients Undergoing Hysteroscopic Surgery
NCT Number: NCT06524752
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Gynecologic Nursing|Postoperative Complications
Interventions: OTHER: The presence of nausea and vomiting within 24 hours after surgery|OTHER: Non-existence of nausea and vomiting within 24 hours after surgery
Sponsor: Weifang Medical University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1583
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-01-01
Completion Date: 2024-06-01
Locations: Weifang People's Hospital, Weifang, Shandong, 265100, China

Summary:
The purpose of this study was to construct and validate a risk prediction model for PONV in patients undergoing hysteroscopic day-case surgery.

Primary Outcome Measures: PONV, The occurrence and severity of PONV is evaluated by Visual Analogue Scale (VAS). The VAS scale ranges from 0 to 10, with larger scores meaning that the patient has more severe PONV., Within 24 hours after surgery
Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS
NCT Number: NCT06524739
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Post-COVID Postural Orthostatic Tachycardia Syndrome
Interventions: BIOLOGICAL: IgPro20|BIOLOGICAL: Placebo
Sponsor: CSL Behring
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 177
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2027-09-24
Locations: Center for Complex Neurology, EDS & POTS, Phoenix, Arizona, 85006, United States|Arkansas Cardiology, Little Rock, Arkansas, 72205, United States|The Heartbeat Clinic, Dallas, Texas, 75230, United States

Summary:
This is a prospective, phase 3, multicenter, double-blind, randomized placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics (PK) of repeat doses of IgPro20 in participants with post SARS-CoV-2 infection 2019 postural orthostatic tachycardia syndrome (post-Coronavirus Disease 2019 \[COVID-19\] POTS \[post-COVID-POTS\]).

Primary Outcome Measures: Proportion of participants no longer meeting diagnostic criteria of post-COVID POTS as measured by standardized standing test (ie, no longer experiencing HR increase of ≥ 30 bpm, in the absence of 20 mmHg decrease of SBP [orthostatic hypotension]), At screening, and at week 25
Secondary Outcome Measures: Change from baseline in orthostatic intolerance score of COMPASS-31, The Composite Autonomic Symptom Score 31 (COMPASS-31) is a self-reported questionnaire that measures autonomic symptoms related to 6 domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder and pupillomotor. The treatment effect of interest is differences from baseline in the orthostatic intolerance score of COMPASS-31., At baseline and at week 25|Change from baseline in COMPASS-31 total score, The COMPASS-31 is a self-reported questionnaire that measures autonomic symptoms related to 6 domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder and pupillomotor. This questionnaire generates a weighted score from 0 to 100, with higher scores representing higher symptom burden., At baseline and at week 25|Change from baseline in heart rate increase within 10 minutes of standing test, At baseline and at Week 25|Number of participants with treatment-emergent adverse events (TEAEs), related TEAEs, serious TEAEs and related serious TEAEs, After treatment, for up to 57 weeks|Percentage of participants with TEAEs, related TEAEs, serious TEAEs and related serious TEAEs, After treatment, for up to 57 weeks|Number of participants with electrocardiogram (ECG) abnormalities, At baseline, at Week 25 and at Week 53|Percentage of participants with ECG abnormalities, At baseline, at Week 25 and at Week 53|Change from baseline in ECG abnormalities, At baseline, at Week 25 and at Week 53
The International PNH Interest Group PNH Registry
NCT Number: NCT06524726
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Paroxysmal Nocturnal Hemoglobinuria
Sponsor: International PNH Interest Group
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-10
Completion Date: 2029-05-10
Locations: International PNH Interest Group, Altamonte Springs, Florida, 32714, United States

Summary:
The aim of this International PNH Interest Group (IPIG) registry is to develop an international database to prospectively collect data on patients with PNH covering clinical outcomes, patient reported outcomes (PROs), and health-resource utilization (HRU) on all enrolled patients, as well as long term safety data.

Primary Outcome Measures: Increase knowledge of PNH and describe the PNH patient population, To describe PNH disease natural history and PNH treatment course, the patterns of treatment usage, long-term safety of PNH treatments, assess patient reported quality of life and describe health resource usage, 5-10 years
A 5-Year Anesthetic Evaluation of Cases Undergoing Cesarean Section Delivery ın Our Clinic
NCT Number: NCT06524713
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anesthesia|Cesarean Section
Sponsor: Kocaeli University
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-01-01
Completion Date: 2024-12-31
Locations: Kocaeli University, Kocaeli, Turkey

Summary:
Despite global efforts to reduce the rate of cesarean section births worldwide, increase recommendations for elective induction of labor, and promote trials of vaginal birth after previous cesarean deliveries, cesarean rates are steadily rising, varying from country to country.

The management of obstetric patients requires the effective and safe application of anesthesia to anticipate and prevent emergencies, ensuring a positive experience for the mother, baby, and their family.

Neuraxial anesthesia is considered the gold standard for cesarean section births. In case of an emergency cesarean, the likelihood of general anesthesia increases, making the safe provision of anesthesia more challenging.

The choice of anesthesia technique for cesarean section is determined by considering maternal and fetal conditions, accompanying diseases, the urgency of surgery, and the difficulty of procedures.

In this study, the investigators will retrospectively examine the anesthesia records of all cesarean section cases treated in the clinic between 2018 and 2022. the investigators aim to analyze demographic data, the anesthesia methods applied, complications, the relationship between surgery time and anesthetic method, the association between anesthesia method and neonatal Apgar scores, and the type of postoperative analgesia administered in the clinic (including regional anesthesia, opioids, non-steroidal anti-inflammatory drugs if performed). The study will be descriptive in nature, aiming to provide insights into commonly applied methods and management in the researcher's clinic.

Primary Outcome Measures: Evaluating the anesthetic management of cesarean section cases in researcher's clinic., Researchers will retrospectively review patients' anesthesia records to examine anesthesia management in emergency and elective cases in the clinic., 2018-2022|Evaluating the anesthetic complications of cesarean section cases in researcher's clinic., Researchers will retrospectively review patients' anesthesia records to examine common anesthesia related complications in emergency and elective cases in the clinic., 2018-2022
Pectopexy Autologous vs Mesh
NCT Number: NCT06524700
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Uterine Prolapse|Vault Prolapse, Vaginal
Interventions: PROCEDURE: pectopexy mesh|PROCEDURE: pectopexy autologous
Sponsor: Ain Shams Maternity Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-02-01
Locations: Urogynecology Unit, Cairo, Egypt

Summary:
prospective comparative study describing using autologous graft for uterine- vault - cervical suspension vs mesh in treatment of apical prolapse

Primary Outcome Measures: POP-Q, assesment of degree of prolapse correction after surgery, 3 month
A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies
NCT Number: NCT06524687
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Idiopathic Inflammatory Myopathies|Inflammatory Myopathies
Interventions: DRUG: Imvotamab
Sponsor: IGM Biosciences, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-11
Locations: Standford University, Palo Alto, California, 94306, United States

Summary:
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with Moderate-Severe Idiopathic Inflammatory Myopathies who have failed prior therapies.

Participants will be given imvotamab through a vein (i.e., intravenously).

Primary Outcome Measures: Safety and tolerability of imvotamab, Incidence of adverse events (AEs), serious adverse events (SAEs), including serious, Time Frame: Up to Week 50