Acute Pancreatitis

Endoscopic retrograde cholangiopancreatography (ERCP) is commonly used to treat biliary and pancreatic diseases but can cause complications ranging from mild to severe, with post-ERCP pancreatitis (PEP) being the most serious and frequent. This study evaluates whether combining rectal indomethacin with cold-water irrigation of the ampulla reduces PEP more effectively than rectal indomethacin alone. The trial is a single-center pilot randomized controlled superiority trial conducted over 12 months with a 30-day follow-up, focusing on an Indian population. Participants will receive either rectal indomethacin alone or rectal indomethacin plus cold saline irrigation (4-10°C, 250 mL for 2 minutes) applied to the ampulla after ERCP. Rectal indomethacin (100 mg suppository) is administered 30-60 minutes before the ERCP procedure. The study compares the combination treatment to standard NSAID prevention methods, aiming to assess if the cooling adds benefit in reducing PEP incidence and severity. Throughout the study, participants will be monitored for PEP categorization within 10 days, with measurements of serum amylase and lipase, abdominal pain scores, and detection of adverse events like gastrointestinal bleeding, perforation, cholangitis, aspiration, and hypoxemia within 24 hours post-ERCP. Researchers will also evaluate hospital or intensive care stay length and adherence to the cooling protocol. The total participation includes the procedure and follow-up assessments for 30 days.

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 patient's 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 child's 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 1b/2a 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 evaluating CTX310, a lipid nanoparticle formulation of CRISPR-Guide RNA-Cas9 nuclease, in adults aged 18 to 75 with dyslipidemias that do not respond to available treatments. This phase 1, open-label, multicenter trial aims to assess the safety and tolerability of this in vivo gene editing approach targeting the ANGPTL3 gene. The study is sponsored by CRISPR Therapeutics AG and explores a new treatment option for difficult-to-treat lipid disorders.

Researchers are studying the development of a minimally invasive blood test to diagnose pancreatic cancer early and to monitor treatment responses. This observational study focuses on pancreatic ductal adenocarcinoma and also includes participants with various pancreatic conditions and healthy controls to compare biomarker changes. Participants are grouped based on their condition: those with advanced or metastatic pancreatic cancer have blood drawn before treatment, after the first chemotherapy cycle, every 8 to 12 weeks during treatment, and at disease progression. Those with acute pancreatitis provide blood samples at diagnosis and then every 6 to 12 months. Participants with chronic pancreatitis, IPMN, or pancreatic cysts have blood collected every 6 to 12 months, while healthy controls provide a single baseline blood sample. Additional samples include tumor tissue and cyst fluid obtained through planned biopsies. During the study, blood samples are collected up to about 50 ml if safe, with specific limits based on participant weight and hemoglobin levels. Researchers will analyze changes in biomarkers over four years to determine how well the test can identify early pancreatic cancer. Participants may also provide previously collected tissue samples. The study is sponsored by Memorial Sloan Kettering Cancer Center and includes regular assessments aligned with clinical care.

Researchers are evaluating the effect of ION775 on fasting triglyceride levels in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (sHTG). This Phase 2 open-label trial aims to assess the safety, tolerability, and effectiveness of ION775 in lowering triglyceride levels in these conditions. The study is sponsored by Ionis Pharmaceuticals, Inc., and focuses on participants with elevated fasting triglycerides despite standard lipid-lowering treatments. Participants will be randomly assigned to one of three groups, all receiving ION775 by subcutaneous injection. The trial includes a 4-6 week screening period followed by a 6-month treatment phase where ION775 is administered, then a 6-month post-treatment follow-up to monitor longer-term effects and safety. The study does not include a placebo group, and all participants receive the investigational drug. During the study, participants will undergo fasting triglyceride measurements at baseline and month 6 to assess changes. Additional monitoring includes tracking treatment-emergent adverse events, clinical lab evaluations, and changes in related cholesterol markers such as apolipoprotein C-III, VLDL cholesterol, remnant cholesterol, and non-HDL cholesterol. Total participation lasts about 12 months, with safety and tolerability closely monitored throughout treatment and follow-up periods.