Kornimate/medical-research-clean huggingface dataset:
prospective study of using novel bipolar scissors in colorectal endoscopic submucosal dissection

Conditions: Colon Polyp; Colon Neoplasia

Summary: this study is an interventional, prospective, single-center study to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (spydrblade flex, creo medical, uk) for colorectal esd in patients with superficial colorectal neoplasia.

this is a prospective study with the following study objectives: 1. to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (spydrblade flex, creo medical, uk) for colorectal esd. 2. to assess the impact of the procedure on patient recovery time and postoperative adverse event. this study is an interventional, prospective, single-center study to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (spydrblade flex, creo medical, uk) for colorectal esd in patients with superficial colorectal neoplasia. patients will undergo a esd for superficial colorectal neoplasia. all esd procedures will be performed by expert endoscopists with at least 50 prior experience of esd.

Eligibility criteria:
inclusion criteria: * adult patient (age ≥18 and ≤80 years-old) * capability of understanding and complying with the study requirements, including signing the informed consent form. * patients with colorectal superficial mucosal neoplasia (clinically adenoma or early intramucosal cancer), scheduled to undergo endoscopic submucosal dissection (esd). exclusion criteria: * patients unable or unwilling to provide consent. * patients with lesions unsuitable for esd, including those suspicious of deep submucosal invasive cancer. * patients with lesions involving the appendiceal orifice or ileocaecal valve. * patients with significant cardiorespiratory comorbidities which may limit their ability to undertake monitored anesthesia for the procedure. * poor performance status (eastern cooperation oncology group performance status ≥3). * pregnant women or those planning pregnancy or breastfeeding women. * uncorrectable coagulopathy defined by international normalized ratio (inr) \> 1.5 or platelet count \< 50000/µl.

Keywords: endoscopic submucosal dissection
construction of a prediction model for macce in elderly patients after elective non-cardiac surgery

Conditions: Major Adverse Cardiac Events; Cerebrovascular Accident; Postoperative Complications; Models

Summary: severe cardiovascular and cerebrovascular complications, including cardiac death, non-fatal angina/myocardial infarction, non-fatal heart failure, stroke, severe arrhythmia, etc., are one of the main types of postoperative complications in elderly patients, and are also the main causes of perioperative death in elderly patients. with the aging population and the large proportion of elderly patients undergoing non-cardiac surgery, it is increasingly important to establish a prediction model for postoperative severe cardiovascular and cerebrovascular events in elderly patients undergoing noncardiac surgery.

this project intends to use a multi-center, prospective cohort study method to include about 3000 elderly patients over 65 years old who are planning to undergo non-cardiac surgery, collect relevant data before, during and after surgery, observe the occurrence of serious cardiovascular and cerebrovascular complications in the perioperative period, establish a "macce risk prediction model for elderly patients after elective non-cardiac surgery", and verify its effectiveness and reliability. the results of this study will help to improve the predictive ability of postoperative complications of severe cardiovascular and cerebrovascular events in elderly patients undergoing elective non-cardiac surgery, which is conducive to early risk assessment, risk classification, strengthening perioperative patient management, reducing the incidence of postoperative macce, and improving the prognosis of elderly patients.

Eligibility criteria:
inclusion criteria: * the subjects were patients with elective non-cardiac surgery; * older than 65 years; * patients signed informed consent. exclusion criteria: * the anesthesia should be received in any of the following ways: local anesthesia; * local anesthesia enhancement, and simple nerve block anesthesia; * patients who are scheduled to undergo day surgery; * expected operation time \<1 hour for patients; * patients who are expected to stay in hospital for less than 3 days after surgery; * patients who refuse to enroll.

Keywords: elderly patients elective non-cardiac surgery macces postoperative complications selective operation predictive model
teachable moment brief intervention for suicide attempt survivors in an inpatient setting

Conditions: Suicide, Attempted

Summary: this study is looking at the helpfulness of a brief treatment targeting suicidality (teachable moment brief intervention \[tmbi\]) and experimental pain responses in an inpatient population as well as collecting comparison data from the community.

the proposed study will use an innovative one-session psychotherapeutic intervention called the teachable moment brief intervention (tmbi) for suicide attempters admitted to a psychiatric inpatient unit. a total of 60 patients will be recruited from the inpatient psychiatry unit at laureate psychiatric clinic and hospital and 30 healthy community members for the study. informed consent will be obtained for all participants and administration of the baseline assessment battery will be completed prior to randomization for patients. patients will then be randomized to either (a) an experimental group receiving tmbi or (b) a group receiving treatment as usual (tau). the intervention will consist of no more than 90 minutes (expected mean is 45 minutes for the intervention based upon previous studies of the tmbi) of 1:1 interaction with a study clinician. all participants will complete a follow-up assessment immediately following tmbi, tau, or a rest period. further, patients receiving the experimental intervention will then be asked to complete a client satisfaction survey. the aim will be to assess whether tmbi affects psychological, experimental pain, and autonomic nervous system responses as compared to tau and community controls.

Eligibility criteria:
tmbi \& tau (data collection at laureate psychiatric clinic and hospital \[lpch\]) inclusion: -admitted to lpch subsequent to a suicide attempt exclusion: * acute psychosis, * inability to read english, or * taking narcotic or opioid pain medication ccg (data collection in the psychophysiology laboratory for affective neuroscience \[plan\] on the university of tulsa campus) exclusion: * acute psychosis, * current suicide ideation, * history of self-harm, * inability to read english, or * taking narcotic or opioid pain medication

Keywords: experimental pain
post-market evaluation of active thrombectomy and proximal aspiration during lower extremity tibial interventions

Conditions: Peripheral Arterial Disease

Summary: post-market evaluation of active thrombectomy and proximal aspiration during lower extremity tibial interventions

this is a prospective, multi-center, non-randomized, open label, single arm post-market clinical study to gather data on the use of the protexus catheter for temporary blood vessel occlusion while standard of care treatment with other therapeutic devices is conducted in patients undergoing infrapopliteal treatment for peripheral arterial disease (pad).

Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years of age 2. subject or authorized representative has signed a written informed consent 3. subject is willing to comply with the protocol requirements 4. rutherford classification 4-6 5. planned intervention of the native infrapopliteal arteries using balloon angioplasty, atherectomy, and endovascular procedures. 6. reference vessel diameter for intended location of the distal tip funnel deployment for the protexus catheter is ≥3.5mm and ≤6.0mm by visual estimate 7. inflow arteries have ≤30% stenosis. inflow arteries can be treated at the time of the study procedure to achieve ≤30% stenosis exclusion criteria: 1. prior intervention within 30 days of treatment in the planned deployment site for the protexus catheter 2. presence of a stent in the planned deployment site for the protexus catheter 3. has perforation, dissection, or other injury of the access vessel or protexus catheter deployment site requiring additional stenting or surgical intervention before enrollment 4. history of bleeding diathesis or coagulopathy and unable to receive standard anticoagulation during the index procedure 5. acute limb ischemia defined as onset of symptoms within two weeks of the planned intervention 6. inflow arteries have \>30% stenosis after treatment at the time of the study procedure 7. pregnant female subject or subject that has a positive pregnancy test within the previous 7 days 8. known hypersensitivity or allergy to nitinol 9. target blood vessels are infected, have extreme tortuosity, or are occluded with calcified material
descriptive epidemiology of clostridium difficile infection in hospitalized adult patients in the asia pacific region

Conditions: Clostridium Difficile Infection

Summary: clostridium difficile is an important pathogen, causing disease that ranges from mild self-limited diarrhea to life-threatening pseudomembranous colitis. it is estimated that c. difficile is responsible for 10% to 25% of all cases of antibiotic-associated diarrhea and for almost all cases of pseudomembranous colitis. c. difficile disease is mediated by two large toxins, a and b. the toxins damage intestinal epithelial cells and cause the clinical illness. primary risk factors for c. difficile clinically apparent infection include antimicrobial therapy, hospitalization, residence in a long-term care facility, older age (≥ 65 years), and increased length of hospital stay. the incidence of cdi both in the hospital and the community is important in the understanding and characterization of the disease and its prevention. this observational, epidemiological study will advance the investigators understanding of cdi risk factors in several hospitals and possibly the community in the asia pacific region.


Eligibility criteria:
inclusion criteria: * adult patients, aged ≥ 20 years at the time of hospitalization in specified wards * pcr-diagnosed cdi while at the hospital * informed consent has been obtained from patients as required by local requirements exclusion criteria: * age \< 20 years
phase i trial of vorinostat (mk-0683, saha) in combination with decitabine in patients with aml or mds (mk-0683-055 ext1)

Conditions: Leukemia, Myelocytic, Acute Myelodysplastic Syndromes; Myelodysplastic Syndromes

Summary: this study is to evaluate the safety and tolerability of vorinostat in combination with decitabine as well as the in vivo molecular and biological effects of vorinostat in patients with refractory or relapsed acute myelogenous leukemia (aml) and intermediate or high risk as defined by international prognostic scoring system (ipss) myelodysplastic syndrome (mds). participants with acute myelogenous leukemia or myelodysplastic syndrome are eligible.


Eligibility criteria:
inclusion criteria: * patient is at least 18 years old with refractory/relapsed aml * if untreated aml, patient is older than 60 years old and not a candidate for standard chemotherapy * patient is at least 4 weeks from prior treatment and has recovered from all prior treatment side effects * patient has no known liver or kidney problems * patient knows of no reason they can not receive transfusions of blood clotting cells (platelets) * patient is able to swallow capsules * patients both male and female are willing to practice birth control during the study exclusion criteria: * patient has received prior treatment with valproic acid, decitabine or azacitidine * being is less than 18 years of age or if patient has untreated aml is below 60 years of age * patient is a women who is pregnant or breastfeeding. patient has an active infection that requires antibiotics * patient has uncontrolled illness including but not limited to the following: heart problems (congestive heart failure, unstable angina pectoris, cardiac arrhythmia), inflammation of the pancreas; a mental or social condition that may interfere with patient following study procedures * patient has known human immunodeficiency virus (hiv) infection or hiv-related malignancy. patient has a known history of hepatitis b or c infection * patient currently has another active cancer other than certain types of skin cancer * patient is heterosexual and able to have a child and is unwilling to practice birth control during the study

Keywords: leukemia myelocytic acute myelodysplastic syndromes
survival study of the genutech® total knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: prospective cohort sudy of patients undergoing a genutech® total knee arthroplasty

a prospective cohort study will be performed collecting patient's data before and after the total knee arthroplasty surgical procedure at one, five and ten years. the main goal of this work is to prospectively study the results obtained with the implantation of the knee prosthesis currently used in the orthopaedic service of sant rafael hospital of barcelona (genutech®). the main outcome of the study is the survival of the implant, that is, having no revision surgeries in the follow-up. the secondary objective is the clinical and radiological evaluation of the implants measured by outcome measueres: oxford knee score (oks), sf12 questionnaire and womac (western ontario and mcmaster universities osteoarthritis index) questionaire. oks and sf12 scores are higher with good results and lower with bad results. womac expresses results the other way around.

Eligibility criteria:
inclusion criteria: * patients older than 18 years with knee osteoarthritis that had not responded to conservative treatment * capable of providing informed consent * patients who receive a genutech® total knee prosthesis at the investigators' institution. exclusion criteria: * having received a prior total knee arthroplasty in the same joint * inability to provide informed consent * not willing to participate in the study

Keywords: total knee arthroplasty knee osteoarthritis
firebird 2 versus excel sirolimus-eluting stent in treating real-world patients with coronary artery disease

Conditions: Coronary Artery Disease

Summary: sirolimus-eluting stent (ses) has been world-widely used in clinical practice in treating patients with coronary artery disease (cad). the efficacy and safety of excel ses (jw medical, shandong, china, ma) with biodegradable polymer has been proved by several clinical trials. here the investigators design a prospective, multicenter, randomized clinical study in purpose of identifying the non-inferiority in the efficacy and safety in treating cad patients by firebird 2 ses (microport, shanghai) with durable polymer, comparing with excel ses.


Eligibility criteria:
inclusion criteria: * age \> 18 years * male or un-pregnant female * stenosis \> 70% in one of major the epicardial coronary arteries * no contra-indications of stent implantation * singed the informed consent exclusion criteria: * acute myocardial infarction within one week * have contra-indications of stent implantation or can not tolerate dual antiplatelet therapy * no history of stent implantation within last one-year * received other brand coronary stent during index procedure * with no achievement of informed consent

Keywords: significant stenosis (>70% of lumen stenosis) epicardial coronary arteries clinical ischemic
erector spinae plane block with bupivacaine for medical thoracoscopy

Conditions: Pleural Disease; Postoperative Pain

Summary: placebo versus erector spinae plane block for medical thoracoscopy study (painless). this is a prospective triple-blind, randomized controlled trial that evaluates the efficacy of erector spinae plane block (espb) with bupivacaine in reducing pain after medical thoracoscopy (mt) in addition to monitored anesthesia care vs monitored anesthesia care alone.

this is a single-site prospect triple-blind, randomized controlled trial, that evaluates the efficacy of erector spinae plane (esp) block with bupivacaine in reducing pain after medical thoracoscopy (mt). the study aims to compare the effectiveness of esp block with monitored anesthesia care (mac) vs mac alone for patients undergoing mt. patient will be evaluated post operatively in the post anesthesia care unit and 24 hours after the procedure.

Eligibility criteria:
inclusion criteria: * referral for medical thoracoscopy * age ≥ 18 exclusion criteria: * inability to provide informed consent. * study subject has any disease or condition that interferes with safe completion of the study including: * allergic reaction to bupivacaine. * need for pleurodesis. * allergies to lidocaine or other local anesthetics. * pregnancy. * advanced liver disease where the clinician deems the procedure unsafe.

Keywords: thoracoscopy pleuroscopy regional anesthesia erector spinae plane block pain control
an examination of the blood pressure lowering ability and safety of olmesartan medoxomil in elderly patients with hypertension

Conditions: Hypertension

Summary: this 14 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients 65 years of age or older with high blood pressure. the medication being tested has been approved by the fda for the treatment of high blood pressure.


Eligibility criteria:
inclusion criteria: 1. males or females greater than 65 years of age 2. patients with a mean seated systolic blood pressure (mssbp) greater than or equal to 150 mmhg but less than 200 mm hg and a mean seated diastolic blood pressure (msdbp) less than or equal to 109 mmhg following a 2-3 week single blind placebo run-in period. 3. the difference in mssbp between visits 2 and 3 or between visits 3 and 3x must be less than or equal to 10 mmhg. 4. patients with a mean daytime (8am-4pm) systolic blood pressure (sbp) greater than or equal to 140 mmhg and less than or equal to 199 mmhg and a mean daytime diastolic blood pressure (dbp) less than or equal to 109 mmhg as measured by an ambulatory blood pressure monitoring device (abpm) following placebo run-in period. exclusion criteria: 1. history of stroke or transient ischemic attack (tia) within the last one year. 2. history of myocardial infarction, angina, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months. 3. severe hypertension (diastolic blood pressure greater than 115 mmhg or systolic blood pressure greater than or equal to 200 mmhg). 4. patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma or cushing's syndrome. 5. type i diabetes or type ii diabetics not on stable treatment for greater than or equal to 4 weeks and plasma glucose greater than 160 mg/dl. 6. evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease. 7. presence of heart block greater than first degree sinoatrial block, wolff-parkinson-white syndrome, sick sinus syndrome, an accessory bypass tract, atrial fibrillation, atrial flutter or any arrhythmia requiring medication. 8. serum creatinine greater than 1.7 mg/dl, or other abnormal laboratory values deemed clinically significant by the investigator.

Keywords: hypertension angiotensin receptor blocker calcium channel blocker angiotensin converting enzyme inhibitor hydrochlorothiazide stage i and ii hypertension
dermacell awm® in chronic wagner grade 3/4 diabetic foot ulcers

Conditions: Diabetic Foot Ulcer; Lower Extremity Wound

Summary: this is a prospective, multicenter, clinical research trial evaluating the clinical outcomes of dermacell awm in dermal regeneration.

this clinical evaluation with dermacell awm will explore its use in the treatment of complex soft tissue defects involving muscle, fascia, tendon, or bone exposure (wagner classification 3 and 4). a total of 50 subjects will be treated with dermacell awm in the operating room for coverage of deep soft tissue defects in the lower extremity. subjects will then be followed in the outpatient clinic for up to 16 weeks. the specific aim of the study is to assess the ability of the product to sustain an optimal dermal layer. the time (days) required for wound bed preparation (granular bed after placement of dermacell awm) and safety data will be collected.

Eligibility criteria:
inclusion criteria: * wagner grade 3 or 4 complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone) * target wound that is either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 1 year in duration) * target wound that is not amendable to primary closure * target wound deemed without any residual infection (as assessed by investigator) or is being treated upon entry into the clinical trial * adequate perfusion to the extremity * laboratory assessments which represent a good potential for wound healing (liver and kidney function, nutritionally stable and diabetes control) exclusion criteria: * untreated infection of soft tissue or bone * untreated autoimmune connective tissue disorders * body mass index (bmi) of ≥ 50 * undergoing chemotherapy/radiation therapy or taking an immunosuppressant medication * active liver disease (e.g. hepatitis a-g), * have undergone previous wound care therapy that included any bioengineered alternative tissue or stsg 30 days prior to enrollment * pregnant * enrolled in any other interventional clinical research trial * an increase or decrease of more than 25% in wound area or volume from the screening to baseline visit.

Keywords: diabetic foot ulcer dfu lower extremity wound skin substitute
asthma navigator intervention to improve health equity in children

Conditions: Asthma in Children

Summary: the goal of this study is to improve health equity in children aged 5-16.9 years admitted to the picu for asthma. the objectives are: * to identify the factors related to differential experiences of asthma self-management * to pilot the effectiveness of an individualized asthma navigator intervention at picu discharge.

despite available asthma treatments, nearly 50% of children with asthma experience exacerbations annually, with disadvantaged children, particularly black and hispanic, being the most affected. these disparities are largely due to social determinants of health (sdoh), including socioeconomics and family hardship, which explain over 80% of the racial disparities in asthma outcomes. children in lower opportunity neighborhoods face additional challenges like poor housing and limited green spaces, increasing exposure to pollutants and allergens. at children's healthcare of atlanta's pediatric icu (picu), 85% of asthma admissions come from low-opportunity areas, with 36.7% having another exacerbation within a year. significant barriers to better outcomes include limited provider understanding of sdoh and challenges in asthma self-management. effective asthma self-management, supported by medical providers, is crucial for improving health outcomes in these disadvantaged children.

Eligibility criteria:
inclusion criteria: * admitted to the picu for asthma exclusion criteria: * cystic fibrosis * immune deficiency * prematurity \<35 weeks * gestation and congenital airway deformities * non-english speaker

Keywords: asthma self-management asthma in children