Kornimate/medical-research-clean huggingface dataset:
controlled study to evaluate the efficacy and safety of racecadotril in infants, children and adolescents with acute diarrhea

Conditions: Diarrhea

Summary: multicenter, open-label, controlled, randomized clinical study to evaluate the efficacy and safety of racecadotril in infants, children and adolescents with acute diarrhea


Eligibility criteria:
inclusion criteria: * signed informed consent from one of the parent(s)/caregiver(s) or subject informed assent * children and adolescents, both genders, age from 3 months to \< 18 years of age * confirmed diagnosis of acute diarrhea (defined as the passage of three or more unformed or liquid stools within the last 24 hours and lasting for less than three days) * females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection, an intrauterine device, or an oral contraceptive taken within the past three months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide exclusion criteria: * known allergy to racecadotril or any of its ingredients * subjects suffering from renal or hepatic impairment * subjects who need treatment for diarrhea other than ors alone * subjects with fever \> 39 degrees celsius * subjects with bloody and/or purulent stools * subjects suffering from antibiotic-associated diarrhea, chronic diarrhea or iatrogenic diarrhea * subjects with alternating bouts of diarrhea and constipation * diarrhea due to exacerbation of chronic gastrointestinal diseases such as irritable bowel syndrome, inflammatory bowel disease or pancreatic exocrine insufficiency * cystic fibrosis or coeliac disease * subjects suffering from prolonged or uncontrolled vomiting * subjects with rare hereditary problems of fructose or galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption syndrome or sucrase isomaltase insufficiency or primary or secondary lactase insufficiency * subjects having received antibiotic treatment at any time within 30 days prior to inclusion into the study * subjects having received antidiarrheal drugs 48 hours prior to inclusion into the study * subjects with severe dehydration required for intravenous/parenteral rehydration * subjects who have reported angioedema with angiotensin converting enzyme inhibitors (such as captopril, enalapril, lisinopril, perindopril, ramipril) * subjects with combined diseases or medical situations that would prevent to be enrolled depending in the judgment of the investigator * intake of experimental drug within 30 days prior to study start * subjects with contraindications to ors or for whom warnings/precautions of ors apply * adolescents (≥ 60 kg) not able to swallow capsules * pregnancy and lactation
relationship between glycemic control and irisin in type 2 diabetic patients with sarcopenic or non-sarcopenic obesity

Conditions: Sarcopenia; Obesity; Diabetes Mellitus, Type 2

Summary: the goal of this observational study is to compare glycemic control and irisin levels in subjects with diabetes mellitus type 2 with sarcopenic obesity vs non-sarcopenic obesity. the main questions it aims to answer are: is glycemic control worse in diabetic patients with sarcopenic obesity? are irisin levels higher in patients with non-sarcopenic obesity? participants will be asked to: * fill in three questionaries on lifestyle * perform two physical performance tests the investigators will collect the following data: * anthropometric measurements * body composition by bioelectrical impedance analysis. * results of routine blood analyses * irisin levels by drawing a vial of blood from the antecubital vein

patients will be enrolled from our diabetology center. eligible patients will be contacted by phone to be informed of the procedures and to schedule the visit. the patients will come to the visit bringing the blood analyses they usually bring for the routine diabetologic visit; they will also be fasting for at least 3 hours, and abstaining from smoking and physical activity since the day before. all visits will be performed in the afternoon, at about 4-6 p.m. participants will be asked to: * fill in three questionaries (sarc-f \[strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire\], ipaq-eit \[international physical activity questionnaire validated in the elderly italian population\], medi-lite \[adherence to the mediterranean diet questionnaire\]) * perform two physical performance tests (5-times chair stand test and handgrip test). anthropometric measurements will be assessed; body composition will be evaluated by bioelectrical impedance analysis. a venous blood draw will be executed for evaluation of irisin levels after signing a written consent form.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 diagnosed less than 10 years before * age \>60 years * bmi (body mass index) \>30 kg/m2 * egfr (estimated glomerular filtration rate) \>30 ml/min * on stable antidiabetic therapy for at least 3 months exclusion criteria: * insulin or insulin secretagogues use * diabetes mellitus type 1, previous diabetic ketoacidosis * neuromuscular diseases * endocrinopathies that may cause myopathies (hypercortisolism, gh \[growth hormone\] deficiency, acromegaly, adrenal insufficiency, partial hypopituitarism or panhypopituitarism, male hypogonadism, hyperparathyroidism, hypoparathyroidism) * severe vit. d deficiency (\<12 ng/ml) * hemoglobinopathies * prolonged immobilization * pathologies with fluid retention (heart failure with nyha \[new york heart association\] class iii/iv, severe renal insufficiency, hepatic insufficiency) * active tumors in the past 5 years * severe arthritis of the knee or hip * pacemaker wearer

Keywords: irisin protein hand strength [e01.370.600.425.500] glycated hemoglobin [d23.946.381.625.500.250]
the role of fetal ductus arteriosus in predicting spontaneous preterm birth

Conditions: Ductus Arteriosus

Summary: preterm birth still remains a major cause of perinatal morbidity and mortality worldwide. the exact mechanism stimulating term and preterm births in humans is still unknown. prostaglandins, by mediating cervical ripening and early stimulation of myometrial contractions, are likely to play a major role in the parturition process. much of the unique fetal circulation is facilitated by the ductus arteriosus. patency of the ductus arteriosus in utero is primarily maintained via prostaglandins which are highly expressed by smooth muscle cells located in the media of the ductus arteriosus. the primary objective of this study is to prospectively assess whether any changes in the fetal ductus arteriosus parameters exist at 32 weeks' gestation. the secondary objective is to investigate whether there is an association between the ductus arteriosus parameters and the time to delivery interval at 32 weeks' gestation.

the rationale is to assess whether physiological responses that occur around the time of delivery, in both the mother and the fetus (elevated prostaglandins level), can be quantified using ultrasound of the fetal ductus arteriosus. whether or not the ductus arteriosus plays an active physiological role in the initiation of parturition is unknown. since prostaglandins are physiologically highly expressed within the fetal ductus arteriosus and also linked to some critical steps throughout parturition, it is hypothesized that structural and doppler flow pattern variations of the ductus arteriosus exist in the period surrounding the birth. these changes might occur before or after the intrinsic rise of prostaglandins and could be quantified using prenatal ultrasound of the fetal ductus arteriosus. identifying new physiological based variables that can assist in predicting the onset of labour, especially surrounding preterm birth, as the one suggested in the current study, is thus of great importance and may provide invaluable information into the overall future care and decision making during pregnancy, especially around the time of delivery. it may assist in creating future recommendations for pregnant women and improved healthcare standards during the delivery process.

Eligibility criteria:
inclusion criteria: * low risk singleton pregnancy at 32 weeks gestation. exclusion criteria: * smoking * underlying cardiac or respiratory illness * fetal growth restriction * medicated gestational hypertension or evolving preeclampsia * gestational diabetes controlled with insulin or oral medications * use of steroids for lung maturation in the current pregnancy * known major congenital anomalies.
a pilot study for the determination of allergenicity of cat dander samples obtained by different methods

Conditions: Cat Dander Allergy

Summary: measurement of skin reactivity of cat dander samples obtained by different methods. subjects will be assessed for the study by of a conventional skin prick test with a positive (histamine), a positive (standardized cat dander extract) and a negative allergen control (a diluent) if they fulfil all other in- and exclusion criteria, too. a screening prick test will be performed in order to confirm positivity (cat dander allergy). a scratch test will be performed in participants after a positive screening prick test, in order to measure skin reactivity to cat dander, originating of three different body areas of the cat. for this purpose, a small amount of cat fur in solution with distilled water will be placed onto the volar aspect of both forearms after the skin has been scratched with a scratch lancet. the distilled water in which the cat hair was solved before will serve as negative control. this procedure will be repeated with fur of the three different areas of the cat, always using triplicates (nine samples per cat). from each of the 20 cats, nine samples will be tested on 20 subjects (one cat/subject).


Eligibility criteria:
inclusion criteria: * written informed consent * male or female between 18 years to 65 years * a positive clinical history with inhalant allergy presumably due to cat allergen. * positive screening prick test (mean wheal diameter ≥ 3 mm) when tested with already standardized cat allergen extract. * positive screening prick test (wheal diameter ≥ 3mm) to histamine dihydrochloride 10mg/ml. exclusion criteria: * impaired in understanding the nature, meaning and scope of the study or incapable of giving written informed consent, * participation in another clinical trial within the last 30 days and during the present study, * pregnant or lactating women, * positive skin reaction in the screening prick test to negative control, * currently suffering from allergy symptoms, * history of systemic reactions to allergens, * severe diseases influencing the results of the present study by discretion of the investigator, * immunotherapy with the allergen preparation during the past two years, * skin lesions and excessive hair-growth in the skin test areas, * treatment with prohibited concomitant medications according to section 9.3 (protocol) with the exception of medications with local effects which will not influence the results of the skin tests, * alcohol or drug abuse.
optimizing the diagnosis of heparin induced thrombocytopenia

Conditions: Heparin-induced Thrombocytopenia (HIT)

Summary: multicentre (ottawa and halifax) prospective cohort study using a diagnostic approach in patients clinically suspected to have hit that combines pretest probability assessment with quantitative interpretation of anti-pf4 assay.

the proposed is a prospective cohort study exploring a novel diagnostic approach to heparin induced thrombocytopenia (hit) using a combination of pretest probability assessment and quantitative interpretation of the anti-platelet factor 4 immunological assay (anti-pf4). patient with a clinical suspicion of hit will follow the study diagnostic algorithm (figure 1). the study algorithm will be considered a safe approach to move forward into a larger rct if the upper limit of the 95% confidence interval for 'false negative management failures' is ≤ 4% based on a serotonin release assay (sra) gold standard. the main objective of the pilot study is to inform feasibility and recruitment barriers for a larger randomized control trial.

Eligibility criteria:
inclusion criteria: * patient with clinical suspicion of hit by treating physician exclusion criteria: 1. less than 18 years of age; 2. prior diagnosis of hit ever; 3. patient enrolled within preceding 100 days; 4. functional/ confirmatory platelet activation results available at the time of enrollment; 5. requiring cardio-pulmonary bypass or percutaneous cardiac angioplasty or any other cardiac or vascular surgery/procedure requiring intra-operative/procedural heparin administration planned within 30 days; 6. unable to complete study follow up; 7. unable to obtain consent (or proxy consent from substitute decision maker where applicable); 8. life expectancy less than 30 days; 9. greater than 72 hours from clinical suspicion of hit and/or request for hit anti-pf4 elisa testing.
efficacy of ipragliflozin compared with sitagliptin in uncontrolled type 2 diabetes with sulfonylurea and metformin

Conditions: Type 2 Diabetes Mellitus

Summary: the objectives of this study are 1) to compare the effect of ipragliflozin 50 mg on glucose-lowering effect with sitagliptin 100 mg in patients with type 2 diabetes mellitus, whose hba1c level is ≥ 7.5% with sulfonylurea and metformin, 2) to investigate changes of other metabolic and cardiovascular risk factors such as triglyceride, hdl-cholesterol, uric acid, blood pressure, and inflammatory markers, 3) to examine changes of body composition including fat and muscle mass with volume status.

the objectives of this study are to compare the effect of 50mg of ipragliflozin, a sglt2 inhibitor, on glucose-lowering effect with 100mg of sitagliptin, a dpp4 inhibitor in patients with type 2 diabetes mellitus, whose hba1c level is ≥ 7.5% with sulfonylurea and metformin. we are also going to investigate changes of other metabolic and cardiovascular risk factors such as triglyceride, hdl-cholesterol, uric acid, blood pressure, and inflammatory markers. changes of body composition including fat and muscle mass with volume status will be also examined.

Eligibility criteria:
inclusion criteria: * type 2 diabetes with hba1c 7.5% - 9.0% at screening visit * male or female between 20 and 75 years of age * patients taking sulfonylurea (glimepiride 1\~8mg or gliclazide 30\~120 mg or equivalent dose) and metformin (≥ 1000 mg or maximum tolerated dose) for more than 3 months * bmi ≥23 kg/m² * estimated gfr ≥ 60 ml/min/1.73m² * women of child bearing potential must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose and must have a negative urinary pregnancy test. exclusion criteria: * type 1 diabetes, gestational diabetes, or diabetes with secondary cause * patients with acute coronary syndrome within 3 months prior to screening visit * patients with acute coronary syndrome within 3 months prior to screening visit * pregnant or breastfeeding women or reproductive-age women who refuse contraception * chronic hepatitis b or c (except healthy carrier of hbv), liver disease (ast/alt \> 3-fold the upper limit of normal) * cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ * other clinical trials within 30 days * alcohol abuse * contraindication to sglt2 inhibitors or dipeptidyl-peptidase 4 inhibitors * taking insulin, oral hypoglycemic agents other than metformin, sulfonylurea, and the study drugs.

Keywords: ipragliflozin sitagliptin
patient recall after orthopedic trauma

Conditions: Education After Trauma

Summary: the purpose of this study is to evaluate whether receiving education after trauma surgeries affects three things: 1) knowledge about injury and treatment ("recall"), 2) how well patients follow treatment recommendations, and 3) how satisfied patients are with their care. to do so, some participants in this study will receive education, and some will not.


Eligibility criteria:
inclusion criteria: * isolated open or closed fracture of the pelvis and/or lower extremity treated surgically exclusion criteria: * patient receiving orthopedic care or follow-up at another institution * non-english speaking * incarcerated (or likely impending incarceration) * currently enrolled in a study that does not permit co-enrollment * traumatic brain injury, dementia, or other cognitive impairment
pilot study of an internet-based program for prevention and early intervention of adolescent depression

Conditions: Depression

Summary: major depression is a highly prevalent and severe mental disease that negatively alters the lives of people, their families, and their social environment. organizations that promote mental health policies have recognized the potential of new information technologies for the prevention and treatment of mental disorders. in this direction, information and communication technologies (icts) generate opportunities for increasing patient well-being through the use of on-line software. such programs often include interactivity, self-monitoring, information materials (sometimes in multimedia format), and exercises on problem solving, recognition and challenging of dysfunctional thoughts, scheduling of activities, behavioral experiments, and other psycho-educational activities. in colombia, there are few preventive mental health interventions scientifically oriented and seeking to demonstrate efficacy in context. the purpose of this study is to determine whether an internet-based program is effective to prevent and to intervene early the depression in adolescents between 11 and 20 years of age in 2 schools in the antioquia region, colombia.


Eligibility criteria:
inclusion criteria: * adolescents who study in schools in antioquia from sixth grade to tenth grade, who can access the internet and a psychological service in case of moderate or severe depressive symptoms. exclusion criteria: * high suicide risk defined by: a score equal to or greater than 2 in the question 9 of the phq-9a, an adolescent who is undergoing treatment with antidepressants and / or currently attends psychotherapy

Keywords: depression in adolescents mental health e-mental health prevention and early intervention
a retrospective analysis of restasis® benefits in dry eye contact lens patients

Conditions: Dry Eye Syndrome

Summary: a retrospective analysis of restasis® benefits in dry eye contact lens patients.

charts of contact lens wearers with diagnosed dry eye who are being treated with restasis will be evaluated to determine success in treatment by retrospectively looking at various outcome measures including but not limited to schirmer, staining and osmolarity levels

Eligibility criteria:
inclusion criteria: * male or female, \> or = 18 years of age * subject was previously diagnosed (prior to baseline visit) with mild to severe dry eye disease (itf level 1, 2 or 3) which required continuous medical therapy with restasis® for a minimum duration of 6 months post-baseline (visit 1); or subject was newly diagnosed (at baseline visit) with mild to severe dry eye disease (itf level 1, 2 or 3) which required continuous medical therapy with restasis® for a minimum duration of 6 months post-baseline (visit 1); * subject was prescribed restasis® therapy at baseline visit (visit 1) and commenced dosing immediately after baseline visit (visit 1) * baseline visit occured between 01 july 2012 and 01 january 2014; * subject had corneal staining and at least one dry eye sign (i.e., schirmer's test score \ 310 mosmol/l * subject had charted tolerability and efficacy data reflecting at least one follow-up visit following restasis® treatment initiation; and * subject wore contact lens(es) concurrently while receiving restasis® treatment for a minimum duration of 6 months post-baseline (visit 1) exclusion criteria: -

Keywords: dry eye
reuse of polyp traps, a way to approach sustainability

Conditions: Cross Infection

Summary: the environmental impact of healthcare practice in the context of climate change is in the spotlight. digestive endoscopy units are the third hospital unit that generates the most waste and environmental impact. for this reason, scientific societies advice studying and adopting more sustainable clinical practices, reconsidering current protocols for reprocessing and disinfection of single-use material. one of the devices, widely used and which generates a large amount of waste, is the polyp trap. it allows an easy recovery of the polyps removed during endoscopy. this device is discarded after a single use in some centers, and reused after washing and disinfection in others. manufacturers recommend the single-use of the device, even there is no scientific evidence to support this action. in the investigators endoscopy unit, 3800 polyp traps are used yearly. the investigators hypothesis is that reusing the polyp catcher has similar safety to disposal after a single use, with better environmental and economic results. objectives: to evaluate the safety of the reused and discarded after a single-use polyp trap. the investigators will assess 1) the post-colonoscopy infection rate and 2) the reliability of the anatomopathological study, 3) co2 emissions and 4) costs of each practice. methodology: a non-inferiority study will be carried out by observing the usual clinical practice of different centers and collecting data that suggest infection, cross-sampling and general complications. the results will be easily applicable in endoscopy units and will serve as a basis for future studies with other more controversial devices.


Eligibility criteria:
inclusion criteria: * all patients who undergo an elective colonoscopy will be recruited for the study. * written informed consent to participate in the study and willingness to be contacted by telephone for follow-up. exclusion criteria: * patients who complete the colonoscopy without a polypectomy. * patients who complete the colonoscopy without the use of a polyp trap.