Kornimate/medical-research-clean huggingface dataset:
mutations in the epidermal growth factor receptor(egfr) gene in non-small cell lung carcinoma (nsclc) and the relation to response of treatment with erlotinib

Conditions: Non-Small Cell Lung Cancer

Summary: recently it has been suggested that specific mutations in the egfr gene in lung cancer patients is associated with response to a novel drug targeting the egf system. recent research also indicates that there is a possible association to the degree of aggressiveness of the disease. the importance of these mutations is controversial, because the data are based on small studies with highly selected patients. in this project the investigators want to study the types and frequencies of egfr mutations in both untreated and treated patients in a systematic manner and relate this to survival. the thorough registration of patient data in dk enables us to create a strong the investigators expect this knowledge to be of greatest importance for future rational use of drugs targeting the egf receptors.

aim: 1. to establish a method for identifying the mutations in the egfr gene in small clinical samples from lung cancer patients. 2. in a retrospective study(n=500) relate survival to the frequency and types of mutations in the egfr gene in a danish population of patients with advanced, inoperable non small cell lung cancer (nsclc) diagnosed prior to the introduction of treatment directed towards egfr. 3. in a prospective study (n=300), to identify the mutations in the egfr gene in patients treated with erlotinib, a tyrosine kinase inhibitor targeting the egfr. presence of mutations will be related to the expression of other parts of the egf system, to mutations in the gene coding for k-ras and to treatment response.

Eligibility criteria:
inclusion criteria: * patients who are starting treatment with erlotinib and who has who has signed the informed consent. exclusion criteria: * none

Keywords: egfr mutations egfr inhibitor erlotinib
efficacy and safety of co2 vs room air insufflation during esd for gastric tumor

Conditions: Gastric Tumor

Summary: insufflation is essential procedure to observe the lumen of gastrointestinal tract in gastroscopy or colonoscopy currently, most of hospital in korea are using room air for insufflation according to recent clinical studies have shown that carbon dioxide have better safe and reduce stomachache than room air when endoscopy and endoscopic procedure is performed. however, there was still no research data or study in korea. in this study, the investigators will try to make comparison between carbon dioxide and room air insufflation for endoscopic submucosal dissection for gastric tumor and investigate the efficacy and safety


Eligibility criteria:
inclusion criteria: * patients who have gastroscopy and colonoscopy or esd for gastric tumor under sedation in department of gastroenterology, gachon university gil medical center exclusion criteria: * age : \< 19 years old * underlying disease : copd requiring o2 * known co2 retention * opiate abuse for chronic pain * nonreader or short in understanding * pregnancy * any medical instabilities expected to not be in safe
an analysis in the use of telecommunication platform

Conditions: the Use of the Platform

Summary: the covid-19 pandemic becomes a global challenge. beneficial to being an island country and having appropriate policies, there were only few imported cases in taiwan. however, many locally acquired cases came out in the mid of this may. the hospital policy about containing infection changed accordingly. a real-time communication platform for the health care workers was designed and embedded in the hospital information system of the emergency department in 2018. the functions included sending messages to certain staff, pop-up reminders, and tracking messages. this study aims to evaluate the use of the communication platform during the covid pandemic.

the covid-19 pandemic becomes a global challenge. beneficial to being an island country and having appropriate policies, there were only few imported cases in taiwan. however, many locally acquired cases came out in the mid of this may. the hospital policy about containing infection changed accordingly. a real-time communication platform for the health care workers was designed and embedded in the hospital information system of the emergency department in 2018. the functions included sending messages to certain staff, pop-up reminders, and tracking messages. this study aims to evaluate the use of the communication platform during the covid pandemic.

Eligibility criteria:
inclusion criteria: healthcare workers with using the communication platform. exclusion criteria: healthcare workers without using the communication platform.
nesiritide use following cardiac surgery in infants

Conditions: Heart Defects, Congenital; Cardiopulmonary Bypass

Summary: the purpose of this study is to determine the effects of nesiritide on urine output and hemodynamics following cardiopulmonary bypass in infants. safety and pharmacokinetic data will also be obtained.

nesiritide, a recombinant human b-type natriuretic peptide, has vasodilatory, lusitropic and diuretic properties in healthy humans, and improves hemodynamics and symptoms in adults with decompensated congestive heart failure. several retrospective case series suggest that nesiritide has beneficial effects on hemodynamics and urine output in adults and children following cardiac surgery. the purpose of this prospective, randomized, double-blind, crossover study is to evaluate the effects of a continuous infusion of nesiritide on postoperative hemodynamics and urine output in infants with congenital heart disease who undergo cardiac surgery requiring cardiopulmonary bypass (cpb). patients less than 1 year of age following cardiac surgery will be eligible for the study if they have received two conventional diuretics (furosemide and chlorothiazide) for at least 12 hours, yet are not effectively achieving a negative fluid balance, thus prohibiting sternal closure or tracheal extubation. patients will be randomized to receive either a 10-hour infusion of nesiritide, a two hour washout period, followed by a 10-hour infusion of placebo, or this study drug sequence in reverse order. during the 24-hour study period, serial cardiac output measurements and bnp levels will be obtained, vital signs and intracardiac filling pressures will be recorded, and urine output will be measured.

Eligibility criteria:
inclusion criteria: * \> 48 hours after cardiac surgery requiring cardiopulmonary bypass * \< 1 year of age * receiving chlorothiazide and furosemide for \> 12 hours * urine output \ output for 2 consecutive days * receiving mechanical ventilation * presence of body wall edema on cxr, defined as a radiologic index of \> 2 * plan for \> 24 hrs further diuresis before chest closure or extubation exclusion criteria: * age \> 365 days at the time of enrollment * corrected estimated gestational age \< 35 weeks at the time of enrollment * serum creatinine \> 2.0 mg/dl at the time of enrollment * significant hemodynamic instability at the time of enrollment * lack of dedicated intravenous access for nesiritide infusion * lack of arterial line for continuous blood pressure monitoring * lack of a foley catheter for continuous urine collection * enrollment in another research study such that the outcomes of either study may be confounded by participation in this study, or such that the amount of blood drawn for research purposes becomes excessive.

Keywords: nesiritide natriuretic peptide, brain heart defects, congenital cardiopulmonary bypass diuretics
china lymphoma patient registry study

Conditions: Lymphoma

Summary: lymphoma is the most common hematologic tumor. it is derived from lymphoid tissue, including hodgkin's lymphoma(hl) and non hodgkin's lymphoma(nhl). the treatment of lymphoma includes chemotherapy, radiotherapy, stem cell transplantation, targeted therapy and surgery etc. with the progress of treatment, the survival rate of lymphoma patients has been improved. but the 5 year survival rate of lymphoma in china is shorter than that in united states. the reason is that there is still a gap between china and the united states in disease screening, diagnosis and treatment. observational studies, especially cohort studies, are important tools for understanding disease progression, treatment, and prognosis in the real world. observational cohort studies which involve over 500 patients are currently launched by south korea and the united states. china, which has more patients, doesn't have a cohort of patients with lymphoma. so the primary objective of this study was to establish an observational cohort of patients with lymphoma in china and follow up the patients for a long period of time to provide basic support for clinical research and drug development, and continuously improve patient outcomes and quality of life. the secondary objective is to collect information about diagnosis, treatment, follow-up and prognosis of lymphoma.

lymphoma is the most common hematologic tumor. it is derived from lymphoid tissue, including hodgkin's lymphoma(hl) and non hodgkin's lymphoma(nhl). the treatment of lymphoma includes chemotherapy, radiotherapy, stem cell transplantation, targeted therapy and surgery etc. with the progress of treatment, the survival rate of lymphoma patients has been improved. but the 5 year survival rate of lymphoma in china is shorter than that in united states. the reason is that there is still a gap between china and the united states in disease screening, diagnosis and treatment. observational studies, especially cohort studies, are important tools for understanding disease progression, treatment, and prognosis in the real world. observational cohort studies which involve over 500 patients are currently launched by south korea and the united states. china, which has more patients, doesn't have a cohort of patients with lymphoma. so the primary objective of this study was to establish an observational cohort of patients with lymphoma in china and follow up the patients for a long period of time to provide basic support for clinical research and drug development, and continuously improve patient outcomes and quality of life. the secondary objective is to collect information about diagnosis, treatment, follow-up and prognosis of lymphoma.

Eligibility criteria:
inclusion criteria: * the disease was diagnosed by hodgkin's or non hodgkin's lymphoma * 18 years of age or older at diagnosis * the diagnosis was confirmed within 6 months before admission * informed consent was obtained exclusion criteria: * there are no special exclusion criteria in this study

Keywords: lymphoma clap china patient registry
olanzapine/fluoxetine combination versus comparator in the treatment of bipolar i depression

Conditions: Bipolar Disorder

Summary: the purpose of this study is to assess olanzapine/fluoxetine combination and lamotrigine comparative efficacy, safety and tolerability in acute and longer term treatment of bipolar depression.


Eligibility criteria:
inclusion criteria: * male or female patients, 18 to 60 years of ages, inpatients or outpatients. inpatients are qualified only if they are hospitalized for current episode of bipolar depression and should be able to leave hospital when clinical criteria are no longer met for acute inpatient hospitalization * patients must fulfill the criteria for bipolar i depression (bipolar i disorder, current episode major depressive) as defined in dsm-iv-tr based on clinical examination and psychiatric assessment * patients must have experienced, in the opinion of the investigator, at least one previous manic or mixed episode as defined in dsm-iv-tr, of sufficient severity to require treatment with a mood stabilizer or an antipsychotic as reported by the patient or the caregiver * each patient must have a level of understanding sufficient to perform all tests and examinations required by the protocol * female patients must test negative for pregnancy and must be using a medically accepted means of contraception exclusion criteria: * current diagnosis of any of the following according to dsm-iv-tr criteria: schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, delirium of any type, dementia of any type, amnestic disorder, any substance-induced disorder, or any psychotic disorder due to a general medical condition, unless there is substantive reason to believe patient was previously misdiagnosed. * treatment with clozapine within 3 months (90 days) prior to visit 1 * treatment with electroconvulsive therapy (ect) within 3 months (90 days) prior to visit 2 * patients with seizure disorders are excluded (except patients with a previous history of seizures due to alcohol withdrawal, which have resolved). * participation in a clinical trial of another drug including olanzapine, fluoxetine or lamotrigine within 30 days prior to study entry (visit 1)
treatment of recalcitrant neovascular amd using brolocizumab with immediate t&e

Conditions: Age-Related Macular Degeneration

Summary: the investigator propose to conduct a randomized clinical trial, investigating the safety and efficacy of brolucizumab for treatment of namd patients with cnv, and plans to specifically target those who are not responding to standard treat and extend (t\&e) treatment. a randomised omized study will be conducted with 2 arms, one with the new drug (brolocizumab) and novel treatment protocol versus a second arm using the current gold standard of aflibercept and the t\&e protocol

in addition, there will also be a rescue option for those in the aflibercept arm who are not responding well to also switch to brolucizumab. the primary outcome is the change in central macular thickness, since we expect the new treatment to be effective in reducing intraretinal and subretinal fluids, which in effect are indicators of disease activity. in addition, investigator will look at the improvement of visual acuity, the reduction of treatment intervals, total number of injections over 1 year, recurrence rate and safety profiles of both drugs.

Eligibility criteria:
inclusion criteria: * age 50 and above * diagnosis of exudative age-related macular degeneration (subfoveal cnv) as shown on optical coherence tomography (oct) - presence of intraretinal fluid, subretinal fluid or subretinal hyperreflective material and/or ffa (leakage classified as subfoveal or as juxtafoveal or extrafoveal) * actively treated with aflibercept and given 3 monthly loading doses followed by treat and extend * maximal interval period is less than or equal to 8 weekly injections * patients must understand and sign the ethics board approved consent form exclusion criteria: * ocular criteria: * co-existing retinal and/or macular disease (dme, rvo, high myopia of 8 diopters or more, retinal detachment, macular hole stage 2 or above, significant vitreomacular traction or epiretinal membrane, etc.) * co-existing ocular disease (glaucoma, uveitis etc.) * history of uveitis or intraocular inflammation, scleritis, or episcleritis * history of corneal transplant, pars planar vitrectomy or aphakia * history of therapeutic radiation to the region of the study eye * media opacity obstructing investigation or assessment (cataract, corneal scar, vitreous hemorrhage) * treat and extend period beyond 8 weeks * any intravitreal injection of steroid within 3 months before randomization * systemic criteria: * poorly controlled systemic disease including hypertension and diabetes * any acute coronary event or stroke within 6 months before randomization * malignancy within 5 years * systemic anti-vegf treatment * allergy or sensitivity to investigational product, including fluoresceine dye, anesthetics, aflibercept or brolucizumab
corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia

Conditions: Progressive Keratoconus; Corneal Ectasia

Summary: prospective, randomized, single site study to determine the safety and effectiveness of performing corneal collagen cross-linking (cccl)using riboflavin and uva light in eyes with corneal ectasia or progressive keratoconus.

subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. corneal collagen cross-linking is performed as a single treatment. subjects are followed for at least 12 months to evaluate the long term effects of corneal collagen cross-linking. subjects may be referred from other physicians but must return to emory vision for completion of all study visits.

Eligibility criteria:
inclusion criteria: * diagnosis of keratoconus with documented progression over the previous 12 months. * diagnosis of corneal ectasia * must be able to complete all study visits exclusion criteria: * prior corneal surgery in the keratoconus group * corneal scarring

Keywords: keratoconus ectasia cross-linking riboflavin uva light cornea
vadadustat for the prevention and treatment of acute respiratory distress syndrome (ards) in hospitalized patients with coronavirus disease 2019 (covid-19)

Conditions: Acute Respiratory Distress Syndrome; Coronavirus Infection

Summary: the purpose of this study is to evaluate the efficacy of vadadustat for the prevention and treatment of acute respiratory distress syndrome (ards) in hospitalized patients with coronavirus disease 2019 (covid-19).


Eligibility criteria:
inclusion criteria: * laboratory-confirmed diagnosis of covid-19 by detection of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) rna by reverse transcription polymerase chain reaction (rt-pcr) from any specimen respiratory * admitted to the hospital within 36 hours * oxygen saturation of hemoglobin by pulse oximetry at room air ≤94% * for patients admitted with respiratory symptoms, enrollment must occur within 36 hours of hospital admission. if the patient is admitted to the hospital with normal saturations, but develops respiratory symptoms during their hospital stay, enrollment may occur within 24 hours of desaturation to 94% or less on room air * understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure exclusion criteria: * hypersensitivity to vadadustat or any of its excipients * placed on mechanical ventilation before randomization * hemoglobin above the gender-specific upper limit of normal (uln) at randomization: 16 g/dl for females and 18 g/dl for males * patients who have erythrocytosis or polycythemia vera * patient taking probenecid, lopinavir or ritonavir * women who are pregnant or breastfeeding, or positive pregnancy test before randomization * patients not on maintenance dialysis with egfc \< 31 ml/min * patients who have received a solid organ transplant, heart, kidney, liver or lung * patients who are prisoners * patients who are currently do not resuscitate (dnr) or do not intubate (dni) * patients with modified rankin scale of 3 or greater * patient who are currently enrolled in any other interventional clinical trial

Keywords: covid-19 ards
fentanyl transdermal matrix patch zr-02-01 to treat chronic, moderate to severe osteoarthritis (oa) pain

Conditions: Pain

Summary: the purpose of this study is to evaluate the effectiveness of the matrix fentanyl patch zr-02-01 in providing pain relief.

this study will evaluate the analgesic efficacy of the matrix fentanyl patch. the study will be conducted in non-opioid tolerant patients with moderate to severe osteoarthritis (oa) pain. this patient population was chosen in anticipation that the patients are otherwise healthy adults being treated with nsaids (nonsteroidal anti-inflammatory drugs) or acetaminophen or who have received intermittent opioid analgesic treatment.

Eligibility criteria:
inclusion criteria: * adults between the ages of 40 and 75 years of age suffering from moderate to severe chronic pain caused by osteoarthritis. exclusion criteria: * patient is already taking chronic opioids or has a history of substance abuse or has a substance abuse disorder.

Keywords: pain chronic pain osteoarthritis pain osteoarthritis
safety and validation of efficacy of oral administration of the food additive colostrum derived anti clostridium difficile antibodies

Conditions: Clostridium Difficile-Associated Diarrhea

Summary: this clinical study is designed to evaluate the safety and efficacy of oral administration of the food additive colostrum derived antibodies to clostridium difficile for prevention of clostridium difficile associated disease (cdad).


Eligibility criteria:
inclusion criteria: * age 18 or older * written informed consent * at least 3 unformed or watery stools in each of the 2 previous 24 hour periods. * confirmed diagnosis of c. difficile associated diarrhea exclusion criteria: * pregnant or breast feeding women * known allergy to milk or milk products * other etiology of diarrhea * active or chronic conditions: ibd, short bowel syndrome, ischemic colitis ileus * pseudomembranous colitis * white blood count \> 50,000 * blood in stools * laxatives or motility drugs within 12 hours * inability to participate in adequate follow up * clinically unstable * investigator deems unsuitable * immune suppression (disease or treatment) * gi surgery * past intestinal parasites

Keywords: clostridium difficile diarrhea colostrum
cpap/psv preoxygenation in obese patients

Conditions: Obesity; Anaesthesia

Summary: the purpose of this study is to determine whether continuouse positive airway pressure (cpap), during induction of anaesthesia in morbidly obese patients, result in higher levels of oxygen in the blood.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) \> 35 kg/m2 * scheduled to undergo elective gastric bypass surgery * age ≥ 18 years * asa physical status classification ii-iii exclusion criteria: * significant cardiopulmonary disease * previous abdominal or thoracic surgery * inability to comprehend the protocol.

Keywords: obesity general anaesthesia preoxygenation atelectasis