pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Study of Hemodynamic Cardiopulmonary Exercise for CHD
NCT Number: NCT06566196
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Congenital Heart Disease
Interventions: PROCEDURE: Cardiac Cath
Sponsor: Mayo Clinic
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10
Completion Date: 2026-12
Locations: Mayo Clinic, Rochester, Minnesota, 55905, United States

Summary:
The purpose of this study is to compare the difference in the ability to detect hemodynamic abnormalities between invasive hemodynamic assessments performed at rest versus exercise, to assess the correlation between invasive and noninvasive (Doppler-derived) rest-exercise hemodynamic indices and to compare the association between indices of disease severity and hemodynamic abnormalities identified at rest versus exercise.

Primary Outcome Measures: Change in left ventricular end-systolic elastance from rest to peak exercise, Change in left ventricular end-systolic elastance will be measured in ΔmmHg/mL, Baseline|Change in Left ventricular cardiac output from rest to peak exercise, Change in left ventricular cardiac output will be measured in ΔL/min, Baseline|Change in systemic vascular resistance from rest to peak exercise, Change in systemic vascular resistance will be measured in ΔWoods Units, Baseline|Change in right ventricular free-wall strain from rest to peak exercise, Change in right ventricular free-wall strain will be measured in Δ%, Baseline|Change in right ventricular cardiac output from rest to peak exercise, Change in right ventricular cardiac output will be measured in ΔL/min, Baseline|Change in pulmonary vascular resistance from rest to peak exercise, Change in pulmonary vascular resistance will be measured in ΔWoods Units, Baseline
Development and Evaluation of A Game-Based Mobile App for Increasing Physical Activity in Autistic Adults
NCT Number: NCT06566131
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism Spectrum Disorder
Interventions: BEHAVIORAL: Gamified mobile health app
Sponsor: University of Delaware
Collaborators: Autism Intervention Research Network on Physical Health
Sex: ALL
Age: ADULT
Enrollment: 75
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-29
Completion Date: 2025-12
Locations: Carpenter Sports Building, Newark, Delaware, 19716, United States|Carpenter Sports Building, Newark, Delaware, 19716, United States

Summary:
The clinical study aims to develop and test a gamified mobile health app called PuzzleWalk (PW) to promote physical activity (PA) and reduce sedentary behavior (SB) in autistic adults, including those with mild intellectual disabilities (ID). The study addresses the need for tailored interventions in this population, who are at higher risk for lifestyle-related chronic health conditions due to lower PA and higher SB. The upgraded version of PuzzleWalk integrates behavior change techniques and gamification strategies, such as translating step counts into puzzle game playtime, to encourage regular PA and reduce SB. The study will evaluate the app's effectiveness on preventive health behavior changes in real-world settings. The ultimate goal is to create an effective, sustainable, and scientifically validated mobile health tool to improve the health and well-being of autistic adults.

Primary Outcome Measures: Changes in MVPA levels, Objective accelerometer-measured MVPA (min/day), Baseline, 3 weeks, 5 weeks, and 8 weeks
Secondary Outcome Measures: Changes in self-reported PA, Measured using the Activities Completed over Time in 24-hours (ACT24). This is a web-based previous-day recall instrument (min/day)., Baseline, 3 weeks, 5 weeks, and 8 weeks|Engagement with the PW app, The level of user engagement in the PW app will be measured using a webmaster server that keeps track of user logs and timestamps (e.g., frequency and duration of app use and leaderboard scores). Time spent on the app in a min/day format will be calculated to represent each participant's level of user engagement., 3 weeks, 5 weeks, and 8 weeks|Changes in light PA levels, Objective accelerometer-measured light PA (min/day), Baseline, 3 weeks, 5 weeks, and 8 weeks|Changes in steps, Objective accelerometer-measured steps (counts/day), Baseline, 3 weeks, 5 weeks, and 8 weeks|Changes in sedentary time, Objective accelerometer-measured sedentary time (min/day), Baseline, 3 weeks, 5 weeks, and 8 weeks|Changes in self-reported sedentary time, Measured using the Activities Completed over Time in 24-hours (ACT24). This is a web-based previous-day recall instrument (min/day)., Baseline, 3 weeks, 5 weeks, and 8 weeks
Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants
NCT Number: NCT06566092
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Soft Tissue Sarcoma|Primary Central Nervous System Carcinoma|Melanoma|Rhabdomyosarcoma|Ewing Sarcoma
Interventions: BIOLOGICAL: LN-145/LN-144
Sponsor: Iovance Biotherapeutics, Inc.
Sex: ALL
Age: CHILD, ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-28
Completion Date: 2028-07
Locations: Rutgers Cancer Institute, New Brunswick, New Jersey, 08901, United States

Summary:
This study is planned to test the safety and tolerability of the TIL regimen. The study will also test how well TIL fights cancer. The study will enroll children, teenagers, and young adults with solid tumors that have returned or are not responding to treatment for whom no effective standard-of-care treatment options exist.

Study details include:

* The study will last up to 2 years after the TIL infusion (Day 0) for each person.
* The treatment will last up to 10 days for each person.
* Study visits will be every 2 weeks until Day 42, every 6 weeks until Month 6, and every 3 months until Year 2.

Primary Outcome Measures: Incidence rate of Treatment-Emergent Adverse Events, To evaluate the safety and tolerability of the TIL regimen that occurs from the start of TIL infusion and up to 30 days after TIL infusion per CTCAE., Up to 24 months
Secondary Outcome Measures: Objective Response Rate, To evaluate the proportion of participants who have confirmed complete response (CR) or partial response (PR) per RECIST v1.1 or RAPNO., Up to 24 months|Duration of Response, To measure the time that criteria are met for complete response (CR) or partial response (PR) per RECIST v1.1 or RAPNO., Up to 24 months|Disease Control Rate, To measure by the percentage of participants with best overall confirmed response of complete response (CR) or partial response (PR) at any time or stable disease (SD) for at least 4 weeks per RECIST v1.1 or RAPNO., Up to 24 months|Progression-Free Survival, To evaluate the time from the date of the TIL infusion until disease progression per RECIST v1.1 or RAPNO., Up to 24 months|Overall Survival, To measure the time from the date of TIL infusion to death due to any cause., Up to 24 months
Establishment of a Predictive System for Perioperative Risk Assessment and Electronic Flowcharting Response Strategies in Thoracic Surgery
NCT Number: NCT06566053
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Perioperative Complications
Interventions: OTHER: Observation
Sponsor: Hengxing Liang
Collaborators: Changsha Xinghong Network Technology Co.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-01
Completion Date: 2027-07-01
Locations: the Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China

Summary:
1. To establish a risk assessment scale for thoracic surgery for the Chinese population, and to classify patients; risk according to the relevant scale;
2. Combining the guidelines for the management of acute and critical illnesses in thoracic surgical care units and the characteristics of diagnosis and treatment operations, to make an AI-assisted diagnosis and treatment process software;
3. Evaluate whether the software can provide timely and correct diagnosis and treatment recommendations for critically ill patients, shorten the time for homogenized training of specialist intensivists, and reduce the hospitalization cost of patients under the review of resident training instructors of various specialties.

Primary Outcome Measures: Acute Respiratory Distress Syndrome, ARDS definition was based on the new global definition of ARDS10. Briefly, intubated ARDS was defined as an oxygenation index of less than 300 under a positive end-expiratory pressure (PEEP) of at least 5 cmH2O, and non-intubated ARDS was defined as patients receiving high-flow nasal oxygen (HFNO) ≥ 30 L/min or noninvasive ventilation/continuous positive airway pressure (NIV/CPAP) with a PEEP of at least 5 cmH2O and meeting PaO2:FiO2 ≤ 300 mm Hg or SpO2:FiO2 ≤ 315 (if SpO2 ≤ 97%)., 2024.8-2024.12
Secondary Outcome Measures: In hospital mortality, refers to the number or percentage of patients who die while being treated in a hospital., 2024.8-2024.12|Length of hospital stay, Length of hospital stay(days): refers to the total number of days a patient spends in the hospital from the time of admission to the time of discharge., 2024.8-2024.12|Length of ICU stay, Length of ICU stay(hours): refers to the total duration of time a patient spends in the Intensive Care Unit (ICU) during a single admission., 2024.8-2024.12|Length of postoperative stay, Length of postoperative stay(days): refers to the duration of time a patient remains in the hospital or medical facility after undergoing surgery., 2024.8-2024.12|Duration of mechanical ventilation, Duration of mechanical ventilation(hours): refers to the length of time a patient requires assistance from a mechanical ventilator to maintain adequate breathing., 2024.8-2024.12|Duration of HFNC, Duration of HFNC(hours): refers to the length of time that a patient is treated with High-Flow Nasal Cannula (HFNC) therapy., 2024.8-2024.12
Wheelchair Provision Time for Hospital Inpatients
NCT Number: NCT06566040
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Wheelchairs
Interventions: DEVICE: Wheelchair
Sponsor: Nova Scotia Health Authority
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 119
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2026-06

Summary:
In a Pilot Study, the median Wheelchair Lead Time (from when a wheelchair was ordered by an Occupational Therapist for an inpatient in the Central Zone of Nova Scotia Health to when the wheelchair arrived at the destination facility) of 119 wheelchairs was 2.98 days, with median Wheelchair Assembly Time and Wheelchair Delivery Time components of 0.98 and 1.00 days respectively. (For the over 3,000 inpatients/year for whom an order is placed, Wheelchair Delivery Time is not routinely recorded.) Reductions in Wheelchair Lead Time have the potential to speed patient mobilization (with benefits to the patient) and reduce both the patient's hospital Length of Stay and the patient-related Cost of Hospitalization. However, these potential benefits remain speculative. The objective of this project is to test the hypotheses that there are significant positive associations between Wheelchair Lead Time and both Length of Stay and the Cost of Hospitalization.

Primary Outcome Measures: Wheelchair Lead Time, Time from order placement to delivery to hospital site, Through initial study completion in 1 year
Secondary Outcome Measures: Length of stay, Duration of hospital admission, Through initial study completion in 1 year|Case cost, Cost of hospitalization, Through initial study completion in 1 year
Activator vs the EF Class II Standard in the Treatment of Severe Overjet in Angle Class II Division 1 Malocclusion
NCT Number: NCT06566027
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Class II Division 1 Malocclusion
Interventions: OTHER: Skeletal, dental, soft tissue index changes in Activator group
Sponsor: Can Tho University of Medicine and Pharmacy
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-04-01
Completion Date: 2024-06-01
Locations: Department of Orthodontics, Ho Chi Minh City Dental Hospital, Ho Chi Minh City, Vietnam

Summary:
Objective: The purpose of this study was to compare the clinical effectiveness of reducing severe overjet in Angle Class II division 1 malocclusion between Activator and the EF (Functional Education) class II standard in treating.

Methods: A randomized clinical trial was conducted on a total of ̉60 patients with an Angle Class II, division 1 malocclusion (ANB angle ≥ 4°, basic normal maxillary status), and an overjet of ≥ 6 mm in the developmental stage (CS1-CS3) who were eligible for the study. Thus, the sample consisted of 60 subjects (29 girls and 31 boys) with a mean age of 9.7 ± 1.31 years. The investigators designed the study to treat patients, randomly assigning them by lottery to receive either an activator or the EF (Functional Education) class II standard. The activator versus the EF (Functional Education) class II standard group consisted of 30 subjects (17 girls, 13 boys) and 30 subjects (12 girls, 18 boys), respectively. The changes in skeletal, dental, and soft tissue were recorded before, at 6 months of treatment. Blinding was not performed. After six months of treatment, the study's endpoint was reached.

Primary Outcome Measures: To compare the clinical effectiveness of reducing severe overjet in Angle Class II division 1 malocclusion between Activator and the EF (Functional Education) class II standard in treating., Every month, the research participants from both groups underwent regular re-examinations, during which they collected cephalometric radiographs for assessment at two specific time points: T0, before treatment, and T1 after 6 months of treatment. A Planmeca ProMax® 2D digital X-ray system (Planmeca, Poland) captured the cephalometric radiographs. The Dental Hospital used the licensed AudaxCeph program to accurately draw lines and perform measurements on the cephalometric images., 6 months
The Study Aims to Improve the Accuracy of Detecting Spina Bifida During Early Ultrasound Scans. To Achieve This, an AI Model Has Been Developed to Provide Feedback About the Presence of Spina Bifida. A RCT Has Been Designed to Compare the Effectiveness of AI Feedback With no AI Feedback.
NCT Number: NCT06566014
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spina Bifida
Interventions: OTHER: Evaluation of XAI-assisted spina bifida diagnosis
Sponsor: Copenhagen Academy for Medical Education and Simulation
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-01
Completion Date: 2024-11-30

Summary:
The study aims to improve the accuracy of detecting spina bifida during early ultrasound scans. To achieve this, an AI model has been developed to provide feedback about the presence of spina bifida. A RCT has been designed to compare the effectiveness of AI feedback with no AI feedback.

Primary Outcome Measures: Evaluation of XAI-assisted spina bifida diagnosis, The study aims to evaluate whether AI feedback improve the accuracy of diagnosing spina bifida by comparing the number of correct and incorrect responses in a task involving 20 images., One month after the survey is distributed.
Comparative Study Between Socket Shield Technique Versus Allograft Buccal Sheet Technique on Alveolar Bone Resorption After Immediate Implant Placement
NCT Number: NCT06566001
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bone Loss in Jaw
Interventions: PROCEDURE: control group
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-03-12
Completion Date: 2024-05-25
Locations: Cairo university, Giza, Egypt

Summary:
22 patient where divided randomly into 2 groups : control group did dental implant utilizing socket shield , while study group did dental implant with allogenic bone graft there is no significant bone loss between the two groups after 4 month follow up

Primary Outcome Measures: measure bone loss by CBCT, Measure bone loss by CBCT mm, 4 month
A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria® Voluma
NCT Number: NCT06565988
Acronym: DAG-VOL
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Midface Volume Deficit
Interventions: DEVICE: Decoria Voluma
Sponsor: Bohus Biotech AB
Collaborators: Key2Compliance AB
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 125
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-09
Locations: Inskinity, Göteborg, 411 07, Sweden|Göteborgs Laser & Estetik, Göteborg, 411 08, Sweden|Svenska Hudkliniker, Karlstad, 652 25, Sweden|Inskinity, Stockholm, 111 28, Sweden|Florakliniken, Stockholm, 113 28, Sweden|The Faculty, Stockholm, 114 46, Sweden|Svenska Hudkliniker, Stockholm, Sweden

Summary:
A post-market-clinical follow-up investigation of safety and performance of Decoria® Voluma by the correction of midface volume deficit by tissue augmentation in cheek region.

Primary Outcome Measures: Primary efficacy endpoint, The primary efficacy endpoint is the blinded evaluator assessment of improvement using the Global Aesthetic Improvement Scale (GAIS). GAIS is a comparative scale, based on assessment of change since before pre-intervention, which ranges from score 1 (exceptionally improved), 2 (much improved), 3 (improved), 4 (no change) to 5 (worse). The blinded evaluator will compare the pre-intervention face to post-intervention face and assign the level of improvement in cheek volume according to the GAIS grading. Each side of the face (left and right) will be assessed independently., From pre-intervention baseline, to 6 months post-treatment|Primary safety endpoint, The primary safety endpoint is to assess the safety of Decoria® Voluma, evaluated by the incidence, intensity, duration, and time of onset of related AEs, including injection site reactions, collected during the study duration., Baseline to end of study (6 months)
Secondary Outcome Measures: Secondary endpoint, 1. Pain will be measured by numerical scale Numeric Pain Rating Scale (NRS) (11-point verbal score completed for each target region treated) for each visit involving an injection., Baseline (visit 1) and (visit 2) (30 days post baseline)|Secondary endpoint, 2. GAIS score at 1- and 6-months post-treatment, as assessed by the treating investigator., 30 days and 180 days post treatment|Secondary endpoint, 3. GAIS score at 1- and 6-months post-treatment, as assessed by the subject., 30 days and 180 days post treatment|Secondary endpoint, 4. Treatment-related adverse events and injection site reactions reported after touch-up should be similar to those reported after initial treatment., Baseline (visit 1) and (visit 2) (30 days post baseline)|Secondary endpoint, 5. Change in cheek volume compared to baseline will be measured after treatment, as well as at

1- month and 6- months post-treatment visits., Baseline, 30 days and 180 days post treatment
The Effect of Carer Training on Pressure Ulcers in Palliative Patients
NCT Number: NCT06565949
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Public Health Nursing
Interventions: OTHER: Education group|OTHER: control group
Sponsor: Firat University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-07-25
Completion Date: 2024-09-15
Locations: Firat University, Elazığ, 23119, Turkey

Summary:
The aim of this article is to examine the effect of the training of carers caring for palliative care patients on the prevention and management of pressure ulcers. In this context, how the training affects the level of knowledge and practices of the carers will be evaluated. The findings obtained will contribute to improving the quality of patient care by providing strategic recommendations for the improvement of palliative care services.

Primary Outcome Measures: Pressure Wound Knowledge Test, CBRT is a 3-point Likert type (true, false, don't know) questionnaire consisting of 17 questions prepared by the researchers in line with the literature. Five of the questions in the test were designed to be reverse scored and 12 were designed to be scored normally. The minimum score of the knowledge test is 0 and the maximum score is 17. The KR-20 value of this measurement tool was calculated as 0.80., 2 month
Study on the Staging and Prognosis Model of Bladder Cancer
NCT Number: NCT06565923
Acronym: 2024-SR-386
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bladder Cancer
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Collaborators: Suzhou Municipal Hospital|Yixing People's Hospital|Wuhan Union Hospital, China|Huai an First People Hospital|Jiangsu Province Hospital of Chinese Medicine|The First Affiliated Hospital of Zhengzhou University|The second affiliated hospital of Xuzhou medical university
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-18
Completion Date: 2025-07-18
Locations: The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China

Summary:
Firstly, we retrospectively gathered the patient information who compliant with the criteria from 2012 to 2023, encompassing basic information, clinical information, along with MRI images, blood/urine samples, and tissue samples, for conducting relevant analyses of radiomics. Subsequently, based on artificial intelligence technology, deep learning and machine learning models were established on the basis of MRI radiomics and pathological histomics. Ultimately, the following research aims were accomplished: 1. Primary research objective: To explore the role of artificial intelligence and multimodal omics features in the staging and prognosis monitoring of bladder cancer. 2. Secondary objective: To explore the correlations among radiomics, case histomics, and test omics.

Primary Outcome Measures: Overall survival (OS), Overall survival (OS) is defined as the duration from surgery to death or the date of the last follow-up., 2013-|Progression-free survival (PFS), Progression-free survival (PFS) refers to the time from surgery until disease progression, the date of the last follow-up, or death from causes other than disease recurrence, 2013-|Recurrence-Free Survival (RFS), Recurrence-Free Survival (RFS), 2013-
Secondary Outcome Measures: Tumor Infiltration Status, Tumor Infiltration Status, 2013-|Lymph node metastasis status, Lymph node metastasis status, 2013-
Other Outcome Measures: Neoadjuvant and Adjuvant Treatment Effects, Neoadjuvant and Adjuvant Treatment Effects, 2013-
Clinical Investigation to Assess the Efficacy of Manual Toothbrushes in the Reduction of Plaque and Gingivitis.
NCT Number: NCT06565897
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Plaque, Dental|Gingivitis
Interventions: DRUG: Test regimen|DRUG: Control regimen
Sponsor: Colgate Palmolive
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-26
Completion Date: 2024-09
Locations: Consumer Research Consulting, LLC, Melbourne, Florida, 32940, United States

Summary:
Qualified subjects will be enrolled and randomized to one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after 1, 3, and 6, weeks of unsupervised product use at home. All subjects will be followed for adverse events throughout the study

Primary Outcome Measures: Plaque assessment, The dentition will be disclosed with disclosing solution and plaque scored according to the Refined Navy Plaque Index. Refinement of the Navy plaque index to increase plaque scoring efficiency in gum line and interproximal tooth areas., Initial reading, reading taken immediately following first brushing, 1-week, 3-weeks, and 6-weeks|Gingivitis Assessment, A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror., Initial reading, 1-week, 3-weeks, and 6-weeks
A Study of HRS9531 Injection in Obese Subjects With Obstructive Sleep Apnea
NCT Number: NCT06565871
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Weight Management
Interventions: DRUG: HRS9531 Injection|DRUG: HRS9531 Injection|DRUG: Placebo Injection
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 108
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12

Summary:
The purpose of this study is to evaluate the effect and safety of HRS9531 Injection in Obese Subjects with Obstructive Sleep Apnea

Primary Outcome Measures: Percentage change from baseline in body weight, Baseline,32week
Secondary Outcome Measures: Change from Baseline in Apnea-Hypopnea Index (AHI), Baseline,32week|Proportion of subjects with weight loss of ≥5% from baseline after 32 weeks of treatment, Week 32|Proportion of subjects with weight loss of ≥10% from baseline after 32 weeks of treatment, Week 32|Proportion of subjects with weight loss of ≥15%from baseline after 32 weeks of treatment, Week 32|Change from Baseline in Body weight, Baseline,32week|Change from Baseline in BMI, Baseline,32week|Percentage change from baseline in AHI, Baseline,32week
Phisical Activity and Sarcoma, Role and Impact on Outcome
NCT Number: NCT06565858
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sarcoma
Sponsor: European Institute of Oncology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 750
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-30
Completion Date: 2026-08-30
Locations: Istituto Europeo di Oncologia, Milano, 20141, Italy

Summary:
The protective role of physical activity (PA) has been demonstrated in numerous diseases, especially cardiovascular and metabolic ones, but also in various neoplastic pathologies.

The aim of this study is to evaluate the role/impact of PA in sarcomas, in their distribution and potentially also on their prognosis, as already demonstrated for other neoplasms. Type, intensity, frequency, duration and circumstance of both occupational and leisure physical activity will be collected through validated questionnaires and self-reported measurement methods.

Primary Outcome Measures: Prevalence PA, The prevalence of physical activity (PA) in patients with sarcoma, 12 months
Analysis of Various Treatment Methods of Granulomatous Lobular Mastitis
NCT Number: NCT06565845
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Granulomatous Mastitis
Interventions: PROCEDURE: Surgery|DRUG: triple anti-tuberculosis drug
Sponsor: First Affiliated Hospital of Harbin Medical University
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-19
Completion Date: 2024-10-19
Locations: First affiliated hospital of Harbin medical university, Harbin, Heilongjiang, 150001, China

Summary:
Granulomatous lobular mastitis (GLM) is a rare benign breast disease that is difficult to distinguish from breast cancer based on clinical and imaging findings, and there is currently no standard treatment. This study aims to analyze the clinical characteristics and demographic data of GLM patients and to compare the overall effectiveness of three treatment methods: surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy, with the goal of providing new insights for clinical treatment.

Primary Outcome Measures: Differences in the cure rate of the three treatment modalities, According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The cure rate was compared among the three groups., Baseline|Differences in the recurrence rate of the three treatment modalities, According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The recurrence rate was compared among the three groups., Baseline|Differences in the incidence of adverse reactions of the three treatment modalities, According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The incidence of adverse reactions was compared among the three groups., Baseline
Secondary Outcome Measures: Differences in the patient satisfaction score (points) of the three treatment modalities, According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The patient satisfaction score (points) was compared among the three groups., Baseline|Differences in the treatment duration (months) of the three treatment modalities, According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The treatment duration (months) was compared among the three groups., Baseline
Reproducibility of Virtual Exercise Assessments Versus Face-to-face Exercise Testing in Adults With Cystic Fibrosis
NCT Number: NCT06565832
Acronym: RExA-CF
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cystic Fibrosis
Interventions: PROCEDURE: One-Minute Sit-to-Stand Test|PROCEDURE: Chester Step Test
Sponsor: Royal Brompton & Harefield NHS Foundation Trust
Collaborators: King's College London
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 19
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-05-01
Completion Date: 2023-08-01
Locations: Royal Brompton Hospital, Guy's and St Thomas's NHS Foundation Trust, London, SW3 6NP, United Kingdom

Summary:
RExA-CF is investing if results from exercise tests (the Chester Step Test and the One-Minute Sit-to-Stand test) completed face to face are comparable to results of the same tests completed via a virtual teleconferencing platform. The study involves two exercise testing sessions (one face-to-face and one via a video link), with participants being randomised to complete the two exercise tests (the 1-minute sit-to-stand test and the Chester Step test). The two testing sessions will be completed within three weeks of each other, the order of which will be randomly allocated. One session will be completed face-to-face during a pre-arranged visit to the hospital, the other test session will be completed through a video call at a time convenient to the participants. After the second testing session participants will be asked some questions about the face-to-face and video tests to get their views about the two formats.

Primary Outcome Measures: Aerobic Capacity from the Chester Step test, This test involves the participant stepping up and down off of a step (this can be a bottom stair or doorstep at home) keeping up with the beat of a recording. The speed of the beat increases every 2 minutes, and the test continues until the participant cannot keep up with the pace, wish to stop or the test ends which takes 10 minutes. Participants will be asked to take their heart rate and oxygen levels before and after the test using a provided pulse-oximeter. This test should take a maximum of 15 minutes. The results of the test will be used to calculate the participants aerobic capacity (range 0-60), Completed at week 0 and within 2 weeks of first test|Number of sit to stands completed during One-Minute Sit-to-Stand test, This test involves the participant sitting down and standing up from a normal height chair (can be a dining room or kitchen chair at home) for one minute. Participants can rest or stop at any time if fatigued. This test should take a maximum of 5 minutes., Completed at week 0 and within 2 weeks of first test
French National Cohort of Patients With Rifampicin-Resistant Tuberculosis
NCT Number: NCT06565806
Acronym: CONTRol-TB
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Rifampicin-resistant Tuberculosis
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2032-09-01

Summary:
A major obstacle in the fight against multidrug-resistant tuberculosis is its treatment. In 2021, only 60% of patients with MDR/RR tuberculosis who received treatment globally were successfully cured, while 12% succumbed to the disease and 10% experienced treatment failure.

In France, a recent study by the National Reference Centre for Mycobacteria showed that while MDR/RR tuberculosis patients treated between 2006 and 2019 in the major reference centres in the Paris region achieved a favourable outcome in 68% of cases, 30% were lost. The main aim of this study is to enhance our understanding of the outcomes for patients suffering from tuberculosis due to rifampin-resistant bacilli, as well as the factors influencing these outcomes. Additionally, it aims to decrease the duration required to relay information to health authorities regarding the status of multidrug resistance and the outcomes of patients in France.

A national longitudinal cohort will be develop to study multidrug-resistant tuberculosis in France. The cohort includes a historical retrospective part from 2006-2019 and a prospective part from 2020, with planned inclusions until 2029. The restrospective cohort includes 298 patients from 2006-2019 and 178 patients from the CNR mycobacteria national registry until 2024. As for the prospective cohort arm, a projected total of roughly 300 patients will be included over the period from 2020 to 2029. Non-identifying clinical data will be derived exclusively from patients medical records at three expert centres in the Paris region for the restrospective cohort and throughout France (national register) for the prospective cohorte. For the retropective cohorte each centers will transcribe pseudonymised clinical data into secure Excel files, while the prospective cohort will enter non-identifying data directly into the national register using a secure platform overseen by the CNR of Mycobactéria.

Registry data will be extracted directly from the registry and merged with the retrospective database every 12 months by the coordinating investigator. Statistical analyses will include descriptive analyses of continuous and categorical variables, comparisons between subgroups using appropriate tests (Student's t, Mann-Whitney, Chi Square, Fisher), and logistic regressions to identify variables associated with treatment outcomes. P value \< 0.05 will be considered statistically significant

Primary Outcome Measures: Outcome of tuberculosis treatment (WHO 2021 outcome definitons), Through out study time period (Till 2029)
Secondary Outcome Measures: Prognostic factors in the evolution of tuberculosis, Through out study time period (Till 2029)
Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring Device at Wrist Against Double Auscultation
NCT Number: NCT06565780
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension
Interventions: DEVICE: Device under test evaluation against references
Sponsor: Aktiia SA
Sex: ALL
Age: ADULT
Enrollment: 85
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-02
Completion Date: 2025-12-31
Locations: Parameters Research Laboratory, Broomfield, Colorado, 80021, United States

Summary:
This study, with N = 85 participants minimum over 8 visits spread over 23 hours, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G0 for up to 23 hours after initialization in a cohort of subjects representative of the US population.

For the study, subjects will be asked to stay seated while measurements are taken at different timepoints.

Primary Outcome Measures: Blood pressure mean value of differences, The mean value of the differences between Aktiia.product-G0 and double auscultation blood pressure measurements., 23 hours|Blood pressure standard deviation of differences, The standard deviation of the differences between Aktiia.product-G0 and double auscultation blood pressure measurements., 23 hours
Secondary Outcome Measures: Heart rate root-mean-square error, The root-mean-square difference between the Aktiia.product-G0 heart rate determinations and the reference method., 23 hours
Continuous Chest Compressions Training Among Schoolchildren With Gamification in Brazil: a Pilot Study
NCT Number: NCT06565767
Acronym: CSC
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiopulmonary Resuscitation|Educational Problems
Interventions: OTHER: cardiopulmonary resuscitation quality
Sponsor: Hospital Israelita Albert Einstein
Collaborators: University of Marília|INVITARE Institute
Sex: ALL
Age: CHILD
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2022-11-10
Completion Date: 2024-12-05
Locations: Uri Adrian Prync Flato, São Paulo, SP, 05411000, Brazil

Summary:
This study employed a randomized cluster intervention design to evaluate differences in chest compression depth among children's groups, using active learning methodologies and serious game-based learning as part of the Kids Save Hearts Project.

Primary Outcome Measures: Depth compression, variability in compression depth among different age groups, taking into account physical attributes in millimetres, one hour after training
Secondary Outcome Measures: Knowledge serious game, difference between game score before and after training CPR (minimum 0 to maximun 500), one hour after training
Effect of Adding Blood Flow Restriction to Strengthening Exercise in Patients With Patellofemoral Pain Syndrome
NCT Number: NCT06565754
Acronym: BFR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: BFR|PFPS|Strengthening Exercises|Quadriceps Strength|Dynamic Balance|Joint Position Sense
Interventions: OTHER: BFR|OTHER: strengthening exercise
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-04-01
Locations: Cairo University, Giza, 12613, Egypt

Summary:
To study the effect of adding BFRT to strengthening exercises and compare it with strengthening exercises alone in improving, muscular strength, pain, function, joint position sense, and dynamic balance test (star excursion test). in patients with PFPS.

Primary Outcome Measures: quadriceps and hip abductors strength, Hand-Held Dynamometer (HHD). The Lafayette® HHD is a valid and reliable instrument of low cost and easy handling compared to the isokinetic dynamometer for assessment of muscle strength, 6 weeks
Secondary Outcome Measures: pain severity using Visual Analog Scale (VAS), The Visual Analog Scale is determined by measuring in millimeters from the left end of the line to the patient's mark. Participants will ask to determine the point at which pain represents the severity of pain maximum is 10 while lowest level of pain is zero, 6 weeks|functional status (Kujala Patellofemoral Score), The 13 items on the scale are used to assess subjective symptoms and functional restrictions. A score can have a minimum of 0 points or a maximum of 100 points., 6 weeks|joint position sense (measured by digital inclinometer), Digital Inclinometer for joint position sense assessment. Device (Digital Protractor, 82201b-00, INSPEC, China) The inclinometer is a valid and reliable method to assess the knee proprioception through JPS in open kinetic chain, 6 weeks|dynamic balance (Star Excursion Balance Test, Four strips of adhesive tape will need to be cut to a length of 6-8 feet each. Two pieces will be used to form a '+', with the other two being placed over top to form an 'x' so that a star shape is formed. It is important that all lines are separated from each other by a 45° angle. The goal of the Star Excursion Balance Test (SEBT) is to maintain single leg stance on one leg while reaching as far as possible with the contralateral leg., 6 weeks
Vitamin D Versus Sildenafil Citrate in Fetal Growth Restriction
NCT Number: NCT06565728
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Fetal Growth Retardation
Interventions: DRUG: Vitamin D3 2000 UNT Oral Tablet
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 99
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-11-03
Completion Date: 2023-05-06
Locations: kasr Alainy University Hospital, Cairo, 11312, Egypt

Summary:
Fetal growth restriction, also named Intrauterine growth restriction is a prevalent disease in pregnancy , it is a descriptive term for a pathological process, and can be described as the process where a fetus who has a certain growth potential based on genetic criteria is limited in its growth because of a pathological environmental influence

Primary Outcome Measures: Gestational age Measurements, Estimation of The Gestational age at the week 28 of gestation by measuring fetal head circumference, Abdominal Circumference and fetal femur length., 6 months
Effect of Remazolam on Hemodynamics During Hepatectomy
NCT Number: NCT06565715
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hemodynamic Instability
Interventions: DRUG: Remimazolam|DRUG: Propofol
Sponsor: Jun Zhang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2024-11

Summary:
There is high incidence of hemodynamic instability in patients undergoing hepatectomy with low central venous pressure, especially in general anesthesia combined with epidural anesthesia. Remazolam, a new benzodiazepine, has no significant cardiovascular inhibitory effect. Investigators hypothesis that remazolam will provide better hemodynamic when compared with propofol in patients undergoing hepatectomy with general anesthesia combined with epidural anesthesia.

Primary Outcome Measures: Hemodynamic instability score, The hemodynamic instability score is calculated as a weighted continuous measure ranging from 0 to 160 points, intended to reflect deviations of blood pressure and heart rate from predefined thresholds, and infusion rates of vasoactive agents and fluids., intraoperative
Secondary Outcome Measures: Cardiac index （CI）, The parameter of CI is measured by advanced hemodynamic monitoring device., intraoperative|Stroke volume variation (SVV), The parameter of SVV is measured by advanced hemodynamic monitoring device., intraoperative|Systemic vascular resistance index (SVRI), The parameter of SVRI is measured by advanced hemodynamic monitoring device., intraoperative|Complications in 1 week after surgery, Complications occured within 1 week after surgery, 1 week after surgery
Clinical Trial on the Accuracy of Blood Pressure Measurement by YE990 Medical Automatic Electronic Sphygmomanometer
NCT Number: NCT06565702
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Blood Pressure
Sponsor: The First Affiliated Hospital of Anhui Medical University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 85
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-20
Completion Date: 2025-12-30
Locations: The First Affiliated Hospital of Anhui Medical University Hospital, Hefei, Anhui, 230000, China

Summary:
This study was a single-center, open-ended, self-controlled clinical study . Same armsequential method was used to measure the blood pressure of the subjects，inclusion of ≥85 subjects aged 12 years or older who met the enrollment criteria.In accordance with the "Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018/Amd 1:2020)",the purpose of this study was to compare the blood pressure and pulse rate measured by an electronic sphygmomanometer with those measured by a reference sphygmomanometer (an upper-arm noninvasive auscultatory sphygmomanometer) and by palpation of the radial artery, and then to evaluate the accuracy and safety of the measurement of systolic blood pressure, diastolic blood pressure, and pulse rate by a fully automated electronic sphygmomanometer for medical use (Model No. YE990), which is manufactured by Jiangsu Yuyue Medical Equipment Co.

Primary Outcome Measures: To evaluate the accuracy of the arm-type electronic blood pressure monitor (Model: YE660D) in measuring systolic blood pressure, diastolic blood pressure and pulse rate in adults aged 12 years and above., Evaluate the relationship between the mean and standard deviation of error, the agreement between the measured and reference blood pressure values, and the relationship between arm circumference and measurement error.Reference standard: 255 sets of data from 85 subjects were calculated and compared separately for systolic and diastolic blood pressure, with a mean deviation of not more than ±5 mmHg and a standard deviation of not more than 8 mmHg., August 20, 2024 - December 30, 2025
Secondary Outcome Measures: Collect and document the occurrence of adverse events and device defects in subjects during use, 1. Incidence of adverse events;
2. Incidence of device defects., August 20, 2024 - December 30, 2025
Other Outcome Measures: Clinical use performance evaluation is mainly product stability evaluation, Evaluation Item 1: Electronic Sphygmomanometer Turning On and Off Evaluation item 2: Whether the device was turned off automatically during the checking process Evaluation item 3: Whether there is any abnormal interruption due to the machine during the inspection process.

Evaluation item 4: Whether inflation and exhaust failure occurs during the inspection process Evaluation item 5: Whether air leakage occurred during the inspection process, August 20, 2024 - December 30, 2025