Clinical Research Center Research Articles

Contraception with levonorgestrel-releasing intrauterine system versus copper intrauterine device: a meta-analysis of randomized controlled trials

Globally, approximately 19.4% of women of reproductive age use intrauterine contraception, encompassing both copper intrauterine devices (Cu-IUDs) and levonorgestrel intrauterine devices (LNG-IUDs). Despite current guidelines endorsing intrauterine contraception as a primary method, there remains debate regarding device selection. Notably, the lack of data regarding reasons for discontinuation has limited previous meta-analyses. This study aims to comprehensively evaluate the potential differences between intrauterine devices using available multinational data, thereby providing a basis for global policy and healthcare services. We systematically searched PubMed, EMBASE, Web of Science, and Cochrane Library for primary studies published from inception to January 13, 2024, with no language or geographic restrictions. The study was registered on PROSPERO (CRD42024496400). We included only randomized controlled trials comparing Cu-IUDs and LNG-IUDs. Data extraction was independently conducted by two reviewers, with unresolved discrepancies referred to a third senior reviewer for consultation. The primary outcome was pregnancy, with secondary outcomes encompassing continuation, reasons for discontinuation, expulsion, satisfaction, and other adverse events. Data were synthesized using a random-effects model. Risk of bias was evaluated with the Cochrane Collaboration's tool, and evidence quality was assessed using the GRADE framework. An analysis of 20 trials showed that compared to Cu-IUDs, LNG-IUDs were associated with lower risks of pregnancy (Risk Ratio 0.22, 95% confidence interval 0.12-0.39), ectopic pregnancy (RR 0.12, 95% CI 0.03-0.47), discontinuation due to increased bleeding (RR 0.49, 95% CI 0.28-0.85), increased bleeding (RR 0.42, 95% CI 0.25-0.7), heavy bleeding (RR 0.41, 95% CI 0.22-0.75), and dysmenorrhea (RR 0.41, 95% CI 0.34-0.48), but they carried a higher risk of discontinuation due to amenorrhea (RR 21.05, 95% CI 8.83-50.00). When comparing LNG (52mg) IUD with copper (380mm2) IUD, The LNG-IUD showed a lower risk of discontinuation due to increased bleeding (RR 0.68, 95% CI 0.55-0.58) and dysmenorrhea (RR 0.42, 95% CI 0.34-0.53), but a higher risk of discontinuation due to bleeding issues (RR 2.83, 95% CI 2.47-3.25) and amenorrhea (RR 5.92, 95% CI 2.81-12.49). There were no significant differences between the two terms of continuation, expulsion, non-medical reasons for discontinuation, satisfaction, and other adverse outcomes. LNG-IUDs and Cu-IUDs are both highly effective contraceptive methods. Compared to Cu-IUDs, LNG-IUDs were associated with a lower risk of pregnancy and adverse reactions. However, LNG-IUDs carry a higher risk of amenorrhea. When recommending contraceptive methods, healthcare providers should fully inform patients of these potential risks and consider patient preferences. The research was funded by Hunan Provincial Natural Foundation of China (2021JJ30040), the National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University (2021KFJJ06), and the National Natural Science Foundation of China (No. 81672225).

Cerebrospinal fluid levels of NfM in relation to NfL and pNfH as prognostic markers in amyotrophic lateral sclerosis

Objective: To evaluate the prognostic potential of neurofilament medium chain (NfM) in CSF from patients with ALS and explore its relationship with the extensively studied neurofilament light chain (NfL) and phosphorylated heavy chain (pNfH). Method: CSF levels of NfL, NfM, and pNfH were analyzed in 235 samples from patients with ALS, ALS mimics, and healthy controls in a well-characterized cohort from Karolinska ALS Clinical Research Center in Stockholm, Sweden. NfM levels were analyzed using an antibody-based suspension bead-array and NfL and pNfH levels were measured using ELISA. Clinical data, including ALS Revised Functional Rating Scale (ALSFRS-R), and survival outcomes were utilized for disease progression estimations. Result: Increased NfM levels were observed in patients with ALS compared with mimics and healthy controls. Similarly, higher NfM levels were found in fast compared with slow progressing patients for baseline and longitudinal progression when evaluating both total and subscores of ALSFRS-R. These findings were consistent with the results observed for NfL and pNfH. All three proteins, used individually as well as in combination, showed comparable performance when classifying fast vs slow progressing patients (AUCs 0.78–0.85). For all neurofilaments, higher survival probability was observed for patients with low CSF levels. Conclusion: Based on this cross-sectional study, the prognostic value provided by NfM aligns with the more established markers, NfL and pNfH. Additional investigations with independent cohorts and longitudinal studies are needed to further assess the potential added value of NfM.

Causal mediation analysis of factors influencing physical activity and community access among people with mild to moderate Parkinson's disease

ObjectiveTo examine how known causal factors (exercise self-efficacy, balance, walking capacity) affect outcomes (moderate intensity physical activity, community access) in people with Parkinson's disease (PD): through a direct pathway, indirectly through potential mediators (non-motor impairments), or through combined direct and mediated paths. DesignCausal mediation analyses using baseline and three-month data from pooled treatment groups in a randomized controlled trial. SettingData were collected at two university clinical research centers. ParticipantsOne hundred thirty-eight people with PD. InterventionsHome and community-based walking and strength exercise program. Main Outcome Measure(s)Exposures were exercise self-efficacy, walking ability, and balance. Potential mediators included pain, fatigue, mood (anxiety, depression, affect, apathy), stigma, and cognition (executive function and cognitive flexibility). Outcomes were physical activity and community access behaviour at three-month follow-up. Separate models were developed for each causal factor-mediator-outcome combination. To minimise bias, all models were adjusted for known confounders (comorbidities, freezing of gait, severity of motor impairments, and/or age) and baseline values of the outcomes. ResultsSelf-efficacy of walking duration had a causal relationship with moderate intensity physical activity through direct and combined paths (p<.001). Walking capacity had a causal relationship with community access through direct (p=.03-.04) and combined (p=.02-.03) paths. Balance did not affect community access (p>.05). There were no significant mediation effects through indirect pathways for either outcome. ConclusionsThe effect of known causal factors on physical activity and community access was not mediated by non-motor impairments. Walking self-efficacy and walking capacity remain the primary intervention targets for improving physical activity and community access, respectively, in people with PD.

2024 Chinese guidelines for the diagnosis and treatment of rheumatoid arthritis

Rheumatoid arthritis(RA) is an autoimmune disease characterized by erosive arthritis, which is an important cause of disability in Chinese population. It is of great significance to formulate and update RA diagnosis and treatment guidelines that meet the standards of international guidelines and clinical practice in China. The update of the Chinese guidelines for the diagnosis and treatment of RA was initiated by National Clinical Research Center for Dermatologic and Immunologic Diseases, jointly with the Chinese Association of Rheumatology and Immunology Physicians, the Rheumatology and Immunology Professional Committee of Chinese Rehabilitation Medical Association, the Rheumatology and Immunology Professional Committee of Chinese Research Hospital Association, and the Rheumatology and Immunology Branch of Beijing Association of Holistic Integrative Medicine. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach and the Reporting Items for Practice Guidelines in Healthcare (RIGHT) checklist were followed to update the guidelines. The guidelines provide evidence-based recommendations on 10 clinical issues which were concerned by Chinese rheumatologists. The aim is to improve the level of diagnosis and standard treatment of RA in China, and to improve the quality of life and prognosis of patients.

Intranasal insulin for the treatment of olfactory dysfunction: a protocol for a systematic review and meta-analysis

IntroductionOlfactory dysfunction (OD) is a prevalent nasal affliction that has detrimental effects on the patients’ quality of life and safety. Conventional therapeutic strategies have various limitations such as high costs,...

Efficacy and safety of Danlou tablets in the treatment of stable angina pectoris with intermingled phlegm and blood stasis syndrome in coronary heart disease: a multicenter randomized controlled study.

In this study, we assessed the clinical efficacy and safety of Danlou tablets in the treatment of stable angina pectoris (SAP) with intermingled phlegm and blood stasis (IPBS), to provide high-quality evidence-based medical evidence for the prevention and treatment of coronary heart disease. In this multicenter randomized controlled study, 304 patients diagnosed with stable angina pectoris with IPBS enrolled from 12 national traditional Chinese medicine (TCM) clinical research centers in China were randomly assigned to the treatment group and the control group at a ratio of 1:1. Each group was divided into four subgroups based on the results of TCM syndrome differentiation: IPBS, IPBS combined with qi deficiency, IPBS combined with qi stagnation, and IPBS combined with toxin accumulation. The control group was treated with routine Western medicine. In addition to routine Western medicine treatment, the treatment group (the IPBS group) was treated with Danlou tablets or Danlou tablets supplemented by interventional therapies based on the results of traditional Chinese medicine differentiation. The frequency of angina attacks per week was the main efficacy evaluation indicator and the secondary efficacy evaluation indicators included angina symptom score, Seattle Angina Questionnaire, an electrocardiogram (ECG) efficacy evaluation, a cardiac Doppler two-dimensional ultrasound, an electrocardiogram treadmill exercise test, blood lipids, blood glucose, a coagulation function test, hemorheology indicators, homocysteine, C-reactive protein (CRP) or high sensitivity-CRP, TCM syndromes (syndrome score, tongue, pulse), and long-term prognosis (endpoint outcome, cardiovascular events). There were 300 cases in the full analysis set (FAS), 266 in the per-protocol set (PPS), and 300 in the safety set. Regarding the main efficacy indicator, after treatment, the reduction in the frequency of weekly angina attacks in the treatment group was significantly greater than that in the control group (P < 0.05). The results of the FAS and PPS were consistent. Regarding the secondary efficacy evaluation indicators, the angina symptom, TCM syndrome, ECG evaluation, Seattle Angina Pectoris Questionnaire, and 36-item Health Status Survey Summary Form scores of the treatment group were significantly higher than the control group (P < 0.05) and the homocysteine levels of the treatment group were significantly reduced (P < 0.05). The results of the FAS and PPS were consistent. In the PPS, the triglyceride levels in the treatment group were significantly lower than those in the control group after treatment (P < 0.05). The activated partial thromboplastin time in the treatment group decreased significantly (P < 0.05). There was no statistically significant difference in the safety indicators and incidence of adverse reactions between the two groups. Treatment with Danlou tablets and the modified combination therapy based on Western medicine treatment could improve angina pectoris symptoms of patients with SAP and IPBS syndrome and its concurrent syndromes, and improve patients' quality of life. Furthermore, the treatment is safe, has a long-term prognosis, and is worth further promotion and application in clinical practice. https://www.chictr.org.cn/showproj.html?proj=39724, ChiCTR registry, ChiCTR1900023708.

Engaging Nursing Students in Clinical Research Through a Unique Academic-Clinical Partnership.

A unique partnership between two academic medical centers, one with a college of nursing and the other with a clinical research center (CRC), provided professional development hours focusing on clinical research and the clinical research nurse's role to generalist entry master's nursing students. Students with clinical research interests were invited to apply for the 32-hour professional development program scheduled during 4 sequential days. Didactic, observational, and role-playing experiences offered students a picture of the clinical research nurse role, research regulatory processes, and career opportunities postgraduation. Evaluation of the four cohorts who completed the program demonstrated that most participants highly agreed that the program was educational and valuable. Partnering with academic medical centers who have CRCs provides master's-level students with innovative professional development hours that foster their understanding of practice areas (e.g., clinical research, specialty role of the clinical research nurse) that are not part of their coursework. [J Nurs Educ. 2024;63(X):XXX-XXX.].

Transforming Care in SEA: Evidence and Considerations for Evolution of the Current Treatment Paradigm

This article reviews an industry symposium held on 8 September 2024 as part of the European Respiratory Society (ERS) Congress 2024 in Vienna, Austria, which brought together four experts to discuss the current treatment paradigm for severe eosinophilic asthma (SEA), including the role of biologics and background medication tapering. Katrin Milger-Kneidinger, Professor of Respiratory Medicine at the University Hospital of the Ludwig Maximilian University Munich (LMU), in Germany, and the MedUni Graz, in Austria, explored the critical role eosinophils play in SEA pathology and how biologic therapies targeting eosinophils can address key disease features, including airway remodelling, airway hyperresponsiveness (AHR), and mucus production. Felix Herth, Professor of Pulmonary and Critical Care Medicine at Thoraxklinik Heidelberg, Heidelberg University Hospital, in Germany, discussed persistent airflow obstruction (PAO) in patients with SEA, focusing on a typical patient profile to understand the clinical manifestation and opportunities for management. Stephanie Korn, Professor of Pulmonary and Respiratory Medicine at Thoraxklinik Heidelberg, Heidelberg University Hospital, in Germany, and Head of the Clinical Research Centre, Institute für Klinische Forschung (IKP) Pneumologie in Mainz, Germany, presented on remission as a clinical target in SEA, focusing on how biologics can help achieve remission in some patients. Lastly, in a discussion led by symposium chair Stefano Del Giacco, Professor of Medicine, Allergy, and Clinical Immunology, at the University of Cagliari, Sardinia, in Italy, the experts agreed that a positive practice change would be to get more patients with relevant clinical manifestations on biologics, and that background medication tapering, when appropriate, could lead to improved patient outcomes and quality of life (QoL) in SEA.

Insulin Resistance in Hypercalciuric Calcium Kidney Stone Patients

Rational and ObjectiveDiabetes and uric acid kidney stones are strongly associated. Patients with calcium kidney stones also have higher risk of developing diabetes compared to non-kidney stone patients yet this has not been further investigated. We aimed to characterize insulin resistance in calcium kidney stone patients. Study DesignObservational Setting & PopulationThis study was performed in the University of Chicago Clinical Research Center. Kidney stone patients (N=42) were selected for having idiopathic hypercalciuria and calcium stones with no other medical conditions and controls (N=27) were healthy. ExposuresAll participants presented to the Clinical Research Center in a fasting state and at least 2 timed fasting blood and urine were collected prior to a fixed breakfast. Six additional timed blood and urine collections were performed after breakfast. OutcomesWe compared fasting and fed indices of insulin resistance between the groups. Analytic ApproachWe used t-tests and multivariable linear regression models. A sensitivity analysis removing all patients who had ever been on a thiazide diuretic was also performed. ResultsIn separate multivariable linear models, kidney stone patients had higher fasting serum insulin (24 (3 to 46pmol/L), p=0.03) and higher homeostatic model of insulin resistance (HOMA-IR) (1.0 (0.2 to 1.8), p=0.02). In separate multivariable linear models, kidney stone patients had higher fed serum glucose (10 (2 to 18mg/dL), p=0.01). Results were similar in a sensitivity analysis removing all patients who had ever been on a thiazide diuretic. There were no differences in urine composition based on HOMA-IR levels. LimitationsSingle institution. Small sample size limited subanalyses by different calcium stone types. ConclusionsCalcium kidney stone patients without diabetes or other medical conditions demonstrated signs of insulin resistance compared to healthy matched controls.

A Multicenter, Longitudinal Maternal and Birth Cohort Study in Latin America to Assess Prevalent Respiratory Tract Infections in Children from 0 to 5 Years of Age. The MINERVAL Study

Abstract Background A maternal and birth cohort study can assess the etiology and clinical course of lower respiratory tract infections and offers the opportunity to evaluate the relationship between sociodemographic, clinical, host characteristics and disease severity. In Latin America, a consortium of clinical research centers in Colombia and Panama has demonstrated its ability to conduct long-term longitudinal studies involving active surveillance of thousands of children with consistent retention rates. The MINERVAL cohort study aims to estimate the incidence, etiology, severity, and burden of lower respiratory tract infections (LRTI) and to identify microbiome and transcriptome profiles to help predict risk and assess disease severity in children from birth to 5 years of age. Methods We are establishing a maternal/birth cohort study in four sites (Cali, Bogota, Barranquilla and Panama), and will be recruiting 542 participants per center. Enrolled pregnant women between 24 and 27 weeks of gestation, and newborns under 4 weeks of age, will be closely followed with active surveillance weekly during the first 2 years for early detection of LRTI. Monthly telephone follow-up calls will continue until five years of age to assess the development of long-term respiratory morbidity and complications, including recurrent wheezing episodes. Clinical samples (NP swabs -for respiratory pathogen detection and microbiome analysis-, and blood -for cytokine and transcriptome analysis-) will be obtained in pregnant women, and in infants in the first 4 weeks of life and every 6 months for two years. Women and children who develop LRTI during the longitudinal follow-up will be evaluated clinically and samples will be collected. Results This cohort will provide prospective data and biological samples at crucial stages of children’s development, to allow estimation of the incidence and burden of LRTI by age and etiology, and the identification of risk factors and possible targets for intervention. Furthermore, the use of transcriptional profiling will allow early identification of variables to predict and guide clinical management in children, the use of antivirals and monoclonal antibodies, and to prioritize the population to be vaccinated according to age and risk factors. Conclusion The establishment of observational maternal and birth cohorts in Latin America could provide information to guide the development of strategies to prevent and mitigate the impact of respiratory tract infections in young children. Collaboration among investigators in the region and partnerships with international investigators optimizes resources and allows standardization of good surveillance practices, data exchange and the generation of new knowledge for future studies.

The effect of ceramides on skin absorption by Raman spectroscopy.

Ceramides are essential epidermal constituents that play a critical role in skin moisturization treatment as a raw material in cosmetics formulation. Recently, ceramides have been known to be frequently applied in various cosmetic formulations. Despite ceramide's beneficial characteristics, academic research regarding ceramides and their skin absorption remains insufficient. Therefore, our study conducted clinical research employing Raman spectroscopy to investigate the effects of ceramides on skin absorption to enhance the understanding of ceramides' dermatological functionality and their topical application in cosmetics science. Twenty healthy individuals with dry skin have participated in this clinical trial. In this double-arm designed trial, the test group received an investigational product with ceramides (5000ppm) and a control group received an investigational product without the ceramides while all other components remained identical. The subjects visited the clinical research center and acclimatized for 30 min in constant humidity and temperature for equilibrium, subsequently conducting a measurement. Before the trial, the research subject's target site (lower arm area) was kept clean, devoid of any cosmetic administering 24h before the trial when investigational product was topically applied. Our findings with Raman spectroscopy statistically demonstrate that skin absorption amount, speed and depth for both groups improved overall (p<0.05) after administration of the investigational product. Notably, the test group received an investigational product with ceramides (5000ppm) indicating superior effectiveness across all parameters compared to a control group from comparison analysis of each parameter (p<0.05). This study concludes that ceramide-containing cosmetics provide a beneficial effect on skin absorption via visual and statistical results of Raman spectroscopy analysis.

Sinonasal Complications of Combined Transseptal–Transnasal and Bilateral Transnasal Approaches for Endoscopic Endonasal Transsphenoidal Pituitary Surgery

BackgroundThe endoscopic combined transseptal–transnasal technique for pituitary adenoma excision is notable for enhanced postoperative functional outcomes. Our study compared the incidence of anterior nasal septal perforation and the resulting sinonasal complications between this method and the bilateral transnasal approach. MethodsUtilizing a retrospective cohort from a preeminent tertiary referral center, we analyzed 141 cases of endoscopic endonasal transsphenoidal surgery performed between March 2018 and May 2023. Outcomes for the transseptal–transnasal group (n = 71) and the conventional bilateral transnasal group (n = 70) were compared. Nasal endoscopy and computed tomography were used to assess anterior nasal septal perforation. Functional outcomes were assessed preoperatively and at 6 months postoperatively using the Connecticut Chemosensory Clinical Research Center (CCCRC) test, Cross-Cultural Smell Identification Test (CCSIT), Sino-Nasal Outcome Test-22 (SNOT-22), and nasal obstruction symptom evaluation (NOSE) ResultsThe transseptal–transnasal approach exhibited reduced rates of postoperative ear fullness (p < 0.001), along with fewer subjective complaints of smell/taste loss (p = 0.022) and thick nasal discharge (p = 0.008), compared to the conventional approach. However, objective smell test results were not significantly different between the two approaches (p = 0.243 and p = 0.454 for CCCRC and CCSIT, respectively). Additionally, although statistically insignificant, a higher incidence of anterior septal perforation was observed with the transseptal–transnasal approach (p = 0.067). ConclusionFor the surgical treatment of pituitary adenomas, the transseptal–transnasal approach offers several advantages over the bilateral transnasal method, particularly in reducing postoperative complications. However, this technique requires careful attention for preventing the occurrence of anterior septal perforation.

Development and validation of a clinical diagnostic model for myocardial ischaemia in borderline coronary lesions based on optical pumped magnetometer magnetocardiography: a prospective observational cohort study

ObjectivesTo develop and validate a clinical diagnostic model based on optical pumped magnetometer magnetocardiography (OPM-MCG) for the detection of myocardial ischaemia in patients with borderline coronary lesions prior to invasive...

Association of mixed exposure to microplastics with sperm dysfunction: a multi-site study in China

Microplastics are environmental pollutants detected in various human organs and tissues. These particles originate from multiple sources including the degradation of larger plastic items and the intentional inclusion in consumer goods. Potential risks for human health resulting from microplastics exposure have also been reported. However, the distribution in the male reproductive system and its effect remains largely unknown. This study aims to investigate the presence of multiple microplastics in human semen and urine and their association with sperm quality in a multi-site study across China. We conducted a cross-sectional study involving 113 male participants from three regions in China. Semen and urine samples were collected and analysed using Raman microscopy to detect eight types of microplastics: polystyrene (PS), polypropylene (PP), polycarbonate (PC), polyethylene (PE), polyvinyl chloride (PVC), polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), and acrylonitrile butadiene styrene (ABS). Semen quality parameters, including total sperm count, concentration, motility, and morphology, were assessed. Statistical analyses, including single and multi-variable models, were used to evaluate the relationship between microplastic exposure and semen quality, with a focus on PTFE, after adjusting confounding factors of age, body mass index (BMI), smoking, alcohol drinking, and sites. Microplastics were detected in all semen and urine samples, with participants typically exposed to 3-5 different types. The detection rates of PS, PP and PE were the highest. Notably, PTFE exposure was significantly associated with decreased semen quality. Participants exposed to PTFE showed reductions in total sperm count [188.90±163.71 vs. 207.67±132.36 million, p=0.091], sperm concentration [52.13±47.47 vs. 58.32±37.26 million/mL, p=0.041], and progressive motility [40.29%±19.06 vs. 34.11%±17.02, p=0.083]. The multi-linear regression analysis indicated that each additional type of microplastic exposure was associated with a significant decrease in total sperm number [β=-15.4 (95% CI:-25.6,-5.2)], sperm concentration [β=-7.2 (95% CI:-12.4,-2.0)], and progressive motility [β=-8.3 (95% CI:-13.5,-3.1)]. Latent category analysis further refined these groups by types of microplastic exposure, highlighting specific types more strongly associated with decreased semen quality (OR=3.5, 95% CI: 1.8, 6.9, p<0.001). The nomogram can be used to assess the risk of sperm damage by combining the type of microplastic exposure in urine with age and BMI. Our findings highlight the potential reproductive health risks posed by microplastic contamination, particularly PTFE, a non-stick pan coating material, and raise concerns about the potential of urine testing as an indicator of male reproductive microplastic exposure. Future research is warranted to further elucidate the mechanisms underlying the adverse effects of microplastics on male fertility and cross-generational effects. This study was funded by the Clinical Research Project of Shanghai Municipal Commission of Health and Family planning (20224Y0085), Open Fund Project of Guangdong Academy of Medical Sciences (YKY-KF202202), CAMS Innovation Fund for Medical Sciences (2019-I2M-5-064), Shanghai Clinical Research Center for Gynecological Diseases (22MC1940200), Shanghai Urogenital System Diseases Research Centre (2022ZZ01012), Key Discipline Construction Project (2023-2025) of Three-Year Initiative Plan for Strengthening Public Health System Construction in Shanghai (GWVI-11.1-35, GWVI-11.2-YQ29) and Shanghai Frontiers Science Research Base of Reproduction and Development.

INSIGHT responsive parenting intervention effects on child self-regulation at ages 3 and 6 years.

Self-regulation encompasses the ability to modulate behavior, cognition, and emotions. Parents can promote child self-regulation with responsive parenting (RP). RP shapes various components of self-regulation and is associated with numerous developmental outcomes. Here, we examine long-term effects of an early-life RP intervention designed for obesity prevention on later child self-regulation and temperament. Participants were from a randomized clinical trial comparing the RP intervention against a safety control (n = 279). RP intervention content in the domains of feeding, sleep, emotion regulation, and interactive play was delivered to primiparous mothers and infants at four home visits during the first year after birth, followed by clinical research center visits at ages 1 and 2 years and phone calls at 1.5 and 2.5 years. Child self-regulation and temperament were assessed with behavioral tasks and the Children's Behavior Questionnaire at child ages 3 and 6 years. A path model tested whether the RP intervention affected child self-regulation in comparison to the control group. At 6 years, children in the RP group had lower parent-reported negative affect (b = -0.34, SE = 0.15, p = .023) and better observed emotion regulation (b = 0.45, SE = 0.16, p = .007). Findings indicate that an RP intervention designed for early obesity prevention promoted emotional aspects of self-regulation in middle childhood, highlighting RP as a strategy for promoting healthy behavior across multiple domains. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

The Influencing Factors and Traditional Chinese Medicine Syndrome Characteristics of Depression/Anxiety in Patients with Coronary Heart Disease: A Cross-sectional Study

Abstract Objective: The objective of the study was to investigate the situation of depression/anxiety in patients with coronary heart disease (CHD) at different stages of the disease and to analyze the influencing factors and the evolution characteristics of traditional Chinese medicine (TCM) syndromes. Materials and Methods: From October 2016 to April 2018, a cross-sectional survey was conducted at 48 clinical research centers in 23 provinces, cities, and autonomous regions across China. A total of 11383 cases were collected by outpatient or inpatient cases, including healthy individuals (n = 1754), low-risk individuals (n = 2339), metabolic syndrome (n = 1475), stable CHD (n = 3366), acute coronary syndrome (n = 704), perioperative intervention treatment (n = 753), and heart failure (n = 992). Survey demographic data, lifestyle habits, disease and health status, TCM symptoms and signs, and other information were collected. Results: The prevalence rates of depression/anxiety in surveyed patients with CHD were 35.7% and 21.0%, respectively, and were higher than those in patients with metabolic syndrome (18.8% and 10.3%, respectively), low-risk individuals (11.7% and 7.5%), and healthy individuals (9.7% and 5.7%, respectively). The significant risk factors for CHD combined with depression analyzed by the generalized linear mixed model included age (odds ratio [OR] = 0.019), gender (OR = 0.632), hypertension (OR = 0.306), course of CHD (OR = 0.022), stent placement (OR = −0.284), heart function level (OR = −4.151/−3.336/−2.118), and phlegm stasis syndrome score (OR = 0.129). The significant risk factors for CHD combined with anxiety included gender (OR = 0.581), heart function level (OR = −1.856), and phlegm stasis syndrome score (OR = 0.094). Factor analysis was conducted on the symptoms and signs of patients with CHD combined with depression/anxiety, and 16 common factors were obtained with cumulative contribution rates of 62.83% and 66.13%, respectively. Disease syndromes included liver and kidney deficiency syndrome, liver stagnation and discomfort syndrome, Qi deficiency syndrome, liver meridian fire heat syndrome, kidney deficiency syndrome, phlegm dampness syndrome, heart and gallbladder Qi deficiency syndrome, blood stasis syndrome, lung Qi inversion syndrome, Yang deficiency syndrome, and three symptoms named diseases, including chest tightness, chest pain, insomnia, and head discomfort. Conclusions: Through cross-sectional design, the data obtained in this study revealed the actual situation of CHD patients with anxiety or depression at different stages. The influencing factors of CHD patients with depression or anxiety were analyzed through the collected cross-sectional information and further revealed the syndromic characteristics of CHD patients with depression or anxiety at different stages from the perspective of TCM syndromes. The data obtained provide a practical basis for further understanding the clinical characteristics of bicardiac diseases and for proposing treatment strategies in stages.

Bone Accrual Trajectories in Children and Adolescents with Perinatal HIV Infection.

Low bone mineral density (BMD) has been reported in children and adolescents living with perinatally-acquired HIV (PHIV). Little is known about their bone accrual through puberty compared to an uninfected healthy cohort. To compare bone accrual in PHIV and healthy children. PHIV children aged 7-16 years had dual energy X-ray absorptiometry (DXA) at entry, 2 years, and then at least 2 years later. Bone accrual was compared to healthy children from the Bone Mineral Density in Childhood Study (BMDCS). United States academic clinical research centers. 172 PHIV; 1321 BMDCS. We calculated height-adjusted whole-body and spine BMD and bone mineral content (BMC) Z-scores in PHIV using BMDCS reference curves. We fit piecewise weighted linear mixed effects models with change points at 11 and 15 years, adjusted for age, sex, race, height Z-score, and Tanner stage, to compare BMD and BMC Z-scores across actual age by cohort.Main Outcome Measure: BMD/BMC Z-scores. Height-adjusted whole-body BMD and BMC Z-scores in PHIV were lower across age compared to BMDCS children. Spine BMD Z-score across age was higher in PHIV after height adjustment. Whole-body and spine bone area tended to be lower in PHIV. PHIV had slower accrual in whole-body and spine bone area before 14 years. After 15 years, bone area accruals were similar, as were height-adjusted spine BMC Z-scores, across age. PHIV had persistent deficits in all measures except height-adjusted spine BMD and BMC Z-scores. Data are needed on PHIV followed to adulthood.

As a phenomenon: Ramadan fasting improves olfactory performance.

The present study objectived to investigate the influence of Ramadan fasting (RF) on olfactory function. Sixty-two participants were included in the current prospective study. The odor threshold and identification performances were determined by using the Connecticut Chemosensory Clinical Research Center (CCCRC) test initially (day 0) and on the first and last day (30th) of RF. Body weight (BW)s were measured initially and at the end of the study. The results were analyzed statistically. The average of baseline and last-day BWs were 78.38 ± 12.96 and 78.36 ± 12.39 kg, respectively. No significant difference was determined in terms of BWs (p = .932, p > .05). In the evaluation of CCCRC test outcomes, significant differences were observed in the scores of butanol thresholds (p = .0001), odor identification (p = .0001), food-related odors identification (p = .0001), and the number of normosmic individuals (p = .0001) at different times (p < .05). The thresholds scores (p = .0001, p = .0001), the identification scores (p = .0001, p = .0001), food-related odors identification scores (p = .0001, p = .0002), and the number of normomic individuals (p = .001, p = .001) detected on 30th day were significantly higher than on 0th and 1st days; respectively (p < .05). Additionally, the threshold scores (p = .0001), the identification scores (p = .003), food-related odors identification scores (p = .007), and the number of normosmic individuals (p = .018) detected on day 1 were significantly higher than on day 0 (p < .05). The current study demonstrated that Ramadan fasting enhances the olfactory detection threshold and odor identification scores, significantly improving the identification of food-related odors. The results may indicate that Ramadan fasting improves olfactory performance. Level II.

Development and validation of a predictive model for tumor lysis syndrome in childhood acute lymphoblastic leukemia

BackgroundTumor lysis syndrome (TLS) frequently manifests shortly after induction chemotherapy for acute lymphoblastic leukemia (ALL), with the potential for swift progression. This study endeavored to develop a nomogram to predict the risk of TLS, utilizing clinical indicators present at the time of ALL diagnosis. MethodsWe retrospectively gathered data from 2243 patients with ALL, spanning December 2008 to December 2021, utilizing the clinical research big data platform of the National Center for Clinical Research on Children's Health and Diseases. The Least Absolute Shrinkage and Selection Operator (LASSO) method was employed to filter variables and identify predictors, followed by the application of multivariate logistic regression to construct the nomogram. ResultsThe LASSO regression identified six critical variables among ALL patients, upon which a nomogram was subsequently constructed. Multifactorial logistic regression revealed that an elevated white blood cell count (WBC), serum phosphorus <2.1 mmol/L, potassium <3.5 mmol/L, aspartate transaminase (AST) ≥50 U/L, uric acid (UA) ≥476μmol/L, and the presence of acute kidney injury (AKI) at the time of initial diagnosis were significant risk factors for the development of TLS in ALL patients (P<0.05). The predictive model achieved an area under the receiver operating characteristic curve (AUC) of 0.824 [95 % CI (0.783, 0.865)], with an internal validation AUC of 0.859 [95 % CI (0.806, 0.912)]. The Hosmer-Lemeshow goodness-of-fit test confirmed the model’s robustness (P=0.687 for the training cohort; P=0.888 for the validation cohort). Decision curve analysis (DCA) indicated that the predictive model provided substantial clinical benefit across threshold probabilities ranging from 10 % to 70 %. ConclusionsA nomogram incorporating six predictive variables holds significant potential for accurately forecasting TLS in pediatric patients with ALL.

Associations of socioeconomic status and healthy lifestyle with incident dementia and cognitive decline: two prospective cohort studies

Little is known about the complex associations of socioeconomic status (SES) and healthy lifestyle with cognitive dysfunction. Using data from the Health and Retirement Study (HRS) [2008-2020] and the English Longitudinal Study of Ageing (ELSA) [2004-2018], SES was constructed by latent class analysis using education level, total household income and wealth. Overall healthy lifestyle was derived using information on never smoking, low to moderate alcohol consumption (drinks/day: (0, 1] for women and (0, 2] for men), top tertile of physical activity, and active social contact. A total of 12,437 and 6565 participants from the HRS and ELSA were included (40.8% and 46.0% men and mean age 69.3 years and 65.1 years, respectively). Compared with participants of high SES, those of low SES had higher risk of incident dementia (hazard ratio 3.17, 95% confidence interval 2.72-3.69 in the HRS; 1.43, 1.09-1.86 in the ELSA), and the proportions mediated by overall lifestyle were 10.4% (7.3%-14.6%) and 2.7% (0.5%-14.0%), respectively. Compared with participants of high SES and favorable lifestyle, those with low SES and unfavorable lifestyle had a higher risk of incident dementia (4.27, 3.40-5.38 in the HRS; 2.02, 1.25-3.27 in the ELSA) and accelerated rate of global cognitive decline (β=-0.058 SD/year; 95% CI:-0.073,-0.043 in the HRS; β=-0.049 SD/year; 95% CI:-0.063,-0.035 in the ELSA). Unhealthy lifestyle only mediated a small proportion of the socioeconomic inequality in dementia risk in both US and UK older adults. This work was supported by grants from the National Natural Science Foundation of China (82088102 and 82370819), the National Key R&D Program of China (2023YFC2506700), the Shanghai Municipal Government (22Y31900300), the Shanghai Clinical Research Center for Metabolic Diseases (19MC1910100), the Innovative Research Team of High-Level Local Universities in Shanghai, the Special Project for Clinical Research in Health Industry of Shanghai Municipal Health Commission (202340084), and Ruijin Hospital Youth Incubation Project (KY20240805). Y.X. is supported by the National Top Young Talents program.