Kornimate/medical-research-clean huggingface dataset:
clinical investigation of buttermere (lens 271) soft contact lenses

Conditions: Myopia

Summary: the purpose of the study is to compare clinical performance between two soft contact lenses.

the purpose of this study is to compare clinical performance of two soft contact lenses in a crossover study over a period of 7 days of wear.

Eligibility criteria:
inclusion criteria: i. age 8 to 18 years; at least half the population will be children or adolescents aged 8 to 15 years. ii. have experience with soft contact lens wear and able to insert and remove soft contact lenses. iii. parent/guardian and participant have read and understood the participant information sheet. iv. parent/guardian and participant have read, signed and dated the informed consent and assent (when applicable). v. best corrected visual acuity of at least 20/25 in each eye. vi. have normal eyes with the exception of the need for visual correction. vii. spectacle refraction: * age 8 to 12: -0.75d to -4.00d spherical equivalent, with cylinder ≤ -0.75d and maximum anisometropia of \<1.00d * age 13-18: -0.75d to -7.00d spherical equivalent, with cylinder ≤ -0.75d and maximum anisometropia of \<1.00d. viii. be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule. exclusion criteria: i. acute and subacute inflammation or infection of the anterior chamber of the eye. ii. any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids. iii. severe insufficiency of lacrimal secretion (dry eyes). iv. corneal hypoesthesia (reduced corneal sensitivity), if not aphakic. v. any systemic disease that may affect the eye or be exaggerated by wearing contact lenses. vi. allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions. vii. any active corneal infection (bacterial, fungal, or viral). viii. the patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so. ix. newly prescribed use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator. x. monocular participants (only one eye with functional vision) or participants fit with only one lens. xi. subjects with slit lamp findings greater than grade 1 (e.g., edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per iso 11980:2012, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit. xii. history of herpetic keratitis, ocular surgery or irregular cornea. xiii. enrolment of the family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
modafinil to prevent postoperative cognitive decline

Conditions: Postoperative Cognitive Dysfunction

Summary: postoperative cognitive dysfunction is a well-recognized complication of surgery. the aim of the study is to investigate whether cognitive dysfunction is reduced by the use of modafinil as shown by neurocognitive testing.the treatment effects will be evaluated compared to placebo as well as a non-surgical group.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists class i or ii * elective surgery * surgery requiring general anesthesia 4.) control group will be-females \& males 65 and older not scheduled for any surgical procedures for at least a 3 month period. exclusion criteria: * neurosurgery * cardiac surgery * narcotic or illicit drug abuse * chronic opioid use * chronic use of anxiolytics * history of pulmonary disease * c02 retention * sleep apnea * obesity
effects of ivabradine on cardiovascular events in patients with moderate to severe chronic heart failure and left ventricular systolic dysfunction. a three-year international multicentre study

Conditions: Chronic Heart Failure

Summary: the primary objective of this study is to demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left ventricular ejection fraction and currently receiving recommended therapy for this disease.


Eligibility criteria:
inclusion criteria: * symptomatic chronic heart failure (nyha ii, iii or iv) * left ventricular systolic dysfunction (lvef ≤ 35%) * sinus rhythm and resting heart rate ≥ 70 bpm * optimal and unchanged chf medications or dosages exclusion criteria: * unstable condition within previous 4 weeks * myocardial infarction or coronary revascularisation within previous 2 months * stroke or transient cerebral ischaemia within previous 4 weeks * congenital heart disease * severe valvular disease * active myocarditis * permanent atrial fibrillation or flutter
radiation plus cetuximab in locally advanced non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this trial is to study combined locoregional radiotherapy with cetuximab in non-operable nsclc stage iii (phase ii trial). endpoints: safety and feasibility (primary) response, survival, time to progression (secondary)

study entry examinations: * blood cell count * liver enzymes * ventilatory function test * pregnancy test (premenopausal women) * ct of the thorax * ct of the brain * ultrasound of the liver * bone scan * fdg pet scan (after inclusion) follow-up examinations (2 months, than every 3 months): * patients history and examination * ct scan of the thorax * ventilatory functions test * fdg pet scan (at least at 6 months) * bone scan (yearly) * ultrasound of the liver (every 6 months) cetuximab administration: * 450 mg / m\^2 body surface on week 1 * 250 mg /m\^2 body surface weekly, week 2 -21 radiation therapy: * intensity modulated radiation therapy of primary tumor and mediastinum (2 gy single dose, total dose 50 gy; 5 fractions per week) with boost to the pet positive sites (2 gy single doses up to 66 gy). radiation therapy during weeks 2-8. amendment 1/07: 3d conformal rt possible, but not if fev1 \< 1.5l of \< 50%

Eligibility criteria:
inclusion criteria: * histologically verified nsclc * not eligible for radiochemotherapy or patient refuses chemotherapy * fev1 \>1.5 l or min. 50% * kpi \>= 70% * life expectancy \> 6 months * weight loss less than 10% of body weight in 12 months * compliance * adequate blood counts (lc \> 3000 x 10\^3/ml, tc \>100000 x 10\^3/ml, hb \> 10 g/dl) * effective contraception amendment 1/07: fev1 \>1.2 l or min 40% exclusion criteria: * active infection * reduced liver function * vena cava superior syndrome * malignant pleural effusion * pregnancy or breast feeding * additional serious systemic disease * secondary malignancy (except carcinoma in situ of the cervix, basalioma of the skin, secondary cancer in remission for \> 5 years) * known allergies against proteins * history of former antibody therapy * allergy against i.v. contrast agents
hd10 for early stages

Conditions: Hodgkin´s Lymphoma

Summary: this study is designed to find the optimum radiation dose and number of cycles for an abvd chemotherapy combined with an involved field irradiation. it is to be tested whether the reduction from 4 to 2 cycles of abvd and/or the reduction of the radiation dose from 30 to 20 gy is feasible without a loss of efficacy.


Eligibility criteria:
inclusion criteria: * hodgkin´s lymphoma (histologically proven) * cs (ps) ia, ib, iia,iib without any of the following risk factors: 1. bulky mediastinal mass (\> 1/3 maximum transverse thorax diameter) 2. extranodal involvement 3. esr \> 50 (a), \> 30 (b-symptoms) 4. 3 or more lymph node areas involved * written informaed consent exclusion criteria: * leukocytes \<3000/microl * platelets \<100000/microl * hodgkin´s disease as "composite lymphoma" * activity index (who) \< grade 2

Keywords: hodgkin´s lymphoma early stages
taurolock hep 500 versus unfractionated heparin as anti-inflammatory in hemodialysis catheters.

Conditions: Hemodialysis Catheter Infection; Thrombosis; Dialysis Catheter

Summary: to assess the efficacy of taurolock-hep500™ as anticoagulant and antimicrobial catheter lock solution in comparison to unfractionated heparin as alock solution to improve performance of hemodialysis catheters and quality of hemodialysis .

in this study,investigators will recruit 60 patients with esrd on regular hemodialysis from hemodialysis units in ain-shams university hospitals, patients will be recruited to study at the time of catheter insertion. they will be randomized into 2 groups. group 1; 30 patients will receive unfractionated heparin (5000i.u/ml) after hemodialysis sessions (control group). group 2; 30 patients will receive taurolock-hep500™ after hemodialysis sessions. all patients will be subjected to; 1. full history including history of esrd and dialysis initiation. 2. clinical examination. aseptic technique will be used in handling with catheters including (sterile gloves, antiseptic solution in dealing with covers and caps topical antibiotics spray and ointment) catheter will be instilled by 10 ml of normal saline in both opening followed by either taurolock hep 500™ or unfractionated heparin 5000 iu/ml. patients will be followed up for one month and will be monitored for clinical symptoms and signs of catheter related bacteremia (fever ,rigors, hypotension, sweating ) on the hemodialysis sessions . also catheter performance will be assessed using the following parameters; 1. blood flow rate measured by hemodialysis machine blood pump in (ml/min). 2. dialysis quality by urr( urea reduction ratio) is a dimensionless number used to quantify dialysis treatment adequacy by calculating difference between urea level before and after hemodialysis session (average of 4 sessions , 1 per each week). 3. cbc ,markers of inflammation (crp) baseline and at time of appearance of symptoms and signs of bacteremia in both groups in addition to (il6) measured by elisa technique baseline and at time of appearance of symptoms and signs .

Eligibility criteria:
inclusion criteria: 1. patients on regular hemodialysis 3sessions/wk. 2. recent catheter insertion at beginning of the study. 3. both males and females. 4. age group ≥ 18 ys. exclusion criteria: 1. patients with intercurrent infections. 2. patients with sepsis. 3. patients receiving drugs affecting immune system like immunosuppressive drugs. 4. patients on antibiotics.
long-term follow-up safety of clonidine micropellets

Conditions: Lumbosacral Radiculopathy

Summary: long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months post injection.


Eligibility criteria:
inclusion criteria: * subject who have successfully completed all stx-015-18-01 study related activities, are reconfirmed to be eligible and have signed informed consent to participate. exclusion criteria: * subjects who, in the opinion of the investigator, have demonstrated significant non-compliance with stx-015-18-01 study procedures. * subjects who were unblinded to their treatment in stx-015-18-01 study.
research on the clinical effect of xuefu zhuyu decoction in treating unstable angina.

Conditions: Unstable Angina

Summary: this study evaluates the clinical efficacy of xuefu zhuyu decoction in the treatment of unstable angina pectoris. all of the patients will be divided into 2 arms randomly. one of the arms will be treated by conventional western medicine, the other one will be treated by xuefu zhuyu decoction at the base of conventional western medicine.

xuefu zhuyu decoction has the function of activating qi and promoting blood circulation, which will be used to treat patients with qi stagnation and blood stasis syndrome.

Eligibility criteria:
inclusion criteria: * participants diagnosed with coronary heart disease through coronary angiography or coronary cta; patients have at least one of these symptoms: 1. the stability of the nature of angina pectoris changes, that is, frequent attacks of angina pectoris, serious degree and prolonged duration; 2. angina pectoris during rest; 3. the recent occurrence of angina pectoris caused by mild physical activity in the last month. exclusion criteria: * patients diagnosed with stable angina; patients with acute myocardial infarction; chest pain caused by congenital heart disease, valvular heart disease, severe neurosis or arrhythmia; the heart function grade is iii or iv; patients with acute cerebral infarction; patients complicated with other serious primary diseases; patients with acute infection in recent 2 weeks; uncontrolled hypertension (the resting blood pressure \>160/95mmhg within one week); diabetics emerged with serious diabetic complications; patients can't finish the questionnaire due to abnormal mental and nervous or mental disorders; pregnant or lactating women.

Keywords: unstable angina xuefu zhuyu decoction
comparative bioavailability study of eplerenone 50 mg tablets under fed conditions

Conditions: Hypertension

Summary: the purpose of this study is to demonstrate the relative bioequivalence of eplerenone 50 mg tablets under fed conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.
evaluating palpation guided injections in trapeziometacarpal arthritis

Conditions: Injection Site; Arthritis;Hand/Finger(S)

Summary: the objective of this study is to evaluate the accuracy of trapeziometacarpal injections using palpation alone. the importance of this study is one of education, cost containment, and decreased risk to the patient. if it can be shown that the accuracy of trapeziometacarpal injections using palpation alone is similar to the reported accuracy of ultrasound and fluoroscopy, then these guided techniques may not be needed.

the objective of this study is to evaluate the accuracy of trapeziometacarpal injections using palpation alone. if it can be shown that the accuracy of trapeziometacarpal injections using palpation alone is similar to the reported accuracy of ultrasound and fluoroscopy, then fluoroscopy and ultrasound guided techniques may not be needed. due to the expenses associated with medications and testing, it is important to not accrue unnecessary costs if there is no perceived benefit. the investigators plan to enroll 50 patients presenting with trapeziometacarpal joint arthritis who agree to participate. these participants will undergo an injection technique consisting of palpating the base of the thumb and placing the needle into the trapeziometacarpal joint without the guidance of ultrasound or fluoroscopy. contrast dye will be included in the standard injection of lidocaine and corticosteroid. after injection, the participant will have 2 fluoroscopy views of the thumb. the images will not be evaluated for injection accuracy prior to the patient leaving the clinic, so as to not introduce any bias by the treating physician. these images will be blindly reviewed by three investigators at a later date, and determined by consensus if there is contrast material in the joint. the accuracy rate can then be compared to data regarding accuracy of fluoroscopic and ultrasound guided injections of the trapeziometacarpal joint. if there is a similar accuracy rate between modalities, it can be concluded that ultrasound may not be worth the added cost to the patient and fluoroscopy may not be worth the added cost or radiation to the participant. additionally, participants will be contacted at 6 weeks post injection to evaluate post-injection arthritis symptoms.

Eligibility criteria:
inclusion criteria: * the patient has clinical signs of trapeziometacarpal arthritis and are willing to obtain a post injection x-ray * the patient is over the age of 18 years of age. exclusion criteria: * the patient has a known allergy to contrast dye * the patient has a planned surgery on the trapeziometacarpal joint within 6 weeks following injection * patients who are pregnant or believe they may be pregnant * prisoners * patients who are unable to provide informed consent

Keywords: trapeziometacarpal arthritis
evaluation of flow diverter technology device for intracranial aneurysm

Conditions: Intracranial Aneurysms

Summary: the jacobs institute is participating in a study designed to collect prospective clinical evidence to evaluate the approved use of the pipeline™ flex embolization device with shield technology™ for the endovascular treatment of adults (22 years of age or older) with wide-necked intracranial aneurysms

the pipeline™ flex embolization device with shield technology™ for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (ias) in the internal carotid artery from the petrous to the superior hypophyseal segments. the pipeline™ flex embolization device with shield technology™ is also indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width ≥ 4 mm or dome-to-neck ratio \< 2) saccular or fusiform intracranial aneurysm (ias) arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm.

Eligibility criteria:
inclusion criteria: * adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (ias) in the internal carotid artery from the petrous to the superior hypophyseal segments. exclusion criteria: * cannot provide consent or legally authorized representative not available to provide consent
effect of using shade blocker versus chameleon effect of two single shade of resin composite in class iv restorations

Conditions: Discoloration, Tooth

Summary: aim of this study will be conducted to compare the shade matching and clinical performance of shade blocker versus chameleon effect of two single-shade of universal resin composite in class iv restorations over 1 year evaluation period

the color matching of both groups will be evaluated visually using modified usph criteria

Eligibility criteria:
inclusion criteria: moderate class iv defect with no lingual wall presence of favorable occlusion and teeth are in normal contact with the adjacent teeth good oral hygiene cooperative patients - exclusion criteria: * tooth hypersensitivity severe periodontal affection non vital teeth heavy smoking
long-term follow-up study to evaluate safety and efficacy of fbx-101 in krabbe patients

Conditions: Krabbe Disease

Summary: this is an observational study that will enroll any patients with krabbe disease that have participated in prior interventional clinical trials involving the administration of fbx-101.

fbx-101-ltfu is a multicenter, non-interventional, long-term follow-up (ltfu) study of participants from prior interventional trials involving the administration of fbx-101. eligible participants will undergo clinical evaluations at prespecified intervals for at least 3 years from the last visit in the prior clinical trial (up to 5 years post-fbx-101 treatment). overall safety and additional signs of efficacy will be collected with a series of laboratory tests, diagnostic tests, and performance surveys. additionally, children participating in interventional trials that are terminated early will be transferred to this ltfu study and will complete any pending visits from the interventional trial before starting the clinical evaluations included in this protocol.

Eligibility criteria:
inclusion criteria: * participants that have completed a prior clinical trial involving the administration of fbx-101. * parent(s)/legal guardian(s) of participant willing and able to complete the informed consent process and comply with study procedures and visit schedule. exclusion criteria: •planned or current participation in any other interventional clinical study that may confound the safety or efficacy evaluation of fbx-101 during this study.

Keywords: lysosomal storage disorder globoid cell leukodystrophy leukodystrophy galc
assess efficacy of vardenafil 10mg in erectile dysfunction within intake of 6 hours

Conditions: Erectile Dysfunction

Summary: assess efficacy of vardenafil within 6 hours after intake


Eligibility criteria:
inclusion criteria: * age: 18 years and older * males with erectile dysfunction * stable heterosexual relationship exclusion criteria: * primary hypoactive sexual desire- history of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months * nitrate use

Keywords: male erectile dysfunction vardenafil
a study of ly900014 in japanese participants with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: this study will compare ly900014, a drug that lowers blood sugar, with insulin lispro (humalog). both drugs will be given by injection under the skin of the abdomen. this study will be conducted in participants with type 1 diabetes to investigate how quickly and how much ly900014 is absorbed and the effect of ly900014 on blood sugar levels in comparison with insulin lispro. the study will last about 3 to 6 weeks for each participant, not including screening.


Eligibility criteria:
inclusion criteria: * are japanese male or female participant with a diagnosis of t1dm, based on the world health organization classification, for at least 1 year prior to screening * have a body mass index (bmi) of 18.5 to 30.0 kilograms per square meter (kg/m²) * have a glycated hemoglobin \<9.0% at screening exclusion criteria: * have, except for current regimen of insulin therapy and concomitant medication(s), regular use of or intended use of any over-the-counter or prescription medications or nutritional supplements that treat hyperglycemia or insulin resistance or that promote weight loss within 14 days before dosing * are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations), or have received such therapy within the 4 weeks before screening * have a history of renal impairment (exclusion only if estimated glomerular filtration rate \[gfr\] \ 1.42 milligrams per deciliter \[mg/dl\]) (male) or ≥111 μmol/l (\>1.25 mg/dl) (female) * have a history of deep vein thrombosis of the leg, or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children), as determined by the investigator * have proliferative retinopathy or maculopathy and/or severe neuropathy; in particular, autonomic neuropathy, as determined by the investigator based on a recent (\<1.5 years) ophthalmologic examination * have had any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening, as determined by the investigator * require daily insulin treatment \>1.5 units per kilogram (u/kg)