Kornimate/medical-research-clean huggingface dataset:
effect of an advanced notification letter on screening colonoscopy participation

Conditions: Colorectal Cancer; Adenoma; Rectal Cancer

Summary: participation in a primary screening colonoscopy programs remains low. advanced notification letter has been shown to increase participation in colorectal cancer screening with fecal occult blood testing and to be cost effective compared to standard invitation. it is unknown whether advanced notification letter increases participation rate in primary colonoscopy screening program. we hypothesize that an advance notification letter will have significant influence on participation in screening colonoscopy, comparing to standard invitation procedure and will thus result in higher efficiency of the program. this randomized controlled study aims to compare the participation rate in screening colonoscopy in response to advanced notification plus standard invitation letter and standard invitation letter alone. material and methods: 6800 individuals aged 55-64 years will be drawn from the population registry and randomly assigned in a 1:1 ratio to the group invited for screening colonoscopy with advanced notification letter (send two weeks before standard invitation) plus standard invitation (send six weeks before planned screening colonoscopy) or to standard invitation only (send six weeks before planned screening colonoscopy). the sample size was calculated to detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.


Eligibility criteria:
inclusion criteria: * all individuals aged 55-64 years living in the counties covered with the organized crc screening program and assigned to invitation to screening colonoscopy in the year 2014 are eligible for the study. exclusion criteria: * message from neighbor/family/post office on death of screenee (not updated in population registry) * resident abroad (not updated in population registry) * return of unopened letter of invitation and/or reminder (address unknown) * diagnosis of crc before the date of draw (not updated in the national cancer registry)

Keywords: advanced notification letter standard invitation participation rate colonoscopy screening colorectal neoplasms digestive system diseases
study evaluating bifeprunox in patients with schizophrenia.

Conditions: Schizophrenia

Summary: an open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to evaluate long-term safety.


Eligibility criteria:
inclusion criteria: 1. outpatients who have successfully completed wyeth study 3168a1-313. 2. a signed and dated informed consent form for this study. 3. no major protocol violations in the previous study. exclusion criteria: 1. clinically important abnormalities in the preceding short-term study that have not resolved. 2. use of prohibited treatments in the preceding short-term study. 3. meeting any exclusion criteria in the preceding short-term study

Keywords: schizophrenia
safety and efficacy of human umbilical cord derived mesenchymal stem cells for treatment of hbv-related liver cirrhosis

Conditions: Liver Cirrhosis; End Stage Liver Disease

Summary: hbv related liver disease is a common medical problem in china. an estimated 7.18% of the chinese (about 93 million) is infected with hepatitis b, and most of the hbv- related hepatitis can developed into liver cirrhosis. liver transplantation is the only available life saving treatment for patients with end stage liver disease. however, lack of donors, surgical complications, rejection, and high cost are serious problems. mesenchymal stem cells (mscs) possess plasticity and have the potential to differentiate into hepatocyte; thus, mscs hold great hope for therapeutic applications. human umbilical cord-derived mscs (huc-mscs) exhibit a more beneficial immunogenic profile and greater overall immunosuppressive potential than aged bone marrow-derived mscs. like mscs derived from bone marrow, huc-mscs can also be used to treat rat liver fibrosis and improve glucose homeostasis in rats with liver cirrhosis. in this study, the patients with hbv-related liver cirrhosis will undergo administration of huc-mscs via hepatic artery to evaluate the safety and efficacy of huc-msc treatment for these patients.


Eligibility criteria:
inclusion criteria: 1. aged 18-65 years 2. hbv-related liver cirrhosis 3. child-pugh score 9-15 4. written consent - exclusion criteria: 1. hepatocellular carcinoma or other malignancies 2. severe problems in other vital organs(e.g.the heart,renal or lungs) 3. pregnant or lactating women 4. severe bacteria infection 5. anticipated with difficulty of follow-up observation 6. other candidates who are judged to be not applicable to this study by doctors

Keywords: liver cirrhosis end stage liver disease umbilical cord mesenchymal stem cells hbv
sleep disturbance in pregnant women in upper egypt

Conditions: Sleep Disturbance

Summary: pregnant women are associated with hormonal, anatomic and mechanical changes that change sleep patterns and quality of sleep. several investigators have reported associations between sleep disturbances and hypertension, coronary artery disease, diabetes, and depression. most of these associations have been established in the association with sleep disturbances


Eligibility criteria:
inclusion criteria: * all viable third trimester pregnancy exclusion criteria: * intrauterine fetal death * any history of neurological, mental disorder. * any previous diagnosed sleep disturbances breathing disorder before pregnancy. * any patient with respiratory infection in the pregnancy.
is verapamil in transradial interventions omittable?

Conditions: Coronary Disease; Verapamil Toxicity

Summary: background verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. however, verapamil may have side effects and is contraindicated in some clinical settings. methods: during an investigator-initiated, randomized, double-blind trial, we evaluate the need for preventive verapamil administration. after vascular access is established, patients receive either 5 mg verapamil (n=297) or placebo (n=294). we compare the rate of access site conversions as primary end point using a superiority margin of 5%. occurrence of code breaks (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural and fluoroscopic times, contrast volume, and subjective pain are investigated as secondary end points.


Eligibility criteria:
inclusion criteria: * patients undergoing transradial coronary angiography and/or percutaneous coronary intervention * successful cannulation of the radial artery exclusion criteria: * reduced left ventricular systolic function (lvef\<35%) * significant aortic stenosis * bradycardia (\<50/min.) * myocardial infarction complicated by cardiogenic shock and/or high grade av block

Keywords: coronary artery disease coronary angiography percutaneous coronary intervention transradial radial artery spasm verapamil adverse effects
tertiary prevention in type ii diabetes mellitus in canary islands study

Conditions: Type 2 Diabetes Mellitus

Summary: objective: * to improve health outcomes of patients with type 2 diabetes mellitus (t2dm) by influencing disease self-management through lifestyle modification and by helping primary care professionals to improve health care provided to patients. * to assess the effectiveness and cost-effectiveness of two complex interventions (education and behavioural modification, independently and conjointly, for primary health care teams (phct) and patients and their relatives) to improve the health results in people with t2dm. methodology: design: randomized clinical trial. setting: basic healthcare district in canary islands. spain. subjects: patients with t2dm, 18-65 years old, without complications. main measures: hba1c, rate of patients with properly controlled t2dm. sample: 2328 patients, 582 per arm. intervention: g1: interventions on the patients: educational and habit modification group program. g2: intervention on the phct: a) educative intervention to improve the knowledge about the disease and their abilities; b) computer-based clinical decision support system; c) feedback of results. g3: interventions on the patients and the phct. g4: control group. patients receive only the usual care.


Eligibility criteria:
inclusion criteria: patients: * t2dm diagnosis * aged between 18 and 65 health professionals: * primary health care teams (phct) comprising a primary care physician and a nurse practitioner associated to a patient will be selected * must have a permanent position or a stable substitute position exclusion criteria: * peripheral vascular disease * diabetic nephropathy and/or chronic kidney disease * cognitive impairment, dementia * major depression * insufficient level of spanish * to be pregnant or planning to become pregnant in the next 6 months * cancer last 5 years * ischemic disease or heart failure * proliferative diabetic retinopathy

Keywords: diabetes self-management lifestyle diet physical exercise computer-assisted decision support systems
gender and opioid consumption

Conditions: Postoperative; Parotitis

Summary: opioids are widely used for pain relief after major abdominal surgeries\[1\]. sex differences in the opioid analgesia have been reported and investigated in human subjects and animal models in this study, effects of sex difference on response to opioid analgesics after abdominal surgeries will be assessed regarding; analgesic duration (primary variable), frequency of analgesic requirement, total opioid consumption, opioid related complications (respiratory depression, nausea \& vomiting, itching, over-sedation, delayed intestinal motility).


Eligibility criteria:
inclusion criteria: * asa i and ii cases scheduled for elective intraabdominal surgeries exclusion criteria: * diabetes, * postmenopausal females, * laparoscopic surgery, * regional anesthesia emergency procedures, * sepsis, * hepatectomy, * renal impairment, and * hepatic impairment, * mental and psychiatric disorders.
dietary impact on continuous glucose monitoring

Conditions: Glucose Metabolism Disorders; Dietary Habits; Pediatric ALL; Adult ALL

Summary: cardiorespiratory fitness (crf), also known as "exercise capacity", is the capacity of respiratory and circulatory systems to supply oxygen to skeletal muscle during exercise for the generation of energy. determinants of crf include lung capacity, capillary density, cardiac output, hemoglobin concentration, and mitochondrial function. the research group studies how crf is related to fuel utilization, yielding a mechanistic understanding of the association between lower crf and worsening metabolic health via mitochondrial function. the objective of this study is to measure fuel utilization in response to habitual diet for one week in adolescents and young adults, ages 14-22 years (n=30). fuel utilization will be estimated by glucose measures using a continuous glucose monitor (cgm). habitual dietary intake will be collected via a mobile phone application (biteai, inc) that uses artificial intelligence to extract nutrient information from food photographs. participants will undergo two standard of care (soc) meal tolerance tests at home - a glucose tolerance test and a ensure® mixed meal tolerance test. crf will be estimated by measuring maximum oxygen consumption (vo2 max) during a graded treadmill test. the hypothesis is that a higher vo2 max will be associated with increased fuel utilization, measured by lower glucose response to the soc meal tolerance tests. the proposed study is described in the following aims: specific aim 1. test for feasibility of completion of self-report dietary food records, completion of two at home meal tolerance tests that are standard of care for metabolic health screening, and completion of a seven-day continuous glucose monitor. specific aim 2. identify nutrients and foods that are associated with an elevated glucose response. specific aim 3. assess the influence of vo2 max on the glucose response to the soc glucose tolerance test and ensure® mixed meal tolerance test.


Eligibility criteria:
inclusion criteria: * adolescents and young adults, ages 14-22 years exclusion criteria: * previous diagnosis of type 1 or 2 diabetes * previous diagnosis of hyperlipidemia or other metabolic disease * use of medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin). * allergies to milk. * inability to participant in the maximal exercise test on the treadmill. * individuals not having android or ios phones * individuals who cannot speak and/or write in english.
study of the efficacy of larazotide acetate to treat celiac disease

Conditions: Celiac Disease

Summary: this study is designed to evaluate the efficacy of a single dose of larazotide acetate in preventing intestinal permeability changes induced by a 6-week gluten challenge in subjects with celiac disease

this study is an extension of study clin1001-006 (nct 00492960). this is a phase iib, randomized, double-blind, placebo-controlled, dose ranging, multicenter study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. subjects will remain on their gluten-free diet throughout the duration of the trial. study drug or drug placebo capsules will be administered tid 15 minutes before each meal. gluten or gluten placebo capsules will be taken tid with each meal.

Eligibility criteria:
inclusion criteria: * male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months * anti-tissue transglutaminase (anti-ttg) ≤ 10 eu. * bmi between 18.5 and 38, inclusive. exclusion criteria * has chronic active gi disease other than celiac disease * has diabetes (type 1 or type 2). * unable to abstain from alcohol consumption or nsaid use for 48 hours prior to each intestinal permeability collection throughout the study. * has hemoglobin value below 8.5 g/dl

Keywords: larazotide acetate gluten
oat and cholesterol

Conditions: Elevated LDL Cholesterol

Summary: the primary objective is to assess the effect of an oat ingredient provided over 4 weeks on serum ldl cholesterol in men and women with elevated ldl-cholesterol compared to a placebo. secondary endpoints are fasting serum total- and hdl-cholesterol, non-hdl-cholesterol, triglycerides, glucose, insulin, glycated albumin, homa-ir and framingham risk score


Eligibility criteria:
inclusion criteria: 1. fasting ldl cholesterol 116-193 mg/dl (3-5 mmol/l) 2. males and non-pregnant, non-lactating females 18-65 years 3. agree to consume the investigational product three times daily for the duration of the study 4. bmi 18.5 to 39.9 kg/m2 5. blood pressure \<160/100 mmhg 6. fasting triglycerides \<4.0 mmol/l 7. fasting serum glucose \<126mg/dl (\<7 mmol/l) 8. serum urea and creatinine \< 1.8 times upper limit of normal (uln) 9. serum aspartate aminotransaminase (ast), alanine aminotransferase (alt) and gamma-glutamyl transferase (ggt) \< 2 times uln 10. hemoglobin \> 0.9 times lower limit of normal and \< 1.1 times uln 11. have a stable body weight (\<7 kg change) over the past 3-months 12. absence of health conditions that would prevent fulfillment of study requirements exclusion criteria: 1. pregnancy, breastfeeding or planning to be pregnant 2. allergy or sensitivity to study product ingredients 3. dislike description of study product 4. diet containing ≥15% of energy from saturated fat 5. consuming \>20g fiber/per 1000 kcal or \>40g fiber/day (including soluble fiber supplements) 6. consumption of more than 2 drinks of alcohol per day, or more than 14 drinks per week 7. extreme dietary habits 8. smoking \>5 cigarettes or equivalent per day 9. use of cholesterol lowering medication or prescription drug or for treating diabetes mellitus within 4 weeks of randomization 10. active major gastrointestinal disorder 11. major trauma or hospitalization for a medical condition or major surgical event within 6 months of randomization 12. history of cancer within two years or randomization, except for non-melanoma skin cancer 13. any condition or substance use which might, in the opinion of the pi, make participation dangerous for the participant, lead to poor attendance or compliance or affect the results

Keywords: beverage beta glucan fiber oat hypercholesterolemia ldl cholesterol
compared efficacy and tolerance of two vasopressors used to treat preoperative hypotension during carotid surgery

Conditions: Endovascular Carotid Surgery; Preoperative Hypotension

Summary: the effects on brain perfusion of the two currently vasopressors used to treat accidental hypotension occurring during carotid surgery (i.e. ephedrine and phenylephrine) is not known, but a disadvantage to use phenylephrine is suspected, due to its mechanism of action and according to published reports

this is a randomised trial comparing ephedrine and phenylephrine as used for accidental hypotension occurring during carotid surgery, on cerebral perfusion, assessed by near-infrared spectroscopy (nirs).

Eligibility criteria:
inclusion criteria: * age over 18 asa score i-iii planned carotid endarteriectomy under general anaesthesia hypotension defined as sap \< 90 mm hg during general anaesthesia informed consent to the trial protected by the french health welfare exclusion criteria: * emergency surgery cardiac arrythmia pregnancy or breastfeeding allergy to the tested treatment allergy to hydroxyethylstarch allergy to the glue of the nirs's electrodes current medication: maoi, intranasal vasopressors

Keywords: ephedrine phenylephrine vasopressor carotid surgery hypotension haemodynamics brain ischemia tissue perfusion stroke anaesthesia
development of an in vitro hematopoietic culture system and application to myelodysplastic syndromes.

Conditions: Hematopoietic Cell Proliferation; Myelodysplastic Syndromes

Summary: myelodysplastic syndromes (mds) are myeloid hemopathies characterized by ineffective clonal haematopoiesis, peripheral cytopenias and a predisposition to the occurrence of acute myeloid leukemias. their diagnosis involves a cytological evaluation of the medulla, while their prognosis, in addition to extrinsic factors depending on the patient himself (age, comorbidities), intrinsic factors. the cytological evaluation is subject to a certain subjectivity since qualitative and the diagnosis is sometimes difficult in the absence of marker of clonality. more and more studies emphasize the interest of flow cytometry (cmf) in the diagnosis of smd: by looking for qualitative and / or quantitative aberrations of the expression of membrane markers, cmf allows to establish scores diagnosis that we have put in place within the laboratory. however, these studies are based on a static model that studies the phenotypic characteristics of patients at a given time but does not really reflect ineffective hematopoiesis. a dynamic model for in vitro reproduction of hematopoiesis would be an innovative tool for the study of smd. this project aims to develop and standardize a system of differentiation in liquid medium of hematopoietic stem cells (csh) in mature cells by studying each stage of the differentiation in terms of proliferation, apoptosis and phenotypic expression. hscs will be obtained by cd34 + sorting from the medullary sample at diagnosis: the investigator will study cell proliferation, apoptosis and the acquisition of surface markers, in order to identify the quantitative and qualitative abnormalities associated with the differentiation of haematopoietic progenitors smart. this should make it possible to identify diagnostic and prognostic factors in terms of response to treatment, acutism and survival.


Eligibility criteria:
inclusion criteria: * patient with diagnosis, major ≥18 years * explained in the blood disease department for cytopenia (s) * for which diagnosis of myelodysplastic syndrome is considered * justifying a diagnostic bone marrow (myelogram) * having been informed of the progress of this study by the referring physician of the patient during the consultation and having expressed their non-opposition exclusion criteria: * high-grade myelodysplastic syndromes on ipss score (intermediate -2 or more) on preliminary cytological analysis * acute mesoblastic leukemia from the outset
the incretin effect in patients with chronic pancreatitis

Conditions: Chronic Pancreatitis; Type 2 Diabetes Mellitus

Summary: the phenomenon that oral glucose elicits a higher insulin response than does intravenous (iv) glucose, even at identical plasma glucose (pg) profiles (isoglycemia), is called the incretin effect. in type 2 diabetes mellitus (t2dm) the incretin effect has been shown to be markedly reduced or even abolished. it is not known whether the reduced incretin effect in t2dm is a primary event leading to t2dm or if it is merely a consequence of the diabetic state. to answer this question the investigators plan to estimate the incretin effect in 8 patients with secondary diabetes mellitus (dm) to chronic pancreatitis (cp) and compare it to the incretin effect of 8 patients with cp and normal glucose tolerance (ngt). eight patients with t2dm and 8 healthy control subjects are studied for comparison. the incretin effect is measured by a 50-g oral glucose tolerance test and an isoglycemic intravenous glucose infusion.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic pancreatitis with secondary diabetes mellitus * diagnosis of chronic pancreatitis with normal glucose tolerance * diagnosis of type 2 diabetes * normal level of hemoglobin * normal level of se-creatinine exclusion criteria: * gad-65 autoantibodies * ica autoantibodies * albuminuria
a study to assess safety of nivolumab in routine oncology practice in china

Conditions: Non-Small Cell Lung Cancer; Squamous Cell Carcinoma of Head and Neck

Summary: the purpose of this study is to assess the safety of nivolumab in routine cancer practice in china. part one of the study will investigate nivolumab for non-small cell lung cancer previously treated with platinum-based chemotherapy that has locally advanced or has spread. part two will investigate nivolumab for post-platinum squamous cell carcinoma of head and neck that is recurrent or has spread. part three will investigate nivolumab for locally advanced or metastatic non-small cell lung cancer. part four will investigate nivolumab for recurrent or metastatic squamous cell carcinoma of head and neck.


Eligibility criteria:
inclusion criteria: part 1 * histologically or cytologically confirmed diagnosis of locally advanced/metastatic non-small cell lung cancer (nsclc) participants * treatment with nivolumab per physician's prescription part 2 * histologically or cytologically confirmed diagnosis of recurrent/metastatic squamous cell carcinoma of head and neck (scchn) * treatment with nivolumab for recurrent or metastatic scchn part 3 * histologically or cytologically confirmed diagnosis of locally advanced/metastatic nsclc * participants with at least one dose of nivolumab administered since june 2018 part 4 * histologically or cytologically confirmed diagnosis of recurrent/metastatic scchn * participants with at least one dose of nivolumab administered since september 2019 exclusion criteria: * prior participation in a clinical trial within the past 4 weeks * current or pending participation in a clinical trial * current or pending systemic treatment for cancer other than nsclc for part 1 and scchn for part 2 * previously treated with immune checkpoint inhibitors for part 3 and part 4 * participants must not have any other concurrent primary tumor(s) for part 3 and part 4 other protocol-defined inclusion/exclusion criteria apply

Keywords: bms-936558 china nivolumab non-small cell lung cancer platinum-based chemotherapy postmarketing observational study squamous cell carcinoma of head and neck