Kornimate/medical-research-clean huggingface dataset:
hyperglycemia and effects of daily 100 mg versus 200 mg of hydrocortisone therapy in patients with septic shock

Conditions: Hyperglycemia

Summary: the purpose of this study is to compare hyperglycemia and other effects, include 28-day mortality and time to reversal of shock between 100 milligrams and 200 milligrams of hydrocortisone as initial dosage in patients with septic shock.

the intervention group will be received 100 milligrams per day of hydrocortisone on the first three day the taper off, whereas the control group will be received 200 milligrams per day of hydrocortisone on the first three day the taper off. hyperglycemia rate will be monitored every 6 hours after hydrocortisone is started until 24 hours after it is stopped. also, 28-day mortality will be follow after hydrocortisone is started.

Eligibility criteria:
inclusion criteria: * septic shock * adequate fluid resuscitation and vasopressor therapy are unable to maintain hemodynamic stability exclusion criteria: * receive systemic steroid in past 3 months * established adrenal insufficiency * currently used in chemotherapy or immunosuppressive agents * radiotherapy currently received * known hiv infection * pregnancy
a rct of low mbo drainage strategies

Conditions: Jaundice, Obstructive; Cholangiopancreatography, Endoscopic Retrograde; Endoscopic Ultrasound-Guided Drainage

Summary: the purpose of this study is to evaluate the efficacy and safety of eus-bd compared with ercp-bd in low biliary obstruction caused by periampullary cancer, pancreatic cancer or low bile duct cancer. this is a single center, prospective, randomized-controlled study. the primary endpoint of this study is stent patency time, and secondary endpoints include technical success rate, clinical success rate, operation time, operation related complications rate, reintervention rate, stent patency rate at 6 months, and 1-year postoperative survival rate.


Eligibility criteria:
inclusion criteria: 1. age:18 years old or above; 2. periampullary cancer/pancreatic cancer according to pathology or clinical judgment of more than 2 senior doctors; 3. distal malignant bile duct obstruction (2cm away from the hepatic hilum); 4. ultrasound evaluation shows that the accessible part of the bile duct has a width of ≥ 12mm; 5. the patient or family member is able to understand the research protocol and is willing to participate in this study, providing written informed consent. exclusion criteria: 1. patients suffer from severe cardiovascular or pulmonary diseases who are unable to tolerate anesthesia or endoscopic examination; 2. uncorrectable coagulation abnormalities or bleeding tendencies (inr\>1.5 or platelets\<50) × 109 /l); 3. there is a plan for subsequent surgical resection of the tumor, accompanied by severe infection or an expected survival period of less than 3 months; 4. successful biliary drainage measures have been implemented, including but not limited to ercp, enbd, ptcd, and surgical procedures; 5. previous surgical changes to the anatomical structure of the pancreas, gallbladder, stomach, and duodenum; 6. pregnancy, lactation, or planned pregnancy; 7. refusal to join or inability to provide informed consent; 8. other researchers evaluated the unsuitability of enrollment.
clinical study of endostatin in improving radiation pneumonia and fibrosis

Conditions: Radiation Pneumonitis; Endostatin

Summary: to verify the efficacy and safety of endostatin in the treatment of srili（symptomatic radiation-induced lung injury） and fibrosis. the results of this study are expected to be a new clinical strategy for the treatment of radiation pneumonia and fibrosis.

radiotherapy is an important treatment of lung cancer, symptomatic radiation-induced lung injury (srilr) is the most common complications. in view of the important role of endostatin in inhibiting angiogenesis and pro-inflammatory factors, combined with randomized controlled clinical study and small sample clinical exploration, the investigators concluded that endostatin is a new clinical technique for the treatment of radiation pneumonia（rp） and radiation fibrosis（rf）, which can reduce the recurrence rate of rp. in order to verify the efficacy and safety of endostatin in the treatment of srili and fibrosis, the investigators intend to use a prospective, randomized, multicenter clinical trial to classify unresectable phase iii-iv non-small cell lung cancer（nsclc） patients with srili above grade 2 into the control group (standard srili treatment) and observation group (endostar® plus standard treatment) on a 1:1 randomized basis. the results of this study are expected to be a new clinical strategy for the treatment of radiation pneumonia and fibrosis.

Eligibility criteria:
inclusion criteria: 1. patients defined as nsclc who could not be operated on, phase iii-iv; 2. eocg ps: 0-3; 3. the clinical diagnosis is rili, with grade 2-3; 4. no major organ dysfunction, such as heart failure and chronic obstructive pneumonia; 5. no endostar use contraindication; 6. volunteer to participate, good compliance, can cooperate with the test observation, and sign a written informed consent. exclusion criteria: 1. patient compliance is poor and violates the test regulations; 2. major organ dysfunction like liver and kidney occurs, such as myocardial infarction, angina pectoris, liver transaminase increased significantly; 3. hemorrhage or thrombus occurs, anticoagulant medication is required; 4. serious adverse drug reactions occur during treatment; 5. the patient asked to be withdrawn from the trial; 6. other antiangiogenic drugs were used.

Keywords: endostatin radiotherapy radiation pneumonitis radiation fibrosis
developing evidence to inform regulatory policy on nicotine content in e-liquids

Conditions: Nicotine Addiction

Summary: the goal of this observational study is to learn if electronic cigarette users who currently choose to use lower nicotine eliquids have reduced harm compared those who choose higher nicotine eliquids. the main questions it aims to answer are: * do lower nicotine users actually consume less nicotine compared to higher nicotine users? * do lower nicotine users have lower amounts of harmful and potentially harmful constituent exposures compared to higher nicotine users? * do lower nicotine users perceive their choice of product to be less harmful than higher nicotine products? researchers will monitor ecig users of different nicotine concentrations for two weeks in their natural environment to determine how much eliquid and nicotine they consumed, assess their daily mood and craving, and measure exposure and health effect. participants will: * complete surveys on history of tobacco use, nicotine dependence and perception. * use their electronic cigarette with their usual nicotine eliquid ad lib for two weeks in their natural environment. * complete daily questionnaires for mood and craving for two weeks in their natural environment. * collect three salivary samples at home, morning, afternoon and evening, each day for two weeks, in their natural environment. * use a topography monitor to record puffing behavior for every puff taken during week two, in their natural environment. * provide saliva, urine and blood samples in the lab at the end of each week.


Eligibility criteria:
inclusion criteria: * age 21 yrs or older * pod-style or pen-style users, not adjustable for power or airflow, nicotine greater than 0 mg/ml * current everyday users * use history of at least 30 days * no current use of combustible tobacco product, or nicotine replacement therapy * co less than 6 ppm at intake * no plans to quit tobacco use in the next 30 days exclusion criteria: * history of acute or chronic asthma * previous diagnosis of cancer * other chronic medical conditions * use of chronic prescription medications * pneumonia in prior six weeks * upper respiratory tract infection or other febrile illness in previous 2 weeks * on antioxidants or anti-inflammatory therapy * pregnant women or women who intend to become pregnant

Keywords: electronic cigarettes nicotine addiction eliquid nicotine concentration perception of risk health effects biomarkers of exposure subjective affect
digital monitoring after af ablation

Conditions: Atrial Fibrillation; Atrial Fibrillation Recurrent; PVI

Summary: recurrence of atrial fibrillation (af) after a pulmonary vein isolation (pvi) procedure is frequent. current follow up with holter monitoring and electrocardiograms (ecg) during outpatient clinic consultations cover only short time stretches and require hospital visits. mobile health solutions with rhythm monitoring using photoplethysmography (ppg) technology on a smartphone could extend rhythm monitoring time, while lowering hospital visits and cost. this study aims to compare the performance of a digital health solution using ppg technology on a smartphone versus the current standard of care to monitor for af recurrence after a pvi procedure.


Eligibility criteria:
inclusion criteria: * subject is scheduled for an ablation procedure for af, at least 4 weeks after the inclusion. * subject provides informed consent. * subject understands and agrees to comply with planned study procedures. * subject is able to perform measurements of the heart rhythm using the fibricheck application at home. exclusion criteria: * insufficient cognitive or comprehensive level of dutch to participate to the trial. * no access to a smartphone or unable to perform fibricheck measurements at home. * pacemaker.

Keywords: atrial fibrillation pvi atrial ablation pulmonary vein isolation ppg photoplethysmography digital health
eggs as part of a healthy breakfast

Conditions: Cardiovascular Diseases

Summary: contrary to popular belief, previous studies have demonstrated beneficial effects of whole egg consumption in modifying biomarkers indicative of a greater risk of coronary heart disease (chd), chronic inflammation, and insulin resistance. the following study is designed to conduct a comprehensive evaluation of consuming an egg-based breakfast compared to an oatmeal-based breakfast on lipid biomarkers, oxidative stress, inflammation, insulin sensitivity, and satiety in young, healthy men and women. the investigators hypothesize that the consumption of 2 eggs per day will not negatively impact plasma lipids in a young, healthy population.


Eligibility criteria:
inclusion criteria: * bmi 18.5-30, willing to consume eggs and oatmeal daily, proficient in english, and with a healthy lipid profile. exclusion criteria: * currently have liver disease, renal disease, diabetes, cancer, history of stroke or heart disease * currently taking glucose lowering drugs or supplements * plasma triglycerides \>500 mg/dl, glucose \>126, total cholesterol \>240 * pregnant, lactating, or have endocrine or metabolic disorders * bmi ≥ 30 * blood pressure \> 140/90 (average of 3 readings) * allergies to eggs * celiac disease or gluten sensitivity

Keywords: risk
comparison of epidural analgesia techniques in percutaneous nephrolithotomy with surgical pleth index

Conditions: Analgesia

Summary: primary aim of this study is to evaluate affect of spi guided antinociception on total intraoperative consumption of local aneshesics during analgesia. secondary aims are defining time interval between la administration and spi value dropping under 50 and hemodynamy. tertiary results are total mean local anesthesic consumption per hour, mean la bolus number, total norepinephrine, ephedrine and atrophine consumption, mean intraoperative heart rate, mean arterial pressure, bis and minimal alveolar concentration, percentage of intraoperative surgery time during which spi\>50, time passed until first post operative analgesia need, time needed to be discharged from pacu after operation (evaluated via aldrte score) and post operative side effects (nausea, vomiting, sedatition and piruritis)


Eligibility criteria:
inclusion criteria: * aged 18-60 * asa i-iii * grade i unilateral pnl exclusion criteria: * bmi \> 40 kg/m2 * drug or alcohol abuse history in the last 6 mounts * chronic opoid usage or had chronic pain longer than 6 weeks * peripheral and central neurological disorders * preoperative hemodynamic disorders * irregular sinus rhythm and pace makers * diabetes, severe lung and major liver diseases with increasing biluribin * use of anti-muscarinics, α2-adrenergic agonists, β1-adrenergic agonists, anti arrhythmic; who used chronic psychoactive drugs in last 90 days * who are pregnant and breast feeding * not willing to participate * allergic or intolerant to any of the drugs in the study * procedures that take less than 2 hours
metabolic support with perhexiline to protect myocardium undergoing coronary artery surgery

Conditions: Myocardial Reperfusion Injury; Cardiac Output, Low

Summary: open-heart surgery causes injury of the heart muscle. although this is usually mild, temporary and reversible, if it is severe it can endanger life and require additional high cost care. during surgery, techniques are used to protect the heart from injury, but these remain imperfect. this study assesses the effect of facilitating sugar metabolism (a more efficient fuel) by the heart muscle using the drug perhexiline given before the operation. this treatment has a sound experimental basis for improving outcome. if this improvement is confirmed surgical results could be improved. the investigators will be studying heart function, heart muscle energy stores and chemicals which quantify the amount of heart muscle injury. the investigators' hypothesis is that perhexiline will improve the protection of the heart by decreasing damage that may occur during heart surgery.


Eligibility criteria:
inclusion criteria: * adult * first-time * isolated coronary artery bypass surgery exclusion criteria: * diabetes mellitus * renal impairment with creatinine greater than or equal to 200micromol/l * atrial fibrillation * amiodarone therapy, recent (in last month) or current * hepatic impairment, significant preoperative * peripheral neuropathy * pregnancy or breast-feeding * emergency surgery or required on clinical grounds within 5 days of referral

Keywords: perhexiline coronary artery bypass myocardial reperfusion injury cardiac output, low troponin
group medical visits for latina women with urgency urinary incontinence

Conditions: Overactive Bladder; Urinary Urgency; Urge Incontinence

Summary: this is a mixed methods study to compare group medical visits (gmvs) to usual care for spanish speaking latina women with urgency urinary incontinence. patients will be randomized to gmvs and to usual care. at the conclusion of each series of gmvs we will hold a focus group for participants.the primary outcome will be improvement in urgency urinary incontinence symptoms.

urinary incontinence, though its effects can be personally devastating, exists most often as a quality of life issue. as such, partnering with the patient toward shared medical decision making is of the utmost importance. research suggests that latina women with pelvic floor disorders are overwhelmed by the amount and speed of information presented by healthcare providers and respond by placing healthcare decisions within the hands of the provider. group medical visits have demonstrated improved quality of life, improved healthcare self-efficacy and closed outcomes gaps in low income groups. we propose a mixed methods study to compare group medical visits (gmvs) to usual care for spanish speaking latinas presenting to gynecology clinics at lac+usc. the study will consist of a randomized control trial of gmvs compared to usual care. in addition we will hold focus group for participants of the gmv arm to gain insight into the patient experience of gmvs and how to improve the visits. the primary outcome will be improvement in urgency urinary incontinence symptoms as measured by the oabq sf. additionally, changes in quality of life and healthcare self-efficacy will be measured before and after the intervention.

Eligibility criteria:
inclusion criteria: patients seen in the urology, gynecology or urogynecology clinics at lac+usc medical center, with a diagnosis of oab, uui or mui not undergoing surgical management, who are able to give informed consent. exclusion criteria: non-spanish speaking, pregnant, unwilling or unable to follow protocol, diagnosis of neurogenic bladder or radiation cystitis or presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
supplementary food for moderate acute malnutrition in children

Conditions: Moderate Acute Malnutrition

Summary: children with moderate acute malnutrition will be recruited in order to receive an intervention which consists in the consumption of a single serving of sf-cookies daily, 7-days a week for 12 months and 12 educational sessions on health and nutrition.


Eligibility criteria:
inclusion criteria: * children (2-5 years old), who are from low socioeconomic classes (e and d classes), * reside in rural areas, and with whz- between \> -3 and ≤ -2, and * informed consent given by the subject's mother or caregiver exclusion criteria: * severe acute malnutrition (haz, waz and whz-scores ≤-3) based on the 2006 world health organization (who) reference values (24) * vitamin a deficiency (softening, ulceration, cloudiness of the cornea, and dryness of the conjunctivitis), and iodine deficiency (visible goiter) * (3 or more episodes of loose/liquid stools/per day and lasted more than 24-hours), fever (high temperature that lasted more than 24 hours as reported by the mother/caregiver), and respiratory infections (coughing and/or runny nose that last more than 24 hours). * current consumption of other supplementary foods. * peanut or other ingredient allergy based on prior report. if some direct family member is allergic to peanuts, child would not be enrolled.
probiotics in the reduction of antibiotic associated diarrhea

Conditions: Clostridium Difficile

Summary: the study will evaluate the effectiveness of probiotic therapy in reducing the incidence of antibiotic associated diarrhea (aad) and clostridium difficile associated diarrhea (cdad) in pneumonia patients.

the study will include patients admitted to good samariatan hospital and placed on the pneumonia order set. after obtaining consent, subjects will be randomized to the proboiotic or placebo group. subjects will be followed for 21 days after starting the study treatment to determine critical outcomes such as incidence of antibiotic-associated diarrhea and c-diff. other outcomes include length of stay, healthcare costs, and death.

Eligibility criteria:
inclusion criteria: * admitted to good samaritan hospital * placed on pneumonia order set * age 18+ exclusion criteria: * patient with inadequate coherency to understand consent * active diarrhea at admission * non-controlled intestinal disease * documented positive c. difficile infection within the 3 months before enrollment * antibiotic use at hospital admission * immunosuppressive therapy * pregnancy * allergic to ingredients in florajen-3 * allergic to ingredients in placebo * immunocompromised state including: * hiv with a low cd4 count * active malignancy receiving chemotherapy * medications including long-term steroids (\>2 weeks), and disease modifying biologic agents * acquired immune deficiency * unable to take oral medication * less than 4 doses of probiotic or placebo * taking probiotic in the past 30 days

Keywords: probiotics antibiotic associated diarrhea clostridium difficile
post-approval study with the kamra inlay

Conditions: Presbyopia

Summary: kamra inlay, to be unilaterally implanted into the cornea of a subject's non-dominant eye. the inlay is to be inserted into a stromal pocket created with a surgical femtosecond laser.

this is a post-approval study of the kamra inlay performance and potential device-related issues in a broader population over an extended period of time after pre-market establishment of reasonable safety and effectiveness. study objectives include: * evaluate the long-term performance (effectiveness) and safety of the device; * evaluate real-world performance of the device in subjects treated by refractive surgeons with a range of experience levels; * evaluate the performance of the device in racial/ethnic subgroups representative of the population for which the device is intended. in addition, the data from a subset of the first 105 subjects who have been enrolled in this study will be used to validate the kamra inlay patient questionnaire (kipq) for the assessment of patients who have received the kamra inlay for the treatment of presbyopia.

Eligibility criteria:
inclusion criteria: 1. meet the indications for use for this device; 2. do not have any of the conditions described in the contraindications in the labeling of the device; 3. are willing and able to provide informed consent; 4. are not participating in any other clinical studies during the course of the study. exclusion criteria: 1. subject has insufficient ability to read or write that would prevent them from completing a questionnaire without help; or 2. subject is not a fluent speaker of u.s. english.
validation study of a new digital treatment test

Conditions: Alzheimer Disease; MCI

Summary: oculomotor behavior and cognitive processing of visual information are intimately connected. ad patients show ocular movement problems. oculomotor deficits are broad consisting mainly of different saccade metrics, altered pupil responses. and smaller and irregular eye vergence movements. here we test an interactive eye-tracking game to improve eye motion control and thereby training cognitive behavior


Eligibility criteria:
inclusion criteria: 1) clinical diagnosis of mci or ad exclusion criteria: 1. severe cognitive deterioration 2. history of neurological disease with clinically relevant impact on cognition 3. severe psychiatric disorder 4. incidental structural brain findings with impact on cognitive impairment 5. presence of relevant visual problems