Kornimate/medical-research-clean huggingface dataset:
clinical validation of the new print on focus dailies toric

Conditions: Myopia

Summary: the purpose of this study is to validate the improvements to the inversion indicator.

this study was conducted in three countries under three separate protocols: p-346-c-009 sub 02 (uk), p-346-c-009 sub 03 (germany), and p-346-c-010 (usa). the data reported represents pooled data from the three protocols.

Eligibility criteria:
inclusion criteria: * be of legal age and sign written informed consent document. if under legal age, parent or guardian must sign informed consent document and subjects ages 12 through 17 must sign informed assent. * willing and able to wear study lenses in both eyes in the available parameters. * light-eyed subjects. * able to achieve 20/40 or better distance visual acuity (va) in each eye at time of dispensing. * optimal or acceptable fit in each eye at time of dispensing. * willing to wear the study lenses at least 8 hours a day, 5 days a week. * other protocol-defined inclusion criteria may apply. exclusion criteria: * eye injury or surgery within twelve weeks prior to enrollment for this trial. * pre-existing ocular irritation that would preclude contact lens fitting. * currently enrolled in an ophthalmic clinical trial. * evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator. * any use of medications for which contact lens wear could be contraindicated as determined by the investigator. * rgp contact lens wearer. * other protocol-defined exclusion criteria may apply.
the effect of covid-19 on the disease course of multiple sclerosis :belgian lessons learned from rocky i to rocky iv

Conditions: COVID-19

Summary: retrospective observational cohort study. tofcoms: two years of follow-up of covid-19 in ms.

methods the nationaal multiple sclerose centrum (nmsc) melsbroek is a large highly-specialized center specifically focusing on neurological management, multidisciplinary care and rehabilitation in patients with ms. since march 2020 (i.e., the onset of the pandemic in belgium, and the first of five waves of spiking infection numbers thus far in our country), clinical data of patients followed at the center have been collected in a local database in case of covid-19 diagnosis. the following items have been recorded: name, gender and date of covid-19 diagnosis; age, expanded disability status scale score, ms duration, clinical subtype and dmt regimen at time of covid-19 diagnosis; covid-19 severity (method 1: categorized as ambulatory, hospitalized, death; method 2: categorized as asymptomatic, mild illness, moderate illness, severe illness, critical illness and death); vaccination status (categorized as non-vaccinated, fully vaccinated, fully vaccinated + booster) at time of covid-19 diagnosis. on february 28, 2022, this database was locked and consisted of 234180 unique individual covid-19 cases. the nmsc melsbroek features a second and more large database containing a broad variety of (para)clinical information gathered during routine follow-up, which includes regular testing of general disability with the edss, leg function/ambulation with the timed 25-foot walk test (t25fwt), hand function/dexterity using the 9-hole peg test (9hpt) and cognition/information processing speed with the symbol digit modalities test (sdmt). for each of these parameters, the first two assessments before covid-19 diagnosis (labelled t0 and t1, respectively; t1 is the closest to covid-19 diagnosis), and the first thereafter (labelled t2), were retrieved for each covid-19 subject. if clinical measurements were performed during an in-house stay for rehabilitation purposes, only those performed on admission were retained (thus not necessarily those the closest to the covid-19 infection).

Eligibility criteria:
inclusion criteria: diagnosis of multiple sclerosis covid 19 infection with pcr test exclusion criteria: other diagnosis than multiple sclerosis
treatment of non-alcoholic steatohepatitis (nash) patients with vitamin d

Conditions: Non-alcoholic Steatohepatitis (NASH)

Summary: test the efficacy of vitamin d to improve non-alcoholic steatohepatitis with regard to biochemical and histological parameters. * trial with medicinal product


Eligibility criteria:
inclusion criteria: * patients with 25-oh vitamin d insufficiency * elevated alanine aminotransferase level * diagnosis of definite or possible steatohepatitis (nash) exclusion criteria: * cirrhosis, present liver disease other than nash * serious diseases limiting life expectancy, * breast-feeding or pregnant women * unhealthy alcohol consumption * drug abuse or substitution therapy * use of vitamin preparations within the previous 6 months and during the study * weight loss \>5% within 12 months before study entry * newly diagnosed diabetes mellitus requiring medical treatment within 12 months before study entry * use of anti-obesity drugs * previous or current hypercalcemia * chronic renal disease
induction chemotherapy prior to radio-immunotherapy in head and neck cancer stage iii/iv - a methodical trial

Conditions: Head and Neck Cancer

Summary: the purpose of the trial is to determine the feasibility of an induction chemotherapy with radio-immunotherapy in patients with head and neck cancer stage iii/iv

3 cycles of: docetaxel 75 mg/m2 on d1, cisplatin 75 mg/m2 on d1, 5-fu 750 mg/m2 on days 1-5 as continuous i.v. infusion, duration of 1 cycle: 21 days; followed by cetuximab 400 mg/m2, start of radiotherapy: 1 week after the first application of cetuximab, during radiotherapy (35 x 2 gy): cetuximab 250 mg/m2 weekly, up to 8 applications of cetuximab.

Eligibility criteria:
inclusion criteria: * histologically confirmed, locally advanced head and neck cancer * stage iii/iv * performance status: ecog 0-1 exclusion criteria: * distant metastases * prior radiotherapy of the head and neck region * myocardial infarct in the last six months * florid peptic ulcer * neuropathy grade iii/iv

Keywords: head and neck cancer, stage iii/iv no prior radiotherapy of head and neck region
dietary oils to sustain energy study

Conditions: Overweight and Obesity

Summary: the research study is an intervention and feasibility crossover design pilot study designed to assess if consuming 3 study foods made with either soybean oil or palm oil per day for 4 weeks can alter whole blood, plasma and erythrocyte fatty acids and body weight in overweight/obese adults. additionally, the study will assess the adherence to consuming 3 study foods per day for 4 weeks and to assess if participant remain unaware of (or masked to) which study food group (soybean oil vs palm oil) they are consuming.

the objectives of the study include * to determine changes in whole blood, plasma and erythrocyte linoleic acid after 4 weeks of consuming 3 foods products made soybean oil and determine changes in plasma and erythrocyte oleic acid and palmitic acid after 4 weeks of consuming 3 food products per day made with palm oil in overweight/obese adults * to determine changes in body weight in overweight/obese adults during four weeks of consuming 3 food products per day made with soybean oil and during four weeks of consuming 3 food products per day made with palm oil * to determine if there is evidence of unmasking of the two food product groups (soybean oil or palm oil) during the study in participants and in study coordinators * to determine adherence of consuming 3 food products per day made with either soybean or palm oil for 4 weeks in overweight/obese adults

Eligibility criteria:
inclusion criteria: * age 25-80 years old * nonsmokers * bmi 25-55 kg/m2 exclusion criteria: * current or previous diagnosis of heart, kidney, and some liver diseases * current or previous diagnosis some circulatory diseases and some autoimmune diseases * treatment of current cancer diagnosis or current cancer diagnosis * current or previous diagnosis of diabetes * gastrointestinal diseases or disorders (including pancreatic) that influence nutrient digestion and absorption or gastric bypass surgery * alcohol or drug abuse * inability to access veins for venipuncture * hypothyroidism or hyperthyroidism diagnosis * food allergy or intolerances * any dietary restriction where consumption of the study foods or any ingredient would be contraindicated * use of medications where consuming the study foods would be contraindicated * use of supplements or medications for weight loss or following a weight loss program * use of supplements high in linoleic acid in the past 4 weeks prior to enrolling * pregnancy and lactation
evaluate pathogens and immunity to acute otitis media in healthy children.

Conditions: Nasopharyngeal Colonization and Acute Otitis Media

Summary: the purpose of this study is to evaluate pathogens and immunity to acute otitis media in healthy children.

a prospective evaluation of bacterial pathogens streptococcus. pneumoniae, haemophilus influenzae, moraxella. catarrhalis and staphylococcus aureus and their antibiotic susceptibility when colonizing the nasopharynx and/or causing acute otitis media in the years 2015-2025. the goal will be to recruit children into a prospective group beginning at 6 months of age and followed to 36 months of age in suburban rochester, new york. nasopharyngeal and nasal wash samples will be obtained at each well child visit and at acute otitis media (aom) episodes. middle ear fluid will be obtained from every child with an acute otitis media episode who undergoes a tympanocentesis procedure. all of the nasopharyngeal and middle ear fluid samples collected will be tested by standard microbiologic techniques to identify the presence of 4 potential otopathogens (s. pneumoniae, h. influenzae, m. catarrhalis and s. aureus). all s. pneumoniae will undergo serotyping and antibiotic susceptibility testing. all samples that are culture negative will be evaluated with a multi-locus pcr test to examine for presence of potential otopathogens.

Eligibility criteria:
inclusion criteria: healthy children: * male or female age greater than/equal to 6 months or less than/equal to 36 months old. * parent/guardian willing to bring to all study visits exclusion criteria: * any major illness/condition that in investigator opinion would put subject at risk during study. * otorrhea or tympanostomy tubes present in either ear @ time of enrollment. * direct descendant of study site personnel. * subjects \ 36 months old at the time of enrollment
epi-743 in friedreich's ataxia point mutations

Conditions: Friedreich's Ataxia

Summary: the purpose of this study is to evaluate the effects of epi-743 in patients with friedreich's ataxia point mutations

the primary objective of this study is to investigate whether treatment with epi-743 has a discernible impact on visual function-including visual acuity, visual fields and color vision as well as on any of a number of functional and subject/clinician-rated scales relevant in the treatment of friedreich's ataxia, and to determine the safety of treatment with epi-743.

Eligibility criteria:
inclusion criteria: 1. diagnosis of genetically confirmed friedreich's ataxia point mutation. 2. visual acuity at baseline more than 15 letters on high contrast edtrs at four meters. 3. fars score of 20 to 90. 4. male or female between 18 and 65 years of age. 5. agreement to use contraception if within reproductive years 6. hormone replacement therapy, if used, must remain stable for the duration of the study. 7. willingness and ability to comply with study procedures. 8. willingness and ability to arrive at study site metropolitan area day prior to evaluations. 9. abstention from use of dietary supplements and non-prescribed medications at least 30 days prior to initiation of treatment and for the duration of the study. this would specifically include idebenone, coenzyme q10 and vitamin e. 10. abstention from foods or beverages or bars fortified with coenzyme q10, vitamin e, super fortified functional foods or beverages at least 30 days prior to initiation of treatment and for the duration of the study. 11. abstention from use of other investigative or non-approved drugs within 30 days of enrollment and for the duration of the study. 12. subject can swallow multiple size 0 capsules. 13. subject has voluntarily signed an irb approved informed consent form to participate in the study after all relevant aspects of the study have been explained and discussed with the subject. exclusion criteria: 1. allergy to epi-743 or sesame oil or nuts. 2. clinically significant bleeding condition or abnormal pt/ptt inr (inr \> two; ptt \> two-times normal). 3. liver insufficiency with lfts greater than three-times upper normal limit at screening. 4. renal insufficiency with creatinine \> 1.5 at screening. 5. fat malabsorption syndromes. 6. any other respiratory chain diseases of the mitochondria or inborn errors of metabolism. 7. any other ophthalmologic conditions. 8. clinically significant cardiomyopathy with ejection fraction \< 40 percent at screening. 9. clinically significant arrhythmia within past two years requiring treatment. 10. surgery planned through the duration of the study, including follow-up. 11. pregnancy or breastfeeding. 12. anticoagulant therapy within 30 days of enrollment.

Keywords: friedreich's ataxia point mutation
neurocognitive outcomes and quality of life in adults with maple syrup urine disease (msud)

Conditions: Maple Syrup Urine Disease

Summary: maple syrup urine disease (msud) is a disorder of protein metabolism that leads to neurological differences. it is an exciting time where people diagnosed with msud are living longer. the investigators want to learn about how adults with msud think, feel, and live. the purpose of this research study is to 1) look at thinking skills, behavior skills, life skills, and quality of life in adults with msud and 2) measure how medical and personal factors impact these areas. the results of the study will be used to learn how to best help adults with msud and how to prepare for their success. in this study, the participants will answer questions on thinking, life skills, behavior skills, and quality of life. these questions will be completed on the internet. the participants will have a formal testing of their thinking and behavior completed virtually. the participants may also have a 1-2-hour telephone conversation about their life. all tests will occur virtually at home. the investigators will send the participants a letter with the results of thinking and behavior tests.


Eligibility criteria:
inclusion criteria for index subjects: * males or females 21 years and older * diagnosis of msud * ability to communicate verbally or using augmentative communication effectively to participate in appropriate neurocognitive testing inclusion criteria for comparison subjects: * males or females 21 years and older * sibling or acquaintance of index subject * ability to communicate verbally or using augmentative communication effectively to participate in appropriate neurocognitive testing exclusion criteria for all subjects: * inability to communicate verbally or using augmentative communication effectively to participate in appropriate neurocognitive testing * subjects or guardians or who, in the opinion of the investigator, may be non-compliant with study schedules or procedures. * subjects or guardians who do not have internet access * subjects who do not speak english as a primary language
identification and validation of biomarkers for infections in burns

Conditions: Burns Involving 20% or More of Body Surface

Summary: in this prospective, multi-center study, 200 patients from four participating texas burn hospitals will be enrolled from admission to discharge. the clinical research study team will collect approximately 11 serum samples and clinical data related to sepsis and infection predictors from severely burned adult patients, ages 18-80 years old. all serum samples from participating sites will be shipped to the lead site, university of texas medical branch. the university of texas medical branch will then validate previously identified biomarkers while simultaneously identifying novel biomarkers through discovery proteomics.

the burn literature is replete with suggested biomarkers of infections for identifying sepsis or other infections in burn patients, however, these reports are largely untested. in order for incorporation of infection biomarker assessment to become the standard of care, validation of these markers in a multi-center prospective study is necessary. as the majority of these biomarkers have been chosen because of success in other patient populations, or ease of measurement, it is possible that the best biomarkers of infection have not yet been discovered in this patient population. prospective identification and validation of novel biomarkers may also improve early identification of infections in burn patients. early treatment of infections and sepsis directly correlated with improved survival and reduced costs of care. in this prospective, multi-center study, 200 patients from four participating texas burn hospitals will be enrolled from admission to discharge. the clinical research study team will collect approximately 11 serum samples and clinical data related to sepsis and infection predictors from severely burned adult patients, ages 18-80 years old. all serum samples from participating sites will be shipped to the lead site, university of texas medical branch. the university of texas medical branch will then validate previously identified biomarkers while simultaneously identifying novel biomarkers through discovery proteomics.

Eligibility criteria:
inclusion criteria: * ages 18-80 years old * greater than 20% total body surface area burn * patient arrival to the burn center within 7 days of burn injury exclusion criteria: * known history of acquired immunodeficiency syndrome (aids), aids-related complex (arc), human immunodeficiency virus (hiv) * history of cancer within 5 years * pregnancy * burn injury due to chemical burns or deep electrical injury * inability to obtain informed consent * decision not to treat due to burn injury severity or futility as deemed by the clinical team at the time of admission (note: this is a clinical determination of futility beyond which survival is rare. these are typically patients whose sum of total body surface area % burn and age (baux score) exceeds 140 or 120 with severe inhalation injury.) * presence of anoxic brain injury that is not expected to result in complete recovery

Keywords: burns
spi and remifentanil in skull pin fixation

Conditions: Pain, Procedural

Summary: forty patients were enrolled, and all patients used total intravenous anesthesia (remifentanil-propofol based total intravenous analgesia) as anesthesia induction and maintenance. according to the preliminary data of this department, patients who underwent intracranial surgery for skull pin fixation used remifentanil 5.0-6.0 ng/ml, while the hemodynamics is relatively stable. therefore, when this plan is implemented, the patient needs to be under the same depth of anesthesia (monitored by electroencephalography, maintaining a value of 40-60), first start with remifentanil 5.0 ng/ml, and use the up and down method as adjust 0.5 ng/ml of concentration of remifentanil each time. inadequate antinociception (surgical pleth index(spi) \> 80 and hyperdynamics (the increased heart rate (hr) and mean blood pressure (mbp) above 20% of baseline or hr\>100bpm and arterial blood pressure(abp)\>180/100mmhg)) is defined as failure, therefore we increase remifentanil by 0.5 ng/ml; otherwise, the setting is considered successful without abovementioned situations. data collection: heart rate, mean blood pressure, surgical pleth index, bispectral index, pulse pressure variance, systolic pressure variance, concentrations of propofol and remifentanil before 2 mins, during, 5, and 15 mins of skull pin fixation were recorded and analyzed.


Eligibility criteria:
inclusion criteria: 1. must be at least 20 years old and less than 80 years old 2. with anesthesia risk grade below grade three (including grade three) (asa i\~iii). 3. patients who are expected to undergo intracranial surgery for skull pin fixation exclusion criteria: 1. those with anesthesia risk classification asa class iv or higher 2. those who are allergic to opioid analgesics or propofol drugs 3. emergency patients

Keywords: remifentanil, pain, surgical pleth index
routine ultrasound screening in the third trimester

Conditions: Fetal Growth Retardation; High-Risk Pregnancy

Summary: late intrauterine growth restriction is infrequently diagnosed with an overall sensitivity of 40 % in low-risk pregnancies. in addition, late intrauterine growth restriction may be associated with intrauterine death and poor neonatal outcomes i.e. birth asphyxia and hospitalization in intensive care unit. the investigators hypothesis that a later third trimester routine ultrasound may be more accurate to diagnose late intrauterine growth restriction.


Eligibility criteria:
inclusion criteria: * accurate gestational dating using crown-rump length at 11-14 weeks * singleton pregnancy * primiparity * normal first trimester (11-14 weeks) and second trimester (20-25 weeks) scans * maternal age \> 18 years * no maternal opposition for the study exclusion criteria: * maternal diseases i.e. chronic renal disease, hypertension, diabetes, collagen vascular disease, antiphospholipid syndrome * pregnancies with congenital anomalies or foetal growth restriction diagnosed before 30 weeks of gestation

Keywords: intrauterine growth restriction screening ultrasound perinatal morbidity maternal complications
sub-dissociative ketamine for the management of acute pediatric pain

Conditions: Pain

Summary: the proposed trial is a prospective, double blinded, randomized control trial with the primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease the total narcotic requirements of pediatric patients requiring intravenous analgesia in an urban emergency department (ed) compared to a group of patients who receive morphine alone for pain management. patients are randomized to receive either a single bolus of ketamine (0.3 mg/kg) or a single bolus of morphine (0.05mg/kg). all subsequent pain management will be accomplished using morphine. patient, family member, and research staff pain scores will be recorded, until 3 hours post study medication administration. family members are contacted via telephone 24 hours post-ed discharge, and again at 7 days post-hospital discharge, for evaluation via post hospitalization behavior questionnaire. narcotic equivalents will be calculated for up to 3 hours post study medication administration and compared between the ketamine and morphine groups.


Eligibility criteria:
inclusion criteria: * age: 3-17 years old * condition (medical or trauma) requiring opioid pain management per standard of care * need to establish an iv per standard of care * treating physician agrees to manage the patient's pain with morphine following randomization. exclusion criteria: * trauma team activation * known allergy to ketamine * family member unable/unavailable to provide informed consent * when appropriate, patient unwilling to provide assent * high suspicion of injury related to child abuse * patient and/or family member is non-english speaking * patient is incarcerated

Keywords: pain management ketamine morphine pediatrics emergency medicine