Kornimate/medical-research-clean huggingface dataset:
a study to evaluate pharmacokinetics (pk) and safety of inaxaplin in participants with renal impairment

Conditions: Renal Impairment

Summary: the purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of inaxaplin (ixp) in participants with severe renal impairment and healthy participants with normal renal function.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.5 to 40.0 kilogram per meter square (kg/m\^2) * stable renal function for at least 1 month prior to enrollment key exclusion criteria: * uncontrolled hypertension * any condition possibly affecting drug absorption other protocol defined inclusion/exclusion criteria may apply.
improving cardiovascular health risks in adults with epilepsy on a modified atkins diet

Conditions: Epilepsy; Dyslipidemia

Summary: ketogenic diet therapies (kdts) emphasize high fat and very low carbohydrate intake and help to control seizures in adults who fail to respond to medications. however, kdt use can lead to increased cholesterol levels in some adults with epilepsy (awe). treatments that can reverse elevations in cholesterol observed with long-term kdt use without compromising diet adherence and seizure control are needed. the proposed study will explore the feasibility and safety of diet modification and statin use to lower cholesterol in this population. study findings will help guide doctors utilizing kdts in adults with epilepsy on how to approach managing elevations in cholesterol.

the scientific premise of this proposal is that established or long-term (≥ 12 months) modified atkins diet (mad) use in awe influences atherosclerotic cardiovascular disease (ascvd) risk and can be modified to reduce dyslipidemia when observed. hence, the overarching goals of this proposal are to explore the safety and feasibility of dyslipidemia management strategies to reduce ascvd risk in awe on mad without increasing seizure risk. this study will collect data before and after randomly assigned interventions to reduce ldl in awe on long-term mad recruited from patients receiving clinical care in the johns hopkins adult epilepsy diet center. awe with dyslipidemia on long-term mad will be randomized 1:1 to either mad modification (10% reduction of dietary energy from saturated fat, replaced with poly-unsaturated fat ) or moderate-intensity statin use (atorvastatin 10mg) for 12 weeks.

Eligibility criteria:
inclusion criteria: 1. modified atkins diet use ≥ 12 months 2. dyslipidemia based on american college of cardiology/american heart association guidelines (i.e., ldl ≥190 mg/dl, 10-year ascvd risk ≥5% with risk enhancers, etc.) 3. 18 years of age or older 4. body mass index (bmi) \> 18.5 5. stable anti-seizure medication regimen for \> 1 month. exclusion criteria: 1. \< 18 years of age 2. body mass index (bmi) \< 18.5 3. changes in anti-seizure medication regimen \< 1 month prior to participation 4. known ascvd (history of acute coronary syndrome, myocardial infarction, angina, stroke, transient ischemic attack, or peripheral artery disease) 5. current statin medication use 6. prior serious adverse response to atorvastatin or other statin medications 7. uncorrected carnitine deficiency 8. pregnancy

Keywords: modified atkins diet ketogenic diet cholesterol
topiramate for the treatment of methamphetamine dependence - 1

Conditions: Methamphetamine

Summary: the purpose of this study is to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence.


Eligibility criteria:
inclusion criteria: * treatment seeking individuals as the time of the study * must be able to proved written informed consent * must have a body mass index greater than 18 kg/m(2) * must meet dsm-iv criteria for methamphetamine dependence * must currently be using methamphetamine as confirmed by a positive urine test over the past 14 days * if female of child bearing potential, must agree to use birth control exclusion criteria: * please contact the site for more information

Keywords: methamphetamine addiction
approach to ankle sprains in the emergency department

Conditions: Ankle Sprains

Summary: the aim of this study is to evaluate the short-term effects of routinely applied agents on pain and joint range of motion (rom) in ankle sprains presenting to the emergency department (ed).

it is aimed to examine the effects of intravenous (iv) 50 mg dexketoprofen, iv ibuprofen 400mg and iv paracetamol 10 mg on pain and joint range of motion. to determine the effects of these agents on pain, the easily applicable numerical rating scale (nrs) and wong-baker faces pain rating scale will be used. a standard handheld half-circle goniometer will be utilized to calculate active ankle joint rom.

Eligibility criteria:
inclusion criteria: * adults aged 18 years and older who present to the emergency department within the first 72 hours after ankle sprain. * grade 1 (mild) and grade 2 (moderate) ankle sprains. * exclusion of fractures and dislocations (after x-ray according to ottawa rules). * absence of muscle-tendon ruptures. * absence of vascular and nerve injuries. * absence of open wounds and burns. * stable vital signs. * patients who provide written and verbal consent. exclusion criteria: * patients who did not present to the emergency department within the first 72 hours after ankle sprain. * grade 3 (severe) ankle sprains. * multiple traumas. * pregnancy or suspected pregnancy. * ankle fractures and dislocations. * forensic cases. * history of previous ankle surgery or fracture.

Keywords: range of motion numerical rating scale
balloon-occluded retrograde transvenous obliteration for gastric variceal rebleeding

Conditions: Gastric Varices Bleeding; Liver Decompensation

Summary: the goal of this randomized controlled trial is to compare the rebleeding rate in cirhotic patients with gastric variceal bleeding receiving balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection. the main questions it aims to answer are: * recurrent gastric variceal bleeding * further decompensation of liver cirrhosis participants will receive balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection. researchers will compare balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection to see if the rebleeding rate associated with balloon-occluded retrograde transvenous obliteration is lower than that associated with endoscopic tissue glue injection.

variceal bleeding is a severe complication of portal hypertension. gastric variceal bleeding (gvb) is more severe than bleeding from esophageal varices. gastric varices also have a higher risk of rebleeding than esophageal varices. previous studies showed that endoscopic injection of cyanoacrylate was superior to endoscopic variceal ligation in the management of gastric variceal bleeding. another study showed that transjugular intrahepatic portosystemic shunt had a lower rebleeding rate than endoscopic cyanoacrylate injection. however, transjugular intrahepatic portosystemic shunt (tips) is more invasive and carries a risk of development of hepatic encephalopathy and is usually preserved for uncontrolled variceal bleeding. therefore, endoscopic cyanoacrylate injection is recommended as the treatment of choice for gvb. balloon-occluded retrograde transvenous obliteration (brto) is a new therapy for gastric variceal bleeding. however, brto is associated with increased portal pressure and worsening of ascites, hepatohydrothorax, and esophageal varices. there are only a few retrospective studies comparing brto and endoscopic cyanoacrylate injection in the prevention of recurrent gastric variceal bleeding.

Eligibility criteria:
inclusion criteria: * age more than 20 years * a history of liver cirrhosis * acute gov2 or igv1 bleeding exclusion criteria: * previous treatment for gastric varices, including endoscopic therapy, transjugular intrahepatic portosystemic shunt, or shunt surgery * hepatocellular carcinoma or other malignancy * stroke, uremia, or active sepsis * serum total bilirubin \>10 mg/dl * grade iii/iv hepatic encephalopathy * refractory ascites * uncontrolled index bleeding * pregnancy * severe heart failure (nyha fc iii/iv) * allergy to cyanoacrylate, lipiodol, iodine, or sodium tetradecyl sulfate * absence of gastrorenal shunt

Keywords: gastric varices bleeding cyanoacrylate balloon-occluded retrograde transvenous obliteration liver decompensation cirrhosis
inflammatory response in appendicitis

Conditions: Appendicitis

Summary: although the presence of sirs has been described in patients with appendicitis, its progressive response related and together with progression of symptomatology from the onset of symptoms to diagnostic has not been characterized. continuation of the systemic inflammation in patients with injury and infectious processes may result in multiple organ dysfunction and ultimately failure. as with any acute inflammatory condition, the patients' systemic inflammatory response to appendicitis will progress and become more intense with the passing of time. the purpose of this study is to characterize the systemic inflammatory response to appendicitis from the beginning of symptoms to diagnostic in patients with appendicitis submitted to emergency surgery.

* a prospective non-interventional, observational, descriptive study was conducted. * at our institution a median of 250 adult patients are submitted to emergency appendectomy every year. from this universe, a sample of 152 patients with a power of 80%, an error of 5% and 95% confidence intervals was required to perform this study. * we included 268 patients in the database, of them 85 cases that did not comply with the inclusion criteria were excluded from the analysis. a total of 183 patients (100%) selected according to the following criteria were studied: patients with appendicitis confirmed by histology operated on our institutional emergency unit with an age range from 15 to 80 years. * any patient with immunosuppressive or immunodeppressive known pathological conditions was excluded, as well as any patient with a pathological report describing a normal appendix. * patients were divided into four groups according to the interval of time calculated from the onset of symptoms to diagnostic: group i from 0 to 24 h, group ii from 25 to 48 h, group iii from 49 to 72 h and group iv more than 73 h. * at admission demographic, clinical data, and the interval of time from the onset of symptoms to diagnostic was recorded, together with the white blood cell (wbc) count, c-reactive protein (crp) values, and sirs score. * the primary outcome measure was to determine the expected systemic inflammatory response to acute appendicitis according to established groups of time intervals from the onset of symptoms to diagnostic using the sirs for that purpose. * the secondary outcome measure was the analysis of the crp to measure the systemic inflammatory response, as another parameter which is habitually included within the diagnostic study of patients with suspected appendicitis.

Eligibility criteria:
inclusion criteria: * patients with appendicitis exclusion criteria: * any patient with immunosuppressive or immunodeppressive known pathological conditions * any patient with a pathological report describing a normal appendix

Keywords: appendicitis sirs c-reactive protein
boluses of ringer's in surgical kids (brisk study)

Conditions: Dehydration in Children; Fluid Therapy

Summary: traditional protocols for intravenous fluid administration in children who have undergone a major abdominal or thoracic operation are based on a landmark paper published in 1957 by holliday and segar. the basic tenets include: (1) continuous intravenous fluid administration; (2) total fluid volume based on the "4:2:1" rule; (3) use of hypotonic electrolyte solutions, most commonly 0.45% sodium chloride (nacl) + 20 milliequivalents per liter (meq/l) potassium chloride (kcl); and (4) inclusion of 5% dextrose to increase the osmolarity of the infusate and to help prevent ketosis and acidemia.

recent studies have questioned the validity of each of these tenets. maintenance rate as defined by holliday \& segar is postulated to be in excess of pediatric patients' post-surgical fluid needs. the investigators propose a novel protocol for the administration of iv fluids to children after major abdominal or thoracic surgery that includes: (1) intermittent boluses; (2) total volume administered in 24 hours closer to 2/3 of the traditional maintenance fluid requirements; and (3) use of a balanced salt solution (lactated ringer).

Eligibility criteria:
inclusion criteria: 1. males or females age 12 months to 21 years. 2. weight \>= 8 kg. 3. patients with an uncomplicated abdominal or thoracic surgical procedure in which the expected postoperative length of stay is anticipated to be at least 2-5 days. 4. patients admitted to a regular bed following surgery. 5. patients who will be inpatient for approximately 4-8 days postoperatively. 6. parental/guardian permission (informed consent). exclusion criteria: 1. patients with a history of diabetes, seizures, hyperglycemia, and hypoglycemia. 2. patients prescribed insulin. 3. patients receiving parenteral nutrition. 4. patients with excessive gi losses (small bowel obstruction, severe diarrhea, large-volume ascites or drainage). 5. complicated surgery that requires an icu or icu transfer immediately after surgery. 6. patients with any form of hypersensitivity to the study fluids. 7. laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease: * serum sodium \ 145 mmol/l * serum potassium \ 5.0 meq/l * serum chloride \ 110 meq/l * serum creatinine ≥ 1.6 mg/dl * serum glucose \ 180 mg/dl * alanine aminotransferase \>200 u/l * total bilirubin \>12.0 mg/dl 8. pregnant or lactating females. 9. parents/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.

Keywords: hydration fluids lactated ringer's hyponatremia dehydration post operative pediatrics children intravenous fluid therapy
intranasal insulin for weight management during smoking cessation

Conditions: Tobacco Abstinence Syndrome

Summary: this fda-approved (ind# 120700) study will evaluate efficacy of intranasal insulin in reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers.


Eligibility criteria:
inclusion criteria: * smokers (\>10 cig/day) for the past 1 year * normosmic olfactory function exclusion criteria: * previous/current use of insulin * current diagnostic and statistical manual-iv-revised (dsm-iv-r) axis i disorder * current pregnancy (or lactation) * lifetime history of endocrine disease * excessive alcohol use (\>25 standard units of alcohol/week) * current use of illicit drugs * current use of a smoking cessation aid (nrt, chantix or wellbutrin), or a psychotropic agent * local infections, inflammation, structural abnormalities, or other nasal pathology * current use of any medications administered intranasally, including intranasal steroids
the predictive value of egfr for adverse cardiovascular events in patients with stemi

Conditions: ST Elevation Myocardial Infarction

Summary: estimated glomerular filtration rate(egfr) is significantly reduced in patients with st-segment elevation myocardial infarction (stemi). the aim of this study is to research that the incidence of adverse cardiovascular events (mace) in patients with st-segment elevation myocardial infarction is significantly higher when the glomerular filtration rate below a certain value.

the investigators retrospectively analyzed the clinical data of 1157 patients with st-segment elevation myocardial infarction. in-hospital adverse cardiovascular events (mace) was defined as: cardiac arrest, cardiac rupture, malignant arrhythmia, and cardiac death. all the patients were divided into 3 groups according to the patient's estimated glomerular filtration rate(egfr) (egfr≥90ml/min/1.73m2; 90ml/min/1.73m2\>egfr≥60ml/min/1.73m2; egfr\<60ml/min /1.73m2). cox regression analysis and k-m survival curves are used to calculate the correlation between egfr and in-hospital mace.

Eligibility criteria:
inclusion criteria: * 1.patients with stemi 2.patients from whom informed consent has been properly obtained in writing prior to start of the trial exclusion criteria: * 1.patients with previous myocardial infarction, congenital heart disease 2.patients with liver disease, and renal failure 3.patients with immunologic disease, malignant tumors, pregnancy, infection caused by various pathogens, chronic inflammatory disease, trauma.
growth hormone for osteoporosis pseudoglioma syndrome

Conditions: Osteoporosis Pseudoglioma Syndrome

Summary: osteoporosis pseudoglioma (oppg) syndrome is a rare autosomal recessive condition of childhood osteoporosis and congenital blindness for which new treatments are needed. we have found that body fat is increased in oppg and muscle mass is reduced. we hypothesize that growth hormone therapy will improve muscle mass and bone strength in oppg.

osteoporosis pseudoglioma (oppg) syndrome is a rare autosomal recessive condition of childhood osteoporosis and congenital blindness for which new treatments are needed. we have found that body fat is increased in oppg and muscle mass is reduced. we hypothesize that growth hormone therapy will improve muscle mass and bone strength in oppg.

Eligibility criteria:
inclusion criteria: * osteoporosis pseudoglioma syndrome * age 4 years and above * not on medication for osteoporosis exclusion criteria: * pregnant * age under 4 yrs * active malignancy

Keywords: osteoporosis pseudoglioma oppg growth hormone osteoporosis
compassionate use: progressive metastatic castrate resistant prostate cancer; monotherapy treatment with trametinib

Conditions: Progressive Metastatic Castrate Resistant Prostate Cancer

Summary: the dosage of trametinib for oral administration is 2mg once daily. the patient is instructed to take the trametinib oncedaily dose at approximately the same time each day, by mouth with approximately 200 ml (almost 1 cup) of water on an empty stomach, either 1 hour before or 2 hours after a meal.

the dosage of trametinib for oral administration is 2mg once daily. the patient is instructed to take the trametinib once daily dose at approximately the same time each day, by mouth with approximately 200 ml (almost 1 cup) of water on an empty stomach, either 1 hour before or 2 hours after a meal. the patient will be provided with complete dosing instructions from his treating physician. if the subject is instructed that if he vomits after taking either of the medications provided under this program, he should not retake the dose. the patient should take the next dose as originally scheduled. if a dose is missed, the patient should not double the next regularly scheduled dose. however, the patient can take the missed dose immediately if the next scheduled dose is at least 12 hours later. if the next scheduled dose is due in less than 12 hours, the patient is instructed to skip the dose and resume dosing the next day at the regular time. then to take the next dose at the usual time the subject is scheduled to take it. it is not known for how long the subject will remain in the program because each patient may respond differently to the treatment. the length of time the patient will take trametinib therapy will depend on his cancer status and how well he tolerates the drugs. if he experiences severe side effects, he is instructed to call his treating physician immediately. the treating physician may advise him stop compassionate used of trametinib or may advise him to lower the dose. trametinib may also be stopped completely at his treating physician's discretion. the treating physician will use his/her clinical expertise considering the intensity of the adverse effect and/or the results of your laboratory tests to make his/her decision. the treating physician may consult with the novartis country pharma organization medical advisor/director about dose interruptions or modifications.

Eligibility criteria:
inclusion criteria: * progressive metastatic castrate resistant prostate cancer exclusion criteria: * absence of progressive metastatic castrate resistant prostate cancer
confirmation of association between cystic fluid analysis with pancreatic cystic lesions

Conditions: Pancreatic Cyst; Molecular, Chemical Analysis of Cystic Fluid

Summary: through a comprehensive analysis of the pancreatic cystic fluid analysis, the role of the cystic fluid analysis is confirmed in terms of accurate diagnosis of pancreatic cysts, appropriate prediction of treatment response, and to select proper treatment indication through analytic results.


Eligibility criteria:
inclusion criteria: 1. patients who diagnosed with pancreatic cystic lesion 2. patients who are able to acquire cystic fluid through eus-fna or surgery 3. patients aged 18 years and older exclusion criteria: 1. patients who did not want to participate in this study 2. patients aged under 18 years old 3. severely mentally ill patients 4. pregnant women