Kornimate/medical-research-clean huggingface dataset:
weight management counseling in medical schools

Conditions: Obesity

Summary: eight u.s. medical schools will be participating in the study: weight management counseling in medical schools, also known as msweight. this is a five-year randomized controlled trial (rct) designed to compare the efficacy of two approaches to learning weight management counseling: 1)traditional education (te) and; 2) multi-modal educational intervention (mme). the study aims are to refine and compare the efficacy of mme to te on observed student weight management counseling skills measured through the primary outcome, the objective structured clinical examination (osce).

eight u.s. medical schools are matched and then randomized to one of two educational interventions, mme or te. schools randomized to te represent "usual care" and will continue the current curriculum. the mme arm will build upon the traditional usual curriculum at the medical school. the mme is a multi-modal educational intervention of a series of interactive learning components focused on integrated weight management counseling. this mme intervention for weight management counseling uses the 5as model based on the updated american heart association (aha) /american college of cardiology (acc) /the obesity society (tos) and updated nhlbi guidelines.

Eligibility criteria:
inclusion criteria: the medical school has: * interest in wmc medical education reform. * curricula resources (e.g. academic computing) to facilitate web-course training and a system to maintain student contact. * the willingness and ability to incorporate all components of msweight into the medical school curriculum, require or strongly encourage students to participate, and award credit for completion. * the willingness and ability to offer the wmc osce for third year medical students upon completion of the family or internal medicine clerkship rotation. exclusion criteria: the medical school does not have: * the ability to incorporate all components of msweight into the medical school curriculum. * the ability to offer the wmc osce for third year medical students upon completion of the family or internal medicine clerkship rotation.

Keywords: weight management counseling medical school education
phase 3 study of nivolumab or nivolumab plus ipilimumab versus ipilimumab alone in previously untreated advanced melanoma (checkmate 067)

Conditions: Unresectable or Metastatic Melanoma

Summary: the purpose of this study is to show that nivolumab and/or nivolumab in combination with ipilimumab will extend progression free survival and overall survival compared to ipilimumab alone.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * histologically confirmed stage iii (unresectable) or stage iv melanoma * treatment naïve patients * measurable disease by computed tomography (ct) or magnetic resonance imaging (mri) per recist 1.1 criteria * tumor tissue from an unresectable or metastatic site of disease for biomarker analyses * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 exclusion criteria: * active brain metastases or leptomeningeal metastases * ocular melanoma * subjects with active, known or suspected autoimmune disease * subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment * prior treatment with an anti-programmed death receptor-1 (pd-1), anti-programmed death-1 ligand-1 (pd-l1), anti-pd-l2, or anti-cytotoxic t lymphocyte associated antigen-4 (anti-ctla-4) antibody
to evaluate the bioavailability of a tablet of azd1656

Conditions: Type 1 Diabetes

Summary: to evaluate the bioavailability of a tablet of azd1656.


Eligibility criteria:
inclusion criteria: * male or female, type i diabetes patients, female with non child-bearing potential. * treated with insulin for more than 3 years. well controlled hba1c. * have a body mass index (bmi) ≥19 and ≤35 exclusion criteria: * clinically significant illness except type i diabetes, or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product * daily use of nicotine containing substances.

Keywords: type i diabetes bioavailability
natural history of gastroesophageal reflux (ger) in children and adolescents

Conditions: Gastroesophageal Reflux

Summary: the goal of this project is to determine the long-term health outcome of children diagnosed with gastroesophageal reflux (ger). we are inviting subjects that were previously followed in the pediatric gi programs at massachusetts general and children's hospital, boston. we have compiled a database of more than 300 subjects that completed diagnostic testing for ger in the 1970's, 1980's, and 1990's. subjects are being contacted initially by mail using a previously approved recruitment letter. subjects that fail to respond to this recruitment letter are called by phone. in each case, contact information has been abstracted from the children's hospital database. subjects are then given the opportunity to complete a questionnaire either by phone or in hard copy. subjects receive no compensation for their participation in this study. subjects will be compared to controls. controls will complete the same questionnaire as the subjects. inclusion of potential controls will be determined by a lack of medical history of gastroenterological diseases before the age of 21 and whether the potential control was born within a year of a subject in the study. controls will receive $25 to participate in the study.


Eligibility criteria:
inclusion criteria for subjects: * patients who were evaluated for gerd at the age of 12-17 years, inclusive at children's hospital, boston or massachusetts general hospital * positive for gerd per biopsies or ph probe results exclusion criteria for subjects: none inclusion criteria for controls: * no gi diseases prior to age 21 including, but not limited to reflux, inflammatory bowel disease,hirschsprung's disease * date of birth is within 1 year of a subject's date of birth

Keywords: ger
avandamet versus metformin for type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this 48-week study will compare avandamet vs. metformin monotherapy for blood glucose control in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * patients between 18 and 75 years of age with type 2 diabetes mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening). * patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening. * women must be post-menopausal, surgically sterile or using acceptable contraceptive measures. exclusion criteria: * prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones. * have a known hypersensitivity to thiazolidinediones or biguanides. * currently using insulin or any oral anti-diabetic agent other than metformin. * history of metabolic acidosis. * history of substance abuse. * have active cancer other than localized squamous or basal cell carcinoma. * chronic disease requiring treatment with corticosteroids. * other criteria will be evaluated at the screening visit.

Keywords: metformin avandamet type 2 diabetes
the outcomes of living donor robotic assisted kidney transplantation

Conditions: Kidney Transplant; Complications; Renal Failure Chronic

Summary: the technology for robot-assisted kidney transplantation (rakt) has become increasingly advanced, with numerous studies demonstrating comparable outcomes between rakt surgery and open surgery. this advancement is particularly noteworthy as it extends its suitability to transplant patients with obesity. it will be important to explore the results of robot-assisted kidney transplantation as compared with open surgery or within cohorts.


Eligibility criteria:
inclusion criteria: 1. living-donor kidney transplant recipients 2. receiving standard triad immunosuppressive regimen exclusion criteria: 1. active infection 2. multi-organ transplantation 3. malignancy history in the donor and recipient 4. human immunodeficiency virus infection

Keywords: robotic surgery
relationship between sleep apnea syndrome and patent foramen ovale among victims of cryptogenic ischemic stroke

Conditions: Apnea Syndrome; Stroke

Summary: obstructive sleep apnea syndrome (osas) and patent foramen ovale (fop) are considered as risk factors for stroke. osas generates a pressure increase in the right cavity during inspiratory efforts, which increases the number of right-left shunt embolus and therefore the risk of stroke. osa and fop are often thought as two separate entities, however, due to their high frequencies, they sometimes coexist and can influence the pathophysiology of each other. more researches are needed in this area to confirm this complex association and its role in triggering stroke.

obstructive sleep apnea syndrome (osas) and patent foramen ovale (pfo) are considered as risk factors for stroke. in most cases, the presence of fop has no clinical impact. certain hemodynamic conditions inducing a right-left pressure gradient can promote the reopening of a fop and allow the passage of blood, presenting micro or macro-thrombi, from the venous system to the arterial system, explaining the mechanism of paradoxical embolism. osas generates a pressure increase in the right cavity during inspiratory efforts, which increases the number of right-left shunt embolus and therefore the risk of stroke. osa and fop are often thought as two separate entities, however, due to their high frequencies, they sometimes coexist and can influence the pathophysiology of each other. evidence of a clinically significant interaction and causation in the genesis of stroke remains limited. more researches are needed in this area to confirm this complex association and its role in triggering stroke.

Eligibility criteria:
inclusion criteria: - patients who have had a cerebral or retinal infarction confirmed by brain imaging or a defined transient ischemic attack without an identifiable cause after a detailed etiological assessment exclusion criteria: * identification of a cause of ischemic stroke: * atheromatous stenosis \> 50% (or atherosclerotic plaque \< 50% threatening) of supra aortic trunk or intracranial arteries on echodoppler of the supra aortic trunk and transcranial or scanner angiography. * emboligenic heart disease : atrial fibrillation and atrial flutter, thrombus in left atrium, spontaneous contrast in left atrium, decreased atrial flow, left ventricular ejection fraction (lvef) \ = 4 mm, ulcerated plaque, thrombus on plaque), aortic dissection * lacunar infarction symptomatic = \< 1.5 cm on the ct scan, = \< 2 cm on the diffusion mri or the flair. * no atherosclerotic arteriopathy : dissection, primary and secondary angitis, spastic angiopathy, etc... * coagulopathy to come a long-term anticoagulant treatment (\> 6 months) (anti-phospholipid syndrome, thrombophilia). * blood disorders and cancer * recent intravenous drug use (in the 6 months before the stroke). * other potential causes: * severe respiratory impairment or pulmonary arterial hypertension

Keywords: obstructive sleep apnea syndrome permeable foramen oval
ultrasound-guided nerve block training model and evaluation method

Conditions: Nerve Blocks; Medical Education, Simulation, Crisis Resource Management; Medical Education in Emergency Ultrasound

Summary: the aim of this study is to assess emergency medicine physician knowledge and technical skill in performance of ultrasound-guided serratus anterior nerve block in a low-fidelity simulation model workshop and to determine the feasibility, acceptability, and usability of the training program. by performing this study, the investigators hope to create a standardized training model which could potentially facilitate pocus and critical procedural performance and thereby improve patient care.


Eligibility criteria:
inclusion criteria: * emergency medicine attending and resident physicians exclusion criteria: * ed nursing, ed technicians, and advanced practice physicians (apps)
evaluation of flortaucipir pet signal and cognitive change in early alzheimer's disease

Conditions: Alzheimer Disease

Summary: this study will evaluate whether visual interpretation of flortaucipir-pet (positron emission tomography) scans, examining patterns of tracer uptake at baseline, can predict the rate of clinically-meaningful cognitive decline due to ad after 18 months. all scans are acquired from cohorts of a previously completed study, i8d-mc-azes (nct02245737, lanabecestat, eli lilly and company sponsor).


Eligibility criteria:
scan reader criteria (5 total readers): * board-certified in radiology or nuclear medicine * professional experience interpreting pet scans scan criteria (205 total scans): * former enrollment in azes study * flortaucipir scan at baseline * clinical dementia rating - sum of boxes (cdr-sb) assessment at 18 months scan study population (azes study): * 55 to 85 years * mci due to ad or probable ad by national institute on aging-alzheimer's association criteria (albert 2011 * mini-mental status exam (mmse) of 20 to 30 inclusive * cdr global score of 0.5 (mci), or 0.5 or 1 (ad) with a memory box score ≥ 0.5, and a score of ≤85 on the delayed memory index of the repeatable battery for the assessment of neuropsychological status. * amyloid positive status confirmed by florbetapir pet or lumbar puncture
pmeg for repair of pararenal and thoracoabdominal aortic aneurysm

Conditions: Pararenal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm

Summary: the primary objective is to evaluate the safety and effectiveness of surgeon modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology in patients who are not candidate for traditional open repair due to comorbid issues and their anatomy is not amenable to commercially available endografts.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. male or female, aged ≥18 years 3. expected survival beyond 1 year following successful aneurysm repair 4. anatomy that would require coverage of the celiac artery, superior mesenteric artery (sma), and/or renal arteries if conventional, fda-approved endograft were implanted to obtain adequate sealing zone length 5. aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection 6. adequate proximal zone of fixation 7. adequate distal zone of fixation 8. no more than 5 non-aneurysmal visceral (celiac, sma, or renal) arteries with diameters between 4-12mm 9. adequate arterial access for delivery system; use of iliac conduit is permitted as necessary exclusion criteria: 1. moderate-to-severe aortic neck calcification, thrombus, or tortuosity 2. severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit 3. proximal landing within zone 0 or 1 4. inability to maintain at least one patent hypogastric artery 5. freely ruptured aneurysm with hemodynamic instability 6. non-ambulatory status 7. severe chf 8. baseline egfr \< 30ml/min, unless currently on or to be initiating dialysis 9. unstable angina 10. stroke or mi within 3 months of planned treatment date 11. active systemic infection and/or mycotic aneurysm 12. uncorrectable coagulopathy or other bleeding diathesis 13. known allergy to device material or contrast material that cannot be adequately pre-medicated 14. body habitus that would preclude adequate fluoroscopic visualization of aorta 15. pregnancy or lactation (confirmed per standard of care surgical practice) 16. major, unrelated surgical procedure planned ≤30 days from endovascular repair 17. patient is ≤30 days beyond primary endpoint for another investigative clinical drug/device trial 18. social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study 19. can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device 20. can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution
photodynamic therapy for covid-19 prevention

Conditions: COVID-19 Respiratory Infection; SARS-CoV-2 Acute Respiratory Disease

Summary: this is a single-center open-label study to evaluate antimicrobial photodynamic therapy (apdt) for upper airway decolonization in patients presenting with sars-cov-2 positive antigen test with mild or no symptoms of covid-19.

there is a wide variety of people who test positive for sars-cov-2. this is directly dependent upon their exposure to the virus, their age and any medical comorbidities that they may have. at this time, it is not possible to predict who will have an adequate immune response to avoid getting covid-19. since this remains unpredictable a universal approach to treating sars-cov-2 positive patients may be the optimal approach. the rational for this study design is that in a real world setting numerous patients across a wide variety of conditions will receive testing for sars-cov-2 for a variety of reasons. for those who test positive and are asymptomatic or have only mild symptoms, the current standard of care is observation and quarantine. the incubation period can range from 2-14 days with a mean of 5-6 days. depending upon an individual's original inoculum of virus, comorbidities and other factors they may progress to covid-19. preemptive treatment during this time frame may avoid or mitigate covid-19 disease severity. in certain high-risk individuals attenuating the disease may avoid hospitalization or death, icu admission and shorten hospital stays. the nasal disinfection process rapidly and lethally disrupts the microbial cell wall, leaving human tissue unharmed. the topically applied photosensitizer formulation selectively stains bacteria by binding with microbial cell wall components. the red light is absorbed by the photosensitizer molecules, causing electronic state transitions within the photosensitizer. the excited photosensitizer immediately transfers energy to surrounding molecular oxygen, thereby producing reactive oxygen species (ros) that are responsible for the lethal cell wall disruption.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female ≥ 18 years of age 4. patient showing a positive test for sars-cov-2 with \< 26 ct of an fda-approved pcr test who is symptomatic or flu-like illness or pneumonia 5. ability to tolerate an 12-minute non-painful nasal light illumination exclusion criteria: 1. inability to tolerate insertion of the light illuminator due to oronasal size, shape, or anatomical variants 2. known allergic reactions to components of the nasal decolonization treatment including methylene blue or chlorhexidine gluconate. 3. covid-19 illness that is moderate or severe in nature.

Keywords: sars-cov-2 antimicrobial photodynamic therapy (apdt) covid-19 viral load nasal decolonization
pectointercostal fascial plane block versus transversus thoracic plane block in adult cardiac surgery patients

Conditions: Pain, Post Operative

Summary: the study will be designed to compare the analgesic effect of ultrasound-guided pectointercostal fascial plane block versus tansversus thoracic plane block in adult cardiac surgery.

a prospective study will be carried out in alexandria main university hospitals on 60 adult patients planned for elective cardiac surgery, after approval of the ethical committee of faculty of medicine, alexandria, and having an informed written consent taken from patients included in the study. patients will be categorized into two equal groups; group p (n=30)) will receive ultrasound-guided pectointercostal fascial plane block and group t (n=30) will receive ultrasound-guided transversus thoracic plane block. all patients will receive the ultrasound-guided block after induction of anesthesia and an equal booster dose of the same block before extubation in the icu. patients in both groups will also receive an ultrasound-guided bilateral serratus anterior plane block before extubation.

Eligibility criteria:
inclusion criteria: 1. adult patient. 2. elective cardiac surgery. exclusion criteria: 1. refusal to participate. 2. redo or urgent cardiac surgery. 3. local infection of the skin at the site of needle puncture. 4. allergy to bupivacaine. 5. coagulation disorders. 6. clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension. 7. when extubation is intentionally planned to be delayed

Keywords: ultrasound, pectointercostal, cardiac surgery
effect of topical nepafenac in macular thickening related to pan-retinal photocoagulation

Conditions: Macular Thickening; Macular Edema

Summary: the purpose of this study is to determine whether topical nepafenac (qid) is effective in preventing and treating macular thickening related pan-retinal photocoagulation in patients with diabetic retinopathy.

objective: to evaluate the effect of topical nepafenac 0.1 %, in preventing and in treating macular thickening related to pan-retinal photocoagulation in diabetic patients. material and methods: this is a prospective, longitudinal, and controlled study in patients with diabetic retinopathy (severe non-proliferative and proliferative retinopathy), with a symmetric severity in both eyes and without a clinical significant macular edema. the best corrected visual acuity (bcva) in all patients was 20/80 or better. all patients will undergo pan-retinal photocoagulation in three different sessions (with 2 weeks in apart between them). each patient will receive topical nepafenac 0.1% (qid) on one eye, and placebo (qid) at the fellow eye, starting 1 week before the first retinal photocoagulation session and continued for 9 weeks ( ending 4 weeks after pan-retinal photocoagulation is completed). spectral domain oct and bcva in etdrs scale will be performed before and at 2 weeks after each laser session, and at 1, 2 and 3 months after treatment completed. bcva and oct outcomes of each studied period will be compared on both eyes, and side effects will be recorded.

Eligibility criteria:
inclusion criteria: * patients with severe and proliferative diabetic retinopathy * symmetric severity grade on both eyes * best corrected visual acuity better than 20/80 exclusion criteria: * clinical significant macular edema * lens opacity * ocular surgery 6 months or less before recruit * uveitis history * actual use of topical or systemic non-steroidal anti inflammatory agents * actual or history of other macular diseases * ocular surface diseases * vitreomacular traction syndrome * other vascular retinal diseases different to diabetic retinopathy * actual or history of use of topical prostaglandin analogues

Keywords: macular thickening macular edema pan-retinal photocoagulation nepafenac topical non-steroidal anti inflammatory agents