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Filter by:Lipid accumulation, with mostly emphasized role of low-density lipoprotein cholesterol (LDL-C), is the pathogenetic cornerstone of atherosclerotic cardiovascular disease. Standard hypolipidemic therapy, based on statins and ezetimibe, does not always decrease LDL-C levels enough to achieve therapeutic goals. A novel and promising direction is inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) in hepatocytes, subsequently reducing LDL-C receptor degradation and increasing intracellular LDL-C uptake. Aim of this study is to evaluate the effect of optimal hypolipidemic pharmacotherapy, including PCSK9 inhibitors and inclisiran, on plasma lipid profile and qualitative features of atherosclerotic plaques in very-high cardiovascular risk patients. This study enrolls patients with an established atherosclerotic cardiovascular disease, receiving PCSK9 inhibitors or inclisiran as add-on treatment to statins in maximally tolerated dose and/or ezetimibe. Effect of hypolipidemic pharmacotherapy is evaluated by analysis of plasma lipid profile parameter changes and qualitative features of atherosclerotic plaques using Near-Infrared Spectroscopy Intravascular Ultrasound Imaging (NIRS-IVUS) method. Results of the study would be sufficient for complementing evidence regarding therapeutic strategy in very-high cardiovascular risk patients.
The present study aims to evaluate whether the use of a "dual trigger" can improve IVF outcomes, compared to GnRH agonist (GnRH-a) alone, in patients at high risk of OHSS undergoing a freeze-all cycle. By examining freeze-all cycles with frozen embryo transfer(s) (FET) only, we eliminate the potential confounding issue of inadequate luteal support to the endometrium and focus primarily on the effect of a "dual trigger" on oocyte quality and embryo potential. To our best knowledge, there have been no randomized, controlled trials conducted to address this hypothesis.
Dairy consumption has shown associations with decreased incidence of cardiometabolic diseases. With the growing interest in plant-based eating, and the mounting evidence for the cardiovascular benefits of plant forward diets, national dietary guidelines have pivoted away from promoting exclusive daily dairy consumption. Soymilk is the most nutritionally comparable non-dairy plant-based alternative to cow's milk. Although the DGA, Health Canada, and various pediatric associations recognize fortified soymilk as the only non-dairy alternative equivalent to cow's milk and it can carry an approved health claim for coronary heart disease risk reduction based on the soy protein that it contains, soymilk is classified by the NOVA classification as an ultra-processed food (the opposite of the classification of cow's milk as an unprocessed or minimally processed food). To be an acceptable iso-sweet alternative to cow's milk, soymilk is also often sweetened with sucrose, which is designated as an added sugar, whereas the lactose that sweetens cow's milk is not (despite lactose in cow's milk being present in quantities that are double that of sucrose in soymilk products designed to be iso-sweet analogues of cow's milk). With near universal recommendations from major public health authorities to reduce the intake of both ultra-processed foods and added sugars and the FDA proposing to update its "healthy" claim criteria to limit added sugars, the role of soymilk as a "healthy" non-dairy alternative to cow's milk is in serious question. The effect of soy protein on other cardiometabolic outcomes is also unclear. To address this question and better inform health claims and guideline development, the investigators will conduct a systematic review and meta-analysis of randomized controlled trials of the effect of soy protein as soy milk, in substitution for cow's milk, on various intermediate cardiometabolic mediators.
The goal of this randomised controlled trial is to study the (cost-)effectiveness of home-based hypnotherapy by self-exercises in children with functional abdominal pain (FAP) or irritable bowel syndrome (IBS) in primary care. The main questions it aims to answer are: - What is the effect of home-based hypnotherapy by self-exercises on adequate relief of abdominal pain and discomfort in addition to care as usual of general practitioners (GPs), compared to care as usual of GPs alone in children with FAP or IBS? - What is the effect of home-based hypnotherapy by self-exercises in addition to care as usual by GPs compared to care as usual of GPs alone in children with FAP or IBS on: - Frequency and intensity of abdominal pain and discomfort - Pain severity - Daily functioning and impact - Anxiety and depression - Pain beliefs - Sleep disturbances - School absence - Use of health care services, including GP visits and referrals to secondary care - Costs (healthcare and societal perspective) Participants in the intervention group will receive home-based hypnotherapy 5 times a week for approximately 15-20 minutes a day during 3 months in addition to care as usual by their GP according to the Dutch society of GPs' guideline for children with abdominal pain. Participants in the control group will receive care as usual by their GP according to the Dutch society of GPs' guideline for children with abdominal pain.
The purpose of this study is to develop and validate a clinical decision support system based on automated algorithms. This system can use natural language processing to extract data from patients' endoscopic reports and pathological reports, identify patients' disease types and grades, and generate guidelines based follow-up or treatment recommendations
This is a Phase I/II, open-label, non-randomized, multicenter study to explore safety, tolerability and antitumor activity of NMS-01940153E as single agent in adult patients with unresectable hepatocellular carcinoma (HCC) previously treated with systemic therapy. The Phase I portion is designed as a dose-escalation study in sequential cohorts of patients aimed to obtain the maximum tolerated dose (MTD) that is defined based on the dose limiting toxicities (DLTs) observed in the first cycle of treatment. The Phase II portion is designed as a two-stage study with an interim analysis for futility and stopping criteria for unacceptable toxicity to assess the antitumor activity of NMS-01940153E in adult patients with unresectable HCC previously treated with systemic therapy measured as objective response rate.
The purpose of this prospective biospecimen collection study is to evaluate the feasibility of measuring circulating tumor DNA (ctDNA) in subjects with muscle-invasive bladder cancer (MIBC) treated with trimodality therapy consisting of a maximal transurethral resection of bladder tumor followed by radiation and concomitant chemotherapy. Cancer cells have unique genes that determine the characteristics of tumors, such as how they will respond to different treatments. The tumor tissue will be used to determine the genes present in cancer cells. Tumor cells sometimes release fragments of DNA into the blood or urine (circulating tumor DNA or ctDNA) and measuring levels of ctDNA may be a way to monitor cancer and predict to determine which treatment works better and what will be the outcome of cancer. Urine, blood, and tumor tissue are called biospecimens. Biospecimens can help researchers understand how the human body works. Researchers may develop new tests to monitor diseases or new ways to treat diseases. Plasma and urine specimens will be collected before, during, and after the standard-of-care treatment. This study will estimate the feasibility of collecting plasma ctDNA detection in subjects with MIBC. If this information can be successfully collected and processed, the usefulness of ctDNA to predict tumor response to certain kinds of treatment or disease progression will be evaluated.
The purpose of the study is to find out if iptacopan is effective and safe in adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who switch from their current standard of care treatment (eculizumab or ravulizumab) to study treatment, iptacopan/LNP023.
Clinical outcomes of post-placental insertion of Cupper T380A and Multiload 375 contraceptive devices during cesarean section
A phase 2b, multicenter, randomized, double-blind, placebo-controlled study of HTD1801 in adult subjects with non-alcoholic steatohepatitis and liver fibrosis who have type 2 diabetes mellitus or pre-diabetes.