Kornimate/medical-research-clean huggingface dataset:
combination of artificial intelligence and mucosal exposure device to enhance colorectal neoplasia detection

Conditions: Adenoma; Colorectal Cancer; Colorectal Neoplasms

Summary: the investigators hypothesize that the combined use of cade system (endoaid) and mucosal exposure device (endocuff vision®) would improve the adenoma detection rate when compared to cade system alone.

high polyp miss rates were reported in standard colonoscopies. as a result, a significant proportion of interval crc was attributed to the missed lesions during index colonoscopy. risk factors of missed lesions included proximal location, serrate or flat morphology, poor bowel preparation, short withdrawal time and endoscopist experience. to overcome this pitfall, various methods were developed to improve adenoma detection rate (adr), including distal attachment devices. among the mucosal exposure devices, endocuff vision® was shown to be superior than conventional colonoscopies. recently, artificial intelligence and automatic computer-aided polyp detection (cade) systems have developed rapidly and revolutionized the medical field. nevertheless, there was a potential limitation of 'blind spot' if the endoscopist failed to expose the colonic mucosa adequately leading to missed lesions. to date, no available data or ongoing clinical trial was reported regarding the combined use of cade and mucosal exposure devices. it may enhance the performance of cade and provide a novel definitive solution to this unaddressed yet important clinical problem. in this prospective parallel randomized controlled trial, we aim to evaluate the impact of combined use of a new cade system (endoaid) and mucosal exposure device (endocuff vision®) on colorectal neoplasia detection.

Eligibility criteria:
inclusion criteria: 1. aged 45-85 years old; 2. they require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or altered bowel habit; 3. written informed consent obtained. exclusion criteria: 1. contraindication to colonoscopy (e.g. intestinal obstruction or perforation) 2. contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets) 3. staged procedure for polypectomy or biopsy of known unresected lesions 4. previous surgical resection of colon 5. personal history of colorectal cancer 6. personal history of familial polyposis syndrome 7. personal history of inflammatory bowel disease 8. advanced comorbid conditions (defined as american society of anesthesiologists grade 4 or above) 9. pregnancy 10. unable to obtain informed consent
glp-1 on non-st-segment elevation myocardial infarction

Conditions: Myocardial Infarction

Summary: the investigators planned to evaluate the effects of liraglutide on left ventricular function in patients with non-st-segment elevation myocardial infarction (nstemi).

patients with non-st-segment elevation myocardial infarction (nstemi) are a heterogeneous group with respect to the risk of having a major adverse cardiac event (mace). elevation of blood glucose is a common metabolic disorder among patients with acute myocardial infarction (ami) and is associated with adverse prognosis. glucagon-like peptide-1 (glp-1) is an incretin hormone that regulates plasma glucose. glp-1 analogues have significant cardiovascular protective effects in patients with ami. glp-1 may have antioxidant and anti-inflammatory properties, and protect endothelial function. studies in conscious, chronically instrumented dogs demonstrated that glp-1 infusion increases insulin sensitivity and myocardial glucose uptake in postischemic contractile dysfunction and dilated cardiomyopathy. liraglutide, a glp-1 analogue, was reported to reduce cardiac rupture and infarct size and improve cardiac output in normal and diabetic mice. continuous infusion of glp-1 (1.5 pmol/kg/min) has been shown to improve functional recovery in patients with ami complicated by decreased left ventricular function glp-1 could protect against ischemia-reperfusion injury and improve cardiac function in patients with acute st-segment elevation myocardial infarction. however, the effects of glp-1 on nstemi patients remain unclear. the aim of this study was to evaluate the effects of liraglutide on left ventricular function in patients with nstemi.

Eligibility criteria:
inclusion criteria: non-st-segment elevation myocardial infarction (nstemi ) exclusion criteria: 1. unconscious at presentation 2. had st-segment elevation acute myocardial infarction 3. nstemi requiring emergency percutaneous coronary angiography 4. valvular heart disease 5. cardiogenic shock 6. hypoglycaemia 7. diabetic ketoacidosis 8. had a history of myocardial infarction 9. stent implantation 10. renal insufficiency 11. had previously undergone coronary artery bypass surgery.

Keywords: glucagon-like peptide-1 non-st-segment elevation myocardial infarction left ventricular ejection fraction
increasing food literacy in preschoolers to reduce obesity risk

Conditions: Food Preferences; Food Selection; Eating, Healthy; Obesity, Childhood

Summary: the goal of this clinical trial is to examine the effects of a nutrition education program on preschool children's food literacy and food acceptance, and to examine the added influence of a healthy eating curriculum and parent education on children's food knowledge and healthful food choices. the project will be evaluated with 450 children ages 3 to 5 years in center-based childcare programs serving predominantly supplemental nutrition assistance program (snap)-eligible families in pennsylvania. outcomes for children who receive the added healthy eating curriculum will be compared to children in classrooms that only receive the nutrition education program.

repeatedly exposing young children to new foods can increase their willingness to try those foods, and they may - with time - learn to like those foods. being able to learn about, touch and taste new foods can be a powerful tool to foster young children's liking of new foods. this project's goals are to test whether a preschool nutrition education program can improve (1) children's ability to name and identify fruits and vegetables, (2) children's knowledge about food and nutrition, (3) children's healthful food choices during a meal, and (4) parenting around children's eating. participants will include 450 children ages 3 to 5 years in center-based childcare programs serving a large majority of families experiencing poverty in pennsylvania. in all classrooms, children will receive food literacy lessons designed to help them learn about different fruits and vegetables, where they grow, and why they are good for our bodies. children in intervention classrooms will receive food literacy lessons, in addition to lessons on healthy eating designed to improve children's nutrition knowledge. teachers in intervention classrooms will be provided with materials designed to increase children's knowledge about nutrition and healthy eating. intervention parents will receive web-based lessons designed to improve parenting practices related to children's eating behaviors. the study will be conducted over a 14-month period, and a variety of child, teacher, classroom and parent outcomes will be measured before, during and after the intervention. the results of this study are anticipated to add new information on ways to improve children's nutrition knowledge and acceptance of fruits and vegetables.

Eligibility criteria:
inclusion criteria: * preschool children enrolled in participating centers exclusion criteria: * severe food allergies that prevent children from consuming project foods * presence of a developmental or sensory disability that affects food intake and/or learning * lack of english fluency (children and caregivers) * children not regularly present during days/times that intervention lessons are delivered * parents who are not involved in feeding/preparing meals for children at least 50% of the time

Keywords: food literacy healthy growth child development food acceptance
can oxytocin level predict postpartum depression?

Conditions: Postpartum Depression

Summary: the goal of this research study is to understand the relationship between the hormone oxytocin and postpartum mood.

postpartum depression (ppd) affects some one in five new mothers, and adversely influences maternal adaptation to motherhood. while it is known that women with a prior history of depression, or depression during pregnancy, are at elevated risk for postpartum depression, many women with no prior history of depression or other risk factors go on to develop depression in the postpartum period. considering the grave consequences of postpartum depression on maternal infant bonding and childhood psychological development, it is critical to develop reliable methods to identify which women, who are not depressed during pregnancy, will become depressed after delivery. the biological pathways leading to depression at any time in life, including around pregnancy, are still poorly characterized. oxytocin (ot), a hormone involved in delivery and lactation, has received recent attention regarding its additional role in maternal emotions and care taking behaviors after birth. the primary goal is explore the relationship between plasma oxytocin and postpartum mood.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age 2. english-speaking 3. pregnant (third trimester at time of visit) exclusion criteria: 1. current active depression or other mental illness at time of study entry in the third trimester (past depression or anxiety is acceptable) 2. current antidepressant treatment 3. severe medical complications in current pregnancy (gestational diabetes, hypertension, thyroid disease) 4. signs of multiple gestation or of fetal malformation in current pregnancy 5. cigarette smoking beyond 10th week of gestation of current pregnancy 6. pre-pregnancy bmi \> 32

Keywords: pregnancy oxytocin postpartum depression depression pregnant women mood anxiety hormones women's health mental health baby blues mood disorders
phase i study of hmpl-523+azacitidine in elderly patients with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: this is a phase i, open-label, non-randomized, multicenter study to evaluate the safety, pharmacokinetics and preliminary efficacy of hmpl-523 in combination with azacitidine in previously untreated elderly patients with aml who are not eligible for standard induction therapy.

there are two stages in this study: a dose-escalation stage (stage 1) and a dose-expansion stage (stage 2). dose-escalation stage (stage 1): the conventional 3+3 design (3 patients per dose cohort, with the potential to add additional 3 patients to the same cohort to further evaluate toxicity) will be applied for dose escalation and maximum tolerated dosage determination. approximately 12 to 18 dose limited toxicities evaluable patients will be enrolled. a dose of hmpl-523 up to 800mg will be taken orally once daily continuously through a 28-day cycle of study treatment. azacitidine will be administered subcutaneously, beginning on day 1 through day 7 of each cycle. dose-expansion stage (stage 2): this phase is to further evaluate the safety, pharmacokinetics and preliminary efficacy of hmpl-523 in combination with azacitidine in approximately 28 previously untreated elderly patients with aml. patients will receive hmpl-523 in combination with azacitidine in a 28-day cycle continuously until disease progression/relapse, death, or intolerable toxicity, whichever comes first.

Eligibility criteria:
inclusion criteria: 1. subject must have confirmation of aml by who criteria, except for apl (m3) 2. subject must be ≥ 65 years of old and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors 3. subject must have received no prior treatment for aml with the exception of hydroxyurea 4. ecog performance status of 0-1. for dose-expansion stage, ecog ps of 2 will also be eligible exclusion criteria: 1. subject has received treatment of hypomethylating agent and/or chemo therapeutic agent for mds or mpn 2. subject has known active cns involvement or extramedullary sarcoma from aml 3. subject has favorable risk cytogenetics as categorized by the nccn guidelines version 1, 2018 for acute myeloid leukemia, such as inv(16) or t(16;16) or t(8;21) or t(15;17) 4. subject has a white blood cell count \> 25 × 109/l (hydroxyurea is permitted to meet this criterion) 5. subject with serum amylase or lipase \> the uln 6. subject is known to be positive for hepatitis b or c infection with the exception of those with an undetectable viral load. 7. subject who don't have enough liver or renal function 8. subject with new york heart association (nyha) class iii or greater congestive heart failure 9. subject received herbal therapy ≤ 1 week prior to initiation of study treatment 10. subject received prior treatment with any syk inhibitors (fostamatinib) or flt3 inhibitor (quizartinib) or multi-target inhibitor with syk or flt3 inhibition activity (midostaurin)
clinical trial to improve treatment with blood thinners in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: to determine whether a comprehensive evaluation and customized multilevel educational interventions will increase the rate of use of oral anticoagulants and the adherence and persistence of use in patients with atrial fibrillation. our hypothesis is that there will be differences in the use of oral anticoagulants and the persistence in patients between the control and interventional group. there will be a greater change in the use of oral anticoagulants over one year in the cohort in the intervention sites than the control sites. this will be due to two factors: greater initiation of oral anticoagulants among patients not treated at baseline and greater persistence of treatment for those on treatment at baseline


Eligibility criteria:
inclusion criteria: * 1. patients over the age of 18 with paroxysmal, persistent or permanent atrial fibrillation who have a 12-lead ecg showing atrial fibrillation and/or more than one rhythm strip showing atrial fibrillation at least 2 weeks apart, not due to a reversible cause (like post-cabg)) * 2. at least one of the traditional chads2 risk factors or at least two cha2ds2 vasc risk factors exclusion criteria: * mechanical prosthetic valve * clinically unstable at the time of enrollment (ie, with ongoing shock) * terminal illness and/or comfort care * unable to provide consent (e.g. severe cognitive impairment) * patients unable to have one year of follow-up for any reason * clear and absolute contraindication to oral anticoagulation (for example, active bleeding or recent life-threatening bleeding such as ich)

Keywords: atrial fibrillation anticoagulation education educational intervention
liver stiffness measurement in alcohol-dependent subjects in relation to abstinence after withdrawal

Conditions: Alcohol Withdrawal

Summary: this study is complementary to the main study "brain derived neurotrophic factor serum levels evolution during the six months after alcohol withdrawal " nct01491347. liver stiffness variation is one of the major somatic effect of chronic alcohol consumption. it is a consequence of numerous mechanisms, including inflammation. liver stiffness seems to depend on alcohol consumption in alcohol dependent patient, more precisely on the time after the last alcohol consumption. this is very few documented after alcohol withdrawal, and has never been explored during several months after withdrawal as a function of alcohol consumption and abstinence. brain derived neurotrophic factor (bdnf) seems to play a major role in general homeostasis and also liver function. we propose here to analyse the serum bdnf levels variations after withdrawal according to liver stiffness levels and alcohol consumption status. we will also measure liver stiffness using fibroscan® in alcohol dependent subjects included in the main study to search for a link with serum bdnf levels and abstinence at day 0, 14, 28 and months 2, 4, and 6.


Eligibility criteria:
inclusion criteria: * participation to the study "bdnf serum levels evolution during 6 months after alcohol withdrawal" (main study) * criteria from the main study exclusion criteria: * criteria from the main study

Keywords: fibroscan alcohol dependence alcohol withdrawal controlled attenuation parameter bdnf
canadian avonex pen productivity study

Conditions: Multiple Sclerosis

Summary: this study is primarily designed to evaluate the impact of avonex pen autoinjector on work capacity of participants with multiple sclerosis (ms) starting on this device. this study will also evaluate as secondary endpoints various patient-reported outcomes over the short-term (1 month), including adherence, treatment satisfaction and convenience, and the long-term (12 and 24 months), including adherence, persistence, quality of life (qol), treatment satisfaction and convenience. it will also assess health resource utilization by ms participants starting on avonex pen autoinjector, as well as overall safety/tolerability, and will correlate all secondary outcomes with the primary (i.e., work capacity).


Eligibility criteria:
key inclusion criteria: * must be prescribed avonex pen as per local labeling (product monograph) and enrolled in ms alliance (msa) program * if being switched from another dmt, must be on this dmt for at least 6 months * last dmt the subject is switched from must be injectable * must be able to physically demonstrate use of the avonex pen autoinjector device and be able to self-administer the injections * must give written informed consent. if required by local law, candidates must also authorize the release and use of protected health information (phi) * must be able to understand and comply with the protocol key exclusion criteria: * female subjects considering becoming pregnant while in the study or who are currently pregnant or breast-feeding * current enrollment in any investigational study involving drug, biologic or non-drug therapy * participation in other clinical studies within the past 6 months * treatment with immunosuppressive regimens (e.g. cyclophosphamide, azathioprine, methotrexate or mitoxantrone) or with intravenous immunoglobulin (ivig) in the last 6 months * the most recent dmt the subject is switched from is non-injectable (i.e., oral) * other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrollment note: other protocol defined inclusion/exclusion criteria may apply.
efficacy and safety of pitavastatin and pcsk9 inhibitors in liver transplant patients

Conditions: Dyslipidemias; Hyperlipidemias; Liver Transplant Disorder; Immunosuppression; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Statins

Summary: to study the efficacy and safety of pitavastatin and pcsk9 inhibitors in liver transplant patients on ongoing immunosuppressive therapy.

1. evaluate the efficacy and safety of lipid-lowering therapy in real clinical practice. 2. to evaluate the efficacy and safety of pitavastatin in patients undergoing liver transplantation and receiving immunosuppressive therapy. 3. evaluate the efficacy and safety of pcsk9 inhibitors in patients undergoing liver transplantation and receiving immunosuppressive therapy. 4. to compare the efficacy and safety of pitavastatin and a pcsk9 inhibitor in patients undergoing liver transplantation and receiving immunosuppressive therapy.

Eligibility criteria:
inclusion criteria: * signed informed consent to participate in the study; * a history of liver transplantation for any reason; * immunosuppressive therapy; * the presence of hyperlipidemia, requiring the prescription of lipid-lowering therapy according to the clinical guidelines of the european society for the study of atherosclerosis (eas) 2019 * failure to achieve the target level of ldl-c against the background of current lipid-lowering therapy; * if the patient within 1 month before randomization took lipid-lowering therapy, then the absence of side effects against the background of previous lipid-lowering therapy. exclusion criteria: * treatment with pcsk9 in previous 6 months; * current treatment in the form of lipoprotein apheresis; * heart failure iv nyha; * active infectious disease, severe hematological, metabolic, gastrointestinal or endocrine dysfunctions (for example, uncontrolled thyroid dysfunction) at the time of the screening or randomization visits; * the presence of an oncological disease, with the exception of hepatocellular carcinoma, which served as the reason for liver transplantation; * cfr\<15ml/min/1,73m2; * pregnancy and breastfeeding.

Keywords: dyslipidemias hyperlipidemias liver transplant disorder immunosuppression immunosuppressive therapy hydroxymethylglutaryl-coa reductase inhibitors pitavastatin statins pcsk9 pcsk9 inhibitors evolocumab alirocumab
n-acetylcysteine for thrombolysis in acute stroke

Conditions: Stroke, Ischemic

Summary: the primary objective of the study is to assess the safety of n-acetylcysteine as a thrombolytic agent in acute ischemic stroke, especially regarding the risk of hemorrhagic transformation.

preclinical studies demonstrated that n-acetylcysteine (nac) is able to break von willebrand factor (vwf) multimers by bisulfide bond reduction. since thrombi in stroke patients are rich in vwf, nac could be used as a thrombolytic agent during the acute phase. this study aims at assessing the safety of nac in combination with alteplase (rt-pa) at the acute phase of ischemic stroke.

Eligibility criteria:
inclusion criteria: * patient presenting with an acute ischemic stroke (non lacunar) as assessed by cerebral imaging (either ct or mri), with or without visible vessel occlusion. * patient eligible to intravenous thrombolysis according to current criteria, including patients who will also benefit from endovascular treatment (if eligible). * personal or familial consent to participate in the study. exclusion criteria: * known hypersensitivity to n-acetylcysteine or to any excipient from the formulation. * coma and/or nihss \<4 or ≥20. * daily treatment with nitrovasodilator before the inclusion. * known asthma or chronic obstructive pulmonary disease requiring bronchodilatators or steroids. * participation to another interventional study if it requires administration of an experimental treatment in the first 3 days after nac treatment. * women of childbearing age (age \< or = to 50) * known history of prior treatment with vitamin-k antagonist or direct oral anticoagulant. * known history of severe hepatopathy including cirrhosis, portal hypertension (esophageal varices) and evolutive hepatopathy.

Keywords: thrombolysis hemorrhagic transformation alteplase thrombectomy