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Filter by:The purpose of this study is to evaluate the safety and efficacy of AS101 1% oral solution as compared to placebo in patients with neovascular Age-Related Macular Degeneration (AMD). AMD Patients who underwent 3 consecutive intravitreal anti VEGF injections and have sub retinal or intraretinal fluid at day 1 of study will be treated orally by AS101 1% solution or placebo once daily for 24 weeks and will be tested for sub retinal or intraretinal fluid every 4 weeks by OCT examination. In case of fluid in macula anti intravitreal anti VEGF injections will be given the same day as needed (PRN). Safety evaluation will be assessed by adverse events related to treatment of 1% AS101 oral solution or placebo. Efficacy will be evaluated in terms of duration of fluid free macula in the AS101 treated group as as compared to placebo treated group;
In the management of patients with acute upper gastrointestinal bleeding from non-variceal causes, endoscopic treatment and acid suppression are now the standard of care. Current endoscopic treatment in the form of either thermo-coagulation or clipping to the bleeding arteries is highly efficacious in the stopping bleeding. Unfortunately in 5 to 10% of patients, bleeding cannot be controlled during index endoscopy or recurs after initial hemostasis. These patients are often elderly with significant co-morbidities. Their bleeding lesions are large eroding into major sub-serosal arteries. In the few who need surgical salvage, mortality increases to around 30%. The Over-the-scope-Clip (OTSC) is a device, which allows endoscopists to capture a large amount of tissue and compress on the bleeding artery. The OTSC also has a high retention rate. Recurrent bleeding with the use of standard hemo-clips can occur because of their low retention rate. We reported the use of OTSC with a high success rate in a case series of patients with refractory bleeding after standard endoscopic treatment. We have also used OTSC in the treatment of bleeding from pseudo-aneurysm arising from large eroded arteries in ulcer base. A multicenter randomized controlled trial that compares OTSC to standard endoscopic treatment in the endoscopic treatment of refractory bleeding lesions has just been completed. The use of OTSC has been shown to be superior in achieving hemostatic control and reducing further bleeding. In this proposed randomized controlled trial, we would test the hypothesis that the use of OTSC, when used as the first or primary treatment, is superior to standard treatment in achieving hemostasis and thereby improve patients' outcomes.
This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet manufactured at two different plants.
After subtotal colectomy, 40% of patients report abdominal pain, gas and diarrhea, and poor quality of life; whose etiology is unknown. The investigators determined whether small intestinal bacterial (SIBO or fungal overgrowth SIFO) could cause these sympotoms (> 1 year).
The mass provision of HIV treatment in rural KwaZulu-Natal, South Africa has raised adult life expectancy by 18 years since 2003. We will conduct a population-based survey to assess young adults' beliefs about HIV, HIV treatment, and expectations for the future in the era of mass HIV treatment. Thh investigators will conduct a randomized evaluation to assess whether a short video providing young adults with information on longevity gains from HIV treatment affects young adults survival expectations, hope for the future, and health and educational behaviours, including uptake of HIV testing, the study's primary outcome.
The usefulness of videolaryngoscope has been verified by several studies, and the frequency of videolaryngoscopy is increasing in clinical practice. Data on the use of videolaryngoscopes, however, were not sufficiently accumulated when compared with data on the use of previously used macintosh laryngoscopes. In addition, videolaryngoscopy increases the success rate of endotracheal intubation compared to conventional macintosh laryngoscopy, but endotracheal intubation with videolaryngoscope is not successful in all cases with one intubation attempt. Therefore, if the difficult endotracheal intubation with the videolaryngoscope can be predicted in advance, it may be possible to improve the success rate of intubation by reducing unnecessary use of the videolaryngoscope and preparing other equipment. There are many studies on the preoperative examination that can predict the difficulty of intubation when using a macintosh laryngoscope. However, there are still attempts to find screening tests that predict precisely the difficult endotracheal intubation because the accuracy of screening tests is not high. In particular, there is a lack of research on factors that can predict difficult endotracheal intubation when using videolaryngoscope. Therefore, the investigators aimed to investigate the factors predictive of difficult endotracheal intubation when attempting intubation using videolaryngoscope.
Investigators plan to study the safety, side effects, and benefits of tumor-infiltrating lymphocytes (TILs) when they are given with the drug nivolumab. Nivolumab is a type of immunotherapy - a drug that is used to boost the ability of the immune system to fight cancer, infection, and other diseases.
This research study is done to test the safety of the new drug selitrectinib in children and adults with cancer having a change in a particular gene (NTRK1, NTRK2 or NTRK3). The drug may treat cancer by interfering with the effect of the NTRK genes on cancer growth. The study also investigates how the drug is absorbed and processed in the human body, and how well and for how long the cancer responds to the drug. This is the first study to test selitrectinib in humans with cancer, for whom no other effective therapy exists.
This study plans to learn more about how to increase postpartum weight loss and how to decrease risk factors for postpartum women at increased risk for diabetes and heart disease. The program is delivered using a mobile application (app) and a lifestyle coach. This mobile application is developed for women who are at higher risk for diabetes and heart disease. Women who have gestational diabetes, (diabetes during pregnancy, or GDM), gestational hypertension (high blood pressure), and/or preeclampsia (high blood pressure and protein in the urine), and/or small-for gestational-age, and/or preterm (early) delivery during their pregnancies have a higher risk for diabetes and heart disease. This mobile application was developed using the latest research studies and using the evidence-based Diabetes Prevention and Colorado Weigh programs. The goal of the program is to help women lose weight and participate in physical activity after delivery.
The purpose of this survey is to evaluate the safety and effectiveness of vonoprazan tablets in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting.