Kornimate/medical-research-clean huggingface dataset:
trifecta™ gt post market clinical follow-up

Conditions: Aortic Valve Disease; Aortic Valve Disorder

Summary: the objective of this study is to evaluate the safety and performance of the trifecta™ gt (glide technology) valve through 5 year follow-up in a prospective, multi-center, real-world setting. this study is intended to satisfy post-market clinical follow-up requirements of ce mark in europe.

the study is a prospective multi-center evaluation of approximately 350 subjects implanted with a st. jude medical (sjm) trifecta™ gt valve. it will be conducted in approximately 35 sites worldwide. subjects will be followed for 5 years. the total duration of the study is expected to be 6 years, assuming all subjects are enrolled within 1 year of study initiation. to ensure enrollment balance across sites, no individual site can enroll more than 10% of the sample size (n=35 subjects) without prior approval from the sponsor.

Eligibility criteria:
inclusion criteria: 1. subject is a candidate for surgical aortic valve replacement per current guidelines and is intended to be implanted with a st. jude medical trifecta gt valve. 2. subject is of legal age in the country where the subject is enrolled. 3. subject must be willing and able to provide written informed consent to participate in this study. 4. subject must be willing and able to comply with all follow-up requirements. exclusion criteria: 1. subject undergoes a concomitant procedure of mitral or tricuspid valve replacement at the time of the trifecta gt valve implantation surgery. 2. subject has contraindication for cardiac surgery. 3. subject is pregnant. pregnancy will be assessed by the subject informing the physicians. 4. subject has active endocarditis (subjects who have previously experienced endocarditis must have two documented negative blood culture results while off antibiotic therapy prior to the valve implantation surgery). 5. subject has had a stroke or transient ischemic attack within 6 months prior to the planned valve implantation surgery. 6. subject is undergoing renal dialysis. 7. subject has a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years. 8. subject has a documented thrombus in the left atrium or left ventricle at the time of the valve implantation surgery. 9. subject has a left ventricular ejection fraction \< 30%. 10. subject previously enrolled in the trifecta gt pmcf study and withdrawn (a subject cannot be enrolled twice in this study). 11. preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm. 12. subject has a life expectancy less than 2 years.
host - dapt duration according the bleeding risk

Conditions: Coronary Artery Disease; Acute Myocardial Infarction; Stable Angina

Summary: * dual antiplatelet agent therapy (dapt) is essential in treating pci patients. dapt can minimize thrombotic adverse events that occur not only at the stented lesion, but along the whole coronary tree. however, dapt has a critical side effect of increasing bleeding complications. addressing the clinical imperatives of lowering bleeding while preserving ischemic benefit requires therapeutic strategies that decouple thrombotic from hemorrhagic risk. * recently, the arc definition of high bleeding risk (hbr) has been published, so as to stress the need of optimal dapt treatment in hbr patients. due to the definitely higher bleeding risk in hbr patients, it would be rather more straight forward to titrate the optimal dapt duration in these patients. in this line, many studies are in progress on hbr patients, with an ultra-short dapt duration (i.e. leaders free, onyx one, master dapt, xience 28, xience 90, evolve short dapt trial, etc.). * as a counteract to the definition of hbr, there is a concept of lbr. due to the relatively vague ischemic/bleeding risk in lbr patients, balancing ischemic and bleeding complications post-pci is more difficult in lbr patients, which may be a more important dilemma for clinicians. in this regards, limited evidence exists on the optimal duration of dapt in lbr patients. various previous studies that have evaluated the optimal dapt in pci populations, did not have the concept of hbr or lbr, making interpretation difficult. * therefore, this study is planning to compare the efficacy and safety of different dapt durations, in patients stratified according to the arb-hbr definition.


Eligibility criteria:
* inclusion criteria: 1. the patient agrees to participate in this study by signing the informed consent form. alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form. 2. the patient in whom the bleeding risk (according to the arc-hbr classification) can be calculated. 3. the patient has a working diagnosis of coronary artery disease which has been treated with percutaneous coronary intervention. * exclusion criteria: 1. hypersensitivity to aspirin or p2y12 inhibitors 2. patients in whom coroanry artery disease has been decided to be medically managed without a coronary stent. 3. positive pregnancy test or is known to be pregnant 4. any other reason the investigator deems the subject to be unsuitable for the study (e.g., any life-threatening condition with life expectancy less than 6months, etc.)

Keywords: percutenous coronary intervention dual antiplatelet therapy bleeding risk
one-4-all initiative

Conditions: Literacy; Burden, Caregiver; Health Care Utilization

Summary: this study aims to improve health outcomes of individuals and populations, enhance the patient experience, reduce the per capita cost of care, and ensure the well-being of our healthcare providers (quadruple aim). these goals are increasingly difficult to achieve, given the challenges of changes to workflow, staffing shortages, and increased costs brought on by the covid-19 pandemic. further, the pandemic brought to light the critical need to transform healthcare access for our racially and culturally minoritized and low-income families that have long been victims of health disparities, specifically with poorer health outcomes.

the overall objective is to successfully implement a patient app that will be used by families to 1) increase throughput for all patients, including minoritized, low-income, and low health literacy patients, and 2) reduce administrative burdens on providers. to evaluate this hypothesis, the following specific aims will be examined: aim 1: document modifiable factors that negatively and positively impact providers' ability to provide high-quality patient care in a post-pandemic healthcare system while addressing health disparities through implementation science. aim 2: create a "boarding pass' experience for providers and patients using technology (app) which allows patients and their families to fully prepare for their clinical visits and bridge care between home, primary care providers, and specialty care. aim 3: investigate multilevel contextual factors related to app implementation, to inform future strategies to promote scalability and sustainability of app in all specialties.

Eligibility criteria:
inclusion criteria: * all guardians of patients and the providers (surgeons, doctors, nurses, etc) that serve these patients. exclusion criteria: * none.
optimization of time-of-flight mass cytometry (cytof) analysis for evaluation of immune changes following surgery

Conditions: Surgical Trauma

Summary: surgical trauma triggers a massive inflammatory response. over time, both the innate and adaptive branches of the immune system are affected by surgical trauma. the purpose of this study is to use a single cell flow cytometry approach to characterize the cellular and molecular mechanisms involved in the inflammatory response to surgical trauma.


Eligibility criteria:
inclusion criteria: 1. ages 18 - 90 2. men and women 3. undergo back surgery exclusion criteria: 1. any systemic disease that might compromise the immune system (e.g. lupus) 2. current diagnosis of cancer 3. any condition that, in the opinion of the investigator, might compromise the integrity of the study or safety of the participant. 4. unwilling to sign informed consent
detecting sars-cov-2 in tears

Conditions: COVID; COVID-19; Corona Virus Infection; SARS-CoV-2

Summary: purpose: * to determine the presence of sars-cov-2 in tears * to determine sars-cov-2 receptors in tear production system

this is a prospective case series. np swab and tear samples will be collected simultaneously from the confirmed or suspected covid-19 patients. the samples will be transferred to the lab for sars-cov-2 testing. the presence of absence of sars-cov-2 will be compared in tears versus np swabs. the second part of the study is a histopathology examination series. normal lacrimal gland and ocular surface tissue samples already stored at the umn ocular pathology lab and lion's gift of sight eye bank will be used for ihc staining for ace2 and similar targets.

Eligibility criteria:
inclusion criteria: - patients presenting at study sites with confirmed or suspected covid-19 exclusion criteria: * pregnancy or nursing * non-english speakers * those unable to read * those in other vulnerable study populations

Keywords: covid-19 sars-cov-2 tear nasopharyngeal swab
high definition endoscopy and virtual chromoendoscopy versus standard resolution endoscopy in detection of colon polyps

Conditions: Colonic Adenoma

Summary: over the last years a number of new endoscopic imaging modalities have been introduced (high-definition and virtual chromoendoscopy). given the theoretical advantage of these new imaging techniques, the investigators aimed to investigate their use for the detection of polyps during colonoscopy.


Eligibility criteria:
inclusion criteria: * referred for colonoscopy * signed informed consent exclusion criteria: * subtotal colectomy * known colorectal tumor or polyp prior to colonoscopy * genetic predisposition to colon cancer namely fap, hnpcc, hyperplastic polyposis syndrome, juvenile polyposis, peutz-jeghers syndrome * inflammatory bowel disease * primary sclerosering cholangitis

Keywords: colonoscopy high-definition endoscopy virtual chromoendoscopy adenoma detection rate (adr)
efficacy and safety of a single dose of canakinumab (acz885) in hospitalized patients with acute gout

Conditions: Arthritis, Gouty

Summary: this is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (acz885) for inflammation and pain associated with acute gouty arthritis.


Eligibility criteria:
inclusion criteria: * score over 50 on the 0-100 vas pain scale * acute, confirmed gout flare for no longer than 3 days exclusion criteria: * treatment with biological anti-tumor necrosis factor (anti-tnf) within the past 3 months * anti-inflammatory medication for the treatment of acute gout within the previous 24 hours * pregnant or breastfeeding women * major surgery with high infection risk * history of severe allergy to food or drugs * history or risk of tuberculosis * active infection other protocol-defined inclusion/exclusion criteria may apply

Keywords: arthritis gouty acz885 il1b protein pain
phase i trial of flac (5-fluorouracil, leucovorin, adriamycin, cytoxan) plus gm-csf (granulocyte-macrophage colony stimulating factor) plus dose escalation of il-3 (interleukin-3) in metastatic breast cancer

Conditions: Breast Neoplasms; Neoplasm Metastasis

Summary: this is a phase i study to determine the maximal tolerated dose of il-3 given alone or sequentially with gm-csf following flac chemotherapy in metastatic breast cancer patients.

phase i study to determine the maximal tolerated dose of il-3 given alone or sequentially with gm-csf following flac chemotherapy.

Eligibility criteria:
patients with stage iv (metastatic) breast cancer are eligible who have a histologically-proven diagnosis. measurable disease is not a prerequisite. patients with stage iii disease or stage ll with 7 or more nodes positive are eligible. patients who have had prior adjuvant chemotherapy and/or hormonal therapy are eligible providing the regimen did not include adriamycin. patients who have had prior radiation therapy may be eligible providing there was not extensive radiation to the cardiac area or to greater than 20% of the bone marrow. patients who have received greater than 360mg/m2 of adriamycin as adjuvant therapy are ineligible. patient must be previously untreated with chemotherapy for metastatic disease. there must be no history of previous malignancy except for cured non-melanoma skin cancer (basal or squamous cell carcinoma), cervical cancer in situ, or a past malignancy that has been inactive for over 5 years. performance status (karnofsky scale) must be greater than 70; ecog 0-2. absolute granulocyte count greater than 1500/mm3 and platelet count greater than 100,000/mm3. liver function tests (scot, alk, phosph., and t. bili) should be less than 1.5 time the upper limits of normal. serum creatinine should be less than 1.7 or creatinine clearance should be greater than 45 ml/min unless these abnormalities are due to tumor involvement. the patient must be able to give an informed consent, and to return to nci for treatment and adequate follow-up for the period the protocol requires. no pregnant patients may be entered on this study; all patients should be informed about the need for contraception. patients must be greater than or equal to 18 years of age. no patients who are poor medical or psychiatric risks because of nonmalignant systemic disease which would preclude them from being subjected to any treatments in this protocol. no patients with a history of cardiac disease must have a normal ejection fraction by muga scan and have no angina. patients who have received prior adriamycin must have a lvef greater than 45%. no history of cns metastasis, or known seizure disorder. no allergy to any study medication. no pregnant or lactacting women. no patients requiring ongoing therapy for asthma. no patients with bleeding disorders.

Keywords: dose-intensive chemotherapy hematopoietic growth factor peripheral blood progenitor cell
preoperative prehabilitation program for geriatric patients in a rural healthcare setting

Conditions: Surgery

Summary: the study will include patients who require elective major abdominal surgery for cancerous or non-cancerous conditions. the goal of the research is to assess the benefit of a prehabilitation program before surgery that includes nutrition, exercise, smoking cessation, and optimization of chronic disease. a group of 10 patients will take part in a prehabilitation program. these patients will be compared to 20 patients who received standard of care.

the study will include patients who require elective major abdominal surgery. the study will compare patients who received standard of care to patients who received a prehabilitation program before surgery. the prehabilitation program will take place for 4-6 weeks before your surgery and will include: * review of frailty risk analysis calculator score obtained in the frailty study (#2212-74) * review of lab results including complete blood count, creatinine, albumin, and prealbumin * review of chronic conditions * an office visit or telehealth visit to review instructions on nutrition, exercise, smoking cessation, and optimization of chronic disease. * drinking surgery immunonutrition shake twice daily for 5 days before surgery. * educational information and video instruction * weekly phone calls to motivate, ensure adherence, and assess progress. * measurements of hand grip strength and body weight

Eligibility criteria:
inclusion criteria: * subjects over age 60 who require elective major abdominal surgery exclusion criteria: * pregnant women

Keywords: frailty
pneumatic dilatation or surgical myotomy for achalasia

Conditions: Achalasia

Summary: patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. minimal follow up five years.

patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. minimal follow up five years. during follow up patients have been interviewed with regular intervals, by use validated questionnaires. the level of symptom control has been assessed as well as the scoring cumulative incidence of treatment failures. health related quality of life (hrql) has been regularly checked.

Eligibility criteria:
inclusion criteria: * newly diagnosed achalasia * age 18-80 years * informed consent exclusion criteria: * previous treatment for achalasia. * stage iv achalasia. * unwillingness to participate.
a study of a novel investigational drug in rheumatoid arthritis patients (mk-0873-012)(completed)

Conditions: Rheumatoid Arthritis

Summary: this study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by participants with the disease.


Eligibility criteria:
inclusion criteria: * rheumatoid arthritis, according to the american college of rheumatology criteria, with active disease despite current medications * other criteria also apply exclusion criteria: * other major illnesses * past history of certain other disorders * certain prohibited medications
bone healing study

Conditions: Bone Fracture

Summary: the aim of the research is to identify structural tissue changes in the early fracture hematomas.

the fracture hematomas obtained during reconstructive bone surgery from patients with bone fractures will be examined. histological methods and ultra-thin sections for electron microscopy will be used to identify structural tissue changes in the granulation tissue in different period of time after bone fracture. immunohistochemical analysis will be performed to estimate the dynamic of proliferation, differentiation and cell migration during granulation and reticulofibrosis bone tissues development.

Eligibility criteria:
inclusion criteria: * patients with fractures of the upper and lower extremities * patients for whom the surgical bone reconstruction are indicated

Keywords: hematoma fracture, angiogenesis, bone formation
intensive pediatric group intervention

Conditions: Cerebral Palsy

Summary: the purpose of the mizzou empower program is to meet the curricular needs of entry-level doctorate of physical therapy students by providing them the real-world experience of implementing recent evidence surrounding physical therapy dosing for children with cerebral palsy (cp) for power, strength, and gait interventions while meeting an unmet community need.

beginning in fall 2024, the investigators will recruit 6 children with cp, gross motor function classification system levels i-iii, ages 7-17 years old, to participate in the program. two students will be assigned to each participant, rotating every 4 weeks due to the structure of the pro-bono clinic. a total of 3 faculty members will supervise. the group will meet for 2 hours, 2 times per week for 15 weeks. each session will include a 10-minute game-based warm-up, 45 minutes of gait interventions to include treadmill and overground walking as well as other aerobic activities, 45 minutes of resistance training (power and strength training as appropriate for their individual goals), and a 10-minute cool-down incorporating yoga and breathing activities. participant assessments will be completed during the first week, 7th week, and 15th week. other programmatic assessments will include students' written reflections on their experiences providing this program, caregiver satisfaction surveys, and participant and caregiver interviews.

Eligibility criteria:
inclusion criteria: * ambulatory children 7-17 years old, children who are participating in empower program * gmfcs levels i-iii * able to follow 2-3 step directions * english speaking exclusion criteria: * orthopedic surgery in the past year * significant visual impairment * significant hearing impairment

Keywords: physical therapy power training strength training pediatrics gait training group therapy
improving discharge communication in the emergency department through information structuring

Conditions: Information Structuring Skills; Empathy Skills

Summary: the goal of the proposed study is to assess the potential of information structuring for improving discharge communication. specifically, the investigators aim to examine the advantages of an information-structuring skills training for physicians (compared to an empathy skills training) on discharge communication and associated patient outcomes, such as patients' information recall and adherence to physician recommendations. the investigators hypothesize that patients receiving structured discharge information from their trained physicians will be able to recall more information and show higher adherence to recommendations relative to controls (i.e., patients receiving discharge information from doctors trained in empathy skills).


Eligibility criteria:
inclusion criteria: * outpatients with chest pain * outpatients with abdominal pain exclusion criteria: * patients younger than 18 years of age (limited ability to provide informed consent) * patients with limited ability to communicate in german, the default language at the hospital (confounder related to language proficiency) * patients with dementia (confounder arising from pathological memory deficits)

Keywords: recall discharge communication satisfaction adherence information structuring empathy skills
use of perfusion index change as a predictor of hypotension during propofol sedation in adult patients undergoing hip surgery under spinal anesthesia: a prospective observational study

Conditions: Hypotension; Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Summary: this observational study is to evaluate perfusion index change as a predictor of hypotension during propofol sedation in adult patients undergoing hip surgery under spinal anesthesia.


Eligibility criteria:
inclusion criteria: * adult patients having hip surgery under spinal anesthesia and propofol sedation exclusion criteria: * asa class iv or above * pregnancy * inability to measure noninvasive blood pressure on the arm * preexisting hemodynamic instability * known peripheral artery occlusive disease * known autonomic nerve dysfunction * uncontrolled hypertension