Kornimate/medical-research-clean huggingface dataset:
direct comparison of cardiac ct with tee to evaluate watchman flx laa occluder device characteristics

Conditions: Device Related Thrombosis; Peri-device Leak

Summary: the current standard of care for patients who underwent left atrial appendage closure (laac) is to have follow-up transesophageal echocardiogram (tee) for device surveillance. tee is an ultrasound of the heart done by placing a probe in the esophagus under conscious sedation. it does not use contrast but can be cumbersome to patients as it involves placing a probe in the esophagus. cardiac computerized tomography angiography (cardiac cta) is a non-invasive imaging modality that involves the use of certain types of x-rays, contrast (dye) and special computers to generate accurate images of the heart. participants in this study will undergo both tee and cta on the same day 90 days after their laac procedure. participants will be in this research study for a period of 1 year, starting from the day of their scheduled laac procedure. participants will undergo a tee at 90 days after their procedure which is the standard of care imaging study after laac. as part of this study, participants will also undergo a cardiac cta at 90 days as well. participants will have a routine follow-up visit following device placement as per standard of care as well as a brief phone "check in" at 1 year.


Eligibility criteria:
inclusion criteria: * subjects \>18 years old planned to undergo laac * egfr ≥ 30 ml/min per 1.73 m2 exclusion criteria: * subjects below the age of 18 * non-english speaking subjects * egfr \< 30 ml/min per 1.73 m2 * subjects with history of contrast allergy * pregnant women

Keywords: watchman flx left atrial appendage (laa) transesophageal echocardiography (tee) cardiac cta
safety and efficacy evaluation of tpn in preterm neonates in nicu of cairo university children hospital

Conditions: TPN in Preterm

Summary: the aim of this work is evaluation of electrolytes and minerals homeostasis and occurrence of complications among preterm babies receiving total parenteral nutrition, and admitted to the neonatal intensive care units of cairo university children hospitals.


Eligibility criteria:
inclusion criteria: - all preterm infants with gestational age \< 34 weeks, receiving total parenteral nutrition. normal serum magnesium. exclusion criteria: * any full-term neonates any patient with torch infection, chromosomal, metabolic disorders or surgical abnormality of the hepatobiliary system
a study to understand the distribution of obesity classes and obesity related diseases in people with obesity across countries in czech republic, hungary and poland

Conditions: Obesity

Summary: the study is intended to understand the distribution of different obesity classes and obesity related diseases (diseases that present along with obesity) in patients with body mass index (bmi) ≥ 30 kg/m\^2. participants will be asked to give information about their health. they will continue their normal way of life and will not get any medication or additional medical test other than those prescribed to you by their doctor. participation in the study will last for about 1 day.


Eligibility criteria:
inclusion criteria: 1. signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. male or female, age greater than or equal to 18 years at the time of inclusion/enrolment in the study. 3. bmi greater than or equal to 30 kg/m\^2 as measured at the inclusion in the study exclusion criteria: 1. previous participation in this study. participation is defined as having given informed consent in this study. 2. mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation as judged by physician.
cni-1493 for treatment of moderate to severe crohn's disease

Conditions: Crohn Disease

Summary: the purpose of this study is to determine whether cni-1493 is safe and effective in the treatment of moderate to severe crohn's disease.

crohn's disease (cd) is a chronic inflammatory disease involving the upper and lower gastrointestinal tract and characterized by abdominal pain, weight loss, gastrointestinal bleeding and formation of fistulas between loops of bowel and from the bowel to the skin or other organs. current therapy for active crohn's disease consists of symptomatic treatment, nutritional therapy, salicylates and immunosuppressants or surgical management. tumor necrosis factor a (tnf-a) plays a central role in the initiation and amplification of the granulomatous inflammatory reaction seen in cd (van deventer, 1997). increased tnf-a is present in gut mucosa as well as in stool of patients with active cd (braegger et al, 1992). cni-1493 is a synthetic guanylhydrazone compound that is an inhibitor of tnf-a synthesis. a monoclonal antibody to tnf, infliximab, is now approved for treatment of cd, but not all patients respond and many who do respond eventually become refractory to this treatment as well. cni-1493 is a synthetic compound which blocks the production of several inflammatory cytokines, including tnf. because it blocks production of multiple inflammatory mediators, it may be more active than products targeted to a specific cytokine. in addition, as it is not a biologic, it should not cause hypersensitivity reactions or induce formation of antibodies. the purpose of this trial is to determine if cni-1493 is safe and effective in treating patients with moderate to severe crohn's disease in a placebo controlled setting.

Eligibility criteria:
inclusion criteria * baseline crohn's disease activity index (cdai) 250-400, inclusive * crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy * patients receiving medications for cd must be on stable doses entering the study * any cd medication which has been discontinued must have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which must have been discontinued at least 8 weeks prior to screening exclusion criteria * patients with any ostomy or extensive bowel resection * current evidence of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery * patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or clostridium difficile toxin * treatment with any other experimental therapeutics within the last 4 weeks before enrollment

Keywords: inflammatory bowel disease
a 16 week evaluation of the novartis health management tool (hmt) in age related macular degeneration (amd)

Conditions: Age Related Macular Degeneration (AMD)

Summary: this is a prospective pilot study to evaluate the usability and applicability of a self monitoring test of visual function with the handheld health management tool (hmt) to remotely monitor neovascular age related macular degeneration (amd) to detect a potential change in disease status.


Eligibility criteria:
inclusion criteria: * patients with cnv secondary to amd and not other causes in at least one eye identified by the investigator to be eligible for ranibizumab treatment * patients with a bcva letter score in the study eye is 24 or better using an etdrs chart measured at 4 meters distance exclusion criteria: * patients with any concurrent ocular condition that may result in visual loss during the study * patients with past (within the prior 6 months) or current use of, or likely need for, systemic medications that are known to be toxic to the lens, retina, or optic nerve * other protocol-defined inclusion/exclusion criteria may apply

Keywords: ranibizumab age related macular degeneration amd health management tool hmt best corrected visual acuity investigator's clinical judgement of change choroidal neovascularization central retinal subfield thickness visual function self test
image content analysis of dural-axis rotational versus standard coronary angiography

Conditions: Coronary Artery Disease

Summary: the investigators hypothesized that dual-axis rotational coronary angiography was non-inferior to standard coronary angiography with respect to diagnosis of coronary artery disease.

the prior studies have demonstrated that dual-axis rotational coronary angiography (darca) is associated with lower contrast usage and radiation exposure compared with standard coronary angiography (sa). single-axis rotational coronary angiography (ra) has been proved by previous studies without any reduction in diagnostic accuracy compared to sa. however, the rotational protocol is obvious different between darca and single-axis ra. a recent study has assessed the diagnostic accuracy of darca, but this study was not designed for image content analysis and the number of patients included did not provide sufficient statistical power to allow a valid comparison of darca with sa. the diagnostic accuracy of darca aroused our attention.

Eligibility criteria:
inclusion criteria: * age\>18 years old, \<80 years old * a clinical indication for diagnostic coronary angiography to evaluate possible coronary artery disease exclusion criteria: * pregnancy * known allergy to iodinated contrast * patients who had received iodinated contrast material within the last week or were unable to give consent * renal insufficiency (\>1.5mg/dl) * acute myocardial infarction within one week * cardiogenic shock * heart function worse than new york heart association functional class iii * left main coronary artery disease * prior coronary artery bypass graft treatment * prior percutaneous coronary intervention treatment

Keywords: coronary angiography rotational coronary angiography contrast media radiation quantitative coronary angiography
routine preoperative evaluation in surgical patient

Conditions: Orthopedic Disorder

Summary: the "routine" pre-operative tests in healthy orthopaedic patients undergoing intermediate/ major surgery are not justified. in this study of 670 healthy orthopedic patients with 7610 preoperative tests, investigators found that surgical plan was influenced in \<1% of patients. surgeons should be sensitized to reconsider this practice particularly with limited resources.

background: routine preoperative tests in healthy patients not only cause extra anxiety, but may delay treatment without influencing surgical plan. this has worse impact in resource-constrained settings where fee for service rather than health insurance is the usual norm. investigators aim to determine if "routine" pre-operative tests are justified in healthy orthopedic patients. methods: investigators conducted a non-commercialized, non-funded matched case control study in tertiary care university hospital and a level-1 trauma centre for healthy patients (asa-1\&2) admitted from january 2014-december 2016 for elective orthopedic intermediate and major procedures. cases (patient who had a change in his/her surgical plan after admission) and controls were selected independently of the exposure of interest then matched randomly to cases on age, gender and procedure type. primary exposure was the routine preoperative lab tests, as defined by the american society of anesthesiologist, which included 13 blood tests. analysis was done using principle component analysis and conditional logistic regression at univariate and multivariable levels reporting matched adjusted odds ratios. the data will bereported in line with strobe criteria. .

Eligibility criteria:
inclusion criteria: * participants irrespective of age and gender. * asa-1 and asa-2 status. * primary elective orthopedic procedures. * blood lab tests done at the institution only. exclusion criteria: * ambulatory care procedures * revision surgery. * participants admitted to other services, high care or intensive care units.

Keywords: preoperative evaluation orthopedic surgery
covid-19 pandemic and pancreatic surgery in italy

Conditions: Pancreatic Cancer

Summary: pancreatic cancer (pc) is recognized as one of the most challenging tumors to deal with and it is still characterized by a poor long-term prognosis. however, treatment of pc in high-volume centers with the support of a multidisciplinary approach has widely demonstrated improvement both in terms of short- and long-term outcomes. the recent worldwide spread of covid-19 pandemic significantly affected the healthcare systems of most countries in the world, particularly in red areas such as italy, with more than 100.000 cases in a two-month time lapse. this inevitably reflected in a reorganization of hospital activities, including the diagnostic and therapeutic pathways for pc treatment. with the aim of giving an objective and real representation of the impact of covid-19 on pc treatment, the investigator here propose a multicenter italian observational study comparing a 6-month period before and during the covid-19 pandemic. only high-volume centers will be involved in the study. a comparison between the general, clinical, endoscopic and surgical outcomes will be performed by means of a global and month-by-month analysis between the two study periods.


Eligibility criteria:
inclusion criteria: all patients with a diagnosis of pancreatic cancer referred to one of the centers involved in the study during the two study periods exclusion criteria: * patients under the age of 18 * inability to give informed consent

Keywords: pancreatic cancer pancreatic surgery covid-19
ease mitral expertise-based assessment study on clinical efficacy of profile 3d in mitral valve annuloplasty

Conditions: Mitral Valve Insufficiency

Summary: the goal of the study is to identify the patients suffering from a mitral valve condition who benefit from the implantation of a profile 3d annuloplasty ring in terms of acute and long-term relief of mitral valve regurgitation.


Eligibility criteria:
inclusion criteria: * indicated for a surgical repair for moderate to severe mitral valve regurgitation at rest (level 2 or higher); * willing to return to the hospital where the implantation originally occurred as part of the standard practice of care exclusion criteria: * heavily calcified valves * valvular retraction with severely reduced mobility * active bacterial endocarditis * already participating in another investigational device study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints; * life expectancy of less than one year; * pregnant or desire to be pregnant within 12 months of the study treatment; * under 18 years or over 85 years of age.
characterization of the microbiome in colonized dystrophic and junctional epidermolysis bullosa wounds before and after use of apr-td011 ® spray solution

Conditions: Epidermolysis Bullosa

Summary: in this pilot study, apr-td011 antimicrobial wound cleansing spray will be given to all enrolled patients with junctional eb (jeb) or dystrophic epidermolysis bullosa (deb) with staphylococcus aureus or pseudomonas aeruginosa culture-positive wounds. the primary aim will be to evaluate the change in skin microbiome (s. aureus, p. aeruginosa, commensal organisms) before, during, after treatment. subjects who are colonized by s. aureus or pseudomonas will be treated for 8 weeks, will stop the spray and return at 12 weeks (4 weeks without the spray), and then will be able to use the spray as desired in a 6-month period of open-label use, with further feedback collected.


Eligibility criteria:
inclusion criteria: * patients 6 months of age or above with junctional or dystrophic epidermolysis bullosa * target wound that has been present for at least 3 weeks and is at least 10 cm2 * target wound that is colonized with staphylococcus aureus and/or pseudomonas aeruginosa exclusion criteria: * patients currently or recently (within past 4 weeks) on topical or systemic antibiotics * do not agree to avoid bathing or topical application at the target starting the night before the visit. * do not agree to avoid dilute bleach or vinegar baths, or other antiseptic use, at the target site starting at screening throughout the study.
prospective evaluation of outcomes for patients undergoing radiofrequency ablation (rfa) using halo ultra device for gastric antral vascular ectasia (gave)

Conditions: Gastric Antral Vascular Ectasia

Summary: the purpose: to determine the safety and efficacy of radiofrequency ablation (rfa) halo ultra system in patients with gastric antral vascular ectasia patient cohort (gave). research design: this is a prospective observational study. procedure used: radiofrequency ablation risks and potential benefits: there are no risks associated with this study as it is a retrospective chart review. potential benefits include the knowledge gained from this study which may be of help to patients in the future. importance of knowledge that may reasonably be expected to result the knowledge gained from this study may be of help to other patients in the future.

the purpose of this study is to see how well study device works at treating people with gastric antral vascular ectasia (gave). the device has already been approved by the food and drug administration (fda) and is a part of standard of care. you have been invited to join this research study because you require diagnostic or therapeutic evaluation of the gastric antral vascular ectasia by rfa. this is a single -site study being performed at the university of texas health science center. the study will enroll a total 1000 patients with gave. this study is purely observational and will collect clinical information regarding your gave

Eligibility criteria:
inclusion criteria: * in-patients * patients diagnosed with gave * patients undergoing radiofrequency ablation with halo ultra device exclusion criteria: * patients who were not diagnosed with gave * patients undergoing rfa with halo ultra device for diseases other than gave. * patients with gave receiving other endoscopic therapies like argon plasma coagulation (apc) or radiofrequency ablation (rfa) with devices other than halo ultra
sympathetic vascular transduction across the menopause transition: contributing mechanisms

Conditions: Menopause

Summary: the investigators aim to assess the interactions between the sympathetic nervous system and the vasculature in women across the menopause transition to better understand why aging women have a higher risk of cardiovascular disease.


Eligibility criteria:
inclusion criteria: * assigned female at birth * 18-70 years of age * body mass index (bmi) \<30 kg/m2 exclusion criteria: * assigned male at birth * pregnancy, breastfeeding * body mass index ≥30 kg/m2 * oral hormonal contraception in last 6 months, history of hormone replacement therapy, oophorectomy * current smoking/nicotine use * increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy * nerve/neurologic disease * cardiovascular, hepatic, renal, respiratory disease * blood pressure ≥140/90 mmhg * diabetes, polycystic ovarian syndrome * communication barriers * prescription medications

Keywords: menopause sympathetic nerve activity sympathetic transduction blood flow women&#39;s health blood pressure
prospective assessment of quality of life in patients with locally recurrent breast cancer and hyperthermic radiotherapy

Conditions: Breast Cancer

Summary: prospective assessment of quality of life in patients with locally recurrent breast cancer after close r0, r1 or r2 resection or local inoperability and hyperthermic radiotherapy.

this prospective monocentric trial evaluates the health-related quality of life in patients with local recurrence of breast cancer after close r0, r1 or r2 resection or local inoperability during and after radiotherapy in combination with hyperthermia of the chest wall. the health-related quality of life and the intensity of fatigue will be documented by the eortc qlq-c30, eortc qlq - br 23, fact - b + 4 and facit - fatigue questionnaires at the end of the hypertermic radiotherapy and during follow-up after 3 and 12 month and then annually up to year 5.

Eligibility criteria:
inclusion criteria: * histologically confirmed local recurrence of breast cancer after close resection (≤1mm resection margin), r1 or r2 resection respectively inoperable recurrence of the chest wall * age ≥18 jahre * ecog ps 0-2 * estimated life expectancy more than 2 years * informed consent exclusion criteria: * extensive distant metastases that have an estimated life expectancy of \<2a * heart disease: severe heart failure (nhya iii / iv), coronary heart disease, state after myocardial infarction within the last 6 months), av block iii ° * cardiac pacemaker * second malignancy (except cervical carcinomas in situ, local controlled basaliomas, superficial bladder carcinomas (ta, tis, t1) or other carcinomas that have lasted more than 5 years behind and have been treated curatively) * pregnancy or breastfeeding * implanted port on the side to be treated in the hyperthermia field (located contralateral is not an exclusion criteria) * subclavian vein thrombosis less than \<6 months behind * other circumstances that preclude hyperthermia * circumstances that conflict with regular follow-up care * transplanted organs * other implants of the ipsilateral chest wall

Keywords: hyperthermic radiotherapy quality of life locally recurrent breast cancer