Kornimate/medical-research-clean huggingface dataset:
a study of cetuximab(erbitux) with cisplatin and capecitabine(xeloda)as 1st line treatment in the advanced gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to investigate whether cetuximab (erbitux®) with cisplatin and capecitabine (xeloda) as 1st line treatment in the advanced gastric cancer is effective.

gastric cancer remains one of the major causes of cancer deaths around the world, especially in asia. previous study of ml17032 has proved that xp(capecitabine plus cisplatin)is effective in advanced gastric cancer, with the overall response rate of 41%, the median pfs of 5.6 month. recently, the egfr monoclonal antibody of cetuximab has shown to be successful in treating advanced colorectal cancer with or without chemotherapy. since egfr also express in gastric cancer, a single arm, open, multicenter phase ii study of cetuximab in combination with cisplatin and capecitabine as first line treatment in patient with advanced gastric cancer.if applicable, the value of mutations in k-ras, b-raf, p53, and egfr copy number to predict the clinical response to cetuximab in advanced gastric cancer patients will also be accessed.tumor tissue from study patients will be checked for k-ras, b-raf, and p53 mutation by sequencing and for egfr copy number by chromogenic in situ hybridization. dna will be extracted from paraffin-embedded samples.

Eligibility criteria:
inclusion criteria: * having signed informed consent * age 18 to 75 years old * histologically confirmed gastric adenocarcinoma * unresectable recurrent or metastatic disease * previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 12 months * measurable disease according to the recist criteria * karnofsky performance status ≥60 * life expectancy of ≥2 month * no prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks * alt and ast\<2.5 times uln (≤5 times uln in patients with liver metastases) * serum albumin level ≥3.0g/dl * serum akp \< 2.5 times uln * serum creatinine \<1.5mg/dl * bilirubin level \< 1.5mg/dl * serum creatinine \<1.5 times uln * wbc\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, hb\>9g/dl exclusion criteria: * brain metastasis (known or suspected) * previous systemic therapy for metastatic gastric cancer * inability to take oral medication * previous egfr pathway-targeting therapy * surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry * heart failure, coronary artery disease, myocardial infarction within the last 6 months * known allergy to any study treatment * pregnancy or lactation period * any investigational agent within the past 28 days * other previous malignancy within 5 year, except non-melanoma skin cancer * previous adjuvant therapy with capecitabine+platinum * pre-existing neuropathy\>grade 1 * legal incapacity

Keywords: cetuximab cisplatin capecitabine first line treatment
the influence of general anesthesia on tumor metastasis and recurrence

Conditions: Tumor Recurrence and Metastasis

Summary: the purpose of this study was to investigate whether general anesthesia will affect the postoperative recurrence and metastasis of malignant tumor.


Eligibility criteria:
inclusion criteria: * asa i - iii primary liver cancer tumor is single and diameter is less than 3 centimeter there is no major vascular invasion phenomenon, no lymph nodes or extrahepatic metastases the child - pugh belong to type a or type b exclusion criteria: * had a history of liver surgery (including radiofrequency ablation) severe disease of heart, lung, kidney, the immune system inr \> 1.5 or platelet count is less than 45000 cells/mm3 history of opioid addiction metastatic liver tumors not sure of primary liver cancer don't agree to participate in this experiment
droperidol and qtc interval changes in ed patients

Conditions: Emergency Department Patient; QTc Intervals Changes

Summary: objectives to assess the association of low-dose droperidol administration in the emergency department with changes in the qtc interval. hypothesis our study is designed to test the null hypothesis that there will be no clinically significant change in qtc interval after administration of 2.5mg of iv droperidol during an emergency department visit.

the investigators plan to conduct ecg evaluation for qt interval both before and after patients are given 2.5 mg of droperidol. specifically, a convenience sample of consenting adult patients, ages 18 years and older, who present to the ed, and are in a cardiac-monitored bed in the ed who, at the discretion of their treating physician, have an ecg recorded and then receive a dose of 2.5 mg of droperidol iv will be enrolled in our study. the investigators will then have a second ecg printed at least 5 minutes and no more than 30 minutes after the droperidol is given. change in qt interval between the two ecgs will be documented. it may be necessary to review the emr in order to document the time of droperidol administration. these post-droperidol ecgs will not be stored in the electronic medical record nor read by a physician in real time. treatment decisions regarding the patient's medical care in the ed will not be affected by these second ecgs; decisions about whether other ecgs may be needed will be made by the treating physician. the primary study outcome will be the percentage of the study population who experience a clinically significant increase in qtc after low-dose droperidol administration, defined as an increase in qtc of 20 ms or greater. secondary outcome measures will be the mean change in qtc across the study population, and the percentage of the study population for whom the administration of low-dose droperidol is associated with an increase in qtc that re-classifies them as having a prolonged qtc (\>450 ms in men and \>470 ms in women).

Eligibility criteria:
inclusion criteria: * ed patients ages 18 years or older in a cardiovascular-monitored bed who have both an ecg and a 2.5 mg dose of iv droperidol ordered by their treating physician will be eligible for inclusion. exclusion criteria: * refusal to provide consent. * administration of droperidol before the first ecg is performed. * inability to complete the consent form and questionnaire due to clinical instability, severe pain, or disorientation as determined by a study physician.

Keywords: droperidol qtc interval changes emergency department patients
pathophysiology analysis of "costello syndrome" on cellular models

Conditions: Costello Syndrome

Summary: the objective is to collect skin biopsies rom patients with costello syndrome to analyze the molecular mechanisms responsible for this syndrome caused by a mutation in the hras gene and the effects of this mutation on energy metabolism and mitochondrial physiology.


Eligibility criteria:
inclusion criteria: * children aged over 2 years and under 18 * children with a costello syndrome or syndrome cardio-facio-cutaneous exclusion criteria: * previous history allergic to anesthetics
a study to explore signs, symptoms, and biomarkers in dry eye disease participants following anti-inflammatory treatment

Conditions: Dry Eye Disease

Summary: this study aims to evaluate the performance of biomarkers and their responsiveness to standard-of-care treatments (vevye® or xiidra®), in participants with dry eye disease (ded) compared to healthy volunteers (control participants).

this study aims to characterize longitudinal changes in signs, symptoms, molecular, and imaging markers of the ocular surface to investigate pathological mechanisms and biomarkers (bms) of ded after treatment with either of two commercially approved therapeutics (vevye® \[cyclosporine ophthalmic solution\], xiidra® \[liftegrast ophthalmic solution\]).

Eligibility criteria:
inclusion criteria: a. inclusion criteria for participants with ded: * the participant reported dry eye-related ocular symptoms for at least 6 months before the screening visit * the participant must have either used lubricant eye drops regularly or had the desire to use lubricant eye drops in the past 3 months * participant must be classified as having moderate/severe ded * the participant is deemed by the physician to require a prescription medication for ded (e.g., cyclosporin a or lifitegrast) b. inclusion criteria for healthy volunteers: - the participant does not have overt clinical signs of ded in either eye exclusion criteria: * intraocular pressure (iop) \>21.00 millimeters of mercury (mmhg) in either eye * acute allergic conjunctivitis in either eye within 3 months prior to screening * use of contact lenses within 30 days prior to screening * current punctal plugs or punctal cauterization or occlusion * use of ocular anti-inflammatory agents or ocular immunosuppressive agents within 3 months prior to screening * any intraocular injections (e.g., intravitreal \[ivt\] anti-vascular endothelial growth factor \[vegf\]) within 3 months prior to screening, or such injections planned for within the study period * any intraocular immunosuppressive implants within 12 months prior to screening * any history of isotretinoin use within 12 months prior to screening * uncontrolled ocular or systemic disease
application of neurally adjusted ventilatory assist to children after congenital cardiac surgery

Conditions: Mechanical Ventilation Complication; Congenital Heart Disease

Summary: neurally adjusted ventilatory assist (nava) is a new mode of mechanical ventilation that delivers ventilatory assist in proportion to neural effort. it was a controlled randomized single-center prospective study in order to explore the efficacy of this new mode of mechanical ventilation after corrective open-heart surgery for congenital heart disease.

1. to evaluate the effect of the patient-ventilator interaction in children underwent open-heart surgery when ventilated with nava, compared with conventional mechanical ventilation. 2. to verify the benefits of nava in improving the gas exchange and hemodynamics after biventricle repair for chd.

Eligibility criteria:
inclusion criteria: * patients underwent cardiac surgery with biventricle repaired * patients need mechanical ventilation more than 24hrs after cardiac surgery exclusion criteria: * age \>18 years * inappositely of catheter insertion * hemodynamic instability * coagulation disorders or bleeding * inclusion in other research protocol

Keywords: patient-ventilator interaction neurally adjusted ventilatory assist diaphragm electrical activity pressure support ventilation
postoperative peripheral neuropathy after laparoscopic colorectal surgery

Conditions: Peripheral Neuropathy; Postoperative Complications

Summary: this prospective cohort study of patients undergoing colorectal surgery positioned conventionally with shoulder braces was performed. after initial results the implementation of the pink pad ® took place in order to compare the two groups. this study favours pink pad over conventional positioning concerning postoperative neuropathy.

laparoscopic colorectal surgery requires perioperative positioning in the dorsal lithotomy position and intermittent trendelenburg position, which is associated with postoperative peripheral neuropathy, which is a substantial cause of anesthesia-related claims. this study aims to primarily assess the incidence of postoperative peripheral neuropathy of patients positioned conventionally by shoulder braces and secondly to compare this group with patients positioned on the foam mattress pink pad ® 24-hours after surgery and secondarily at a 30-day postoperative follow-up. this consecutive single-center prospective cohort study of 155 patients undergoing colorectal surgery was performed between november 2014 and june 2015. after initial results the implementation of the pink pad ® took place and a total of 52 patients were included between may 2016 and february 2017 in order to compare the two groups. position related postoperative peripheral neuropathy is an important complication after laparoscopic colorectal surgery. this study concludes that careful attention should be payed to positioning and favors pink pad ® over conventional positioning with shoulder braces.

Eligibility criteria:
inclusion criteria: * age \>18 years * elective laparoscopic colorectal surgery * sufficient written and verbal danish skills * awake, responsive and oriented in the post-surgical inclusion period exclusion criteria: * pre-existing peripheral neuro- or musculopathy, * conversion to open operation * lack of consent were defined as exclusion criteria.

Keywords: positioning neuropathy trendelenburg
severe asthma research program - wake forest university

Conditions: Asthma; Severe Persistent Asthma

Summary: the mission of sarp is to improve the understanding of severe asthma through the integrated study of the effect of genetics on the clinical and biological features of asthma and to investigate how these change over time. the ultimate goal of these efforts is to promote better treatments for severe asthma.

the mission of the sarp is to improve the understanding of severe asthma to develop better treatments. the sarp will gain a better understanding of asthma and its endotypes, in children and adults, by defining the disease at the molecular and cellular levels in the context of the temporal phenotypic expression of the disease. to this end, the sarp investigators will utilize both mechanistic and evoked phenotype approaches to: 1) characterize developmental molecular, cellular and physiologic phenotypes in children and adults with mild to severe asthma, and 2) to further elucidate the evolving pathobiology and pathogenesis of severe asthma and its sub-phenotypes and 3) compare these features over time. this approach involves a shared longitudinal protocol conducted across all participating centers which includes common information on all sarp participants. additionally, sarp investigators have each identified mechanistic research questions to be included in the shared longitudinal protocol. at wake forest university investigators are specifically interested in genetic influences on disease severity and the use of statistical modeling techniques to better understand disease phenotypes. together, these longitudinal and mechanistic approaches will enable prediction of phenotype stability/fluctuation and pharmacologic responses and identification of novel, disease-modifying targets for treatment.

Eligibility criteria:
inclusion criteria: 1. physician diagnosis of asthma, 2. age 6 years and older 3. evidence of historical reversibility, including either: * fev1 bronchodilator reversibility ≥ 12%, or * airway hyperresponsiveness reflected by methacholine pc20≤16 mg/ml. exclusion criteria: 1. no primary medical caregiver 2. pregnancy (only if undergoing methacholine challenge or bronchoscopy) 3. current smoking 4. smoking history \> 10 pack years if ≥ 30 years of age or smoking history \>5 pack years if \< 30 years of age (note: if a subject has a smoking history, no smoking within the past year) 5. other chronic pulmonary disorders associated with asthma-like symptoms, including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic bronchitis, vocal cord dysfunction that is the sole cause of asthma symptoms, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways 6. history of premature birth before 35 weeks gestation 7. planning to relocate from the clinical center area before study completion

Keywords: severe asthma sarp
impact of vitamin a on gene expression, in multiple sclerosis patient

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: the aim of this study is the comparison between the effects of supplementation with vitamin a (retinyl palmitate) or placebo for 6 months on gene expression of t cd4+ lymphocyte in multiple sclerotic patient.

multiple sclerosis (ms) is a chronic inflammatory demyelinating disease of the central nervous system (cns).the most important reason for the limited success obtained in the treatment and prevention so far is most likely related to the limited knowledge about its cause and pathogenesis of ms.one of the recent proposed mechanism for autoimmunity base of ms is th1/th2 implance of as well as other inflammatory and anti-inflammatory t cell such as th17 and treg and their releasing cytokines. therefore the control of cytokine production may become potential therapeutic targets and modulation of the th1/th2 balance may provide a new pharmacological tool to treat this disease. vitamin a (va) or va-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. high level dietary vitamin a enhances th2 cytokine production and iga responses, and is likely to decrease th1 cytokine production. retinoic acid inhibits il 12 production in activated macrophages, and ra pretreatment of macrophages reduces ifnγ production and increases il4 production in antigen primed cd4 t cells. supplemental treatment with vitamin a or retinoic acid (ra) decreases ifnγ and increases il5, il10, and il4 production. thus, vitamin a deficiency biases the immune response in a th1 direction, whereas high level dietary vitamin a may bias the response in a th2 direction.

Eligibility criteria:
inclusion criteria: patients who have used interferon beta in last 3 months. patients with 1-5 edss exclusion criteria: * patients who have diseases which affect on th1/th2 balance such as asthma, active viral infections, and autoimmune diseases, or * patients who have allergy to vitamin a compounds, or * patients who have used vitamin supplements in last 3 months. -

Keywords: multiple sclerosis myelin oligodendrocyte glycoprotein(mog) vitamin a cd4-positive t-lymphocytes gene expression th1 cells th2 cells
intravenous (iv) nitroglycerin for versions in nulliparous women

Conditions: Breech Presentation; Complication of Pregnancy

Summary: breech presentations (where a baby presents with feet or bottom down) have an increased risk of perinatal and neonatal complications, and are usually delivered by cesarean section. as an alternative, so that the baby can be delivered vaginally, an attempt can be made to turn the baby so that it is head down: this manoeuvre is called an external cephalic version (ecv). drugs that relax the uterus (tocolytic agents) are sometimes used to help improve ecv success rates. nitroglycerin is a tocolytic agent, but intravenous nitroglycerin has not been tested as an agent to help ecv. there is some suggestion that nitroglycerin may be more helpful in women who have not previously been pregnant (nulliparous women) than in women who have been pregnant more than once (multiparous women), and so we have planned two trials. this study is designed to answer the following questions for nulliparous women: will administration of iv nitroglycerin for uterine relaxation improve ecv success rates? will an increase in ecv success result in a decreased cesarean section rate?


Eligibility criteria:
inclusion criteria: * any non-cephalic presentation * singleton pregnancy * \>/= 37 weeks gestational age * normal amniotic fluid volume * reassuring fetal heart rate exclusion criteria: * labor * ruptured membranes * history of third trimester bleeding * any pre-existing uterine scar * pregnancy induced hypertension and gestational diabetes * oligohydramnios and polyhydramnios * intrauterine growth restriction or macrosomia * hypotension or any serious medical illness * inability to comprehend the consent form
prenatal consult with illustrated literature

Conditions: Premature Birth; Prenatal Stress

Summary: the overall purpose of this study is to determine whether implementing a 'prenatal consult bundle' to the existing prenatal consult, including provision of sample questions, added discussion points and handouts, and a return visit, will decrease parental anxiety and improve information recall. additionally, this study will determine if this effect is further increased with the use of illustrated literature.

this study will be a prospective randomized control trial. seventy participants will be enrolled for the 'standard' consult. these women will receive a questionnaire 6-24 hours after their consult. then 140 participants will be randomized to either the 'standard upgrade' or 'illustrated upgrade' arm. randomization will additionally be stratified based on estimated gestational age. these participants will receive an upgraded consult implementing the 'prenatal consult bundle' which emphasizes the parents' role and follow up, with or without an illustrated handout. these participants will receive the same questionnaire 6-24 hours after their consult. demographic information collected will include maternal age, gravidity, use of magnesium, social support and health literacy. all data will be collected to assess whether either arm of the consult 'upgrade' reduces anxiety or improves knowledge retention after the prenatal consult. analyses will be completed using statistical analysis software (sas) using appropriate statistical testing.

Eligibility criteria:
inclusion criteria: * pregnant women admitted to ob unit at the university of virginia medical center * estimated gestational age of \>25 weeks and \<35 weeks exclusion criteria: * non-english speaking * pregnant women \<15 years of age * known critical conditions or congenital anomalies * women who have had any prior prenatal consultations regarding current pregnancy
novel paradigm to improve inflammatory burden in esrd (repair): a pilot and feasibility randomized controlled trial

Conditions: Chronic Periodontitis; End Stage Renal Disease

Summary: the goal of this project is to assess repeated and ongoing oral care and the way it may affect inflammation and quality of life in hemodialysis patients. two treatment groups will be compared: * 1) ongoing and repeated gum disease therapy including deep tooth cleaning followed by multiple appointments of maintenance * 2) single session of gum disease therapy with only one session of deep tooth cleaning samples of blood will be obtained for study to examine the changes of inflammatory substances in the blood as a result of the two different gum disease treatments. also, a 14-question survey will be discussed with you to assess oral health related quality of life (ohip-14) and the way it is affected by oral care. for this project, four dialysis centers will be randomly assigned to either of the treatment groups #1 or #2 prior to your enrollment. for this purpose, there are two distinct consent forms explaining the visits, procedures and risks of the two treatment groups #1 or #2. as a result, all participants in the same dialysis center will belong to the same treatment group (either #1 or #2) and presented with the corresponding consent form. this dialysis center has been randomized to treatment group # 1; therefore you will receive ongoing and repeated gum disease therapy including deep tooth cleaning followed by multiple appointments of maintenance.


Eligibility criteria:
inclusion criteria: * patient must be referred by nephrologist * patient must be diagnosed with esrd and on hemodialysis * life expectancy more than one year * at least 21 years of age * 12 or more teeth * must meet the periodontal diagnosis criteria (the diagnosis of periodontitis is based on the definition of moderate periodontitis with at least 2 sites with cal≥4mm or at least 2 sites with pd≥5mm not on the same tooth (page and eke 2007).) exclusion criteria: * anticipating a kidney transplant * aids * active malignancy * poor adherence to hemodialysis * dementia * currently prescribed anti-inflammatory medication * temporary catheter for dialysis access * gum disease treatment within the last year

Keywords: periodontitis, end stage renal disease, periodontal treatment