title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Ad libitum vending machine diet. | chocolate milk | For the last 3 days of each inpatient stay, participants were given ad libitum access to a computerized vending machine (StarFood, Necta). The macronutrient self-selection paradigm procedure (MSSP) was used to select items for stocking the vending machine (Vending machines were stocked with traditional breakfast, lunch... | PMC10371234 | |
MRI | REGRESSION, SENSITIVITY | On the afternoon following the morning PET scanning, high-resolution anatomical brain MRI was acquired with a HDx General Electric 3 Tesla scanner (echo time [TE] = 2.7ms, repetition time [TR] = 7.24 ms, flip angle 12°, voxel size 0.937 Under each diet condition, all subjects were scanned at 18:00, 4.5 hours after a st... | PMC10371234 | |
PET | TRANSMISSION, SEPARATION, RESOLUTION | PET scanning was performed using a High Resolution Research Tomograph (HRRT; Siemens Healthcare) a dedicated brain PET scanner with a resolution of 2.5–3.0 mm and a 25 cm axial field of view. Transmission scanning was performed with a 137Cs rotating pin source to correct for attenuation. Two hours after a standard brea... | PMC10371234 | |
Statistics | Power calculations were based on cross-sectional data, not within-subject repeated measurements of D2BP change and fMRI response in response to dietary manipulation, which had not previously been measured. To detect a meaningful difference of effect size in D2BP (ratio of the expected mean and the standard deviation of... | PMC10371234 | ||
Study approval | Diabetes & Digestive & Kidney Diseases | All study procedures were approved by the IRB of the National Institute of Diabetes & Digestive & Kidney Diseases. Written informed consent was received prior to participation, and compensation was provided. | PMC10371234 | |
Author contributions | PH, WKS | KDH, ABC, WKS, PH, and AM designed the research study. WKS, JAA, JEI, and ABC conducted experiments and acquired data. VLD, JG, ABC, IG, JAA, and WKS analyzed data and performed statistical analysis. VLD and KDH drafted the manuscript. All authors contributed intellectually and approved the manuscript. | PMC10371234 | |
Supplementary Material | PMC10371234 | |||
Supplemental data | PMC10371234 | |||
ICMJE disclosure forms | PMC10371234 | |||
06/22/2023 | Electronic publication | PMC10371234 | ||
Study design. | obesity | OBESITY | Seventeen men and women with obesity were admitted as inpatients to the Metabolic Clinical Research Unit at the NIH Clinical Center. They completed fMRI and PET scans on the third day of a 5-day inpatient eucaloric baseline diet, after which they were randomized to either a 30% reduced-calorie diet achieved by selectiv... | PMC10371234 |
Selective reduction of dietary fat, but not carbohydrates, alters brain activity in reward regions. | ( | PMC10371234 | ||
Characteristics of participants completing baseline and portions of neuroimaging during reduced-calorie interventions. | PMC10371234 | |||
Locations of clusters displaying changes in BOLD responses within a priori reward-region mask or D2BP to reduced-fat or -carbohydrate diets. | PMC10371234 | |||
Ad libitum intake over 3 days from vending machines after RF and RC diets. | PMC10371234 | |||
Background and Aims: | primary biliary cholangitis | PRIMARY BILIARY CHOLANGITIS | ENHANCE was a phase 3 study that evaluated efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor-δ (PPAR) agonist, versus placebo in patients with primary biliary cholangitis with inadequate response or intolerance to ursodeoxycholic acid (UDCA). | PMC10344437 |
Approach and Results: | NASH, pruritus, NRS | SECONDARY | Patients were randomized 1:1:1 to oral seladelpar 5 mg (n=89), 10 mg (n=89), placebo (n=87) daily (with UDCA, as appropriate). Primary end point was a composite biochemical response [alkaline phosphatase (ALP) < 1.67×upper limit of normal (ULN), ≥15% ALP decrease from baseline, and total bilirubin ≤ ULN] at month 12. K... | PMC10344437 |
Conclusions: | pruritus, primary biliary cholangitis, PBC | PRIMARY BILIARY CHOLANGITIS, PBC | Patients with primary biliary cholangitis (PBC) with inadequate response or intolerance to UDCA who were treated with seladelpar 10 mg had significant improvements in liver biochemistry and pruritus. Seladelpar appeared safe and well tolerated.
| PMC10344437 |
INTRODUCTION | abnormal serum liver tests, inflammation, granulomatous lymphocytic cholangitis, cholestatic, liver injury, bile duct injury/cholangitis, fibrosing liver injury, PBC, cholestasis, pruritus, NASH, primary biliary cholangitis, hepatitis, Histologic damage | DISEASE PROGRESSION, PBC, PRIMARY BILIARY CHOLANGITIS, INFLAMMATION, DISEASE, CHOLESTASIS, HEPATITIS | People living with primary biliary cholangitis (PBC) frequently have impaired quality and quantity of life, resulting from a chronic autoimmune-mediated, cholestatic, and fibrosing liver injury.Histologic damage characterized by a granulomatous lymphocytic cholangitis is associated with abnormal serum liver tests, incl... | PMC10344437 |
METHODS | PMC10344437 | |||
Patients | PBC | Patients aged 18 to 75 years diagnosed with PBC [≥2 of the following criteria: history of ALP > ULN for ≥6 months, positive antimitochondrial antibody titers (>1/40 on immunofluorescence or M2-positive by ELISA) or PBC-specific antinuclear antibodies, or documented liver biopsy histology consistent with PBC] were scree... | PMC10344437 | |
Study design | This phase 3, double-blind, randomized, placebo-controlled study was conducted at 111 sites in 21 countries. The protocol was approved by appropriate local and national institutional review boards or independent ethics committees, and the trial was conducted in accordance with the Declaration of Helsinki and Good Clini... | PMC10344437 | ||
Original study design | pruritus, NRS | The study was initially designed as a 12-month study where eligible patients were centrally randomized 1:1:1 through an interactive voice/web response system to receive seladelpar (CymaBay Therapeutics, Inc., Newark, CA) 5 or 10 mg QD orally or matching placebo following a 2-week screening period and subsequent 2-week ... | PMC10344437 | |
Amended analysis plan | NASH | Because of unexpected histological findings in a concurrent phase 2 study of seladelpar in patients with NASH, dosing in ENHANCE was interrupted on November 25, 2019, and the study was terminated prematurely on December 20, 2019. The biopsy tissues and full clinical profile of each patient in the NASH trial were review... | PMC10344437 | |
Study assessments | pruritus, itching, Cancer | ADVERSE EVENTS, ADVERSE EVENT, CANCER | Study assessment visits were performed at screening; run-in; day 1 (randomization); months 1, 3, and 6; and at a follow-up visit 4 weeks after the end of treatment. Fasting blood samples were obtained at each visit for ALP, total bilirubin, other biochemistry, lipids, bile acid precursor 7α-hydroxy-4-cholesten-3-one (C... | PMC10344437 |
Primary end point | The primary end point was a composite biochemical response defined as ALP <1.67×ULN, ≥15% ALP decrease from baseline, and total bilirubin ≤ ULN | PMC10344437 | ||
Secondary end points | pruritus | SECONDARY | Key secondary end points were the proportion of patients with ALP ≤1.0×ULN (normalization) at month 3 and the change in pruritus NRS from baseline at month 3 in patients with baseline pruritus NRS ≥4, which was considered symptomatic. | PMC10344437 |
Statistical analysis | pruritus | SECONDARY | A sample size of 80 patients per treatment group, or 240 patients total, was estimated to provide (1) >90% power to detect a difference in the composite end point response rate (based on estimated response rates of <15%Efficacy was assessed in the modified intent-to-treat (mITT) population, which included all randomize... | PMC10344437 |
RESULTS | PMC10344437 | |||
Patient disposition | primary biliary cholangitis, cholestasis | PRIMARY BILIARY CHOLANGITIS, CHOLESTASIS, DISEASE CHARACTERISTIC, PBC | Among 501 patients screened, 265 were randomized to receive placebo (n=87) or seladelpar 5 mg (n=89) or 10 mg (n=89). Two patients completed study treatment through month 12; 255 of 265 (96.2%) patients discontinued treatment due to study closure, 6 (2.3%) discontinued due to TEAEs, 1 (0.4%) withdrew consent, and 1 (0.... | PMC10344437 |
Efficacy | PMC10344437 | |||
Composite biochemical response and ALP normalization | At month 3, significantly greater proportions of patients in the seladelpar 5-mg (57.1%, Proportion of patients who achieved the composite biochemical end point at month 3. Composite end point was defined as alkaline phosphatase (ALP) serum levels < 1.67× upper limit of normal (ULN), ≥15% decrease in ALP serum levels, ... | PMC10344437 | ||
Pruritus | SE, pruritus, itch, NRS | Among patients in the prespecified subgroup with moderate-to-severe pruritus (pruritus NRS ≥4) at baseline who were evaluable at month 3 (placebo, n=18; seladelpar 5 mg, n=17; and seladelpar 10 mg, n=18), the mean decrease from baseline in pruritus NRS was significantly greater in the seladelpar 10-mg (−3.14, Absolute ... | PMC10344437 | |
Liver biochemistry and lipids | Reductions (LS mean) in ALP from baseline at all time points through month 6 were greater in both seladelpar treatment groups versus the placebo group. At month 3, mean ALP decreased by 3.7% from baseline in the placebo group, whereas it decreased by 35.7% in the seladelpar 5-mg group and by 44.2% in the 10-mg group (L... | PMC10344437 | ||
Bile acid synthesis (C4) and IgM concentrations | Seladelpar was also associated with greater LS mean reductions in serum levels of C4 and IgM at months 1 and 3 compared with the placebo group (Supplemental Table S5, | PMC10344437 | ||
Safety | cirrhosis, pruritus, SD, insomnia | ATRIOVENTRICULAR BLOCK, RHEUMATOID ARTHRITIS, CIRRHOSIS, ADENOID CYSTIC CARCINOMA, ADVERSE EVENT | Mean (SD) duration of exposure was 17.7 (11.7) weeks in the total population. The large SD is due to the early termination of the study with patients having a wide range of treatment durations. Overall, the proportion of patients with ≥1 TEAE was greater in the placebo group (73.6%) versus either the seladelpar 5-mg (6... | PMC10344437 |
DISCUSSION | itch, Pruritus, points)Seladelpar, liver injury, pruritus, PBC, deaths | DISEASE PROGRESSION, PBC, PRURITUS, DISEASE, ADVERSE EVENT | New approved therapies remain important for people living with PBC. Current agents do not optimally address disease activity or symptoms. Seladelpar is a selective PPARδ agonist that has documented anticholestatic, anti-inflammatory, and antipruritic effects.Among patients with clinically significant itch (baseline pru... | PMC10344437 |
Supplementary Material | PMC10344437 | |||
SUPPLEMENTARY MATERIAL | PMC10344437 | |||
DATA AVAILABILITY | Requests for additional data should be directed to the study sponsor through the corresponding author. | PMC10344437 | ||
AUTHOR CONTRIBUTIONS | Study concept and design: all; acquisition, analysis, and interpretation of data: all; and drafting and/or critical revision of manuscript for important intellectual content and final approval of manuscript: all. | PMC10344437 | ||
ACKNOWLEDGMENTS | The authors thank Ke Yang and Kalyan Palla of CymaBay Therapeutics Inc., for assistance with statistical analyses and Holly Capasso-Harris of Certara Synchrogenix for writing assistance that was funded by CymaBay Therapeutics.
| PMC10344437 | ||
FUNDING INFORMATION | PBC | PBC | This study and preparation of this manuscript were funded by CymaBay Therapeutics, which had a role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. Palak J. Trivedi received institutional salary support fr... | PMC10344437 |
CONFLICTS OF INTEREST | cholestatic pruritus, A. McWherter, Zambon, Nordisk, Nordisk, Metacrine, PBC | PBC, MITCHELL, ONCOLOGY, EVENTS, STUART | Gideon M. Hirschfield consults for and received payment/honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from GlaxoSmithKline, Intercept Pharma, and Ipsen. He consults for CymaBay Therapeutics, Escient, Gilead, Mirum, and Pliant. Mitchell L. Shiffman consults for, is on... | PMC10344437 |
REFERENCES | PMC10344437 | |||
Background | disordered eating | Given the heightened emphasis on physical appearance and the prevalence of social media in young women, they are particularly vulnerable to experiencing negative body image and disordered eating. Therefore, modified social media portrayals of pregnancy could cause young women to have negative attitudes toward a potenti... | PMC9883907 | |
Methods | Weight Gain | The sample consisted of 154 women aged 18–30, who were given the Eating-Attitudes Test-26, randomly shown either modified or unmodified social media portrayals of pregnancy, then given the Attitudes Toward Potential Pregnancy Scale and the Gestational Weight Gain Psychosocial Risk Assessment Tool. | PMC9883907 | |
Results | weight gain, disordered eating | REGRESSIONS | A series of hierarchal regressions revealed that there were no significant main effects or interactions for young women’s attitudes toward potential pregnancy. However, women who viewed modified portrayals of pregnancy had higher self-efficacy, and women with higher levels of disordered eating had lower self-efficacy, ... | PMC9883907 |
Conclusions | disordered eating and social media | These results highlight the myriad of different attitudes that young women have toward a potential pregnancy and how these attitudes are influenced by disordered eating and social media. Our findings can be used for educating caregivers and implementing intervention strategies for women. | PMC9883907 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12905-023-02177-7. | PMC9883907 | ||
Plain English summary | Young women are more likely to have a negative body image and an unhealthy relationship with food because they are more focused on their physical appearance, especially with the rise of social media. If young women with these struggles see edited representations of pregnancy, they can develop a negative attitude about ... | PMC9883907 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12905-023-02177-7. | PMC9883907 | ||
Keywords | PMC9883907 | |||
Background | disordered eating, eating disorder | Individuals who are highly concerned with their weight-related appearance and/or preoccupied with thoughts of eating are at-risk for developing harmful behaviors to control their eating. Such patterns of attitudes and behaviors are referred to as disordered eating (DE) [Young women (between the ages of 18 and 30) are e... | PMC9883907 | |
Disordered eating | guilt, eating; compulsive eating, anxiety | PURGING, DISORDERS, ANOREXIA NERVOSA AND BULIMIA | Clinical eating disorders, such as anorexia nervosa and bulimia nervosa, affect about 5% of the general population [DE represents a variety of thoughts and behaviors that highlight a preoccupation with food, including guilt, shame, and anxiety about eating; compulsive eating; frequent fluctuations in weight; restrictin... | PMC9883907 |
Social media portrayals of pregnancy | Social media allows for people to edit their photos to show their most flattering selves, blurring one’s real self with a digital self [Social media portrayals of pregnancy are also subject to substantive edits. A qualitative review of pregnancy portrayals on Instagram showed that images were often professionally looki... | PMC9883907 | ||
Attitudes toward potential pregnancy | Often, pregnancies are discussed in terms of intended or unintended. However, women’s attitudes toward potential pregnancies are much more complex than just intending to be or not intending to be pregnant [ | PMC9883907 | ||
Overview and hypotheses | weight gain | The current study examined if there is a relationship between DE and young women’s attitudes toward a potential pregnancy. Additionally, the study assessed if various portrayals of pregnancy on social media influence such attitudes. Specifically, we manipulated whether participants saw modified or unmodified images of ... | PMC9883907 | |
Methods | PMC9883907 | |||
Participants | Participants were recruited from psychology classes at Texas A&M University – Corpus Christi and through posts on social media. Only participants who are 18 years old or older, female, and college students were eligible to participate in the study. The initial sample consisted of 177 participants. Six participants were... | PMC9883907 | ||
Measures | PMC9883907 | |||
Eating Attitudes Test-26 (EAT-26) | eating disorder | The Eating Attitudes Test-26 (EAT-26), developed from the original Eating Attitudes Test-40, is a three-part questionnaire that uses body mass index (BMI), scores from a 26-item questionnaire, and four behavioral assessment questions as a screening to identify whether people are at-risk of developing an eating disorder... | PMC9883907 | |
Attitudes Toward Potential Pregnancy Scale (APPS) | The Attitude Toward Potential Pregnancy Scale (APPS) is a brief self-report questionnaire that was developed to measure women’s feelings toward a potential pregnancy and their efforts to either become pregnant or avoid pregnancy [ | PMC9883907 | ||
Gestational Weight Gain Psychosocial Risk Assessment Tool | weight gain | The Weight-Related Behaviors Questionnaire (WRB-Q) is a validated measure used to assess pregnancy-related factors that affect weight gain and retention during and after pregnancy [ | PMC9883907 | |
Pregnancy photos | The social media app Instagram was used to find pictures that show portrayals of pregnancy in either modified or unmodified images. After reaching out to several women on Instagram asking if they would be willing to grant us permission to use their photos in our study, two women agreed. We used six pictures from each w... | PMC9883907 | ||
Procedure | eating-disorder | Participants were first presented with an informed consent before proceeding to the survey. All participants completed the full Eat-26 questionnaire. Next, participants were randomly assigned to view either six photos of the pregnant women that were highly modified or six photos of the pregnant women that were not high... | PMC9883907 | |
Results | weight gain, disordered eating and pregnancy portrayal, eating disorder | REGRESSION, REGRESSIONS | According to the guidelines of the EAT-26, 95 women (67.4%) had lower levels of DE, and 43 women (30.5%) had higher levels of DE and would qualify for a referral to an eating disorder specialist. A series of hierarchal regressions were used to test if the presence of DE and the presentation of either modified or unmodi... | PMC9883907 |
Discussion | weight gain | This research examined how DE and social media portrayals of pregnancy influence young women’s attitudes toward a potential pregnancy, perceived self-efficacy about maintaining healthy eating habits throughout pregnancy, attitudes toward gestational weight gain, and pre-pregnancy body image. Specifically, we hypothesiz... | PMC9883907 | |
Limitations and future directions | weight gain | One limitation was the likely floor effect we observed regarding young women’s attitudes toward potential pregnancy. Young women from 18 to 30 years-old are less likely to desire or try to become pregnant, regardless of their level of DE, because they are focused on their education, starting their careers, or just wait... | PMC9883907 | |
Conclusion | weight gain | This study examined the influence of DE and social media portrayals of pregnancy on young women’s attitudes toward a potential pregnancy, self-efficacy about maintaining healthy eating habits throughout pregnancy, attitudes toward gestational weight gain, and current body image when considering a potential pregnancy. O... | PMC9883907 | |
Acknowledgements | We would like to thank Dr. Amy Houlihan and Dr. Steven Seidel who provided feedback throughout the research process. | PMC9883907 | ||
Author contributions | AHG and YZ conceptualized the study. AHG conducted the literature review. AHG and YZ curated the data and conducted the statistical analysis. AHG wrote the first draft of the manuscript. Both authors reviewed and approved the final manuscript. | PMC9883907 | ||
Funding | Not applicable. | PMC9883907 | ||
Availability of data and materials | The datasets generated during and/or analyzed during the current study are not publicly available because informed consent provisions did not cover public data sharing but are available from the corresponding author on reasonable request. | PMC9883907 | ||
Declarations | PMC9883907 | |||
Ethics approval and consent to participate | This study was approved by the TAMU-CC Institutional Review Board (TAMU-CC-IRB-2022-0352). All participants were provided informed consent to participate and were informed that they could withdraw without consequence at any time during the study. All the experiments in the study were conducted in accordance to the rele... | PMC9883907 | ||
Consent for publication | Informed consent was obtained from the depicted pregnant women to use their photos in the study and in the publication. | PMC9883907 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9883907 | ||
References | PMC9883907 | |||
Keywords | diabetic nephropathy, renal injury, MR, renal damage, hypertension | HYPERTENSION, DIABETIC NEPHROPATHY | Angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) are recommended as first-line drugs for hypertension with diabetic nephropathy owing to their renoprotective effect; however, their effect beyond lowering blood pressure (BP) has not been confirmed. Recent studies have shown that ... | PMC9899688 |
Introduction | MR, hypertension, hypertensive, diabetic nephropathy | HYPERTENSION, DIABETIC NEPHROPATHY | Renin-angiotensin system (RAS) inhibitors, such as angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), are recommended as first-line drugs for hypertensive patients with diabetic nephropathy mainly for their blood pressure (BP)-lowering effects [Esaxerenone is a new nonsteroidal M... | PMC9899688 |
Methods | The reporting of this | PMC9899688 | ||
Study design and population | This was a In the ESAX-DN study, patients were randomized to either esaxerenone or placebo treatment for 52 weeks after a 4-week run-in period, continuing their treatment with RAS inhibitors at a constant dosage throughout the study. To minimize the risk of increasing serum potassium (K | PMC9899688 | ||
Outcomes | albuminuria | ADVERSE EVENTS, SECONDARY, REMISSION | The primary endpoint of the ESAX-DN study was the proportion of patients with UACR remission at the end of treatment, and the key secondary endpoint was the percentage change in the UACR from baseline at the end of treatment. The changes in BP and creatinine levels and the rate of transition to overt albuminuria were a... | PMC9899688 |
Assessments | renal disease | RENAL DISEASE | The UACR, calculated from first morning urine samples, was measured during the run-in period and every 4 weeks up to week 52 during the subsequent treatment period. BP and eGFR were monitored every 2 weeks up to week 8 and every 4 weeks from week 12 to week 52 during the treatment period. The eGFR with the modification... | PMC9899688 |
Clinical assumptions | albuminuria | Several mechanisms may explain the renoprotective effect of esaxerenone. First, esaxerenone primarily reduces BP, which then leads to a reduction in glomerular pressure, and it can also reduce urinary albumin excretion. Second, esaxerenone may directly affect renal function and may also affect urinary albumin excretion... | PMC9899688 | |
Statistical analysis | To quantitatively investigate direct and indirect effects, we used the concepts of the “natural direct” effect and the “indirect effect” [Some strong assumptions are required to identify natural direct and indirect effects: (i) no unmeasured confounding of the exposure-outcome relationship; (ii) no unmeasured confoundi... | PMC9899688 | ||
Results | PMC9899688 | |||
Patients | A total of 455 patients were randomized, but 6 patients were excluded from the full analysis set ( | PMC9899688 | ||
Discussion | albuminuria, microalbuminuria, diabetic nephropathy, diabetic kidney disease | DIABETIC NEPHROPATHY, DIABETIC KIDNEY DISEASE | In this This There are various discussions in the literature about microalbuminuria changes as a surrogate endpoint of diabetic kidney disease [There are several methodologies that can directly handle multiple and/or time-dependent mediators [The current analysis has several limitations. This was a In conclusion, esaxe... | PMC9899688 |
Supplementary information | The online version contains supplementary material available at 10.1038/s41440-022-01008-w. | PMC9899688 | ||
Acknowledgements | The authors would like to thank all the people who participated in this study and the reviewers for their useful and helpful comments on our manuscript. We also thank Diane Williams, PhD, of Edanz ( | PMC9899688 | ||
Author contributions | Conceptualization, investigation: all authors. Statistical plan and analysis: YO and MT. All authors agree with the final version of the manuscript, the publication in this journal, and to be held accountable for all aspects of the work. | PMC9899688 | ||
Funding | The ESAX-DN study and this | PMC9899688 | ||
Data availability | Deidentified individual participant data and applicable supporting clinical study documents may be available upon request at | PMC9899688 | ||
Compliance with ethical standards | PMC9899688 | |||
Conflict of interest | YO and TS are employees of Daiichi Sankyo Co., Ltd. SI, NK, KS, MN and TW have received personal fees from Daiichi Sankyo Co., Ltd., and MT has received consultant fees from Daiichi Sankyo Co., Ltd. NK, KS and MN have received grants/research funding from Daiichi Sankyo Co., Ltd. | PMC9899688 | ||
References | PMC9899688 | |||
1. Introduction | HIGH BLOOD PRESSURE | This article reports the results of Regular aerobic physical activity (PA) improves numerous cardiometabolic risk factors, including high blood pressure [Despite the established cardiometabolic health benefits of aerobic PA, only 27% to 40% of African American (AA) women meet national PA guidelines [Culturally tailored... | PMC9859082 | |
2. Materials and Methods | PMC9859082 |
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