Kornimate/medical-research-clean huggingface dataset:
real-world evaluation of prevalence of ocular adverse events in patients with neovascular (wet) age-related macular degeneration (amd) who received anti-vascular endothelial growth factor (vegf) agents (komodo health)

Conditions: Age-related Macular Degeneration (AMD)

Summary: this was the cross-sectional study to assess the period prevalence of ioi in patients with wet amd who were treated with anti- vegf agents (excluding brolucizumab) over a one-year period in 2019.

in this cross-sectional study of patients with wet amd who received ≥1 anti-vegf injection (excluding brolucizumab), evidence was generated to describe the period prevalence of specific ocular aes. the study was conducted using the komodo healthcare map, and all results were based on the study period from 01/01/2018 to 12/31/2019. komodo healthcare map data from 01/01/2018 to 12/31/2019 for patients with a diagnosis of wet amd who were treated with ≥1 anti-vegf agent (excluding brolucizumab) were included. * identification period: patients fulfilling the selection criteria during the period from 01/01/2019 to 12/31/2019 were identified * index date: 01/01/2019 * study period: 01/01/2018 to 12/31/2019 * pre-index period: 01/01/2018 to 12/31/2018 * post-index period: 01/01/2019 to 12/31/2019

Eligibility criteria:
inclusion criteria: * ≥1 international classification of diseases, clinical modification-9/10 (icd-9/10) code for wet amd in 2019 * ≥1 healthcare common procedure coding system (hcpcs) code (j code) or national drug code (ndc) code for treatment with an anti-vegf agent (excluding brolucizumab) in 2019 * ≥18 years old in 2019 * ≥2 wet amd-related office visits in 2019 exclusion criteria: - ≥1 hcpcs code (j code) or ndc code for treatment with brolucizumab in 2019

Keywords: amd, brolucizumab, anti-vegf switchers, treatment-naive
the combiotic-study

Conditions: Healthy Term Infants

Summary: the primary objective of this study is to demonstrate that a synbiotic formula, fed for the duration of the first year of life (infant and follow-on formula) reduces the incidence rate of episodes of infectious diarrhea in infants during the first year of life compared to a standard infant formula.


Eligibility criteria:
inclusion criteria: * healthy term infants * female or male gender * gestational age between 37 and 41 weeks completed (= 41 weeks + 6 days) * age at time of v1 visit : 4 +/- 7 days * birth weight between 2500 ans 4200g, with regular weight gain (≥ 150g / week) * two legal representatives (parent(s) / guardian(s)) who are capable of and willing to comply with the protocol and have signed the informed consent in accordance with legal requirements. * at least one of the legal representatives is affiliated to with a social security scheme. additionnaly , criteria of inclusion in one of the formula-fed groups or in the breast-fed group, respectively, are the following: * to be included in one of the formula arm, infants will have to be exclusively formula-fed (no breast milk meal) at the time of v1 visit (randomization). or * to be included in the breastfeeding arm, infants will have to be exclusively breast-fed (no more than one formula meal per day) at v1 visit (randomization) and its mother will have to be willing to pursue exclusive breastfeeding at least until the infant will be 4-month old. exclusion criteria: * intensive care during at least the first 14 days of life * neonatal health problems, such as: respiratory distress, asphyxia, hypoglycemia, sepsis, nec (necrotizing enterocolitis),... * clinical evidence of chronic illness or gastrointestinal disorders such as : ger (gastrooesophageal reflux), gastroenteritis,... * known metabolic disorders, such as diabetes, lactose intolerance,.... * known immune deficiency * subjects recommended to receive formula with hydrolized protein (e.g. children with allergy risk) * subject under oral antibiotic treatment at v1 visit * participation in another biomedical study * whose legal representatives have psychological or linguistic incapability to sign the informed consent form * reasons to presume that parents are unable to meet the study plan requirements (e.g. impossibility to contact study representatives in case of emergency, drug addiction etc)

Keywords: synbiotic formula infant formula diarrhea
compare the pharmacokinetics and safety of ckd-391

Conditions: Hyperlipidemias

Summary: phase i clinical trial to compare the pharmacokinetics and safety of ckd-391 with co-administration of d090 and d337 in healthy adult volunteers


Eligibility criteria:
inclusion criteria: 1. between 19 aged and 45 aged in healthy male adult 2. subjects in good health as determined by physical exams and medical examinations. no congenital or chronic diseases and no abnormal signs determined by medical examinations. 3. not abnormal or not clinically significant lab values. 4. subjects who signed informed consent form with good understandings after explanations by investigators. exclusion criteria: 1. no history or presence of clinically significant diseases. 2. subjects showing adverse reaction to investigational product 3. genetic problems in galactose intolerance, lapp lactose deficiency, or glucose-galactose malabsorption. 4. history of myopathy 5. unable to stop drinking and smoking during clinical trials 6. subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days 7. history of drug abuse 8. disagree to contraception 9. subjects who are in any conditions impossible participating in the clinical trials
nidek rs3000 comparative study

Conditions: Glaucoma; Retinal Disease; Corneal Disease

Summary: the primary objective of this clinical study is to compare the nidek rs-3000 optical coherence tomography (oct) device to the optovue rtvue oct. the secondary objective is to evaluate any adverse events found during the clinical study.


Eligibility criteria:
inclusion criteria: 1. subjects of legal age and who have full legal capacity to volunteer on the date the informed consent is signed. 2. subjects who follow the instructions by principal/clinical investigator or clinical staff at the clinical site, and can visit on a scheduled examination date. 3. subjects who sign an informed consent form to participate in the clinical study. 4. subjects who agree to take the qualifying examination and rs-3000 and rtvue data acquisition. exclusion criteria: 1. diabetes mellitus (dm) and/or diabetic retinopathy 2. hypertension (ht) 3. cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision 4. cardiac, hepatic, renal and hematologic diseases 5. current systemic administration of steroid 6. history of anticancer agent etc. 7. optically-stimulated epileptic seizure 8. dementia 9. subjects who have other life threatening and debilitating systemic diseases note: additional detailed inclusion/exclusion ophthalmic criteria dependent upon study population also exist

Keywords: viewing and axial cross sectional imaging of ocular structures, including the anterior chamber
a study to assess the effect of pf-03893787 on lung function following an allergen challenge in asthmatic subjects

Conditions: Asthma

Summary: pf-03893787, a novel anti-inflammatory agent should attenuate the effect of a bronchial allergen challenge on lung function and hence provide proof of mechanism for this agent.


Eligibility criteria:
inclusion criteria: * males and females 18-60 years. * mild asthma * atopic to allergens exclusion criteria: * unstable asthma. * smokers or recent ex-smokers * recent allergen challenge

Keywords: asthma allergen challenge
802np302 efficacy and safety study of biib074 in participants with trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: the primary objective of the study is to evaluate the efficacy of biib074 in treating pain experienced by participants with trigeminal neuralgia (tn). the secondary objectives are to investigate the safety and tolerability of biib074 in participants with tn and to evaluate the population pharmacokinetic(s) (pk) of biib074.


Eligibility criteria:
key inclusion criteria: * a diagnosis of trigeminal neuralgia (tn) for at least 3 months based on international headache society (ihs) diagnostic criteria. * participant must have failed at least 1 prior standard of care pharmacologic treatment for tn (defined as an inadequate response or intolerance to treatment), as determined by the investigator based on medical history. * age ≥18 years at the time of informed consent. * participants must have recorded their pain score in their ediary on at least 5 days during the run-in period (days -7 to -1). * allowed concomitant medications must have been stable for at least 4 weeks prior to day 1 of the dose-optimization period. the maximum dosage of carbamazepine allowed on day 1 is 400 mg/day (or 600 mg/day for oxcarbazepine). key exclusion criteria: * history or positive test result at screening for hepatitis c virus antibody or current hepatitis b infection (defined as positive for hepatitis b surface antigen \[hbsag\] and/or hepatitis b core antibody \[hbcab\]). * positive history of human immunodeficiency virus (hiv) or a positive hiv test at screening. * participants with facial pain other than tn. * personal or family (first-degree relative) history of seizures (except for simple febrile convulsions) or clinically significant head injury. * positive drug screen for drugs of abuse at screening (amphetamine \[methamphetamines and 3,4-methylenedioxymethamphetamine\], phencyclidine, barbiturates, benzodiazepines, cocaine, opioids) except if explained by use of allowed prescription medicines. prospective subjects with a positive screen for tetrahydrocannabinol must agree to discontinue use upon study enrollment and for the duration of the study. * known hypersensitivity to biib074 or components of the biib074 formulation or matching placebo. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: tgn tn
bcx9930 for the treatment of paroxysmal nocturnal hemoglobinuria (pnh) in participants not receiving other complement inhibitor therapy

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Summary: the purpose of this study was to determine the efficacy and safety of bcx9930 monotherapy for the treatment of adult participants with pnh not currently receiving complement inhibitor therapy.

this was a randomized, placebo-controlled, double-blind, parallel-group, 2-part study. parts 1 and 2 was to be conducted in the same participants. part 1 of the study was designed to evaluate the efficacy, safety, and tolerability of treatment with oral bcx9930 monotherapy for 12 weeks versus placebo in participants with pnh who were not currently receiving treatment with complement inhibitor therapy. participants were randomized to receive bcx9930 or placebo under double blind conditions for the 12-week randomized treatment period. the primary efficacy and safety analyses were based on part 1. part 2 of the study was designed to evaluate the long-term safety, tolerability, and effectiveness of open-label bcx9930 monotherapy when administered through week 52. all participants in part 2 received bcx9930. participants who were randomized to bcx9930 monotherapy in part 1 continued to receive bcx9930 in part 2. participants who were randomized to placebo in part 1 discontinued that therapy at the week 12 visit and received bcx9930 in part 2.

Eligibility criteria:
inclusion criteria: * male or female, aged ≥ 18 years old * body weight ≥ 40 kg * documented diagnosis of pnh * no complement inhibitor therapy for ≥ 12 months prior to screening * contraindication to or no access to approved (c3 or c5) complement inhibitor therapies * documentation of current vaccinations against neisseria meningitidis and streptococcus pneumoniae or willingness to start vaccination series * at screening: pnh clone of ≥ 10%, hemoglobin ≤ 10.5 g/dl and lactate dehydrogenase ≥ 2 × upper limit of normal exclusion criteria: * known history of or existing diagnosis of hereditary complement deficiency * history of hematopoietic cell transplant or solid organ transplant or anticipated candidate for transplantation * myocardial infarction or cerebrovascular accident within 30 days prior to screening, or current and uncontrolled clinically significant cardiovascular or cerebrovascular condition * history of malignancy within 5 years prior to the screening visit * active bacterial, viral, or fungal infection or any other serious infection within 14 days prior to screening * treatment with anti-thymocyte globulin within 180 days prior to screening * initiation of treatment with an erythrocyte or platelet growth factor, or danazol within 28 days prior to screening * receiving iron supplementation with an unstable dose in the 28 days prior to screening

Keywords: bcx9930 factor d inhibitor proximal complement inhibitor oral therapy paroxysmal nocturnal hemoglobinuria
investigating the effect of simulated live piano music on preoperative cancer patients, health care providers and hospital volunteers using validated questionnaires and proteomic analysis

Conditions: Symptoms and Signs Involving Cognition Perception Emotion & Behaviour; Abdominal Cancer Patients

Summary: the goal of this research study is to learn if simulated live piano music can change the amount of stress felt in patients with cancer before surgery, health care providers caring for cancer patients, and/or hospital volunteers. this is an investigational study. up to 304 participants (200 patients, 52 volunteers, and 52 healthcare providers) will be enrolled in this study. all will take part at md anderson.

if you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. participants in the first group will wait for 30 minutes in a standard pre-surgery waiting area without music. participants in the other group will go to a waiting room with a steinway spirio grand piano that plays 30 minutes of simulated piano music. a steinway spirio grand piano is a special type of piano that plays music by itself (also called a player piano). the music will be chosen by the study staff and pre-recorded on the piano. although the keys will move on the piano as if someone is playing the piano, you will be alone in the room. you will have an equal chance (50/50) of being assigned to either group. both you and the person in charge of this study will know to which group you have been assigned. you do not get to choose which group you are in. study procedures: before and about 30 minutes after you either listen to music or stand in the waiting room without music: * blood (about 1½ teaspoons each time) will be drawn to learn how your body is responding to the music or silence by measuring the amount of cortisol in your body (a type of hormone related to stress) and for biomarker testing. biomarkers are found in the blood and may be related to your reaction to the music or silence. if you are a healthcare provider or volunteer, you will not have these blood draws. * you will complete 2 questionnaires about your anxiety and stress levels. it should take about 20-30 minutes to complete. length of study: you participation on this study will be over after the last blood draw and questionnaire are completed.

Eligibility criteria:
inclusion criteria: 1) patients: to preserve a homogenous cohort and comply with the departmentally-organized research infrastructure, we will include ppreoperative abdominal cancer patients undergoing surgery, or healthcare provider from all specialties at mdacc or volunteer from mdacc volunteer service. exclusion criteria: 1. cannot give informed consent 2. are deaf or hearing-disabled 3. less than 18 years in age 4. profess extreme dislike of music. 5. wait time is longer than 240 min. 6. underlying structural brain abnormality or neurologic comorbidity

Keywords: symptoms and signs involving cognition perception emotion & behaviour abdominal cancer patients musical preop intervention surveys questionnaires blood draws
improving the diagnosis of tonsillitis in emergency rooms

Conditions: Tonsillitis

Summary: a point-of-care laboratory (poc) was set at north hospital, marseille, france for the diagnosis in less than two hours of tonsillitis caused by known pathogens, close to the reception of emergency service. in this instance 30% of patients have no etiological diagnosis after the poc tonsillitis tests . this lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large deoxyribonucleic acid (dna ) viruses. also, the laboratory of emerging viruses discovered many ribonucleic acid (rna) viruses transmitted by arthropods. based on this collection of new pathogens described in poc laboratory, this study proposes to expand the etiological diagnosis strategy of tonsillitis after poc tests. the objective of this study is to implement a new diagnosis strategy relying on the hypothesis that a second pharyngeal swab would improve the etiological diagnosis of tonsillitis of at least 5%.


Eligibility criteria:
inclusion criteria: * patient admitted at hospital for tonsillitis requiring, for the emergency physician, a microbiological examination with a "poc tonsillitis kit." * patient who has freely signed the informed written consent * patient affiliated to a social security scheme exclusion criteria: * pregnant woman, parturient or nursing * adult patient under guardianship * patient deprived of liberty under court order * patient refusing or unable to sign the informed consent form.
comparison of inflammatory profiles and regenerative potential in alcoholic liver disease

Conditions: Liver Diseases; Acute on Chronic Hepatic Failure

Summary: the main objective of this study is the comparison of the profile of the pro-inflammatory cytokines at the patients suffering from an alcoholic hepatitis to that of two groups witnesses: patients suffering from an alcoholic cirrhosis and unhurt patients of chronic liver disease


Eligibility criteria:
inclusion criteria: * group a: patients with acute alcoholic hepatitis * active alcohol abuse defined by dsm iv and excessive alcohol consumption prior to admission (\> 60 g per day for men and\> 40 g per day for women) * moderate elevation of transaminases (less than 500 u / l) with a typical asat / alat ratio of 2: 1 * bilirubin\> 50 mg / l * absence of autoimmune liver disease (ana \<1/80, aml \<1/80, lkm1 neg, aam neg) * absence of hepatitis b and c and hiv infection (negative anti-hiv antibodies, negative hbsag, negative hcv pcr) * patients with other acute complications than alcoholic hepatitis may be included (eg, digestive hemorrhage, acute renal failure, infection, etc.) * because there is no validated noninvasive tool for the diagnosis of alcoholic hepatitis, histological confirmation is required in all patients (preferably by transjugular biopsy): alcoholic hepatitis will be diagnosed on the presence of the following histological characteristics: hepatocellular lesions (ballooning, mallory body)/ inflammatory infiltrate with polymorphonuclear neutrophils * group b1: patients with alcoholic cirrhosis * decompensated or non-decompensated alcoholic cirrhosis, defined according to the has guidelines, ie by a liver biopsy or a cluster of clinico-biological arguments (www.has-sante.fr) * group b2: patients free from chronic liver disease * justification of blood and liver sampling for the management of a pathology other than chronic liver disease (eg liver metastasis of digestive cancer occurring on healthy liver) exclusion criteria: * for groups a and b1: * patients with hepatocellular carcinoma of progressive non-hepatic cancer * presence of hbsag * presence of anti-hcv antibodies by positive pcr * presence of antibodies to hiv 1 +2 * pregnancy * for group b2: * alcoholic liver disease * presence of hbsag * presence of anti-hcv antibodies by positive pcr * presence of antibodies to hiv 1 +2 * pregnancy
artificial intelligence enables precision diagnosis of cervical cytology grades and cervical cancer

Conditions: Cervical Cancer; Diagnostic Platform; Diagnosing Cervical Cytology Grades and Cancer; Artificial Intelligence

Summary: cervical cancer, the fourth most common cancer globally and the fourth leading cause of cancer-related deaths, can be effectively prevented through early screening. detecting precancerous cervical lesions and halting their progression in a timely manner is crucial. however, accurate screening platforms for early detection of cervical cancer are needed. therefore, it is urgent to develop an artificial intelligence cervical cancer screening (aics) system for diagnosing cervical cytology grades and cancer.


Eligibility criteria:
inclusion criteria: 1. women aged 25-65 years old. 2. availability of confirmed diagnostic results of the cervical liquid-based cytological examination, and satisfactory digital images from the liquid-based cytology pap test: at least 5000 uncovered and observable squamous epithelial cells, samples with abnormal cells (atypical squamous cells or atypical glandular cells and above). exclusion criteria: 1. unsatisfactory samples of cervical liquid-based cytological examination: less than 5000 uncovered, observable squamous epithelial cells, and more than 75% of squamous epithelial cells affected because of blood, inflammatory cells, epithelial cells over-overlapping, poor fixation, excessive drying, or contamination of unknown components. 2. women diagnosed with other malignant tumors other than cervical cancer.

Keywords: diagnostic platform cervical cytology grade diagnosis thinprep cytologic test artificial intelligence deep learning algorithm