Kornimate/medical-research-clean huggingface dataset:
evaluation of central corneal thickness in patients with vernal keratoconjunctivitis using topical steroids

Conditions: Vernal Keratoconjunctivitis

Summary: this prospective observational cohort study aims to assess changes in central corneal thickness (cct) in vernal keratoconjunctivitis (vkc) patients using topical steroids. data will be collected from tertiary care hospitals such as al-mustafa eye hospital and jinnah hospital, lahore.

a total of 34 participants, including an adjustment for a 10% dropout rate, will be recruited using purposive sampling. the study will last six months. eligible participants (aged 5-25 years) must have a confirmed vkc diagnosis and be on topical steroids, with exclusions for prior ocular surgery, systemic steroid use, and contact lens wear. baseline assessments will include demographic data, vkc severity, and cct measurements via pachymetry and optical coherence tomography. follow-up evaluations at one and three months will track cct changes. a paired t-test will compare baseline and follow-up measurements. this study will help understand the impact of topical steroids on cct in vkc patients.

Eligibility criteria:
inclusion criteria: * young adults aged between 5-25 years * confirmed diagnosis of vkc * currently prescribe topical steroid e.g, dexamethasone, prednisolone * no prior history of corneal surgery or trauma * willing to attend follow-up visits and comply with the treatment protocol. exclusion criteria: * history of ocular surgery or trauma * presence of other corneal pathologies (e.g., keratoconus) * systemic immunosuppressant use or history of systemic steroid use in the past 06 months * use of other medications that could influence corneal thickness e.g, antiglaucoma drugs * contact lens use within 1 month prior to the study * severe dry eye or another ocular surface disease"
promoting neuroplastic changes of patients with tbi

Conditions: Traumatic Brain Injury

Summary: this project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. it involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-tbi including patients who are paralyzed with no motor output. the early acute tbi rehabilitation device will be evaluated in this clinical trial.

early after tbi, patients often have significant sensorimotor impairment. there is heightened neural excitability, which may be used to facilitate recovery in the acute phase post stroke. however, there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy. the proposed randomized clinical trial using a wearable rehabilitation robot, muscle electromyography (emg), and/or potentially brain electroencephalogram (eeg) signal seeks to provide early intensive sensorimotor training facilitated by real-time audiovisual and haptic feedback, intelligent stretching and sensory stimulation, active movement training through motivating movement games to promote neuroplasticity and reduce sensorimotor impairments. for acute tbi survivors who cannot generate any motor output yet, emg or eeg may be used to detect the earliest re-emerging motor control signal and the robot can be used to provide demo and feedback of the intended movement.

Eligibility criteria:
inclusion criteria: * acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment) * hemiplegia or hemiparesis * 0≤manual muscle testing (mmt)\<=2 * age 30-85 * ankle impairments including stiff calf muscles and/or inadequate dorsiflexion exclusion criteria: * medically not stable * associated acute medical illness that interferes with ability to training and exercise * no impairment or very mild ankle impairment of ankle * severe cardiovascular problems that interfere with ability to perform moderate movement exercises * cognitive impairment or aphasia with inability to follow instructions * severe pain in legs * severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion) * pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee

Keywords: traumatic brain injury (tbi) paraplegia acute
grazoprevir (mk-5172) and elbasvir (mk-8742) combination in treatment-naïve hepatitis c virus participants (mk-5172-067)

Conditions: Hepatitis C

Summary: this is a randomized, parallel-group, placebo-controlled, multi-site, multinational, double-blind followed by open label period, phase 3 trial of 100 mg of grazoprevir (mk-5172) in combination with 50 mg of elbasvir (mk-8742) (grazoprevir/elbasvir fixed-dose combination \[fdc\]) in treatment-naïve (tn) participants with chronic hepatitis c virus (hcv), genotype (gt) 1, 4 or 6 infection. the primary hypothesis is that the percentage of participants receiving grazoprevir/elbasvir fdc in the immediate treatment group (itg) achieving sustained virologic response 12 weeks after the end of all study therapy (svr12) will be superior to the historical reference rate of 73%.


Eligibility criteria:
inclusion criteria: * has documented chronic hcv gt1, gt4, or gt6 (with no evidence of non-typeable or mixed genotype) infection * meets clinical criteria for presence or absence of cirrhosis based on liver disease staging assessment * is abstinent or uses acceptable method(s) of contraception exclusion criteria: * has evidence of decompensated liver disease * is coinfected with hepatitis b virus or human immunodeficiency virus (hiv) * shows evidence of hepatocellular carcinoma (hcc) or is under evaluation for hcc * has a clinically-relevant drug or alcohol abuse within 12 months of screening * is pregnant or breast-feeding * has any condition or abnormality that might confound the results of the trial or pose an additional risk to the participant
study on the clinical and mechanism of wenyang huoxue decoction in treating heart failure after myocardial infarction

Conditions: Heart Failure; Myocardial Infarction

Summary: this study is a randomized, double-blind, placebo-controlled, parallel clinical trial in a chinese population with heart failure after myocardial infarction. the objective is to observe the efficacy and safety of wenyang huoxue fang in the treatment of heart failure after myocardial infarction.

currently, there is a lack of high-quality evidence-based support for tcm treatment of heart failure after myocardial infarction. in addition, previous studies have found that the method of warming yang and activating blood circulation is effective in treating coronary heart disease, and the core pathogenesis of heart failure after myocardial infarction is also yang deficiency and blood stasis. therefore, this project aims to evaluate the clinical value of warming yang and activating blood circulation in the treatment of heart failure after myocardial infarction. through pharmacological research and detection, the efficacy of wenyang huoxue prescription in heart failure rats after intervention of myocardial infarction was evaluated, mir-233-iso signaling pathway was detected before and after treatment, and its mechanism of action was further clarified from the perspective of epigenetics and classical pathway of heart failure. objective to investigate the efficacy and safety of wenyang huoxue fang in the treatment of heart failure after myocardial infarction.

Eligibility criteria:
inclusion criteria: * 18-75 years old; * a history of acute myocardial infarction; * cardiac function grade ii-iv; * lvef 40% or less; nt-probnp level ≥ 450 pg/ml; -all men and women can sign the informed consent form.- exclusion criteria: * coronary artery bypass grafting was performed within 12 weeks. * undergo or possibly undergo cardiac resynchronization therapy; * primary valvular disease, left ventricular outflow tract obstruction, myocarditis, aneurysm, uncontrolled severe arrhythmia, cardiogenic shock, unstable angina pectoris, or acute myocardial infarction; * having a serious primary liver, kidney or blood system disease or having a serious mental illness or a systemic disease that is out of control; * serum creatinine \> 194.5 mol/l or serum potassium \> 5.5mmol /l; * the level of alanine aminotransferase or alkaline phosphatase is 1.5 times of the normal upper limit ; * abnormal blood pressure control, systolic blood pressure exceeding 180mmhg or diastolic blood pressure exceeding 110mmhg; * pregnancy or lactation; * known or suspected allergy to research drugs; * to receive another investigational drug within 30 days of randomization or to be unwilling or unable to provide written consent.

Keywords: wenyang huoxue decoction
osteoporosis and fragility fractures among sle patients. (frail trial)

Conditions: Lupus Erythematosus, Systemic

Summary: the trial is designed to evaluate prevalence of fragility fracture, their impact on quality of life of sle patients and disease or treatment variables such as steroids dosage or use of specific drugs like hydroxychloroquine, dmards or belimumab. patients will perform dxa evaluation, blood tests and pros questionnaires. moreover, the investigators want to correlate those variables to bone turnover markers and bone metabolism modulators. a secondary aim is also to assess the fracture risk of those patients as described by frax and defra tools.


Eligibility criteria:
inclusion criteria: * sle fulfilling 2019 acr/eular or 2012 slicc criteria * willing to perform dxa/ x-ray investigation (common clinical practice) * willing to donate blood sample * willing to complete questionnaires * the patients should be in a stable disease activity. exclusion criteria: * uncontrolled endocrinological disease. * metabolic bone disease other than osteoporosis ( e.g. paget disease). * celiac disease, inflammatory bowel disease or pancreatic exocrine deficiency resulting in malabsorption * patients lacking medication history information (sle and bone related medications). * have any other clinically significant abnormal laboratory value in the opinion of the investigator * have any intercurrent significant medical illness that the investigator considers would make the candidate unsuitable for the study. * the patients shouldn't be enrolled during a moderate to severe flare of disease requiring an escalation of therapy ( especially glucocorticoid) - no new bilag a or b in the last 3 months. * pregnant patients or during the first year after child birth.
effectiveness of self-monitoring and treatment of blood pressure following stroke or transient ischaemic attack

Conditions: Stroke

Summary: this blinded end point rct will recruit high risk tia and mild stroke patients (through the emergency tia clinics and the acute stroke services at the norfolk \& norwich university hospital) who require anti-hypertensive therapy to examine the clinical and cost effectiveness of self-monitoring and self management of blood pressure compared to self monitoring alone and treatment as usual.

research question: in patients with a mild/moderate stroke or tia who require drug treatment for bp control, does bp self-monitoring with or without patient-led management using a previously agreed treatment regime result in better bp control and patient satisfaction than standard gp based management? planned sample size: 165 eligible participants distributed 1:1:1 between three groups. group 1 (control) - treatment as usual (tau). group 2 - self-monitoring only (se-mo). group 3 - self-monitoring and self-management (se-man). primary outcome: number reaching target ambulatory bp levels at follow-up and change in mean ambulatory bp levels between baseline and follow-up at 6 months. secondary outcomes: number of changes in anti-hypertensive treatment during study side-effects profiles and adverse events bp variability pulse wave velocity (pwv) changes all cause and cause-specific mortality outcome at six month recurrent tia or stroke incident cvd- stroke, tia and myocardial infarction costs health related quality of life assessed quality adjusted life years (eq-5d based) patient satisfaction and experience of the process (qualitative data)

Eligibility criteria:
inclusion criteria: * patients aged =/\> 18 years old with tia or stroke of mild/moderate severity (nihss =\<15) who require bp management and are able and willing to undertake self bp measurement and guided alterations in therapy. exclusion criteria: * those with terminal illness with life expectancy less than six months including end staged condition e.g. end stage copd * dementia or moderate to severe cognitive impairment * those not receiving or expected to start anti-hypertensive therapy

Keywords: blood pressure monitoring self bp monitoring self bp management
feasibility of a clinical trial comparing the use of cetirizine to replace diphenhydramine in the prevention of reactions related to paclitaxel

Conditions: Breast Cancer; Lung Cancer; Ovarian Cancer; Oesophageal Cancer; Head Cancer Neck; Cervical Cancer; Endometrial Cancer

Summary: explore the randomized, controlled, double-blind design targeted for the final clinical trial to assess the acceptability of interventions and clinical outcome measures and to provide data making it possible to estimate the parameters necessary for the preparation, modification or even abandonment of the final study.

paclitaxel is known to cause 30 to 40% of infusion-related reactions when no premedication is administered. it is agreed that all patients should receive premedication with dexamethasone, an h1 antagonist, such as diphenhydramine, and an h2 antagonist before the administration of paclitaxel. there are several cases where undesirable effects (eg. drowsiness, dry mouth, motor impatience) have been reported following the administration of this conventional premedication. diphenhydramine is often accused because of its pharmacological properties. a definitive, randomized, double-blind, non-inferiority study can assess whether cetirizine, a non-sedating h1 antagonist, can be used as an effective and safe alternative to diphenhydramine in the prevention of paclitaxel infusion-related reactions. in the current proposed feasibility study, patients will be followed for the first two doses of paclitaxel. the goal is to explore the randomized, controlled, double-blind design targeted for the final clinical trial to assess the acceptability of interventions and clinical outcome measures and to provide data making it possible to estimate the parameters necessary for the preparation, modification or even abandonment of the final study.

Eligibility criteria:
inclusion criteria: * receiving intravenous chemotherapy treatments at the maisonneuve-rosemont hospital outpatient oncology clinic * starting their first lifetime treatment with paclitaxel (alone or in combination with other anticancer agents). * capable of giving free and informed consent and who agrees to participate by signing the consent form * aged 18 and over * able to complete questionnaires exclusion criteria: * does not understand french or english * taking chronic h1 antagonist orally * taking chronic systemic corticosteroids * contraindication or possible medical danger, such as a documented allergy or previous intolerance, related to the administration of cetirizine, diphenhydramine, placebo or any ingredient in their formulation * has received paclitaxel, docetaxel or paclitaxel nanoparticles linked to albumin in the past * receiving paclitaxel nanoparticles linked to albumin * severe renal impairment (cockcroft-gault \<10 milliliters/minute) * pregnant or breastfeeding women * receiving paclitaxel under desensitization protocol * documented or reported dysphagia or other pathophysiological condition preventing a tablet from being swallowed whole * interactions preventing the full dose of oral cetirizine from being absorbed * participating in another clinical trial simultaneously
a study of continuous endostar intravenous infusion combined with pemetrexed and carboplatin in advanced non small cell lung cancer patients

Conditions: Non-Small Cell Lung Cancer

Summary: this study is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics of continuous endostar intravenous infusion combined with pemetrexed and carboplatin in advanced non small cell lung cancer (nsclc) patients.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of inoperable stage iiib/iv non-squamous nsclc * at least one measurable lesion (recist criteria) * life expectancy \> 3 months * ecog performance status 0-2 * adequate hematologic function: wbc ≥ 3.0×109 /l，anc ≥ 1.5×109 /l，hb ≥ 90 g/l，plt ≥ 100×109 /l * adequate renal, hepatic and coagulation function * written informed consent exclusion criteria: * with uncontrollable malignant pleural effusion or ascites * thoracic or abdominal surgery within 28 days prior to study entry * history of cerebral stroke or tia within 6 months prior to study entry * with uncontrollable hypertension, hypertensive emergency or hypertensive encephalopathy * arrhythmia in need of antiarrhythmic treatment, history of angina pectoris, myocardial infarction, myocardial ischemia or congestive heart failure (\> nyha class ii) * with serious infection (\> nci ctc grade 2) * gastrointestinal perforation, fistula formation, and/or intra-abdominal abscess within 6 months prior to study entry * symptomatic brain metastases * patient who has epilepsy * history of hiv infection or chronic hepatitis b or c * allergic to any of the study drugs * pregnant or lactating women

Keywords: endostar carboplatin pemetrexed nsclc phase i
ruxolitinib (incb018424) in participants with primary myelofibrosis (pmf), post essential thrombocythemia-myelofibrosis and post polycythemia vera-myelofibrosis (ppv-mf)

Conditions: MPN (Myeloproliferative Neoplasms)

Summary: to evaluate the effects of treatment with ruxolitinib (incb018424) on spleen volume, symptoms and potential side effects in participants with pmf, ppv-mf and pet-mf who have platelet counts of 50 x 10\^9/l to 100 x 10\^9/l. it is anticipated that individualized dose optimization from the starting ruxolitinib level of 5 mg bid will be associated with reductions in splenomegaly, mf-associated symptoms and inflammatory cytokine levels.


Eligibility criteria:
inclusion criteria: * diagnosed with pmf, ppv-mf or pet-mf as confirmed by bone marrow biopsy * discontinuation of all drugs used to treat underlying mf disease at least 14 days prior to baseline visit * inr \<= 1.5 or ptt value \< 1.5 x upper limit of normal (uln) at study entry * hemoglobin level at least 6.5 g/dl at screening visit * willingness to be transfused to treat low hemoglobin levels exclusion criteria: * females who are pregnant, unable to comply with birth control use to avoid becoming pregnant or breastfeeding * males who cannot comply with birth control use to avoid fathering a child * platelet count \< 50 x10\^9/l or absolute neutrophil count (anc) \< 1 x10\^9/l at the screening visit * inadequate liver or renal function; intracranial bleeds or invasive malignancy over the previous 2 years - international normalized ratio (inr) laboratory values cannot be \> 1.5 x upper limit of normal at study entry.

Keywords: pmf ppv-mf pet-mf
study investigating administration of prevenar for post-marketing surveillance

Conditions: Pneumococcal Infections

Summary: the purpose of this study is to identify the following problems and questions with respect to the safety of pneumococcal 7-valent conjugate vaccine (diphtheria crm 197 protein), prevenar, during the post-marketing period in korea, as required by korea food and drug administration (kfda) regulations. 1. adverse reactions (especially serious adverse reactions) 2. incidences of adverse reactions under routine vaccine use 3. factors that may affect the safety of the vaccine


Eligibility criteria:
inclusion criteria: * infants and children aged 6 weeks to 9 years, provided the conditions pertaining to contraindications, warnings, precautions, and interactions stated in the package insert do not apply. exclusion criteria: * hypersensitivity to latex or to any component of the vaccine, including diphtheria toxoid * suffering from a current or recent febrile illness.

Keywords: vaccine heptavalent pneumococcal conjugate vaccine
a multicenter, randomized, parallel, two-period, non-inferiority study of eurofarmavsalenia in asthma and copd treatment

Conditions: Asthma Copd

Summary: a phase iii study, multicenter, randomized, parallel, open, two-period, comparative non-inferiority of eurofarma versus alenia® in the treatment of moderate to severe persistent asthma with and without obstructive pulmonary disease (copd). ⚠️study will only be conducted in research centers in brazil (please do not send e-mail if your center is outside brazil).

in the first study period (period 1), patients with moderate to severe persistent asthma according to gina criteria, with or without copd, will be randomized at a 1: 1 ratio to receive formoterol 12mcg / budesonide 400mcg eurofarma or alenia® 12mcg / 400mcg during 12 weeks participants who maintain asthma control at the end of this treatment period (no more than one exacerbation during this period) will be included in period 2, in which the dose of each investigational product will be reduced (step-down), and the patients will receive formoterol 6mcg / budesonide 200mcg eurofarma or alenia® 6mcg / 200mcg, respectively, for an additional 12 weeks. the primary non-inferiority assessment will be performed at the end of 24 weeks of treatment, with intermediate assessment at the end of week 12. the study will be conducted in an open label since the devices for inhalation of products have different aspects, making it impossible to blind the treatments of the study. the primary efficacy variable (forced expiratory volume in one second \[fev1\]) minimizes the potential bias arising from the open label of the study. ⚠️study will only be conducted in research centers in brazil (please do not send e-mail if your center is outside brazil).

Eligibility criteria:
inclusion criteria: * age ≥ 12 years * presence of moderate to severe persistent asthma according to global initiative for asthma (gina) 1 criteria for at least 1 year, clinically stable (controlled) for at least 30 days. exclusion criteria: * occurrence of asthma exacerbation within 30 days prior to initiation of study treatment. * presence of acute or chronic symptomatic airway infection.
effects of postoperative analgesic modalities on plasma creatine phosphokinase(cpk) levels after knee artroplasty

Conditions: Myotoxicity

Summary: regional anesthesia and analgesia technics are widely and securely used during orthopedic surgery. interfascial plane blocks are the latest used ones for analgesia. there are studies in literature indicating that bupivacaine cause myotoxicity. we aimed to examine plasma cpk(creatine phosphokinase) levels to see whether myotoxicity occurs or not after suprainguinal fascial plane block is applied to patients undergoing knee artroplasty surgery.

during 2 months period all elligible patients undergoing knee artoplasty surgery will be included in the study. different postoperative analgesic modalities will be used according to the anesthesists experience. during routine blood sample tests plasma cpk levels will be tested 3 times of all patients.(preoperative, postoperative 6th hour, postoperative 24th hour) this data will be recorded for 2 months. after this period of time data will be analysed and patients will be grouped according to the analgesic modalities used.

Eligibility criteria:
inclusion criteria: * asa 1-3 * knee artoplasty patients * under spinal anesthesia exclusion criteria: * local anesthetic allergies * myopathies * coagulopathies * obstructive sleep apne syndrome * hearth diseases * liver diseases * kidney diseases * thyroid-parathyriod dieseas * hiperlipidemias using statins(hmg-coa reductase inhibitors) * pregnancy

Keywords: bupivacaine, myotoxicity, creatine phosphokinase,sfipb