Kornimate/medical-research-clean huggingface dataset:
high-dose icotinib treatment beyond progression in egfr mutant nsclc

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to investigate whether high-dose icotinib treatment beyond disease progression is beneficial for nsclc patients who have egfr mutation and who have responded to egfr tki.


Eligibility criteria:
inclusion criteria: * histologically confirmed stage iiib/iv nsclc * investigator confirmed progression according recist 1.1 during previous icotinib treatment * patients whose tumors: * are egfr mutation-positive or * t790m mutation-negative * performance status: who 0-2 * measurable disease according to recist 1.1 * at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology * a single diameter of lesion could be measured by at least one of the following methods: chest or abdominal computed tomography(ct)or magnetic resonance imaging(mri),conventional methods of diameter at least 20mm diameter spiral ct or at least 10mm * anc ≥ 1.5\*109/l, platelets ≥ 75\*109/l, hgb≥ 9g/dl, alanine amino transferase ≤ 2 × upper limit of normal (uln), alkaline phosphatase ≤ 2.5 × uln (\< 5 × uln if liver metastases), serum creatinine ≤ 1.5 × uln * women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures * patient must be able to comply with the protocol exclusion criteria: * patient with symptomatic central nervous system metastases * patient has known active hepatitis b or c, or hiv infection * pregnant or breastfeeding. * patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study
safety and tolerability of repeat courses of im alefacept

Conditions: Chronic Plaque Psoriasis

Summary: previous biogen studies have provided experience with the tolerability, immunogenicity, and efficacy of a single and multiple 12-week courses of therapy of alefacept. at this stage, experience in larger studies, as well as the fda-approved labeling, is confined to treatment courses of 12 weeks. the purpose of the present study is to offer an extended course of therapy with alefacept.

twenty statistically matched patients (15 males, 5 females, aged between 28 and 70 years, median 50 years) with moderate to severe psoriasis (pasi: 7-36) were included in this study. they were treated with 15 mg alefacept i.m. weekly. peripheral blood was taken prior to first alefacept application and then weekly until week five and thereafter every second week, until the end of treatment at week 13. at the same time points severity of disease and thereby possible reduction of symptoms was evaluated applying the pasi. investigators analysing the samples were blinded to the outcome of the study. the protocol concerning human subjects was approved by the ethics commission of the charité university medicine berlin campus mitte, germany .

Eligibility criteria:
inclusion criteria: 1. must give written informed consent. 2. must require systemic therapy or phototherapy for their psoriasis, as determined by the investigator prior to visit 1. exclusion criteria: 1. female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded. 2. current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed). 3. serious local infection (e.g., abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug. 4. any subject whose cd4+ lymphocyte count at study entry is less than 404 cells/mm3. 5. treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration. 6. treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine or other systemic immunosuppressant agents within the 28 days prior to investigational drug administration. 7. phototherapy, including ultraviolet b (uvb) and psoralen + ultraviolet a (puva), within 28 days prior to investigational drug administration. 8. known hiv+, known viral hepatitis infection, known tuberculosis infection.

Keywords: alefacept skin diseases psoriasis skin diseases, papulosquamos therapeutic uses dermatologic agents
the effect of adding either propofol or ketamine to magnesium and lidocaine infusions in nasal surgeries.

Conditions: Intraoperative Bleeding

Summary: nasal surgeries are common day case procedures. although surgical complications are rare, bleeding decreases surgical field visibility and may cause vascular, orbital or intracranial complications in addition to failure of procedure. so, it is crucial to maintain hypotensive anaesthesia to optimize the surgical field.

in this study the investigators compare the effect of; propofol- lidocaine-magnesium and ketamine- lidocaine- magnesium infusions to dexmedetomidine- lidocaine- magnesium infusion on surgical field quality, intraoperative haemodynamics, surgical time, recovery time, sedation score, time to first rescue analgesic and incidence of ponv in patients undergoing nasal surgeries

Eligibility criteria:
inclusion criteria: * asa i-ii, * scheduled for elective nasal surgery exclusion criteria: * patients with uncontrolled hypertension. * patients with cardiac disease. * patients with renal, hepatic or cerebral insufficiency. * patients with coagulopathy or receiving drugs influencing blood coagulation. * anaemia, haemoglobinopathies or polycythemia. * pregnancy. * patients with known sensitivity to any of the study drug.
optimizing the ocular surface prior to cataract surgery

Conditions: Corneal Dystrophy, Epithelial Basement Membrane

Summary: prospective study to evaluate the efficacy of using self-retained cryopreserved amniotic membrane after debridement in treating epithelial base membrane dystrophy (ebmd) to optimize the ocular surface integrity and intraocular lens calculation before cataract surgery.


Eligibility criteria:
inclusion criteria: 1. subjects with significant ebmd that are contemplating cataract surgery. 2. age range: 50 years and older. 3. both genders and all ethnic groups comparable with the local community. 4. subjects able to understand and willing to sign a written informed consent. 5. subjects able and willing to cooperate with the investigational plan. 6. subjects able and willing to complete postoperative follow-up. exclusion criteria: 1. subjects with known intolerance to pks or known allergy to its preservative media. 2. subjects with symblepharon or lid abnormality preventing pks placement. 3. ocular infection within 14 days prior to study entry. 4. previous ocular surgery or injury within 3 months before enrollment. 5. subjects with a history of non-healing epithelial defect or neurotrophic keratitis. 6. inability or unwillingness of subject to give written informed consent, follow investigational plan or complete postoperative follow-up.
a study to determine the effect of welchol tablets on cholesterol in patients who have been taking atorvastatin for at least 4 weeks.

Conditions: Hypercholesterolemia

Summary: to determine the effects of welchol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on atorvastatin therapy for at least 4 weeks.


Eligibility criteria:
inclusion criteria: * male or female \> or greater than 18 years of age * on a stable dose of atorvastatin * ldl-c \> or = to 115 mg/dl and \< or = to 250 mg/dl * tg \< or = to 300 mg/dl * women are not pregnant or breast-feeding or planning to become pregnant * women of child-bearing potential had a hysterectomy or tubal-ligation, or * women were post menopausal, or * women practiced an acceptable method of contraception as specified in the protocol exclusion criteria: * bmi \> 40 kg/m2 * history of allergic or toxic reaction to colesevelam hcl * history of swallowing disorders * any serious disorder that could impact the conduct of the study * history of drug or alcohol abuse
brain perfusion evaluation by contrast-enhanced ultrasound

Conditions: Cerebral Hemorrhage; Subarachnoid Hemorrhage; Ischemic Stroke; Cerebrovascular Circulation; Perfusion

Summary: the objective of the study is to assess brain tissue perfusion by contrast-enhanced ultrasound perfusion imaging (perceus) in acute brain injuries. more precisely, it aims : * to evaluate the heterogeneity of brain perfusion and thus diagnose brain tissue hypoperfusion with contrast-enhanced ultrasound. * to correlate contrast-enhanced ultrasound with perfusion measurements by usual multimodal monitoring.

the main aim is to evaluate the heterogeneity of brain perfusion, thus diagnosing brain tissue hypoperfusion with perceus, then to correlate it with the usual multimodal monitoring. earlier after hospitalization in neurointensive care, when the study physician needs to realize a contrast ultrasound imaging and without delaying any emergency procedure, a perceus will be performed in patients with an acute brain injury. after acquisition, data from perceus will be transferred to an external evaluation unit and analysed offline, using commercially available software qlab (philips ®). according to the localization of acute brain injuries with magnetic resonance imaging (mri) and/or computed tomography (ct), several regions-of-interest (roi, at least three in each area) will be chosen : * area 1 : in the core of the lesion (supposed non perfused) * area 2 : just next to the lesion (supposed hypoperfused) * area 3 : in the saner hemisphere, symmetrically to area 2 each time it's possible (supposed well-perfused). every parameters of multimodal monitoring used at the moment of perceus will be relieved : * intracranial pressure (icp), cerebral perfusion pressure (cpp), mean arterial pressure (map) * mean flow velocity (mfv) by transcranial doppler (tcd) * regional cerebral oxygen saturation (rso2) by near infrared spectroscopy (nirs) * jugular venous oximetry (sjvo2). the actual perceus measurement takes place at the bedside, is performed by the study physician, and takes about 5 minutes. the trial duration per patient is 30 minutes, ending after 25 minutes of oversight

Eligibility criteria:
inclusion criteria: * age ≥18 * intensive care unit admission for acute brain injury * proven acute brain injury by ct and/or mri * requiring a contrast ultrasound imaging * informed consent of patient or relative exclusion criteria: * pregnancy * not sufficient temporal window * contraindications to sonovue ® : acute coronary syndromes, severe ischemic heart disease (requiring revascularization), pulmonary arterial hypertension \> 90 mmhg, right-left shunt, ards, dobutamine's use, known allergy or adverse reaction to sonovue® * patient on state medical assistance

Keywords: brain perfusion cerebral blood flow diagnostic imaging ultrasonography doppler doppler ultrasound transcranial doppler contrast enhanced ultrasound contrast-enhanced ultrasonography contrast ultrasound ultrasound perfusion imaging ultrasound contrast agent intra-cranial pressure intracerebral hematoma neurocritical care
cardiometabolic effects of pecans as a snack

Conditions: Cardiovascular Diseases

Summary: a randomized, 2-arm, parallel trial will be conducted to examine the effect of pecans on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control.

a randomized, 2-arm, parallel trial will be conducted to examine the effect of including 2 oz./day of pecans, as a snack, compared to a diet typically consumed by participants intake (devoid of nuts) on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control. participants will be randomized to pecans or control for 12-weeks. outcome assessments will be measured at baseline and 12-weeks.

Eligibility criteria:
inclusion criteria: * bmi 25-40 kg/m2 * ≥ 1 criterion for metabolic syndrome (i.e., waist circumference ≥ 94 cm men or ≥ 80 cm women; triglycerides ≥150 mg/dl; hdl-cholesterol ≤ 40 mg/dl men or ≤ 50 mg/dl women; systolic blood pressure ≥130 mmhg or diastolic blood pressure ≥85 mmhg; fasting plasma glucose ≥100 mg/dl) at screening exclusion criteria: * current use of tobacco-containing products or (≤6 months) cessation * allergy/sensitivity/intolerance/dislike of study foods * women who are pregnant, lactating, planning to become pregnant or have given birth in the past year * individuals who have had a cardiovascular event (heart attack, revascularization, stroke), or have a history of heart failure, liver, kidney, autoimmune diseases or inflammatory conditions such as gastrointestinal disorders or rheumatoid arthritis. * type 1 or type 2 diabetes * unstable weight ≥10% body weight for 6 months prior to enrollment * systolic blood pressure \>160 mmhg for systolic pressure and/or diastolic blood pressure \>/100 mmhg for diastolic pressure at screening * fasting blood glucose ≥126 mg/dl at screening * triglycerides ≥350 mg/dl at screening * taking any medications known to affect lipids, blood pressure, or blood glucose levels * diagnosed inflammatory conditions or taking prescribed , taking any chronic anti-inflammatory medications (\>1 time per week over the past 3 months) * use of antibiotics within the prior 8 weeks * taking supplements (e.g., psyllium, fish oil, soy lecithin, and phytoestrogens) and botanicals known to affect study outcomes and not willing to cease for the duration of the study * individuals consuming \>14 alcoholic drinks/week, and not willing to avoid alcohol consumption for 48 hours prior to test visit * pre-menopausal women who do not have a regular menstrual cycle of 25-35 days * pi discretion
dual antiplatelet therapy (dapt) in patients with baseline thrombocytopenia

Conditions: Baseline Thrombocytopenia

Summary: the use of clopidogrel as part of dapt will be associated with lower bleeding rates compared to ticagrelor in patients with chronic thrombocytopenia requiring percutaneous intervention (pci )with drug eluting stent (des) or bare metal stint(bms).

patients with thrombocytopenia are at an increased risk of both bleeding and ischemic events following pci; however, there is a paucity of data on how to optimally manage these risks. data indicates that ticagrelor is associated with reduced ischemic outcomes with an accompanying increased risk of bleed in the broader population. this study will assess p2y12 agent selection in patients with chronic thrombocytopenia to determine if one better balances risks of ischemic and bleeding events following coronary intervention

Eligibility criteria:
inclusion criteria: * ≥ 18 years * pci with either des or bms during study time period (april 1, 2018 through july 1 2021) * thrombocytopenia defined as platelet count \<100 x103 /µl on at least one occasion prior to pci * at least one dose of dapt post-pci with aspirin and either clopidogrel or ticagrelor exclusion criteria: * death within 48 hours post-pci * dapt prior to cardiac catheterization
electroacupuncture is effective in cardiac deconditioning induced by head-down bed rest

Conditions: Cardiovascular Abnormalities; Weightlessness

Summary: to investigate the changes of cardiovascular function during short-term simulated weightlessness after electroacupuncture (ea) treatment．

spaceflight is associated with cardiovascular deregulation. however, the influence of microgravity on the cardiovascular system and the underlying mechanisms and countermeasures remain largely unknown. our previous studies have demonstrated that electroacupuncture (ea) is effective at improving orthostatic tolerance (ot). the purpose of this study was to determine if ea treatment can attenuate cardiovascular deconditioning induced by a 4-day -6° head-down bed rest (hdbr). fourteen healthy male subjects were randomly allocated into a control group (con, n=6, 4 days hdbr without countermeasure) and an ea treatment group (ea, n=8, 4 days hdbr with ea at neiguan \[pc-6\] for 30 min daily for 4 consecutive days during hdbr). ot was estimated with a combination of +75°/20 min head-up tilt and lower body negative pressure test before and after hdbr. plasma hormones and heart rate variability were assessed before and after hdbr. cardiac systolic functions and cerebral blood flow were measured before, during, and after hdbr. the data showed that ea treatment applied daily for 30 min during a 4-day hdbr prevented ot and cardiac systolic function from decrease, prevented autonomic dysfunction (a decrease in the activity of the parasympathetic nervous system), and increased the concentrations of plasma angiotensin ii (ang ii) and aldosterone (ald). these results indicate that 30 min of daily ea treatment at pc-6 is highly effective in partially maintaining ot and cardiac systolic function. activation of the peripheral sympathetic nervous system and increased plasma hormones is largely responsible for maintaining ot after a 4-day hdbr. therefore, ea treatment appears to be an effective countermeasure against cardiovascular deconditioning induced by hdbr.

Eligibility criteria:
inclusion criteria: * the subjects were healthy and physically fit but were not athletes.comprehensive physical, psychological and routine blood chemistry examinations were performed to select qualified subjects for this research.no medication, smoking, alcohol, or caffeinated drinks were allowed during the study. exclusion criteria: * skeleton-muscle diseases, visual or acoustic dysfunction, organic and functional diseases of psychiatry and neurology as well as sleep disorders

Keywords: electroacupuncture cardiovascular function orthostatic tolerance head-down bed rest
the safety and efficacy of canakinumab in patients aged 4 years or older diagnosed with cryopyrin-associated periodic syndromes (caps) in canada

Conditions: Cryopyrin Associated Periodic Syndrome

Summary: this study will assess the safety, tolerability and efficacy of canakinumab treatment in canadian patient diagnosed with cryopyrin-associated periodic syndrome over a period of 18 months.


Eligibility criteria:
inclusion criteria: 1. male and female patients at least 4 years of age at the time of the screening visit 2. patient's informed consent for \> or = 18 years of age before any assessment is performed 3. parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients \< 18 years of age. 4. patients with a diagnosis of caps: fcas/fcu, mws, or nomid/cinca 5. body weight \> or = 15 kg 6. able to communicate with the investigator and comply with the requirements of the study (for children the parent can assist when necessary) exclusion criteria: 1. patient is pregnant or breastfeeding. women of childbearing potential must have a negative urine pregnancy test at baseline 2. patient of childbearing potential (man or woman) and unwilling to use double barrier method of contraception. it is required that double barrier method of contraception be used (i.e. condom with spermicide or diaphragm with spermicide) by patients of childbearing potential (man or woman) regardless of whether a hormonal agent is also used as a method of contraception. 3. participation in any clinical investigation within 4 weeks prior to dosing 4. live vaccinations within 3 months prior to the start of the trial, during the trial and up to 3 months following the last dose. 5. history of significant medical conditions, which in the investigator's opinion would exclude the patient from participating in this trial (this can be discussed with novartis on a case by case basis in case of uncertainty). 6. history of drug or alcohol abuse within 12 months prior to dosing 7. history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes "other protocol-defined inclusion/exclusion criteria may apply"

Keywords: canakinumab cryopyrin-associated periodic syndromes familial cold autoinflammatory syndrome (fcas) familial cold urticaria (fcu) muckle-wells syndrome (mws) neonatal-onset multisystem inflammatory disease (nomid) chronic infantile neurological cutaneous articular syndrome (cinca) treatment of patients diagnosed with caps (cryopyrin associated periodic syndrome)
epidemiology of body mass index rebound

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity

Summary: to investigate the relationship between obesity, body mass index (bmi) rebound, body composition changes, associated factors (e.g., diet, physical activity), and cardiovascular risk factor status in a longitudinal study of young children, age three at the beginning of the study.

background: obesity is the most prevalent nutritional problem in the united states. it appears that both the prevalence and severity of obesity have been increasing in recent years. obesity often begins in childhood and has a number of severe sequelae, including non insulin dependent diabetes mellitus and cardiovascular disease. unfortunately, obesity is very resistant to treatment. this places a premium on prevention. however, the identification of clinically useful predictors of obesity which are present prior to the onset of excess weight gain has been problematic. recently, it has been shown that the timing of body mass index (bmi) rebound may be a predictor of future obesity. bmi increases during the first year of life. it then declines until it reaches a minimum value during childhood and subsequently increases into adolescence and adulthood. the nadir of bmi is called bmi rebound. studies have shown that bmi rebound at a young age is associated with increased risk of obesity later in life. currently, very little is known about the epidemiology of bmi rebound. design narrative: the investigation is a cohort study designed to follow 320 children from age three to age seven years. the study design will be a longitudinal one in which the children will be followed for a period of four years during which repeat measurements of body composition, diet, and physical activity will be made every four months. parental height and weight data will be collected, in addition to family health history, parental smoking and alcohol intake.

Eligibility criteria:
no eligibility criteria