Kornimate/medical-research-clean huggingface dataset:
effects of eicosapentaenoic acid on endothelial function in diabetic subjects

Conditions: Type 2 Diabetes; Coronary Artery Disease

Summary: this pilot trial seeks to obtain preliminary data on the effects of eicosapentaenoic acid (epa) (4g/d) on endothelial function measured via endopat2000 after 12 weeks of intervention among adults with elevated triglycerides and type 2 diabetes.

thirty adults aged 30-75 y will be randomized to either 4 g/d of eicosapentaenoic acid or no drug for 12 weeks. endothelial function will be measured at baseline and after 12 weeks. in a secondary aims, we will evaluate effects of eicosapentaenoic acid (epa) on plasma levels of c-reactive protein, oxidized low-density lipoprotein cholesterol, and endothelin-1.

Eligibility criteria:
inclusion criteria: * age 30+ years * hypertriglyceridemia (150-400 mg/dl) * statin use for at least six months at the time of screening * type 2 diabetes treated with diet and/or oral hypoglycemic agents diagnosed 1+ year * ability to provide informed consent and provide blood samples * willingness to abstain from fish oil, epa, over the counter niacin, and other omega-3 fatty acid supplements during the study period (12 weeks) * ability to travel to the study site at brigham and women's hospital for 3 study visits * reactive hyperemia index (rhi) of ≤ 2.0 exclusion criteria: * eating disorder or heavy drinkers * treatment with chronic prescription pharmacotherapy for metabolic or cardiovascular disease management or risk factor modification * pregnant or lactating women * statin use \<6 months at the time of screening * allergy to epa, fish oil, or other omega-3 fatty acids * current use of insulin, cyclophosphamide, estrogen, fibrates, niacin, hormone replacement therapy, testosterone, oral contraceptives, growth hormones, insulin-like growth factor-1, and other systemic steroids. * inability to provide informed consent or blood samples * history or prevalent diagnosis of cancer, asthma, kidney insufficiency, stroke, seizures, allergic disorders, or congestive heart failure * diagnosis of diabetes \< 1 year prior to enrollment * intention to move out of greater boston area within one year * current use of omega-3 supplements, fish oil, or \>2 servings of fish per week * bleeding disorder or uncontrolled endocrine (i.e., thyroid) or metabolic disorders * treatment with blood thinning drugs (i.e. warfarin and clopidogrel) * major surgical operation 3 months before or after screening * organ transplantation * current participation in another trial or plan to do so during the study * inability to give informed consent or to travel to the study center at brigham and women's hospital * rhi of \>2.0 * triglycerides \ 400 mg/dl * body mass index of 40+ kg/m2

Keywords: endothelial function eicosapentaenoic acid triglycerides
comparison of changes of inflammatory proteins in aqueous humour of subjects treated with avastin vs lucentis

Conditions: Proliferative Diabetic Retinopathy (PDR)

Summary: pdr is a leading cause of irreversible vision loss in north america. this disease is caused by the growth of abnormal blood vessels in the retina. these abnormal blood vessels can bleed inside the eye, causing a vitreous hemorrhage (vh). sometimes when patients have this bleeding, a surgery called vitrectomy is required to remove the blood from within the eye. in order to reduce complications during the surgery, most retina surgeons will inject avastin into the eye a few days before the surgery. avastin (bevacizumab) is currently not approved by health canada to treat any ocular disease. lucentis (ranibizumab) is approved by health canada as a treatment for age-related macular degeneration, diabetic macular edema, and retinal venous occlusive disease. while avastin is not approved by health canada for the treatment of these diseases, the majority of retina specialists around the world are now using avastin "off-label" to treat these diseases. that is because avastin and lucentis both tend to work equally well in these disease, but avastin is significantly cheaper. while avastin and lucentis are generally regarded to be equal, there may be some differences between these two drugs that have not been discovered. the aim of this study is to look for these differences. previous research by the investigators in this study has shown that injecting avastin into eyes causes increased inflammatory proteins to develop inside the eye. this increase in these proteins was related to complications that developed after the vitrectomy surgery. lucentis may be associated with less of an increase in inflammatory proteins (and less complications). the aim of this study will be to compare avastin and lucentis with respect to how they affect inflammatory proteins in the eye, as well as the rate of complications during surgery. study participants will be divided into two arms ("groups") of 30 subjects. subjects will receive avastin or lucentis a few days before vitrectomy surgery. the assignment will be random and the study is double-masked. masking is done so that the investigators can clearly determine any differences between the 2 drugs.

60 subjects will take part in this study at 2 sites in canada: vancouver (eye care centre, vancouver general hospital, and mount saint joseph hospital) and toronto (sunnybrook health sciences centre).

Eligibility criteria:
inclusion criteria: 1. pdr and vitreous hemorrhage scheduled for vitrectomy surgery and bevacizumab pre-treatment. exclusion criteria: 1. vitreous hemorrhage from other causes such as central retinal vein occlusion or ocular ischemic syndrome. 2. pregnant or breastfeeding women. 3. less than 19 years of age.

Keywords: proliferative diabetic retinopathy vitrectomy inflammatory cytokines
the effect of peripartum magnesium sulfate use on the occurrence of postpartum depression

Conditions: Postpartum Depression

Summary: this is an observational study that will be conducted on pregnant women under vaginal delivery or cesarean section. the magnesium sulfate will be given to appropriate participants with a protocol that obstetrician are already using in our hospital. after delivery, participants are asked to answer sequential questionnaires to assess postpartum depression.


Eligibility criteria:
inclusion criteria: * pregnant women who will do delivery. * gestational week \>= 30 week * singleton exclusion criteria: * history of depression
the effect of kinesio taping on pain and disability in pregnancy-related low back pain

Conditions: Pregnancy-related Low Back Pain

Summary: pregnant women may experience pregnancy-related low back pain and this pain may negatively affect function. there are studies in the literature that kinesiotape applications improve pain. there is no study examining the effect of kinesiotape application in addition to exercise on pregnancy-related low back pain and function. at the end of our study, we will compare the effects of kinesiotape application for a total of 8 sessions for 4 weeks on pain and function.

kinesio tape (kt) application is a physiotherapy method whose use has increased in recent years in the treatment of chronic pain. kinesio tape, an alternative method to support fascia, muscles and joints, dr. developed by kenzo kase. although the therapeutic effects of the kt method are still unclear, the putative therapeutic effects include facilitating muscle activity, providing sensory stimuli to the skin, muscles or facial structures, and regulating joint range of motion (rom) . kt method increases blood and lymph circulation by lifting the skin, and prevents pain by reducing nociceptive stimuli . kt has been administered to pregnancy to improve low back pain. in addition to publications showing that kt can reduce pregnancy-related low back pain, there are studies showing that it has no effect compared to the control group . the aim of this study is to examine the effect of 8 sessions of kt applied in addition to 4-week core stabilization exercises on pain and quality of life in pregnant women with pregnancy-related low back pain.

Eligibility criteria:
inclusion criteria: * maternal age between 18 and 40 years, any birth, * gestational age between 13 and 30 weeks, * low back pain anywhere from t12 to gluteal fold without leg pain and at least moderate pain intensity (vas ≥ 4). exclusion criteria: * known or suspected orthopedic or rheumatological disorders such as scoliosis, * spinal injuries, * ankylosing spondylitis or rheumatoid arthritis; * intervertebral disc pathology; * a history of low back pain before pregnancy; * twin pregnancy or fetal anomaly; and any uncontrolled medical conditions

Keywords: pregnancy low back pain function kinesiologic tape core stabilization
evaluation report of the urea / urine creatinine as a marker of nutritional status predictive of icu care associated infections

Conditions: Brain Injury; Malnutrition

Summary: malnutrition is defined by an energy supply deficit, protein, macro-molecules or micro-nutrients, resulting from an imbalance between nutrient intakes and metabolic needs of the body. it concerns 40 to 60% of patients upon entry into resuscitation and influences their prognosis. studies over the past decade have shown that nutritional deficiency increases the morbidity and mortality in intensive care. several clinical and biological parameters were evaluated as markers of malnutrition, including the ratio of urea / urine creatinine. the report would identify patients in a state of malnutrition, to optimize their nutritional care. this setting is easy to obtain in all patients by simple urine collection unlike other clinical and biological criteria of resuscitation malnutrition assessment. this ratio of urea / urien creatinine would optimize energy intake of critically ill patients, for which nutritional management methods are widely debated.

at present, many clinical studies have shown a link between malnutrition and infectious complications in intensive care particularly because of immune disorders. many studies testing different nutritional strategies used as the main criterion infectious complications. so this is a robust standard, well documented in the literature as a reflection of malnutrition in intensive care, and we also want to use in our study. in a pilot study in the surgical icu of the hotel-dieu report the urea / creatinine urine as a biomarker of poor outcome of nutritional status in the icu seems extremely discriminating in predicting the existence of nosocomial infection. furthermore the kinetics of the relationship between the intake and the 5th day of resuscitation, also appears to be relevant in predicting the occurrence of nosocomial infection. surgical icu of the hotel-dieu proposes to conduct a multicenter study to confirm the relationship between the ratio of urea / creatinine urine, malnutrition marker, and nosocomial infections (ni) in intensive care. primary objective: to evaluate the predictability of the ratio of urea / creatinine urinary j5 on the occurrence of nosocomial infection in intensive care.

Eligibility criteria:
inclusion criteria: * 18 or more * admission in icu * estimated length of stay superior to 5 days exclusion criteria: * pathologies modifying the ratio of urea / urine creatinine: end stage renal disease ( creatinine clearance less than 15 ml / min), gastrointestinal bleeding, right ventricular failure
minimally invasive nasal trabeculostomy: long-term follow-up extension study

Conditions: Open Angle Glaucoma

Summary: this study is a follow-up extension study conducted in continuation of the prior mint study (mms-eeu-4), in which the long-term (i.e., 18, 24 months) clinical outcomes of minimally invasive nasal trabeculostomy (mint) will be explored.


Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 years to ≤ 85 years old 2. subject who underwent mint, and surgery was performed not earlier than 18 months from enrollment

Keywords: mint trabeculostomy minimally invasive glaucoma surgery migs intraocular pressure
epidemiologic study of persistent polyclonal b-cell lymphocytosis (ppbl)

Conditions: Persistent Polyclonal B-Cell Lymphocytosis

Summary: the main purpose of this study is the description of all french cases of ppbl and the establishment of minimal criteria for the pathology diagnosis and its follow-up. the secondary objective is the immunologic and genetic characterization of lymphoid cells causing the disease.


Eligibility criteria:
inclusion criteria: * ppbl diagnosis established during a previous medical visit exclusion criteria: * none
training of orthopedic residents in op treatment

Conditions: Osteoporotic Fractures

Summary: objective: to assess whether residents (r1, r2 or r3 according to the year of residency) of an orthopedic tertiary service, investigate, treat and / or refer the patient with an osteoporotic fracture to treat osteoporosis (op) and whether this learning is improved over the years of residence. methods: residents answered diagnostic and therapeutic questions related to a clinical case of osteoporotic fracture (of) in 4 scenarios, which were the initial care in the emergency room, at the time of discharge from hospital, during their outpatient return in 3 and 6 months. answers were compared between years of residence.


Eligibility criteria:
inclusion criteria: * physicians enrolled in the medical residency program in orthopedics and traumatology at iot-hc-fmusp. exclusion criteria: * abandonment of the medical residency program in orthopedics and traumatology at iot-hc-fmusp. * withdrawal from the medical residency program in orthopedics and traumatology at the iot-hc-fmusp for a period of more than 120 days. * expulsion from the medical residency program in orthopedics and traumatology at iot-hc-fmusp. * transfer of the medical residency program in orthopedics and traumatology from iot-hc-fmusp to another institution.

Keywords: osteoporotic fractures secondary prevention brazil orthopedics medical professionals knowledge gap osteoporosis treatment
brain uptake of gsk1034702: a positron emission tomography (pet) scan study

Conditions: Cognitive Disorders

Summary: gsk1034702 is being developed for improving cognitive impairment in diseases such as alzheimer's disease and schizophrenia. this study will be done in healthy men to investigate how much of the study drug gets into the brain. this will be done using positron emission tomography (pet).

this is an open label, single dose, non-randomized pet study in healthy male subjects to ascertain if gsk1034702 is crossing the blood-brain barrier to enable it to elicit a central effect. gsk1034702 has been shown in vitro to be a substrate for human pgp, therefore the distribution of gsk1034702 into human brain could be adversely affected. this use of pet in conjunction with radioactively labelled gsk1034702 will help ascertain the role pgp plays in limiting brain penetration in the presence and absence of a pharmacological relevant oral non labelled dose of 5 mg. subjects will have an mri scan to aid definition of brain anatomy, a baseline pet scan and a post-dose pet scan. for each subject the study will consist of at least three visits; screening visit, scanning day and follow-up.

Eligibility criteria:
inclusion criteria: * generally healthy. * male between 35 and 55 years of age. * willing to use appropriate contraception method. * weight more than 50 kg. * bmi within the range 19 - 29 kg/m2. * adequate blood supply to the hand. exclusion criteria: * abuse of drugs or alcohol. * smoker or history of regular use of tobacco- or nicotine-containing products in the past 6 months. * ecg abnormality (personal or family history). * psychiatric disorder. * asthma or a history of asthma. * medical illness. * worked as a welder, metal worker or machinist. * suffers from claustrophobia or would be unable to lie still in a pet or mri scanner for 1-2 hours. * has a cardiac pacemaker or other electrical device or ferromagnetic metal foreign bodies. * neurological disorder

Keywords: cognitive impairment schizophrenia alzheimer's disease pet
clinical evaluation of cats tonometer prism

Conditions: Ocular Hypotension

Summary: prospective, open-labeled, randomized, controlled, multicenter study at two clinical investigative sites in tucson, arizona. the subjects will undergo intraocular pressure measurement with the cats tonometer prism and the goldmann applanation tonometer prism (gat). seventy-five (75) subjects 18 and older and will be enrolled. subjects will be screened based on standard of care vision examination at the clinical investigation sites. all subjects will undergo a standard ophthalmic exam and informed consent. iop will be measured using a goldmann tonometer armature with both the standard flat gat prism and the modified curved cats prism alternately inserted. the only additional measurement is central corneal thickness (cct) which is used to correct for one of the corneal biomechanical errors seen in the gat prism and is currently standard of care.


Eligibility criteria:
inclusion criteria: * written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. * male and female patients, at least 18 years of age exclusion criteria: * subject has undergone ocular surgery within the last 3 months * uncontrolled systemic disease that in the opinion of the investigator would put the subject's heath at risk * pregnant or nursing women * subjects with only one functional eye * those with one eye having poor or eccentric fixation * eyes displaying an oval contact image * those with corneal scarring or who have had corneal surgery including corneal laser surgery * microphthalmos * buphthalmos * contact lens wearers * severe dry eyes * lid squeezers - blepharospasm * nystagmus * keratoconus * any other corneal or conjunctival pathology or infection. * central corneal thickness between 0.600 mm and 0.500 mm (more than 2 standard deviations about the human mean)
umbilical cord derived mesenchymal stem cell (uc -msc) transplantation for children suffering from biliary atresia

Conditions: Primary Biliary Cirrhosis

Summary: biliary atresia (ba) is the most frequent cause of chronic cholestasis in neonates, accounting for at least 50% of pediatric liver transplantation. ba incidence is estimated to range from 1:5000 to 1:19000 live births. all patients will die due to complications of liver cirrhosis if the operation is not performed. recently, mesenchymal stem cell (msc) transplantation has been found as a promising therapy for liver cirrhosis in adults. bone marrow-derived stem cell transplantation was also performed successfully for children with ba. compared to msc isolation from bone marrow, isolating mscs from umbilical cord (uc) tissue is a less invasive procedure. furthermore, uc-derived mscs (uc-mscs) have been demonstrated to be safe and effective for liver cirrhosis in adults and different pediatric diseases, including liver cirrhosis due to primary biliary cirrhosis. the investigators will compare the outcomes of 17 kasai operated ba patients who receive uc-msc transplantation to 17 ba patients who only undergo kasai operation. two transplantations of uc - mscs will be performed via the hepatic artery: the first transplant will be performed at baseline, and the second one will be performed 6 months later with a dosage of 1 million mscs per kg of body weight. the frequency and severity of the adverse events or serious adverse events associated with uc-msc injection at 72 hours post-injection will be used to assess the safety. the efficacy of the therapy will be measured using pediatric end-stage liver disease (peld) score, liver function, and liver biopsy. this study would open a novel cell therapy to improve outcomes of patients with ba.

the study protocol was approved by the vinmec international hospital ethics committee, and national ethics committees. the stem cell products are conducted in accordance with (gmp) requirements and good clinical practice (gcp). all patients and primary caregivers will receive a written consent form, a cover letter and a clear explanation of the safety issues, potential risks and benefits, and the procedure involved. moreover, patients will be provided the updated results related to disease and the study during conducting the study and will be fully funded by the project.

Eligibility criteria:
inclusion criteria: * children diagnosed with liver cirrhosis due to biliary atresia after kasai's operation * from 5 months to 2 years old * weight ≥ 6 kg * patients with manifestation of cirrhosis on liver biopsy during kasai's operation. * parents or primary caregivers signed the informed consent form. exclusion criteria: * under 6kg or over 2 years old * coagulation disorders * allergy to anesthetic agents * active infections

Keywords: liver cirrhosis biliary atresia kasai's operation
vaccine exposure in patients with ms

Conditions: Multiple Sclerosis

Summary: vaccines in ms patients have been controversial, in particular hepatitis b vaccine in the 90s and more recently human papillomavirus vaccine. there was an important flu incidence during the winter 2016-2017 that has revealed a low exposure to the flu vaccine in health professionals in france. vaccine exposure of multiple sclerosis (ms) patients has not been evaluated yet. objectives the primary objective is to evaluate exposure to the flu vaccine in patients with ms during the 2016-17 campaign. secondary objectives are to evaluate exposure to mandatory vaccines, non mandatory vaccines, in the context of immunoactive treatments; to identify potential limitations to vaccines in general in patients with ms. methods cross-sectional observational multicentric study, performed in auvergne-rhône-alpes (france). data will be collected through an auto-questionnaire administered during an out-patient visit or hospitalization, during a two-week period. statistical analysis description of the percentage of patients exposed to the flu vaccine, and to other vaccines. stratification according to demographics (age, sex) and ms related criteria (disability level, relapse in the year before, disease-modifiying drug) expected results vaccine exposure of patients with ms will be put in perspective with the general population exposure. the study can provide information regarding potential reluctance of patients with ms towards vaccines. this could lead to develop specific communication tools for patients with ms and/or health professionals.


Eligibility criteria:
inclusion criteria: * multiple sclerosis according to macdonald 2010 criteria * age 18 and more exclusion criteria: -
cryovalve® sg aortic human heart valve combination study

Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency

Summary: the purpose of this study is to assess the probable benefit of cryovalve sg aortic human heart valve used in pediatric patients as an aortic valve replacement.

the cryovalve sg aortic human heart valve is recovered from deceased human donors, treated with the synergraft® (sg) process,which is designed to reduce the donor cells present on the graft. the valve is then cryopreserved for storage until use. removing cells from the heart valve has been shown to reduce a component of the immune response after implant compared to a standard allograft valve. however, it is not known how this affects the long-term durability of the valve.

Eligibility criteria:
inclusion criteria: * patients implanted with a cryovalve sgav as an aortic valve replacement. * patients who were ≤ 21 years of age at the time of implant. exclusion criteria: * patients in whom the cryovalve sgav was used as a patch or a non-valved conduit. * patients implanted with a cryovalve sgav as a pulmonary valve replacement. * patients that were ≥ 22 years of age at the time of implant.

Keywords: aortic valve