Kornimate/medical-research-clean huggingface dataset:
clinical validation of biofinity toric mto (made to order) lenses

Conditions: Myopia; Astigmatism

Summary: the study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings.

evaluate the clinical performance of biofinity toric mto lenses against current commercial biofinity toric lenses over 6 hours of lens wear.

Eligibility criteria:
inclusion criteria: * has had a self-reported oculo-visual examination in the last two years. * is at least 18 years of age and has full legal capacity to volunteer. * has read and understood the information consent letter. * is willing and able to follow instructions and maintain the appointment schedule. * is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. * currently wears soft contact lenses. * has clear corneas and no active ocular disease. * has not worn lenses for at least 12 hours before the examination exclusion criteria: * has never worn contact lenses before. * has any systemic disease affecting ocular health. * is using any systemic or topical medications that will affect ocular health. * has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * is aphakic. * has undergone corneal refractive surgery. * is participating in any other type of eye related clinical or research study.
effect of ibuprofen, paracetamol and their combination on radical oxygen species (ros) production

Conditions: Pain

Summary: the purpose of this study is to determine whether paracetamol, ibuprofen or their combination can modify generation of radical oxygen species (ros) from stimulated neutrophils.

non-steroidal anti-inflammatory drugs (nsaid) are used to alleviate clinical inflammatory symptoms (e.g. pain, swelling and reduced function). leukocytes, upon activation during inflammatory states, generate radical oxygen species (ros) which primarily are intended for host defence against invading pathogens. certain nsaid can modify the generation of ros from stimulated neutrophils ranging form increased production to reduced production. preliminary experiments in our laboratory have shown that different nsaids have opposing effects on the ability of leukocytes (granulocytes and monocytes) to produce ros upon a standardized stimulus, i.e. phorbol myristate acetate (pma). paracetamol has a marked inhibitory effect and ibuprofen has a facilitating effect on ros production. an inhibitory effect of paracetamol was also seen when examining platelet activation markers, whereas acetylsalicylic acid showed a clear enhancing effect in this respect. we want to examine if intake of paracetamol or ibuprofen in vivo have similar effects on leukocyte ros production and platelet activation, respectively.

Eligibility criteria:
inclusion criteria: * volunteers of both sexes (asa type i). * females who are not pregnant or plan conception. (a pregnancy test will be conducted before each test day) * persons who have not used analgesics for 3 days prior to the blood sampling. * persons without known active peptic ulcer or gastrointestinal bleeding. * persons without any known hypersensitivity for nsaids. * persons under no other drug treatment than contraceptives. * age 18 to 35 years of caucasian origin exclusion criteria: * pregnancy during the test period. * development of active peptic ulcer during the test period. * change in medication status during the test period (after inclusion).

Keywords: acetaminophen ibuprofen platelets leukocytes oxygen species humans blood platelets reactive oxygen species platelet activation
study to assess the immunogenicity and safety of an investigational influenza vaccine in children

Conditions: Influenza

Summary: the objective of this study is to evaluate the immunogenicity and safety of gsk biologicals' investigational vaccine gsk1557482a.


Eligibility criteria:
inclusion criteria: * subjects and/or subject parent(s)/legally acceptable representative(s) (lar) who the investigator believes can and will comply with the requirements of the protocol. * a male or female child aged between 3 years and 17 years of age at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable. * written informed consent obtained from the subject/from the parent(s)/lar(s) of the subject. * healthy subjects as established by medical history and history-directed clinical examination before entering into the study. * female subjects of non-childbearing potential may be enrolled in the study. * female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. exclusion criteria: * use of any investigational or non-registered product other than the study vaccines within 30 days preceding the administration of the study vaccine, or planned use during the study period. routine, registered childhood vaccinations or registered and recommended pandemic influenza vaccine are not an exclusion. * receipt of a seasonal influenza vaccine outside of this study, during current (2009-2010) flu season. * child in care * receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. topical, intra-articular or inhaled glucocorticoids are allowed. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * history of hypersensitivity to any vaccine. * history of guillain-barré-syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * acute disease and/or fever at the time of enrolment. * administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * pregnant or lactating female. * history of chronic alcohol consumption and/or drug abuse. * female planning to become pregnant or planning to discontinue contraceptive precautions. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

Keywords: gsk biologicals influenza vaccine gsk1557482a influenza infection
evaluation of the vivo isar stent system in routine clinical practice

Conditions: Artery Coronary Stenosis

Summary: the rationale for this observatory is to evaluate clinical outcomes and collect data of the polymer free sirolimus eluting coronary stent system in real world cad patients with follow-up at 12 months. all medications and procedures to be used/ performed in this observatory are commonly used/performed for clinical indications as part of standard of care and have well-defined safety profiles.


Eligibility criteria:
inclusion criteria: * ≥18 years old * ability to provide signed informed consent form. * male or non-pregnant female patient (pregnancy status to be confirmed verbally from the female patient of reproductive age) * presentation with acute coronary syndrome or chronic coronary syndrome with stable angina or angina equivalent symptoms or with a positive noninvasive test for ischemia or evidence of a functionally significant coronary stenosis. * patient having social security number. * patient treated only with vivo isar stent in case of single or multiple vessel stenting exclusion criteria: * concurrent participation in another clinical trial. * having benefited from an angioplasty of ≤ 1 month with a stent other than vivo isar. * planned elective surgery in next 6 months * cardiogenic shock/ hemodynamically unstable patients * concurrent medical condition with a life expectancy of less than 12 months * history of cerebrovascular accident in the last 6 months. * vulnerable patient under guardianship or curatorship
pocdoc lipids out-of-surgery study

Conditions: Dyslipidemias

Summary: this study seeks to improve access to lipid testing in out-of-surgery locations using pocdoc, a ukca approved ivd device that measures a full 5 marker lipid panel using a smartphone or tablet. the study will investigate whether pocdoc can close the gap in people not tested by exploring 3 new out-of-surgery methods: 1. lipid testing for high-risk individuals on existing cvd register who have not attended in-surgery appointments 2. footfall lipid testing conducted in pharmacy or at community events 3. corporate wellness lipid testing performed by employers for employees as part of an organised corporate wellness check

lipid testing in out-of-surgery (oos) locations using a digital lipid measuring device called pocdoc promises to increase access to lipid testing and cardiovascular disease health assessment. pocdoc lipids comprises a smartphone-compatible disposable microchip test strip which uses proprietary colorimetric microfluidic technology to accurately detect lipid biomarkers from a droplet of blood. pocdoc lipids professional was launched in 2022 to enable professional users to perform lipid screens as part of lifestyle or preventative healthcare screens. the investigator's hypothesise that providing easier, more cost-effective access to lipid testing at scale, without patients having to attend the gp surgery could: 1. identify previously unidentified patients (including key "hard to reach" cohorts) who have elevated lipid levels and get them into a lipid lowering clinical pathway which reduces risk of cvd event 2. enable increase in "treat to target" and move more patients from low / medium intensity statin onto high intensity, which reduces risk of cvd events 3. identify more cases of undiagnosed fh and getting those patients into a lipid lowering pathway the sbri 21 phase 3 program is funding this collaborative project in partnership with smash pcn and ahsn nenc with the objective of increasing access to lipid testing in those geographies.

Eligibility criteria:
inclusion criteria: * consent indicated from within pocdoc app * subjects are legally competent and capable to understand character, meaning and consequences of the study * subjects own an approved mobile device (these will be available at the time of the study on the pocdoc website and the central team will verify individuals have appropriate mobile devices before pocdoc tests are sent to them) exclusion criteria: * being unable to give informed consent * \ 85 years * legally incompetent * language barriers potentially compromising an adequate compliance with study procedures
effectiveness of dual light electric toothbrush vs. manual toothbrush in orthodontic patients undergoing oral surgery

Conditions: Toothbrushing; Gingivitis; Cleft Lip and Palate

Summary: the study is a randomized clinical trial to compare the effectiveness of a dual light ultrasonic toothbrush on periodontal health in orthodontic patients undergoing surgery. patients with cleft lip and palate undergo bone graft and orthognathic surgery. the study will compare the periodontal outcomes in patients who use these toothbrushes during the post-surgical period.

pilot study, randomized control clinical trial, study groups 1) craniofacial and/or unilateral and bilateral cleft palate patients undergoing orthognathic surgery . 2) craniofacial and/or unilateral and bilateral cleft palate patients undergoing bone-graft surgery 3) craniofacial and/or unilateral and bilateral cleft palate patients with no pending surgery. three investigational device include dual light therapy sonic toothbrush (bristltm toothbrush), sonic toothbrush(bristltm) and manual toothbrush to target disease gingivitis in 189 patients. categorical variables scored from plaque index and gingival index will be analyzed using fisher exact test and mcnemar test. parametric methods will be used to analyze data from bleeding on probing and periodontal probing depth. to determine differences between groups and within each test at all time points, student t-test will be used.

Eligibility criteria:
inclusion criteria: * patient of record of the craniofacial and special care orthodontic clinic at children's hospital los angeles * between the ages of 6 and 20 years * physical status of asa i or ii * diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate exclusion criteria: * physical inability to brush teeth * cognitive inability to comprehend and follow directions.
compare efficacy nebulized and intravenous magnesium sulphate in thai children

Conditions: Acute Severe Asthma

Summary: the purpose of this study is to determine whether nebulized magnesium sulphate is effective in the treatment of acute severe asthma when comparison with intravenous magnesium sulphate

intervention: at randomization eligible patients were allocated to receive 2.5ml of isotonic magnesium sulphate (150 mg,245 mmol/l) on three occasional at 20 minutes interval or standard treatment 50 mg/kg intravenous magnesium sulphate. the asthma severity score was record at 0,20,40,60,120,180,240 minutes post randomization. adverse event were assessed at each assessment point. patients were followed up until discharge from hospital to collect secondary outcome data.

Eligibility criteria:
inclusion criteria: * children age 2-15 years presenting with severe asthma or persistent wheeze without responding to conventional therapy exclusion criteria: * chronic lung disease * history of adverse reaction form magnesium sulphate * life threatening condition

Keywords: magnesium sulphate nebulized
a study to investigate the efficacy and safety of tezepelumab in adult participants with moderate to very severe copd

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: a multicenter, randomized, double-blind, placebo-controlled, parallel group, phase 3 study to evaluate the efficacy and safety of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (copd)

this is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (copd) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, copd exacerbations in the 12 months prior to visit 1. subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. the study also includes a off-treatment safety follow-up period of 12 weeks.

Eligibility criteria:
inclusion criteria: 1. ≥40 to ≤80 years old 2. copd diagnosis ≥1 year, 3. post-bd fev1 ≥ 20% and ≤ 70% pn, fev1/fvc \<0.70 at screening 4. triple (ics+laba+lama) or dual inhaled copd therapy ≥3 consecutive months prior to v1 5. ≥2 moderate or ≥1 severe copd exacerbations in the prior year; at least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids 6. eos ≥ 150 cells/μl during screening 7. cat ≥15 at screening 8. former or current smokers ≥10 pack-years exclusion criteria: 1. clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than copd 2. asthma, incl. pediatric, or acos 3. any unstable disorder that can impact participants safety or study outcomes 4. tuberculosis requiring treatment within 12 months prior v2 5. malignancies current or past concomitant therapies: * macrolides (less than 6 months) * systemic immuno-suppressive, -modulating medications 6. ltot \>4.0 l/min or o2 saturation \<89% despite ltot

Keywords: copd moderate copd severe copd very severe copd chronic obstructive pulmonary disease
mini-dose mtx plus standard-dose steroid for the initial treatment of acute gvhd

Conditions: Acute Graft Versus Host Disease

Summary: this trial is a randomized (1:1) phase iii open label study of frontline mini-mtx plus methylprednisolone 2mg/kg/day compared to methylprednisolone 2mg/kg in allogeneic stem cell transplant recipients with grade 2-4 agvhd.

allo-hsct is an effective treatment of malignant hematopoietic diseases. however, agvhd remains a major complication after allo-hsct. corticosteroid is the standard first-line therapy for agvhd. however, the response rate of corticosteroid was approximate 50%, and the clinical outcomes of patients with corticosteroid refractory gvhd were poor. thus far, no combination therapy had been prove to be superior to corticosteroid alone as initial therapy for agvhd. the study hypothesis: mtx combined corticosteroid treatment could help to control agvhd.

Eligibility criteria:
inclusion criteria: 1. patients who are fully informed and sign informed consent by themselves or their guardians; 2. patients receiving first allogeneic hematopoietic stem cell transplantation; 3. patients with acute graft-versus-host disease of grade ii-iv were diagnosed after transplantation; 4. kps\>60, estimated survival \>3 months; 5. no serious organ damage: 1. anc in peripheral blood is greater than 0.5×109/l 2. creatinine \< 1.5mg/dl 3. cardiac ejection index \> 55% exclusion criteria: 1. patients with severe brain, heart, kidney or liver dysfunction unrelated to graft-versus host disease; 2. patients with uncontrollable active infection; 3. patients with recurrence of primary malignant hematopathy; 4. expected survival is less than 3 months 5. patients who have histories of severe allergic reactions 6. pregnant or lactating women 7. the researcher judges that there are other factors that are not suitable for participating 8. patients who received donor lymphocyte infusion
tygacil drug use investigation

Conditions: Intra-Abdominal Infections; Skin Disease, Infectious

Summary: secondary data collection study; safety and effectiveness of tigecycline .under japanese medical practice


Eligibility criteria:
inclusion criteria: * all patients who are prescribed tigecycline (tygacil). exclusion criteria: * subject who have not been prescribed tigecycline (tygacil).

Keywords: tygacil tigecycline post marketing surveillance japanese infection
physical activity level and cognitive functions in children with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: although there are studies showing that the effect on motor performance over time in children with dmd is associated with a decrease in the level of physical activity, no publication has been found that directly examines the relationship between cognitive functions and physical activity level. therefore, the aim of our study is to investigate the relationship between physical activity level and cognitive functions in children with dmd.

in dmd; as a result of mutations in the xp21.2 region of the dystrophin gene, which encodes the dystrophin protein, which plays an important role in the normal contraction and relaxation of the muscle, progressive weakness starting from the proximal extremity muscles, chronic degeneration, replacement of the muscle with fat and connective tissue occurs due to the production of deficient or fully functional dystrophin. although motor performance is one of the most prominent features in children with dmd, it has been reported that cognitive functions are also significantly affected in one third of children compared to their healthy peers. in addition, the physical activity levels of children with dmd show a significant decrease in physical activity levels after the age of 5, when motor problems are more pronounced than their healthy peers. recently, interest in studies on physical activity level and cognitive skills in pediatric neuromuscular diseases such as dmd has increased, and studies have revealed the relationship between cognitive functions and motor performance. there are also studies showing that the effect on motor performance over time is associated with a decrease in physical activity level. however, there are no publications that directly examine the relationship between cognitive functions and physical activity level in children with dmd. therefore, the primary aim of our study is; to investigate the relationship between physical activity level and cognitive functions in children with dmd. the secondary aims of our study are to reveal the relationship between balance and body mass index and physical activity level in children with dmd.

Eligibility criteria:
inclusion criteria: * children who diagnosed with duchenne muscular dystrophy (dmd), between the ages of 8-14, to have cognitive functions at a level to understand and apply test directives, level 1-5 according to brooke lower extremity functional classification will be included. exclusion criteria: * children who have any chronic or systemic disease in addition to dmd, being above level 5 according to the brooke lower extremity functional classification, have a cooperation problem, have had any lower/upper extremity injury and/or surgery in the last 6 months and children who did not give consent will be excluded.

Keywords: muscular dystrophy physical activity cognitive function