Kornimate/medical-research-clean huggingface dataset:
clinical research of femtosecond laser-assisted cataract surgery

Conditions: Cataracts

Summary: since femtosecond laser was approved for cataract surgery by fda in 2010, femtosecond laser assisted cataract surgery (flacs) has demonstrated high precision of capsulotomy, reduced phacoemulsification power and time, and comparable refractive outcome in clinic. it is still unknown whether there are toxic substances produced due to photochemical or high-energy physical effect of femtosecond laser during flacs.

phacoemulsification is one of the main surgical procedures for cataract surgery owing to the advantages of small incisions and rapid recovery. however, the surgical outcome of phacoemulsification can be negatively affected due to the problem of accuracy and repeatability for capsulorhexis, and the corneal endothelial cell damage by ultrasound energy.to overcome those problems from the phacoemulsification, femtosecond laser-assisted cataract surgery (flacs) had been used in the past few years and showed unique advantages. the purpose of this study is to investigate the preliminary clinical outcomes of femtosecond laser-assisted cataract surgery.this prospective comparative study enrolled consecutive patients,will be randomly assigned to trial group underwent flacs and control group underwent conventional cataract surgery. the phacoemulsification time, energy, and complications during operation were recorded. the anterior capsule and aqueous humor were collected. morphology of the cutting edge and cells of anterior capsule was assessed by light microscopy. the proteins in the aqueous humor were identified by mass spectrometry . electrolyte in the aqueous humor was detected by a chemistry analyzer. postoperative refraction at 1 day, 1 week, 1 and 3 months, the capsulorhexis size and corneal endothelial density at 1 and 3 months were also measured.

Eligibility criteria:
inclusion criteria: 1. normal cornea 2. dilated pupillary diameter greater than 6mm 3. no local or systemic contraindications to cataract surgery exclusion criteria: 1. corneal pathological changes 2. glaucoma 3. ocular inflammation 4. previous ocular trauma or surgery

Keywords: femtosecond laser
evaluation of azr-md-001 in patients with meibomian gland dysfunction (mgd)

Conditions: Meibomian Gland Dysfunction

Summary: az202001 is a multicenter study of azr-md-001 ointment and azr-md-001 vehicle in patients with meibomian gland dysfunction (mgd)

az202001 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study evaluating the safety, efficacy and tolerability of azr-md-001 ointment and azr-md-001 vehicle in patients with meibomian gland dysfunction (mgd)

Eligibility criteria:
inclusion criteria: * male or female * 18 years of age or older * best-corrected visual acuity (bcva) of 20/40 or better (snellen equivalent), using the logarithm of the minimum angle of resolution (logmar) in each eye * evidence of meibomian gland obstruction * reported dry eye signs and symptoms within the past 3 months exclusion criteria: * uncontrolled ocular disease (except for mgd and dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease * glaucoma, ocular hypertension, or intraocular pressure (iop) in either eye at screening ≥24 mm hg or has planned insertion/removal of glaucoma filtration shunts/devices during the study * corneal abnormality or disorder that impacts normal spreading of the tear film or corneal integrity * bcva worse than 20/40 in either eye * current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye
validation of new therapeutic targets to prevent collagen accumulation during cardiac fibrosis: procollagen c-proteinase enhancers

Conditions: Valvulopathy; Heart Surgery; Procollagen C-Proteinase Enhancers

Summary: heart failure is characterized by cardiac fibrosis linked to extracellular collagen deposits. collagens are synthesized as soluble precursors, procollagens, which must undergo proteolytic maturation to assemble into fibres. this step is under the control of two extracellular proteins, procollagen c-proteinase enhancer 1 and 2 (pcpe-1 and -2). the mechanism of action of these highly effective and specific activators was recently elucidated by one of our partners. preliminary results, as well as data from the literature, indicate a strong correlation between the expression rates of pcpes and cardiac fibrosis. the aim of this study is to validate in humans, by analysis of endomyocardial tissue biopsies, the hypothesis that pcpes contribute to the anarchic accumulation of collagen during cardiac fibrosis and to evaluate the interest of developing new diagnostic and therapeutic strategies for cardiac fibrosis using pcpe agonists.


Eligibility criteria:
inclusion criteria: * person who has given written consent * patient aged 18 to 85 for men and 60 to 85 for women * patient requiring cardiac surgery for aortic valve replacement or aortic plastic surgery or aortic plasty or ascending aorta replacement more or less associated with aortic valve surgery exclusion criteria: * person not affiliated or not benefiting from national health insurance * person subject to a measure of legal protection (curatorship, guardianship) * person deprived of liberty, by judicial or administrative decision * major incapable or incapable of giving consent * minor * pregnant or breastfeeding woman * emergency surgery * acute infectious endocarditis
probiotic intervention in pcos

Conditions: Polycystic Ovary Syndrome

Summary: the investigators are conducting a double-blinded randomized controlled trial to determine whether a probiotic mixture is effective in reducing pcos-related symptoms. for this purpose, 180 participants will be recruited in three intervention arms (probiotic, placebo and metformin), with 60 participants per arm. the intervention period will last 6 months, with extensive medical history, blood work, urine and stool analysis at the beginning and the conclusion of the trial.


Eligibility criteria:
inclusion criteria: * polycystic ovary syndrome diagnosed based on at least two out of three rotterdam criteria: hyperandrogenism, polycystic ovarian morphology, oligo-/anovulation * signed informed consent exclusion criteria: * missing or withdrawn consent * hyperandrogenism of a cause other than pcos (cushing´s syndrome, hyperprolactinemia, adrenal tumours, congenital adrenal hyperplasia, rare genetic disorders) * pregnancy or nursing period (first 6 months after giving birth) * soy or other allergies with respect to study procedures * diabetes mellitus type 1 * chronic inflammatory bowel disease, history of cancer in the gastrointestinal tract or acute gastrointestinal infection * any malignancies that required treatment within the last 3 years prior to study procedures * any other chronic disease requiring medical check-ups or hospital treatments at least once every three months (exception: diabetes mellitus type 2) * major surgery in the gastrointestinal tract (e.g. colectomy, gut segment excision with stoma surgery, whipple´s surgery.) surgical removal of the appendix and/or the gall bladder is not considered major surgery. * therapy with antidiabetic drugs (metformin, sulfonylureas, dipeptidyl peptidase 4 (dpp-4) inhibitors, glucagon-like peptide 1 (glp-1) analogs, sodium-glucose-cotransporter 2 (sglt-2) inhibitors, insulin variants) within the last six months prior to study procedures * therapy with proton pump inhibitors within the last six months prior to study procedures * therapy with hormonal contraceptives or systemic (oral) intake of steroids within the last six months prior to study procedures * oral or intravenous therapy with antibiotics less than three months before the onset of study procedures * alcohol and/or drug abuse

Keywords: pcos probiotic metformin rct
danshen dropping pill for coronary heart disease heart and artery structure and function

Conditions: Coronary Heart Disease; Essential Hypertension

Summary: the impact of compound danshen dropping pill for coronary heart disease (chd) heart and artery structure and function in patients with hypertension

compound danshen dropping pill for coronary heart disease (chd) heart and artery structure and function in patients with hypertension.we can accorand the pwv ,imt and mda to assess the impact of heart and artery structure and function.

Eligibility criteria:
inclusion criteria:coronary heart disease，primary hypertension， - exclusion criteria:secondary hypertension，diabetes mellitus，chronic renal disease，cardiac insufficiency -
nutrition study of effect of high iron beans on iron status

Conditions: Iron Deficiency

Summary: the purpose of this study is to determine whether beans bred to have a high iron content are effective in improving the iron status of young women.

the goal of the study is to determine the efficacy of biofortified beans in improving the iron status of young women in rwanda.

Eligibility criteria:
inclusion criteria: * non-pregnant adolescent subjects of reproductive age with low iron stores with or without mild anemia, who are otherwise healthy, will be enrolled in the study exclusion criteria: * pregnant, lactating, severe anemia, low bmi would be excluded

Keywords: ferritin
the diagnostic value of the first clinical impression of patients presenting to the emergency department (prekeydia)

Conditions: Emergencies

Summary: finding a diagnosis for acutely ill patients places high demands on emergency medical personnel. while anamnesis and clinical examination provide initial indications and allow a tentative diagnosis, both laboratory chemistry and imaging tests are used to confirm (or exclude) the tentative diagnosis. the more precise and targeted the additional laboratory chemical or radiological diagnosis, the more quickly and economically the causal treatment of the emergency patient can be initiated. one examination modality, which in addition to the medical history and clinical examination, could quickly provide information about the condition of the patient, their clinical picture and severity of illness, is the first clinical impression of the patient (so-called "first impression" or "end-of-bed view"). this describes the first sensory impression that the medical staff gathers from a patient. this includes visual (e.g., facial expression, gait, breathing), auditory (e.g., voice pitch, shortness of breath when speaking), and olfactory (e.g., smell of exhaled air, body odor) impressions. clinical practice shows that a great deal of important additional information can be gathered through this first clinical impression, which, together with the history and clinical examination of the emergency patient, provides valuable clues to the underlying condition. to date, however, only scattered data and study results exist in the medical literature on the value of the first clinical impression in the care of emergency patients. in the present prospective observational study, the study attempts to evaluate the predictive value of the first clinical impression in identifying a leading symptom and other important clinical parameters.


Eligibility criteria:
inclusion criteria: * patients presenting to the emergency department between 2019-09-01 and 2020-02-28. exclusion criteria: * none.
a study of rozanolixizumab in pediatric study participants with moderate to severe generalized myasthenia gravis

Conditions: Generalized Myasthenia Gravis

Summary: the purpose of the study is to assess the safety and tolerability of subcutaneous (sc) administration of rozanolixizumab in pediatric participants aged ≥2 to \<18 years with generalized myasthenia gravis (gmg).


Eligibility criteria:
inclusion criteria: * study participant must be ≥2 to \<18 years of age inclusive, at the time of signing the informed consent/assent according to local regulation * study participant must have a documented diagnosis of generalized myasthenia gravis (gmg) at screening that includes a record confirming the presence of mg specific autoantibodies to acetylcholine receptor (achr) or muscle-specific kinase (musk) prior to screening * study participant has myasthenia gravis foundation of america (mgfa) clinical classification ii to iva at screening * study participant has received existing conventional treatment(s) for gmg (eg, pyridostigmine, corticosteroids, and/or immune suppressants) prior to screening * study participant has had an unsatisfactory clinical response or worsening of gmg symptoms and is in need of additional therapy (for example, plasma exchange (pex) or treatment with intravenous immunoglobulin (ivig)) exclusion criteria: * study participant with severe weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis at screening or baseline * study participant has a known hypersensitivity to any components of the investigational medicinal product (imp) or other anti-neonatal-fc receptor (fcrn) medications * study participant with any active or untreated thymoma * study participant has a history of thymectomy within 6 months prior to screening * study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of imp * study participant has received a live vaccination within 4 weeks prior to baseline or intends to have a live vaccination during the course of the study

Keywords: generalized myasthenia gravis gmg rozanolixizumab pediatric
functional lipids and appetite regulation

Conditions: Obesity

Summary: to evaluate the short-term effects of structured lipids on appetite regulation.

background obesity is a major health problem worldwide, and it is a risk factor for several chronic disorders. even small changes in energy intake, leading to a positive balance may lead to weight gain over time. thus, slight modifications in food intake, such as the inclusion of foods that effect energy balance, may prevent weight gain and even facilitate weight loss. replacing dietary fat with low-calorie fat (lcf), such as modified triglycerides with medium and long chained pufa.may be an efficient way to reduce body fat. bray et al. (2002) has shown a sustained weight loss of \~6 kg over a 9 month period where one-third of a fat-reduced diet (25% fat) was replaced by olestra. this weight loss can not solely be explained by the decreased caloric content of olestra. thus, inhibition of appetite leading to lower food intake, may be a potential mechanism of the observed weight loss. a reduced absorption of lcf leaves undigested fatty acids in the middle and lower intestine, which may generate increased feelings of satiety and decrease caloric intake due to regulating peptides and hormones such (cck, glp-1, etc.). in addition, intraduodenal fatty acids may also promote distension of the stomach and distension of the intestine, which are well-known gastrointestinal signals controlling mechanisms for food intake. taken together, in addition to the acute reduction in caloric intake, lcf may encourage a gastrointestinal hormone response promoting beneficial effects on appetite regulation and energy balance. aims to evaluate the short-term effects of lcf on primary: * appetite sensations after a meal (vas) * postprandiel secretion of appetite regulating hormones * ad libitum caloric intake 4,5-h subsequent to a fixed meal secondary: • palatability of the test meal

Eligibility criteria:
inclusion criteria: * healthy males * normal weigh, e.i. bmi between 18,5-25 kg/m2 * age 18-40 years exclusion criteria: * donation of blood 3 monhts prior or during the study * gastrointestinal disorders, diabetes, hypertension, hyperlipidemia, chronic infectious disease * smoking * consumption of more than 21 alcoholic drinks/week * elite athletes * on mediation * diet supplements

Keywords: appetite regulation hormones energy intake
safety and efficacy study of chimerivax™-je and je inactivated mouse brain vaccine in children of descending age

Conditions: Japanese Encephalitis

Summary: this randomised, double-blind study is to be conducted on 96 subjects at multiple sites in india. subjects will be enrolled by age group and randomised to either chimerivax™-je (je-cv) or je mouse brain derived vaccine (je-mbdv). study consists of a screening period, a treatment period and a 2 year follow-up period. primary safety endpoints will be the adverse event (ae) rates 28 days after completion of vaccination course. the primary efficacy endpoints will be the rate of seroconversion 28 days after completing vaccination.


Eligibility criteria:
inclusion criteria: * all aspects of the protocol explained and written informed consent obtained from the subject's parent or guardian and assent from the child if ≥ 8 years of age. * aged ≥ 9 months to \< 10 years * in good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results * subject had to be available for the study duration for the study duration, including all planned follow-up visits. exclusion criteria: * a history of vaccination against, or infection with, je or other flaviviruses (e.g. kyanasur forest disease, west nile virus, dengue fever). previous je vaccination was to be determined by history (interview of subject's parent or guardian) or by inspecting the child's official vaccination record. * demonstration of parasitemia on malaria blood smear at screening. * history of residence in or travel to a je-endemic region of india or elsewhere in asia (for periods of 4 weeks or more). * hypersensitivity to thimerosal or gelatin * have received a transfusion of blood, blood products or serum globulin in the preceding 6 months, * have an immunodeficiency or neurological disorder, or take drugs that suppress the immune system, * have a history of severe reaction to other vaccines, * have a chronic condition requiring medication, * intend to travel out of the area during the study period, * have spent at least 4 weeks in a je-endemic region, * plan to receive any other vaccination within the double-blind treatment period, or who have received a vaccination in the month preceding screening, * exhibit signs of secondary or tertiary malnutrition, * are seropositive to human immunodeficiency virus (hiv), hepatitis b or c, * have malaria infection, or who have a fever within 3 days before vaccination. * those with an acute fever, or with previously scheduled vaccinations, may be rescheduled. * consideration of the routine immunisation schedule should be made such that it is ensured that routine vaccinations due are either given before entry to the trial, or afterwards if delayed because of the trial.

Keywords: japanese encephalitis
trial of operative fixation of fractured ribs in patients with flail chest

Conditions: Flail Chest; Ventilation

Summary: background: fracture of several ribs in more than one place as the result of trauma, leads to paradoxical movement of the chest wall and ventilatory failure. the mainstay of management in these patients has traditionally been analgesia and positive pressure ventilation to splint the chest wall and allow healing of the ribs to begin. however, this management option leads to prolonged intensive care unit (icu) stay with increasing complication rates as patients remain on a ventilator for prolonged periods. patients often remain on a ventilator for two to three weeks while waiting for enough rib healing to provide sufficient chest wall stability to allow the patient to take over all their breathing themselves. until that time, patients are at risk of pneumonia and sepsis and other complications. long term disabilities which have been reported in these patients include ongoing pain syndromes, inability to return to work, particularly manual type labour and cosmetic chest wall deformities. an alternative treatment strategy is to operatively fix the ribs. by fixing the ribs operatively, the patient no longer requires internal pneumatic stabilization (provided by mechanical ventilation) and can be weaned from the ventilator within days rather than weeks. this can potentially lead to earlier discharge from the intensive care unit, and an avoidance of the multiple complications which arise in the ventilated patient. rib fixation may also lead to less pain and deformity, improved mobility in the post injury phase and earlier return to work. hypothesis: that early operative fixation of ribs in patients presenting with flail chest secondary to trauma will result in less mechanical ventilatory requirements, earlier discharge from the intensive care unit and lower rate of complications associated with prolonged mechanical ventilation. this will lead to cost savings in the treatment of these patients.


Eligibility criteria:
inclusion criteria: * patients with multiple (\>3) fractured ribs between the level of ribs 3 to 10 resulting in a paradoxical movement of the chest wall - exclusion criteria: * age \> 75 years * spinal injuries which would preclude placement of the patient in a lateral decubitus position * open rib fractures with soiling or infection * severe head injury * uncorrected coagulopathy * adult respiratory distress syndrome * sepsis
glucose variability

Conditions: Glucose Variability

Summary: a retrospective data review of 243 pregnant women (≤32 wks gestational age), dtat collected prior to 5/18/2014, with gdm, or t2dm, and their infants (until discharge from the hospital, typically up to 1 week after deliver) will be conducted. these women are of any age and all ethnic backgrounds delivering at st. mary's health center.

maternal glucose control is considered to be a major determinant of neonatal outcome in pregnancies complicated by diabetes. studies have examined the link between neonatal mortality and morbidity using specific mean preprandial or postprandial plasma glucose levels, however, have not taken into account the daily wide excursions that occur in maternal glucose levels. limited data are available on glucose variability (gv) in pregnancy and affect on maternal or neonatal outcomes. a recent study amongst diabetics showed that glucose variability between two data points, a morning fasting blood glucose and an afternoon blood glucose, increased the rate of adverse neonatal outcomes1. glycosylated hemoglobin (a1c), which has been considered the "gold standard" for diabetes control since the diabetes control and complication trial (dcct)2, lacks the specificity to predict pregnancy outcomes. through review of data, we propose to examine other methods of evaluating daily maternal glucose variations to determine the correlation to maternal and neonatal outcomes. the objective of this study is to determine the effect of glucose variability and/ or other elements on maternal and neonatal outcomes in the obese diabetic patient. we hypothesize that glucose variability will be a stronger indicator of neonatal outcome than a1c or any single given blood glucose value. glucose variability, including the magnitude of hyperglycemia or the incidence of acute maternal hypo- or hyperglycemic events, will be explored. we hypothesise that obese pregnant women with higher magnitude of glucose fluctuations have more maternal and fetal co morbidities.

Eligibility criteria:
inclusion criteria: * women with diabetes in pregnancy of any age, any ethnic background who deliver at st. mary's health center, 1/1/2000 to 5/18/2014. exclusion criteria: * data collected ager 5/18/2014