Disease Registry Study Research Articles

P16‐12: Key findings of the Fukuoka tobacco‐related lung disease (FOLD) registry study in Japan

P16‐12: Key findings of the Fukuoka tobacco‐related lung disease (FOLD) registry study in Japan

Association between Multimorbidity and Kidney Function among Patients with Non-Dialysis-Dependent CKD: The Fukuoka Kidney Disease Registry Study.

Aim: Individuals with chronic kidney disease (CKD) have a high prevalence of comorbidities, including cardiovascular disease (CVD) and its risk factors. However, epidemiological results to assess the association between multimorbidity and kidney function among the CKD population remains limited. Methods: We performed a cross-sectional analysis of the association between 23 comorbid conditions and reduced kidney function in 4,476 patients with non-dialysis-dependent CKD enrolled in a multicenter cohort in Japan. Reduced kidney function was defined as an estimated glomerular filtration rate of ≤ 60 mL/min/1.73 m2. Results: The mean age of patients was 67 years (male, 56.0%). The prevalence of hypertension, diabetes mellitus, dyslipidemia, prior CVD, cancer, and bone fracture, which are the major comorbidities, was 83.3%, 28.7%, 45.9%, 23.3%, 12.7%, and 6.3%, respectively. Multivariable-adjusted analyses revealed that age, male sex, hypertension, dyslipidemia, prior CVD, body mass index, urinary protein excretion, and underlying kidney disease were independent factors associated with reduced kidney function. Importantly, the odds ratios (ORs) for reduced kidney function increased linearly as the number of major comorbid conditions increased (OR for 1–2 conditions: 2.22, 95% confidence interval [CI]: 1.65–2.97; OR for 3–4 conditions: 3.04, 95% CI: 2.12–4.37; OR for ≥ 5 conditions: 4.37, 95% CI: 1.75–10.9). The upward trend in OR was more pronounced with cardiovascular comorbidities but not significant with non-cardiovascular comorbidities. Conclusions: In conclusion, we observed an independent association between cardiovascular comorbidity and its risk factors and reduced kidney function. The results of this study highlight the importance of managing multimorbidity among patients with CKD.

Associations Between Surrogates of Skeletal Muscle Mass and History of Bone Fracture in Patients with Chronic Kidney Disease: The Fukuoka Kidney disease Registry (FKR) Study.

Patients with chronic kidney disease (CKD) are at increased risks of both sarcopenia and fragility fractures. However, information on the association between skeletal muscle mass (SMM) and the risk of bone fractures in patients with CKD is lacking. We performed a cross-sectional analysis of 4146 patients with CKD using the baseline dataset of the Fukuoka Kidney disease Registry Study, as a multicenter, prospective cohort study of pre-dialysis CKD patients. The main measure was estimated SMM (eSMM) calculated using an equation validated by bioelectrical impedance analysis with two independent datasets of 100 and 81 CKD patients. The main outcome was historical bone fractures. The associations between sex-specific quartiles (Q1-Q4) of eSMM and fracture history were assessed by logistic regression analyses. The prevalence of a history of fractures increased and eSMM decreased with progressive CKD stages. Among the 4146 patients, 249 had prior bone fractures, including 111 patients in Q1 (lowest quartile), 65 in Q2, 46 in Q3, and 27 in Q4 (highest quartile). A multivariable-adjusted model revealed that patients in Q1 had a significantly higher odds ratio (95% confidence interval) for bone fracture history than those in Q4 (reference): Q1, 2.77 (1.32-5.80); Q2, 1.95 (1.05-3.65); and Q3, 1.57 (0.90-2.75) (P-value for trend < 0.001). Similar associations were obtained when other skeletal muscle surrogates were applied: serum creatinine to serum cystatin C and daily urinary creatinine excretion. These results suggest that a lower eSMM is associated with an increased prevalence of historical bone fractures in pre-dialysis CKD patients.

Non-invasive fibrosis assessments of non-alcoholic fatty liver disease associated with low estimated glomerular filtration rate among CKD patients: the Fukuoka Kidney disease Registry Study.

A growing body of evidence has shown that non-alcoholic fatty liver disease (NAFLD) is associated with chronic kidney disease (CKD). Non-invasive fibrosis assessments of NAFLD such as Fibrosis-4 (FIB-4) index and NAFLD fibrosis score (NFS) have been developed to substitute liver biopsy. Little is known about the association between FIB-4 index or NFS and the components of CKD. In the present cross-sectional study, we assessed of 3640 Japanese CKD patients. We examined the association between FIB-4index or NFS and the odds of having low estimated glomerular filtration rate (eGFR) defined as eGFR < 60mL/min/1.73 m2 or albuminuria defined as urinary albumin-to-creatinine ratio (UACR) ≥ 30mg/g. Patients were divided into quartiles according to their baseline FIB-4 index and NFS levels. Linear and logistic regression analysis were conducted, with adjustment for potential confounding factors. FIB-4 index and NFS were negatively associated with eGFR, but not UACR, after adjustment for potential confounding factors. Both FIB-4 index and NFS were significantly associated with low eGFR after adjustment for potential confounding factors. Meanwhile, in the multivariable-adjusted model, no associations were found between FIB-4 index or NFS and albuminuria. The addition of FIB-4 index or NFS to the established clinical CKD risk factors improved diagnostic accuracy of prevalence of low eGFR. We also found that there was a significant trend of higher FIB-4 index and NFS with more advanced renal fibrosis using the kidney biopsy data. Higher non-invasive fibrosis assessments of NAFLD were associated with higher odds of decreased eGFR.

Canadian Fabry disease registry study group: Report on the A143P Nova Scotia genotype

Canadian Fabry disease registry study group: Report on the A143P Nova Scotia genotype

Relationship between serum lipid concentrations and impaired renal function in patients with chronic kidney disease: the Fukuoka Kidney Disease Registry Study.

Patients with chronic kidney disease (CKD) have a higher risk of atherosclerotic cardiovascular disease (ASCVD). Dyslipidemia has been established as a risk factor for ASCVD. In the present study, we aimed to determine the prevalence of dyslipidemia at each stage of CKD. We conducted a cross-sectional study among 4476 patients registered in the Fukuoka Kidney Disease Registry Study, a Japanese prospective cohort study in patients with non-dialysis-dependent CKD. Outcomes were the prevalence of hyper-low-density lipoprotein (LDL) cholesterolemia, hyper-non-high-density lipoprotein (non-HDL) cholesterolemia, hypertriglyceridemia, and hypo-high-density lipoprotein (hypo-HDL) cholesterolemia at each stage of CKD. We analyzed the relationships between CKD stage and the prevalence of dyslipidemia using logistic regression models. Patients in the advanced stages of CKD were more likely to have hypertriglyceridemia [OR 2.16 (95% CI 1.03-4.56), OR 2.24 (95% CI 1.04-4.84), OR 2.62 (95% CI 1.19-5.78), and OR 2.47 (95% CI 1.04-5.88) for CKD stages G3a, G3b, G4, and G5, respectively] and hypo-HDL-cholesterolemia [OR 2.66 (95% CI 1.21-5.82), OR 3.10 (95% CI 1.38-6.95), OR 2.86 (95% CI 1.25-6.53), and OR 3.30 (95% CI 1.35-8.10) for CKD stages G3a, G3b, G4, and G5, respectively] as compared with patients in CKD stage G1. The prevalence of hyper-LDL-cholesterolemia and hyper-non-HDL-cholesterolemia was not related to CKD stage. Patients with advanced CKD stages are more likely to have hypertriglyceridemia and hypo-HDL-cholesterolemia than those in early stages. This type of lipid profile may represent a risk factor for ASCVD in patients with CKD.

Design and Conduct of a Real-World Single-Center Registry Study on Testosterone Therapy of Men with Hypogonadism

Aims: Despite the prevalence of hypogonadism (testosterone deficiency [TD]) and widespread use of testosterone therapy (TTh), the effectiveness and safety of long-term testosterone use remains highly contested. Over the past 15 years, we have conducted a registry study of men with TD with a focus on several health outcomes associated with TTh. Design: Observational patient disease registry study. Materials and Methods: Noninterventional disease registry with prospective longitudinal data on a large sample of adult hypogonadal men (n = 858) who were treated in a single Urology Clinic. The registry evaluates men with symptomatic TD during a urological exam of patients who have not been previously treated with TTh. There were no inclusion/exclusion criteria. All hormone assays are carried out in a single laboratory. Standard-of-care treatment of each patient is the sole responsibility of the attending clinician. The registry data consist of comprehensive medical records and questionnaire data collected during patient visits. The registry has a dedicated statistician to ensure adequate statistical analyses of all outcome measures assessed. Main Outcome Measures: We measured the following parameters: height, weight, waist circumference, hemoglobin, hematocrit, fasting glucose, glycated hemoglobin, insulin, systolic and diastolic blood pressure, heart rate, lipids (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides), highly sensitive C-reactive protein, and total testosterone (T). We assessed quality of life, erectile and urinary function. Clinical parameters were measured two to four times a year. Data are analyzed in regular intervals. Results: As of 2019, 858 men have been enrolled, of whom 85 patients exhibited primary hypogonadism, and the remaining 773 exhibited secondary or functional hypogonadism. Findings from this registry study on the benefit of TTh on anthropometric parameters, cardiometabolic function, diabetes, and prostate health have been reported. Conclusions: This registry study has provided real-world clinical evidence and produced new important findings regarding the effectiveness and safety of long-term TTh in hypogonadal men.

Bone Fractures and Antihypertensive Drugs in CKD Patients: The Fukuoka Kidney Disease Registry (FKR) Study

Bone Fractures and Antihypertensive Drugs in CKD Patients: The Fukuoka Kidney Disease Registry (FKR) Study

The Practical Patterns of Medication and the Association Between CKD Stage and Polypharmacy: The Fukuoka Kidney Disease Registry Study

The Practical Patterns of Medication and the Association Between CKD Stage and Polypharmacy: The Fukuoka Kidney Disease Registry Study

Association between urinary salt excretion and albuminuria in Japanese patients with chronic kidney disease: the Fukuoka kidney disease registry study

Several large population-based studies have demonstrated that urinary salt excretion (USALT) is associated with albuminuria. However, this relationship has not been assessed in a large cohort study of patients with chronic kidney disease (CKD). Thus, the present study aimed to elucidate whether USALT was independently associated with albuminuria in a large cohort of patients with CKD. This cross-sectional study was conducted in 4075 patients with CKD not on dialysis. USALT (g/day) was estimated from spot urine. Patients were divided into quartiles (Q1-Q4) according to estimated USALT. Multivariable regression models were used to determine whether USALT was independently related to urinary albumin-to-creatinine ratio (UACR) or the presence of macroalbuminuria. In multivariable linear regression analyses, 1-g/day increment in USALT was significantly associated with log UACR [coefficient 0.098, 95% confidence interval (CI) 0.075-0.121]. In addition, compared with the first USALT quartile, the third and fourth quartiles exhibited significant associations with log UACR (Q3: coefficient 0.305, 95% CI 0.154-0.456; Q4: coefficient 0.601, 95% CI 0.447-0.756). Furthermore, multivariable logistic regression analyses showed that USALT (1-g/day increment) was significantly associated with the presence of macroalbuminuria [odds ratio (OR) 1.11, 95% CI 1.07-1.14]; the third and fourth USALT quartiles exhibited significantly greater risks of macroalbuminuria, compared with the first quartile (Q3: OR 1.33, 95% CI 1.09-1.62; Q4: OR 1.89, 95% CI 1.54-2.32). This significant association of USALT with UACR and macroalbuminuria suggests that higher USALT may cause increased albuminuria, thereby contributing to kidney disease progression.

Association Between Plasma Intact Parathyroid Hormone Levels and the Prevalence of Atrial Fibrillation in Patients With Chronic Kidney Disease - The Fukuoka Kidney Disease Registry Study.

Parathyroid hormone (PTH) has been associated with cardiovascular disorders; however, it is unknown whether plasma PTH concentrations are associated with atrial fibrillation (AF) in patients with chronic kidney disease (CKD).Methods and Results:The present cross-sectional study analyzed baseline data of 3,384 patients registered in the Fukuoka Kidney Disease Registry Study, a Japanese multicenter prospective cohort study of patients with non-dialysis-dependent CKD. The outcome was prevalence of AF, and the main risk factor was plasma intact PTH concentration. Associations between plasma intact PTH concentration quartiles (Q1-Q4, from lowest to highest) and the presence of AF were analyzed using logistic regression. In all, 185 patients had AF; 22, 34, 59, and 70 patients were in Q1, Q2, Q3, and Q4 of PTH concentrations, respectively. The prevalence of AF increased incrementally with increases in plasma intact PTH. In the logistic regression model, patients with higher plasma intact PTH concentrations (Q2-Q4) had higher adjusted odds ratios (95% confidence intervals) for the prevalence of AF relative to the reference group (Q1), namely 1.33 (0.76-2.34), 1.82 ([1.06-3.13), and 1.99 (1.08-3.64), respectively (P=0.016). Higher plasma intact PTH concentrations were significantly and incrementally associated with an increased prevalence of AF in non-dialysis-dependent CKD patients.

Characteristics of tobacco-related lung diseases in Fukuoka Prefecture, Japan: A prospective, multi-institutional, observational study.

Tobacco smoking causes a variety of smoking-related diseases, death, and economic damage. Despite targeted anti-smoking campaigns, tobacco-related deaths are expected to increase in Japan. We investigated the current state of non-cancerous lung diseases such as idiopathic interstitial pneumonias (IIPs), chronic obstructive pulmonary disease (COPD), and combined pulmonary fibrosis and emphysema (CPFE), which are known to be highly related to tobacco smoking. This prospective multi-institutional observational study involved 29 major hospitals within the Fukuoka Prefecture area (Fukuoka tobacco-related lung disease registry study group). Patients diagnosed with IIPs, including CPFE and COPD, registered from September 1, 2013 to April 30, 2016 were included. Clinical background information, laboratory and pulmonary function test results, findings of imaging tests, including chest radiography and chest computed tomography, and DNA isolated from peripheral blood were collected from each patient. Follow-up surveillance involved collection of data regarding the exacerbation of disease and death until 5 years of registration. In the present study, we report the baseline characteristics of the patients registered in this surveillance study. Overall, 1016 patients (524 with IIPs, including 145 CPFE and 492 with COPD) were enrolled. Among the patients with COPD, 96.8% were current or former smokers. Among the patients with IIPs, 69.9% were current or former smokers. This study revealed the current status of lung diseases potentially related to tobacco smoking in Fukuoka Prefecture. Both COPD and CPFE were highly related to tobacco smoking, whereas 30% of patients with IIPs had never smoked.

Validation of randomized controlled trial-derived models for the prediction of postintervention outcomes in chronic limb-threatening ischemia

BackgroundChronic limb-threatening ischemia (CLTI) represents the most severe form of peripheral artery disease and has a large impact on quality of life, morbidity, and mortality. Interventions are aimed at improving tissue perfusion and averting amputation and secondary cardiovascular complications with an optimal risk-benefit ratio. Several prediction models regarding postprocedural outcomes in CLTI patients have been developed on the basis of randomized controlled trials to improve clinical decision-making. We aimed to determine model performance in predicting clinical outcomes in selected CLTI cohorts. MethodsThis study validated the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL), Finland National Vascular registry (FINNVASC), and Prevention of Infrainguinal Vein Graft Failure (PREVENT III) models in data sets from a peripheral artery disease registry study (Athero-Express) and two randomized controlled trials of CLTI in The Netherlands, Rejuvenating Endothelial Progenitor Cells via Transcutaneous Intra-arterial Supplementation (JUVENTAS) and Percutaneous Transluminal Angioplasty and Drug-eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia (PADI). Receiver operating characteristic (ROC) curve analysis was used to calculate their predictive capacity. The primary outcome was amputation-free survival (AFS); secondary outcomes were all-cause mortality and amputation at 12 months after intervention. ResultsThe BASIL and PREVENT III models showed predictive values regarding postintervention mortality in the JUVENTAS cohort with an area under the ROC curve (AUC) of 81% and 70%, respectively. Prediction of AFS was poor to fair (AUC, 0.60-0.71) for all models in each population, with the highest predictive value of 71% for the BASIL model in the JUVENTAS population. The FINNVASC model showed the highest predictive value regarding amputation risk in the PADI population with AUC of 78% at 12 months. ConclusionsIn general, all models performed poor to fair in predicting mortality and amputation. Because the BASIL model performed best in predicting AFS, we propose use of the BASIL model to aid in the clinical decision-making process in CLTI. However, improvements in performance have to be made for any of these models to be of real additional value in clinical practice.

Orosomucoid As a Biomarker for Chronic Kidney Disease Associated with Sickle Cell Anemia

BACKGROUND: Chronic kidney disease (CDK) is a serious and highly prevalent complication of Sickle cell anemia (SCA). Proteinuria and microalbuminuria can be under-detected in SCA because of the renal concentrating defect. Hence, complementary diagnostic biomarkers are necessary for early detection of CKD in patient with SCA. Our recent study identified alpha 1-acid glycoprotein (orosomucoid, ORM) (1) as potential biomarker of CKD. ORM is a major acute phase inflammatory protein synthesized by the liver and its presence in urine may indicate underlying inflammation in SCA patients.OBJECTIVES: We aimed to validate ORM as biomarker for CKD in a cohort of SCA patients recruited at Howard University.METHODS: We analyzed samples collected from patients enrolled in a sickle cell disease registry study at Center for Sickle Cell Disease, Howard University. Plasma and urine samples were collected and stored at -80°C. Plasma samples were assayed for creatinine and cystatin C. Urine samples were analyzed for albumin, creatinine and ORM. Multistix was used to determine protein, blood, pH and specific gravity (SG) in urine samples. Estimated GFR (eGFR) was calculated using CKD-EPI creatinine-cystatin equation. CKD stages were assigned according to the National Kidney Foundation, Kidney Disease Outcomes Quality Initiatives (K/DOQI) guidelines: stage 0 - eGFR>60 ml/min/1.73m2 and AL/CRE<30 mg/g; stage 1- eGFR>90 ml/min/1.73m2 and AL/CRE≥30 mg/g; stage 2 - eGFR 60-89 ml/min/1.73m2 and AL/CRE≥30 mg/g, stage 3 - eGFR 30 - 59 /1.73m2; stage 4 - eGFR 15 - 29 ml/min/1.73m2 and stage 5 - eGFR < 15 ml/min/1.73m2. Glomerular hyperfiltration was defined as eGFR>130 ml/min/1.73 m2 for females and eGFR>140 ml/min/1.73 m2 for males.RESULTS: The Howard University registry study group consisted of 96 patients (mean age 38.1 years, range 18 - 67 years, 55% females) and included 65.6% HbSS, 21.8% HbSC, 7.2% HbS β+thalassemia, 4.1% HbS β0 thalassemia. Based on urinary dipstick test, proteinurea was detected in 16.5% patient. Hyperfiltration was detected in 45 patients (56.3%). CDK (combined stage 1-4) was detected in 35.8% patients. No difference was found between females and males in CKD prevalence. Prevalence of CKD in HbSC patients was 11% whereas it was 37% in HbSS patients. Prevalence of CDK increased with the age.The overall urinary ORM/CRE levels demonstrated modest correlation with CKD stage (R2=0.22). Next we stratified samples based on the levels of ORM/CRE. The samples were separated into two groups: (i) samples with no or mild inflammation (ORM/CRE<10μg/mg) and (ii) samples that displayed significant inflammation (ORM/CRE>10 μg/mg). We observed strong inverse correlation between the percentage of samples without inflammation and CKD stage (R2=0.996). We also observed strong correlation of CDK progression with number of samples with significant inflammation (R2=0.996). Sensitivity of ORM/CRE was 53.8%, specificity 70.2% and odds ratio OR 2.72 for samples with CKD stages 1-4 compared to the samples without CKD (stage 1).CONCLUSIONS: In our cohort, determination of proteinurea evaluated by dipstick (16%) grossly underestimated CKD prevalence (35%) determined by eGFR and AL/CRE ratios. Subjects with HbSC had 3-fold less prevalence of CKD comparing to the patients with HbSS. ORM/CRE levels correlated with the stages of CKD stages (OR 2.72). Further longitudinal study is needed to determine whether ORM/CRE ratio can be used as a prognostic marker of renal disease development.ACKNOWLEDGMENTS: This work was supported by NIH Research Grants 1P50HL118006, 1R01HL125005 and 5G12MD007597. AT was supported by ASH MMSAP summer program. The content is solely the responsibility of the authors and does not necessarily represent the official view of NHLBI, NIMHD or NIH.REFERENCES:Jerebtsova, M., Saraf, S. L., Soni, S., Afangbedji, N., Lin, X., Raslan, R., Gordeuk, V. R., and Nekhai, S. (2018) Urinary orosomucoid is associated with progressive chronic kidney disease stage in patients with sickle cell anemia. American journal of hematology93, E107-E109 DisclosuresTaylor:Pfizer: Research Funding; NHLBI: Research Funding. Nekhai:NIAID, NIH: Research Funding; NIMHD, NIH: Research Funding; NHLBI, NIH: Research Funding.

Delay of insulin initiation in patients with type 2 diabetes mellitus inadequately controlled with oral hypoglycemic agents (analysis of patient- and physician-related factors): A prospective observational DIPP-FACTOR study in Korea.

Aims/IntroductionTo assess the time to initiation of insulin therapy, and concurrently investigate both patient‐ and physician‐related factors associated with delaying insulin therapy in Korean patients with type 2 diabetes uncontrolled by oral hypoglycemic agents (OHAs).Materials and MethodsThis prospective, observational disease registry study was carried out across 69 centers in Korea. Type 2 diabetes patients who had received two or more OHAs within the past 5 years, had a glycated hemoglobin ≥8% in the past 6 months and had not received insulin were included. Data recorded on data collection forms during a 12‐month period were analyzed.ResultsOf 2168 patients enrolled, 1959 were evaluated and classified as the insulin‐initiated or insulin‐delayed group. Insulin was prescribed for just 20% of the patients during a 1‐year follow‐up period, and less than half (44.5%) of the patients who were taking two OHAs started insulin after 6 years. Patient‐related factors for delay in insulin initiation included older age, shorter duration of diabetes and lower glycated hemoglobin. Physician‐related factors included age (~50 to <60 years), sex (women) and number (<1000) of patients consulted per month. Patient refusal (33.6%) and physicians’ concerns of patient non‐compliance (26.5%) were the major physician‐reported reasons for delaying insulin therapy. Inconvenience of insulin therapy (51.6%) and fear of injection (48.2%) were the major reasons for patient refusal.ConclusionsInsulin initiation is delayed in patients with type 2 diabetes uncontrolled by two or more OHAs in Korea. Patient‐ and physician‐related factors associated with this delay need to be addressed for better diabetes management.

THE PREVALENCE OF NON-ALCOHOLIC FATTY LIVER DISEASE IN OUTPATIENTS IN THE FAR EAST FEDERAL DISTRICT

The rapidly growing incidence of obesity and diabetes mellitus, especially in developed countries, stimulates medical experts to closely study the epidemiology of non-alcoholic fatty liver disease (NAFLD). According to the published results of the epidemiological study DIREG 2, the prevalence of NAFLD in outpatients inRussiaincreased over the period from 2007 to 2015 and amounted to 37.3%. In the present report, the population of patients with NAFLD in the Far East Federal District (FEFD) was studied as part of the multicentre epidemiological study DIREG 2. The aim. To analyze the data on FEFD obtained in the DIREG 2 study and compare those with the DIREG 2 data on the entireRussia. Materials and Methods . The prospective disease registry study: epidemiological, observational, cross-sectional, multicentre study on the prevalence of NAFLD in outpatients. The total number of participating patients in FEFD was 2500, including 900 males and 1600 females. Epidemiological data were collected within two routine patient visits to the participating research centers. Results . The major result of this study is that the prevalence of NAFLD in FEFD was significantly lower than that in the entireRussia (21.4% vs 37.3%). Although the rank distribution of the concomitant diseases in FEFD patients was comparable to that in the across-Russia population, the prevalence of metabolic syndrome, menopausal syndrome and hypertriglyceridemia was significantly higher in the FEFD population. Conclusion . Despite the lower prevalence of NAFLD there is a significantly higher prevalence of disorders associated with NAFLD in the FEFD patients as compared with the acrossRussian patients from DIREG2. A set of measures preventing these risk factors from converting into full-scale disease is needed.

Prevalence of nonalcoholic fatty liver disease in outpatients in Rostov-on-Don: Regional results of the DIREG-2 study

to analyze and summarize the data of the DIREG-2 study of the nonalcoholic fatty liver disease (NAFLD) register in Rostov-on-Don versus those in Russia. The prospective disease registry study encompasses an epidemiologic, observational, cross-sectional, multicenter study estimating the prevalence of NAFLD in outpatients in Rostov-on-Don. A total of 3200 patients participated in this study. The investigators were 65 outpatient physicians. Epidemiological data were obtained during two patient visits to the research centers. The key result obtained from this study was the significantly higher prevalence of NAFLD in Rostov-on-Don than that in the general population (40.4 and 37.3%). In addition to the higher prevalence of NAFLD, there was also a higher spread of risk factors (RFs), such as abdominal obesity, female age of 45-55 years, and hyperlipidemia. The prevalence of NAFLD in the outpatients of Rostov-on-Don was 3.1% greater than that in Russia; this might be due to the significantly higher spread of some RFs (abdominal obesity, female age of 45-55 years, hyperlipidemia). The findings are undoubtedly necessary for the elaboration of measures for the primary and secondary prevention of NAFLD in Rostov-on-Don.

The Fukuoka Kidney disease Registry (FKR) Study: design and methods.

Chronic kidney disease (CKD) is an established independent risk factor for progression to end-stage renal disease (ESRD) and incidence of cardiovascular disease (CVD). The onset and progression of CKD are associated with both genetic predisposition and various lifestyle-related factors, but little is known about the influence of genetic-environmental interactions on the incidence of ESRD or CVD in patients with CKD. The Fukuoka Kidney disease Registry (FKR) Study is designed as one of the largest prospective, multicenter, observational cohort studies in non-dialysis dependent CKD patients. The FKR Study aims to enroll approximately 5000 individuals at multiple clinical centers and follow them for up to at least 5years. At baseline, subjects enrolled in the FKR Study will fill out extensive lifestyle-related questionnaires. Further, their health status and treatments will be monitored annually through a research network of nephrology centers. Blood and urine samples, including DNA/RNA, will be collected at the time of enrolment and every 5-years follow-up. The FKR Study will provide many insights into the onset and progression of CKD, which will suggest hypothesis-driven interventional clinical trials aimed at reducing the burden of CKD. The features of the FKR Study may also facilitate innovative research to identify and validate novel risk factors, including genetic susceptibility and biomarkers, using biomaterials by high-throughput omics technologies.

Management of common vismodegib (VISMO)-related adverse events in patients with locally advanced basal cell carcinoma (laBCC): RegiSONIC Disease Registry Study

Management of common vismodegib (VISMO)-related adverse events in patients with locally advanced basal cell carcinoma (laBCC): RegiSONIC Disease Registry Study

Preliminary effectiveness and safety in the first 88 patients with newly diagnosed locally advanced basal cell carcinoma treated with vismodegib in the RegiSONIC Disease Registry study

Preliminary effectiveness and safety in the first 88 patients with newly diagnosed locally advanced basal cell carcinoma treated with vismodegib in the RegiSONIC Disease Registry study