Acute Pancreatitis

Endoscopic retrograde cholangiopancreatography ERCP is widely used to manage biliary and pancreatic diseases, but it can lead to complications ranging from mild to severe, with post-ERCP pancreatitis PEP being the most common serious adverse event. This research aims to evaluate whether combining rectal indomethacin with cold-water irrigation of the ampulla reduces the incidence of PEP compared to rectal indomethacin alone, focusing on an Indian adult population. The study also compares PEP severity, adverse effects, hospital stay duration, and protocol adherence. Participants will receive either rectal indomethacin alone or rectal indomethacin plus cold saline irrigation 4-10C, 250 mL for 2 minutes applied before ERCP. Rectal indomethacin is administered 30 to 60 minutes prior to the procedure. This is a single-center pilot randomized control superiority trial lasting 12 months with a 30-day follow-up period. The study will explore effects based on baseline PEP risk, ERCP type, and use of prophylactic pancreatic stenting. During the study, participants will be assessed for post-ERCP pancreatitis classification within 10 days, with evaluations of serum amylase and lipase, abdominal pain scores, and adverse events such as gastrointestinal bleeding, perforation, cholangitis, aspiration, and hypoxemia within 24 hours after ERCP. The study includes monitoring for feasibility, adherence, and safety through clinical evaluations and laboratory tests. Total participation includes treatment and follow-up lasting up to 30 days after the procedure.

Pancreatic ductal adenocarcinoma PDAC is a deadly cancer often diagnosed late due to its silent early phase, leading to poor survival rates. Current early detection mainly relies on invasive and costly imaging methods like MRI and endoscopic ultrasound, which have limited sensitivity. This study investigates using circulating cell-free and exosome-bound microRNAs as less invasive markers to identify PDAC risk and understand disease behavior in adults at increased risk due to family history, hereditary conditions, or pancreatic cysts. The study focuses on analyzing stored plasma samples from adults 18 years and older who are at higher risk for PDAC because of familial pancreatic cancer, hereditary pancreatic cancer syndromes, or mucinous pancreatic cystic lesions. No new treatments or devices are given instead, researchers measure microRNA levels from these samples using validated laboratory techniques. The goal is to see if this combined microRNA profiling can better predict PDAC risk and progression compared to standard imaging surveillance alone. Participants have already provided plasma samples and clinical data collected during their routine medical care, which researchers will use for microRNA analysis and risk assessment. The study measures how accurately these biomarkers detect PDAC by tracking sensitivity, specificity, and overall prediction accuracy over about one year. There is no impact on clinical care, and no additional procedures are required from participants during the study period that extends until early 2032.

This research aims to learn more about vitamin C deficiency in patients with either acute or chronic diseases. It focuses on understanding how symptoms change over time and how well patients tolerate treatment. The study involves patients diagnosed with vitamin C deficiency either by lab tests or based on symptoms such as fatigue, infections, bleeding gums, joint pain, and poor wound healing. The study observes patients treated with Vitamin C Injektopas 7.5 g, given for an expected average of about 3 weeks for acute diseases or 12 weeks for chronic diseases. Two groups are included those with acute underlying diseases and those with chronic underlying diseases, both receiving this vitamin C therapy during the study period. Participants will be followed to assess changes in general and disease-specific symptoms, as well as treatment tolerability and overall effectiveness from the patients perspective. Researchers will also record the number of vitamin C infusions and measure quality of life for chronic disease patients. The study duration ranges up to approximately 12 weeks, with evaluations at the last visit to understand symptom improvement and treatment impact.

Researchers are studying the effects of MAR001 on adults with high triglycerides and remnant cholesterol. This phase 2, randomized, double-blind, placebo-controlled trial aims to compare MAR001 with a placebo to see how it changes triglyceride levels after eating a mixed meal. The study focuses on the postprandial after eating state in adults aged 18 to 75 years with elevated triglycerides and remnant cholesterol. Participants receive either MAR001 or a matching placebo through subcutaneous injections. The treatment period lasts 12 weeks, during which researchers measure changes in triglycerides and remnant cholesterol levels after a mixed meal. The study uses a quadruple-blind design, meaning participants, care providers, investigators, and outcomes assessors do not know who receives MAR001 or placebo. During the study, participants will have fasting triglyceride tests at screening and regular assessments throughout the 12 weeks. Researchers will track the area under the curve and peak plasma concentrations of triglycerides and remnant cholesterol after meals to evaluate treatment effects. Participants must maintain stable diets and medication regimens during the trial. Safety and adherence will be monitored with ongoing assessments to understand the impact of MAR001 compared to placebo.

Pancreatic cancer is a serious and often deadly disease, with pancreaticoduodenectomy being the standard treatment for tumors in the pancreatic head and nearby areas. However, this surgery carries a high risk of complications, especially postoperative pancreatic fistula, which can affect 25% to 50% of patients. Researchers are studying whether using external versus internal pancreatic duct stents can lower the risk of these complications, focusing on patients with different levels of risk as determined by the Updated Alternative Fistula Risk Score ua-FRS. The study compares two types of pancreatic duct stents during pancreaticoduodenectomy an external stent, which exits through the abdominal wall, and an internal stent, a silicone catheter placed inside the pancreatic duct and jejunum. All surgeries are performed by the same specialized team using laparoscopic or open approaches, with reconstruction using the childs technique. Patients are assigned randomly to receive either the external or internal stent to evaluate the effect on postoperative outcomes. Participants will be monitored for at least one month after surgery to track the occurrence of clinically relevant postoperative pancreatic fistula CR-POPF and other complications. Assessments include clinical evaluations and follow-up to measure the primary outcome of CR-POPF incidence. The study aims to clarify the safety and effectiveness of external stents in both high-risk and low-risk patients undergoing pancreaticoduodenectomy, with all procedures and outcomes carefully recorded by the research team.

Researchers are evaluating the safety and tolerability of multiple subcutaneous injections of JMT202 in Chinese adults with hypertriglyceridemia. This study is a Phase 1b2a randomized, double-blind, placebo-controlled trial aimed at assessing how participants respond to this investigational treatment, including its effects on triglyceride levels and overall health markers. Participants will receive either JMT202 injections or placebo injections according to the study protocol. The study involves multiple doses administered under medical supervision. Some participants in each dose group will also undergo MRI-PDFF scans to assess fat content. Throughout the trial, participants are expected to maintain their usual diet and exercise habits while avoiding alcohol and strenuous exercise before visits. During the study, participants will undergo regular safety assessments including monitoring for treatment-emergent adverse events, vital signs, physical exams, laboratory tests, electrocardiograms, and injection site reactions from Day 1 to Day 99. The trial period includes careful observation of health changes and adherence to stable lipid-lowering treatments. The total duration of participant involvement spans from screening through approximately three months of follow-up after treatment begins.

Researchers are evaluating the effectiveness of low volume Transanal Irrigation TAI using the Qufora IrriSedo MiniGo device combined with standard conservative treatments compared to conservative treatment alone for patients with Low Anterior Resection Syndrome LARS. This condition affects individuals who have undergone surgery for rectal cancer. The study aims to assess improvements in clinical symptoms of LARS over a three-month period. Participants are divided into two groups one receiving low volume TAI with the MiniGo device plus standard conservative care, which includes dietary management, counseling, and prescribed medications excluding suppositories and physiotherapy and another group receiving only the standard conservative treatments. The study includes follow-ups at 6 weeks, 3 months, and up to 12 months to monitor various outcomes. During the study, participants will be regularly assessed using the LARS score to measure symptom changes, quality of life questionnaires EORTC QLQ-C30 and QLQ-CR29, incontinence scores, patient satisfaction, treatment compliance, bowel management time, and healthcare resource usage. Data will be collected at multiple intervals including 6 weeks, 3 months, 6 months, 9 months, and 12 months to thoroughly evaluate the treatment impact and patient preferences.

Trauma is a leading cause of death in children in the US, with abdominal trauma accounting for 30% of pediatric traumatic deaths, second only to brain injury. This research evaluates the use of the Focused Assessment with Sonography for Trauma FAST examination, a bedside abdominal ultrasound, to determine if it can safely reduce abdominal CT scans in hemodynamically stable children with blunt abdominal trauma. The study aims to improve care quality and reduce morbidity and mortality by identifying appropriate evaluation strategies for injured children. The trial is a multicenter, randomized, controlled study involving 3,194 children under 18 years presenting within 24 hours of blunt abdominal trauma. Participants are assigned to either the FAST examination arm, where a bedside ultrasound is performed to detect blood in the abdomen, or to the standard care arm without FAST. The FAST exam is quick, radiation-free, and performed by emergency or trauma physicians. The study compares CT scan rates and tracks delayed or missed diagnoses of intra-abdominal injuries over up to 30 days. Throughout the emergency department stay and initial hospitalization up to 24 hours, participants undergo assessments including FAST or standard evaluation, CT scan monitoring, and tracking of injuries for up to 30 days if hospitalized. Outcomes measured include CT scan frequency, missed injuries, emergency department length of stay, hospitalization rates, physician suspicion of injury, and surgery rates. The study also examines factors influencing CT use in low-risk patients after a negative FAST exam, aiming to optimize diagnostic care in pediatric trauma.

Researchers are studying CTX310, a new gene-editing treatment, in adults aged 18 to 75 with dyslipidemias that do not respond to current therapies. This early-phase, open-label trial aims to evaluate the safety and tolerability of CTX310, a lipid nanoparticle formulation designed to edit the ANGPTL3 gene involved in lipid regulation. Participants will receive a single intravenous infusion of CTX310. The study is conducted across multiple centers and follows an ascending dose design to assess safety at different dose levels. The treatment period includes monitoring for up to 12 months after infusion to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary effects on lipid levels. During the study, participants will have regular assessments including laboratory tests to monitor lipid levels and organ function, safety evaluations, and pharmacological measurements. Researchers will track adverse events and treatment effects for up to one year following the infusion. Participants must adhere to study visits and contraception requirements during this time to ensure accurate monitoring and safety.

Researchers are developing a minimally invasive blood test to diagnose pancreatic cancer at early stages and to monitor how patients respond to treatment. This observational study includes patients with various pancreatic conditions and healthy controls, aiming to improve early detection and treatment tracking for pancreatic cancer. The study is sponsored by Memorial Sloan Kettering Cancer Center. Participants are grouped into several cohorts based on their pancreatic condition, including advanced pancreatic cancer, operable pancreatic cancer, acute and chronic benign pancreatic diseases, pancreatic cysts, and healthy controls. Blood and sweat samples will be collected, and tissue samples may be obtained through planned biopsies or surgeries. Sampling schedules vary by cohort, with some involving samples before treatment or surgery and others involving repeated samples every 6 to 12 months according to institutional guidelines. During the study, participants will provide blood and possibly tissue or cyst fluid samples for biomarker analysis. Researchers will assess changes in these biomarkers over four years to determine the tests sensitivity and specificity for early pancreatic cancer diagnosis. Participation involves periodic sample collections and clinical evaluations, with safety monitored throughout. The study is open to adults aged 18 and older and includes healthy volunteers as well.