Kornimate/medical-research-clean huggingface dataset:
a study of bms-986466 with adagrasib with or without cetuximab in participants with kirsten rat sarcoma virus glycine 12 to cysteine (kras g12c)-mutant solid tumors

Conditions: Advanced Solid Tumors

Summary: the purpose of this study is to find a safe, tolerable, and efficacious dose of bms-986466 when given orally, in combination with adagrasib with or without cetuximab in participants with advanced kras g12c-mutant non-small cell lung cancer (nsclc), pancreatic duct adenocarcinoma (pdac), biliary tract cancer (btc), or colorectal cancer (crc).


Eligibility criteria:
inclusion criteria: key inclusion criteria: part 1: * individuals with a confirmed diagnosis of advanced kras g12c mutant nsclc, crc, pdac and btc that has spread to other parts of the body and cannot be removed surgically, may or may not have received previous treatment with kras g12c inhibitors. * for nsclc and crc: individuals must have a documented kras g12c mutation status from nys or fda approved/cleared or ce marked test or, when such result is not available, positive kras g12c mutation status should be confirmed by a central laboratory in blood sample collected at the time of screening. * for pdac and btc: participants must have a documented kras g12cmutation from nys or fda-approved/cleared, or ce-marked test and blood samples will be collected only for retrospective testing. * are relapsed or refractory to available standard of care treatments. part 2: * individuals with a confirmed diagnosis of advanced kras g12c-mutant nsclc (part 2a) or crc (part 2b) that has spread to other parts of the body and cannot be removed surgically and have not received previous treatment with kras inhibitors. * individuals must have a documented kras g12c mutation from fda or nys approved/ cleared or ce marked test or, when such result is not available, positive kras g12c mutation status should be confirmed by a central laboratory in blood sample and /or tumor samples collected at the time of screening or from archival biopsies (less than 1 year old). * have failed or disease recurrence or are not able to tolerate after at least 1 pervious line of therapy. key exclusion criteria: * have tumors with known barf v600x, ptpn11 or krasq61x mutations. * have or any significant heart disease or condition. * receiving any medications that are substrate of cyp3a4 or inducers and/ or inhibitors note: other protocol-defined inclusion/exclusion criteria apply.

Keywords: bms-986466 kras g12c-mutant pancreatic duct adenocarcinoma biliary tract cancer colorectal cancer non-small cell lung cancer
a study on the bone-health effectiveness of applying recombinant factor viii fc (rfviiifc) to patients with hemophilia a (prototype a)

Conditions: Severe Hemophilia A Without Inhibitor

Summary: study objectives\* 1. provide a systematic evaluation of the treatment outcomes in patients with hemophilia a 2. emphasize the importance and clinical benefits of rfviii-fc in joint and bone health. 3. compare the clinical outcomes from 1 year before and after switching to ehl. 4. exploratory: identify biomarkers that could provide more useful and convenient evaluations of joint and bone health. (time-saving and easy to monitor)

in this study, we would like to focus on the evaluation of joint and bone health in persons with severe hemophilia a (pwha) treated with rfviiifc prophylaxis. we also aim to identify potential biomarkers for assessing the joint and bone health of pwha. since the joint and bone health examinations are time-consuming, expensive, and require special equipment, the patients could only receive the examinations annually to realize the status of their joint health. the biomarkers testing will provide a more convenient and time-saving option on the joint and bone health evaluation for pwha. therefore, surrogate of biochemical marker(s) to represent the joint and bmd progression is an unmet need for clinical practice. investigating different biomarkers and combining them with the joint and bmd results to provide a systematic approach for elucidating the treatment outcomes of pwha treated with rfviiifc is major goal of this study.

Eligibility criteria:
inclusion criteria: 1. patients with severe hemophilia a (all ages). 2. patients with moderate type hemophilia a with hemophilic arthropathy. 3. currently on rfviiifc regular prophylaxis and have previous medical record with regular prophylaxis with standard half-life product for one year 4. able and willing to undergo joint and bone examinations exclusion criteria: 1. participants of other interventional studies. 2. patients with current inhibitors. 3. history of major neurological disease (eg. stroke, parkinson's disease, neuropathy, etc.) 4. history of major psychiatric disease (eg. schizophrenia, bipolar disorder) 5. significantly impaired vision/hearing
mechanisms of weight loss with sglt2 inhibition

Conditions: Type 2 Diabetes; Overweight; Obesity

Summary: the purpose of this study is to investigate the effect of canagliflozin, a medication approved by the fda for the treatment of type 2 diabetes, on body weight and metabolism in people with type 2 diabetes who are overweight or obese. canagliflozin lowers glucose levels in the blood by making the kidneys excrete, rather than absorb, glucose. canagliflozin is also often associated with weight loss. the study population will generally be type 2 diabetics, ages 18-75 years old, who are overweight or obese.


Eligibility criteria:
inclusion criteria: 1. type 2 diabetes 2. bmi 25-45 kg/m2 3. hemoglobin a1c \> 6.5% but \< 9% 4. normal renal function (gfr \> 60) 5. age 18-75 exclusion criteria: 1. type 1 diabetes 2. history of recurrent uti or mycotic genital infections 3. treatment with insulin or a glp1 agent 4. pregnant or breastfeeding

Keywords: canagliflozin obesity weight loss body weight body weight changes overweight sodium-glucose transporter subtype 2 inhibitor
study of sand versus wood chip surfaces on school playgrounds to minimize injury in school children

Conditions: Wounds and Injuries; Closed Head Injury

Summary: this study will compare children's injury rates (arm fracture, head injury and other injuries) when playing on playground equipment on granite sand versus wood fibre playing surfaces. the hypothesis is that injury rates (arm fracture, head injury and other injuries) among school children are equal on granite sand and wood fibre playground surfaces.


Eligibility criteria:
inclusion criteria: * school children * ages 5-11 * injured on falls from play equipment during supervised school hours exclusion criteria: * children injured outside of supervised school hours

Keywords: pediatrics injury arm fractures trauma playground surfaces fractures
effects of rifampicin and probenecid on the pharmacokinetic profile of rongliflozin in healthy subjects

Conditions: Type 2 Diabetes Mellitus

Summary: this is a phase i, open-label, fixed-sequence study in healthy chinese subjects, performed at a single study centre. cohort a will assess the pharmacokinetic (pk) profile of rongliflozin when administered alone and the combination with rifampicin; cohort b will assess the pk profile of rongliflozin when administered alone and combination with probenecid.


Eligibility criteria:
inclusion criteria: * sign the informed consent form before the trial and fully understand the trial content, process and possible adverse reactions; * be able to complete the test according to the requirements of the protocol; * subjects (including partners) are willing to take effective contraceptive measures from screening to 6 months after the last dose of drug administration; * male subjects weigh at least 50 kg and female subjects at least 45 kg. body mass index (bmi) = weight (kg)/height 2 (m2), bmi within the range of 18 to 28 kg/m2 ; * physical examination and vital signs are both normal or do not have clinical significance. exclusion criteria: * smoking more than 5 cigarettes per day; * those who are allergic to or have allergies to the test drug; * have a history of drug or alcohol abuse; * blood donation or massive blood loss (\>450 ml) within three months prior to screening; * difficulty swallowing or any history of digestive system diseases which could affect drug absorption and excretion within 6 months before screening; * taking any drugs that could alter liver enzyme activity, such as barbiturates, rifampin, etc., within 30 days before screening; * have taken any prescription, over-the-counter, vitamin product or herbal medicine within 14 days prior to screening; * have taken special diets (including dragon fruit, mango, grapefruit, etc.) or exercised strenuously within 2 weeks before screening; * take an inhibitor or inducer of glucuronide transferase (ugt), p-glycoprotein (p-gp) or breast cancer resistance protein (bcrp), such as itraconazole, ketoconazole, or dronedarone, within 30 days before screening; * significant changes in dietary or exercise habits within 2 weeks prior to screening; female subjects are breastfeeding or have a positive blood pregnancy result during the screening period; * during the screening period, the serum uric acid level was \>420 µmol/l, or had a history of gout; during the screening period, the estimated glomerular filtration rate (egfr) was \<90 ml/min/1.73m2) or had a history of kidney stones or bladder stones (applicable to cohort b); * have a clinically significant laboratory tests or medical history; * positive for hepatitis b, hepatitis c, aids, syphilis; positive for urine drug test; * history of urinary tract infection or genital infection before 6 months * those who participated in any drug clinical trial and used the experimental drug 3 months ago; * subjects with other factors deemed inappropriate by the investigator.
german adrenocortical carcinoma registry

Conditions: Adrenocortical Carcinoma

Summary: basic objective of the german adrenocortical carcinoma registry is to improve the care of patients with adrenocortical cancer. the registration of as many patients as possible helps to collect data for the prognosis and prospects of success regarding different treatment plans. this data will be taken into consideration for planning prospective studies. with this registry, the recruitment of patients for prospective studies will be significantly facilitated. in this way - and in cooperation with networks in other countries (e.g. in italy and france) - a structure allowing systematic improvement of therapy will be developed.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of adrenocortical carcinoma

Keywords: adrenal cancer treatment surgery mitotane
saalt: subtracting salt and adding losartan trial (0954a-335)

Conditions: Hypertension

Summary: to evaluate the effectiveness of diet management with a losartan based titration regimen versus losartan based titration regimen alone on blood pressure reduction in hypertensive patients.


Eligibility criteria:
inclusion criteria: * non diabetic, newly diagnosed and untreated for mild to moderate hypertension (blood pressure \> 161; \< 221; 140/90 mm hg but \< 180/110 mm hg) * non diabetic, newly diagnosed and untreated for severe hypertension (blood pressure \> 180/110 mm hg but \< 200/120 mm hg); patients who are asymptomatic with no evidence of significant end organ damage including direct pressure effects can be included. patients in an urgency/emergency state are to be excluded * or diabetic, newly diagnosed with hypertension and untreated with mild to moderate hypertension (blood pressure \> 161;\ 161;\ 161;\ 161;\< 221; 150/90 mm hg * the antihypertensive agent will need to be discontinued prior to starting study drug exclusion criteria: * known secondary hypertension of any aetiology (e.g., uncorrected renal artery stenosis, malignant hypertension, hypertensive encephalopathy. patient with symptomatic heart failure (classes 3 and 4). patient with a prior myocardial infarction or stroke within the last 6 months * patient has undergone percutaneous coronary angioplasty, has had coronary artery bypass within the last 6 months or has unstable angina * patient with anuria or confirmed clinically significant renal or hepatic dysfunction (taken from current/past medical records) and/or electrolyte imbalance laboratory test within the last 3 months prior to visit 1: serum creatinine \> 130 ìmol/l or creatinine clearance \ 3 times above the normal range, alt \> 3 times above the normal range, serum potassium \ 5.5 meq/l * significant liver or respiratory disease, cancer or other concomitant disease that is likely to affect life expectancy of the patient
assessing the system for high-intensity evaluation during radiotherapy during changes in response to covid-19

Conditions: COVID-19; Cancer

Summary: the primary objective of this research study is to assess radiation oncology healthcare providers (i.e. faculty, residents and advanced practice providers (apps) implementation and perception of telehealth for on treatment patients in lieu of in person on treatment visits during standard of care radiotherapy during covid-19.

a secondary aim will be to evaluate the rates of acute care during covid-19 with telehealth in comparison to the rates during our prior quality improvement (qi) project (nct04277650), considering the risk prediction based on our previously developed ml algorithm. patient risk during this period will be assessed by the ml algorithm and actual rates of emergency department visits and hospitalizations (acute encounters) will be compared to the results of our prior qi project. these data will be used to discern how actual rates of acute care compare to providers' expectations both with and without telehealth implementation. reasons for acute encounters and associated healthcare costs compared to patients undergoing standard of care assessments in nct04277650 will be assessed to determine the percentage that are covid-19 related. basic demographic, disease, location of acute care, form of clinical assessments (video, in-person, telephone, etc.), and treatment information regarding the patients will also be captured following the completion of the research project for assessment. these endpoints will establish how our current covid-19-based precautions impact treatment-related outcomes in patient care.

Eligibility criteria:
inclusion criteria: • started outpatient radiation therapy with or without concurrent systemic therapy at duke cancer center during the covid-19 outbreak exclusion criteria: * undergoing total body radiation therapy for hematopoetic stem cell transplantation * undergoing therapy as inpatient * completed radiation therapy prior to algorithm execution
frda investigator initiated study (iis) with elamipretide

Conditions: Friedreich Ataxia

Summary: to evaluate the safety, tolerability, and activity of elamipretide in treating vision loss in friedreich ataxia (frda).

to evaluate the effect of high dose (40-60mg) versus low dose (20-30mg) elamipretide on high contrast visual acuity in frda compared to baseline at 52 weeks with the option to extend for an additional 52 weeks if there are objective signs of clinical improvement on primary or secondary endpoints. the interim analysis will be based on data from a 36-week visit. for subjects worse than 20/800 at study start, they will be followed using low vision alternatives only.

Eligibility criteria:
inclusion criteria: 1. genetically confirmed frda (point mutations allowed). 2. age \>16 years. 3. disease onset before 18 years of age. 4. if female, the subject is not pregnant or lactating or intending to become pregnant before, during, or within 30 days after the last dose of study drug. female subjects of child-bearing potential must have a negative serum pregnancy test result at screening, a negative urine pregnancy test result at baseline. 5. all subjects must agree to use a reliable method of contraception throughout the study and for 30 days after the last dose of study drug. male subjects should not father a baby during the study or for at least 30 days after the last dose of study drug. 6. all concomitant medications (including over-the-counter medications), vitamins, and supplements must be at stable doses for 30 days prior to study entry and kept stable throughout the study to the best of their ability. 7. visual acuity (va) worse than 20/40 (binocular) on the basis of frda. must not be correctable by refraction, or subjects must have sufficient physical exam findings of optic neuropathy (funduscopic, visual fields, or retinal ganglion cell loss) to justify the primary diagnosis of frda related optic neuropathy or 8. ejection fraction (ef) less than 50% at last evaluation (within 1 year before screening), with a history consistent with cardiomyopathy from frda, and va 20/25- 20/40. exclusion criteria: 1. any unstable illness that in the investigator's opinion precludes participation in the study. 2. use of any investigational product within 30 days prior to screening. 3. a history of substance abuse. 4. diagnosis of active hiv or hepatitis b or c infection. 5. presence of severe renal disease (egfr \ 2x the upper limit of normal\] as evidenced by laboratory results at screening. 6. clinically significant abnormal white blood cell count (anc \ 500 k) as evidenced by laboratory test results at screening. 7. any other active cause of optic neuropathy (vitamin b12 deficiency, vitamin e deficiency, etc.) or cardiac disease 8. ef less than 35% at last echocardiographic evaluation 9. uncontrolled arrhythmia 10. current use of any systemic chronic immunosuppressive drugs 11. current use of metformin

Keywords: friedreich ataxia
impact of computerized physician order entry on medication prescription errors in the intensive care unit: a controlled cross-sectional trial.

Conditions: Medication Errors; Patient Safety

Summary: device: computerized physician order entry. we wanted to investigate if the introduction of a computerized intensive care unit system reduced the incidence and severity of medication prescription errors (mpes). a prospective trial was conducted during 5 weeks in a paper-based unit versus a computerized unit. the registration of different classes of mpes was done by a clinical pharmacist. an independent panel evaluated the severity of mpes.


Eligibility criteria:
inclusion criteria: * adult patients admitted to the surgical intensive care unit exclusion criteria: * adult patients admitted to other units * pediatric patients
the use of lansoprazole to treat infants with symptoms of gastroesophageal reflux

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of this study is to assess the safety and efficacy of lansoprazole microgranules oral suspension, once daily (qd), in infants with gastroesophageal reflux symptoms during a 4-week treatment period.

this study will be conducted by approximately 20 investigative sites in the u.s. and poland. participants who qualify will be randomized in equal proportions to receive either lansoprazole pediatric suspension (0.2-0.3 mg/kg/day in infants \ 10 weeks of age) or placebo. this study consists of three periods: pretreatment period of 7-14 days, double-blind treatment period of 4 weeks (dosing), and the post-treatment period of 30 days (follow-up).

Eligibility criteria:
inclusion criteria: * at least 7 days post-surgery at the time of screening (study visit 1) with no anticipated need for surgery during the study. * experiencing symptoms of gastroesophageal reflux disease (regurgitation, vomiting or "spitting up," fussing/irritability, feeding refusal, crying during feeding, arching back, poor weight gain, or extraesophageal manifestations) or endoscopy proven reflux disease. * must continue to have reflux symptoms during the pretreatment period despite reducing or eliminating exposure to tobacco smoke, using one positioning and feeding strategy the last 7 days as documented in the daily diary. * the infant exhibited crying, fussing, or irritability during or within 1 hour of feeding in \>25% of all feedings during the last 4 days of the pretreatment period as documented in the daily diary. exclusion criteria: * body weight \<2.0 kilogram at dosing day 1 of the double-blind treatment period. * unstable, congenital or acquired, clinically significant disease of any major organ system (cardiovascular, respiratory, renal, hepatic, metabolic, etc.), including suspected and/or documented culture-proven sepsis. * coexisting esophageal disease (e.g., eosinophilic esophagitis, viral, bacterial or fungal infection) or caustic or physiochemical trauma to the esophagus. * any congenital anomaly of the upper gastric intestinal tract that might interfere with gastrointestinal motility, ph, absorption, or active or known history of necrotizing enterocolitis that has been surgically corrected. * use of a proton pump inhibitor within 30 days prior to dosing day 1. * use of h2 blockers (i.e. zantac) within 7 days prior to dosing day 1. * allergy to proton pump inhibitors (i.e. prilosec, prevacid). * use of prokinetics (e.g., metoclopramide) unless on a stable dose for at least 3 days prior to entering the pretreatment period. * unable to obtain stable drug levels after continuous treatment with required drugs including theophylline derivatives, digoxin, phenytoin, phenobarbital, or carbamazepine within the 7 days prior to dosing day 1. * clinically significant abnormalities in clinical laboratory values.

Keywords: gastroesophageal reflux disease infant lansoprazole oral suspension ppi