Kornimate/medical-research-clean huggingface dataset:
prehabilitation for eoc, fallopian tube, primary peritoneal carcinoma and pancreatic cancer w/ nact

Conditions: Ovarian Cancer; Epithelial Ovarian Cancer; Pancreatic Adenocarcinoma

Summary: the purpose of this study is to see whether participants who are assigned to a multimodal prehabilitation intervention during chemotherapy are able to adhere with exercise and nutrition program to prepare for their cancer surgery.

elderly participants with epithelial ovarian cancer (eoc) and pancreatic adenocarcinoma (pdac) undergoing neoadjuvant chemotherapy (nact) are often frail and malnourished. both chemotherapy and disease burden are associated with a decline in muscle mass leading to decrease in physical strength and cardiovascular fitness. limited efforts have focused on decreasing morbidity at time of chemotherapy and surgery and improving functional capacity. exercise during chemotherapy has been shown to improve chemotherapy related symptoms and quality of life in participants with breast cancer participants. in surgical patient populations, preoperative rehabilitation (prehabilitation) has been shown to improve walking capacity, decrease hospital length of stay, perioperative complications, and cost. however, whether multimodal prehabilitation improves the functional capacity and perioperative outcomes of eoc and pdac participants undergoing nact compared to standard of care is unknown. investigators aim to evaluate if prehabilitation in participants with eoc and pdac undergoing nact improves physical fitness/ functional outcomes, perioperative outcomes, nutritional status, and quality of life compared to standard of care.

Eligibility criteria:
inclusion criteria: * age 65 and older * patients with diagnosis of advanced (stage iii or iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (eoc) undergoing neoadjuvant chemotherapy; or patients with diagnosis of pancreatic adenocarcinoma undergoing neoadjuvant chemotherapy exclusion criteria: * life expectancy less than 3 months in the opinion of the treating physician * patients unable to provide informed consent. * wheelchair bound patients/ physical immobility. * severe cardiopulmonary disease defined as nyha class iii or iv * patients with malignant bowel obstruction who will require surgical intervention or nutritional support in the form of enteral or parenteral nutrition will also be excluded. * patients with any other comorbidity or condition, which, in the opinion of the enrolling investigator, would place the patient at unnecessarily higher greater risk or burden, or participating in the study would not be in the best interests of the patient.

Keywords: ovarian cancer neoadjuvant chemotherapy
surgical telemedicine in the covid-19 pandemic era

Conditions: COVID; Surgery

Summary: the current covid-19 pandemic has caused delays in initial or follow-up encounters between surgical patients and physicians. while this delay allows for resource allocation to those most severely affected by the pandemic, surgeons are faced with potential important delays in diagnosis and the expanding backlog of elective cases and initial evaluations. this project will assess surgeon and patient telemedicine perspectives. pre-pandemic views on telemedicine among a cohort of surgeons will be obtained and compared to views at 3 months from the peak of the pandemic. patients will be surveyed following telemedicine appointments with an anonymous questionnaire to learn about patient receptiveness to telemedicine. barriers to implementation will be addressed throughout the duration of the study.


Eligibility criteria:
inclusion criteria 1. surgical faculty at participating institutions will receive surveys regarding telemedicine early in the start of the study to assess baseline perceptions. these same group of surgeons will receive subsequent surveys 3 months after the peak of the pandemic to evaluate telemedicine perceptions following a rapid implementation and adoption of telemedicine. 2. surgical patients evaluated from the start of the study through a 6-month period will be included in the study. they will have the option after each telemedicine encounter to complete an anonymous survey regarding perceptions to this technology. exclusion criteria 1. no exclusions for surgical faculty are identified. accrual of data from this group will be limited only by response rates to administered surveys. 2. exclusions for surgical patients will include the inability to access the technology required for a telemedicine consultation (e.g.: absence of a camera enabled smartphone, absence of a required internet or cellular connection to perform a telemedicine encounter). the investigators will keep a list of reasons for the inability to perform a telemedicine encounter to identify the barriers to implementation among patients.

Keywords: telemedicine covid surgery
s9925: collecting and storing samples from patients with lung cancer

Conditions: Lung Cancer

Summary: rationale: collecting and storing samples of tissue, blood, and sputum from patients with cancer to study in the laboratory may help the study of cancer in the future. purpose: the purpose of this study is to collect and store tissue, blood, and sputum samples from patients with lung cancer to be tested in the laboratory.

objectives: * establish a central lung cancer specimen repository to serve as a resource for current and future scientific studies. * correlate clinicopathologic information in the southwest oncology group clinical data base with results of studies using the repository. * test new hypotheses with the specimens in the repository. outline: peripheral blood, sputum, and biopsy specimens are collected from patients. tissue samples are frozen and stored in a lung cancer specimen repository for later use in correlative studies. projected accrual: not specified

Eligibility criteria:
disease characteristics: * enrolled on one of the following southwest oncology group protocols: * swog-8805, swog-9019, swog-9416, swog-9509, swog-s9900, swog-s0003, swog-s0023, swog-s0126, swog-s0435, swog-s0220, swog-s0222, swog-s0327, swog-s0310, swog-s0339, swog-s0342, swog-s0341, swog-s0509, swog-s0429, or swog-s0124 patient characteristics: not specified prior concurrent therapy: not specified

Keywords: non-small cell lung cancer small cell lung cancer
quality of life in operated adult patients with tetralogy of fallot and correlation with myocardial strain analysis by cmr

Conditions: TOF

Summary: title: functional assessment and arrhythmia prediction in adult patients with repaired tetralogy of fallot using a multimodality approach background: tetralogy of fallot (tof) is the most common cyanotic congenital heart defect. surgical repair has improved survival into adulthood, but long-term complications like arrhythmias and heart failure remain common. assessing health-related quality of life (hrqol) and cardiac function is essential. aim: assess functional status of adult patients with repaired tof using a multimodal approach, including myocardial strain analysis via cmr. identify predictors of arrhythmia using strain and clinical parameters. methods: design: prospective observational study over one year. population: adults (≥18 years) with repaired tof undergoing follow-up cmr. assessments: clinical evaluation (nyha class) echocardiography (rv size, function, valve status) laboratory tests (bnp, nt-probnp) exercise testing (mets, vo₂ max) ecg \& 24-hour holter monitoring (qrs duration, arrhythmias) cmr (volumes, flow, fibrosis, strain analysis of ra, rv, lv) outcomes: primary: functional assessment of repaired tof patients. secondary: detection of arrhythmia and need for further interventions (e.g., icd or ablation). statistical analysis: comparison between arrhythmic and non-arrhythmic groups. logistic regression for predictors of arrhythmia. roc analysis to determine optimal strain cut-off values. ethical considerations: ethics committee approval and informed consent. data confidentiality maintained.


Eligibility criteria:
* inclusion criteria: * adult tof patients who were referred for surgical repair of tof either valve sparing repair (vsr) or valved conduit (stented valve conduits, freestyle valved conduits, bio-prosthesis, or homograft). * adults (age ≥18 years) with repaired tof. * undergoing routine cmr for clinical follow-up. * sinus rhythm or known history of ventricular arrhythmia. * exclusion criteria: * confounding other congenital defects e.g. av canal. * significant aortic regurgitation or stenosis. * significant mitral regurgitation. * residual significant major aorto-pulmonary collaterals (mapcas). * patients with contraindications to cmr (e.g., pacemakers, severe renal impairment, claustrophobic). * poor-quality cmr images precluding strain analysis.
safety of gebauer's pain ease and gebauer's ethyl chloride

Conditions: Spray; Pain; Safety Issues

Summary: this study aims to determine if gebauer's pain ease or gebauer's ethyl chloride topical anesthetic sprays are safe for use as numbing agents prior to placing epidurals and arterial lines, based on whether they introduce increased microbial growth after application to skin. due to the recent national shortage of lidocaine, we hope to find a suitable alternative to lidocaine for topical analgesia when placing arterial lines and epidurals. our hypothesis is that the sprays will not affect the sterility of the area. we will compare microbial growth from three subsequent swabs taken from a single area of skin on the wrist and lower back: one with no treatment, the second after treatment with chloraprep, and the third after applying one of the numbing sprays. if there is significantly higher growth in the swabs containing the topical anesthetic spray versus the chloraprep alone, this will indicate that the sprays introduce microbes to the sites of skin.

the purpose of this study is to determine whether gebauer's pain ease and ethyl chloride topical anesthetic sprays are safe for application on the areas of skin where epidurals (lower back) and arterial lines (wrist) are placed, based on whether they introduce microbial growth to these areas. the investigators will compare microbial growth by swabbing both of these skin sites following: 1) no treatment 2) chloraprep treatment and 3) chloraprep plus numbing spray (ethyl chloride or pain ease) treatment. the cultures will then be incubated to test for anaerobic bacteria, aerobic bacteria, and mold growth. the microbial growth will be compared between the three treatment groups based on the number of colony forming units present. funding for the project will be from the manufacturer of the numbing sprays, gebauer company. based on power analysis, for each of the numbing sprays, a total of 72 subjects must be enrolled, with 6 swabs taken per subject (untreated, chloraprep, and topical anesthetic spray samples will be taken from both the wrist and lower back of each subject). a sample size of 72 pairs achieves 80 % power to detect an odds ratio of 24 using a two-sided mcnemar test with a significance level of 0.05.

Eligibility criteria:
inclusion criteria: * henry ford employees exclusion criteria: * people with infections at the site of prep * people with history of hypersensitivity to numbing sprays or chloraprep

Keywords: pain ease ethyl chloride safety topical anesthetic chloraprep topical refrigerant microbial growth
perioperative oral decontamination and immunonutrition (point) in elderly

Conditions: Postoperative Complications; Pulmonary Complication

Summary: the goal of this multicenter randomized controlled trial is to explore the efficacy of perioperative oral decontamination and immunonutrition supplement to prevent postoperative pulmonary complications in elderly patients(≥65 years) receiving elective non-cardiac operations. participants will be either given immunonutrition supplement versus routine nutrition advice, and oral chlorhexidine decontamination versus routine oral care randomly. the two interventions will be compared with control groups separately regarding postoperative pulmonary complications and other outcomes.

this study is a prospective, multicenter, two-by-two factorial randomized controlled trial evaluating the efficacy of immunonutrition supplementation and oral chlorhexidine decontamination. patients aged 65 years and older who are scheduled for elective non-cardiac surgeries will be recruited. participants will be excluded if they have contraindication to the intervention. the patients will be randomized into four groups in 1:1:1:1 ratio (oral decontamination vs routine oral care, immunonutrition supplementation vs routine nutrition advice). the primary outcome is the incidence of postoperative pulmonary complications within 7 days after surgery. secondary outcomes include incidence of pneumonia, infectious complications, comprehensive complication index, postoperative functional recovery, length of hospital stay and hospital expense.

Eligibility criteria:
inclusion criteria: 1. age≥65 years; 2. undergoing major non-cardiac surgery; 3. scheduled for general anesthesia and endotracheal intubation; 4. american society of anesthesiologists (asa) physical status classification i-iv; 5. with intermediate to high risk of respiratory complications assessed by assess respiratory risk in surgical patients in catalonia (ariscat) score; 6. informed consent obtained. exclusion criteria: 1. emergency surgery; 2. preoperative pneumonia; 3. allergic to chlorhexidine; 4. severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases, taking immunosuppressant or immunoregulation medications, or with other contraindication to immunonutrition supplementation; 5. expected intervention of immunonutrition\<3 days.

Keywords: immunonutrition oral decontamination postoperative pulmonary complications
second line induction therapy and healthy diet for patients with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to determine whether a diet intervention (the fasting mimicking diet) will help induce clinical and biochemical response to an advanced therapy in patients with ulcerative colitis. study period will be 8 weeks during induction of advanced therapies. the primary aims of this study will be clinical response, as determined by the simple clinical colitis activity index (sccai). secondary outcomes will be improvement in fecal calprotectin and c-reactive protein levels.

advanced therapies included will be: jak inhibitors (tofacitinib or upadacitinib) il-23 inhibitors (ustekinumab or risankizumab) anti-tnf (infliximab) patients will be provided these medications as part of their standard of care, as decided by their treating physician.

Eligibility criteria:
inclusion criteria: 1. patients with ulcerative colitis who are beginning tofacitinib therapy. 2. patients with ulcerative colitis who are initiating second line biologic therapy with ustekinumab 3. patients with ulcerative colitis who are initiating second line biologic therapy with infliximab 4. patients aged 18 years or older. 5. patients with active disease defined as simple clinical colitis activity index (sccai) \>2 6. patients who have not been on antibiotics for 2 weeks or probiotics. exclusion criteria: 1. patients younger than 18 years. 2. patients that do not meet the inclusion criteria specified above. 3. patients with clinical signs of fulminant colitis, toxic megacolon, ischemic colitis or impending hospitalization for severe ulcerative colitis. 4. patients with concomitant infectious colitis. 5. patients allergic nuts/soy/sesame/oats. 6. patients who do not like the food items that form part of the kits for the fasting mimicking diet (see below). 7. patients that are diabetics on a glucose lowering drug. 8. individuals with a history of syncope/presyncope with fasting or from medical conditions. 9. women who are pregnant or nursing. 10. individuals with very low bmi\< or equal to 18. 11. patients with the following comorbidities: chronic kidney disease, diabetes, active cancer. 12. prohibited concomitant therapies will include tnf antagonists, azathioprine, methotrexate, and mercaptopurine. 13. patients who routinely have fasting eating habits
topical nepafenac as supplement for diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: diabetic macular edema (dme) is a major cause of visual loss in patients with diabetes mellitus. the standard treatment is with focal/grid laser therapy. topical nepafenac was used as an adjunct therapy for treatment of dme. the aim of this study is to compare the difference of best corrected visual acuity (bcva) and central macular thickness (cmt) at 3 months post treatment between combination therapy of laser and topical nepafenac and laser monotherapy in patients with dme.

diabetes mellitus with its systemic complications has been an enormous health treat to the world population today. in the us, the ophthalmic related complications has been estimated to cause up to 4.2 million (28.5%) people in 2005 till 2008 to suffer from blindness. one of the most common causes of visual acuity loss in patients with diabetes mellitus is diabetic macular edema (dme). the gold standard of treatment for clinically significant macular edema (csme), a form of dme, is through focal and grid laser as shown by the early treatment diabetic retinopathy study. the development of newer drugs such as anti vascular endothelial growth factors anti (vegfs), an alternative to laser treatment, has become a topic of interest in the recent years. other alternative to treatment of dme is steroid such as triamcinolone injection and dexamethasone injections. however, both anti vegfs and steroids are expensive and not readily available in all centres. both types of medications require repeated treatment and the route of administration through intravitreal also poses risk of endophthalmitis, lens injury, retinal detachment, vitreous hemorrhage, increase in intraocular pressure and cataract. the pathophysiology of dme is not fully understood yet. it was suggested that it is likely to be a chronic low-grade inflammation. through this theory, topical non-steroidal anti-inflammatory drugs (nsaids) have been used to treat dme. the investigators postulate that the addition of topical nsaids in patients receiving standard treatment of laser therapy may help to improve the outcome of patients with dme. it has the advantage of no needles involved, convenient, easy to use and minimal side effects. the aim of this study is to evaluate the outcome of visual acuity and macular thickness at 3 months post treatment between laser monotherapy and combination of laser and topical nepafenac in dme.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus with csme * aged 18 to 70 years old * clear media (able to perform oct) * hba1c less than 12% at 3 months exclusion criteria: * csme with severe non-proliferative diabetic retinopathy (npdr) or proliferative diabetic retinopathy(pdr) * previous laser treatment * previous ocular injury or surgery * history of taking topical or systemic anti inflammatory agents * allergic to nsaids * other ocular pathology (armd, glaucoma, ipcv) * high myope

Keywords: diabetic macular edema nepafenac laser therapy clinically significant macular edema adjunct treatment topical nepafenac
relapse-prevention study with levomilnacipran er (f2695 sr) in patients with major depressive disorder

Conditions: Depression; Major Depressive Disorder

Summary: the purpose of this study is to evaluate the safety and efficacy of levomilnacipran er relative to placebo in the prevention of depression relapse in patients with major depressive disorder (mdd).

patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with levomilnacipran er are randomized to continue levomilnacipran er or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.

Eligibility criteria:
inclusion criteria: * men and women, 18-65 years old * currently meet the dsm-iv-tr criteria for major depressive disorder * the patient's current depressive episode must be at least 4 weeks in duration exclusion criteria: * women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control * patients with a history of meeting dsm-iv-tr criteria for: * any manic or hypomanic episode * schizophrenia or any other psychotic disorder * obsessive-compulsive disorder * patients who are considered a suicide risk
introduction of protein s100 in diagnostics in minor brain injury patients at our hospital

Conditions: Intracerebral Hemorrhage

Summary: in patients with minor head injury measurement of protein s100 will be introduced to the emergency departement as another tool to rule out intracerebral bleeding.

severe intracerebral bleeding is still a complication even in obvious minor head injury (mhi) that makes the use of ct scanning necessary in patients with only few signs of intracerebral injury. to reduce the number of cerebral ct scans without pathologic findings measurement of protein s100 level in serum will be used in the emergency departement (ed) at our hospital. our hypothesis: with measurement of s100 levels cct scans and inpatient treatment can be reduced, radiation and costs can be reduced. from january 1st 2010 for 3-6 months all patients with head injury (all gcs) will be tested for their initial s100 level. cut off level is set at 0,105ng/ml. during this period test results will be blinded. decisions for further diagnostics (x-ray, cct) and inpatient vs. outpatient treatment are made on clinical impressions as they are made now. the test results will be monitored and compared with clinical cases. sensitivity, specificity, positive and negative predictive values will be measured. the aim is to identify patients without risk for intracerebral bleeding (ie s100 level lower than 0,105ng/ml). those can be managed in an outpatient way. all other patients will be diagnosed and treated as it is now. if the test will not miss one intracranial bleeding and will save cct scans and inpatient treatment, measurement of protein s100 will become a routine diagnostic in our ed for patients with mhi.

Eligibility criteria:
inclusion criteria: * history of mhi during last 6 hours * older than 3 years exclusion criteria: * more than 6 hours after mhi * younger than 4 years * informed consent not given

Keywords: intracerebral hemorrhage ct scans protein s100 inpatient treatment
a bengali dietary salt study to control blood pressure

Conditions: Hypertension

Summary: the aim of this study is to assess the benefits of using low-salt and healthy eating educational programme, designed specifically for bangladeshi kidney patients, compared to the usual diet advice given by the clinic dietitians.

we conducted an exploratory study initially to learn about the east london bangladeshi (elb) kidney patients salt intake. furthermore, we assessed their educational needs to inform the development and implementation of an educational programme to reduce dietary salt intake in line with the department of health recommendations for a good blood pressure control. the educational programme will be tested in a randomized controlled trial. we are interested in salt because studies have shown that salt is one of the causes of high blood pressure. scientific studies have also shown that the longer a person has high blood pressure the more the damage to the kidneys.

Eligibility criteria:
inclusion criteria: * adult bengali kidney disease hypertensive patients exclusion criteria: * non-hypertensive bengali patients and those on dialysis therapy

Keywords: blood pressure