Kornimate/medical-research-clean huggingface dataset:
handheld device compared with a standard eye care diagnostic device in measuring ophthalmic refraction

Conditions: Refractive Errors; Vision Disorders

Summary: this study is exploratory and examines whether the best-corrected visual acuities (bcva's) from trial frames created with the refraction results obtained from a novel handheld optical device yields results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.

this study is exploratory and examines whether the best-corrected visual acuities (bcva's) from trial frames created with the refraction results obtained from a novel handheld optical device yields results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.

Eligibility criteria:
inclusion criteria: * male or female * ages =\>18 y.o. and =\<65 y.o. * binocular vision * willing and able to give informed consent and follow all study procedures and requirements * fluent in english exclusion criteria: * has been diagnosed within 4 weeks, or currently has signs or symptoms, of covid-19. * has traveled outside the country within the last 4 weeks. * at the discretion of the investigator: age strata has achieved minimum evaluable population. * spherical correction \> +8 or \< -10 * using anticholinergic medications (including first-generation antihistamines) or other medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior to enrolling in this study * using an investigational drug or approved therapy for investigational use within the greater of 3 days or 5 half-lives prior to enrolling in this study * has initiated any new medication in the past 2 weeks that, in the best medical judgment of the investigator, would impact their participation in the study or ability to use the eyeque eq103 device * any self-reported mental illness or condition, including but not limited to: claustrophobia, fear of simulators, nyctophobia. * any self-reported neurological diseases, including but not limited to: epilepsy, alzheimer's, nystagmus per subject self-reporting: eye disease, including but not limited to: * glaucoma * cataracts * macular degeneration * eye infection (by self-report or observation) * keratoconus * diabetic neuropathy/retinopathy * cytomegalovirus retinitis * color blindness (any color deficiency) * diabetic macular edema * amblyopia * chronic or acute uveitis * strabismus * astigmatism \> 3 diopters * macular hole subjects that: * lack physical dexterity to properly operate the eyeque device. * lack the ability to follow instruction * lack a command of the english language * lack binocular vision * are colorblind * had eye surgery within the last 12 months (including lasik)
the effect of routine antibiotic use in the outpatient treatment of severely malnourished children without complications

Conditions: Severe Acute Malnutrition

Summary: this study will be conducted as a randomized, double-blind, placebo-controlled trial to compare routine antibiotic prescription vs. no routine antibiotic prescription in the management of uncomplicated cases of severe acute malnutrition treated in the community in terms of nutritional recovery. the investigators hypothesize that there will be no significant difference in terms of the risk of nutritional recovery among children uncomplicated cases of severe acute malnutrition treated in the community that receive routine antibiotic prescription and those who receive no routine antibiotic prescription.


Eligibility criteria:
inclusion criteria: * age from 6 to 59 months * muac \< 11.5 cm or whz \< -3 * absence of bipedal edema * absence of current illness requiring inpatient care * eligible for new admission for outpatient nutritional therapy for sam at 3 crenas in madarounfa operated by forsani * absence of current clinical illness requiring prescription of specific antibiotic therapy and decision by the study physician to use a specific antimicrobial drug on admission * written consent of parent or caregiver * residence within niger exclusion criteria: * age \ 59 months * muac ≥ 11.5 cm and whz ≥ -3 * presence of bipedal edema * presence of current illness requiring inpatient care * decision by the study physician to use a specific different antimicrobial drug on admission * presence of any congenital abnormality or underlying chronic disease that may affect growth or risk of infection * treatment with any antibiotic within 7 days * admission to any nutritional program for the treatment of sam within 3 months * known contraindication / hypersensitivity to amoxicillin
cerebrolysin registry study in stroke - a high-quality observational study of comparative effectiveness

Conditions: Acute Ischemic Stroke

Summary: this study investigates the clinical practices, safety and effectiveness of cerebrolysin in routine treatment of patients with moderate to severe neurological deficits after acute ischemic stroke.

patients registered: acute ischemic stroke patients with moderate to severe neurological deficits all patients receive acute stroke care according to local treatment standards, not amended or influenced by the study: cerebrolysin group: patients who are treated with cerebrolysin; dosage, frequency and duration follows local clinical practice in accordance with terms of the local marketing authorization control group: patients who are not treated with cerebrolysin observation criteria: * signed informed consent * clinical diagnosis of acute ischemic stroke confirmed by imaging * moderate to severe neurological deficits with nih stroke scale (nihss) 8 to 15, both inclusive * no prior stroke * no prior disability * patient's independence prior to stroke onset (pre-morbid mrs of 0 or 1) * reasonable expectation of successful follow-up (max. 100 days) the study follows the recommendations of the principles for good research on comparative effectiveness (grace). in order to comply with recent calls for high-quality non-interventional comparative effectiveness research, a risk-based centralized statistical approach to monitoring is introduced in combination with targeted on-site monitoring for ongoing surveillance of study conduct, thus ensuring highest standards of data quality and integrity according to the most recent requirements of the ich e6 guideline for good clinical practice (gcp, amendment r2, july 2015), the fda guidance for industry on a risk-based approach to monitoring, and the ema reflection-paper on risk-based quality management in clinical trials.

Eligibility criteria:
inclusion criteria: * signed informed consent * clinical diagnosis of acute ischemic stroke confirmed by imaging * moderate to severe neurological deficits with nih stroke scale (nihss) 8 to 15, both inclusive * no prior stroke * no prior disability * patient's independence prior to stroke onset (pre-morbid mrs of 0 or 1) * reasonable expectation of successful follow-up (max. 100 days) exclusion criteria: * none

Keywords: acute ischemic stroke
is there intravascular hemolysis in patients with pulmonary hypertension?

Conditions: Pulmonary Artery Hypertension

Summary: patients with hemolytic disorders (e.g. sickle cell anemia or thalassemia) are known to develop pulmonary hypertension. hemolysis is where red blood cells are destroyed and their contents released into the circulation. it is thought that these red-cell contents cause constriction and thrombosis of the blood vessels in the lungs. conversely, it is possible that patients with pulmonary hypertension have hemolysis. in this study we will be drawing blood from a range of patients and normal controls for a panel of blood tests related to hemolysis.


Eligibility criteria:
inclusion criteria: one of the following four conditions : * pulmonary artery hypertension * obstructive sleep apnea with pulmonary hypertension * lung transplant candidates without pulmonary hypertension * normal controls exclusion criteria: * known hemolytic disorder * recent blood loss (\<3 months) * recent blood transfusion (\<3 months) * liver disease
helical blade vs lag screw fixation for cephalomedullary nailing of low energy intertrochanteric hip fractures

Conditions: Hip Fractures

Summary: the purpose of this study will be to compare the failure and complications rates of and orthopedic implant (cephalomedullary nail) fixed with two different options actually available: lag screw or helical blade. the study population will be patient who have been diagnosed with an intertrochanteric hip fracture. hypothesis: our hypothesis is that the helical blade will have a higher failure rate compared to the lag screw

hip fractures in the elderly are recognized worldwide as a major public health problem, its incidence is increasing and it is expected to have 6,26 million cases per year worldwide by 2050. surgical treatment is recognized as the best option in these patients because it allows early rehabilitation and decreases mortality and complications. currently, the fixation with a cephalomedullary nail is the most commonly used treatment, since it has some mechanical advantages compared to other fixation methods and achieves adequate stability allowing early weight bearing and rehabilitation with low failure rates. changes in the design of these implants have tried to reduce the failure rate. the main change has been the introduction of the helical blade for cephalic fixation, instead of a lag screw. the concept behind this modification is that the blade would have greater fixation to the bone and less risk of cut out, because it is supposed to compact the bone around the helical blade instead of removing it. in spite of some biomechanical studies in cadaveric or artificial models validating this biomechanical advantage, clinical series have shown controversial results. recently, retrospective clinical studies have shown similar results with the use of the helical blade, and even some studies have shown a higher failure rate compared to the sliding screw. currently there is no prospective evidence regarding the failure rate of these two fixation methods. our objective is to contribute with solid evidence to solve this answer. that is why we have designed a prospective randomized study with strict inclusion criteria, follow up and radiographic measurements.

Eligibility criteria:
inclusion criteria: * low energy mechanism * hip fracture classified as 31.a1.2 - 31 a1.3 and 31.a2 in the ao classification (year 2018) exclusion criteria: * medical contraindication to surgery * a fracture due to malignancy * peri implant fractures * inability to walk before the fracture * an inability to comply with rehabilitation * non-ambulatory pre-fracture

Keywords: hip fractures intertrochanteric fractures helical blade cut-out
duostim and ai: is there a difference between oocyte performance in the follicular and luteal phases?

Conditions: Infertility

Summary: in vitro fertilization (ivf) has revolutionized assisted reproductive techniques, bringing hope to thousands of people seeking to fulfill their dream of parenthood. however, patients with low ovarian reserve face additional challenges, such as limited response to ovarian stimulation and difficulty in obtaining good-quality eggs. innovative protocols such as duostim (dual stimulation) have shown promise in these cases, allowing the maximum number of eggs to be retrieved in a short period of time. in addition, technological advances in the analysis of the quality of mature eggs, such as the use of the magenta tool, are transforming the way specialists evaluate and select the best gametes to increase the chances of success. this article explores how these approaches complement each other, offering new possibilities for patients with low ovarian reserve and raising the standards of reproductive medicine.

the analysis of the two stimulation phases in a duostim protocol for ivf using the magenta tool may have significant clinical relevance, especially in the context of patients with low ovarian reserve or who require optimization in the number of embryos available in ivf cycles in a short period of time. the magenta tool, being based on ai and machine learning, can identify patterns related to the quality of oocytes and embryos obtained in both phases. this can help determine if there are significant differences in embryo competence between oocytes collected in the follicular phase and the luteal phase. magenta-powered analysis can provide robust data to validate the duostim protocol, identify subgroups that benefit most from it, and promote greater clinical efficiency in ivf treatments, especially in challenging cases. this approach can revolutionize the way personalized protocols are designed and monitored to maximize reproductive success. the aim of this study is to compare the two phases of ovarian stimulation - follicular and luteal - in patients undergoing the duostim protocol, using the magenta tool for detailed analysis of mature eggs obtained in each phase. the research seeks to identify differences in oocyte quality between the two stages, as well as to evaluate the efficiency of the protocol in maximizing results in patients with low ovarian reserve.

Eligibility criteria:
inclusion criteria: * patients undergoing ivf with duostim protocol and magenta analysis of mature eggs. exclusion criteria: * canceled duostim magenta ivf cycles
ramadan flash glucose monitoring study

Conditions: Diabetes Mellitus

Summary: many muslim patients with diabetes observe dawn to sunset fasting during the month of ramadan. hyperglycaemia and hypoglycaemia are possible problems amongst these patients. the aim of this study is to investigate glucose profiles in diabetes and non-diabetes patients that decided to fast or not to fast during ramadan.

a good knowledge of the profiles of blood glucose with different treatments can help in making ramadan fasting free of unwanted effects for such patients. previous studies, including the epidiar have shown an increased risk of hypo- and hyperglycaemia in patients with diabetes who fast during the holy month of ramadan.although self-monitoring of blood glucose (smbg) is useful in fasting diabetes patients when used within a structured testing regimen, it requires a lot of effort and compliance from the patient and doesn't provide continuous blood glucose data. the amount of data provided using smbg depends on the frequency of finger pricks measurements. flash glucose monitoring (fgm) sensors provide a record of the individual's glucose levels, trends and patterns for up to 14 days. this sensor doesn't require calibration using finger pricks. fgm data show how day-to-day decisions and behaviours impact the control of blood sugar levels. availability of fgm makes it possible to explore glucose profiles in a continuous fashion during ramadan period and make comparisons with non-fasting times outside ramadan. the aim of this study is to investigate glucose profiles in diabetes and non-diabetes patients that decided to fast or not to fast during ramadan. the study will compare several parameters extracted from the fgm trace such us the incident of hypoglycaemia and hyperglycaemia, standard deviation, coefficient of variance and time in/above/below range. for this purpose the freestyle libre sensor will be used. patients will be asked to use the freestyle libre sensor for a period of 3 months: 1 month before ramadan, during ramadan and one month after ramadan.

Eligibility criteria:
inclusion criteria: * diabetes, age\>=18 exclusion criteria: * pregnancy, renal failure

Keywords: type 1 diabetes type 2 diabetes
health benefits of functional oil (mega 3 fatty acids from fish oil) on obese people

Conditions: Obesity

Summary: examine the effects and safety of functional oil (olive oil with omega 3 fatty acids from fish oil) on different inflammatory markers in obese subjects with dietary intervention for weight lost.


Eligibility criteria:
inclusion criteria: * men and women from 30 to 75 years old. * body mass index (bmi) ≥ 30 kg/m2 * signed informed consent. exclusion criteria: * individuals with special diet due to disease as celiac disease, chronic renal failure, etc. * individuals with diabetes mellitus insulin dependent. * individuals with disorders associated with eating behaviour. * individuals with mental disease or low cognitive function. * individuals with consumption of drugs to weight lost. * individuals treated with drugs whose direct effect is on lipid profile (statins, fibrates, diuretics, corticosteroids or oral anti-inflammatory). * individuals with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.) * pregnant women or lactating. * individuals with recurrent infections. * individuals with regular consumption of anti-inflammatory or glucocorticoids. * individuals with consumption of oil fish supplements (except if they gave up its consumption 1 month before). * individuals with fish allergy. * individuals with consumption of more than two fatty fish servers twice a week. * individuals with physical problems complying with the recommendations of physical activity and diet indicated.
long acting fsh plus antagonist versus daily fsh plus antagonist versus short agonist protocol in poor responders undergoing ivf

Conditions: Female Infertility; Poor Responder

Summary: despite the progression in assisted reproductive technology (art), poor ovarian response to controlled ovarian stimulation remains a challenge for clinicians and a source of distress for patients. multiple strategies have been tried to overcome these obstacles. the increase of the gonadotropin administration have been associated with a very low pregnancy rate. the introduction of gnrh agonist protocol, which takes advantage of the initial rise in endogenous gonadotropins that follows the agonist administration in the early follicular phase and subsequently prevents a premature lh surge, with fewer cycle cancellations, have improved cycle parameters and increased pregnancy rate. recently, gnrh antagonists were introduced in art treatment. they are effective in preventing a premature lh surge and allow for a more natural recruitment of follicles in the follicular phase in a non suppressed ovary. however, the randomized studies comparing the efficacy of these two regimens reported conflicting and nonsignificant results. moreover, more recently adjuvant therapies for coh such as growth hormone therapy or pyridostigmine, oral l-arginine, and transdermal testosterone failed to improve ivf outcomes. recently, the new treatment option with corifollitropin alfa, able to keep the circulating fsh level above the threshold necessary to support multi-follicular growth for an entire week, in a gnrh antagonist protocol seems to have a potential beneficial effect in poor responders. the aim of this study is to compare long-acting fsh/gnrh antagonist with daily fsh/gnrh antagonist with short gnrh agonist protocol on ivf outcome in poor responder patients .


Eligibility criteria:
inclusion criteria: * women with at least two of the following criteria: i) age \> 40 years old; ii) basal follicular stimulation hormone (fsh) \> 12 miu/ml; iii) three or fewer oocytes retrieved in the previous ivf cycle; iv) low estradiol levels on the day of human chorionic gonadotropin (hcg) administration (\< 1500 pmol/ml). exclusion criteria: * body mass index \> 30 * biochemical and ultrasound evidence of polycystic ovary syndrome * stage iii-iv endometriosis * inflammatory or autoimmune disorders * metabolic disease * infertility medications (gonadotropins, clomiphene citrate) within the past two months

Keywords: poor responders, ivf, gnrh agonist, gnrh antagonist, recombinant fsh
sonographic diaphragm function in aecopd

Conditions: Copd

Summary: the study will be conducted as a single-center, prospective cohort study. the primary objective of this study is to investigate the responsiveness of sonographic parameters of diaphragm to detect change in borg score for dyspnea during hospitalisation for aecopd without respiratory acidosis.

to investigate the responsiveness of sonographic parameters to detect change in borg score for dyspnea during hospitalisation for aecopd without respiratory acidosis, we propose a prospective cohort design. after inclusion, participants will have assessment of diaphragm function (excursion, thickness, thickening fraction) using ultrasound within 48 hours of admission to the emergency ward, striving to assessment within 24 hours of admission. additionally, dyspnea grade will be assessed using validated questionnaires. further diagnostic work-up and treatment for aecopd is performed at the discretion of the treating physician. both ultrasound measurements and dyspnea grade questionnaires will be repeated when the participant is reported suitable for hospital discharge by the treating physician.

Eligibility criteria:
inclusion criteria: * hospitalisation primarily because of severe acute exacerbation of copd * copd, according to gold 2018 definition * post-bronchodilator fev1/fvc \< 0,70 and fev1% \< 80%pred. within last 5 years exclusion criteria: * respiratory acidosis (ph \ 6 kpa) * need for (non-)invasive ventilation based on other criteria (e.g. severe hypoxia) upon presentation. * established diagnosis of diaphragm diaphragm paralysis. * inability for diaphragm imaging (e.g. mechanical ventilation, or unable to follow vocal instructions). * those not able or unwilling to give written informed consent. * pregnant women

Keywords: diaphragm copd thoracic ultrasound
multiple ascending doses of pf-04958242 in subjects with stable schizophrenia

Conditions: Schizophrenia

Summary: this study aims to assess the safety, tolerability and pharmacokinetics of pf-04958242 in multiple ascending doses in subjects with stable schizophrenia.

this study aims to assess the safety, tolerability and pharmacokinetics of pf-04958242 compared to placebo over 14 days twice a day dosing in multiple ascending doses in subjects with stable schizophrenia. this study was previously posted by pfizer, inc. sponsorship of the trial was transferred to biogen.

Eligibility criteria:
key inclusion criteria: * psychiatrically stable (≥3 months) male and female subjects with schizophrenia of non-childbearing potential between the ages of 18 and 55 years, inclusive. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>55 kg (121 lbs). * dsm-iv diagnosis of schizophrenia; on stable medication treatment regimen ≥2 months. key exclusion criteria: * suicide attempt within 3 months prior to screening. * history of or risk of seizures; head injury with long term abnormal resulting condition, abnormal eeg, clinically significant additional diseases or conditions, current medication with a significant risk of seizures, currently receiving antipsychotic medications. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: multiple ascending doses safety tolerability pharmacokinetics cognitive impairment associated with schizophrenia (cias)