Kornimate/medical-research-clean huggingface dataset:
phase 2b randomized controlled study of tecemotide (l-blp25) for immunotherapy of nsclc (non-small cell lung cancer)

Conditions: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Summary: this is a prospective open label, controlled, randomized study to test the safety and efficacy of active specific immunotherapy with tecemotide (l-blp25) for the treatment of subjects with stage iiib or stage iv non-small cell lung cancer (nsclc). to be eligible, subjects entering the trial will have to demonstrate either stable disease or a clinical response after first-line treatment (chemotherapy alone, or chemotherapy and radiotherapy) and have an eastern cooperative oncology group (ecog) performance status of 0, 1 or 2. following a 3 week washout period, subjects will be stratified by disease status (either stage iiib locoregional disease or stage iiib with malignant pleural effusion and stage iv), and randomized to either best supportive care (bsc) plus tecemotide (l-blp25) treatment or bsc alone.


Eligibility criteria:
inclusion criteria: * stage iiib or stage iv nsclc * stable disease or a clinical response following first-line treatment, consisting of either chemotherapy alone or chemotherapy and radiotherapy. subjects must have completed the first-line treatment at least 3 weeks prior to study entry * eastern cooperative oncology group (ecog) performance status of greater than or equal to (\>=) 2 * ability to understand and willingness to sign a written informed consent * other protocol-defined inclusion criteria could apply exclusion criteria: * received immunotherapy within 4 weeks prior to study entry * received immunosuppressive drugs within 3 weeks prior to study entry * subjects with known brain metastases * past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years * autoimmune disease or immunodeficiency * clinically significant hepatic, renal or cardiac dysfunction * subjects with clinically significant active infection * pregnant or breast feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator * other protocol-defined exclusion criteria could apply
the effect of irrigation solution volume on electrolytes and acid-base balance

Conditions: Acid Base Imbalance; Percutaneous Lithotripsy

Summary: background: there are several surgical procedures in which irrigation fluids are used to enable vision and treatment in body cavities, such as hysteroscopy, arthroscopy and cystoscopy. several solutions are used for irrigation: normal saline, glycin, mannitol, sorbitol and others. post-operative complications, as visual disturbances, confusion and other neurologic symptoms were attributed to irrigation fluid absorption, water intoxication and hyponatremia, and are refered to as "turp syndrome" when appearing following transurethral prostatectomy (turp). historically, a reduced serum sodium concentration has been used to diagnose absorption of electrolytes-free irrigating fluid during urologic procedures. however, neurologic symptoms following transurethral prostatectomy (turp) do not correlate with blood sodium level, moreover, hyponatremia may not be the sole or even the primary cause of the neurological manifestations of turp syndrome. other techniques were suggested for evaluating the volume of irrigation solution absorption though none is used routinely in the clinical setting. percutaneous lithotripsy (pcnl) is a procedure used to treat patients with nephrolithiasis. in this procedure irrigation fluid is administered into the kidney and urinary tract collecting system. the solution used is normal saline. in earlier studies there was no evidence for absorption of the irrigation fluids, though medical literature on this issue is limited. however, minute changes in electrolytes and acid-base balance may indicate the opposite is true. indeed, the volume of irrigation and duration of the procedure may have an effect as well. according to the investigators hypothesis, the change in ph and reduction in base content in patients undergoing pcnl may be the result of irrigation fluid absorption, since chloride from the normal saline is known to cause such effect. methods this is an observational prospective study of consecutive 200 adult patients undergoing elective surgery of pcnl in the investigators operating rooms. the investigators will collect data that is taken from the patient's file and routine management of these patients: age, gender, weight, pre-operative blood tests including: electrolytes, creatinine, hematocrit, ph, bicarbonate, base, length of the procedure, volume and type of irrigation fluids used, volume and type of intravenous fluids used. post-operative blood tests will be recorded. the investigators will compare pre and post-operative blood tests, especially ph, bicarbonate, base content, sodium. the investigators will analyse statistically the correlation between the change of each parameter (delta x) and the volume of irrigation fluids used during the surgery.


Eligibility criteria:
inclusion criteria: * adult consent patients, undergoing elective percutaneous lithotripsy. exclusion criteria: * pregnancy * pre-operative acid-base imbalance * urgent/emergent surgery.

Keywords: acid base balance percutaneous lithotripsy
the effect of exercise on myokine production in aging persons

Conditions: Aging; Exercise

Summary: the incidence of age-related diseases, such as cancer and cardiovascular diseases, rapidly rises. these days, age-related diseases cause the majority of all healthcare expenses. during ageing senescent cells secrete a range of harmful inflammatory signals, which leads to chronic inflammation (inflamm-aging) and accelerates aging throughout the rest of the body. interestingly, people who regularly exercise show less signs of inflamm-aging compared to people with a sedentary lifestyle. molecules secreted by skeletal muscles, called myokines, may play an important role. however, the underlying molecular mechanisms remain unknown. this pilot study aims to investigate if an acute bout of resistance training is an appropriate tool to induce an increase in the release of muscle derived myokines in aged persons.


Eligibility criteria:
inclusion criteria: * healthy persons exclusion criteria: * smoking * infection \< 2 weeks ago * received a vaccine \< 2 weeks ago * allergy to lidocain * immune deficiency * presence of a tumour or in treatment * usage of anti-coagulant medication * presence of following conditions: * haemophilia * auto-immune disease * cardiovascular disease * musculoskeletal diseases which refrains the patient from exercising
skeletal muscle wasting and insulin resistance following surgical stress

Conditions: Insulin Resistance

Summary: background: skeletal muscle wasting or decrease in muscle mass occurs as a result of alteration in the body's mechanisms to make or break muscle protein. in animal models, the pathway termed as 'ubiquitin-proteasome pathway' (upp) is primarily responsible for the regulation of skeletal muscle protein loss in wasting conditions and during infection(sepsis). skeletal muscle wasting is noticed in patients having major surgery due to the inflammatory reaction triggered by special group of proteins called cytokines (inflammatory proteins), resulting in reduced muscle strength, impaired capacity to fight infections, change in bowel function, increased clinical complications and prolonged recovery. major surgery also leads to decreased sensitivity to hormone known as insulin, resulting in 'diabeteslike'state. we hypothesize that susceptibility of patients undergoing major abdominal surgery, to skeletal muscle wasting and insulin resistance, is determined by stress response to surgery over time, leading to changes in the pathways that make or break muscle protein, namely the akt/foxo signalling and upp. therefore, the aim of this study is to establish the underlying mechanisms of skeletal muscle wasting and insulin resistance in patients undergoing major abdominal surgery.

experimental plan fifteen adult patients undergoing major open elective abdominal surgery will be included in this nonrandomized study. objectives: 1. to study the expression proteins and metabolites involved in upp mediated protein degradation, in blood and muscle biopsy samples. 2. to correlate the effects of surgery on the release of bacteria in blood from the bowel. the analysis of the samples will include the following techniques, namely, rtpcr, elisa, western blotting and metabolomics. establishing the association between these signaling mechanisms and expression of the individual proteins secondary to inflammation following surgery and infection would enable application of suitable therapeutic strategies that could reduce the inflammatory response to benefit all patients undergoing surgery.

Eligibility criteria:
inclusion criteria: * all adult patients undergoing major open elective gastrointestinal surgery lasting 3 hours or more will be eligible for the study. exclusion criteria: * patients who are: 1. undergoing emergency surgery 2. suffering from chronic illness, (e.g. diabetes) or other debilitating diseases 3. on long term anti-inflammatory drugs, (e.g. nsaids, steroids, immunosuppressant) 4. on long term antibiotics 5. on statins 6. on full therapeutic dose of anticoagulants, or aspirin \> 325 mg/day, clopidogrel \> 75 mg/day 7. suffering from bleeding diathesis 8. unable to give consent 9. pregnant or breastfeeding

Keywords: major abdominal surgery
ultrasound biomicroscopy study of accommodative state in smartphone abusers

Conditions: Spasm of Accommodation

Summary: detection if there is association between spasm of accommodation and smart phone abuse by ultrasound biomicroscopy on anterior segment of the eye


Eligibility criteria:
inclusion criteria: 1. age 18 - 35 year. 2. smart phone excessive use. 3. emmetrope and myope patients. exclusion criteria: 1. hypermetrope patients. 2. any form of tropia. 3. anterior segment diseases either congenital or acquired. 4. previous intraocular surgeries. 5. presbyopic subjects. 6. drugs induced spasm of accommodation: psychiatric drugs, pilocarpine, physostigmine, echothiophate, prostigmine, isoflurophate, muscarine, digitalis overdose and with sulphonamides 7. cns diseases : neurosyphilis, raeder paratrigeminal neuralgia syndrome, cyclic oculomotor palsy, pineal tumor, chiari malformation, pituitary tumor, metabolic encephalopathy,
clinical trial to evaluate the efficacy and safety of ckd-342

Conditions: Rhinitis, Allergic, Perennial

Summary: clinical trial to evaluate the efficacy and safety of ckd-342

a randomized, double-blind, active-controlled, multicenter phase 3 clinical trial to evaluate the efficacy and safety of concomitant mometasone furoate and levocabastine hcl in perennial allergic rhinitis patients

Eligibility criteria:
inclusion criteria: 1. male, female, age: over 13 years(no age limiation in upper) 2. subject who has experienced perennial allergic rhinitis for over 1 year 3. subject who has identified allergens throughout the year within 12 months 4. subject who has the symptoms of moderate to severe allergic rhinitis 5. subject who can record the the patient diary during the clinical trial period 6. subject who agreed to keep the same environment during the clinical trial period exclusion criteria: 1. asthma 2. previous medical history at screening (nasal polyps within the previous two months, biopsies, ulcers, trauma, surgery, atrophic rhinitis, patients with a history of drug rhinitis) 3. patients with untreated localized infection in nasal mucosa 4. patients following administration of a combination of prohibited drugs in patients administered concomitant medications or trial period is expected to be inevitable 5. patients with abnormal following laboratory test results at screening * ast, alt\>2times the upper limit of normal at screening * serum creatinine \>1.5times the upper limit of normal at screening 6. previous history of acute or severe chronic sinusitis within 30 days at screening 7. the continue use of drugs that may affect the efficacy of the investigational product 8. start the immunotherapy or a change of doge within 1 month, at screening 9. if you have glaucoma or cataracts, herpes simplex, or around the eyes 10. chronic obstructive pulmonary disease (copd) 11. history of hypersensitivity reactions and for treaties or major components of the ip 12. pregnant women, breast feeding women or women of childbearing potential must agree to use appropriate contraception methods 13. alcohol or illegal drug abuse or dependence in patients 14. participation in any investigational or maketed drug within 4weeks preceding the screening visit 15. patients that can not be participating in a clinical trial by investigator's discretion
differential characteristics of neuropathy in type 2 diabetics with and without lower extremity wounds

Conditions: Diabetic Foot Ulcer; Diabetic Neuropathy; Type 2 Diabetes

Summary: the primary purpose of this study is to determine the degree of loss of epidermal nerve fibers near a foot wound in patients with diabetic foot ulcers. the secondary purpose will be to determine whether the degree of epidermal nerve fiber loss, the clinical examination, nerve conduction studies or the molecular profile correlates with appearance of lower extremity ulcers in patients with diabetes.

neuropathy is a common complication of diabetes seen in up to 43% of patients with diabetes. the relationship between neuropathy and diabetic lower extremity wounds is strong and in fact, 80% of patients with an existing diabetic foot ulcer (dfu) have neuropathy. understanding the factors that contribute to the increased risk of wounds in patients with neuropathy is important in creating optimal strategies to reduce this risk. traditionally, the severity of diabetic neuropathy has been evaluated using the clinical exam and nerve conduction studies. more recently, new techniques such as intra-epidermal nerve fiber density have shown promise in evaluating neuropathy especially the small nerve fiber neuropathies that might affect pain sensation and autonomic function. there are also new molecular markers that may correlate with the risk of neuropathy that may also be useful in clinically evaluating the diabetic patient with neuropathy. the primary purpose of this study is to determine the degree of loss of epidermal nerve fibers near a foot wound in patients with diabetic foot ulcers. the secondary purpose will be to determine whether the degree of epidermal nerve fiber loss, the clinical examination, nerve conduction studies or the molecular profile correlates with appearance of lower extremity ulcers in patients with diabetes.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * type 2 diabetes defined as hga1c ≥ 5.9% * must be willing and able to provide written informed consent exclusion criteria: * active osteomyelitis * gangrene * purulent drainage * any experimental drugs applied topically or taken by mouth within 4 weeks of study entry * inr \> 2.5

Keywords: diabetic foot ulcer dfu type 2 diabetes neuropathy
relationship between folic acid and warfarin metabolism and effect

Conditions: Folic Acid Deficiency

Summary: folic acid supplementation has been shown previously to be associated with enhanced formation of p-hpph from phenytoin, a metabolic pathway which is predominantly mediated through the activity of cyp2c9. the metabolism of s warfarin, the more active enantiomer of warfarin, is also mediated predominantly through the activity of cyp2c9. the purpose of the present study was to examine the relationship between folic acid concentration and warfarin pharmacokinetic as well as warfarin dose requirement among patients treated by warfarin. in addition the effect of folic acid supplementation (5 mg/d) for 3 weeks on warfarin pharmacokinetic and warfarin dose requirement will be evaluated in the second part of the study.


Eligibility criteria:
inclusion criteria: * patients on chronic warfarin therapy exclusion criteria: * refusal to participate in the study
a twelve month long term safety study to evaluate the safety of albuterol in a dry powder inhaler with both repeated and as needed dosing

Conditions: Asthma

Summary: this is a one-year study to look at the safety of a dry powder inhaler with albuterol. after a one-week run in, for the first 3 months subjects will use an inhaler with either albuterol or a dummy drug at regular times four times a day. then for the last nine months of the study, all subjects will be given the albuterol dry powder inhaler and will use it only when needed to help with breathing problems. subjects will need to keep a daily diary (both paper and electronic) throughout the study recording any inhaler use and health problems. there will be visits to the study doctor about once a month for a year. this study is intended to show that the albuterol dry powder inhaler works well and is safe for use over a long period of time.

the sponsor terminated this study due to the need for a modification to the spiromax device utilized in this study; the problem identified has no impact on patient safety. exposure ranged from 3 to 49 days with the majority of subjects receiving ≤30 days of double-blind treatment.

Eligibility criteria:
inclusion criteria: * documented history of persistent asthma with rescue use of albuterol on average of at least once/ week over the 4-weeks prior to screening. * female subjects who are of childbearing potential (as judged by the investigator) must be currently using and willing to continue to use a medically reliable method of contraception for the entire study duration * general good health * capable of understanding the requirements, risks, and benefits of study participation * non-smoker for at least one year prior to the screening visit and a maximum pack-year smoking history of 10 years * other criteria apply exclusion criteria: * pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject's last study related visit * participation in any investigational drug trial within 30 days preceding the screening visit * a known hypersensitivity to albuterol or any of the excipients in the formulations. * history of severe milk protein allergy * history of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza, etc) which is not resolved within 1 week prior to the screening visit. * use of any protocol prohibited concomitant medications for asthma or any protocol prohibited concomitant non-asthma medications * inability to tolerate or unwillingness to comply with the protocol requirements. * history of life-threatening asthma * any asthma exacerbation within 3 months of the screening visit requiring oral or systemic corticosteroids * history of life-threatening asthma * other criteria apply

Keywords: asthma dry powder inhaler short-acting beta2-agonist saba bronchoconstriction bronchodilation bronchodilator metered dose inhaler
bilateral dispensing study of fanfilcon a toric versus enfilcon a toric lenses

Conditions: Myopia; Hyperopia; Astigmatism

Summary: bilateral dispensing clinical trial of fanfilcon a toric lens verses enfilcon a toric lens over two weeks.

evaluation of the clinical performance of an investigational silicone-hydrogel lens called fanfilcon a (test) compared to a fda-cleared commercially available contact lens called enfilcon a toric lens (control) when worn on a daily wear basis over 2 weeks in a randomized, bilateral, cross-over, dispensing study.

Eligibility criteria:
inclusion criteria: * are at least 17 years of age for canada and 18 years of age for the usa and have full legal capacity to volunteer; * have read and signed an information consent letter; * are willing and able to follow instructions and maintain the appointment schedule; * are an adapted soft contact lens wearer; * require spectacle lens powers in both eyes; * sphere: between -0.50 to -6.00 diopters and * astigmatism: between -1.25 to -2.00 and * axis: 180 ± 20 degrees * are willing to wear contact lens in both eyes; * have manifest refraction visual acuities (va) equal to or better than logmar equivalent of 20/25 in each eye; * to be eligible for lens dispensing, the subject must have va of logmar equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit including toric orientation as acceptable; exclusion criteria: * are participating in any concurrent clinical or research study; * have any known active\* ocular disease and/or infection; * have a systemic condition that in the opinion of the investigator may affect a study outcome variable; * are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; * have known sensitivity to the diagnostic pharmaceuticals to be used in the study; * are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit); * are aphakic; * have undergone refractive error surgery;