Kornimate/medical-research-clean huggingface dataset:
cap assisted upper endoscopy versus high definition white light endoscopy and narrow band imaging alone in the detection of visible lesions barrett's esophagus: a randomized tandem study

Conditions: Barrett Esophagus

Summary: the hypothesis is that the addition of a transparent cap to the end of the endoscope will increase the detection and diagnostic yield of visible lesions in barrett's esophagus. thus, the goal of this tandem design trial is to compare the diagnostic yield (dy) of cap assisted endoscopy with that of conventional endoscopy using high definition-white light endoscopy (hd-wle) and narrow band imaging (nbi) in patients with barrett's esophagus.


Eligibility criteria:
inclusion criteria: * must be at least 18 years of age. * must be patients undergoing standard of care egd for the confirmation of dysplasia in be or eet for dysplasia in be. * must be able to understand and willing to sign an irb-approved written informed consent document. exclusion criteria: * pregnant or breastfeeding. * prior endoscopic treatment for be. * unable to tolerate sedation due to medical comorbidities.
study of bimonthly vegf trap-eye compared to as-needed administration or other therapy for exudative age-related macular degeneration

Conditions: Exudative Age-related Macular Degeneration

Summary: over the last several years, the standard of care for wet macular degeneration has become treatment with intravitreal injections of ranibizumab (lucentis, genentech), administered as frequently as every 4 weeks. in contrast, clinical trials of a soluble vegf receptor, aflibercept/vegf trap-eye (eylea, regeneron pharmaceuticals) have demonstrated maintained anatomic and visual improvement with many fewer injections (typically monthly injections for 3 months, followed by every-other-month injections, and as few as 5 injections a year). the purpose of this study is to determine whether patients who have switched from ranibizumab to vegf trap-eye have comparable results.


Eligibility criteria:
inclusion criteria: 1. patients older than the age of 50 determined by a retinal physician at the byers eye institute at stanford to have exudative amd requiring treatment. 2. patients with an established diagnosis of exudative amd who have been maintained on a regimen of intravitreal ranibizumab injections. 3. postmenopausal or negative pregnancy test 4. patients with an established diagnois of exidative amd who have been switched from intravitreal ranibizumab to intravitreal vegf trap-eye. exclusion criteria: 1. patients with any previous or concurrent history of treatment of other retinal diseases with pharmacologic agents other than ranibizumab, including verteporfin photodynamic therapy, bevacizumab, triamcinolone, or dexamethasone. 2. patients with prior history of vitrectomy surgery in the study eye. 3. patients enrolled in any previous or current clinical trial or study of any medication for amd or any other retinal vascular disease, including diabetic retinopathy or retinal vein occlusion. 4. ocular media opacity precluding proper retinal imaging 5. inadequate pupillary dilation to achieve proper retinal imaging 6. concurrent use of systemic anti-vegf agents 7. cnv due to other causes, including histoplasmosis, uveitis, trauma, or myopia 8. active or recent (\< 4 weeks) or recurrent inflammation in the eye 9. current vitreous hemorrhage in the study eye limiting visualization of the fundus 10. active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis 11. untreated glaucoma with iop \> 25 in the eye 12. other ocular diseases that can compromise the visual acuity of the study eye such as amblyopia and anterior ischemic optic neuropathy 13. pregnancy or lactation 14. history of other disease, exam finding, or clinical laboratory that contraindicates the use the drug 15. current treatment for active systemic infection 16. evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, pulmonary, renal, hepatic, endocrine, or gi disorders 17. history of recurrent significant infections or bacterial infections 18. inability to comply with study or follow-up procedure
a study of bms-813160 in combination with chemotherapy or nivolumab in participants with advanced solid tumors

Conditions: Colorectal Cancer; Pancreatic Cancer

Summary: the purpose of this study is to evaluate the safety profile, tolerability, drug levels, drug effects, and preliminary efficacy of bms-813160 alone or in combination with either chemotherapy or nivolumab or chemotherapy plus nivolumab in participants with metastatic colorectal and pancreatic cancers.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * must have metastatic colorectal or pancreatic cancer * eastern cooperative oncology group (ecog) performance status of ≤1 * ability to swallow pills or capsules * required to undergo mandatory pre and on-treatment biopsies * adequate marrow function * adequate other organ functions * ability to comply with study visits, treatment, procedures, pharmacokinetic (pk) and pharmacodynamic (pd) sample collection, and required study follow-up exclusion criteria: * histology other than adenocarcinoma (neuroendocrine or acinar cell) * suspected, known, or central nervous system (cns) metastases (imaging required only if participants are symptomatic) * active, known or suspected autoimmune disease * condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration * interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity * prior treatment with cysteine-cysteine chemokine receptor 2 (ccr2) and/or cysteine-cysteine chemokine receptor 5 (ccr5) inhibitors, programmed death-1 receptor (pd-1), programmed death-ligand 1 \[pd(l)-1\] or cytotoxic t-lymphocyte antigen-4 (ctla-4) antibodies * history of allergy to study treatments or any of its components of the study arm that participant is enrolling other protocol-defined inclusion/exclusion criteria apply
a study to assess s-309309 in healthy and obese participants

Conditions: Obesity

Summary: the primary aim of the study is to assess the safety and tolerability of s-309309 after oral administration in healthy adult or obese but otherwise healthy adult participants. the secondary aim of the study is to assess the pharmacokinetics of s-309309 and the effects on ecg parameters after oral administration in healthy or obese but otherwise healthy participants.

this study will consist of 2 parts. part 1 will include healthy participants who will be assigned to a dose group. participants will then be randomized to receive a single oral administration of s-309309 or placebo in a fasted state. administration will be initiated in the lowest dose group, and administration in the next dose group will not occur until a review of safety and tolerability has been completed for the preceding group. part 2 will include 2 groups. healthy participants and obese but otherwise healthy participants will receive multiple oral administrations of s-309309 or placebo in a fed state.

Eligibility criteria:
inclusion criteria: * healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead ecg at the screening visit and upon admission to the clinical research unit (cru). * body weight ≥50 kilograms (kg), and body mass index (bmi) within the range ≥18.5 to \<30.0 kilogram/meter square (kg/m\^2) for all groups except group g-2. for group g-2, bmi ≥ 30 to \< 40 kg/m2 at the screening visit. exclusion criteria: * history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data. * lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. * breast cancer within the past 10 years. * unable to swallow capsules. * chronic history of or current liver disease or known hepatic or biliary abnormalities (with the exception of gilbert's syndrome or asymptomatic gallstones).
the clinical and economic impact of pharmacogenomic testing of warfarin therapy in typical community practice settings

Conditions: Embolism and Thrombosis; Embolism; Vascular Diseases; Warfarin; Venous Thromboembolism; Thrombosis; Thromboembolism

Summary: the purpose of this quasi-experiment study, which could also be classified as a prospective observational intervention study, is to assess the impact of cytochrome p450 2c9 (cyp 2c9) and vitamin k epoxide reductase complex, subunit 1 (vkorc1) testing within a primary patient care setting.

anticoagulation therapy with warfarin is the most common mode of treatment and prophylaxis for venous and arterial thromboembolic conditions. warfarin is metabolized in the liver by the cytochrome p450 system, the cytochrome p450 2c9 (cyp 2c9) isoenzyme specifically, and polymorphisms in the cyp 2c9 gene have been associated with changes in metabolic function of the translated isoenzyme . these polymorphisms result in reduced metabolism of warfarin as compared to subjects having the wild type gene, consequently leading to systemic accumulation of warfarin; it is theorized that this leads to higher risk of adverse events. other allelic variations have also been linked to changes in vitamin k conservation through their effects on vitamin k epoxide reductase complex, subunit 1 (vkorc1) . the combined impact of cyp 2c9 and vkorc1 polymorphisms on warfarin's pharmacology have recently been reported. it is hypothesized that evaluation of genomic allelic type guided warfarin dosing will reduce thromboembolic and bleeding risks associated with warfarin therapy, and that adoption of a genetic testing strategy in a primary patient care setting would improve warfarin effectiveness and patient safety, and reduce costs to health care payers.

Eligibility criteria:
inclusion criteria: * female and male age range of 40-75 * patients who are in the induction phase of warfarin * patients receiving warfarin to prevent or treat thromboembolic conditions (e.g., post orthopedic surgery prophylaxis, deep venous thrombosis, atrial fibrillation, pulmonary embolism, heart failure) * patient willing to provide informed consent prior to the specimen collection procedure * patient whose physician is willing to order the genetic test exclusion criteria: * age \ 75 * previous use of warfarin within 180 days of initiating new warfarin therapy * hospitalized for seven or more days before first claim for warfarin * previous history of genetic testing for warfarin therapy * known hypersensitivity to warfarin * patient or physician refusal to participate in the study * patients using warfarin residing in olmsted county, mn

Keywords: cyp2c9 vkorc1 polymorphism warfarin coumadin
the effect of methylprednisolone on the reversal time of rocuronium by sugammadex in the pediatric patient group

Conditions: Sugammadex Reversal Time; Muscle Weakness

Summary: the aim of this study is to thoroughly investigate the interaction between methylprednisolone and sugammadex in the pediatric patient population. our hypothesis is that methylprednisolone will interact with sugammadex, leading to a prolonged reversal time of rocuronium by sugammadex and, at the same time, a reduction in the effect profile of methylprednisolone. approximately 80 volunteers will be included in the study. patients will not have any additional responsibilities related to this study. there are no risks or benefits to patients associated with this research. the study will begin immediately before the patient's surgery and will end two hours after the operation. volunteers participating in the study will be randomly assigned to one of two groups: one group will receive methylprednisolone during surgery, and the other group will not. methylprednisolone is a medication used to prevent postoperative pain, swelling, nausea, and vomiting. if these complaints are detected in patients from either group after surgery, appropriate treatments will be administered to alleviate them.


Eligibility criteria:
inclusion criteria: * patients who are able to provide informed consent and reliably report symptoms to the research team, * classified as physical status 1 and 2 according to the american society of anesthesiologists (asa). exclusion criteria: * patients for whom parental or personal consent could not be obtained * asa physical status 3 or higher * known history of allergic reactions to the drugs specified in the protocol * patients requiring emergency surgery * expected difficult airway * preoperative corticosteroid use * presence of respiratory system diseases * presence of neuromuscular diseases * presence of enzymatic or endocrine disorders * presence of liver or kidney failure * presence of cardiovascular diseases * patients with abnormal cognitive or physical development * history of treatment with drugs that have a high potential for interaction with sugammadex (e.g., toremifene, flucloxacillin, fusidic acid).

Keywords: sugammadex methylprednisolone reversal time rocuronium pediatric patients
pancreatic insulin production capacity (pipc) - a feasibility study

Conditions: Type 2 Diabetes

Summary: the standard treatment for type 2 diabetes involves management of the disease based on average of blood glucose control over the past few months. in this study, the investigators test for the participants' ability to produce insulin, which is the hormone that the body makes to control blood sugar levels. the body produces insulin in response to eating. the participants will drink a meal replacement shake, and then test the blood for levels of insulin produced over 2 hours. with blood tests taken five times over two hours, the investigators will measure the blood glucose (sugar), and insulin levels. this study will assess the differences in insulin produced in the participants and try to understand the reasons for these differences.

this study will measure the ability of the pancreas to produce insulin after the participant drinks a boost original meal replacement shake. the boost original meal replacement shake contains nutrients similar to a typical meal, and allows to standardize this "meal" for all participants. this is a cross-sectional study for 90 participants with type 2 diabetes mellitus who undergo a single study visit that lasts 2 hours with blood drawn at five time points. the area under the curve will be a quantitative measure of each participant's pancreatic insulin production capacity.

Eligibility criteria:
inclusion criteria: 1. consent provided 2. age \>= 18 years. 3. diagnosed as type 2 diabetes mellitus. 4. not on insulin therapy. exclusion criteria: 1. diagnosed as another form of diabetes mellitus. 2. allergic to one or more ingredients in boost meal replacement shake. 3. unable to fast since midnight and attend in person for the morning protocol.
effect of canned beans of multiple varieties in daily amounts of 1 cup and 1/2 cup on serum ldl cholesterol and other cardiovascular disease risk biomarkers in adults with elevated ldl cholesterol

Conditions: Hypercholesterolemia; Cardiovascular Diseases

Summary: the bean study will examine the effects of consuming two daily amounts of canned beans of multiple varieties on fasting serum cholesterol profile in adults with elevated ldl cholesterol.

the bean study (tbs) is a a multi-centre, randomized, crossover design study which will examine the effects of consuming two daily amounts of canned beans of multiple varieties on fasting serum cholesterol profile in adults with elevated ldl cholesterol. participants will consume daily amounts of 1 cup canned beans, ½ cup of canned beans and 1 cup of white rice for 4 weeks each, separated by minimum 4-week washout periods. at the start and end of each 4-week treatment period, fasting blood samples will be collected and analyzed for lipids, glucose insulin and short chain fatty acids (scfas). fecal samples will also be collected and analyzed for scfa, bile acids and gut microbiota. body weight and bmi will be also be measured at the start and end as well as mid-way of each treatment period. finally 3-day food records will be completed mid-way during each treatment period.

Eligibility criteria:
inclusion criteria: * male and female adults (≥18 years) * bmi 18.5-35 kg/m2 * ldl cholesterol 3.0-5.0 mmol/l exclusion criteria: * triglycerides ≥3.0 mmol/l * diabetes (fasting blood glucose ≥7.0 mmol/l) * blood pressure \>140/90 mmhg * major medical conditions * medical or surgical events requiring hospitalization within the last 3 months * medication use that would interfere with the study outcomes (e.g. cholesterol-lowering medications, diabetes-related medications, steroids). all other medications are okay if at a stable (3-month) dose * antibiotic use within the last 3 months * tobacco product use (\>5 times per week) * cannabis use during the study * probiotic supplement use (could do a 1-month washout before study) * dietary fibre supplement use (could do a 1-month washout before study) * nhps used for cholesterol lowering or glycemic control. all other nhps are okay if at a stable (3-month) dose. * pulse consumption \>4 servings per week * food allergy or non-food life-threatening allergy * pregnant or breastfeeding * alcohol consumption (\>14 drinks/week or \>4 drinks/sitting) * recent or intended significant weight loss or gain (\>4 kg in previous 3 months) * national-level or professional athlete * overnight shift worker

Keywords: mixed beans
economic and medical evaluation of the whole mitochondrial dna screening by surveyor and mitochips techniques

Conditions: Mitochondrial Disease

Summary: mitochondrial diseases are the most frequent metabolic diseases (2.5 persons among 10 000) and are clinically heterogeneous making diagnosis particularly challenging for clinicians. molecular analysis of mitochondrial dna (mtdna) is a critical step in diagnosis and genetic counselling of respiratory chain defects. dna sequencing remains the gold standard but it is time-consuming and fails to detect mutations that may be present at a low heteroplasmic level (20% or below); therefore the diagnosis is yet based on the detection of a few number of pathogenic mutations. the present study aims to evaluate the benefit and the cost of a diagnosis strategy based on the combined use of 2 techniques named "surveyor nuclease" and "mitochip". surveyor nuclease is a mismatch-specific dna endonuclease that will be used for screening the entire mtdna in order to identify heteroplasmic mutations. in absence of any identified mutation, another technique based on the use an oligonucleotide sequencing microarray (mitochip) will be performed for the identification of homoplasmic mutations. mitochip is an array-based sequencing platform for rapid and high-throughput analysis of mitochondrial dna. the economical study will compare the cost of these techniques to the standard diagnosis method in term of direct and indirect costs


Eligibility criteria:
inclusion criteria: * patients without deletion of mitochondrial disease and/or 3243, 8344 and 8993 mutation * patient with health insurance exclusion criteria: * patients with deletion of mitochondrial disease and/or 3243, 8344 and 8993 mutation * absence of patient consent
nightmare rescripting and rehearsal

Conditions: Nightmare; Sleep

Summary: this study aims to test the efficacy of an abbreviated version of imagery rehearsal therapy administered by non-mental health professionals in a primary care setting. this treatment, to be called 'nightmare rescripting and rehearsal therapy' (nrrt) would arm primary care medical personnel with a nonpharmacologic, ten minute intervention for treating recurring nightmares. the study will provide sleep hygiene education to both the control and experiment groups, nrrt to the experiment group only, and compare their nightmare distress questionnaire and nightmare frequency tool at two (2), four (4), and six (6) week intervals.

this is a prospective randomized controlled trial to determine if a standard of care sleep hygiene handout plus a brief 10 minute intervention for recurring nightmares (nightmare rescripting and rehearsal therapy) reduces scores on the nightmare distress questionnaire and nightmare frequency tool, when compared to patients solely receiving a handout outlining sleep hygiene techniques. individuals with a minimum score on the nightmare distress questionnaire and nightmare frequency tool of 15 out of a possible 52 who meet all other inclusion criteria will be invited to participate. a clinically significant reduction will be considered if a decrease in nightmare distress and frequency measures is greater than or equal to 25% from baseline. secondary outcomes will include pcl-5 (ptsd), phq9 (depression), gad7 (anxiety), isi (insomnia severity index) scores.

Eligibility criteria:
\*\*patients must be able to get care at nellis air force base (a military installation) in order to participate in this study\*\* inclusion criteria: * active duty members and dod beneficiaries. * aged 18 years or older * recurring disturbing dreams (at least three times per month for the past one month) * participants must score a 15 out of a possible 52 on the nightmare distress questionnaire and nightmare frequency tool in order to qualify. exclusion criteria: * aged less than 18 years old * unwilling to refrain from taking an over the counter or prescription medication for the purpose of improving sleep during the course of the study. * participants that score less than a 15 out of a possible 52 on the nightmare distress questionnaire and nightmare frequency will be excluded

Keywords: nightmare rescripting dreams behavioral health sleep
the covid-iyon study - study examining data pertaining to clinical outcomes and organisational responses to the 2020 sars-cov-2 pandemic"

Conditions: Cancer; COVID-19

Summary: this is a prospective, multisite, descriptive, observational clinical/epidemiological study examining both quantitative and qualitative data pertaining to clinical outcomes and organizational responses to the 2020 sars-coronavirus-2 (sars-cov-2) pandemic.

this study collects real-time observational data regarding the impact of sars-cov-2 infection on patients with cancer, and on the functioning and organisation of cancer and malignant haematology services in the republic of ireland in response to the 2020 sars-cov-2 pandemic.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. informed consent has been obtained. 3. cytotoxic chemotherapy, targeted anticancer therapy, immunomodulatory anticancer therapy, hormonotherapy, radiotherapy, oncologic surgery, or other anticancer treatment within the last 12 months (ongoing and completed). 4. tested positive for sars-cov-2. exclusion criteria: there are no exclusion criteria
effects of watermelon or low-fat cookie consumption on wellness

Conditions: Overweight and Obesity

Summary: the objective of the proposed research is to determine the effects of fresh watermelon consumption on physiological indicators of wellness regarding sexual, skin and gut health in adults.


Eligibility criteria:
inclusion criteria: * generally healthy subjects * bmi 20-40 kg/m2 exclusion criteria: * smoker * pregnant woman * required antibiotics use * required dietary supplement use * required medication of metabolic disorders, mental health and sexual health * allergy to watermelon or wheat