Kornimate/medical-research-clean huggingface dataset:
study of soft contact lens use with 7 day extended wear

Conditions: Ametropia

Summary: to compare the safety and efficacy of the cvi silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the acuvue 2 soft contact lenses.

to compare the safety and efficacy of the cvi silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the acuvue 2 soft contact lenses in this open-labeled randomized study.

Eligibility criteria:
inclusion criteria: 1. be at least 18 years of age as of the date of evaluation. 2. require lens powers between -0.50 and -6.00 diopters sphere with no more than 1.00 diopter of refractive astigmatism and be willing to wear lenses in both eyes. 3. be correctable to visual acuities of at least 20/25 in each eye with spectacles. 4. be in good general health, based on his/her knowledge. 5. be able and willing to adhere to the instructions set forth in this protocol and able to keep all specified appointments. 6. possess wearable and visually functional eyeglasses. exclusion criteria: 1. previously unsuccessful with contact lens wear. 2. rigid gas permeable contact lens wear within the past 12 months. 3. previous refractive surgery; current or previous orthokeratology treatment. 4. subject is wearing lenses in a modified monovision modality (multifocal lens in one eye). note: subjects may not wear monovision lenses at any time during the study unless they are wearing spherical monovision lenses prior to enrollment. 5. aphakia, keratoconus or an irregular cornea. 6. a known history of corneal hypoesthesia 7. clinically significant (grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures. 8. ocular or systemic disease or need for medication which might interfere with contact lens wear. i.e., sjögren's syndrome, type ii diabetes, etc. 9. slit lamp findings that would contraindicate contact lens wear, including but not limited to: * history of corneal ulcer, corneal infiltrates or fungal infections. * pterygium, pinguecula or corneal scars within the visual axis * pathological dry eye or associated findings (examples: sjögren's syndrome, lupus erythematosus, sclerodermia) * neovascularization or ghost vessels \> 1mm in from the limbus * seborrheic eczema, seborrheic conjunctivitis * history of papillary conjunctivitis greater than grade 2 (mild) * anterior uveitis or iritis (past or present) 10. known sensitivity to the care systems used in this study. 11. poor personal hygiene 12. current pregnancy or is lactating (to the best of the subject's knowledge) or subject is planning pregnancy within the next 13 months. 13. any active participation in another clinical study within 30 days prior to this study. 14. subject is a member, relative or household member of the office staff, including the investigator(s). subjects must read, indicate understanding of, and sign the informed consent form.

Keywords: myopia hyperopia extended wear ametropia
interactive care coordination and navigation:rct to assess the impact of a mhealth intervention for homeless individuals

Conditions: Number of Emergency Department and Hospital Visits Among Adults Experiencing Homelessness; Medication Adherence; Social Support; Pyschological Distress; Attainment of Social Needs (i.e., Housing, Employment, Receipt of Benefits)

Summary: people experiencing homelessness (peh) are at exceptionally high risk of frequent emergency department (ed) and hospital use, poor functional outcomes, and increased morbidity and mortality from poorly managed chronic health conditions and complex social needs. evidence-based interventions of particular promise for reducing ed and hospital utilization and improving health outcomes and meeting social needs involve:1) providing care in the community to overcome barriers including transportation and fear of stigmatization; 2) coordination of care transitions following ed or hospital discharge to improve access to needed community supports and reduce the risk of readmission; and 3) using mhealth technology to link peh with appropriate community-based health and social services. this project builds on evidence from two feasibility studies in order to integrate and test a mhealth intervention, comprised of gps technology and text messaging components, into a community setting to connect peh with a community-based case manager and healthcare and social services. our hypothesis is that integrating the mhealth intervention into an established, trusted navigation center for peh will mitigate barriers to care and gaps in the care continuum resulting in decreased ed and hospital use and improved health outcomes and attainment of social needs. the study aim is to conduct a stratified rct to compare a mhealth intervention with usual care community-based case management to examine the impact on healthcare utilization (primary outcome), medication adherence, social support, psychological distress and social needs attainment (secondary outcomes) in peh.


Eligibility criteria:
inclusion criteria: * 18 years old homeless (defined as where the person slept most nights in past 30 days (street, shelters, transitional housing, doubling-up with family or friends) currently own a cell phone with service or use phone with wifi (when available) at baseline currently prescribed ≥ 2 medications for chronic medical conditions (self-report) diagnosis of at least two chronic health conditions (self-report): e.g., hypertension, diabetes, depression * 2 hospitalizations or ed visits in the last 6 months (self-report) score of at least 4 on the realm-sf health literacy measure score \> 17 on the mini-mental state exam exclusion criteria: unable to communicate verbally in english. this is an exclusion criteria because the text messaging, apps, procedures and measures are not validated in in other languages.

Keywords: mhealth among people experiencing homelessness
randomised crossover trial of dbs of differential psa regions in parkinson's disease and tremor

Conditions: Parkinson's Disease; Tremor

Summary: the posterior subthalamic area holds promise as a target region for deep brain stimulation in tremor and parkinson's disease. using the magnetic resonance-directed implantable guide tube surgical technique, subregions of the posterior subthalamic area can be individually targetted on a single electrode lead trajectory. the hypothesis is that the caudal zona incerta may provide improved control of movement disorder symptoms than the more commonly stimulated dorsal zona incerta.

randomisation between two treatment locations each programmed up to 3 milliamps in amplitude for 3 months: (1) caudal zona incerta and (2) dorsal zona incerta. this 6-month-long randomised phase is followed by 6 months of unblinded individualised empirically optimised settings programmed by a neurologist. each of the three treatment periods ends with a full clinical, functional and quality of life assessment.

Eligibility criteria:
inclusion criteria: * medication-refractory tremor and/or parkinson's disease as defined by uk brain bank criteria with either inadequate control of motor fluctuations or dyskinesia despite optimised medical therapy exclusion criteria: * significant cognitive, psychiatric and medical co-morbidities * dementia with mini mental state examination score of less than 25/30 * limited life expectancy due to a co-morbid condition

Keywords: parkinson's disease essential tremor tremor deep brain stimulation posterior subthalamic area zona incerta
the correlation between genetic polymorphism, platelet activity, clopidogrel responsiveness, and serum adipokine concentration in asian acute coronary syndrome patients

Conditions: Acute Coronary Syndrome; Chronic Coronary Artery Disease

Summary: in this study, we evaluate the acute coronary syndrome patients to see if there is correlation between platelet activity, genetic polymorphism (cyp2c19 and abcb1), serum adipokines level, and clopidogrel responsiveness.


Eligibility criteria:
inclusion criteria: 1. age \> 18 y/o 2. acute coronary syndrome patients 3. chronic coronary artery disease patients 4. healthy volunteers exclusion criteria: 1. patient refusal 2. allergy to clopidogrel 3. receive gp iib/iiia inhibitor simultaneously 4. cancer history 5. severe renal and liver function impairment 6. coagulopathy

Keywords: acute coronary syndrome and chronic coronary artery disease patients
increasing potassium intake in hypertensive individuals

Conditions: Hypertension

Summary: this study evaluates the safety of increasing dietary potassium intake in a hypertensive population that may be at risk for hyperkalemia.

the blood pressure lowering benefits of increasing dietary potassium (k⁺) are well known. as such dietary recommendations for hypertension focus on a diet rich in high k⁺ food sources such as fruits and vegetables. an important theme to be addressed is the safety of achieving high dietary k⁺ intake in hypertensive individuals who are also receiving medical therapy that might predispose to elevated serum k⁺ levels (hyperkalemia). the purpose of this study was to assess the impact of aggressively increasing dietary k⁺ on serum k⁺ concentrations in hypertensive individuals with intact renal function medicated with raas blocking drugs. the investigators hypothesized that dietary k⁺ supplementation would not provoke hyperkalemia despite treatment with either an angiotensin converting enzyme (acei) or an angiotensin receptor blocker (arb). the investigators conducted an open controlled clinical trial in 20 hypertensive subjects with normal renal function who were randomized to a usual diet group (ud n=10), or a high potassium diet group (hkd, n= 10). fruits and vegetables were used to increase potassium intake. all participants were on an acei or and arb. serum potassium concentration, 3- day food records and 24 hour urine collections were completed at baseline and at the end of the 4-week study.

Eligibility criteria:
inclusion criteria: * medically treated hypertension as diagnosed hypertension was established by the participant's cardiologist or if recruited from the online community hypertension was self-reported and confirmed by study investigators based on participant's medical prescription. * treatment with an beta blocker, ace inhibitor, or angiotensin receptor blocker without any adjustment over the previous 3 months * k+ intake at baseline of less than 80 mmol/day (food diary of 24 hour food recall). exclusion criteria: * patients with an episode of acute coronary syndrome, or revascularization within the previous 3 months will not be included. * serum k+ concentration 5.0 mmol/l * serum creatinine \> 130 mmol/l. * inability to provide informed consent.

Keywords: nutrition potassium
relation of circulating endothelium-derived microparticle to carotid atherosclerosis

Conditions: Atherosclerosis

Summary: the investigators hypothesized that circulating endothelium-derived microparticle (emp) may be a useful surrogate marker of atherosclerosis and future episode of cerebrovascular events. peripheral blood is drawn at the time of carotid ultrasound examination. circulating emps are counted using flow-cytometry. the correlation among circulating emp, ultrasound findings, and atherosclerotic risk factors are determined by multiple stepwise regression analysis. the prevalence of cerebrovascular events is also determined during 3-year follow-up period.


Eligibility criteria:
inclusion criteria: * patients who undergo carotid ultrasound examination for screening of atherosclerosis exclusion criteria: * cerebrovascular events within the last 12 months * acute coronary syndrome, coronary and peripheral intervention within the last 6 months * uncontrolled heart failure * other severe systemic diseases
lobag30 diet in patients on metformin

Conditions: Diabetes Mellitus; Diet

Summary: we will determine the metabolic response to a low biologically available glucose diet (lobag30) in subjects currently receiving the maximum dose of metformin as monotherapy in whom the glycohemoglobin is not at an acceptable level (\>8.0%). our hypothesis is that introduction of a lobag30 diet to subjects currently treated with a full therapeutic dose of metformin will improve blood glucose control in people who have not achieved an acceptable total glycohemoglobin on metformin alone.

subjects will ingest a control diet (55% carbohydrate (cho), 15% protein, 30% fat) or a lobag30 diet (30% cho, 30% protein, 40% fat) in a parallel design with block randomization in pairs of two. subjects will return to the study center twice each week while on the diets to have blood glucose, glycohemoglobin, lactate, weight and blood pressure measured, and to have urine assayed for urea and creatinine. at the beginning and end of the 5 week study period, the subjects will be admitted to the study center for 28 hours during which time blood will be drawn for 24 hour profiles of glucose, insulin, other hormones and several metabolites. for those subjects randomized to the lobag30 arm of the study, the control diet will be given during the first 24 hour study period; the assigned diet will be given at the end of the 5 week period.

Eligibility criteria:
inclusion criteria: * people with type 2 diabetes mellitus who currently are receiving the maximal dose of metformin monotherapy (2500 mg/day). * these subjects will have had a stable glycohemoglobin (tghb) in an unacceptably high range (8-11%) for at least 4 months prior to beginning the study. * subjects with tghb \> 11% (hba1c \> 10%) will not be recruited into the study. exclusion criteria: * hematological abnormalities * liver disease * kidney disease * macroalbuminuria (\>300 mg albumin/24 hours) * untreated thyroid disease * congestive heart failure * angina * life-threatening malignancies * proliferative retinopathy * severe diabetic neuropathy * peripheral vascular disease * serious psychological disorders * a body mass index \> 35 * and a fasting triglyceride of \>400 mg/dl. * subjects taking slow-release metformin will not be studied. * subjects taking medications other than metformin, known to affect fuel metabolism such as: * insulin * the sulfonylureas * glucagon-like peptide 1 (glp-1) analogs and metabolic inhibitors * pramlintide * prednisone and similar steroids * thyroid hormone * antipsychotic medications * thiazide diuretics * medroxyprogesterone * high dose aspirin, also will be excluded. * if concentrations of serum folate, b12 or iron are low, the subject will be excluded from the study until corrected, i.e. until normal concentrations are recorded.

Keywords: diabetes mellitus (type 2) diet glycohemoglobin lipids kidney function glycemic index dietary protein dietary carbohydrate
functional assessment for surgery by a timed walk

Conditions: Surgery-Complications; Postoperative Complications

Summary: the fast walk study aims to determine whether a walking test called the 6-minute walk test (6mwt) can help identify people who are more likely to experience complications after surgery. this test will be completed before surgery. we hope that the results of this study will help improve care for patients having major surgery in the future.


Eligibility criteria:
inclusion criteria: 1. age ≥40 years 2. ≥1 risk factors for postoperative complications 3. elective non-cardiac surgery with expected post-surgery stay ≥2 days 4. preoperative 6mwt is feasible 5. working knowledge of official language(s) in country of study recruitment exclusion criteria: 1. endovascular surgery 2. lower limb orthopedic surgery 3. contraindications to 6mwt

Keywords: six minute walk test functional assessment
nuss procedure: clinical options in pediatric pain management?

Conditions: Pectus Excavatum

Summary: a retrospective chart review study analyzing the benefits of patient controlled analgesia, thoracic epidural analgesia, and paravertebral nerve block catheters in patients having surgical repair of pectus excavatum using the nuss procedure.


Eligibility criteria:
inclusion criteria: * patients undergoing the nuss procedure since the beginning of 2011 to sept. 30th, 2013. exclusion criteria: * none
rispect: risperdal safety protocol evaluation consta treatment, a post authorization safety survey to obtain information on the safety and efficacy of risperidone when used in routine clinical practice

Conditions: Schizophrenia; Psychotic Disorders; Schizoaffective Disorder

Summary: the purpose of this research study is to gather information on the safety and efficacy of risperidone when used in routine clinical practice.

this post-authorisation safety survey (pass) is an international, multicentre, naturalistic, descriptive survey to confirm safety of risperidone in daily practice. this is a single-arm, prospective, observational survey to compare the safety profile between groups defined by existing risk or disease factors or patient characteristics. the study duration is 6 months with 4 patient visits. the primary objective of this pass is to confirm safety, as identified in phase iii clinical trials of risperidone, by collecting data when the drug is used under marketed conditions in routine clinical practice. a secondary objective is to evaluate effectiveness and reasons for initiating risperidone. each investigator is to document data for 4-10 treated patients for whom risperidone long-acting injectable (rlai) treatment is determined to be clinically indicated. risperidone long-acting injectable (rlai) is given as intramuscular injections every 2 weeks. the starting dose of rlai will be in accordance with the product label (usually 25 mg). if necessary, the dosage of the injection may be increased gradually. treatment duration is 26 weeks. to ensure continued antipsychotic coverage until the main release of risperidone from the microspheres, previous antipsychotic therapy will be continued concomitantly during the first three weeks of the study.

Eligibility criteria:
inclusion criteria: * all patients treated with long-acting injectable risperidone as decided after agreement between the physician and the patient, in accordance with the local summary of product characteristics (smpc), are eligible for inclusion in this survey. according to the global smpc, long-acting injectable risperidone is indicated for the treatment of schizophrenia and schizoaffective disorder exclusion criteria: * according to the smpc, long-acting injectable risperidone is contraindicated in patients with a known hypersensitivity to the product or any of its components. these patients must be excluded from the survey

Keywords: pass safety assessment efficacy assessment long-acting injectable risperidone
study of oral scio-469 in relapsed, refractory patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: the main objective of this study is to assess the efficacy of scios-469 as monotherapy in relapsed, refractory patients with multiple myeloma (mm), based on response rates.

the main objective of this study is to assess the efficacy of scio-469 as monotherapy in relapsed, refractory patients with multiple myeloma (mm), based on response rates. patients took scio-469 two capsules (60 mg) by mouth three times a day with water, preferably with a meal, for 72 days except on days 1 and 30 of monotherapy and days 1 and 11 of combination therapy. on these days, the second dose of scio-469 was administered after collection of the 12-hour pk sample, and the third dose was not administered.

Eligibility criteria:
inclusion criteria: * life expectancy more than three months * diagnosed with multiple myeloma (mm) * relapsed following a response to any conventional mm therapy, and refractory to their most recent mm therapy * karnofsky performance status = 60 * no electrocardiographic evidence of acute ischemia or new conduction system abnormalities * no history of myocardial infarction within last 6 months * serum concentrations of aspartate aminotransferase (ast) and alanine aminotransferase (alt) = 3x upper limit of normal (uln) * total serum bilirubin = 2x uln * calculated or measured creatinine clearance \>30 ml/min * platelet count = 30 x 10(9)/l * hemoglobin concentration = 8 g/dl * white blood cell count = 2.0 x 10(9)/l exclusion criteria: * patients with non-secretory myeloma, plasma cell leukemia, or poems syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, m-protein and skin changes) * major surgery within four weeks of enrollment * severe elevated serum calcium * heart failure * receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents * receipt of corticosteroids equivalent to more than 10 mg/day of prednisone within two weeks before enrollment * known allergies to agents used in bortezomib (e.g., boron or mannitol) * poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol

Keywords: multiple myeloma scio-469 p38 map kinase myeloma bone marrow
normal saline versus heparinized solution flush for maintaining patency of peripheral venous catheters in children

Conditions: Infection of Intravenous Catheter; Phlebitis; Extravasation of Diagnostic and Therapeutic Materials

Summary: the aim of the study is to verify if the periodic flush with normal saline 0.9% nacl causes a longer or equal duration of patency of peripheral venous catheters, compared with heparin solution 50 u / ml flush, in children from 2 years to 14 years. only 22 and 24 gauge catheters will be included in the study.the study will assess in particular: * the difference of permanence in situ of the device * the difference in incidence of complications (in detail: obstruction, phlebitis, thrombocytopenia, systemic anticoagulation) * the difference in costs between use of saline normal saline 0.9% nacl solution and heparinized 50 u / ml.


Eligibility criteria:
inclusion criteria: * age between 2 years and 14 years old * medical prescription of intravenous antibiotic therapy for at least 2 doses on the day * presence of informed consent to participate to the study provided by the parents * no known hypersensitivity to heparin * no known hypersensitivity to the patch fixing materials (polyurethane and / or glue) * absence of diseases buoyancy coagulation (haemophilias and / or thrombophilias) * no antecedents trombopenie dued to the use of any type of heparin or a pentosan polysulfate * no existing treatment based on corticosteroids and / or anti-inflammatory exclusion criteria: * age outside the range 2 - 14 years * children for which there is no prescription of intravenous antibiotic therapy for at least 2 times a day * children for which the parents have not consented to the study * children with known hypersensitivity to heparin * children with known hypersensitivity to the patch fixing materials (polyurethane and / or adhesive) * children with disease-causing buoyancy coagulation (hemophilia and / or thrombophilia) * children with antecedents of trombopenie occurring by the use of any type of heparin or of a pentosan polyphosphate * children in treatment with corticosteroids and / or anti-inflammatory

Keywords: peripheral venous catheter, children.