Kornimate/medical-research-clean huggingface dataset:
a study of pertuzumab in combination with trastuzumab and chemotherapy in patients with her2-positive advanced gastric cancer

Conditions: Gastric Cancer

Summary: this randomized, multicenter, open-label study will evaluate two different doses of pertuzumab in combination with herceptin (trastuzumab) and chemotherapy in the first-line treatment of participants with metastatic her2-positive adenocarcinoma of the stomach or gastroesophageal junction. participants will be randomized in a 1:1 ratio to two treatment arms. participants in the pertuzumab 840/420 mg arm will receive a pertuzumab loading dose of 840 mg for cycle 1 and a dose of 420 mg for cycles 2-6, and participants in the pertuzumab 840/840 mg arm will receive pertuzumab 840 mg for all six cycles. participants in both treatment arms will receive trastuzumab, cisplatin, and capecitabine.


Eligibility criteria:
inclusion criteria: * adult participants, greater than or equal to (\>=) 18 of age * adenocarcinoma of the stomach or gastroesophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy * measurable disease, according to the response evaluation criteria in solid tumors (recist), v1.1 * her2-positive tumor * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy of at least 3 months exclusion criteria: * previous chemotherapy for advanced or metastatic disease (except (prior adjuvant or neoadjuvant therapy at least 6 months before enrollment in the study) * lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome * active (significant or uncontrolled) gastrointestinal bleeding * abnormal laboratory values
using radiogenomics to predict malignant potential of intraductal papillary mucinous neoplasms of the pancreas

Conditions: Pancreatic Cancer; Pancreatic Cyst

Summary: the florida pancreas collaborative wants to partner with individuals who are known to have, or are suspected to have a pancreatic lesion, tumor, cyst, mass, cancer, or pancreatitis and are undergoing diagnosis and treatment at a participating institution. the goals of this project are to build a large database of information obtained from blood, tissue, medical images, surveys and information from routine care to develop noninvasive diagnostic approaches that could be used as decision-making tools to effectively personalize clinical care.


Eligibility criteria:
inclusion criteria: * individuals who present to the gi clinic, surgery, or endoscopy at moffitt, florida research institute (fri), or um with a clinical suspicion for (or diagnosis of) a pancreatic lesion, cyst, mass, cancer, or pancreatitis based on symptoms, imaging, or blood-work and has not had any treatment involving their pancreas. * able to understand and voluntarily sign the informed consent. * willing to complete study questionnaire(s) and donate medical images and/or biological specimens (including blood, cystic fluid, and/or tissue) obtained at the time of standard of care procedures (biopsy, surgery, and venipuncture) after signing the informed consent document exclusion criteria: * no suspicion or diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis. * has a diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis and has already undergone treatment involving the pancreas (which may involve surgery, chemo- or immuno-therapy, and/or radiation). * unable to provide informed consent. * unwilling to complete study questionnaire(s) and/or donate biological specimens or images.

Keywords: pancreatic lesions
an implementation model for clinical decision support for heart failure prescribing

Conditions: Decision Support Systems, Clinical; Heart Failure

Summary: the objective of this proposal is to compare clinical outcomes, implementation metrics (i.e., patient reach and clinician adoption), and clinician preferences of two designs (customized vs. commercial) of a clinical decision support (cds). beta blocker prescribing for patients with heart failure will be used as a test case. the best practices in cds design, including the user-centered design will be incorporated into the customized cds and compared to a commercially-available cds in the electronic health record using a cluster randomized trial.


Eligibility criteria:
study subjects are providers inclusion criteria: * prescribing primary care clinicians at university of colorado health (uchealth) who provide care for patients with heart failure and reduced ejection fraction exclusion criteria: * none
oral bevacizumab-800cw and cetuximab-800cw administration to detect early esophageal adenocarcinomas

Conditions: Barrett's Esophagus Without Dysplasia; Barrett Oesophagitis With Dysplasia; Esophageal Adenocarcinoma

Summary: previous studies have confirmed the great potential of quantitative fluorescence molecular endoscopy (qfme) when looking at additional lesion detection initially missed by high-definition white light endoscopy (hd-wle) for surveillance of barrett's esophagus.

however, the investigators hypothesized, that additional lesions can potentially be identified by simultaneous use of two targeted tracers because of variable expression of vascular endothelial growth factor a (vegfa) and epidermal growth factor receptor (egfr )within oesophageal adenocarcinoma (eac). until now, solely intravenous and topical administration of the tracers has been investigated. however, optimization of tracer administration and shortened incubation is necessary for clinical translation and implementation of this new technique from barrett's esophagus (be) expert centers to regional non-expert centers. be surveillance procedures normally takes up to 15 minutes at regional hospitals, of which most of the procedural time is needed to take biopsies according to the seattle protocol. introducing qfme into these hospitals would elongate the procedure time with at least 10 - 15 minutes. this would increase healthcare costs and put increased pressure on be healthcare. ideally, the gastroenterologist can immediately start with the qfme procedure without any incubation time while maintaining the best target-to-background ratios (tbr) possible. oral administration by drinking the tracer prior to the procedure would eliminate incubation time and its consequences. quantified qfme with oral tracer administration and targeted biopsies could potentially replace the time-consuming, high miss rate seattle protocol, improve lesion detection and decrease global healthcare costs associated with be.

Eligibility criteria:
inclusion criteria: * be patients without dysplasia and with suspected/diagnosed low-grade dysplasia (lgd), high-grade dysplasia (hgd) or superficial eac and planned diagnostic and/or therapeutic endoscopy * written informed consent is obtained exclusion criteria: * patients under the age of eighteen. * submucosal and invasive eac, also defined as eac with tumor, node and metastasis (tnm)-classification other than t1. * previous radiation therapy for esophageal cancer * known immunoglobulin allergy * previous chemotherapy, immunotherapy or related surgery * prior bevacizumab or cetuximab treatment * medical or psychiatric conditions that compromise the patient's ability to give informed consent * pregnancy or breast feeding.

Keywords: fluorescence molecular endoscopy spectroscopy barrett's esophagus esophageal adenocarcinoma
pharmacokinetics of thiamine in breastfeeding mothers and infants

Conditions: Beriberi

Summary: thiamine deficiency causes beriberi and is common in parts of rural cambodia, where it appears to be a leading cause of infant death. the change in maternal and infant thiamine level after administration of thiamine to either cambodian mothers or their infants is unknown. normal human breast milk thiamine levels in thiamine-replete mothers are poorly characterized. the aim of this study is to determine if thiamine administered to nursing cambodian mothers normalizes maternal and infant thiamine levels. levels will also be obtained in nursing caucasian mothers residing in the united states.

in this pharmacokinetic study, thiamine hydrochloride 100 mg will be administered to nursing cambodian mothers and thiamine levels will be measured in their blood and breast milk before and after supplementation. their infant's blood thiamine levels will also be measured. a control arm of american breast feeding mothers taking prenatal vitamins will also be enrolled, to allow comparison of maternal blood and breast milk levels between cambodian and american mothers. ethics committee approval was obtained in cambodia (national ethics committee for health research #208, 2011) and in the united states (mayo clinic rochester irb #12-004047)for the cambodian and american portions of the protocol, respectively.

Eligibility criteria:
inclusion criteria: * mother is at least 18 years of age * infant is between 1 and 12 months of age * cambodian infant is exclusively breast fed * cambodian mother has not taken vitamin supplements within the past month * american mother has been taking prenatal vitamins throughout pregnancy and postpartum while breastfeeding * mother and infant do not have an acute illness at the time of enrollment * mother and infant are able to comply with study visits exclusion criteria: * mother is not able to provide informed consent * cambodian infant has received thiamine injections within the past 2 months

Keywords: thiamine deficiency
long-term study in us cystic fibrosis patients receiving digestive enzyme supplements to assess narrowing of the large intestine causing adverse intestinal symptoms (fibrosing colonopathy)

Conditions: Fibrosing Colonopathy

Summary: this is a long-term study in cystic fibrosis patients who are participating in the cystic fibrosis patient registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). patients will be followed at their regular clinical care visits over a 10-year period and approached if they develop symptoms of fibrosing colonopathy for collection and use of further detailed information.

this is a prospective, observational, population-based cohort study in us cystic fibrosis patients participating in the cystic fibrosis patient registry in order to assess the incidence of and risk factors for fibrosing colonopathy. cystic fibrosis (cf) patients participating in the registry from participating sites, as well as new cf patients enrolled in the registry at these sites over a 2-year period, will serve as the base study population (estimated to include 24,500-25,000 cystic fibrosis patients between the first patient encounter documented in the registry from any participating site and the 31st of july 2014). cystic fibrosis patients in the base study population will be followed at their regular clinical care visits and, any patients presenting over a 10-year period with signs and symptoms of suspected fibrosing colonopathy, based on a prospective definition, will be approached to obtain a study-specific informed consent for collection of additional data outside the standard registry data collection form in order to augment surveillance. data routinely collected via the standard cf registry will be used to determine exposure to any specific pancreatic enzyme replacement therapy and to assess potential risk factors for the outcome of confirmed fibrosing colonopathy. an independent adjudication panel will be utilized to validate the diagnosis of fibrosing colonopathy based on a prospective case definition as well as decision rules.

Eligibility criteria:
inclusion criteria: the inclusion criteria for enrollment in the base study population * diagnosed with cystic fibrosis, * enrolled in the cystic fibrosis patient registry * receiving medical care at a cystic fibrosis foundation-accredited care center providing data to the cystic fibrosis patient registry exclusion criteria: * none

Keywords: prospective observational pancreatic insufficiency pancreatic enzyme replacement therapy fibrosing colonopathy patients with cystic fibrosis
efficacy between serratus plane block and local infiltration in vats

Conditions: Lung Cancer

Summary: robotic video-assisted thoracoscopic surgery (vats) is increasingly being used as it is a less invasive surgery compared to traditional methods, but the acute pain at an early stage after vats has a major impact on perioperative outcomes. effective post operative analgesia is believed to reduce morbidity, quicken recovery, improve patient outcome and reduce hospital costs. the site and extent of the incision influences the degree of pain due to disruption of intercostal nerves as well as inflammation of chest wall and pleura. neuraxial and systemic opioids have been a gold standard as a part of multimodal analgesia for thoracic surgeries. numerous modalities have been studied: thoracic paravertebral nerve blocks, thoracic epidural analgesia, intercostal nerve blocks, patient controlled analgesia (pca), cryo-analgesia, transcutaneous electrical nerve stimulation (tens), inter-pleural blocks, stellate ganglion blocks, long thoracic nerve blocks, and infiltration under direct vision by the surgeon. serratus plane block is an emerging regional technique that has proven to be effective in comparison to paravertebral blocks in patients undergoing breast surgery and mastectomy with reduced perioperative opioid consumption and improved pain scores. the lateral pectoral nerve, medial pectoral nerve, intercostal nerves and long thoracic nerve are all targets for the serratus plane block. it can be safely performed under ultrasound guidance. the purpose of the study is to evaluate the difference in quality of analgesia between efficacy of serratus plane block and local surgical infiltration by surgeon as measured by patient opioid consumption and pain scores.

participants will be assigned randomly using a computer-generated table of numbers to either serratus group or infiltration group. block team will perform all blocks.

Eligibility criteria:
inclusion criteria: * asa (american society of anesthesiology) class i-iv * age 81-75 exclusion criteria: * asa class v * morbid obesity * patient refusal * patients with chronic pain or on pain medications * allergy to la * patients receiving any additional regional techniques * coagulopathy * patients receiving systemic anticoagulation * local infection * procedures anticipated to last more than 5 hours.

Keywords: video assisted thoracoscopic surgery serratus plane block local infiltration
the assessment of the effect of vitamin d supplementation on inflammatory and endothelial factors in the patients with type 2 diabetes .

Conditions: Type2 Diabetes

Summary: the aim of this study is to determine the effects of vitamin d or placebo for 3 months on the gene expression of glyoxalase enzyme, rage, and ykl40 in the peripheral blood mononuclear cell (pbmc) and serum levels of ykl40,ages, tnf-α, pai-1, il-6, and hba1c of diabetes type 2 patients.

the aim of this study is to determine the effects of vitamin d or placebo for 3 months on the gene expression of plasma human cartilage glycoprotein 39(ykl40), receptor for advanced glycation end products (rage) and glyoxalase enzyme in the peripheral blood mononuclear cell (pbmc) and serum levels of ykl40 ,plasminogen activator inhibitor-1 (pai-1), tnf-α, advanced glycation end products (ages ), il-6, and hba1c of diabetes type 2 patients. in this randomized, double-blind clinical trial, placebo-controlled study, 84 women and men with type 2 diabetes are enrolled from the iranian center of diabetes. at the start of study, all participants will sign informed consent and complete a general information form. 24-hour food record for 3 days will be taken from the patients at the beginning and the end of the study. selected samples by using stratified randomization method based on sex, gender and body mass index (bmi) are classified into 2 groups: 1) receiving vitamin d supplement 2) receiving vitamin d placebo bo. the vitamin d supplement group will receive 4000 iu (100 microgram) daily for 3 months. the vitamin d placebo group will also receive placebo containing starch both similar in terms of color, shape and size. participants are advised to maintain their diet, level of physical activity and medication dose during the study. blood samples will be collected after anthropometric parameter measuring then target biochemical parameters, gene expression and serum levels and physical activity will be measured before and after the trial.

Eligibility criteria:
inclusion criteria: - diabetic type 2 patients 35-65 years old, body mass index in the range 18.5- 30 ,literate, willingness to participation,avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention - exclusion criteria: * people who have used vitamin d supplements in last 3 months, having chronic renal disease , gi disease, hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, treatment with orlistat or sibutramine for weight loss, pregnancy and lactation, treatment with insulin or thiazolidinediones, smokers,sever change in regular diet and life style,change in type and dosage of regular medication (s)

Keywords: vitamin d ykl40 pai-1 rage ages glyoxalase enzyme tnf-alpha il-6 diabetes
amg 827 in subjects with psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: the study will examine the safety and effectiveness of amg 827 for the treatment of psoriatic arthritis

the study will examine the safety and effectiveness of amg 827 for the treatment of psoriatic arthritis. patients will randomly receive either amg 827 or placebo (a look-a-like liquid that does not have any drug in it) and neither the doctor nor the patient will know what treatment is being given.

Eligibility criteria:
inclusion criteria: * subject has had a diagnosis of psoriatic arthritis (by the classification of psoriatic arthritis (caspar) criteria) for at least 6 months * subject has ≥ 3 tender and ≥ 3 swollen joints exclusion criteria: * subject has an active infection or history of infections (systemic anti-infectives were used within 28 days; requiring hospitalization or intravenous anti-infectives within 8 weeks; recurrent or chronic) * significant concurrent medical conditions * pregnant or breast feeding * significant laboratory abnormalities * use of sulfasalazine, hydroxychloroquine, systemically administered calcineurin inhibitors, azathioprine, parenteral corticosteroids including intramuscular or intraarticular administration, or live vaccines within 28 days * use of anti-tnf therapy within 2 months * use of an anti-interleukin (il)12/il-23 drug or other experimental or commercially available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months * prior use of rituximab * prior use of anti-il-17 biologic therapy, including amg 827

Keywords: psoriatic arthritis il-17 amg 827 amg827 musculoskeletal disease spondylarthropathy
pharmacodynamic evaluation of pl2200 versus enteric-coated and immediate release aspirin in diabetic patients

Conditions: Diabetes Mellitus, Type 2

Summary: this study will determine if aspirin from pl2200, an investigational product, gets into the blood stream as quickly as plain aspirin and enteric coated aspirin, and to test whether pl2200 is able to prevent blood clots as effectively as these other products, when administered to patients with diabetes.


Eligibility criteria:
inclusion criteria: * adults 21-79 * body mass index (bmi) of 30-40 kg/m2 * non-insulin-dependent type-2 diabetics (as confirmed by hemoglobin a1c (hba1c) of \> 6.4% and/or fasting plasma glucose of \>125 mg/dl or current anti-diabetic medication) * aa-induced platelet aggregation response of \>60% within 3 hours prior to initial dose of study drug administration exclusion criteria: * contraindications to aspirin * previous history of vascular disease * patient requires insulin * use of non-steroidal anti-inflammatory drugs, anti-secretory agents, antacids, and salicylate-containing nutritional supplements within 2 weeks of randomization
austria study - analysis of difference between active and passive fixation leads

Conditions: Bradycardia; Heart Block; Sick Sinus Syndrome

Summary: in this study the difference between screw in leads actively fixed in the septum and tined leads passively fixed in the apex concerning electrical parameters and implantation time will be evaluated. in addition the influence of the stimulation location by type of lead on qrs width, ejection fraction and nyha class will be evaluated using and electrocardiogram and echocardiogram.


Eligibility criteria:
inclusion criteria: age \< 18 years, indication for pacemaker implantation according to current guidelines, written consent of the patient exclusion criteria: live expectancy \ 150ms), functional (rate dependent) bundle branch bloc
effects of nocturnal nasal oxygen on biomarkers in sleep apnea patients with heart failure

Conditions: Sleep Apnea; Heart Failure

Summary: sleep apnea syndrome is clinically defined by frequent pauses in breathing during sleep and symptoms, such as being tired. it can decrease the restfulness of sleep and decreases the level of oxygen in the blood. sleep apnea patients suffer from daytime sleepiness, hypertension, coronary artery disease (cad), stroke, ischemic heart disease, arrhythmias, pulmonary hypertension, heart failure, and premature death. there is significant evidence suggesting that nighttime decreases in blood oxygen levels are the primary cause of many of the abnormalities associated with this disease. epidemiological studies have demonstrated a surprisingly high prevalence of sleep apnea. mild sleep apnea is present in 17% of adults in the general population and moderate to severe sleep apnea is present in 5.7% of adults. among patients with heart failure the prevalence skyrockets. multiple studies have found the prevalence of moderate to severe sleep apnea to be anywhere from 11-53% in heart failure patients. continuous positive airway pressure (cpap) therapy is currently the standard of care for sleep apnea sufferers regardless of the severity of their disease. in patients without heart failure, cpap therapy has numerous benefits and several long term studies have reported that cpap causes less cardiovascular disease as well as a long term improvement in cardiovascular symptoms and mortality among patient with severe sleep apnea. in heart failure patients, cpap has shown some beneficial short term effects but evidence of long term improvements in symptoms and mortality are lacking. compliance with cpap therapy reduces systolic blood pressure, improves cardiac function, raises oxygen levels, and increases exercise tolerance. on the other hand, cpap has not been shown to affect survival or number of hospitalizations in heart failure patients. moreover, compliance with cpap is often poor and many people cannot tolerate it. this further limits the therapeutic effectiveness of this intervention. the purpose of this study is to assess whether nocturnal oxygen administration via nasal cannula alone can improve outcomes in congestive heart failure patients with moderate to severe sleep apnea. the effects of nocturnal oxygen administration will be assessed by using biomarkers of heart stress and markers of whole body inflammation.


Eligibility criteria:
inclusion criteria: * rdi \> 15 * symptomatic heart failure * oxygen saturation \< 88% during apnea * not currently be on nocturnal oxygen therapy, cpap, or other pap therapy exclusion criteria: * hypoxemia requiring oxygen supplementation * serum creatinine \> 2.5 or on chronic dialysis * blood pressure \> 160 * pregnant * chronic physical disability that would prevent subjects from participating in any aspect of the trial

Keywords: sleep apnea syndrome heart failure oxygen inhalation therapy