Kornimate/medical-research-clean huggingface dataset:
coldplay cryoablation of dysplastic squamous tissue in patients with esophageal squamous cell dysplasia

Conditions: Esophageal Squamous Cell Dysplasia

Summary: to demonstrate the feasibility, safety and efficacy of the cryoballoon ablation system for the treatment of esophageal squamous cell dysplasia.

multi-center, prospective, single arm, non-randomized study. the study will proceed in two phases: a pilot phase, followed by the feasibility, safety and efficacy phase. in the pilot phase, up to five (5) patients at one (1) site will be treated with the cryoballoon ablation system to confirm its safety and feasibility in the treatment of squamous dysplasia. the second phase will be conducted at two (2) centers and will enroll up to 50 subjects to evaluate the feasibility, safety and efficacy of the cryoballoon ablation system for the treatment of squamous dysplasia.

Eligibility criteria:
inclusion criteria: * at least one unstained lesion (usl) in the esophagus upon high resolution endoscopy with lugol's staining * flat (type 0-iib) appearance of the usl * total area of usls is a maximum longitudinal size of 6cm and covering a maximum of one-half of the circumference of the esophagus * proven (by histopathological analysis) medium-grade or high-grade intraepithelial neoplasia (mgin or hgin) in at least one usl * older than 18 years of age at time of consent * operable per institution's standards * provides written informed consent on the ethics committee-approved informed consent form * willing and able to comply with study requirements for follow-up exclusion criteria: * esophageal stenosis or stricture preventing advancement of a therapeutic endoscope within 4cm of the treatment zone * other usls containing mgin, hgin, or essc outside the designated treatment area * any previous ablative therapy in the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment) or any radiation therapy to the esophagus * any previous esophageal surgery (except anti-reflux surgery) * any cancer (squamous cell or non-squamous cell) within the previous five (5) years * active inflammation in the treatment zone due to esophageal reflux, as confirmed by endoscopic examination * known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions or follow-up guidelines * pregnant or planning to become pregnant during the study follow-up period * life expectancy ≤2 years
outflow facility ait vs microshunt

Conditions: Glaucoma

Summary: the purpose of this study was to asses differences in nycthemeral (24-h) intraocular pressure (iop) profiles and outflow facilities between patients who have undergone epibulbar microshunt implantation and ab interno trabeculectomy, respectively.

recent studies involving continuous, 24-hour intraocular pressure (iop) monitoring in glaucoma patients linked iop variation to disease progression. no study has previously compared the postoperative iop variation of microshunt (preserflo, p) implantation to ab interno trabeculectomy (trabectome, t). in this prospective cohort, the investigators analyzed 68 patients (34 p and 34 t) who presented for 24-hour iop monitoring 6 to 12 months after surgery. surgery must have been conducted between october 2020 and july 2021. patients were assigned to each study group according to the intervention undergone, p or t. iop and tonographic outflow facility were measured in the habitual position using a pneumatonometer. the iop variation was considered the primary outcome measure.

Eligibility criteria:
inclusion criteria: * patients that have undergone microshunt implantation or ab interno trabeculectomy between 6-12 months ago * patients suffering from open-angle glaucoma exclusion criteria: * patients that have undergone microshunt implantation or ab interno trabeculectomy less than 6 months or over 12 months ago * patients suffering from angle-closure glaucoma

Keywords: outflow facility microshunt ab interno trabeculectomy pneumatonometer intraocular pressure
transcutaneous electrical nerve stimulation improves vascular conductance after coronary artery bypass graft surgery

Conditions: Acute Myocardial Infarction

Summary: the investigators will test the hypothesis that transcutaneous electrical nerve stimulation (tens) may attenuate peripheral vasoconstriction and to improve blood flow redistribution during handgrip exercise in acute myocardial infarction (ami) patients after coronary arterial bypass graft surgery (cabg).

thirty-eight patients will be randomized to a (4 times/day; 30 min/session) for 5-day program of tens (n = 20) or to placebo-tens (p-tens, n = 18) applied on cervical region (c7-t4). acute sympathetic stimulation by cold pressor test (cpt), maximal voluntary contraction (mvc), femoral blood flow (fbf) and femoral vascular conductance (fvc) will be measured as primary outcome pre and post-cabg, even as the 6-minute walk test (6-mwt), inspiratory and expiratory muscle strength (pimax and pemax) and β-endorphin as a secondary clinical parameters. in addition, amount of opioid analgesic and pain intensity also will be measured throughout at first 24 hours after cabg (immediately, 6, 12 and 24 hours).

Eligibility criteria:
inclusion criteria: * a previous history of more than 1 vessel coronary artery disease, * lifelong abstinence from tobacco, and * formal indication for cabg, according to established guideline. exclusion criteria: * patients older than 70 years of age, with chronic renal failure, or with unstable angina in the 48 h prior to cabg, moderate or severe valve disease, complex cardiac arrhythmias, stroke, and/or inability to exercise the lower limbs.

Keywords: exercise neuromodulation blood flow exercise capacity
jewel electrophysiology (ep) lab study

Conditions: Sudden Cardiac Arrest

Summary: single arm open label evaluation of the jewel patch wearable cardioverter defibrillator (p-wcd) defibrillation waveform in adult cardiac patients.

the primary objective of this study is to demonstrate safety and clinical effectiveness of the jewel, using a single transthoracic defibrillation shock to terminate life-threatening vt or vf.

Eligibility criteria:
inclusion criteria: 1. subjects of both genders of at least 18 years of age. 2. subjects who are scheduled for a standard ep clinical procedure where fast vt or vf may spontaneously occur or may be induced. exclusion criteria: 1. subjects who may require sterile access to the right upper pectoral or lower left torso regions during the planned ep procedure. 2. subjects who have taken amiodarone in the past 3 months. 3. subjects with an existing unipolar pacemaker. 4. subjects who exhibit a left ventricular ejection fraction (lvef) less than 20% (as assessed by techniques such as echocardiography, magnetic resonance imaging, or radionuclide angiography) within the last 6 months. 5. subjects who have been diagnosed with heart failure (class iv) or experienced an acute heart failure exacerbation within the previous 30 days. 6. subjects who exhibit unstable angina. 7. subjects with atrial fibrillation with contraindication to anticoagulation or improper anticoagulation management. 8. subjects who are participating in an investigational study of a drug, biologic, or device not currently approved for marketing. 9. subjects who are allergic to or have had a known adverse reaction to medical adhesives. 10. subjects who have active skin breakdown, erythema, or other signs of infection in the pectoral or torso regions where the study device is applied. 11. subjects with a lower abdomen circumference of less than 68.5 cm or greater than 142 cm. 12. females who are pregnant or breastfeeding, or planning to be pregnant in the next 12 months. 13. subjects who cannot provide or have diminished capacity to provide informed consent. 14. any condition that an investigator believes would interfere with the intent of the study or is not in the best interest of the patient. 15. any patient that according to the declaration of helsinki is unsuitable for enrollment.
efficacy and safety of midodrine and atomoxetine for neurogenic oh

Conditions: Neurogenic Orthostatic Hypotension

Summary: this was a randomized, open-label clinical trial. we will enroll patients with symptomatic neurogenic oh and randomize them to 1 of 2 treatments: (1) midodrine only, (2) atomoxetine only. we will follow up patients at 1 and 3 months after treatment. if the patients meet bp criteria for oh at 1 month, they will receive combination treatment with both midodrine and atomoxetin. the primary outcome measure is amelioration of questionnaire score evaluating oh-associated symptoms at 3 months. secondary end-points were improvement in orthostatic blood pressure (bp) drop at 1 and 3 months.

visit 1. 1. enroll, baseline evaluation of the patients 2. questionnaire * evaluate orthostatic hypotension symptom: orthostatic hypotension questionnaire (ohq) * quality of life: korean version of short-form 36 * depressive symptom: korean version of beck depression inventory(bdi)-2 3. blood test (6cc): elisa for alpha 1,2 and beta 1,2 adrenergic receptor antibody and nicotinic acetylcholine receptor antibody. preserve sample for genetic testing. 4. randomization: randomize patients to three group in 1:1 ratio (midodrine 5mg/day single, atomoxetine 18mg/day single) 5. treatment education visit 2. 1 month after treatment orthostatic bp check/ check drug compliance and side effect/ questionnaire if the patients meet bp criteria for oh, initiate combination treatment (midodrine 5mg/day+atomoxetine 18mg/day) visit 3. 3 months after treatment orthostatic bp check/ check drug compliance and side effect/ questionnaire

Eligibility criteria:
inclusion criteria: * age \>=19 patients who complained of dizziness * orthostatic hypotension after 3-minute standing (systolic blood pressure drop \>=20 or diastolic blood pressure drop \>=10 exclusion criteria: * drug-induced hypotension, if necessary, evaluate patient after discontinuing the causative drug for one month * heart failure or chronic renal failure * severe supine hypertension (systolic blood pressure \>180 or diastolic blood pressure\>110mmhg) * pregnant women, breast-feeding * unable to perform questionnaire

Keywords: orthostatic hypotension midodrine atomoxetine treatment
short messaging service for optimizing hemoglobin a1c management in low-income diabetics

Conditions: Diabetes

Summary: the purpose of this study is to determine the impact of two-way short message service (sms) on glycemic control in low-income, poorly-controlled adult diabetic patients.

this multi-center, unblinded, prospective randomized controlled trial will enroll adult diabetic patients of the wilson community health center, harvest family health center, and freedom hill community health center living below 200% of 2013 poverty level with a serum hemoglobin a1c \>9% and who currently own a mobile device with text messaging capacity. after written informed consent has been obtained, subjects will be randomized to intervention or control group (1:1), stratified based on insulin initiation within 1 week of study inclusion. participants randomized to the intervention group will be further divided into subgroups as "insulin user" or "non-insulin user" and both will receive sms messages every 7 days. the content of the message consist of medication reminders, reporting of blood glucose results, insulin technique assessment (if applicable), or d) medication adherence assessment. participants will be asked to respond with a simple text within 7 days. the intervention group will receive the standard medical appointment reminder via telephone one to two business days prior to the appointment at the health center plus a unidirectional text message two business days prior to scheduled health center appointments. control group participants will receive the standard medical appointment reminder via telephone one to two business days prior to the appointment at the health center. all participants in the study (control and intervention) will undergo venipuncture at 3 months (+/-) 2 weeks for the determination of hemoglobin a1c. demographic information, and frequency of hemoglobin a1c concentrations in the past 6 months will be assessed at baseline. each week for 12 weeks, the number of texts sent per week and by type, percent of respondents weekly by text or by phone, content of participant responses, number of patients unable to be reached via text, total investigator time spent per week, and time spent per contact will be recorded. at the three month visit, the hemoglobin a1c concentration, blood transfusions since study initiation, and medication changes will be recorded.

Eligibility criteria:
inclusion criteria: * new or existing patient of carolina family health centers inc. (wilson community health center, harvest family health center, freedom hill community health center) * diagnosis of diabetes * single serum hemoglobin a1c equal to or greater than 9% within 2 weeks of study enrollment * below 200% of 2013 poverty level * currently own a mobile device with text messaging capacity and anticipated service for duration of 12 week study period exclusion criteria: * anemia diagnosed within past 3 months * blood transfusion within the past 3 months * unable to read english at the fifth grade level

Keywords: diabetes
intramuscular benzathine penicillin injection procedure

Conditions: Injection Site Discomfort

Summary: the aim of this study was the determination of the effect of applying vr and dc distraction methods on patients' pain and satisfaction levels during im benzathine penicillin injection. the research hypothesis: 1. are virtual reality and distraction card effective in reducing pain due to injection of im benzathine penicillin? 2. does the use of virtual reality and distraction card during the injection process of im benzathine penicillin have an effect on patient satisfaction?


Eligibility criteria:
inclusion criteria: * agree to participate in the research, * being over the age of 18, * being native speaker, * not having vision and hearing problems, * being prescribed benzathine penicillin with a dose of 1.200.000 iu, * being experienced of im injection, * not having im injection for the last 1 month exclusion criteria: * volunteers who have scar, incision, lipodystrophy, abscess, necrosis, hematoma, ecchymosis, infection, pain and paralysis at the vg site * volunteers are excluded if the injection process cannot be performed at one time
a study of zn-c5 and abemaciclib in participants with breast cancer

Conditions: Breast Cancer

Summary: this is a phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (pk), and preliminary efficacy of zn-c5 administered orally in combination with abemaciclib (verzenio®) in participants with advanced estrogen-receptor positive, human epidermal growth factor receptor-2 negative (er+/her2-) breast cancer.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age * women can be peri- or postmenopausal, as defined by at least one of the following: * age ≥ 60 years; * age \< 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle-stimulating hormone (fsh) level within the laboratory's reference range for postmenopausal females; * documented bilateral oophorectomy; * must receive a gonadotrophin-releasing hormone agonist beginning at least 4 weeks prior to the first dose of study medication * histologically or cytologically confirmed diagnosis of advanced adenocarcinoma of the breast * estrogen receptor positive disease * human epidermal growth factor receptor 2 negative disease * measurable disease per response evaluation criteria in solid tumors v1.1 exclusion criteria: * prior therapy within the following windows: * tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy \< 14 days; * any investigational drug therapy \< 28 days or 5 half-lives (whichever is shorter) * any prior systemic chemotherapy regardless of the stop date, but the subject must have recovered to eligibility levels from prior toxicity * prior treatment with cdk4/6 inhibitors * unexplained symptomatic endometrial disorders (including, but not limited to, endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)

Keywords: dose escalation phase 1 combination selective estrogen receptor degrader hormone sensitive estrogen receptor hormone receptor
the effects of altering physical activity on cardiometabolic health

Conditions: Insulin Resistance

Summary: the effects of physical inactivity on variations in blood glucose and vascular health are not fully understood. the purpose of this study is to determine if an acute transition from physical activity to inactivity alters vascular health. specifically, the investigators wish to examine in healthy, lean physically active individuals (obtaining greater than 10,000 steps/day) if decreasing physical activity (obtaining less than 5,000 steps/day) will alter blood flow following a meal a marker of vascular health. furthermore, the investigators wish to examine if a one day return to physical activity (obtaining \>10,000 steps/day) can restore the detrimental effects on blood flow following a meal.

herein, we tested the hypothesis that an acute reduction in daily activity (from \>10,000 to \<5,000 steps/day) for 5 days in healthy individuals reduced meal-stimulated blood flow and if a 1 day return to activity improved this outcomes.

Eligibility criteria:
inclusion criteria: * bmi: less than 30 kg/m2 * physically active: exercise greater than 60mins per week exclusion criteria: * smoking * type 2 diabetes * underlying conditions that limit ability to exercise safely * recent weight gain or loss(\> 5% of body weight in 3 months) * recent (\< 3 mo) changes in medication use or dose * pregnancy

Keywords: insulin resistance exercise continuous glucose monitoring blood flow endothelial function
interest of a visual scale for evaluating food portions as a screening tool for nutritional risk in pediatrics

Conditions: Undernutrition

Summary: in current practice, there are various nutritional risk scores and diagnostic tools which are used in both inpatient and outpatient settings,however, in some cases, these tools cannot be used due to lack of data. that's why a tool that doesn't require any anthropometric parameters, such as a visual food intake scale, could be useful to for medical and paramedical staff. in this way, a larger proportion of the paediatric population could benefit from nutritional screening.

has defines undernutrition as a state of nutritional imbalance, characterized by a negative energy and/or protein balance. this negative balance may be linked to a deficit in isolated intake and/or an increase in energy and/or protein expenditure. in current practice, there are various nutritional risk scores and diagnostic tools which are used in both inpatient and outpatient settings. practitioners can use discs to quickly and easily determine bmi, which corresponds to the ratio of weight (kg) / height² (m). however, in some cases, these tools cannot be used due to lack of data. that's why a tool that doesn't require any anthropometric parameters could be useful to for medical and paramedical staff. in this way, a larger proportion of the paediatric population could benefit from nutritional screening. in adults, a visual food intake scale exists and has been validated for screening for nutritional risk. the hypothesis of this study is that the visual food intake scale could be a good tool for screening for nutritional risk in paediatrics

Eligibility criteria:
inclusion criteria: * child able to be weighed and measured * family with internet access and telephone number * child and at least one parent present during day hospitalization, * child able to respond to the sefi® scale and having completed the 3-day food intake at home exclusion criteria: * children and/or parents with comprehension and/or communication difficulties * children with any pathological condition making interpretation of results difficult from the investigator's point of view * children receiving nutritional support: enteral and parenteral nutrition. * child with nutritional follow-up

Keywords: undernutrition diagnostic screening
study of the use of the drug ingaron in patients with covid-19

Conditions: COVID-19 Respiratory Infection; Viral Pneumonia

Summary: interferon gamma is a powerful endogenous regulatory cytokine that activates the antiviral immune response, while it also has its own antiviral activity. the objective of this study was to evaluate the effectiveness of the proposed treatment regimen with ingaron (inn: recombinant interferon gamma human, lyophilisate for preparing a solution for intramuscular and subcutaneous administration of 500,000 iu) in patients with viral pneumonia.

the study drug was prescribed for therapeutic purposes according to the following scheme: 500,000 iu s / c 1 time per day daily for 5 days. a total of 4 visits were scheduled. visits 0 and 1 could be combined provided that the chronological sequence of screening and randomization procedures was followed. the main stages of the study: screening - lasting no more than 1 day; treatment - within 10-14 days, including the use of the investigational medicinal product for 5 days (from the first day of the basic therapy, daily). the total duration of observation is up to 14 days. patients who completed participation in the study or dropped out of the study ahead of schedule were followed up by the attending physician in accordance with the rules for managing such patients for a medical institution.

Eligibility criteria:
inclusion criteria: * patients with viral pneumonia according to ct scan, regardless of: * degree of damage to the lungs; * results of a laboratory test for the presence of sars-cov-2 rna; * epidemiological history. * patients of both sexes over 18 years of age. * patients who are able to read, understand and independently certify in writing the informed consent form. * negative pregnancy test for female patients of reproductive age with preserved reproductive function. exclusion criteria: * any clinically confirmed or documented history of disease that may make it difficult to interpret the data being assessed. * no symptoms of a respiratory infection. * severe liver or kidney failure, and/or failure of other vital organs, in the stage of decompensation (kidney - creatinine level\> 2x uln, liver tests: liver enzymes (ast and alt) \> 3x uln). * diseases of the central nervous system with severe impairment of intellectual and mnestic functions. * any other disease or condition that, in the opinion of the investigator, may confound the results of the study, limit the patient's participation in the study, or place the patient at greater risk. * serious diseases and pathological conditions (pe, oncological diseases, etc.) that require emergency medical care or threaten the patient's life. * mild, subclinical, asymptomatic or severe form of the course of the disease. * acute respiratory distress syndrome, sepsis, septic shock. * contraindications to the use of the investigational medicinal product. * individual intolerance to the ingredients that make up the study drug. * participation in any clinical trial within 1 month prior to baseline visit (day 0-1). * pregnancy or breastfeeding.

Keywords: covid-19 treatment interferon gamma