Kornimate/medical-research-clean huggingface dataset:
optic coherence tomography in patients with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: amyotrophic lateral sclerosis (als) is an adult-onset, devastating, neurodegenerative disease characterized by the loss of cortical, brain stem, and spinal motor neurons. visual evoked potentials studies in patients with als suggest visual pathway involvement. optic coherence tomography (oct) is a non-invasive cross-sectional imaging modality measuring the optical reflections in biological tissues. the main objective of this observational cohort study is to explore the correlation between changes on oct retinal parameters and and clinical disability as measured by the als functional rating scale (als-frs-r) in patients with als at baseline, 3 and 6 months. a secondary objective is to explore the correlation between changes in retinal oct parameters and pulmonary function tests (fvc and fev1) in this cohort of patients with als. a parallel cohort of healthy age and sex matched subjects will participate as controls to obtain reference values of their retinal layers' thickness at baseline, 3 and 6 months.


Eligibility criteria:
inclusion criteria: * diagnosis of als according to the el escorial criteria. * age 18 years to 80 years old * disease duration less than 36 months * patients logistically able to attend and be evaluated at baseline, 3 and 6 months exclusion criteria: * patients with diabetes mellitus * patients with glaucoma, refractive errors of ± 6 diopters or more, or other ophthalmologic disorders such as media opacities that could interfere with retinal oct assessment
does treatment with macrobid reduce urinary tract infections in patients receiving a sub-urethral sling for incontinence

Conditions: Stress Incontinence

Summary: this project will determine whether post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.

this project will be a randomized, double blinded, placebo controlled clinical trial. the aim of the trial is to determine whether or not post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.

Eligibility criteria:
inclusion criteria: * women over the age of 18 who will undergo the placement of a sub-urethral sling for the treatment of stress urinary incontinence exclusion criteria: * exclusion criteria are those with a known allergy to macrobid, those with glucose-6-phosphate deficiency, renal impairment, women breast feeding or with a known pregnancy, patients taking medications for gout, and those with known risk factors for complicated uti (polycystic renal disease, nephrolithiasis, neurogenic bladder, diabetes, immuno-suppression, etc).

Keywords: urinary tract infection (uti) suburethral sling prevention nitrofurantoin prophylaxis
altitude related illness in patients with respiratory disease

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing acute mountain sickness in lowlanders with chronic obstructive lung disease travelling from 700 m to 3200 m.

this is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of dexamethasone prophylaxis in reducing the incidence of acute mountain sickness in lowlanders with chronic obstructive pulmonary disease travelling to altitude. participants living in the bishkek area, kyrgyzstan (700m), will be transferred by car within 4h to the tuja ashu high altitude clinic (3200 m), and stay there for 2 days. dexamethasone 2x4mg/day (or placebo), will be administered before departure at 700 m and during the stay at altitude. outcomes will be assessed during the stay at 3200 m.

Eligibility criteria:
inclusion criteria: * chronic obstructive pulmonary disease (copd), gold grade 1-2 * living at low altitude (\<800m) exclusion criteria: * copd exacerbation * severe copd, gold grade 3 or 4 * arterial oxygen saturation \<92% at low altitude (\<800 m) * diabetes, uncontrolled cardiovascular disease such as systemic arterial hypertension, coronary artery disease; previous stroke; pneumothorax in the last 2 months, untreated or symptomatic peptic ulcer disease, glaucoma, obstructive sleep apnea. * internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day). * pregnant or nursing patients

Keywords: airway disease bronchitis emphysema lung treatment
biobank renal transplantation university hospitals leuven

Conditions: Kidney Failure

Summary: this study aims to maintain a prospective biobank of human samples obtained from donors and recipients of renal allografts, including biopsy tissue, peripheral blood samples and urine samples.

clinical data and bio-specimens are prospectively collected and stored for undefined future translational research projects.

Eligibility criteria:
inclusion criteria: * renal transplant recipients/donors exclusion criteria: * none
stress hyperglycemia and acute ischemic stroke

Conditions: Stress Hyperglycemia

Summary: whereas diabetes mellitus is clearly a risk factor for the occurrence of stroke and for its poor prognosis, hyperglycemia per se is also linked to increased morbidity and mortality in stroke patients.therefore, the objective of this work was to study the glycemic status of acute ischemic stroke patients and to assess its impact on stroke outcome.

using pass program, setting alpha error at 5% and power of 80%, the total sample size was estimated to be 80 cases. the nihss was used as a primary outcome; 40 cases were needed in each group. secondary outcomes were hemorrhagic transformation, hospital stay duration, mechanical ventilation, need for vasopressors, and 30-days mortality.

Eligibility criteria:
inclusion criteria: * acute ischemic stroke within 24 hours of onset of symptoms exclusion criteria: * subdural hematoma * transient ischemic attack * subarachnoid hemorrhage * hemorrhagic stroke * major comorbidities hyperglycemia on admission that was controlled (random blood sugar (rbs) \< 150 mg/dl) within 24 hours with insulin therapy, diabetic * ketoacidosis * rbs less than 70 mg/dl on admission
determination of the prevalence and prognostic importance of unrecognized non-q-wave myocardial infarction by mri

Conditions: Coronary Arteriosclerosis; Myocardial Infarction

Summary: the first aim of this study is to determine how often unrecognized myocardial infarction occur in patients using a magnetic resonance imaging (mri) technique (known as delayed enhancement mri), as compared to the electrocardiogram. the second aim of this study is to determine the severity of coronary heart disease of the patients with unrecognized myocardial infarction. the final aim is to determine how the presence of unrecognized myocardial infarction detected by the mri affects lifespan.

unrecognized myocardial infarction (mi) is known to constitute a substantial portion of lethal coronary heart disease. however, since the diagnosis of unrecognized mi is based on the appearance of incidental q-waves on 12-lead electrocardiography, the syndrome of unrecognized non-q-wave mi has not been described. delayed-enhancement cardiovascular magnetic resonance (de-cmr) can accurately identify non-q-wave mi. the aims of this study are three-fold: 1. to determine the prevalence of unrecognized non-q-wave and q-wave mi, 2. to define predictors of unrecognized non-q-wave mi, 3. to determine the prognostic significance of unrecognized non-q-wave mi.

Eligibility criteria:
inclusion criteria: * patients with suspected coronary artery disease referred for invasive coronary angiography exclusion criteria: * clinical history of myocardial infarction * percutaneous coronary intervention * coronary artery bypass surgery * known uncured malignancy * history of hypertrophic cardiomyopathy, myocarditis, or infiltrative heart disease * contraindication of magnetic resonance imaging
evaluation of nilotinib in patients with advanced gastrointestinal stromal tumor (gist)

Conditions: Gastrointestinal Stromal Tumor

Summary: this study will assess time-to-disease progression in patients with advanced gastrointestinal stromal tumor (gist) previously treated with imatinib ≥600 mg.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of gist that is unresectable and/or metastatic * radiological confirmation of disease progression or intolerance to imatinib therapy at a any dose * at least one measurable site of disease on ct scan at visit-2 * who performance status of 0, 1 or 2 at visit-2 * patients must have normal organ, electrolyte, and marrow function at visit-1 and visit-2 exclusion criteria: * prior treatment with nilotinib or any other tyrosine kinase inhibitors except imatinib. * treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks * prior or concomitant malignancies other than gist * impaired cardiac function at visit-1 or 2 * patients with severe and/or uncontrolled concurrent medical disease * use of therapeutic coumarin derivatives * use of any medications that prolong the qt interval * use of cyp3a4 inhibitors * patients who have undergone major surgery ≤ 2 weeks prior to visit-1 or who have not recovered from side effects of such surgery * patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation \< 2 weeks prior to visit-1 or who have not recovered from side effects of such therapy other protocol-defined inclusion/exclusion criteria may apply

Keywords: unresectable metastatic gastrointestinal stromal tumor disease progression progression-free survival
a study of inhalation of 20,000 eu ccre and mucociliary clearance (mcc) in otherwise healthy individuals who are current cigarette smokers

Conditions: Healthy; Cigarette Smoking

Summary: the purpose of this phase 1 research study is to identify a dose of inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other problems), but causes changes in sputum cell samples that the scientists can measure. the investigators are also interested in seeing if the exposure to the endotoxin decreases the body's natural ability to clear mucus from the lungs.

the purpose of this study is to determine the range of neutrophil response (influx of pmns to the airways as determined in sputum) after inhalation of ccre (20,000 eu), shown in previous studies of healthy, nonsmoking volunteers as well as in a limited number of otherwise healthy smokers to be well tolerated. this dose induces measurable increases in neutrophil content of induced sputum that can be employed to screen large populations for susceptibility to the inflammatory effect of inhaled endotoxin. limitations of the understanding of actions of inflammatory stimuli on airway function are likely due to the fact that functional assessments of dynamic airway response /in vivo/ have generally been limited to those based on spirometry and examination of airway samples for assessment of cells and mediator content. slowing of mucociliary clearance (mcc), a key component of airway defense, can be induced by inflammation and almost certainly contribute to mucus plugging and decreased clearance of inhaled irritants. measures of mucociliary clearance (mcc), by inhalation of radiolabeled particles to label airway surface liquid, suggest that clearance of secretions is impaired to a mild degree in smokers and more severely in patients hospitalized for acute exacerbations.

Eligibility criteria:
inclusion criteria: * must be current cigarette smokers * must be otherwise healthy * must be good sputum producers exclusion criteria: * any acute illness any chronic illness which would impact results

Keywords: otherwise healthy current cigarette smokers current cigarette smokers
erlotinib plus pemetrexed to treat lung adenocarcinoma with brain metastases

Conditions: Lung Adenocarcinoma; Brain Metastases

Summary: the purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.

non-small lung cancer (nsclc) is the leading cause of death in the world. brain metastases are a frequent complication of nsclc, especially in lung adenocarcinoma. 30-50% or more these patients will develop brain metastases at first time or during the treatment. limited treatment options, whole brain radiotherapy (wbrt) combined with or without stereotactic radiosurgery (srs) as the primary treatment approach, are available for brain metastases patients with poor survival. so the availability of effective therapies are therefore of great importance. currently, two agents (erlotinib and pemetrexed) are reported more effective in lung adenocarcinoma patients with brain metastases. the heterogeneity of nsclc tumors provides a strong rationale for using combination therapy with targeted agents that have different mechanisms of action, moreover different combination offering synergistic effects. so we investigate if erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.

Eligibility criteria:
inclusion criteria: 1. histological or cytological diagnosis of lung adenocarcinoma histology with brain metastases 2. 18 years or older 3. eastern cooperative oncology group (ecog) performance status no more than 3 (poor ps caused by neurological symptom) 4. appraisable intracranial disease, the presence of at least one lesion, and the longest diameter \> 5 mm by brain mri 5. haemoglobin 10.0 g/dl, absolute neutrophil count (anc) 1.5\^9/l, platelets 100 x 10\^9/l 6. total bilirubin 1.5 x upper limit of normal (uln) 7. alanine aminotransferase (alt) and aspartate aminotransferase (ast) \< 2.5 x uln in the absence of liver metastases, or \< 5 x uln in case of liver metastases 8. creatinine clearance 60ml/min (calculated according to cockcroft-gault formula) 9. if received brain radiotherapy, patients included at least 8 weeks after the end of radiotherapy. exclusion criteria: 1. mixed non-adenocarcinoma cell lung cancer histology 2. previous treatment with pemetrexed or tarceva 3. be allergic to pemetrexed or tarceva

Keywords: lung adenocarcinoma brain metastases erlotinib pemetrexed
a study assessing the safety and efficacy of de-101 ophthalmic suspension in dry eye patients

Conditions: Dry Eye Disease

Summary: to investigate the safety and efficacy of de-101 to improve the signs and symptoms in dry-eye disease.


Eligibility criteria:
inclusion criteria: * individuals considered for entry into the study will be of either sex and any race who have: * a confirmed diagnosis of dry eye, * are willing to use no ocular treatments during the study other than study medication, * have a corrected early treatment diabetic retinopathy study (etdrs) visual acuity score of +0.7 logarithm of the minimum angle of resolution (logmar) or better in each eye, * will not use contact lenses during the study, * females of child-bearing potential must have a negative urine pregnancy test and be willing to use an acceptable method of contraception to be eligible for, and continue participation in, the study, * 18 years of age or older, * able to understand and provide written informed consent exclusion criteria: * subjects with any of the following are not eligible to participate in the study: * fluorescein corneal staining or conjunctival staining that is too severe * conditions requiring the use of ophthalmic prescription or over the counter medications during the study (except for study medications) * any type of current punctal occlusion including punctal plugs, intracanalicular punctal plugs or cauterized puncta * any type of ocular surgery within 90 days prior to visit 1 (day 1) * known history of steven-johnson's syndrome, riley-day syndrome, and/or ocular pemphigoid * ocular(including lid)disease/abnormality that may interfere with the study * corneal transplant in either eye, at any time prior to enrollment in the study * laser refractive surgery less than one year prior to visit 1 (day 1) * conditions requiring the use of any systemic medication that is not ongoing at a stable dosage for at least 30 days prior to visit 1 (day 1) * application of isotretinoin within 30 days prior to visit 1 (day 1) * known allergy or sensitivity to any of the study medication components * uncontrolled systemic conditions or other conditions which would confound the study evaluations or endanger the safety of the subject * a woman who is pregnant, nursing, or planning a pregnancy * participation in another investigational drug or vaccine trial, or participation in such a trial within 30 days prior to visit 1 (day 1)
olaparib for patients with recurrent brca deficient ovarian cancer

Conditions: Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Summary: this research study is a way of gaining new knowledge about a drug called olaparib in women who have either: 1)never received a parp inhibitor before to treat ovarian cancer (group 1) or 2)participants who have received a parp inhibitor before to treat ovarian cancer, with the exception of olaparib (group 2). parp inhibitors are drugs tht prevent cancer cells from repairing their dna. in this research study, we are looking to see how well the drug olaparib works in women who have never received a parp inhibitor for recurrent ovarian cancer as well as those who have received a prior parp inhibitor and whose cancer has re-grown after receiving that parp inhibitor.

olaparib tablets will be taken twice daily, orally, in treatment cycles lasting 4 weeks. on days 1, 8, 12 and 22 of the first 2 cycles and day 1 of all other cycles, subjects will have a physical exam, be asked questions about their general health, and specific questions about any problems they might be having and any medications they are taking. tumor will be assess by either ct or mri scan every 2 cycles (every 2 months). tumor biopsies will be optional in this study. only participants that have received a parp inhibitor in the past will be asked to have a biopsy of their tumor.

Eligibility criteria:
inclusion criteria: * histologically confirmed ovarian, peritoneal or fallopian tube cancer that has recurred following a platinum-based regimen used at initial diagnosis * measurable disease * estimated life expectancy greater than 16 weeks * normal organ and marrow function * evidence of non-childbearing status for women of childbearing potential * able to swallow oral medication exclusion criteria: * pregnant or breastfeeding * prior parp inhibitor use for another cancer such as breast cancer * receiving any other study agents or any other anti-cancer treatment * known brain metastases * history of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib * uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive hear failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * history of a different malignancy unless disease-free for at least 5 years * currently experiencing seizures or currently being treated with any anti-epileptic for seizures * human immunodeficiency virus (hiv) positive on combination antiretroviral therapy * presence of gastrointestinal disorders that, in the investigator's opinion, are likely to interfere with the absorption of olaparib, or with the patient's ability to take regular oral medication

Keywords: brca1 mutation brca2 mutation
performance of baccalaureate nursing students in insertion of laryngeal mask: a trial in mannequins

Conditions: Respiratory Failure

Summary: the purpose of this study is to compare if there difference in acquisition of knowledge and skills in airway management to baccalaureate nursing students submitted to different learning strategies: exhibition-dialogued class and practical activity in skill lab with low-fidelity mannequin or simulation class with low-fidelity mannequin.

the airway control is priority in patient resuscitation. the laryngeal mask airway (lma) can minimize complications, establishing a safe airway. is fundamental to nurse acquired skills to act in emergency situations; the simulation is a important learning tool for this, because allows a realistic environment and allows to student the possibility of training skills. hypothesis: there difference in acquisition of knowledge and skills in airway management to baccalaureate nursing students submitted to different learning strategies: classroom lecture-dialogued follow of laboratory activity practice with low-fidelity mannequin or simulation in laboratory with low-fidelity mannequin? the aim of this study is compare the effect of teaching-learning strategies: classroom lecture-dialogued follow of laboratory activity practice with low-fidelity mannequin or simulation in laboratory with low-fidelity mannequin, in the acquisition of knowledge and skills to baccalaureate nursing. this is a randomized controlled trial, the population is all students of baccalaureate nursing of eerp-usp, eighth period, 69 students in total; the sample will be voluntary and composed for students that accept participate of study. the intervention group (ig) will be submitted to simulation class and the control group (cg)to exhibition-dialogued class, and practical activity in skill lab. the study will have 3 steps: 1. the participants will be recruited with letters and posters, randomized to ig or cg and follow submitted to write pre-test. 2. the gi will submitted to simulation in laboratory and de cg classroom lecture-dialogued follow of laboratory activity practice. the focus will be the airway management with emphasis in lma. 3. all participants will be submitted to write post test and follow to practice test in simulation scenario, with medium-fidelity mannequin, which simulates human physiologic conditions. the scenario will have a appraiser with a checklist which performance scores of skills and interventions observed. the activities will be filmed and recorded. to data analysis will be used the spss software: descriptive statistics, chi-square test, t-test of student.

Eligibility criteria:
inclusion criteria: * student must be in the eighth period of course; * must be registered regular in the baccalaureate nursing course. exclusion criteria: * absence in any step of study.

Keywords: teaching patient simulation laryngeal masks baccalaureate nursing education teaching strategies simulation