Kornimate/medical-research-clean huggingface dataset:
continuing assessment of patients treated with ranibizumab for retinal vein occlusion (capture)

Conditions: Retinal Vein Occlusion

Summary: this research is being done to assess the long term prognosis of patients treated with ranibizumab for edema due to retinal vein occlusion.

people treated with ranibizumab for edema due to retinal vein occlusion as part of previous studies at the wilmer eye institute and who are currently being seen by their ophthalmologist at the wilmer eye institute are followed up to assess long term outcomes

Eligibility criteria:
inclusion criteria: * all patients who have been enrolled in the following three trials will be included in the study: a) "a pilot, open-label study of the safety, tolerability, and bioactivity of multiple intravitreal injections of ranibizumab in subjects with macular edema secondary to vein occlusions.", b) "extended follow-up of patients with macular edema due to branch retinal vein occlusion (brvo) or central retinal vein occlusion (crvo) previously treated with intravitreal ranibizumab (retain) " c) "ranibizumabdose comparison (0.5mg and 2.0mg) and the role of laser in the management of retinal vein occlusion - a pharmacodynamic approach (relate)" exclusion criteria: * none

Keywords: retinal vein occlusion
a real-world, prospective observational study of rimegepant odt for the acute treatment of migraine attacks in adults.

Conditions: Migraine

Summary: this study aims at characterizing the effectiveness of rimegepant as an acute migraine treatment in a real world setting on two aspects: * consistency of response to rimegepant across multiple attacks * effectiveness of rimegepant in users taking concomitant migraine preventive medications, namely monoclonal antibodies targeting cgrp and onabotulinumtoxina

this study will be conducted in a real-world setting in the us using a bespoke interface contained in the migraine buddy mobile application. participants who report using rimegepant for the acute treatment of migraine will be recruited and will be asked to complete a series of questionnaires during the screening and study period. patient reported outcome measures will be collected at study enrollment, daily during the 28-day observation period, and at the end of the study period. research questions: 1. in adult patients currently receiving a prescription for rimegepant for the acute treatment of migraine, what is the population-level consistency of rimegepant response for pain reduction, meaningful pain relief, performance in daily activities, and return to normal function across multiple attacks in a real-world setting, regardless of prophylactic background? 2. what is the satisfaction level of patients receiving rimegepant on background migraine prophylaxis (specifically, anti-cgrp mabs or onabotulinumtoxina (botox)? 3. what is the efficacy, safety, and tolerability of rimegepant for the acute treatment of migraine, when taken in combination with preventive medications that act on the same pathway?

Eligibility criteria:
inclusion criteria: * female or male patients with migraine ≥18 years old * having received a prescription for rimegepant for acute treatment * experienced between 3 and 14 headache days in the last 30 days * planning to use rimegepant for attacks happening during the next 30 days exclusion criteria: * report currently using rimegepant as preventive * report currently using concomitantly onabotulinumtoxin and any of the mabs * currently participating in a migraine-related clinical trial * reports a diagnosis from a doctor or other health professional of cluster headache, post-traumatic headache, new daily persistent headache, or hemicrania continua

Keywords: rimegepant acute migraine treatment real-world setting
beneficial effects of a polyphenol enriched beverage on type 2 diabetes prevention and on cardiovascular risk profile of men and women with insulin resistance.

Conditions: Diabetes; Cardiovascular Disease

Summary: the purpose of this study is to measure the beneficial effects of an optimized berries extracts on diabetes and cardiovascular diseases prevention. our hypothesis is that including a polyphenol rich berries extract in daily feeding will improve insulin sensitivity, glucose tolerance, pancreatic β-cells function, lipids and inflammatory profile, and oxidative stress markers.

type 2 diabetes is an up rising disease that makes it a major public health problem. while 221 millions cases were estimated in 2010, the prevalence would be 366 millions in 2030. it is well recognized that regular consumption of fruits and vegetables can lower the incidence of chronic diseases such as cancer, cardiovascular diseases, diabetes and inflammatory diseases. recently, drs desjardins, abrams and marette's research team discovered a high amount of a sesquiterpene in berries. this molecule is recognized for its ability to improve glucose tolerance and insulin sensitivity, and to lower pro-inflammatory profile of obese mice. the aim of this study is to determine the effect of a polyphenol rich berries extract mix on insulin sensitivity, glucose tolerance, pancreatic β-cells function, lipids and inflammatory profile, and oxidative stress markers, on human obese subjects that have insulin resistance.

Eligibility criteria:
inclusion criteria: * 40-65 year old * non-smoking * overweight (bmi\>27) * insulin resistant (fasting insulin \>90pmol/l, with fasting glycemia \< 7,0 mmol/l and \< 11,1 mmol/l after a 120-min oral glucose tolerance test) exclusion criteria: * diabetes * chronic diseases * taking drugs that could affect glucose or lipids metabolism * major surgery 3 months prior to the study * weight variation of ±10% 6 months prior to the study * strawberry or cranberry allergy * consumption of berries rich in polyphenol and/or wine more then 3 times per week

Keywords: insulin sensitivity, glucose tolerance, inflammatory markers, lipid profile, oxidative stress, pancreatic β-cell function
validation of pathologic diagnosis of invasive fungal infection by molecular method

Conditions: Mycoses

Summary: 1. isolate fungal dna(deoxyribonucleic acid) from paraffin-fixed tissue specimens to distinguish and compare aspergillus species to the existing optical pathological diagnosis. 2. pcr(polymerase chain reaction) validation. 3. compare pcr results, microbial results and treatment results with the medical record.

this study is a retrospective pcr(polymerase chain reaction) analysis of paraffin-fixed sample with a participants chart review. the pcr analysis will consist of two phases; a pcr test validation phase and an azole resistance test phase. the investigators will also perform a retrospective chart review to investigate the association of participants' fungal clinical outcomes and the presence of azole resistance. i. pcr analysis 1. pcr test validation phase * validating pcr assay by mock tissues and invasive fungal infection proven tissues(microbiologically and pathologically proven cases). * the number of validation samples will be 1000 (200 samples \* five target pcr). * for the enough validation of pcr results, inter-laboratory comparisons, especially with the core laboratory, are performed to verify the pcr results of the same test sample among laboratories and to standardize a certain protocol for the molecular identification of fungal infection from the clinical specimens. * positive controls (human β-globin gene and mouse actin gene) and negative controls (non-infected samples) are used for validating of pcr assays. precision of each pcr set is checked using the false discovery rate (fdr) which can be the acceptable level of false positives among a set of significant results. if fdr is \>5%, it will be rejected. * the intra-assay repeatability will be evaluated on 10 replicates of one of the dna subsamples analyzed in a single assay. the inter-assay reproducibility will be assess on the same dna subsample five separate times while the inter-sample reproducibility will be determine on separate extractions of the four subsamples amplified a single time. statistical analysis will be carry out using sas software. 2. azole resistance test phase * the investigator will perform a pcr assay using participants biopsied paraffin embedded tissues. technical method of the pcr assay is attached separately. * around a hundred biopsied samples under impression of fungal infection from june 1st, 2009 to june 31st, 2014 will be included for the pcr testing. ii. retrospective chart review of all enrolled participants. 1. data collection * all available participants' electronic medical record data will be reviewed for collecting demographic and clinical information. 2. outcome measures * the investigators will evaluate invasive fungal infecrion treatment results, survival rates, and prognosis according to the existence of azole resistance and antifungal treatment modalities including medications.

Eligibility criteria:
inclusion criteria: * patients who were diagnosed with invasive fungal disease based on the biopsy from june 2009 to may 2014 exclusion criteria: * patients who do not currently have residual paraffin-fixed specimens
simplified anti-thrombotic therapy for ffr

Conditions: Coronary Artery Disease

Summary: despite the routine use of procedural anti-coagulation and anti-platelet therapy for ffr calculation, no study has evaluated the optimal anti-thrombotic regimen in patients undergoing ffr. therefore, the aim of the evaluation of simplified anti-thrombotic therapy for coronary fractional flow reserve (smart-ffr) study was to evaluate the safety of using a simplified anti-thrombotic regimen with only upstream dual anti-platelet therapy (dat) with aspirin and clopidogrel, compared with anticoagulation plus single- or- dat therapy in patients with intermediate coronary artery stenosis undergoing ffr calculation during elective coronary angiography.


Eligibility criteria:
inclusion criteria: * all patient regardless of sex, or age were eligible for the study if they were scheduled for an elective coronary angiography using a femoral approach, and were agreeable to participate in the study after signing informed consent, and had a coronary stenosis in any major native epicardial coronary artery between 50-70% determined by quantitative angiography that was an adequate target for ffr at the discretion of the operator. exclusion criteria: * exclusion criteria included patients requiring mandatory dat, patient undergoing radial access due to concomitant anticoagulation, patients with contra-indications or intolerant to dat, patients with severe left ventricular hypertrophy defined as a wall thickness greater than 14 mm by echocardiography in the septal or lateral wall, patients with hypertrophic cardiomyopathy, left ventricular function less than 30%, severe aortic valvular stenosis defined as an aortic valve area of less than 1 cm2, presenting with an acute coronary syndrome in the past two weeks, hemodynamic instability, cardiogenic shock, reported allergy to clopidogrel, aspirin or bivalirudin, planned to be anticoagulated during or previous to the time of the coronary angiography, using prasugrel or ticagrelor, patients with coronary arteries unsuitable for ffr calculation due to severe tortuousity and/or calcification, lesions supplied by a bypass conduit, any mental condition rendering the subject incapable to understand the nature, scope, and possible consequences of the study such that the patient is unable to give appropriate informed consent or refusal or inability to sign an informed consent .
fase i clinical trial on nk cells for covid-19

Conditions: Covid19; Sars-cov 2

Summary: coronavirus disease 2019 (covid-19) is spreading worldwide and has become a public health emergency of major international concern. currently, no specific drugs or vaccines are available. this study aims to investigate the safety and efficacy of intravenous infusion of natural killer cells patients with covid-19.

in march 2020, the world health organization secreted covid-19 as a pandemic. although most infected individuals can develop effective immunity, the population at risk (elderly, obese and individual with comorbidities) develop a rapid and frequently fatal disease, with severe acute respiratory syndrome, cytokine storm and coagulopathies; for those who recover, severe pulmonary sequels are frequently observed. we propose a phase i clinical trial to test safety and feasibility of nk cells adoptive immunotherapy for covid-19. natural killer cells are innate granular lymphocytes able to rapidly recognize and kill, without previous exposition, altered cells; it is widely recognized as immune effectors specialized in lysing virus infected cells releasing antigens and activating cytokines to antigen presenting cells and, by doing so, stimulating effective adaptive immunity. we hypothesize that the early infusion of highly activated nk cells will activate adaptive immune effectors preventing the severe clinical evolution of covid-19 infection. adoptive nk cell immunotherapy for severe virus infections is innovative. our proposition is in line with the brazilian public health system purposes, which is to offer secure and effective therapies for all covid-19 infected individuals. upon proving nk cell immunotherapy effectiveness for serious virus infections, we can evolve to test this strategy for common viruses that cause epidemics and endemics such as the ones caused by dengue, zika, chikungunya, c and b hepatitis and hiv.

Eligibility criteria:
inclusion criteria: * laboratory confirmation of covid19 infection by reverse-transcription polymerase chain reaction (rt-pcr); * the patient or legal donor agrees to participate in the study and signs the informed consent; * patients with white or yellow criteria according to the score proposed by liao et al (2020). exclusion criteria: * patient with pregnancy, are planning to become pregnant or breastfeeding; * patients with malignant blood-borne diseases such as hiv or syphilis; * not consenting for clinical trial; * patients with other than white or yellow criteria according to the score proposed by liao et al (2020).

Keywords: natural killer cells covid-19 sars-cov2
crassostrea gigas for liver health

Conditions: Nonalcoholic Fatty Liver

Summary: this study aimed to observe whether a hydrolyzed oyster extract improves liver health in participants whose alanine transaminase (alt) levels are1-3 fold above the normal. a total of 96 participants will be randomly allocated to active (oyster) or placebo group (1:1). each group will receive 750 mg of oyster extract or placebo per day for 8 weeks. primary outcome will be the change in alt level and secondary outcomes will be; (1) ratios of participants with normal alt, aspartate aminotransferase (ast), and gamma-glutamyl transferase (ggt); (2) the change in serum bilirubin; (3) the change in multi-dimensional fatigue inventory; (4) the changes in serum lipids; (5) the changes in antioxidant enzymes.


Eligibility criteria:
inclusion criteria: * age over 19 * ast, alt, and ggt levels above the upper limit of the normal but less than 3 times the upper limit of the normal * participants with normal physical activity who sign an informed consent form * fatty liver detected by ultrasound exclusion criteria: * allergic reaction to oyster * uncontrolled diabetes mellitus * active viral hepatitis and any liver diseases that can affect trial outcomes (positive for hbs ag or hcv ab) * liver cirrhosis of child-pugh class b or c * chemotherapy or radiation therapy for cancer within 6 months * cholelithiasis * systemic medications that can affect liver function such as inh, valproic acid, tetracycline, allopurinol, phenytoin, phenelzine, sertraline, naproxen and diclofenac within 4 weeks * medication of cholagogues, cholelitholytics \& hepatic protectors, antidotes, detoxifying agents, and drug abuse (drugs used in substance dependence) within 4 weeks * alcoholism or excessive alcohol intake of more than 168 g/week in men and 112 g/week in women * kidney diseases or serum creatinine level above 2.0 mg/dl * uncontrolled hypertension or angina pectoris or myocardiac infarction * history of bowel resection (not including surgery on simple appendicitis) * medication of antipsychotic drugs * herbal medication within 2 months * pregnancy or breastfeeding * participation of other clinical trial(s) within 1 months from screening day * uncooperativeness * intake of dietary supplements within 4 weeks
dexamethasone added to levobupivacaine improves postoperative analgesia

Conditions: Brachial Plexus Anesthesia; Analgesia

Summary: adding dexamethasone to local anesthetic will significantly prolong duration of brachial plexus anesthesia and analgesia.

operations of upper extremities are often performed in regional anesthesia blocks. single-injection blocks are effective, but time limited. adding 4mg of dexamethasone to 0.5% levobupivacaine will significantly prolong duration of brachial plexus anesthesia and analgesia for fracture operations of upper extremity. this effect will result in less opioid use postoperatively.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * asa (american society of anesthesiologists) physical status i, ii or iii exclusion criteria: * refusal of the patients to give informed consent * preexisting coagulation disorders * local infection at the site of the block * neuropathy * drug or alcohol abusers * known allergy to the drug used in study * operation time exceeding six hours

Keywords: analgesia regional anesthesia surgery duration of analgesia dexamethasone added to levobupivacaine compared to levobupivacaine alone
diffusion tensor imaging of median nerve in diabetic peripheral neuropathy

Conditions: Diabetic Polyneuropathy; Magnetic Resonance Imaging

Summary: this study is a diagnostic accuracy study that aims to evaluate the role of dti in evaluation of dpn in comparison to clinical scores and nerve conduction studies (ncs). the study included 30 patients with diabetes mellitus complaining of neuropathy symptoms and 15 healthy volunteers. all subjects underwent evaluation using 1.5t dti of median nerves and ncs. patients underwent clinical evaluation using neuropathy deficit score (nds), neuropathy impairment score in the lower limbs (nis-ll) and diabetic neuropathy examination (dne) score. the values of these tests were compared and correlated and diagnostic accuracy tests were performed together with identification of cut-off score for abnormal diffusion tensor imaging parameters in diabetic neuropathy


Eligibility criteria:
inclusion criteria: * diabetic patients with symptoms suggestive of peripheral neuropathy. exclusion criteria: * patients with evidence of nerve entrapment or neuropathy due to causes other than dm

Keywords: diabetic polyneuropathy diffusion tensor imaging neuropathy scores
effect of anodal transcranial direct current stimulation (tdcs) over the right-hemisphere on picture naming in chronic aphasia

Conditions: Aphasia

Summary: there are two opposing hypotheses, namely the interference and laterality-shift hypotheses, regarding the role of the right hemisphere (rh) in language recovery following a left hemisphere damage. transcranial direct current stimulation (tdcs) has received increasing attention as a potential complement to behavioural therapy. this preliminary study aimed to examine the effect of excitatory (anodal) stimulation of right inferior frontal gyrus (ifg) on naming abilities of chronic people with aphasia (pwa) to examine the compensatory versus interference role of rh in language recovery, and to confirm the application of tdcs does not induce adverse effects on other cognitive and language functions.


Eligibility criteria:
inclusion criteria: * people with chronic aphasia following the stroke exclusion criteria: * history of seizure or epilepsy, * previous adverse reactions to tms/tdcs, * having a pace-maker or a metal implanted in the brain * being pregnant

Keywords: tdcs aphasia naming
gastric volume in diabetic patients undergoing staged bilateral total knee arthroplasty

Conditions: Degenerative Arthritis

Summary: aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality. diabetic patients have a higher incidence of autonomic dysfunction, causing gastropathy. they are known to have gastroparesis and the consequent delayed gastric emptying which predisposes them to an increased risk of aspiration than the general population. furthermore, other common factors can influence the gastric emptying rate, as for example, old age, pain, and the use of opioid analgesics. in the previous study, evidence of increased pain was reported in patients undergoing staged bilateral total knee arthroplasty, in whom the second operated knee had greater sensitivity (tertiary hyperalgesia) due to the surgical injury to the first operated knee. in the present study, we will evaluate the effect of old age, diabetes, surgical stress, pain, and the use of analgesics on the residual gastric volume in elderly patients undergoing staged-bilateral total knee arthroplasty.


Eligibility criteria:
inclusion criteria: * patients scheduled for staged bilateral total knee arthroplasty aged 65 to 85 years * american society of anestheiologist physical status classification 1, 2, and 3 * body mass index \< 35 kg/cm2 exclusion criteria: * previous surgery of the upper gastrointestinal tract * achalasia
safety, pharmacokinetics, and pharmacodynamics of arc1779 in healthy volunteers

Conditions: Thrombosis

Summary: the purpose of this study is to establish the overall safety and tolerability of arc1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von willebrand factor activity.

the purpose of this study is to establish the overall safety and tolerability of arc1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von willebrand factor activity.

Eligibility criteria:
inclusion criteria: * ≥ 18 to ≤ 65 years of age * weight ≤ 110 kg * negative qualitative urine drug/alcohol test * female volunteers must be of non-childbearing potential * male volunteers must agree to use a medically acceptable contraceptive * volunteers must be capable of understanding and complying with the protocol and must have signed the informed consent document exclusion criteria: any clinically significant medical disorder (e.g. diabetes, hypertension, etc.) * tendency to bleed easily * history of recent trauma or surgery * history of gout or renal stones clinically significant abnormal lab parameters for the following: * pt inr \> 1.4 * aptt \> reference laboratory values * serum creatinine \> 1.3 mg/dl * platelet count of ≤ 100,000/mm3 * alt/ast \> 2 times uln * wbc ≤ 3000 x 109/l * hemoglobin \< 11 g/dl * total bilirubin \> 1.2 mg/dl * cbt \> 15 min