AND019 / Hangzhou Andao Pharma - LARVOL DELTA

A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=61 | Recruiting | Sponsor: Kind Pharmaceuticals LLC | Trial completion date: May 2026 ➔ Nov 2026 | Trial primary completion date: May 2026 ➔ Nov 2026

First-in-human • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

DIETARY DILEMMA: A COMPREHENSIVE ANALYSIS OF GLOBAL ESOPHAGEAL CANCER TRENDS LINKED TO LOW FRUIT AND VEGETABLE DIETS (1990-2019) (DDW 2024) - " Utilizing data from the Global Burden of Disease Study 019 (GBD 019) covering 04 countries we extracted EC deaths and disability-adjusted life years (DALYs) from High Middle and Low SDI countries between 1990 and 019...In conclusion our study reveals the substantial global burden of esophageal cancer linked to a diet low in fruits and vegetables. Despite overall declines in mortality and DALYs from 1990 to 019 marked disparities persist across SDI regions and genders. Males consistently bear a higher burden notably in Low SDI countries."

Clinical • Esophageal Cancer • Gastrointestinal Cancer • Oncology

THE GLOBAL BURDEN OF ALCOHOL-ASSOCIATED CIRRHOSIS AND CANCER IN YOUNG ADULTS (DDW 2024) - "Between 000 and 019 ASDRs of cancer in the young from alcohol decreased (APC: -0...Conclusion : The increasing burden of cancer and cirrhosis from alcohol in the younger generation remains concerning . A comprehensive approach that targets alcohol consumption is needed to mitigate this growing burden."

Clinical • Colorectal Cancer • Fibrosis • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Immunology • Liver Cancer • Oncology • Oral Cancer • Solid Tumor

ADVERSE EVENTS OF THE SPYGLASS™ SINGLE OPERATOR CHOLANGIOSCOPY SYSTEM: A MAUDE DATABASE ANALYSIS (DDW 2024) - "The US Food and Drug Administration (FDA) approved the DS and DSII generation of digital spyglass cholangioscope systems in 015 and 019 respectively however data regarding device-related safety and outcomes has not yet been published. Our analysis of the MAUDE database suggests that the vast majority of reported problems with the SpyGlassâ„¢ Digital System DS including its accessories are device-related with a relatively small percentage of patient related AEs."

Adverse events • Hematological Disorders • Infectious Disease • Pancreatitis • Septic Shock

THE YIELD OF EGD IN PATIENTS LESS THAN 60 YEARS OF AGE WITH DYSPEPSIA WITHOUT ALARM FEATURES (DDW 2024) - "We reviewed inpatient data from multiple HCA hospitals in the southeast region of US between 014 and 019 and included a total of 446 patients <60 years old who had EGD procedure for at least one of the following diagnoses: dyspepsia epigastric pain post prandial fullness abdominal fullness or distension but without alarm features of dysphagia weight loss or anemia...This study supports the ACG guidelines for Dyspepsia management to refrain from unnecessary early EGD evaluation in this age group and try the medical therapy as first approach to limit the overall costs and possible adverse events from such procedures. Further larger studies from such community hospital settings are needed to confirm these results."

Clinical • Anemia • Anesthesia • Diabetes • Dyspepsia • Hematological Disorders • Infectious Disease • Metabolic Disorders • Oncology • Pain • Peptic Ulcer

RISK STRATIFICATION OF SYNCHRONOUS GASTRIC CANCERS INCLUDING ALCOHOL-RELATED GENETIC POLYMORPHISMS IN PATIENTS WITH ENDOSCOPIC SUBMUCOSAL DISSECTION FOR EARLY GASTRIC CANCERS: A MULTICENTER PROSPECTIVE COHORT STUDY (DDW 2024) - "[Results] Among 80 patients enrolled between 016 and 019 SGCs were found in 130 patients (16...[Conclusions] This multicenter study with the largest cohort to date firstly demonstrated that both the ADH1B Arg and ALDH Lys alleles were at high risk for SGCs. The risk stratification by these three factors may be a less invasive and promising tool for predicting their risk."

Clinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • ADH1B

URBAN VS. RURAL: EXPLORING IN-HOSPITAL DISPARITIES IN INFLAMMATORY BOWEL DISEASE ACROSS THE NATION: A RETROSPECTIVE STUDY. (DDW 2024) - "Methods Data were obtained from the 016 and 019 National Inpatient Sample (NIS) database...ConclusionsThe findings of our study can be explained by more complex nature of pathology that may have required in-hospital transfers or referrals for specialized IBD care; however more studies are warranted to identify and mitigate the reversible factors contributing to disparities in care provided for IBD patients between urban and rural areas. More studies are required to develop cost-effective management of IBD patients in urban hospitals."

Retrospective data • Acute Kidney Injury • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Nephrology • Renal Disease • Septic Shock

PRE-COLECTOMY EXTRAINTESTINAL MANIFESTATIONS AND CROHN’S DISEASE LIKE POUCHITIS ARE SIGNIFICANTLY ASSOCIATED WITH THE DEVELOPMENT OF POST-ILEAL POUCH ANAL ANASTOMOSIS EXTRAINTESTINAL MANIFESTATIONS (DDW 2024) - "Methods This was a retrospective cohort analysis of patients with UC or IBD-Unspecified (IBD-U) who underwent IPAA between 008 and 019...Full univariable and multivariable analysis are reported in Table 1 . ConclusionsIn a large retrospective cohort analysis of patients with UC who underwent IPAA pre-colectomy EIMs and CDLP were significantly associated with the development of post-IPAA EIMs."

Ankylosing Spondylitis • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Musculoskeletal Pain • Ocular Inflammation • Ophthalmology • Pyoderma Gangrenosum • Rheumatology • Scleritis • Seronegative Spondyloarthropathies • Ulcerative Colitis • Uveitis

A SYSTEMATIC ANALYSIS OF CHANGES IN THE EPIDEMIOLOGY OF NON-ALCOHOLIC FATTY LIVER DISEASE IN THE UNITED STATES BETWEEN 1990-2019 (DDW 2024) - "We extracted data from the GBD 019 database to study the prevalence incidence mortality and DALY changes in the US between 1990 and 019... This systematic analysis reveals a substantial and concerning rise in the prevalence incidence mortality and DALYs of NAFLD in the United States from 1990 to 019. The alarming upward trends in incidence and mortality were observed across most states emphasizing the urgent need for targeted interventions and public health strategies to mitigate the growing burden of NAFLD in the US population."

Clinical • Gastrointestinal Disorder • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease

ACUTE ON CHRONIC LIVER FAILURE AFTER TIPS IN PATIENTS WITH PREEXISTING EXTRAHEPATIC ORGAN DYSFUNCTION (DDW 2024) - " We performed a retrospective cohort study of patients with available data between 1999 and 019 undergoing de-novo TIPS... Increasing severity of extrahepatic end organ dysfunction as measured by the CLIF-ACLF score prior to TIPS is associated with increased ACLF post TIPS and 30 day mortality. Cirrhosis etiology and covered stent type are not associated with ACLF post TIPS. Approximately one-fourth of patients have resolution of extrahepatic end-organ dysfunction following TIPS."

Clinical • Cardiovascular • CNS Disorders • Fibrosis • Hepatic Encephalopathy • Hepatology • Hypertension • Immunology • Infectious Disease • Liver Failure • Portal Hypertension • Respiratory Diseases

ARE WE DETECTING COLORECTAL CANCER AT AN EARLY STAGE IN THE 45-50-YEAR GROUP WITH UPDATED SCREENING COLONOSCOPY GUIDELINES? REAL-WORLD DATA (DDW 2024) - "4%) and 019 to 0 0 (68...However an ADR of about 0% is significant and there is a trend toward early detection of CRC with the implementation of an early screening colonoscopy strategy. The survival benefit of early screening colonoscopy (<50 years) in average-risk individuals is to be determined."

Clinical • Real-world • Real-world evidence • Colonic Polyps • Colorectal Cancer • Gastroenterology • Gastrointestinal Cancer • Oncology • Solid Tumor

CHRONIC LIVER DISEASE AS A RISK FACTOR FOR POST-ERCP COMPLICATIONS: RETROSPECTIVE NATIONWIDE ANALYSIS (DDW 2024) - "METHODS We used the National Inpatient Sample (NIS) database to inquire for all adult patients who underwent ERCP between 016 and 019 using the International Classification of Disease Tenth Revision (ICD-10) coding...Our study represents newer data with use of revised ICD codes to demonstrate increased risk in patients with liver disease. Based on these results the use of ERCP should be carefully considered in this population and further studies are required for identifying reversible risk factors to improve outcomes."

Retrospective data • Fibrosis • Hematological Disorders • Hepatology • Immunology • Liver Cirrhosis • Nephrology • Pancreatitis • Renal Disease

OUTCOMES FOLLOWING INTERMITTENT VS CONTINUOUS PROTON PUMP INHIBITOR THERAPY IN CRITICALLY ILL PATIENTS WITH GASTROINTESTINAL BLEED (DDW 2024) - "This database contains de-identified medical data of over 40 000 patients who were admitted to the intensive care unit (ICU) at Beth Israel Deaconess Medical Center (BIDMC) between the years 008 and 019...Of the 567 patients admitted to the ICU for GI bleed 1 19 and 1 47 received intermittent PPI and continuous infusion PPI therapies respectively. Both cohorts were similar in demographics including age gender and severity of illness as measured with charlson comorbidity index. The continuous infusion (or PPI gtt) cohort had a significantly lower ICU LOS hospital LOS and mortality rate."

Clinical • Critical care • Gastrointestinal Disorder

VALIDATION OF DISEASE SEVERITY INDEX FOR PREDICTING COMPLICATED DISEASE IN CROHN'S DISEASE: A COMPARISON STUDY WITH LÉMANN INDEX (DDW 2024) - "The consecutive patients with CD in a referral center between 017 and 019 were reviewed...ConclusionHigher DSI was validated to be associated with a complicated disease outcome. DSI might play a better role than LI in identifying patients at high risk of disease progression."

Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

INSIGHTS INTO THE RELATIONSHIP BETWEEN ALCOHOLIC PANCREATITIS AND CHRONIC VIRAL HEPATITIS. A NATIONWIDE STUDY (DDW 2024) - " Our study utilized data from the National Inpatient Sample a comprehensive US database of inpatient hospital stays between 016 and 019... We found a significant association between chronic viral hepatitis and AIP. Additionally our findings provide insight into the demographic variations in alcohol-induced pancreatitis cases among patients with chronic viral hepatitis infections. Further research should be performed to evaluate if prevention strategies such as screening and counseling could be deployed to prevent the development of detrimental outcomes."

Addiction (Opioid and Alcohol) • Cardiovascular • Chronic Kidney Disease • Coronary Artery Disease • Diabetes • Dyslipidemia • Hepatitis B • Hepatology • Hypertension • Infectious Disease • Inflammation • Nephrology • Pancreatitis • Renal Disease

REAL-WORLD EXPERINECE SHOWES DISMAL ADHERENCE TO CLINICAL GUIDELINES ON SCREENING FOR BARRETT'S ESOPHAGUS: A MULTICENTER STATEWIDE, HEALTHCARE DATABASE STUDY (DDW 2024) - "We included adult patients diagnosed with GERD between 01 and 019...ConclusionsMost patients with multiple BE risk factors who should undergo screening endoscopy never had EGD. This translates to very poor adherence to the existing guidelines on BE screening."

Adherence • Clinical • Clinical guideline • Real-world • Real-world evidence • Barrett Esophagus • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Obesity

IMPACT OF RESPIRATORY SYNCYTIAL VIRUS INFECTIONS ON HOSPITAL ADMISSIONS AND OUTCOMES IN INFLAMMATORY BOWEL DISEASE PATIENTS: A NATIONWIDE EMERGENCY DEPARTMENT ANALYSIS (DDW 2024) - "Methods : This retrospective study used Nationwide Emergency Department Sample 018 and 019 focusing on patients aged ≥18...Conclusion : Our findings indicate that IBD notably raises hospital admissions for RSV ALRTI while RSV infections in patients with IBD lead to more all-cause and IBD-specific admissions and poorer outcomes. This highlights the need for RSV vaccination in patients with IBD to prevent severe complications and reduce hospital stays."

Clinical • Asthma • Cardiovascular • Chronic Kidney Disease • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Diabetes • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Heart Failure • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Metabolic Disorders • Obesity • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

BACKGROUND RISK OF NON-PARTICIPANTS IN COLORECTAL CANCER SCREENING (DDW 2024) - "Methods In this population-based cohort study we included all invitees for CRC screening in 018 and 019 in the Netherlands...Other low-participation groups have a lower risk such as individuals with a non-Western migration b ackground. Interventions should prioritize the most vulnerable groups considering both participation and risk of CRC."

Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

ELEVATED NEUTROPHIL TO LYMPHOCYTE RATIO UPON HOSPITALIZATION IS ASSOCIATED WITH INCREASED RISK OF DEVELOPING SEPTIC SHOCK AND MORTALITY IN PATIENTS WITH ACUTE CHOLANGITIS (DDW 2024) - " We conducted a retrospective study based on data obtained from the Medical Information Mart for Intensive Care - IV (MIMIC -IV) database comprising de-identified data from patients hospitalized between 008 and 019... Among hospitalized patients with acute cholangitis elevated NLR at the time of hospitalization was associated with higher odds of developing septic shock and death."

Clinical • CNS Disorders • Critical care • Diabetes • Hepatology • Metabolic Disorders • Nephrology • Oncology • Renal Disease • Septic Shock • Vascular Neurology

FAECAL CALPROTECTIN TESTING IN PATIENTS PRESENTING WITH LOWER GASTROINTESTINAL SYMPTOMS; A RETROSPECTIVE PRIMARY CARE STUDY IN THE UNITED KINGDOM. (DDW 2024) - "Methods Retrospective open cohort study using Clinical Practice Research Datalink (CPRD Aurum) of adults aged 18 years and above with lower GI symptoms between 015 and 019...8% of patients were still referred to secondary care with very few patients diagnosed with IBD (0. 4%)."

Retrospective data • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Obesity • Pain

THE POSITIVITY OF SERUM POLLEN-SPECIFIC IMMUNOGLOBULIN E TEST MAY NOT BE ASSOCIATED WITH SEASONAL ONSET OF EOSINOPHILIC ESOPHAGITIS DURING DISPERSE PERIOD (DDW 2024) - " This study included 141 patients diagnosed as EoE between 010 and 019... The positivity of serum pollen-specific IgE test may not be associated with seasonal onset except alder."

Allergy • Atopic Dermatitis • Dermatitis • Dermatology • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Pain

A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=61 | Recruiting | Sponsor: Kind Pharmaceuticals LLC | Trial completion date: May 2025 ➔ May 2026 | Trial primary completion date: May 2025 ➔ May 2026

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=61 | Recruiting | Sponsor: Kind Pharmaceuticals LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=61 | Not yet recruiting | Sponsor: Kind Pharmaceuticals LLC | Initiation date: Mar 2022 ➔ Aug 2022

Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2