Kornimate/medical-research-clean huggingface dataset:
safety and vascular remodelling after bvs implantation for stenotic or occluded lesions in children and young adults with kd.

Conditions: Kawasaki Disease

Summary: to investigate the safety and long-term vascular remodeling after bioresorbable vascular scaffold (bvs) implantation for stenotic or occluded lesion in children or young adults with kawasaki disease (kd). background: kd occurs worldwide, most prevalent in japan and east asian countries. coronary artery lesion is the predominant determinant of kd outcome in the long-term. children with kd with aneurysms at least 6 mm in maximal diameter had a greater than 50% chance of developing a clinically significant stenotic lesion during follow-up. they are at risk of myocardial infarction-related sudden death or congestive heart failure as young adults. bypass surgery could be the reasonable strategy but the long-term patency of the graft remains unsatisfactory. percutaneous angioplasty with drug-eluting stents (des) implantation is the alternative. however, metallic stenting remains problematic in several aspects mainly due to the restriction of vessel expansive remodeling. the novel bvs has the potential to be free from the limitation due to scaffold degradation.

we will conduct a single-center, single-group prospective study with safety and imaging endpoints. a total of 10 kd children or young adults with indication of revascularization are enrolled, and bvs will be implanted for stenotic or occluded lesions. qca and optical coherence tomography (oct) are used to evaluate the baseline lumen area, plaque characteristics, and bvs expansion or eccentricity after deployment. at 12 months, scaffold restenosis is evaluated by multislice computed tomography. at 30 months, patients will receive follow-up by angiography and oct to evaluate lumen area, neoplaque characteristics, and side branch conditions. otherwise, the composite endpoint including cardiac death, myocardial infarction, and ischaemia-driven target lesion revascularisation are assessed at 30 days, 6 and 9 months, and 1, 2, 3 years.

Eligibility criteria:
inclusion criteria: 1. in the single-group prospective study with safety and imaging endpoints, a total of 10 kd patients \< 18 years will be enrolled. 2. the diagnosis of kd was made based on clinical criteria for kd. exclusion criteria: patients presenting with an acute myocardial infarction or unstable arrhythmias, or those who has severe left ventricular dysfunction (ejection fraction less than 35%), intrastent restenotic lesions, lesions located in the left main coronary artery, and tight lesions which could not be well dilated even after rotational atherectomy are excluded. those with chronic renal insufficiency (creatinine \>1.5 mg/dl) are also excluded due to the limitation of oct (optical coherence tomography) use.

Keywords: kawasaki disease optical coherence tomography multislice computed tomography
a study of taspoglutide versus sitagliptin for the treatment of patients with type 2 diabetes mellitus inadequately controlled with metformin.

Conditions: Diabetes Mellitus Type 2

Summary: this 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. after 24 weeks of treatment, patients on active treatment will continue on the same treatment and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). the anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age; * type 2 diabetes receiving metformin (\>=1500mg/day) for at least 12 weeks; * hba1c \>=7.0% and \<=10.0% at screening; * bmi \>=25 (\>23 for asians) and \<=45kg/m2 at screening; * stable weight +/- 5% for at least 12 weeks prior to screening. exclusion criteria: * history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months; * evidence of clinically significant diabetic complications; * clinically symptomatic gastrointestinal disease; * myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months; * known hemoglobinopathy or chronic anemia.
electroacupuncture on post-stroke urinary retention

Conditions: Urinary Retention; Stroke, Complication

Summary: this study aimed to evaluate the effectiveness of adjuvant electroacupuncture therapy for the post-stroke patients with urinary retention under conventional treatments, compared with sham electroacupuncture.


Eligibility criteria:
inclusion criteria: * male or female aged over 19 * patients diagnosed with stroke (cerebral hemorrhage or infarction) based on the ct or mri examination * those whose onset is within 2 years * those who have urinary retention after stroke onset (every pvr result is equal or more than 100ml on the 2 consecutive tests) * those who signed on the informed consent form exclusion criteria: * patients who have any bleeding disorders based on medical history hearing * patients who have ever had any medical procedures or surgeries for peripheral vascular diseases based on medical history hearing * patients who have any psychiatry disorders based on medical history hearing * patients who have any severe diseases in lower urinary tract symptom based on medical history hearing * patients who have any acute or chronic infectious diseases in lower urinary tract symptom based on medical history hearing * acute stage stroke patients (onset within 1 week) whose glasgow coma scale ≤ 8 * patients who have fear about acupuncture * patients who have changed medications for urinary retention or relevant symptoms, such as urinary incontinence drugs or diuretics, within 3 days * female who diagnosed with pregnancy by urinalysis * those who primary or sub investigators judge not to be suitable for the study

Keywords: urinary retention poststroke electroacupuncture randomized controlled trial effectiveness safety
isotonic solutions and major adverse renal events trial in the medical intensive care unit

Conditions: Critical Illness; Acute Kidney Injury

Summary: the administration of intravenous fluids is ubiquitous in the care of the critically ill. commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. recent studies have associated solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased mortality but no large, randomized-controlled trials have been conducted. smart-med will be a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the medical icu at vanderbilt university from june 2015 until april 2017. the primary endpoint will be the incidence of major adverse kidney events in 30 days after enrollment (make30 is the composite of death, new renal replacement, or persistent renal dysfunction at discharge).

smart-med is a large, cluster-randomized, multiple-crossover trial of 0.9% saline versus physiologically-balanced isotonic crystalloids (lactated ringers or plasma-lyte© a) with regard to the incidence of major adverse kidney events by 30 days in patients admitted to the medical intensive care unit. between june 2015 and april 2017, all patients admitted to the medical intensive care unit at vanderbilt university medical center who are 18 years or older will be enrolled. the study will occur in one-month blocks. the icu will be randomized to an initial fluid group (0.9% saline or physiologically balanced crystalloids). the assigned fluid will be used exclusively for all patients receiving isotonic crystalloid for the duration of the month-long block (except in the presence of pre-specified contraindications). the assigned study fluid will switch at the end of each month-long block such that half of the months are assigned to 0.9% saline and half of the months are assigned to physiologically balance fluid. it is anticipated that around 5,300 patients will be enrolled from the medical icu during the study period. all aspects of study design, intervention, and data collection will be harmonized with an independent study addressing the same question in the non-medical intensive care units at vanderbilt university during a similar study period (smart-surg). a pre-specified data analysis plan will dictate the harmonized analysis of smart-med and smart-surg.

Eligibility criteria:
inclusion criteria: * admitted to the medical intensive care unit (icu) at vanderbilt university medical center exclusion criteria: * age\<18 years old

Keywords: crystalloid acute kidney injury
"effects of balloon-blowing exercises with abdominal & lumbar core muscle activation position among smokers"

Conditions: Smoking

Summary: the principle function of the lungs is the facilitation of the gaseous exchange, commonly referred as respiratory or breathing. cigarette smoking has detrimental effects on nearly every organ in the body, leading to a higher incidence of diseases and contributing to a gradual deterioration of the smoker's health.cigarette smoking has detrimental effects on nearly every organ in the body, leading to a higher incidence of diseases and contributing to a gradual deterioration of the smoker's health. cigarette smoking is linked to mild airway obstruction and a deceleration in the growth of lung function.performing balloon-blowing exercises with abdominal and lumbar core muscles activation position leads to an improvement on pulmonary function and quality of life in smokers.

cigarette smoking has detrimental effects on nearly every organ in the body, leading to a higher incidence of diseases and contributing to a gradual deterioration of the smoker's health, including a progressive impairment of lung function. cigarette smoking is linked to mild airway obstruction and a deceleration in the growth of lung function. smokers may experience inflammation and narrowing of their airways, resulting in increased resistance to the outward flow of air during exhalation. this restriction in airflow can negatively impact respiratory parameters, exercise tolerance, and overall quality of life. performing balloon-blowing exercises with abdominal and lumbar core muscles activation position leads to an improvement on pulmonary function and quality of life in smokers.

Eligibility criteria:
inclusion criteria: * adults: aged (25-59 years) * gender: both males and females * grade1- grade 4 on modified mrc dyspnea scale * copd classes (mild, moderate ) according to gold copd guidelines * participating voluntarily and follow the instructions \& performing * the number of packs of cigarettes smoked per day by the number of years the person has smoked. 1. pack yr = 20 cig/day x 1 yrs 2. pack yr = 20 cig/day x 2 yrs exclusion criteria: * severe cases of obstruction like severe asthma \& status asthmaticus, severe copd, bullous emphysema for pneumothorax. * any congenital deformities of chest wall, demonstrated neuromuscular or neurological deficit/disease of chest wall * other serious cardiopulmonary diseases including pulmonary embolism, pulmonary ----hypertension, active tb, pneumonias or other acute illnesses * any recent cardiothoracic or abdominal surgery, trauma or injury * pregnancy * any psychiatric illnesses

Keywords: dysnea cigarette smoking spirometry quality of life
a cohort study on anti-microbial stewardship in picu

Conditions: Infections

Summary: appropriate antimicrobial therapy is essential to ensuring positive patient outcomes. inappropriate or suboptimal utilization of antibiotics can lead to increased length of stay, multidrug-resistant infections, and mortality. critically ill intensive care patients are at risk of antibiotic failure and secondary infections associated with incorrect antibiotic use. initiating effective therapy for infections based upon patients' risk factors, collection of appropriate cultures, daily evaluation of clinical status, and laboratory data, including antibiotic time outs, and shortened duration of therapy are ways to improve patients outcomes. antimicrobial stewardship teams can assist icu providers in managing and implementing these tactics. icus would benefit from employing empiric guidelines for antibiotic use, collecting appropriate specimens and implementing molecular diagnostics, optimizing the dosing of antibiotics, and reducing the duration of total therapy.

appropriate antimicrobial therapy is essential to ensuring positive patient outcomes. inappropriate or suboptimal utilization of antibiotics can lead to increased length of stay, multidrug-resistant infections, and mortality. critically ill intensive care patients are at risk of antibiotic failure and secondary infections associated with incorrect antibiotic use. initiating effective therapy for infections based upon patients' risk factors, collection of appropriate cultures, daily evaluation of clinical status, and laboratory data, including antibiotic time outs, and shortened duration of therapy are ways to improve patients outcomes. antimicrobial stewardship teams can assist icu providers in managing and implementing these tactics. icus would benefit from employing empiric guidelines for antibiotic use, collecting appropriate specimens and implementing molecular diagnostics, optimizing the dosing of antibiotics, and reducing the duration of total therapy. this study conducted an antibiotic management cohort study in picus to discover the distribution of nosocomial infections in picus and to find controllable factors for the occurrence of nosocomial infections.

Eligibility criteria:
inclusion criteria: * patients admitted to the icu for more than 48 hour exclusion criteria: * patients admitted to icu less than 48 hours
accelerated resolution therapy (art) for psychological trauma

Conditions: Psychological Trauma; PTSD

Summary: service members and veterans often experience symptoms of psychological trauma following combat deployments. while efforts are being made in the military and at the veteran's affairs to meet the large number of soldiers and veterans experiencing symptoms of psychological trauma, there remains a need to evaluate new treatments, particularly those that are designed to be brief in length. a new therapy, known as accelerated resolution therapy (art), is a type of psychological therapy that is designed for rapid resolution of symptoms of psychological trauma. this approach uses a combination of talking and sets of eye movements guided by the therapist. during therapy, this interactive personal guidance is thought to be helpful in resolving problems (such as bad memories). the purpose of this study is to: 1. evaluate how effective art is in treating symptoms of psychological trauma among non-active duty veterans who served in operation iraqi freedom and operation enduring freedom in iraq and in afghanistan or other combat conflicts. 2. learn if there is improvement in symptoms of psychological trauma (such as bad memories, anxiety, depression, and guilt) after receiving accelerated resolution therapy (art).


Eligibility criteria:
inclusion criteria: * non-active duty u.s. veteran of any prior deployment(s) with recruitment emphasis on those who previously served in iraq and/or afghanistan (oif and oef). * at least 18 years of age. * symptoms indicative of psychological trauma. this includes a score of \>40 on the pcl-m checklist, or in the absence of a score \>40, therapist assessment of symptoms of ptsd, as determined from the checklist for accelerated resolution therapy (art) standard protocol. individuals with previous treatment for psychological trauma, yet with residual symptoms, will be eligible. * ability to read and speak english to complete survey questions. * denial of suicidal ideation or intent, including homicidal ideation or intent, and no evidence of psychotic behavior or being in psychological crisis exclusion criteria: * brain injury prohibiting speech, writing, and purposeful actions * identified to have current suicidal ideation * major psychiatric disorder concomitant to symptoms of psychological trauma * currently undergoing substance abuse treatment * previous diagnosis of eye movement disorder * any medical condition that, in the judgment of the principal investigator and/or art therapist, may place the individual at high risk due to a potential heightened emotional reaction
molecular forms of plasma and urinary b-type natriuretic peptide and its n-terminal prohormone in health and disease in pediatric cardiology

Conditions: Heart Disease; Health

Summary: b-type natriuretic peptide (bnp) is a cardiac hormone secreted from the cardiac myocytes in response to volume load. plasma levels of bnp, as measured by immunoassay methods, are elevated in patients with heart diseases. however, the biological effects of bnp are blunted in heart failure and other cardiac conditions. moreover, the peptide levels are also elevated in non cardiac conditions such as the neonatal period, sepsis and renal failure. recent investigations suggest alteration of the peptide molecular structure in heart failure. these alterations may explain, at least partially, the reduced biological activities of bnp in heart failure. immunoreactive bnp and nt-probnp have been identified in human urine. it has been suggested that urinary bnp correlates with plasma bnp, and may serve as a non-invasive measure for this cardiac marker. it is unclear what bnp fractions are cleared in the urine in health and disease. the aim of the proposed studies is to elucidate precisely the molecular form of bnp in various disease and specific physiological states in plasma and urine of infants and children.


Eligibility criteria:
inclusion criteria: 1. healthy newborn infants with normal pregnancy and delivery 2. premature infants 3. infants and children with heart disease who have nt-probnp levels taken as part of cardiac evaluation exclusion criteria: 1. patients with non cardiac disease (renal, hepatic) 2. patients with acute urinary disease or other acute non-cardiac diseases.

Keywords: children with heart disease infants healthy newborns
iressa (zd1839) plus anastrozole (arimidex) in patients with ovarian cancer

Conditions: Ovarian Cancer; Peritoneal Carcinoma; Tubal Carcinoma

Summary: the main purpose of this study is to determine the effects (good and bad) iressa plus anastrozole has on patients with relapsed ovarian cancer.

* patients will receive iressa and anastrozole orally once daily until treatment is ended. treatment will end if any of the following occur: unacceptable adverse effects; bowel obstruction; initiation of systemic chemotherapy; development of new ascites or pleural effusions, development of co-morbid disease or disease progression. * patients will be given a drug log in which to record the date and time they take their pills, as well as any symptoms and concomitant medications. * patients will be seen monthly for the following tests and procedures; a physical examination and repeat blood work. patients who remain free of clinical symptoms should have repeat abdominal/pelvic ct scans and chest x-rays on an every 3 month basis.

Eligibility criteria:
inclusion criteria: * histologic or cytologic history diagnosis of primary ovarian, primary peritoneal or tubal carcinoma * asymptomatic from ovarian cancer * evidence of recurrent ovarian, peritoneal or tubal carcinoma * tumor sample must be positive for er and/or pr * 18 years of age or older * ecog performance status of less than or equal to 1 * must be able to tolerate oral intake exclusion criteria: * known hypersensitivity to iressa or any of the excipients of this product * other coexisting malignancies or malignancies diagnosed within the last 5 years * concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital or st. john's wort * treatment with a non-approved or investigational drug within 30 days * any unresolved chronic toxicity greater than ctc grad 2 from previous anticancer therapy (except alopecia) * incomplete healing from previous oncologic or other major surgery * serum creatinine level greater than ctc grade 2 * pregnant or breast feeding * severe uncontrolled systemic disease * significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate * patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment * patients previously treated with anastrozole or other aromatase inhibitor * unable to tolerate oral medications * clinical and/or radiographic evidence of current or impending bowel obstruction

Keywords: iressa zd1839 anastrozole arimidex
cascade-lung: cancer screening assay using delfi; a clinical validation study in lung

Conditions: Lung Cancer

Summary: cascade-lung is an event-driven, multisite, prospective, observational, blood specimen collection study in the elevated-risk lung cancer screening population. the primary objective is to determine the sensitivity and specificity of the delfi lung cancer screeningtest (dlcst).

participants will be enrolled into the delfi-l201 study after informed consent and eligibility is confirmed. delfi identifies circulating tumor dna (ctdna) to detect cancer. the study purpose is to validate the performance of the delfi-based test for the detection of lung cancer among individuals eligible for routine lung cancer screening. participants will have blood collected and medical record review at baseline and will have medical records reviews at two additional timepoints.

Eligibility criteria:
inclusion criteria: * all subjects 1. ability to understand and provide written informed consent 2. age ≥ 50 years 3. current or former smoker 4. ≥ 20 pack-years (pack years = number of packs per day × number of years smoked) 5. an initial or annual follow-up lung cancer screening chest ct planned/scheduled within 30 days after enrollment (i.e., enrollment chest ct scan) exclusion criteria: * all subjects 1. evidence of any diagnosed cancer (including prior lung cancer) other than non-melanoma skin cancer or carcinoma in situ within 2 years prior to enrollment 2. prior systemic therapy, definitive therapy, radiation, or surgical resection for any cancer diagnosis within 2 years prior to enrollment (with the exception of surgery for nonmelanoma skin cancer and biopsies) 3. any history of hematologic malignancy or myelodysplasia within 2 years prior to enrollment 4. any history of organ tissue transplantation 5. any history of blood product transfusion within 120 days prior to enrollment 6. current pregnancy 7. any condition that in the opinion of the investigator should preclude the participant's participation in the study 8. past or current participation in any clinical study sponsored by delfi diagnostics or any history of a ldt (laboratory developed test) for early detection of lung cancer by delfi diagnostics

Keywords: lung cancer screening