Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized participants with severe covid-19 pneumonia

Conditions: COVID-19 Pneumonia

Summary: this study will evaluate the efficacy and safety of combination therapy with remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized patients with covid-19 pneumonia.


Eligibility criteria:
inclusion criteria * hospitalized with covid-19 pneumonia confirmed per a positive polymerase chain reaction (pcr) of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest x-ray or ct scan * requiring more than 6 l/min supplemental oxygen to maintain spo2 \> 93% * agrees to not participate in another clinical trial for the treatment of covid-19 while participating in this study exclusion criteria * known severe allergic reactions to tocilizumab or other monoclonal antibodies * known hypersensitivity to remdesivir, the metabolites, or formulation excipients * active tuberculosis (tb) infection * suspected active bacterial, fungal, viral, or other infection (besides covid-19) * in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments * treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months * concurrent treatment with other agents with actual or possible direct-acting antiviral activity against sars-cov-2 within 24 hours prior to study drug dosing. in addition, participants with prior or current treatment with \> 2 doses of remdesivir for covid-19 are excluded * participating in other drug clinical trials * estimated glomerular filtration rate (egfr) \< 30 ml/min (including patients receiving hemodialysis or hemofiltration) * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 5 x upper limit of normal (uln) detected within 24 hours of screening (according to local laboratory reference ranges) * absolute neutrophil count (anc) \< 1000/ul at screening * platelet count \< 50,000/ul at screening * body weight \< 40 kg * treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
study comparing whole breast radiotherapy with a daily versus a weekly tumor

Conditions: Breast Cancer

Summary: all patients (with stages 0-ii breast cancer) will receive an accelerated three week regimen of prone whole breast radiotherapy. the study intends to test the hypothesis that a weekly boost to the tumor bed, delivered on friday, before the weekend break, is as well tolerated as the daily boost during accelerated prone radiotherapy.

arm 1 is a concomitant boost protocol over three weeks which has previously been evaluated in over 500 patients (nyu 03-30 and nyu 05-181) and has shown excellent tolerance, and results. arm 2 evaluates a weekend boost dose (wbd) regimen which may have a radiobiological advantage by counteracting tumor repopulation which can occur over the weekend break. at the time of registration in the study, patients will be randomized to either treatment arm and stratified according to pre or post-menopausal status and on previous chemotherapy received or not.

Eligibility criteria:
inclusion criteria: * pre or post-menopausal women with stage 0,i, and ii breast cancer * biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm * status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (dcis and tumors \<5mm do not require nodal assessment) * at least 2 weeks from last chemotherapy * patient needs to be able to understand and demonstrate willingness to sign a written informed consent document exclusion criteria: * previous radiation therapy to the ipsilateral breast * more than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation * active connective tissue disorders, such as lupus or scleroderma * prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free \>3 years * pregnant or lactating women

Keywords: whole breast radiotherapy tumor bed boost
dose ranging study of pegylated interferon lambda in patients with hepatitis b and positive for the hepatitis b e antigen

Conditions: Hepatitis B Virus

Summary: at least 1 dose of pegifnλ will be identified which is safe, well tolerated, and efficacious for the treatment of chronic hepatitis b virus infection (chb) amendment 7, part b sub study: the primary purpose of this amendment is to obtain preliminary data on the safety of pegylated interferon lambda (lambda) when administered in combination with entecavir(etv) to patients with hepatitis e antigen-positive (hbeag-positive) chronic hepatitis b(chb) infection employing a sequential therapy approach

part b sub study is open label

Eligibility criteria:
inclusion criteria: * infection with the hepatitis b virus (hbv) and positive for the hepatitis b e antigen * between the ages of 18 and 70 * have not been previously treated with an interferon * hbv nucleos(t)ide-naive exclusion criteria: * not infected with the hepatitis c virus (hcv), hepatitis d virus (hdv) or human immunodeficiency virus (hiv) * do not have a serious liver, psychiatric, blood, thyroid, lung, heart or eye disease * able to tolerate oral medication
oral anticoagulation in haemodialysis patients

Conditions: Kidney Failure, Chronic

Summary: guidelines recommend oral anticoagulation with vitamin k antagonists for atrial fibrillation whenever the chads2vasc score is superior or equal to 2. as there are no specific guidelines for the hemodialysis patients with atrial fibrillation, the general guidelines apply. however, several retrospective studies suggest that these patients do not benefit from the oral anticoagulation regarding the risk of stroke and may even experience more bleedings and deaths. the aim of this prospective study is to prospectively compare the hemorrhagic and thrombotic risks of oral anticoagulation in comparison with no anticoagulation in hemodialysis patients with atrial fibrillation.


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years) * patient on hemodialysis treatment for at least 1 month * patient with a history of, or presenting a new episode of atrial fibrillation (either permanent or paroxysmal). * patient with a chads2vasc score ≥2 * patient with high risk of bleeding as defined by (1) hasbled score ≥3 or (2) hasbled ≥ chads2vasc score, or (3) recent history of severe bleeding (type 3a, 3b, 3c), particularly cerebral or gastrointestinal, or (4) prior recurrent (\>2) history of falls. * patient capable of understanding information about the study and of giving his/her consent * patient informed of the preliminary medical exam results * patient with healthcare insurance * written consent signed exclusion criteria: * formal indication to oral anticoagulation beside atrial fibrillation (mechanic heart valves, recurrent thrombophlebitis, antiphospholipid syndrome) * life expectancy \< 6 months (e.g., terminal cancer) * live donor transplantation scheduled within 6 months * pregnancy (β-hcg blood-based assay)or nursing (lactating) women * women of child bearing potential, unless they are using an effective method of birth control * patient under legal guardianship * patients under law protection * known hypersensibility to coumadin or indoine derivatives or to any excipients (ci to oral avk) * severe liver failure (ci to oral avk)
mucosta in gastric ulcer treatment, effectiveness and safety evaluation

Conditions: Gastric Ulcer

Summary: a prospective randomized, multi-center study to assess the safety and efficacy of mucosta (rebamipide), in combination with omeprazole as adjuvant therapy in gastric ulcer patients.


Eligibility criteria:
inclusion criteria: * patients with dyspepsia or epigastric pain and endoscopically proven gastric and duodenal ulcers * required laboratory parameters and time limits (screening blood tests will be taken including hemoglobin, white blood cell count, random glucose, potassium, sodium, chlorine, creatinine, ast, alt, bilirubin, and alkaline phosphatase) * age \> 18 years * a statement that all patients must have signed an informed consent form prior to registration in study exclusion criteria: * patients who had undergone surgery for ulcers * history of hypersensitivity to drugs to be used in the study * women who are pregnant or lactating or intended to get pregnant during the study period
covid-19 vaccine biomarker study in multiple sclerosis

Conditions: Multiple Sclerosis; COVID-19

Summary: sars cov-2 is the virus responsible for the pandemic covid-19, which has resulted in nearly five million deaths worldwide since its spread in the beginning of 2020. in the united states, there are now two emergency use authorized vaccines that make use of messenger ribonucleic acid (mrna) based technology that are highly effective for preventing covid. however, because multiple sclerosis is an autoimmune condition, many individuals with multiple sclerosis take medicines that affect the immune system. the investigators are not sure whether individuals on certain ms medications, including medications that lower a type of immune cell called b lymphocytes, will form as robust of a response to the vaccines. in this study, the investigators will be gathering more information about effectiveness of these vaccines and bloodwork that looks at antibodies and other markers of vaccine response and by asking patients about covid-19 infections.

sars cov-2 is the virus responsible for the pandemic covid-19, which has resulted in nearly five million deaths worldwide since its spread in the beginning of 2020. in the united states, there are currently two emergency use authorized mrna based vaccines against severe acute respiratory syndrome coronavirus 2 (sars-cov-2). multiple sclerosis (ms) is a neurological autoimmune disease involving the central nervous system and requiring long-term immunomodulating therapy to control relapse and progression. while there are many approved medications for the treatment of ms, agents that work through b-lymphocyte depletion or sequestration are among the commonly used treatments. there is concern that individuals with low levels of circulating b-cells might not mount an effective humoral or cellular immune response after vaccination. moreover, it remains to be understood whether, at certain timepoints within the treatment cycle, there is a greater immune response mounted while on b-cell depleting medication. availability of such knowledge could guide counseling and management of patients on immunomodulatory therapy. aim: to ascertain efficacy of mrna based sars cov-2 vaccines in individuals with ms across the immunotherapy spectrum, via biomarker data of humoral and cellular immunity and via clinical data. blood will be drawn for markers of immunity and sequence-based analysis before and after vaccination at predetermined time points. the investigators will document the type of immunotherapy being used at the time of vaccination. clinical data on diagnosis of sars-cov2 infection will be collected at each of the prespecified timepoints.

Eligibility criteria:
inclusion criteria: * diagnosis of any form of multiple sclerosis based on 2017 mcdonald criteria * ages 18 to 70 * no history of prior vaccination against sars-cov-2 at the start of the study exclusion criteria: * unable to obtain blood draws at predetermined time points * pregnant at time of enrollment or planning pregnancy during upcoming 6 month period after vaccination

Keywords: vaccine
effect of a mental wellness app on the mental wellness of medical and nurse anesthesia students

Conditions: Mental Health Issue

Summary: mental health issues and suicide are becoming increasingly common among health care trainees and providers. suicide is the leading cause of death among male medical residents and the second leading cause of death among female residents.

training programs are usually very rigorous, caring for patients is stressful, and those who care for others often feel that they can't or shouldn't admit that they need care themselves. unfortunately, there is often a stigma associated with mental illness, and trainees may feel that admitting that they struggle could damage their careers. the need exists for easily accessible, immediate, crisis support for medical trainees who are experiencing a mental health crisis. although the effectiveness of mental health apps has been evaluated in college students, there is very little data assessing their use in medical and nurse anesthesia students. the purpose of this study is to evaluate the effect of a mental wellness app on the mental wellness of medical and nurse anesthesia students.

Eligibility criteria:
inclusion criteria: * first-year medical students and second-year nurse anesthesia (crna) students from wake forest university school of medicine during the 2023 - 2024 academic year (approximately july 2023 - june 2024). exclusion criteria: * none

Keywords: stress levels anxiety depression
the effects of consuming palm oil with different macronutrient intakes on blood lipids

Conditions: Cardiovascular Diseases; Inflammation

Summary: the purpose of this study is to determine the effects of palm oil when consumed as either part of a low carbohydrate diet or a high carbohydrate diet on blood lipids, cardiovascular health and inflammation. the study will help us better understand how the quality of saturated fat and the quantity of carbohydrate interact to impact blood lipids and cardiovascular health.

the purpose of this study is to determine the effects of palm oil on blood lipids, cardiovascular health and inflammation. potential subjects will be screened until 24 qualifying healthy participants are enrolled. after enrollment participants will undergo a baseline battery of tests including blood draws, body composition, measures of height and weight, blood lipid profile (cholesterol, lipoprotein particle size, quantity and fatty acid composition), insulin sensitivity using a static index, inflammation, antioxidant status and measurement of energy expenditure and substrate oxidation by indirect calorimetry. participants will be randomly divided into one of two arms/tracks, either a low carbohydrate diet arm or a high carbohydrate diet arm. each diet arm consists of 3 phases a low saturated fat control diet where the primary cooking oil is canola oil and two saturated fat diet phases where the primary cooking oil is either palm oil or butter. participants will begin with the low saturated fat diet phase first which consists of 50% of fat calories derived from canola oil for 3 weeks. at the end of this control diet phase the battery of tests completed at baseline will be repeated. after a 2-week washout period participants will then proceed in random order into either the palm oil or butter diet phases of their diet arm/track. the palm oil and butter diet phases are also 3 weeks in duration and separated by a 2 week washout period. the palm oil and butter diet phases will derive 50% of the fat calories from either palm oil or butter. both oils are high in saturated fat but differ in the quality of saturated fat. at the end of each diet phase the testing battery completed at baseline will be repeated. the subjects will never be exposed to more than minimal risk and in return will receive 9 weeks of food, individualized reports of their study results and a monetary stipend. the study will help us better understand how the quality of saturated fat and the quantity of carbohydrate interact to impact blood lipids and cardiovascular health. this knowledge can be used to aid dietary recommendations for cardiovascular health and control of blood lipids.

Eligibility criteria:
inclusion criteria: * normocholesterolemic exclusion criteria: * hypercholesterolemia * diabetes * liver disease * kidney disease * other metabolic or endocrine dysfunction * diagnosis of cancer within the previous 5 years * hypertension * current use of cholesterol reducing medications * current use of diabetic medications

Keywords: lipids saturated fat palm oil
psycho-social impact of amelogenesis and dentinogenesis imperfecta

Conditions: Dentinogenesis Imperfecta; Amelogenesis Imperfecta

Summary: the purpose of this research is to study the impact of dentinogenesis (di) and amelogenesis (ai) imperfecta on oral quality of life, exposure to bullying and dental anxiety in a population of adolescents. wthe present study will use validated scales to evaluate the impact of bullying on the oral quality of live of youth aged 10 to 18 years, with non-syndromic di or ai treated in seven national competence or reference centers in rare oral diseases.


Eligibility criteria:
inclusion criteria: * be between 10 and 18 years of age, * consult for a care or follow-up consultation * having a non-syndromic amelogenesis imperfecta or dentinogenesis imperfecta * having access to a cell phone and/or tablet and/or personal or family computer * covered by the social security of one of his parents * understand french and one of whose parents (or legal representative) understands french * have declared his or her non-opposition and one of whose parents (or legal representative) has declared his or her non-opposition to participate in the study. exclusion criteria: * child presenting for diagnostic consultation and child who cannot read or whose 2 parents (legal representatives) cannot read

Keywords: amelogenesis imperfecta dentinogenesis imperfecta bullying oral health related quality of life dental anxiety
surveillance endoscopy after proximal gastriectomy with double tract reconstruction.

Conditions: Gastric Cancer; Proximal Gastric Adenocarcinoma

Summary: the primary purpose of surveillance endoscopy after gastric cancer surgery is to detect malignancy recurrence in the remnant stomach. this study aims to analyze the rate of proper remnant stomach observation following proximal gastrectomy(pg) with double tract reconstruction (dtr). data from patients who underwent pg with dtr for gastric cancer at six institutions in south korea from 2011 to 2023 were included. clinicopathological and serial endoscopic data were retrospectively reviewed and analyzed. successful surveillance endoscopy was defined as obtaining an endoscopic image of the pyloric antrum. factors associated with successful endoscopy were analyzed using a mixed-effects logistic regression model. a total of 634 surveillance endoscopies were performed on 160 patients after pg with dtr. the median duration from surgery to the endoscopy was 17.5 months (range, 0-137 months). the success rate of the endoscopies was 75.6%, with a mean time of 271.7±300.5 seconds to reach the pyloric antrum. the average total procedure time for successful endoscopic examinations was 439.4±336.0 seconds, compared to 373.7±326.0 seconds for failed examinations. (p=0.033). among patients who underwent the procedure twice or more, 6.5% had all endoscopic examinations fail, while 2.8% of those who underwent the procedure three times or more experienced failure in all examinations. factors associated with successful endoscopy included longer procedure time (or 1.32, 95% ci 1.01-1.72), endoscopy performed by a non-surgeon (or 0.19, 95% ci 0.11-0.36), longer duration after surgery (or 1.33, 95% ci 1.02-1.72) and younger age (or 0.70, 95% ci 0.49-0.97). understanding the anatomic alterations after pg with dtr is crucial for the success of surveillance endoscopy. additionally, the duration from surgery to endoscopy is associated with the success of the examination, and the rate of failure across all serial endoscopies is very low. therefore, clinicians should perform endoscopies with sufficient procedure time and conduct endoscopies regardless of the failure of previous examinations.


Eligibility criteria:
inclusion criteria: patients who underwent proximal gastrectomy with double tract reconstruction and had at least one postoperative surveillance endoscopy. exclusion criteria: patients who did not undergo postoperative surveillance endoscopy.
using calcium dobesilate to treat chinese patients with mild to moderate non-proliferative diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: calcium dobesilate has been recommended to treat diabetic retinopathy due to its potential in protecting against retinal vascular damage. however, there was limited evidence exploring its efficacy in combating diabetic retinopathy progression. this study, a single-blind, multicenter, cluster-randomized, controlled superiority trial, was designed to evaluate whether calcium dobesilate could prevent diabetic retinopathy progression into an advanced stage among chinese patients with mild to moderate non-proliferative diabetic retinopathy.

a total of 1,200 patients with mild to moderate non-proliferative diabetic retinopathy will be enrolled and randomly assigned at a ratio of 1:1 into the control group (that is, conventional treatment group) and the intervention group (that is, conventional treatment plus calcium dobesilate \[500 mg, 3 times per day\] for 12 months). the severity of diabetic retinopathy will be assessed by the early treatment diabetic retinopathy study scale.

Eligibility criteria:
inclusion criteria: * being diagnosed with mild to moderate diabetic retinopathy * being older than 18 years * being willing to attend this trial. exclusion criteria: * being allergic hypersensitive to experimental drugs or comparator drugs * having alanine aminotransferase or aspartate aminotransferase ≥2 times higher than the upper limit of normal value, or total bilirubin ≥1.5 times higher than the upper limit of normal value upon the exclusion of mild fatty liver disease * having severe renal insufficiency (defined as an estimated glomerular filtration rate ≤30 ml/min/1.73 m\^2) * having malignant tumor and some other life-threatening diseases * being in pregnancy, expecting pregnancy, or breast feeding * being with unstable conditions, such as: uncontrolled high blood pressure (e.g., blood pressure \>180/100 mmhg); hemoglobin a1c \>8.0% or uncontrolled high blood glucose or hypoglycemia; acute cardiovascular events like unstable angina, congestive heart failure, stroke, transient ischemic attack, or myocardial infarction within the previous 3 months; uncontrolled infection; and diabetic ketoacidosis or hyperosmolar state in the past 1 month * being with glaucoma, cataracts, or other opacities that may interfere with retinal examination and fundus photography * receiving laser treatment, cryo-coagulation, or vitrectomy * taking drugs such as diabetic retinopathy or traditional chinese medicine that may help to improve micro-vascular function in the past 2 weeks * receiving vascular endothelial growth factor therapy in the past 4 months or will be judged to take vascular endothelial growth factor therapy because of disease progression * having attended other clinical trials in the past 1 month, being attending some clinical trials, or some other conditions that were judged unfit for this trial by investigators

Keywords: calcium dobesilate mild to moderate non-proliferative diabetic retinopathy cluster-randomized controlled trial