Kornimate/medical-research-clean huggingface dataset:
a clinical trial to evaluate the effect of fimarsartan on pharmacodynamics, pharmacokinetics, and the safety of warfarin in healthy male volunteers

Conditions: Essential Hypertension

Summary: to evaluate the effect of fimarsartan on pharmacodynamics, pharmacokinetics, and the safety of warfarin in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * age: 20 - 40 years * sex: male * body weight: greater than 55 kg * written informed consent exclusion criteria: * known allergy to fimasartan and warfarin * existing cardiac or hematological diseases * existing hepatic and renal diseases * existing gastrointestinal diseases * acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder * positive drug or alcohol screening * smokers of 10 or more cigarettes per day 3 month ago * participation in a clinical trial during the last 2 months prior to the start of the study

Keywords: fimasartan drug interaction
study of impact of behavioral intervention- exercise, nutrition, education- on body mass index (bmi)

Conditions: Obesity

Summary: this study will evaluate the impact a behavioral intervention can have on bmi. the researchers anticipate the intervention group will experience a decrease in bmi of approximately five points. the intervention group will be compared to a control group. this is a long term, randomized, controlled study. the behavioral intervention is conducted during a four hour monthly session. the behavioral intervention includes: exercise, education on medical aspects and nutrition, and empowerment.

this is a long term randomized controlled trial, looking at the impact of a behavioral intervention on bmi,in participants ages 10-20 with a bmi \> 85%. the intervention group will: * have baseline and follow up blood work (fasting insulin, glucose, lipid panel) * have baseline and follow up bmi, blood pressure measurements * see a dietician-minimum of three visits during study * attend monthly, four hour sessions. these sessions include: 1. registration-monitoring of choices of liquid intake using standardized models, monitoring of sedentary behaviors-hours watching television, computer, video games, monitoring of heart rate at baseline and after exercise, monitoring of mets (metabolic equivalents), motivational interviewing, monitoring of exercise abilities (endurance, agility, curl ups, balance, power) 2. one hour of exercise (including strength training) 3. educational lectures on nutrition and the medical aspects of obesity and type 2 diabetes epidemic 4. projects/games 5. empowerment tools such as leading exercises and presenting food labels for discussion the control group will have: 1. baseline and follow up blood work (fasting insulin, glucose, lipid panel) 2. baseline and follow up bmi and blood pressure measurements 3. visits to dietician (minimum of three visits during study) 4. standard education on nutrition and exercise given during office visit with primary care doctor

Eligibility criteria:
inclusion criteria: * ages 10-20 years * bmi\>85% exclusion criteria: * endocrine disorder * on psychotropic medications

Keywords: bmi obesity behavioral intervention longterm randomized controlled trial exercise empowerment nutrition
continuous infusion of linezolid versus intermittent dosing in the treatment of nosocomial pneumonia

Conditions: Pneumonia

Summary: the investigator's goal in this study is to determine the clinical efficacy and safety of continuous infusion in comparison with standard intermittent infusion.

prospective randomized controlled clinical trial on critically ill pneumonic patients, included two groups, over one year period. the first group will be administered intravenous (iv) linezolid 600mg twice daily. the second group will be prescribed linezolid (iv) 600 mg loading dose followed by 1200 mg by continuous infusion. both groups will be co-administered intravenous (iv) meropenem 1g every 8 hours empirically.

Eligibility criteria:
inclusion criteria: * patients admitted to icus diagnosed as hap or vap * chest x-ray/ computed tomography showing new or progressive infiltrate. * new onset of purulent sputum or change in sputum character. * body temperature greater than 38 ℃ or less than 35.5℃. * white blood cell counts greater than 10000 /mm3 or less than 4000 /mm3. * significant quantitative pathogen cultures from respiratory secretions. exclusion criteria: * age \<18 years, pregnancy, lactation * previous known allergic reaction to linezolid * creatinine clearance (crcl) \<10 ml/min, calculated according to the cockcroft-gault formula * thrombocytopenia (platelet count less than 80,000/mm3) * severe hepatic failure (child-pugh c) * concomitant treatment with other drugs that can potentially interfere with linezolid (i.e., macrolides, serotonin modulators, omeprazole) * acute dic score \> 4 points or hematological disorder * concurrent drug-associated thrombocytopenia

Keywords: linezolid continuous infusion pneumonia critically ill patients
vitamin c & exercise induced bronchoconstriction (eib)

Conditions: Exercise-induced Bronchospasm

Summary: the purpose of this research is to assess the association between diet and pulmonary function during standardized eib testing. determine the effect of vitamin c supplementation on airway inflammatory markers and bronchoconstriction after a standardized eib test compared to usual diet and placebo control.

this study will use a double-blind, randomized, cross-over design with subjects serving as their own controls. this study will be conducted over a consecutive five-week period. all subjects will be asked to discontinue taking their short- and long-acting beta-agonist medication 12 and 24 hours respectively prior to data collection. also, all subjects will be asked to refrain from caffeine, physical activity, and nsaid use 24 hours prior to testing. in addition all subjects will be asked to abstain from taking any vitamin supplement during the course of the study.

Eligibility criteria:
inclusion criteria: * student or student-athlete who has tested positive for eib * able to communicate in english exclusion criteria: * forced expiratory volume in 1 second (fev1) \< 70% of predicted, cardiac history, * current respiratory infection * \> 10 pack year history of smoking * pregnancy.
registry of angiovac procedures in detail outcomes database-rapid registry

Conditions: Venous Thromboembolic Disease; Deep Venous Thrombosis; Right Heart Pathology; Pulmonary Embolism

Summary: venous thromboembolic disease is a significant cause of morbidity and mortality. the purpose of the rapid registry is to collect information on the angiovac procedure and angiovac device used in the treatment of deep venous thrombosis (dvt), right heart pathology and pulmonary embolism.

venous thromboembolic disease is a significant cause of morbidity and mortality. thrombolytic therapy has been shown to be a successful treatment modality, however its use is somewhat limited due to the known risk of hemorrhage (overall 22%, with up to 3% intracranial hemorrhage), and suggested risk of distal embolization where large mobile thrombi are encountered. in patients where either thrombolysis is contraindicated or unsuccessful and conventional therapies inadequate, bulk thrombectomy may be considered. until recently this was primarily achieved with surgical thrombectomy; however the angiovac device is posited to offer a minimally invasive alternative. this registry will collect data on patients in whom the angiovac device was placed into the body for management of inferior vena cava (ivc) clots, right atrial (ra) masses or pulmonary emboli (pe) will be included. this registry is to capture high quality patient safety and effectiveness data on use of the angiovac device for 3 separate, but overlapping conditions; a) iliofemoral and caval dvt, b) right heart masses, and c) pe. the goal will be achieved by capturing a concise set of immediate and short-term functional and clinical outcome data for all patients who have the angiovac catheter deployed into the vascular system. any center performing angiovac procedure and wishing to contribute patient data will be offered participation in the registry. these core sites will be required to submit the registry protocol for institutional review board (irb) review. once documentation of irb approval has been received, centers may transmit their data via secure redcap (research electronic data capture) database in accordance with federal regulations in the health insurance portability and accountability act (hipaa

Eligibility criteria:
inclusion criteria: * all patients in whom the angiovac device was placed into the body for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours. exclusion criteria: * angiovac device not deployed

Keywords: inferior vena cava (ivc) clots right atrial (ra) masses pulmonary emboli (pe)
prognostic assessment of contrast echocardiography (pace study)

Conditions: Coronary Artery Disease

Summary: this study will demonstrate whether patients with prognostically-significant myocardial abnormalities detected with ai-700 contrast echo have a rate of cardiac death or mi that is higher than that of patients with normal ai-700 contrast echo.

this observational study will investigate the ability of ai-700 contrast echo to predict risk of future cardiovascular events occurring in patients who had a recent history of chest pain at the time of echo evaluation. eligible patients were enrolled in either ai-700-32 or ai-700-33, which are completed phase 3 international, multicenter, open-label, dual-injection studies of the myocardial imaging capabilities and safety of ai-700 administered intravenously in patients with chest pain. in the course of these phase 3 studies, patients were evaluated with ai-700 contrast echo. in addition, eligible patients were to have had an evaluable pharmacologic stress-induced ai-700 echo assessment as part of ai-700-32 or ai-700-33.

Eligibility criteria:
eligible patients were enrolled in either ai-700-32 or ai-700-33.

Keywords: coronary artery disease echocardiography cardiac imaging heart disease ultrasound contrast agent prognosis
impact study (improving measurements of persistence on "actonel" treatment)

Conditions: Osteoporosis

Summary: the primary objective of this study is to assess the impact of physician's reinforcement using bone marker data on the subject's compliance (at least 50% drug taken) and persistence on treatment after one year in postmenopausal osteoporotic women.


Eligibility criteria:
inclusion criteria: * ambulatory women, * caucasian, oriental or multiracial * not previously diagnosed for osteoporosis. exclusion criteria: * females of black descent and for the us african american are excluded because of the very low incidence of postmenopausal osteoporosis * and having used oral or parenteral glucocorticoids (\>= 5 mg prednisone or equivalent per day) within 3 months of starting study drug or for more than one month within six months prior to study entry. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
shear-wave elastography diffuse liver disease

Conditions: Chronic Hepatic; Chronic Liver Disease and Cirrhosis

Summary: the aim of this study is to correlate between quantitative results of shear wave elastography and ct picture in diffuse liver disease, including liver cirrhosis.

many pathophysiological processes can lead to diffuse parenchymal liver diseases and the end-result of all chronic liver diseases is healing by fibrosis and regeneration. liver fibrosis is a slowly progressing disease in which healthy liver tissue is replaced with scar tissue ended with liver cirrhosis, with a variety of causes, including viral, drug induced, autoimmune, cholestatic, and metabolic diseases. liver biopsy is the gold standard but limited due to its invasiveness, sampling error, and intra- and interobserver variability. non-invasive tests are preferred in the management of chronic liver diseases. several serum tests for liver function and markers of liver fibrosis are available and have moderate sensitivity and specificity; however, they are confounded by a wide range of extra-hepatic diseases. currently, several methods are available for assessing hepatic fibrosis and progression of fibrogenesis including scintigraphy, magnetic resonance diffusion weighted imaging, and magnetic resonance spectroscopy could differentiate between cirrhosis or severe fibrosis and normal liver. however, an accurate staging of fibrosis or diagnosis of mild fibrosis was often not achievable. shear-wave elastography (swe) is a real-time freehand ultrasonography-based elastography method for liver stiffness measurement.

Eligibility criteria:
inclusion criteria: * both sexes are included: patients who diagnosed to had chronic liver diseases with or without present hepatic focal lesions. exclusion criteria: * lactating and pregnant women * patients known to had high serum creatinine
concurrent chemotherapy for elderly patients with locoregionally advanced nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: concurrent chemotherapy for elderly patients with locoregionally advanced nasopharyngeal carcinoma

to evaluate concurrent chemotherapy for elderly patients with locoregionally advanced nasopharyngeal carcinoma treated by intensity-modulated radiotherapy

Eligibility criteria:
inclusion criteria: * previously untreated and histologically confirmed locoregionally advanced nasopharyngeal carcinoma exclusion criteria: * a history of another invasive cancer, prior rt to the head and neck area, prior cytotoxic chemotherapy or anti-egfr therapy or the presence of any serious medical conditions,supposed to live less than 6 months.
adstiladrin early utilization and outcomes in the real world setting

Conditions: Bladder Cancer

Summary: multi-center, prospective non-interventional study to collect data on the early use of adstiladrin in the us and israel. data will be collected from patients and prescribing physicians in a real-world setting


Eligibility criteria:
inclusion criteria: * prescribed and scheduled treatment with adstiladrin per physician discretion or received the first instillation of adstiladrin per physician discretion after 5 september 2023 but prior to site activation * signed and dated icf. * age 18 years or older at day icf is signed. exclusion criteria: * currently enrolled in a clinical trial. * participants who have previously been treated with adstiladrin in the context of a clinical trial * participant is pregnant or breastfeeding.

Keywords: bladder cancer nmibc cis ta/t1 bcg unresponsive vesical instillation treatment
validation of international warfarin pharmacogenetics consortium (iwpc) algorithm in elderly patients with comorbidity

Conditions: Atrial Fibrillation; Thrombus Due to Heart Valve Prosthesis

Summary: the purpose of this study is to validate the international warfarin pharmacogenetics consortium (iwpc) algorithm in a prospective cohort of elderly people (65 years or older) with heart valves and/or nonvalvular atrial fibrillation (af) and at least one comorbid condition, and to assess the algorithm's prognostic relevance.


Eligibility criteria:
inclusion criteria: * age ≥ 65 years * patients who initiate warfarin because of non valvular atrial fibrillation or heart valve replacement * at least one comorbid condition * at least two other drugs regularly assumed over and above warfarin exclusion criteria: * presence of systemic coagulopathies * presence of malignancies needing chemotherapy * inability or refusal to give informed consent

Keywords: warfarin international warfarin pharmacogenetics consortium algorithm atrial fibrillation heart valve prosthesis implantation elderly comorbidity
healthy eating asd

Conditions: Food Selectivity

Summary: most studies which have addressed food selectivity among children with autism spectrum disorders have been conducted in either clinic or home settings. school-based research has been conducted to increase healthy eating, but this research was largely conducted with children without special needs or if children with special needs did participate, they were not identified. this study will focus on increasing consumption of fruits and vegetables among children with an autism spectrum disorder in a school setting.

food preference inventory: a survey of food preference and eating habits, developed by the experimenter, will be provided to the parents/guardians of prospective participants. the food preference inventory is anticipated to take between 10 and 20 mins to complete. the parent/guardian of the prospective participant is asked to return toe inventory to the school if 1) the parent/guardian gives permission for his/her child to participate and 2) if the child does not have a food allergy. general procedures: each day of the study (1-5 days per week), school staff will offer participants a small portion of a fruit or vegetable (about 1/8 cup) to eat during lunch time. the participant will have about 5 min to consume the item before it is recollected by school staff. baseline: the fruit or vegetable is presented with the participants lunch. eating the item produces no programmed consequences. single item presentation: the fruit or vegetable is presented before the participants lunch (about 5 min). eating the item produces no programmed consequences. single item presentation + modeling: the fruit or vegetable is presented before the participants lunch (about 5 min). school staff will model eating the food item. single item presentation + token economy: the fruit or vegetable is presented before the participants lunch (about 5 min). eating the item will produce a token (e.g., a sticker or hole punch). once the student collects a few tokens (e.g., 3-5), he/she can exchange the tokens for a small price (e.g., pencil or crayon). data collection: data will be collected by school staff. staff will record whether each participant consume the fruit or vegetable item. safety procedures: school staff will monitor lunch - as they typically do.

Eligibility criteria:
inclusion criteria: * participants will be students in a private school with a diagnosis of an autism spectrum disorder and between 6-14 years of age. exclusion criteria: * parents who report their children have food allergies of any kind will be excluded.
assessment with ccta and mri in asymptomatic patients with type 2 diabetes for detection of unrecognized myocardial scar in subclinical coronary atherosclerosis

Conditions: Type 2 Diabetes Mellitus; Coronary Atherosclerosis

Summary: the study aimed to prospectively investigate the prevalence of myocardial scar on dotarem-enhanced cardiovascular magnetic resonance imaging (mri) in asymptomatic patients with type-2 diabetes mellitus and to assess its correlation with subclinical coronary artery disease on cardiac computed tomography angiography (ccta).

patients underwent a cardiac mri examination with dotarem within 60 days after screening visit. the myocardial ccta examination with xenetix 350 was performed within 1 to 30 days (but no sooner than 24 hours) after the mri examination.

Eligibility criteria:
inclusion criteria: * patient with onset of type 2 diabetes occurred at age 30 years or older * patient between the ages of 50 and 75 years at enrolment time * patient with at least two identified cardiac risk factors who will undergo a cmr and a ccta examinations to evaluate his/her coronary and cardiac status exclusion criteria: * patient with angina pectoris or chest discomfort * patient with stress test or invasive coronary angiography within the prior 3 years * patient with history of myocardial infarction, overt non compensated heart failure, or coronary revascularization * patient with hemodynamic instability. * patient with a contraindication or intolerance to beta-blocker administration
wechat intervention for smartphone addiction in college students: a randomized trial

Conditions: Smartphone Addiction

Summary: the goal of this clinical trial is to assess the effectiveness of an intervention based on the information-motivation-behavioral skills (imb) model to treat smartphone addiction in college students. the main questions it aims to answer are: does the imb model-based intervention via wechat public accounts significantly reduce smartphone addiction scores compared to a control group? does the intervention lead to an increase in motivation and behavioral skills scores among participants? researchers will compare the intervention group, which receives imb-enhanced content through wechat public accounts, to the control group, which maintains regular activities, to see if there are significant improvements in addiction scores, motivation, and behavioral skills in the intervention group. participants will: be stratified by gender and randomly assigned to either the intervention or control group. the intervention group will receive information, motivation, and behavioral skills enhancement via wechat public accounts over a period of 6 weeks. both groups will be assessed for smartphone addiction scores, information-motivation-behavioral skills scores, average daily smartphone use time, sleep duration, sleep quality, and somatic and psychological symptoms before and after the intervention.


Eligibility criteria:
inclusion criteria: meeting the criteria of the smartphone addiction scale-short version (sas-sv), with a score of ≥31 for males and ≥33 for females indicating smartphone addiction. college students over 18 years old. active use of wechat software. voluntary participation in this study and signing of the informed consent form. exclusion criteria: currently not enrolled in school due to reasons such as suspension. currently participating in other research projects. self-reported diagnosis of any neurological or psychiatric disorder.

Keywords: smartphone addiction behavior change information-motivation-behavioral skills model
dr registry: prospective observational study of adhf patients with insufficient response to diuretics

Conditions: Acute Decompensated Heart Failure

Summary: the study objective is to observe and measure clinical outcomes, urine output, and safety events occurring during standard medical treatment of adhf patients deemed to have insufficient diuretic response.


Eligibility criteria:
inclusion criteria: 1. subject is \>18 and \< 85 years of age. 2. subject is hospitalized with primary diagnosis of adhf. 3. n-terminal-pro-brain natriuretic peptide (nt-probnp) ≥1,600 pg/m or bnp≥400 pg/ml. 4. evidence of fluid overload as indicated by 2 or more of the following criteria: 1. peripheral edema ≥ 2+ 2. radiographic pulmonary edema or pleural effusion 3. enlarged liver or ascites 4. pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea 5. jugular venous distention \> 7 cmh2o 5. subject insufficiently responds to iv diuretic therapy exclusion criteria: 1. systolic blood pressure \<90 mmhg at the time of screening. 2. acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleural synthesis within past 7 days or cardiovascular intervention within past 4 days. 3. known lvef \< 15% by echocardiography within 1 year prior to enrolment. 4. complex congenital heart disease (e.g., tetralogy of fallot subjects, single ventricle physiology). 5. known active myocarditis, hypertrophic obstructive cardiomyopathy, constrictive pericarditis or cardiac tamponade. 6. severe aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \\severe regurgitation) or severe mitral disease with planned intervention. 7. evidence of active systemic infection documented by either one of the following: fever \>38°c/100°f, or ongoing uncontrolled infection (i.e., inflammatory parameters not decreasing despite \> 48 hours of antibiotic treatment). 8. moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.

Keywords: adhf