Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of systane® gel drops in dry eye subjects

Conditions: Dry Eye

Summary: the purpose of this study is to evaluate the efficacy and safety of systane® gel drops in dry eye subjects following 90 days of qid (4 times/day) dosing.


Eligibility criteria:
inclusion criteria: * must give informed consent, and be willing and able to attend all study visits. * best-corrected visual acuity (bcva) of ≥ 55 letters in each eye as measured by etdrs (letters read method). * dry eye in both eyes diagnosed by an ophthalmologist. * other protocol-specified inclusion criteria may apply. exclusion criteria: * women of childbearing potential who are pregnant, test positive on a pregnancy test, or breast-feeding. * any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude the safe administration of test article or safe participation in the study. * any contraindications or hypersensitivities to the study medications or their components. * ocular surgery (of any type, including prk, lasik, epilasik, etc.) or ocular trauma requiring medical or pharmacological treatment within 1 year of screening. * use of topical ocular prescription or non-prescription medications, restasis or topical ocular steroids within 14 days of screening. * chronic medications (over the counter, prescription, or vitamins) that have not been on a stable dose for at least 30 days prior to screening. * contact lens wear within 1 week of screening and/or unwillingness to discontinue contact lens wear for the duration of the study. * participation in any other clinical trial within 30 days prior to screening. * other protocol-specified exclusion criteria may apply.
causes of visual impairment among patients applying for the visually disability certification

Conditions: Visual Impairment

Summary: causes of visual impairment among patients applying for the visually disability certification in upper egypt: a retrospective study

there are at least 2.2 billion individuals with near- or far-sightedness worldwide. nearly half of these cases-at at least 1 billion-have untreated vision impairment that may have been avoided. the leading cause of blindness or impaired distant vision among these 1 billion people is diabetic retinopathy (3.9 million), age-related macular degeneration (8 million), cataracts (94 million), refractive error (88.4 million), and glaucoma (7.7 million). presbyopia (826 million) is the primary ailment that impairs close vision. according to estimates, there are four times as many cases of distant vision impairment in low- and middle-income areas as there are in high-income areas. aging populations and population expansion are predicted to raise the likelihood that more people may have visual impairment. early on, irreversible severe visual impairment in young children can lead to delayed motor, verbal, emotional, social, and cognitive development, which can have long-term effects. children of school age who are visually impaired may also perform less academically. the quality of life is significantly impacted by vision impairment in adult populations. adults who are visually impaired may have greater rates of anxiety and depression as well as decreased employment rates. vision impairment in older persons can increase their risk of falling and breaking bones, walking difficulties, social isolation, and early admission into nursing homes or other care facilities. according to estimates, vision impairment costs the world's economy $411 billion annually in lost productivity (purchasing power parity) . this amount is greatly above the predicted $25 billion cost gap incurred from treating vision impairment. this study is to demonstrate the causes of visual impairment in upper egypt among the different age groups and evaluate the possibility of preventing these disorders

Eligibility criteria:
inclusion criteria: * all patients referred to the ministry of social solidarity with visual disability in upper egypt who were examined in the visual disability screening program from 2020-2024. exclusion criteria: * the patients who had decreased vision but did not fit with the who definition of visual disability.
a trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of gzr4 in subjects with type 2 diabetes

Conditions: Diabetes

Summary: this trial is conducted in china. the aim of the trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of mutiple-dose gzr4 in subjects with type 2 diabetes


Eligibility criteria:
inclusion criteria: * male or female at the age of 18-65 (inclusive) at the time of informed consent * body mass index (bmi) between 18.5 and 35 kg/m2 (inclusive) at screening * diagnosis of type 2 diabetes mellitus for over 3 months * hemoglobin a1c (hba1c) ≥ 6.5% and ≤ 10.0% at screening. exclusion criteria: * history of drug abuse within 1 year before screening, or positive drug abuse screening results during the screening period or at baseline * malignancy or increased risk of malignancy before screening: any suspected and/or diagnosed malignancy or documented history of malignancy * confirmed or suspected type 1 diabetes mellitus, gestational diabetes mellitus, or specific types of diabetes mellitus from other causes (monogenic diabetes syndrome, cystic fibrosis, pancreatitis, drug-induced or chemically induced diabetes mellitus, etc.) prior to screening * presence of the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma; proliferative retinopathy or maculopathy that is unstable or requiring treatment; symptomatic diabetic neuropathy, intermittent claudication or diabetic foot * severe hypoglycaemic events (level 3 hypoglycaemia) within 6 months prior to screening, or 3 or more hypoglycaemic events (blood glucose ≤ 3.9 mmol/l) within 1 month prior to screening, or recurrent hypoglycaemia-related symptoms

Keywords: gzr4 pk pd
randomized study on postmenopausal women with early stage breast cancer: wbi versus apbi

Conditions: Cancer of Breast

Summary: selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: hypofractionated whole breast irradiation versus accelerated partial breast irradiation.

patients treated with hypofractionated whole breast irradiation (wbi) received sib irradiation of the whole breast and surgical bed at two different dose levels. dose prescription was 40.5 gy to ptvwb and 48.0 gy to ptvboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2gy/fraction for each ptv respectively. daily image guided radiotherapy (igrt) were generated before each treatment session in each patient to verify the set-up. accelerated partial breast irradiation (apbi) using external intensity -modulated radiotherapy (vmat ra) was delivered at a dose of 30 gy in five 6-gy/day fractions over 10 days (every other day) with igrt at each treatment.

Eligibility criteria:
inclusion criteria: * 55\< age \<70 * tumor size ≤ 2 cm * pn0 (sn biopsy or alnd) * er/pgr positive * margins \> 5 mm (either at initial surgery or at re-excision) * clips placed in the surgical bed (minimum of 4 clips) * unicentric only * no lymphovascular invasion * any grade * no extensive intraductal component (\>25%) * written informed consent exclusion criteria: * prior thoracic radiation therapy * oncoplastic surgery / no clips in the surgical bed * multicentric cancer * autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelae
hspa12b as a potential biomarker for sepsis and severe sepsis

Conditions: Sepsis

Summary: * molecules indicating endothelial injury may serve as biomarkers for severe sepsis because of the critical role of endothelial injury in organ dysfunction during severe sepsis. * hspa12b is primarily located in endothelial cells and detectable during sepsis. * the investigators speculated that hspa12b from endothelial cells might be correlated with severe sepsis.


Eligibility criteria:
inclusion criteria: * adult patients * patients meet the diagnostic criteria according to the grouping exclusion criteria: * patients without informed consent * patients who were undergoing continuous renal replacement therapy before sampling * patients with special infection induced by virus, tubercle bacillus, mycoplasma, chlamydia, and so on

Keywords: sepsis biomarker hspa12b
timing of direct current cardioversion (dcc) in patients undergoing ablation of persistent/permanent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to compare which strategy is superior in patients with persistent/permanent atrial fibrillation (af) undergoing ablation, direct current cardioversion (dcc) prior to empirical pulmonary vein isolation (pvi) ; or pulmonary vein isolation (pvi)ablation in atrial fibrillation then direct current cardioversion (dcc) if the patient remains in atrial fibrillation.

ablation of persistent/permanent atrial fibrillation (af) remains a challenge. there are several strategies to improve the outcomes of persistent/permanent af ablation. at the cleveland clinic one of the commonly used strategies is direct current cardioversion (dcc). depending on physician preference, patients may be ablated in atrial fibrillation then direct current cardioverted; or direct current cardioverted and ablated in sinus rhythm. neither approach has been shown to be superior. as both approaches are currently being performed based on physician preference, the investigators propose to study and compare both approaches in a randomized fashion for evidence based practice. the purpose of this study is to compare which standard of care strategy is superior in patients with persistent/permanent atrial fibrillation undergoing ablation, direct current cardioversion prior to empirical pulmonary vein isolation; or ablation in atrial fibrillation then direct current cardioversion if the patient remains in atrial fibrillation

Eligibility criteria:
inclusion criteria: * persistent or long standing persistent af resistant to anti-arrhythmic medication. must have been present for more than 2 months * therapeutic anticoagulation for at least three weeks prior to initiation of therapy, or tee performed prior to the procedure * age \>= 18 years old. (females must be either post-menopausal \>12 months, practicing a protocol-acceptable method of birth control * scheduled for pulmonary vein isolation * amiodarone will be stopped at least 3 months prior to procedure exclusion criteria: * reversible causes of af such as pericarditis, hyperthyroidism * presently with valvular heart disease requiring surgical intervention * presently with coronary artery disease requiring surgical intervention * early post-operative af (within three months of surgery) * previous maze or left atrial instrumentation * life expectancy \<= 2 years * social factors that would preclude follow up or make compliance difficult. * contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin * enrollment in another investigational drug or device study * patients with severe pulmonary disease * documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction

Keywords: af
short-term study of two soft contact lenses in wearers with low astigmatism

Conditions: Astigmatism; Myopia; Hyperopia

Summary: the primary objective of the study is to evaluate and compare the performance of two soft contact lens.

the primary objective of the study is to evaluate and compare the performance of two different soft contact lens in existing spherical soft contact lens (cl) wearers with low levels of refractive astigmatism over a 2-week wear period.

Eligibility criteria:
inclusion criteria: 1. at least 17 years and no more than 42 years of age. 2. have read and signed the study consent form. 3. are willing and able to follow instructions and maintain the appointment schedule. 4. are habitual wearer of spherical soft contact lenses (not toric or multifocal design), any brand and any replacement frequency. 5. are willing to wear the study contact lenses for 6 days a week while in this study and on three days (day 1, day 7 and day 13) for at least 12 hours. 6. are willing to provide a contact email and telephone number and to use a device that allows them to respond to a short online questionnaire every 3 hours on days 1, 7 and 13 of each lens arm, while wearing one of the 2 study lenses. 7. are non-presbyopic i.e. no requirement for a reading addition for routine daily tasks (self report). 8. have astigmatism of either -0.50, -0.75, -1.00 or -1.25 dc in each eye by subjective sphero-cylindrical refraction. 9. achieves at least 0.10 logmar in each eye by subjective sphero-cylindrical refraction. 10. can be fit with available study contact lens powers of between +6.00 to -10.00 ds. 11. demonstrate an acceptable fit with the study contact lenses. exclusion criteria: 1. are participating in any concurrent clinical interventional study. 2. have worn rigid contact lenses in the last 3 months. 3. have worn soft toric contact lenses in the past 3 months. 4. have any known active ocular disease or allergies and/or infection. 5. have clinically significant biomicroscopy findings or have an ocular condition that contraindicate contact lens wear. 6. have a systemic condition that in the opinion of the investigator may affect a study outcome variable or contraindicate wearing soft contact lenses. 7. are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable or contraindicate wearing soft contact lenses. 8. have known sensitivity to the diagnostic sodium fluorescein to be used in the study. 9. have undergone refractive error surgery or intraocular surgery. 10. are an employee of the centre for ocular research \& education directly involved in this study.
innate immunity and the allergic response

Conditions: Nasal Allergies

Summary: the purpose of this study is to determine if a certain cell type (the cd49d+ neutrophil) is associated with the presence or development of allergic disease.

a specific subset of neutrophils (cd49d+) will be recruited to the nasal tissue of individuals with allergic disease, and that these cells will also be found in the peripheral blood of allergic subjects. normal subjects (those without atopy) and those treated for atopic disease will lack the presence of these cells.

Eligibility criteria:
inclusion criteria: 1. must give written informed consent before any study related activity is performed 2. male and female adult and adolescent patients aged ≥18 years and ≤ 65 years. 3. allergic or non-allergic subjects as proven by allergy skin tests in the past 2 years. exclusion criteria: 1. the presence of any of these diseases: atopic dermatitis, persistent controlled asthma, any level of severity of uncontrolled asthma, immunodeficiency or suspected immunodeficiency, any co-morbid disease (cardiac, congenital, diabetes, renal, gastrointestinal, hematologic, and oncologic). 2. any prior history of immunodeficiency, cardiac, congenital, diabetes, renal, gastrointestinal, hematologic, or oncologic disease. 3. the use of any intranasal and inhaled corticosteroids within the last month. 4. current therapy with any medication other than as needed over-the-counter medications or as-needed (not scheduled) antihistamine use. 5. current pregnancy. 6. women of childbearing potential not using an acceptable birth control method, as well as women who are breastfeeding 7. patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required) 8. use of any other investigational agent in the last 30 days
does low back position matters in manual therapy treatment

Conditions: Chronic Low-back Pain

Summary: the study will be carried out at the faculty of nursing and physiotherapy of the university of alcalá. the study has been approved by the animal research and experimentation ethics committee of the university of alcalá. a total of 46 subjects of legal age with non-specific chronic low back pain will be selected and randomized into two interventions. the first group will receive lumbar posteroanterior mobilizations with the lumbar spine in extension and the second group will receive lumbar mobilizations with neutral position of the spine. both groups will also receive a home exercise program for the lumbar spine. the total duration of the treatments will be 6 weeks, with pre-treatment, at 3 weeks of the treatment, post-treatment evaluations at 6 weeks, with a follow-up after 1 month and with a follow-up after 3 months. the objective will be to evaluate which of the two interventions is more effective in addressing disability variables (main variable), pressure pain threshold, pain location, pain intensity, quality of life, quality of sleep, depression and kinesiophobia.


Eligibility criteria:
inclusion criteria: * subjects with unspecific low back pain of 3 or more months of evolution prior commencement of the intervention exclusion criteria: * lumbar pain related to infectious diseases * fractures * oncological processes * women in gestation period.
cdp323 biomarker study

Conditions: Relapsing Multiple Sclerosis

Summary: comparison of the effects of different cdp323 doses given over a period of four weeks on blood biomarkers in subjects with relapsing forms of multiple sclerosis.


Eligibility criteria:
inclusion criteria: * female and male subjects aged 18-65 years * relapsing form of ms with at least one clinical relapse in the 24 months before screening; * screening edss score of 0-6.5; * must be fully immunocompetent * female subjects of childbearing potential must agree to practice contraception methods exclusion criteria: * any conditions that could interfere with the contrast-enhanced mri; * any clinically significant disease state or findings other than ms; * any clinically significant deviation from the pre-defined ranges for laboratory tests; * concomitant treatment with ms disease modifying drugs

Keywords: cdp323 relapsing multiple sclerosis blood biomarkers
integrative oncology outcomes study in breast cancer

Conditions: Breast Cancer

Summary: this nih-nccam funded epidemiologic research is being conducted as an observational prospective case-control study of the use of complementary and alternative medicine (cam) and integrated oncology (io) and their effects on breast cancer patients in community settings. hypothesis: io services improve patients' quality of life and decrease cancer recurrence rates in breast cancer patients as compared to women with similar disease states and prognoses who do not receive io care, and may or may not use cam treatment on their own.


Eligibility criteria:
the patients enrolled into the study will include patients who meet the following criteria: cohort 1: io clinic breast cancer patients 1. confirmed breast cancer of primary breast cancer with icd9 code of 174.x, 233.0 or v10.3 2. female 3. ≥18 years of age 4. can provide signed informed consent 5. 1st io clinic visit ≤3 months prior to enrollment 6. can read and understand the questionnaires cohort 1a: sub-cohort of io clinic patients (cases) who meet the following additional criteria and for whom matched controls have been found from the css database. 1. icd9 code of 174.x or 233.0 2. primary ductal or lobular breast cancer diagnosis ≤2 years prior to 1st io clinic visit 3. minimum of two io clinic visits within 7 months 4. provided baseline questionnaire cohort 2: matched controls from css database for cohort 1a patients 1. confirmed breast cancer 2. female 3. ≥ 18 years of age 4. can provide informed consent
covidig (covid-19 hyper-immunoglobulin)

Conditions: Covid19

Summary: the objective of this study is to evaluate the efficacy and safety of 5131a for hospitalized patients of covid-19.


Eligibility criteria:
inclusion criteria: * the covid-19 patient who diagnosed by pcr within 3 days prior to randomized and who is hospitalized with covid-19 related symptoms * the subject who has symptoms of covid-19 within 7 days * the subject with pneumonia confirmed by imaging diagnosis related to covid-19 or a 70-year-old or older or 60-year-old or older with underlying disease (diabetes or hypertension or obesity or smoker) * willing and able to provide written informed consent prior to performing study procedures exclusion criteria: * asymptomatic patient * the subject who requiring mechanical ventilation or ecmo * the subject who are underlying oxygen therapy before affected by covid-19 * the subject who have received antiviral drugs for other disease within 4 weeks * history of allergy to ivig or plasma products * the subject who received ivig or convalescent plasma from a person who recovered from covid-19 * iga deficiency * cretinine \> 2 x uln * the subject with a history of thrombosis or high risk of thromboembolism * the subject with reduced heart function \[nyha (new york heart association) functional class iii or iv\]; or cerebral cardiovascular disorder or a patient with the medical history (ischemic disease, cardiovascular disease, cerebrovascular disorder, blood vessel disorder, etc.)
protocol of diuretics use in congestive therapy in heart failure

Conditions: Heart Failure; Acute Heart Failure; Chronic Heart Failure

Summary: the main objective of the study is to determine if a diuretic adaptation protocol in the decompensation of chronic heart failure is more effective but also safer than the current non-protocolized practice.

diuretics are the main treatment for congestive decompensation of chronic heart failure. for symptomatic purposes, the goal is to decrease the volume overload. in these patients, loop diuretics are used in high doses, sometimes in combination with other classes of diuretics such as thiazides to achieve synergistic, faster and more effective action, and to combat diuretic's resistance. this use, well known to cardiologists and based on a rich pharmacology, more than 40 years old, lacks robust scientific data in real life. current studies are mainly based on patients with renal insufficiency or limited to cardio-renal syndrome. the carress-h study in 2012 is one of them. the protocol for the use of diuretics from this study was included in 2017 as a benchmark in a publication of the nejm. it therefore seems necessary to consider the exercise of this protocol in the management of the decompensation of chronic cardiac heart failure. there is, to the investigator's knowledge, no similar study to test this protocol as a "real life" exercise.

Eligibility criteria:
inclusion criteria: * adult patients hospitalized for chronic decompensated congestive heart failure without acute pulmonary edema and acute cardiac decompensation against a background of hypertensive crisis * covered under a social security program * with legal capacity to give voluntary informed consent to participate in the study exclusion criteria: * first episode of decompensated congestive heart failure * protocolized shock or hypotension (\<90 mmhg blood pressure) managed or requiring nitrovasodilators or non-invasive ventilation * one of the following cardiovascular pathologies: acute myocardial infarction / cardiac tamponade / aortic dissection / acute pulmonary embolism / heart transplant / ventricular assist device / acute pulmonary edema / hypertensive crisis * more than 12h of intravenous diuretics administered prior to inclusion * generalized edema caused by cirrhosis or nephrotic syndrome * requiring pleural or peritoneal tap for therapeutic purposes * patient allergic or intolerant to furosemide and on long-term bumetanide use * patient in dialysis or end-stage chronic kidney disease (ckd-epi-calculated gfr \<15 ml/min/1.73m²) or acute kidney injury of known non-cardiac cause * severe hypokalemia (\< 3 mmol/l) on admission * patient who is pregnant, breastfeeding, or of childbearing age not on effective contraception * adult patient safeguarded under court protection measures (guardianship, wardship, or judicial protection)

Keywords: heart failure diuretics diuretic resistance loop diuretics furosemide