Kornimate/medical-research-clean huggingface dataset:
vision improvement for patients with age-related macular degeneration

Conditions: Macular Degeneration

Summary: this study is being conducted to assess the safety and efficacy of the vis, llc (vis) opti-k low vision aid device and treatment to provide vision improvement to patients with age-related macular degeneration.

this study is being conducted to assess the safety and efficacy of the vis, llc (vis) opti-k low vision aid device and treatment to provide vision improvement to patients with age-related macular degeneration.

Eligibility criteria:
inclusion criteria: subjects who meet all of the following criteria are candidates for this study: 1. male or female 2. any race 3. patient is at least 50 years old. 4. patient has diagnosed end stage dry or wet age-related macular degeneration in one or both eyes, as verified by a complete ocular examination. 5. patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated. 6. patient has manifest refraction, spherical equivalent (mrse) between -1.50 d to 1.50 d in eye(s) to be treated. 7. patient has moderate to severe vision impairment due to age-related macular degeneration with best spectacle-corrected distance visual acuity (cdva) of 20/80 or worse (decimal less than or equal to 0.25; logmar ≥ 0.60).in the better eye. 8. patient has cdva of 20/400 or better (decimal greater than or equal to 0.05; logmar ≤ 1.30) in the worse eye. 9. patient is not a contact lens (cl) wearer. 10. patient is willing and able to comply with all examinations. 11. patient must be competent to sign an informed consent form before study entry. exclusion criteria: subjects who meet any of the following criteria are to be excluded from this study: 1. corneal disease or corneal disorder in either eye. 2. pathological retinal morphology in either eye that completely affects the entire 10° (3 mm diameter) of the retina centered on the foveola. 3. gonzalez-markowitz chart potential visual acuity (pva) in the eye to be treated that is not improved by at least four lines compared to cdva; 4. increased iop (above 20 mm hg), glaucoma or history of glaucoma; 5. previous corneal surgery in the eye to be treated; and 6. presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study.
bedside monitoring to identify impaired cerebral autoregulation in women with postpartum hypertension

Conditions: Preeclampsia; Hypertension in Pregnancy

Summary: the purpose of this research study is to develop a protocol for nirs-based bedside monitoring to identify impaired cerebral autoregulation in women admitted to the high-risk obstetrics unit with postpartum hypertension. the investigators will then pilot this protocol in 10 patients with high-risk neurological features, such as headache.

maternal neurological complications are a leading cause of postpartum severe maternal morbidity and maternal mortality (smm/mm). the lack of biomarkers to identify women at highest risk of these rare, but devastating postpartum complications, including stroke, seizures, and posterior reversible encephalopathy syndrome, has impeded efforts to prevent neurological smm/mm. impaired cerebral autoregulation may be such a biomarker. preliminary results using transcranial doppler (tcd) based techniques to quantify cerebral autoregulation have demonstrated severely impaired cerebral autoregulation in the postpartum period in some women. however, tcd is operator dependent, and cannot be used for extended monitoring due to discomfort. in contrast, near-infrared spectroscopy (nirs) is fully automated and can be continued for hours at the bedside. identifying personalized blood pressure (bp) targets using nirs has been shown to improve outcomes in acute stroke patients, another population with impaired cerebral autoregulation. however, this method has not been applied in postpartum women. this is a single center feasibility study that will include up to 10 women. postpartum women admitted to the obstetrics high-risk stepdown unit for management of postpartum hypertension will be eligible for this study. informed consent will be obtained from participants prior to enrollment in the study.

Eligibility criteria:
inclusion criteria: * women who have given birth within the previous 12 weeks * admitted to the high-risk inpatient obstetrics unit for management of hypertension * with headache or other neurological symptoms such as vision changes exclusion criteria: * acute ischemic stroke * intracerebral or subarachnoid hemorrhage * eclamptic seizures * any other neurological complication requiring transfer to the neurological intensive care unit or stroke stepdown unit * history of reynaud's syndrome

Keywords: near-infrared spectroscopy (nirs) preeclampsia pregnancy
step count monitoring as a measure of physical activity in patients with newly diagnosed glioma undergoing radiation therapy

Conditions: Glioma; Radiation Therapy Patient

Summary: this trial studies the feasibility of monitoring step count as a measure of physical activity in patients with newly diagnosed glioma undergoing radiation therapy. physical activity measured by step count may help to improve the quality of life and symptoms for patients with newly diagnosed glioma.

primary objective: i. evaluate the feasibility of monitoring step count as a measure of physical activity in patients with newly diagnosed glioma undergoing radiation therapy (rt) at md anderson cancer center (mdacc). secondary objective: i. estimate the effects of physical activity as measured by step count on cognition, fatigue, anxiety and depression scores and assess differences between groups. outline: patients are randomized to 1 of 2 groups. group i: patients wear a pedometer for step count monitoring over 6 weeks. group ii: patients wear a fitbit for step count monitoring over 6 weeks. after completion of study, patients are followed up at 3 and 6 months after completing radiation therapy.

Eligibility criteria:
inclusion criteria: * diagnosed with a glioma and going to receive at least 4 weeks of rt at mdacc at the texas medical center campus with at least 20 fractions * karnofsky performance status (kps) of 70 or above * wearable activity tracker (wat) - naive * able to read and speak english * able to provide informed consent * access to a smartphone * access to wi-fi exclusion criteria: * cognitive and/or major sensory deficits that would impede the completion of assessment instruments as deemed by the clinical team
apioc presbyopic contact lens

Conditions: Presbyopia; Refractive Errors

Summary: in this study, you will wear an invesetigational contact lens, apioc-p or apioc-pt, the way you wear your current contact lenses for approximately one month (no more than 35 days).

apioc-p and apioc-pt is an investigational contact lens, which means it has not been approved by the u.s. food and drug administration (fda), although the contact lens material, called definitive 74, is already approved and marketed for contact lenses that are similar to apioc-p and apioc-pt. in this study, participants will wear an apioc-p and apioc-pt contact lens the way they wear their current contact lenses for approximately one month (no more than 35 days). participation in this study will include a minimum of four study visits. the first will last up to 90 minutes, the second will last up to 45 minutes, the third will last up to 45 minutes, and the final visit will be up to 90 minutes. if the lens does not appear to be fitting properly at the second visit, then another lens will be ordered for participants and they will be asked to return for an additional visit for up to 45 minutes. up to 60 subjects will participate in this study.

Eligibility criteria:
inclusion criteria: 1. the subject must provide written informed consent. 2. the subject must appear willing and able to adhere to the instructions set forth in this protocol. 3. at least 40 years of age and no more than 70 years of age. 4. ≤ 4.00 d of corneal astigmatism. 5. ≤ 4.00 d of refractive astigmatism. 6. refractive error range +20.00 ds to -20.00 ds 7. keratometry readings within 40 to 50d. 8. clear, healthy corneas with no irregular astigmatism. 9. normal, healthy conjunctiva in both eyes. 10. free of active ocular disease. refractive error and presbyopia are permitted. 11. be a current or former (within the last 12 months) contact lens wearer. 12. best-corrected near and distance visual acuity better than or equal to 20/25. exclusion criteria: 1. irregular corneal astigmatism. 2. corneal scarring unless off line-of-site and well healed. 3. pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear. 4. recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. use of artificial tears less than 3 times per week is permitted. 5. systemic disease that would interfere with contact lens wear. 6. currently pregnant or lactating (by self-report). 7. history of strabismus or eye movement disorder, including exophoria at near that is 4d or greater than at far, and a receded near point of convergence break that is 6 cm or greater. 8. active allergies that may inhibit contact lens wear. 9. upper eyelid margin at or above the superior limbus. 10. history of ocular or lid surgery.

Keywords: contact lens soft contact lens
corticosteroid sparing effect of certolizumab in crohn's disease

Conditions: Crohn's Disease

Summary: the current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe crohn's disease. subjects had to be in remission (cdai\<=150) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization.


Eligibility criteria:
inclusion criteria: * men and women * age 18 years or older with moderate to severe crohn's disease (crohn's disease activity index (cdai) score of ≥ 220 ≤450) exclusion criteria: * active or draining fistula present at screening * lactating and/or pregnant female subjects * a history of any health condition that could potentially interfere with the disease and/or the treatment * a history of an adverse reaction to polyethylene glycol (peg) or a protein medicinal product * any other condition which in the investigator's judgment would make the patient unsuitable for inclusion in the study * history of drug or alcohol abuse in the prior year * receipt of any experimental therapy within or outside a clinical trial in the 3 months prior to visit 0

Keywords: certolizumab pegol cimzia crohn's disease inflammatory bowel disease
tongue fur and metabolites in diabetes mellitus

Conditions: Diabetes Mellitus; Pre-diabetes

Summary: this study is a prospective cross-sectional study. the investigators enroll participants form the department of endocrinology and of metabolism, china medical university hospital. in total, 300 participants , composed of 100 of type 2 diabetes , 100 of pre-dm and 100 healthy participants. the investigators apply tongue diagnosis system, pulse wave analysis, body constitution questionnaires, and nailfold capillaroscopy to assess the differences of tcm diagnosis. after collecting the tongue coating and analyzing the metabolite signals with a flying mass spectrometer, the investigators collect the data to establish metabolite pattern and biomarkers. this study aims to identify the clinical symptoms of dm with tcm diagnostic tools and investigate the pattern difference and treatment for dm. furtherly, the investigators add mass spectrometer to analyze the metabolites of tongue coating, the investigators propose to establish a metabolite pattern and biomarker to identify important biological indicators of dm.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of type 2 dm 2. clinical diagnosis of pre-dm 3. participants in the control group had a normal fasting glucose level exclusion criteria: 1. comorbidity of inadequate heart, liver, kidney, or other serious diseases. 2. pregnancy or lactation. 3. history of mental illness.

Keywords: diabetic mellitus , tongue fur, metabolites, and biomarkers
effect of ace-inhibitors on aortic stiffness in elderly patients with chronic kidney disease

Conditions: Cardiovascular Disease; Chronic Kidney Disease

Summary: the goal of this proposal is to investigate the potential for ace-inhibitors (ace-i)(drugs primarily used to treat hypertension or congestive heart failure) to prevent or delay cardiovascular disease (cvd) in older adults with chronic kidney disease (ckd) by examining their impact on aortic stiffness in people with stage 3 ckd in a randomized, controlled study.

this study will be the first to examine whether aortic stiffness is increased in elderly patients with ckd compared to their age-matched healthy controls and further examine whether ace-i may delay the progression of aortic stiffness in elderly ckd patients. if ace-i therapy appears beneficial in preventing or delaying arterial stiffening in elderly patients with ckd, this work has important implications for improving the overall health of this population.

Eligibility criteria:
inclusion criteria: * age \> 60 years * bp 120/80 or higher \*(bps will be checked weekly first 4 weeks to ensure \ 130/80 we will administer other bp meds per jnc vii guidelines) * ckd stage 3 (gfr 30 - 59 ml/min) for ckd group; no ckd for control group exclusion criteria: * known significant cvd (history of myocardial infarction (mi), recurrent stroke, or new york heart association (nyha) class iii or greater). * serum potassium \> 5.2 meq/l * known allergy or hypersensitivity to ace inhibitor or arb * female of childbearing age not practicing contraception * current treatment with an angiotensin converting enzyme inhibitors (ace-i) or angiotensin-receptor blockers (arb) (note: can participate if on ace-i after 6 week washout period) * history of ace-i induced angioedema * history of angioedema, hereditary or idiopathic * persons lacking consent capacity * 500 mg/dl proteinuria on 2 consecutive spot urine protein/creat ratios

Keywords: cardiovascular disease angiotensin converting enzyme inhibitors chronic kidney disease cardiovascular disease in elderly patients with ckd
acrylate intraocular lenses in cataract surgery of uveitis patients

Conditions: Uveitis; Cataract

Summary: cataract is a common complication in uveitis patients. cataract operations with intraocular lens implantation are difficult in these patients because of complication due to the biocompatibility of the intraocular lens. in this study, uveal and capsular biocompatibility of two widely used acrylate intraocular lenses are compared.


Eligibility criteria:
inclusion criteria: * non infectious uveitis * no active inflammation * significant visual disturbance related to lens opacification exclusion criteria: * vitreous opacification * ocular hypertension/glaucoma
evaluation of the prophylactic use of omeprazole in patients admitted to the state hospital of américo brasiliense

Conditions: Omeprazole

Summary: introduction. the prevalence of the use of drugs that act on the gastric system has increased in the population. omeprazole is an inhibitor of the protons pump and has a widespread use, mainly as a prophylactic to prevent reflux esophagitis, gastric pathological hypersecretory conditions, prevention of recurrence of gastric or duodenal ulcers, gastric mucosal protection against damage caused by nonsteroidal anti-inflammatory drugs and during zollinger-ellison syndrome. however, omeprazole is associated with several adverse events due to abusive use or irrational prescribing, in disagreement with the indication, which may cause the ineffectiveness of the drug and decreased patient safety. objectives. to assess the risk (occurrence of adverse events) and the benefit (effectiveness) of the prophylactic use of omeprazole in hospitalized patients and to know the reasons for the prophylactic use (indicated use or not approved). patients and methods. a observational and cross pharmacoepidemiological study will be performed from june to november 2014, in the general state tertiary referral américo brasiliense hospital. hospitalized patients will be separated into three groups: those who make indicated and approved prophylactic use of omeprazole (exposed group 1), those who make not indicated and not approved prophylactic use (exposed group 2), and those who do not use the omeprazole (non-exposed group). patients who do not make prophylactic use of omeprazole will be excluded. patients will have their pharmacotherapy monitored and data will be collected daily using an investigation guide of the first day of admission and will be included in group 1 or 2, from the first use of omeprazole to discontinuation (washout period of seven half-lives or higher). national coordinating council for medication error reporting and prevention (nccmerp) algorithm will be used for causality analysis is used. data will be tabulated according to the presence or absence of effectiveness and the presence or absence adverse events in the three groups. the odds ratio of adverse events and effectiveness of indicated and approve or not indicated and not approved prophylactic use of omeprazole will be calculated. expected results. it is intended to know the odds ratio of adverse events in the prophylactic use of omeprazole with or without indication or use approval, and the potential indications, dosage and unapproved methods of prophylactic use in omeprazole label.


Eligibility criteria:
inclusion criteria: patients in use of omeprazole prophylactic (off label or indicated use) who will be admitted at the hospital under study, exclusion criteria: patients transferred from another hospital or ward; those with prescheduled surgery; those unable to communicate (intubated, in isolation, or mentally disoriented); and those with a hospital stay ≤24 hours.

Keywords: risk assessment pharmacovigilance pharmacoepidemiology drug toxicity adverse drug reaction reporting system omeprazole
early ultrasound screening of heterotopic ossification after severe neurological trauma

Conditions: Heterotopic Ossification

Summary: prospective, bi-centric diagnostic, performance study on a new diagnostic procedure with ultrasounds against a reference diagnostic procedure. the primary objective is to study the performance of ultrasound coupled with clinical examination at 1 week of admission for early screening of heterotopic ossification (ho) in patients admitted to a post intensive care rehabilitation unit (picru) after a severe neurologic trauma. the ct scan at 5 weeks of admission is considered as the gold standard. ct scan reader will be blinded to clinical data.

heterotopic ossification still pose the problem of diagnosis and clinical management that is too late and invasive when complications arise. the challenge would be to identify patients at earlier stage of ho development in order to start an early treatment. this study will focus on the performance of ultrasound in the early screening of ho for patients admitted to a post intensive care rehabilitation unit after severe neurological trauma, this population being at high risk of ho. patient enrollment will be performed only at the picru of the raymond poincaré hospital (ap-hp). another center (the imaging department of the same hospital) will participate in this research for ultrasounds and ct scans, but will not perform any recruitment.

Eligibility criteria:
inclusion criteria: * patients ⩾ 18 years; * admitted to a neurological post intensive care rehabilitation unit for the first time; * hospitalized in icu before being admitted to picru for a for traumatic brain injury (initial glasgow coma scale \< 14 and brain radiological abnormalities at the time of admission to icu and / or a traumatic spinal cord injury (para- or tetraplegia with at least half of key muscles of the 2019 isncsci classification with a strength of less than 3 below the neurological level of the injury at the time of admission to picru); * patient's written consent obtained (or from an authorized relative); * affiliation to a social security scheme. exclusion criteria: * history of moderate or severe traumatic brain injury; * history of spinal cord injury (para- or tetraplegia); * history of stroke or disabling neurological disease; * history of hospitalization in neurological or neurosurgical or traumatological icu for another reason; * breast-feeding or pregnancy; * under court protection.

Keywords: heterotopic ossification post intensive care rehabilitation unit early screening ultrasound neurological trauma
efficacy and safety in transfusion independent non-severe aplastic anemia

Conditions: Aplastic Anemia

Summary: aplastic anemia (aa) is a rare bone marrow failure disease characterized by bone marrow hypocellularity and peripheral blood pancytopenia. aa is divided into severe aa (saa) and non-severe aa (nsaa) based on the degree of cytopenia. the first line therapy for saa or transfusion dependent nsaa is either immunosuppression therapy (ist) or hematopoietic stem cell transplantation (hsct). little attention has been paid to patients with anemia but not transfusion dependent, whose quality of life is significantly impaired due to the anemia and other complications.

recombined human erythropoietin (rhepo) has been shown to increase the erythroid response and response rate when combined with ist for patients with newly diagnosed aa, either saa or nsaa. different from rhepo, luspatercept is a recombinant fusion protein that binds to select transforming growth factor β superfamily ligands and enhances late-stage erythropoiesis, and has been shown the promising efficiency in the erythropoiesis in patients with lower risk myelodysplastic syndrome (mds) in the phase ii and iii clinical trials. this randomized control study aimed to compare the 6-month efficacy and safety of the combination of luspatercept and ciclosporin versus ciclosporin monotherapy in patients with newly diagnosed transfusion independent nsaa.

Eligibility criteria:
inclusion criteria: 1. age≥18 year-old; 2. hemoglobin level between 60g/l\~10 g/dl; 3. newly diagnosed patients have at least one of the followings: #absolute neutrophil count \<1.5×109/l, #platelet count \< 30×109/l, # hemoglobin level \< 100g/l; 4. with normal baseline liver and kidney function; 5. with no active infection; are not pregnant or nursing; 6. agree to sign consent forms; 7. eastern cooperative oncology group (ecog) performance status 0-2 exclusion criteria: 1. congenital aplastic anemia; 2. presence of chromosomal aberration; 3. evidence of a clonal hematologic bone marrow disorder (mds, aml) on cytogenetics; 4. presence with pnh clone ≥50%; 5. patients received hsct before; 6. uncontrolled infection or bleeding with standard treatment; 7. allergic to luspatercept csa or accessories; 8. hiv, hcv or hbv active infection or liver cirrhosis or portal hypertension; 9. patient with qtcf (fridericia's qt correction formula) at screening \ 180/100mmhg)#pulmonary artery hypertension; 10. have any concomitant malignancies within 5 years expect for local basal cell carcinoma of the skin; 11. past history of thromboembolic event, heart attack or stroke (including anti-phospholipid antibody syndrome) and current use of anticoagulants; 12. pregnant or nursing (lactating) woman; 13. have attended other clinical trials within 3 months

Keywords: nsaa luspatercept orr non-transfusion dependent