Kornimate/medical-research-clean huggingface dataset:
pk/pd study with g-pump (glucagon infusion) in t1dm patients

Conditions: Hypoglycemia

Summary: the purpose of the study is to assess the safety, speed of absorption, and onset of action of g-pump™ (glucagon infusion) at three subcutaneous doses as compared to novo glucagen®, all delivered via an omnipod® infusion pump to patients with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * males or females diagnosed with type 1 diabetes mellitus for at least 24 months * current usage of subcutaneous insulin pump treatment * age 18-65 years * c-peptide level \< 0.5 ng/ml * willingness to follow all study procedures, including attending all clinic visits * subject has provided informed consent and has signed and dated an informed consent form before any trial-related activities exclusion criteria: * pregnant and/ or lactating: for women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study. * hba1c \>10.0% * renal insufficiency (serum creatinine of 1.2 mg/dl or greater) * serum alt or ast equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.0 g/dl; or serum bilirubin of over 2.0. * hematocrit of less than or equal to 34% * congestive heart failure, nyha class ii, iii or iv * history of coronary artery disease * active foot ulceration * history of a cerebrovascular accident * active alcohol abuse or substance abuse * active malignancy, except basal cell or squamous cell skin cancers * major surgical operation within 30 days prior to screening * seizure disorder * current administration of oral or parenteral corticosteroids * use of an investigational drug within 30 days prior to screening * bleeding disorder, treatment with warfarin, or platelet count below 50,000 * proliferative or severe non-proliferative retinopathy * gastroparesis * personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (men 2, neurofibromatosis, or von hippel-lindau disease) * insulinoma * allergies to glucagon or glucagon-like products, or any history of significant hypersensitivity to glucagon or any related products. * glycogen storage disease * any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen * whole blood donation of 1 pint (500 ml) within 8 weeks prior to screening. * any reason the principal investigator deems exclusionary

Keywords: hypoglycemia glucagon artificial pancreas
a drug-drug interaction study to examine the impact of itraconazole and cyclosporine on pf-07081532 pharmacokinetics in overweight or obese adults

Conditions: Healthy

Summary: this is a phase 1, open-label, fixed-sequence, 3-period study to evaluate the effect of multiple doses of itraconazole and a single dose of cyclosporine on the single-dose pk of pf-07081532 in otherwise healthy, overweight or obese, adult female and male participants. the 3 study periods will be conducted consecutively without a break.


Eligibility criteria:
inclusion criteria: 1. otherwise healthy female and male participants must be at least 18 years of age at the time of signing the icd (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination, including blood pressure and pulse rate measurement, standard 12-lead ecg and clinical laboratory tests). 2. bmi: ≥25.0 kg/m2 at screening. 3. stable body weight, defined as \<5 kg change (per participant report) for 90 days before screening. exclusion criteria: 1. evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). 2. diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at screening. 3. any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin) 4. personal or family history of mtc or men2, or study participants with suspected mtc per the investigator's judgment. 5. acute pancreatitis, a history of repeated episodes of acute pancreatitis, or history of chronic pancreatitis. 6. symptomatic gallbladder disease. 7. medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders (eg, cushing syndrome). 8. history of depressive disorder or history of other severe psychiatric disorders (eg, schizophrenia or bipolar disorder) within the last 2 years from screening. 9. known medical history of active liver disease, including chronic hepatitis b or c, primary biliary cirrhosis, alcoholic liver disease, primary sclerosing cholangitis, autoimmune hepatitis, overlap syndrome, or prior known drug-induced liver injury. 10. history of hiv infection. 11. any lifetime history of a suicide attempt. 12. use of prohibited medications 13. screening supine bp ≥140 mm hg (systolic) or ≥90 mm hg (diastolic), following at least 5 minutes of supine rest. 14. standard 12-lead ecg that demonstrates clinically relevant abnormalities that mayaffect participant safety or interpretation of study result. 15. participants with clinical laboratory test abnormalities at screening. -
effects of simeox on flow and volume in healthy subjects and patients with copd

Conditions: Healthy; Pulmonary Disease, Chronic Obstructive

Summary: this study will investigate the effects on the simeox technology on flow and volume generated in healthy subjects and patients with copd

this is a crossover study assessing the immediate physiological effects of simeox and a pep device on the exhalation phase in healthy subjects and patients with copd. participants will perform (1) a slow vital capacity, (2) a maximal expiration from total lung capacity to residual volume with simeox, (3) a maximal expiration from total lung capacity to residual volume with a pep device.

Eligibility criteria:
inclusion criteria: * healthy subjects: able to understand the instructions, no acute or chronic respiratory upper or lower airway disease, normal lung function. * patients with copd: able to understand the instructions; fev1\<80% predicted value, naive to the simeox device. exclusion criteria: * healthy subjects: obesity (bmi \> 30kg/m²); active or former smoker; severe scoliosis; cardiovascular or neuromuscular disease. * patients with copd: obesity (bmi \> 30kg/m²); severe scoliosis; cardiovascular or neuromuscular disease.
cardiovascular complications of sickle cell disease

Conditions: Sickle Cell Disease

Summary: in this research study, we are using heart imaging exams and blood testing, in order to gain an improved understanding of the pulmonary (lung) hypertension and cardiovascular (heart) complications that often occur in sickle cell patients. information gathered from the healthy volunteers that participate in this study will be compared to information from the sickle cell patients in this study in order to help further our understanding.

cardiac magnetic resonance (cmr) has gained increasing clinical application in cardiopulmonary diseases. due to its 3-dimensional nature, cmr is considered the gold-standard for quantifying left and right ventricular systolic function and size. additionally, its high tissue contrast allows for a detailed characterization of myocardial tissue. specifically, the use of techniques such as late gadolinium enhancement can be used to detect the presence of tiny amounts of myocardial scar. other techniques have been shown to correlate strongly with myocardial iron content. just as importantly, cmr perfusion imaging can accurately quantify myocardial blood flow and can provide tremendous insight into the function of the microcirculation. cmr's high spatial and temporal resolution, its 3-dimensional approach, its ability to characterize the tissue, and its ability to evaluate the micro- and macro-circulation make it a comprehensive technique for the evaluation of heart disease. recently, one cmr study has already shown the presence of cardiac microvascular disease in a subset of adult sickle cell disease (scd) patients in the absence of infarcted myocardium, myocardial iron overload, or coronary artery disease, increasing the evidence for the contribution of left heart disease to pulmonary hypertension (ph) development in these patients; unfortunately, strong conclusions could not be made because the study was underpowered. thus, this proposal will leverage the advantages offered by cmr to better characterize and detect the ph and cardiopulmonary subphenotypes in the scd patient population.

Eligibility criteria:
inclusion criteria: * patients must be 18+ * patients who were diagnosed with scd confirmed by high-pressure liquid chromatography or hemoglobin electrophoresis will be eligible for the study * only patients in stable condition will be included * patients receiving transfusions will not be excluded exclusion criteria: * patients with vaso-occlusive crises or an episode of acute chest syndrome within the previous four weeks (after 4 weeks have passed, the patients may be re-evaluated for eligibility) * patients with high degree heart block; active, hemodynamically significant, ventricular arrhythmias; unstable coronary syndromes; history of myocardial infarction within 1 month of the study. * contraindications to gadolinium-enhanced magnetic resonance examination such as severe claustrophobia, pacemaker, defibrillators, cerebral aneurysm clips, or neurostimulator. * pregnancy * patients with sinus node dysfunction

Keywords: sickle cell disease cardiac magnetic resonance imaging coronary disease pulmonary hypertension
suprarenal proximal cuff study for treatment of abdominal aortic aneurysm

Conditions: Abdominal Aortic Aneurysm

Summary: the use of a suprarenal extension device during the index aaa procedure to accommodate the patient's anatomy and to prevent or repair leakage.


Eligibility criteria:
inclusion criteria: * 18 years old * informed consent understood and signed * will comply with post-treatment follow-up requirements up to 5 years * candidate for powerlink infrarenal bifurcated graft exclusion criteria: * life expectancy \< 2 years * participating in another clinical research study * pregnant or lactating women * patient has other medical or psychiatric problems, which in the opinion of the investigator, precludes them from participating in the study * creatinine level \> 1.7mg/dl * renal transplant patient * patient with \> 75% renal artery stenosis and not eligible for pta/stent intervention prior to suprarenal device fixation

Keywords: aaa aneurysm suprarenal proximal cuff extension endograft endovascular repair evar endoleak type i
skills training within a family-based obesity treatment intervention

Conditions: Obesity, Childhood

Summary: this study is investigating the impact of a skills training program in stimulus control of meals and snacks on zbmi. participants will be randomized to a standard family-based obesity treatment intervention with education on child health or a standard family-based obesity treatment intervention with experiential learning about meal stimulus control strategies.

family-based obesity treatment interventions can successfully reduce weight in children, but are often limited in the practice of skills being taught during treatment sessions. skills training focused on a particular behavioral strategy can provide parents with an experiential component of learning where the information learned as part of a family-based obesity treatment intervention is also practiced. health education simply provides knowledge to a family about a topic.

Eligibility criteria:
inclusion criteria: * caregiver of child is ≥18 years of age; * the caregiver has a child between the ages of 4 and 8 years-old who is classified as overweight (body mass index for age ≥ 85th percentile); * the caregiver and child are able to read, speak and understand english due to delivery of the program in english; * has transportation to the university of delaware; and * is willing and able to commit to the 3-month study. exclusion criteria: * the child has a medical condition impacting physical activity or eating (e.g. type 1 or type 2 diabetes); * the child have a medical condition that affects growth (e.g. prader willi syndrome); * the child is currently participating in a weight management program, and/or taking weight loss medication; or * the caregiver or child has an inability to participate in regular physical activity.
clinical trial on onychomycosis with p-3058 nail solution in pediatric population

Conditions: Onychomycosis

Summary: pediatric patients affected by mild-to-moderate distal subungual onychomycosis (dso) or affected by white superficial onychomycosis (wso), due to dermatophytes, will be treated topically with p-3058 nail solution according to the appropriate treatment schedule.


Eligibility criteria:
inclusion criteria: * age between 2 to 17 years * males and females * clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis without spikes/dermatophytoma and without lunula involvement or white superficial onychomycosis. * positive mycroscopy examination from the target nail at screening. * positive culture for dermatophyte from the target nail at screening. exclusion criteria: * patients with onychomycosis caused by yeasts or non-dermatophytes mould. * patients with nail psoriasis. * patients with nail changes due to eczema, lichen planus or alopecia areata. * patients with one-hand two-foot syndrome. * patients with immunodeficiency disorder or use of immune suppressive therapy 3 months prior to screening visit or need for it. * use of systemic antifungal drugs in the 6 months prior to screening visit. * use of topical nail antifungal drugs in the four weeks prior to screening visit.
femoral artery blood flow during rest and one-leg knee extensor exercise in patients with copd

Conditions: COPD; Healthy; Chronic Obstructive Pulmonary Disease

Summary: doppler ultrasound is generally considered to provide reliable femoral blood flow measurements between rest and exercise, and the blood flow response to exercise is widely believed to be reduced in patients with chronic obstructive pulmonary disease (copd). however, the test-retest reliability of the method during one-leg knee extensor exercise has not previously been compared between matched healthy individuals.

experimental assessments of changes in skeletal muscle blood flow during exercise in humans are important for elucidating the factors that limit exercise capacity and adaptations, both in healthy humans, including athletes, as well as in various disease states with functional impairment, such as chronic obstructive pulmonary disease copd). a classical 'gold standard' for measuring blood flow is thermodilution, and this has notably applied to provide data on femoral blood flow during exercise. because thermodilution required invasive catheterization, many have replaced it with doppler ultrasound, but the test-retest reliability of doppler ultrasound in this context is unknown. however, many studies have used doppler ultrasound to document that the femoral blood flow response to exercise is impaired in copd, which ultimately affects oxygen uptake and thus exercise capacity, but the interpretation of these findings is currently hampered by the lack of knowledge regarding the test-retest reliability of the method in this patient group. the investigators aim is to compare the femoral blood flow response to one-legged knee extensor exercise in patients with copd vs. healthy participants, and to provide an estimate of the test-retest reliability the femoral blood flow measurements obtained by doppler ultrasound.

Eligibility criteria:
inclusion criteria for copd patients: * men and women * 45-80 years * copd (gold stage i to iii) * forced expiratory volume in 1 sec (fev1)/forced vital capacity ratio (fvc) \< 0.8, fev1 \< 90% of predicted value * modified medical research council score (mmrc 0 - 3) resting arterial oxygenation \> 90% exclusion criteria for copd patients: * symptoms of ischaemic heart disease * known heart failure * claudication * symptoms of disease within 2 weeks prior to the study * participation in pulmonary rehabilitation within 6 months * known malignant disease * pregnancy * unstable cardiac arrhythmic disease * renal or liver dysfunction inclusion criteria for healthy matched controls: * men and women * 45-80 years * normal fev1, fvc, fev1/fvc, and single-breath diffusion capacity * same sex, age (± 3 years) as the copd patients exclusion criteria for healthy matched controls: * known chronic lung disease * known ischaemic heart disease * known heart failure * symptoms of disease within 2 weeks prior to the study * known malignant disease * claudication * pregnancy * unstable cardiac arrhythmic disease * renal or liver dysfunction

Keywords: ultrasound copd test-retest
comparing a randomised controlled intervention with observational data.

Conditions: Obesity, Morbid

Summary: comparison of participants in a randomised controlled trial (rct) with observational data from patients operated in sweden during the same period of time. the primary objective is to compare effects from a complex surgical intervention from rct and observational data.

randomised controlled trials (rct) are "golden standard" for assessing interventions in medical science. due to ethical or practical reasons, rcts may however not always be feasible. the study objective was to test if the results from the rct differ from observational data in a setting with a complex surgical intervention. using the scandinavian obesity surgery registry database we intend to compare patients operated with laparoscopic gastric bypass surgery within a register based rct from may 1st 2010 until nov 14th 2011, with all patients operated with the same procedure registered in the database during the same period of time. primary end-point measures are severe complications within 30 days (safety outcome) and surgery for small bowel obstruction (efficacy outcome) within 4 years.

Eligibility criteria:
inclusion criteria: * the same as acceptance criteria for bariatric surgery according to the 1991 nih consensus statement exclusion criteria: * retrocolic gastric bypass procedure * previous bariatric procedures * primary open procedures * missing data on handling of the mesenteric defects

Keywords: bariatric surgery gastric bypass intestinal obstruction postoperative complication methods laparoscopy
continuous passive paracentesis for intra-abdominal hypertension

Conditions: Ascites Hepatic; Cirrhosis, Liver; Hypertension, Intraabdominal; Critical Illness; Paracentesis

Summary: liver cirrhosis patients in intensive care present intra-abdominal hypertension and this is an independent risk factor for increased organ disfunction and mortality. patients will be randomized into intermittent or continuous passive paracentesis and the clinical results of these two strategies for preventing and treating intra-abdominal hypertension will compared.

intra-abdominal hypertension is an independent risk factors for increased mortality in intensive care patients and is highly prevalent in the critically ill cirrhotic patient. this study compares two strategies in minimizing intra-abdominal pressure and optimizing abdominal perfusion pressure in the prevention and treatment of intra-abdominal hypertension associated morbidity and mortality. critically ill cirrhotic patients will be allocated into a standard-of-care large-volume paracentesis group (control) and a continuous passive paracentesis (intervention) group using randomization. results will assess renal function and multi-organ function using standard clinical scales and vital outcomes.

Eligibility criteria:
inclusion criteria: * liver cirrhosis diagnosis with ascites * icu admission for medical reason exclusion criteria: * prior liver transplant * haemorrhagic ascites * extreme severity: clif-sofa number of organ failures 5 or more * less than 24 hours of icu stay * any of the following conditions at 24 hours of icu stay: i. hemorrhagic shock with active uncontrolled bleeding ii. refractory shock (map\<60mmhg) with multiple vasopressors iii. predictably short icu stay (\<72 hours) iv. therapeutic futility determined by the medical staff

Keywords: hepatic ascites liver cirrhosis intraabdominal hypertension paracentesis puncture and drainage critical illness acute-on-chronic liver failure
obesity as a risk factor for musculoskeletal diseases in the u.s. air force: associations and implications for force readiness

Conditions: Obesity

Summary: to study the first hypothesis, a retrospective cohort analysis of air force members from january 2005 to december 2010 will be performed to evaluate the association of obesity as an independent predictor variable with musculoskeletal disease as the dependent variable.

to study the first hypothesis, a retrospective cohort analysis of air force members from january 2005 to december 2010 will be performed to evaluate the association of obesity as an independent predictor variable with musculoskeletal disease as the dependent variable. a second analysis will be performed on the same cohort using musculoskeletal disease as an independent predictor variable, as well as evaluating a potential interaction between obesity and musculoskeletal disease, to determine the association of these variables with the dependent variable of service member readiness for duty. the independent variables for the analyses include: * age * sex * bmi * fitness data (pimr: pft scores, weight, height, bmi, abdominal circumference) * profile data (pimr: number of profiles, number of profiles due to musculoskeletal diagnoses, total days on duty limitation, total days on mobility limitation) * total number of deployments served * all new musculoskeletal diagnoses (see attached abbreviated icd-9 list) * incidence of member separation from af * incidence of disability retirement * x-rays * surgeries (orthopaedic, general) * referrals to the orthopaedic department * referrals to the pain clinic * new diagnosis of diabetes mellitus * death all data will be gathered by sg6h, healthcare informatics division, and de-identified. then the de-identified data will be coded and sent to the principal investigator for analysis. all informational data sets will be totally de-identified prior to releasing to the principle investigator to be analyzed by a statistician.

Eligibility criteria:
exclusion: active duty air force members with the following conditions will be excluded from the study: * documented preexisting musculoskeletal injury/disease before onset of obesity * hypothyroidism/hyperthyroidism * hyperparathyroidism * osteopenia/osteoporosis * nicotine dependence * alcohol dependence * eating disorders (anorexia nervosa, bulimia nervosa) * cancer requiring chemotherapy or radiation therapy * status-post gastrectomy * status-post bilateral oophorectomy * crohn's disease * ulcerative colitis * celiac disease * cushing's disease * prior to or during the study period, more than 6 months of taking proton pump inhibitors, medroxyprogesterone acetate, bisphosphonates, methotrexate, selective serotonin reuptake inhibitors, or inhaled/intranasal corticosteroids * prior to or during the study period, more than 1 month of taking fluoroquinolones, oral or intramuscular corticosteroids, oral or intramuscular testosterone, or leuprolide