title
stringlengths
1
1.19k
keywords
stringlengths
0
668
concept
stringlengths
0
909
paragraph
stringlengths
0
61.8k
PMID
stringlengths
10
11
Ancillary and post -trial care
GHD
GHD
Indemnity arrangements for the GHD Reversal Trial will be undertaken by the sponsor University College London. University College London holds insurance against claims from participants for injury caused by their participation in the clinical trial. Full insurance and indemnity details are given in the study protocol.
PMC10440873
Confidentiality and data protection
Personal data recorded on all documents will be regarded as strictly confidential and will be handled and stored in accordance with the Data Protection Act 2018 and Regulation (EU) 2016/679 (General Data Protection Regulation). Full details are given in the current study protocol.
PMC10440873
Regulatory aspects
The trial will be conducted in compliance with the approved protocol, UK Policy Framework for Health and Social Care Research 2017, Regulation (EU) No. 536/2014 (Clinical Trial Safety Reporting requirements), the Data Protection Act 2018, and Regulation (EU) 2016/679 (General Data Protection Regulation) and the princip...
PMC10440873
Discussion and potential impact
GHD
ADVERSE EFFECTS, GHD
Five previous studies have demonstrated reversal of GHD (mean 49%; range 19–95%) with earlier re-testing, before or during puberty [Assuming that GH discontinuation will be non-inferior to GH continuation, the expected impact of the study will be:A change in inter/national guidance on GH therapy in I-GHDImproved QoL, f...
PMC10440873
Trial status
RECRUITMENT, RECRUITMENT
Publication based on Protocol V2.0, 8 April 2022. At the time of publication, several study sites are open to recruitment, but no patients have yet been recruited into the study. Recruitment is estimated to take three and a half years. A list of study sites can be found on the study website:
PMC10440873
Acknowledgements
PIsWolfgang
We would like to thank the NIHR HTA for funding the study. We are also most grateful for the support of the sponsor, University College London, and the University of Birmingham Clinical Trials Unit and the Child Growth Foundation. We would like to thank our DMC and TSC members and the principal investigators (PI) at ou...
PMC10440873
Authors’ contributions
EB drafted the manuscript and managed the co-ordination of the study. WH conceived of the study, led in its design and co-ordination, and contributed to the writing of the manuscript. MD led in the co-ordination of the study, contributed to the study design, and contributed to the writing of the manuscript. CC particip...
PMC10440873
Funding
Funding body: National Institute for Health Research Health Technology Assessment programme: NIHR127468.The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research, Health Education England or the Department of Health and Social Car...
PMC10440873
Declarations
PMC10440873
Competing interests
Mehul Dattani and Wolfgang Högler have both received travel support, lecture fees and consultation fees from companies marketing growth hormone over the last few years.Jonathan Mathers, Elizabeth Brettell, Carole Cummins, Rebecca Woolley, Laura Roy, Adam Khan Charmaine Hunt and Raymond Oppong have no conflicts of inter...
PMC10440873
References
PMC10440873
Background
The practical training course of internal medicine of traditional Chinese medicine (PTC-IMTCM) is primarily based on traditional case teaching, which can be stressful for teachers. The use of virtual standardized patient (VSP) applications could be an alternative; however, there is limited evidence regarding their feas...
PMC10551797
Objective
This study aimed to build a VSP-TCM application according to the characteristics of PTC-IMTCM and the needs of students and to compare its efficacy with that of traditional teaching in improving TCM clinical competence among students.
PMC10551797
Methods
A prequestionnaire investigation was conducted before the course, and a VSP-TCM system was developed based on the results of the questionnaire. A randomized controlled trial was then conducted between February 26, 2020, and August 20, 2021. A total of 84 medical students were included and were divided into 2 groups: an...
PMC10551797
Results
All participants completed the study. In the formative assessment, the VSP-TCM group performed better in medical interviewing ability (mean 7.19, SD 0.63, vs mean 6.83, SD 0.81;
PMC10551797
Conclusions
VSP-TCM enhances students’ TCM clinical competence and dialectical thinking and improves their ability to work autonomously. Moreover, the VSP-TCM system is feasible, practical, and cost-effective and thus merits further promotion in TCM education.
PMC10551797
Introduction
TCM
Clinical practice is the most crucial experience for undergraduate medical students [An alternative training approach could be the use of virtual standardized patient (VSP) programs, which use computerized characters for SP encounters [Traditional Chinese medicine (TCM) is a comprehensive medical system that emphasizes...
PMC10551797
Methods
PMC10551797
Study Design
First, we conducted a questionnaire investigation to gain the perspectives of TCM students who have taken the PTC-IMTCM course. The final version of the VSP-TCM system was designed and developed based on the characteristics of TCM and the results of the questionnaire investigation [Flow diagram of the study. PTC-IMTCM:...
PMC10551797
Ethical Considerations
The study was approved by the Ethics Committee of Chengdu University of Traditional Chinese Medicine (CDUTCM; approval no. 25382) and adhered to the principles of the Declaration of Helsinki. Curriculum planning adhered to the guidelines set by the “Undergraduate Medical Education Standards - Traditional Chinese Medici...
PMC10551797
Development of the VSP-TCM System
PMC10551797
Prequestionnaire Investigation
A questionnaire was administered to 1628 medical students who had taken the PTC-IMTCM course. The questionnaire was formulated based on the characteristics and teaching objectives of the course, which included basic information, learning methods, learning habits, learning interests, and acceptance and demand for VSP-TC...
PMC10551797
Design of the VSP-TCM System
DISEASES
The teaching goal of VSP-TCM is to enhance the clinical competence of TCM students. We constructed a case database that included diseases that met the requirements of the latest version of the physician qualification examination outlines. The included diseases were all foundational. Subsequently, we developed an intell...
PMC10551797
User Flow of the VSP-TCM System
The operation procedures of the VSP-TCM system (Operation procedures of the VSP-TCM system.
PMC10551797
Protocol of the Course
PMC10551797
Participants
The participants were recruited offline from 112 TCM (5+3 integration) sophomores enrolled in the CDUTCM in 2019. Based on previous studies, a minimum sample size of 78 was required [
PMC10551797
Inclusion and Exclusion Criteria
TCM (5+3 integration) students in their second year at the CDUTCM were included. The exclusion criteria were as follows: participants who (1) had received VSP or SP training; (2) had taken courses related to IMTCM, such as PTC-IMTCM and reception and clinical thinking skills; and (3) failed to adhere to the study sched...
PMC10551797
Randomization and Blinding
Using computer-generated randomization, the participants were randomly assigned to either a VSP-TCM group or a control group in a 1:1 ratio. The randomization was performed by individuals who were not in contact with the participants. The participants, staff, and investigators were blinded to the training assignments. ...
PMC10551797
Teacher Training and Eligibility
coin toss
Teachers in the course group underwent standardized training 1 month before the course started. The standardized training planning was set based on the “Eight-Year Undergraduate Talent Training Guide of Traditional Chinese Medicine” issued by the CDUTCM. Subsequently, experienced clinical experts were invited to assess...
PMC10551797
Training Interventions and Data Collection
DISEASE, PATHOGENESIS, SYNDROME
PTC-IMTCM was conducted in the second semester of the sophomore year (36 class hours, 3 class hours/week, a total of 12 weeks). Both groups had the same teaching materials, such as Microsoft PowerPoint presentations and textbooks. The VSP-TCM group received 36 class hours of VSP-TCM training. The teaching methods were ...
PMC10551797
Evaluation of Training Effectiveness
PMC10551797
Formative Evaluation
The mini-clinical evaluation exercise (mini-CEX), a tool developed by the American College of Internal Medicine in 1995 based on the traditional clinical evaluation exercise, has teaching functions and was used to assess the residents’ clinical ability [
PMC10551797
Summative Assessment
SYNDROME
After the course, students were given 1 week to review for the assessment, and the summative assessment was conducted on a day in week 13. The summative assessment was divided into online and offline assessments. Students completed the systematic knowledge test of PTC-IMTCM online before entering the clinical skill cen...
PMC10551797
Online Systematic Knowledge Test
TCM
SYNDROME
After the course, students completed an objective and standardized online case-based examination. They had 90 minutes to complete 6 cases. For the first 5 cases, there were 5 multiple-choice questions in each case, and students were required to select the right diagnosis, syndrome, treatment principle, treatment method...
PMC10551797
Offline Clinical Skill Test
Following the online examination, students proceeded to the clinical skill center of the CDUTCM for a 45-minute offline clinical skill test. For this test, we used previously developed offline clinical skill assessment methods [
PMC10551797
Scores for the Application of TCM Technology
TCM
In the assessment process, a TCM professional who was not part of the research team and did not participate in activities such as teaching and proposition scored the students’ clinical skills using a pre-established checklist. The checklist included the following items: introduction (4 points), chief complaint (8 point...
PMC10551797
Scores for Written Medical Records
TCM
The medical writing checklist included the following items: general information (3 points), chief complaint (5 points), current medical history (30 points), past medical history (10 points), personal medical history (10 points), family medical history (6 points), physical examination (20 points), and 4 TCM examinations...
PMC10551797
Scores for TCM Syndrome Differentiation and Therapeutic Regimen
TCM syndrome, TCM
SYNDROME
The following were items were included in the checklist for TCM treatment based on syndrome differentiation: TCM diagnosis (6 points); basis for TCM diagnosis (6 points); WM diagnosis (6 points); basis for WM diagnosis (14 points); TCM syndrome type (10 points); analysis of TCM syndrome differentiation (24 points); TCM...
PMC10551797
OSP Real-Time Assessment Scores
Following each interaction, OSPs used the Arizona Clinical Interviewing Rating (ACIR) scale to assess students’ interpersonal communication and interview skills. The ACIR scale is a 20-item scale, with points ranging from 1 to 5 points, with 5 being the highest [
PMC10551797
Postcourse Feedback Questionnaire
A previous study’s [
PMC10551797
Statistical Analysis
A blinded research analyst conducted the test. The intraclass correlation coefficient (ICC) was calculated to determine the consistency of the Mini-CEX scores. Statistical analysis was conducted using SPSS 25.0 (IBM). Continuous variables were expressed as the mean (SD) and categorical variables as a frequency or perce...
PMC10551797
Results
PMC10551797
Evaluation of Training Effectiveness
PMC10551797
Summative Assessment
PMC10551797
Online Systematic Knowledge Test
After 12 weeks of the course, the VSP-TCM group mastered the systematic knowledge of the course better than the control group (Scores of summative assessment (*
PMC10551797
Offline Clinical Skill Test
PMC10551797
Scores for the Application of TCM Technology
The VSP-TCM group outperformed the control group in receiving VSP-TCM. The VSP-TCM group performed better in the application of TCM skills (mean 87.86, SD 3.04, vs mean 86.19, SD 3.08; t
PMC10551797
Scores for Written Medical Records
VSP-TCM did not provide the expected benefits in improving students’ ability to write medical records. The VSP-TCM group scored lower than the control group (mean 75.07, SD 3.61, vs mean 75.71, SD 2.86; t
PMC10551797
Scores for TCM Syndrome Differentiation and Therapeutic Regimen
TCM syndrome
SYNDROME
VSP-TCM effectively improved core TCM skills, including syndrome differentiation and treatment. The VSP-TCM group had higher scores for TCM syndrome differentiation and treatment than the control group (mean 90.93, SD 2.42, vs mean 89.60, SD 2.86; U=636,
PMC10551797
Real-Time Assessment Scores From OSPs
VSP-TCM had a satisfactory effect on improving students’ interpersonal communication and interview skills. The real-time evaluation score from OSPs for the VSP-TCM group was significantly higher than the control group (mean 90.67, SD 4.52, vs mean 88.24, SD 4.56; U=618.5,
PMC10551797
Discussion
PMC10551797
Principal Findings
TCM
DISEASES, SYNDROMES, SYNDROME
This study demonstrated that compared with traditional academic training, VSP-TCM significantly improves abilities in medical interviewing, clinical judgment, TCM technology application, and systematic knowledge among TCM students. The VSP-TCM system enabled TCM education to be more efficient and less stressful for tea...
PMC10551797
Limitations
Although the findings of this study are positive, it has some limitations that should be acknowledged. First, in this prospective study, we only evaluated the clinical skills of students during and after the course, with no long-term follow-up. We were unaware of how VSP-TCM maintained the trainees’ competence. Second,...
PMC10551797
Conclusion
HY, JGYB2019008
This randomized controlled trial demonstrated the feasibility of VSP-TCM in improving the clinical competence of medical students. VSP-TCM may be a replacement for OSPs and SSPs in universities with limited expenditure. VSP-TCM deserves more attention and promotion. Therefore, future studies aiming to improve VSP-TCM s...
PMC10551797
Abbreviations
Arizona Clinical Interviewing RatingChengdu University of Traditional Chinese Medicineintraclass correlation coefficientinternal medicine of traditional Chinese medicinemini-clinical evaluation exerciseonline systematic knowledge testoccupational standardized patientpractical training course of internal medicine of tra...
PMC10551797
Data Availability
The “Eight-Year Undergraduate Talent Training Guide of Traditional Chinese Medicine” issued by the Chengdu University of Traditional Chinese Medicine is available upon reasonable request.
PMC10551797
1. Introduction
bleeding, hematological abnormalities, TPO-RAs, thrombocytopenia, cirrhosis, hepatocellular carcinoma, transfusion-associated, CLD
CHRONIC LIVER DISEASE, BLEEDING, THROMBOCYTOPENIA, ADVERSE EVENTS, THROMBOCYTOPENIA, CIRRHOSIS, HEPATOCELLULAR CARCINOMA, PORTAL VEIN THROMBOSIS, CLD, CHRONIC LIVER DISEASE
The phase 4 observational cohort study assessed the effectiveness and safety of the thrombopoietin receptor agonist avatrombopag in patients with chronic liver disease (CLD) and thrombocytopenia undergoing a procedure. Patients with CLD may have thrombocytopenia, increasing the risk of periprocedural bleeding. Prophyla...
PMC10553023
2. Materials and methods
PMC10553023
2.1. Study design
MAY
This was a phase 4, multicenter, observational cohort study (NCT03554759) conducted from July 2018 to January 2019. The study planned to enroll a total of 500 subjects from sites in the USA after avatrombopag was approved for this indication by the FDA in May 2018.Data were collected prospectively or retrospectively fr...
PMC10553023
2.2. Inclusion criteria
CLD, thrombocytopenia
THROMBOCYTOPENIA, CLD
All patients enrolled were ≥ 18 years, had thrombocytopenia associated with CLD and were planned to undergo, or underwent, treatment with avatrombopag prior to a procedure. For retrospective enrollment (patients enrolled and consented after procedure day) patients must have had, at a minimum, a platelet count from appr...
PMC10553023
2.3. Treatment
Avatrombopag was taken orally and doses were determined by the treating physician in conjunction with the FDA-approved US prescribing information.
PMC10553023
2.4. Effectiveness analysis
The effectiveness of avatrombopag was assessed by the change from baseline in platelet count on procedure day and the proportion of patients who received a platelet transfusion after the baseline visit and up to 7 days post-procedure day. The effectiveness of avatrombopag was also assessed by subgroup analyses of the c...
PMC10553023
2.5. Safety analysis
death, bleeding, congenital anomaly, blood loss, thrombotic
THROMBOEMBOLIC EVENT, BLEEDING, ADVERSE EVENTS, BLOOD LOSS, EVENT, EVENTS, COMPLICATIONS
The safety of avatrombopag was assessed by recording adverse events (AEs). These were reported by the patient or, when appropriate, by a caregiver, surrogate, or the patient’s legally authorized representative, and/or collected from data recorded in the patient’s medical record. The severity of each AE was recorded, wi...
PMC10553023
2.6. Statistical analysis
The sample size for this study was based on clinical, rather than statistical rationale, and was considered adequate to address the study objective, which was to observe the treatment patterns and effects of avatrombopag in real-world practice. This objective was neither related to the testing of a specific hypothesis,...
PMC10553023
3. Results
PMC10553023
3.1. Patient population
autoimmune hepatitis, primary biliary cholangitis, biliary cirrhosis, acid-related disorders, liver cancer, hepatoportal sclerosis, hepatic cirrhosis, hepatocellular carcinoma, CLD
AUTOIMMUNE HEPATITIS, BILIARY CIRRHOSIS, PRIMARY BILIARY CHOLANGITIS, LIVER CANCER, CRYPTOGENIC CIRRHOSIS, HEPATIC CIRRHOSIS, HEPATOCELLULAR CARCINOMA, CIRRHOSIS OF THE LIVER, PRIMARY SCLEROSING CHOLANGITIS, CLD
This phase 4 observational registry study was conducted at 43 sites in the USA and was terminated by the sponsor, due to enrollment challenges, prior to completing the planned enrollments. When terminated, 29 of the 43 active sites had screened a total of 65 patients, and 25 of the sites had enrolled a total of 50 pati...
PMC10553023
3.2. Types of procedures
umbilical hernia, right inguinal hernia
SECONDARY
Procedures that occurred during the study could be defined as either the primary procedure or the secondary procedure when multiple procedures occurred at the same time. The most common procedure was upper gastrointestinal (GI) endoscopy (56% [n = 28] of primary procedures and 4% [n = 2] of secondary procedures). Of th...
PMC10553023
3.3. Effectiveness analysis
Treatment with avatrombopag resulted in an increased platelet count, with a mean (SD) change in platelet count from baseline to procedure day (days 8 to 15 after the first dose of avatrombopag, n = 38) of 41.1 × 10Platelet count by study visit. Treatment is defined as the day of initiation of avatrombopag up to and inc...
PMC10553023
3.4. Additional effectiveness analysis
cirrhosis
CIRRHOSIS
A subgroup analysis by the severity of cirrhosis, using reported CTP Grade at baseline, was performed. The change in platelet count from baseline to procedure day, within each CTP Grade, was consistent with the overall analysis (Fig. Platelet count at baseline and procedure day by Child–Turcotte–Pugh Grade. Baseline CT...
PMC10553023
3.5. Responder analysis
A responder analysis (patients achieving a platelet count of ≥ 50 × 10When evaluated by baseline platelet count cohort, 9 of 18 patients with a baseline platelet count < 40 × 10
PMC10553023
3.6. Safety analysis
bleeding, TEAEs, pyrexia, deaths, TEAE
ADVERSE EVENTS, EVENTS, BLEEDING, ADVERSE EVENT
All enrolled patients received 5 days of once-daily exposure to avatrombopag with no significant safety issues observed. No deaths occurred and 5 serious AEs were reported in 2 (4%) patients, with none considered related to avatrombopag treatment. The majority of patients had TEAEs that were mild (n = 3 [6%]) or modera...
PMC10553023
4. Discussion
bleeding, TPO-RAs, thrombocytopenia, cirrhosis, TEAEs, CLD
THROMBOCYTOPENIA, BLEEDING, CIRRHOSIS, CLD
The objective of this phase 4 study was to collect real-world data on the ability of avatrombopag to increase platelet counts and reduce the need for platelet transfusions or rescue procedures for bleeding in patients with CLD scheduled to undergo a procedure. Avatrombopag was effective and well tolerated by all patien...
PMC10553023
4.1. Challenges and limitations
TPO-RAs
THROMBOCYTOPENIA
A limitation of this study is the small sample size that limits the conclusions, especially those regarding observations drawn from subgroups of patients. Nonexperimental observational studies typically involve a more diverse group of patients than experimental and interventional clinical studies and more accurately re...
PMC10553023
5. Conclusion
CLD, bleeding
THROMBOCYTOPENIA, BLEEDING, CLD
The results of this real-world study indicate that avatrombopag is effective in a patient population with CLD of diverse etiologies and severity. Importantly, avatrombopag was well tolerated and effective in increasing platelet counts, allowing procedures to be performed with greater confidence. The limited data presen...
PMC10553023
Supplementary Material
PMC10553023
Abbreviations:
thrombocytopenia, chronic liver disease
THROMBOCYTOPENIA, MITCHELL, CHRONIC LIVER DISEASE
adverse eventsconfidence intervalchronic liver diseaseChild–Turcotte–Pughelectronic case report formfood and drug administrationgastrointestinalstandard deviationtreatment-emergent AEsthrombopoietin receptor agonistThe datasets generated during and/or analyzed during the current study are not publicly available, but ar...
PMC10553023
References
PMC10553023
Aims
hip arthroplasty
Robot-assisted total hip arthroplasty (rTHA) boasts superior accuracy in implant placement, but there is a lack of effective assessment in perioperative management in the context of enhanced recovery after surgery (ERAS). This study aimed to compare the effectiveness and safety of rTHA versus conventional total hip art...
PMC10506298
Methods
blood loss, pain
BLOOD LOSS, POSTOPERATIVE COMPLICATIONS
In this prospective trial, a total of 60 eligible patients aged between 18 and 80 years were randomly divided into two groups to undergo either rTHA or cTHA. The primary outcomes included blood loss parameters. Secondary outcomes were the duration of the operation, surgical time, WOMAC pain score, WOMAC stiffness score...
PMC10506298
Results
SEVERE ANEMIA
The study cohort analyzed 59 eligible participants, 30 of whom underwent rTHA and 29 of whom underwent cTHA. Analysis could not be conducted for one patient due to severe anemia. Notably, the cTHA group had a significantly shorter surgical time than the rTHA group (69.49 ± 18.97 vs. 104.20 ± 19.63 min,
PMC10506298
Conclusions
blood loss, pain
BLOOD LOSS, COMPLICATIONS
Despite the longer surgical time, rTHA did not negatively affect blood loss, pain, or functional recovery or lead to an increased risk of complications in ERAS-managed patients, suggesting that rTHA can be safely and effectively incorporated into an ERAS program for primary THA.
PMC10506298
Keywords
PMC10506298
Introduction
blood loss, end-stage hip joint diseases, THA, pain
BLOOD LOSS, COMPLICATIONS
Total hip arthroplasty (THA) is widely considered one of the most successful surgical procedures in the twentieth century and a common approach in treating end-stage hip joint diseases [Robot-assisted THA is a relatively new technology that has shown great clinical prospects [In this prospective trial, we aimed to comp...
PMC10506298
Materials and methods
PMC10506298
Patients
neuromuscular dysfunction, dysplasia, hip arthroplasty, infection, bony ankylosis, hip deformity
DYSPLASIA, WEST, INFECTION, DISEASES, ANKYLOSING SPONDYLITIS
The Ethics Committee on Clinical Trials of West China Hospital of Sichuan University approved this single-center, prospective trial (HX-IRB-AF-12-V4.0) involving participants aged 18–80 years. All patients provided written informed consent. Exclusion criteria included neuromuscular dysfunction, active infection lesions...
PMC10506298
Sample size calculation
bleeding
BLEEDING
This study was designed as a randomized controlled trial to assess non-inferiority. The experimental group consisted of patients undergoing rTHA, while the control group comprised patients undergoing cTHA. The primary outcome measure was the total amount of bleeding in the study participants. Based on the findings from...
PMC10506298
Surgical procedure and perioperative management
blood loss, thrombosis, THA, pain
BLOOD LOSS, THROMBOSIS
Patients underwent either conventional THA or robotic arm-assisted THA. The rTHA was operated with a single semiactive surgical robot (YUANHUA-THA) whose surgical procedures were described in the technical manuals provided by the manufacturer. All patients were administered the standard ERAS protocol in our hospital in...
PMC10506298
Clinical outcomes
bleeding, blood loss, intraoperative blood loss, numbness, anemia, dislocation, infection, dysuria, hypokalemia, arthralgia
PULMONARY EMBOLISM, BLEEDING, POSTOPERATIVE COMPLICATIONS, BLOOD LOSS, DEEP VEIN THROMBOSIS, HYPOPROTEINEMIA, ANEMIA, INFECTION, SECONDARY, INTRAOPERATIVE BLOOD LOSS, COMPLICATIONS
The primary outcome was assessed by measuring various parameters related to blood loss, as blood management was a very crucial component of ERAS. Objective indicators such as total blood loss, intraoperative blood loss, drainage volume, blood transfusion volume, and hidden blood loss were measured. The theoretical blee...
PMC10506298
Statistical analysis
Means and standard deviations were used for quantitative variables, and percentages were used for qualitative variables. Independent sample
PMC10506298
Acknowledgements
We would like to thank the surgeons, nurses, and research staff at our joint center for their support.
PMC10506298
Author contributions
HPL and HCS drafted the work and provided critical revision for important intellectual content. HPL, QX, and HX performed data collection, analysis, and interpretation. QZ, LYL, and TFY participated in final approval of the version to be published. DW and ZKZ contributed to the conception and design of the study, and r...
PMC10506298
Funding
This study was supported by the Key Research & Development Program of the Science & Technology Department of Sichuan Province (2021YFS0125), and the Regional Innovation & Cooperation Program of the Science &Technology Department of Sichuan Province (2021YFQ0028). The funders had no role in study design, data collection...
PMC10506298
Declarations
PMC10506298
Ethical approval and consent for participants
WEST
This trial received approval from the Ethics Committee on Clinical Trials at West China Hospital of Sichuan University (HX-IRB-AF-12-V4.0). Prior to their participation, all patients provided written informed consent. A statement of the location where the work was performed: The work was performed in Department of Orth...
PMC10506298
Competing interests
No conflict of interest exits in the submission of this manuscript, and manuscript is approved.
PMC10506298
References
PMC10506298
Rationale
PREMATURE BIRTH
Premature birth is an independent predictor of long-term cardiovascular risk. Individuals affected are reported to have a lower rate of
PMC10161761
Objectives
The primary objective was to determine whether the
PMC10161761
Methods
Fifty-two preterm-born and 151 term-born participants were randomly assigned (1:1) to 16 weeks of aerobic exercise training (
PMC10161761
Measurements and Main Results
term-born
For term-born participants,
PMC10161761