Kornimate/medical-research-clean huggingface dataset:
renal denervation by iberis multielectrode renal denervation system in patients with primary hypertension

Conditions: Primary Hypertension

Summary: the purpose of iberis-htn trial is to evaluate the safety and effectiveness of renal denervation in subjects with primary hypertension by using iberis multielectrode renal denervation system

the purpose was to evaluate 3-month outcomes of rdn for the treatment of primary hypertension in chinese patients.in a prospective, multi-center study, 216 chinese patients with primary hypertension would be recruited to undergo rdn by iberis multielectrode denervation system. the primary effectiveness endpoint wasreduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up.

Eligibility criteria:
inclusion criteria: * age 18 - 65 years * primary hypertension * stable medication regimen including 3 antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to screening) and 1) office sbp ≥150 and ≤180 mmhg, and dbp ≥90 , 2) average 24-hour ambulatory systolic blood pressue and/or dbp ≥135 and ≤170 mmhg * main renal arteries with ≥3 mm diameter or with ≥20 mm treatable length (by visual estimation) * written informed consent exclusion criteria: clinical exclusion criteria: * known secondary hypertension * type 1 diabetes mellitus * has an implantable cardioverter defibrillator (icd) or pacemaker * myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period * has hemodynamically significant valvular heart disease * pregnant, nursing, or planning to be pregnant * any serious medical condition that may adversely affect the safety of the participant or the study * currently enrolled in another investigational drug or device trial 2.angiographic exclusion criteria * renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery * history of prior renal artery intervention including balloon angioplasty or stenting * multiple renal arteries where the main renal artery is estimated to supply \<75% of the kidney * main renal arteries with \<3 mm diameter or with \<20 mm treatable length (by visual estimation) * renal artery abnormalities
healing at home 2.0 - enhanced chat tool for lowering postpartum depression

Conditions: Depression, Postpartum; Postpartum Care

Summary: the purpose of the study is to determine if access to a text-message based holistic chatbot support program "healing at home 2.0" decreases depressive symptoms as measured by the edinburgh postnatal depression scale (epds) compared to usual postpartum care for patients of color.

healing at home (h@h) 2.0 is a comprehensive technology-based postpartum support program which provides 24/7 support to individuals through use of an sms chatbot for six weeks postpartum. this will be a randomized controlled trial (rct) with an intervention arm consisting of patients who are planning to be discharged at routine timing (as determined by their clinical team) with access to h@h 2.0 postpartum sms chatbot platform and a control arm which consists of usual postpartum care.

Eligibility criteria:
inclusion criteria: * postpartum patients who have delivered a singleton baby at or after 37w0d at the hospital of the university of pennsylvania * self-identify as a person of color (listed on chart as non-white race and confirmed with patient) * able to speak, read and write english * age ≥18 * prenatal care at outpatient practice affiliated with the hospital of the university of pennsylvania * completion of clinically administered epds during inpatient stay * routine discharge timing, day 2 or more after vaginal delivery, day 3 or more after cesarean delivery exclusion criteria: * unable to provide informed consent * baby not discharged with mother at postpartum discharge * does not have access to a mobile phone

Keywords: chat tool depression text message based program postpartum care
early versus late intubation trial in physician manned emergency medical services

Conditions: Trauma; Craniocerebral Trauma; Intracerebral Hemorrhage; Seizures; Unconsciousness

Summary: this study looks at advanced airway management in critically ill or injured patients treated by physician manned emergency medical services, comparing early (on-scene) intubation to late (emergency department) intubation.

the elite trial is a prospective randomized controlled trial (rct) to compare competent early-intubation to late-intubation in patients with on-scene glasgow coma scale (gcs) \< 9 and short ambulance transport times (\< 20 min) to hospital. the study aims to establish if advanced airway management with endotracheal intubation (eti) in the field by specially trained emergency medical services (ems) physicians - compared to endotracheal intubation (eti) performed by physicians in the emergency department in the same group - improves outcome in terms of 30-day mortality, degree of disability at discharge, complications and length of hospital stay, and neurologic outcome at 6 months.

Eligibility criteria:
inclusion criteria: * adult patients (\> 18 years) * initial gcs \< 9 independent of cause. * intact airway reflexes and no impending airway obstruction. * located \< 20 min ambulance transport time from nearest hospital emergency department. exclusion criteria: * pediatric patients (under 18 years). * primary cardiorespiratory arrest (of non-traumatic / medical cause). * planned helicopter transport to hospital.
stability and outcomes of non-displaced lisfranc injuries

Conditions: Lisfranc Injury; Sprain of Foot

Summary: in this multicenter cohort study, the stability of non-displaced lisfranc injuries as well as their outcomes will be evaluated.

injuries to the tarsometatarsal joints ("lisfranc injuries") that are non-displaced on non-weightbearing radiographs and ct are common injuries. to refer these injuries to the right treatment, evaluating their stability is essential. for this purpose, both weightbearing radiographs and stress fluoroscopy have been proposed. however, there is no consensus concerning both the use and interpretation of weightbearing radiographs and no standardized technique and interpretation of stress fluoroscopy in non-displaced lisfranc injuries. in the current study, participants will be assigned to non-operative or operative treatment based on lisfranc joint stability evaluation by weightbearing radiographs. all patients with negative weightbearing radiographs will be treated conservatively. in addition, their injured feet will be evaluated by manual stress fluoroscopy. depending on the result of the stress fluoroscopy (positive/negative), the conservatively treated patients will be assigned to 2 cohorts, whose outcomes will be compared. patients with positive weightbearing radiographs will be treated operatively by minimally invasive stabilization of the midfoot (eg. isolated "homerun screw"). the operatively treated patients will be followed up as an independent cohort.

Eligibility criteria:
inclusion criteria: * acute lisfranc injuries that are non-displaced (\< 2mm) on non-weightbearing radiographs and ct * patients between 18 and 70 years of age * acute presentation at one of our departments, enabling evaluating the stability of the injuries within 4 weeks exclusion criteria: * fractures with an intraarticular step of \> 2mm on the initial non weight-bearing radiographs and/or ct * delayed presentation (weight-bearing radiographs taken \> 4 weeks after injury) * bilateral injuries * concomitant major injuries of the foot, ankle or leg that affect the rehabilitation process * multitraumized patients * previous injury or surgery of the mid foot * charcot foot * noncompliant patients * insufficient norwegian or english language skills * patients not available for follow-up * inability to conduct the rehabilitation protocol

Keywords: lisfranc injury weightbearing radiographs stress fluoroscopy homerun screw
supernormal goal for proximal femur fracture

Conditions: Femoral Fractures

Summary: this is an observational pilot study of supernormal oxygen delivery goal for patients with proximal femoral fracture.

augmentation of oxygen delivery using fluids with or without inotropes has been shown to improve surgical outcome in high-risk patients. patients with proximal femoral fracture are considered high risk. however, most of this cohort elderly patients have poor cardiovascular condition and may not achieve the oxygen delivery goal. we will perform an observational pilot study whether the supernormal oxygen delivery is a valid hemodynamic goal for patients with proximal femoral fracture.

Eligibility criteria:
inclusion criteria: * patients aged over 70 yr * weight over 35 kg * underwent proximal femur fracture (pff) surgery under peripheral nerve block and laryngeal mask airway anesthesia. exclusion criteria: * patients who could be harmed due to the treatment (ongoing myocardial infarction, chronic dialysis) * monoamine oxidase inhibitor use within the last 14 days * pathological fractures and conditions * inability to give informed consent(as judged by a research team member) * anticipated difficulties obtaining data during the first postoperative year (as judged by a research team member)

Keywords: oxygen delivery proximal femoral fracture goal-directed therapy
phase 2 study on use of a combination of pemetrexed in patients with advanced gastric carcinoma

Conditions: Gastrointestinal Neoplasms

Summary: pemetrexed has shown an anti-tumor activity in advanced gastric cancer patients in a previous study, while cisplatin is widely used in the combination chemotherapy of gastric cancer. pemetrexed has shown synergy with cisplatin in preclinical models and in various human cancers. the introduction of vitamin supplementation has made treatment with pemetrexed plus cisplatin safe and well tolerated. the present phase 2 study is an effort to determine the efficacy and safety of the combination of pemetrexed and cisplatin in korean patients with gastric carcinoma who had no prior palliative chemotherapy for advanced disease. the patients, who will give their consent for participating in this study, will be screened for their eligibility and on meeting pre-defined study eligibility criteria, they will receive an intravenous therapy of the combination of pemetrexed and cisplatin for number of times that in the opinion of their treating physician is appropriate for them. a response rate of 30% is considered as the minimum activity level of interest for this patient population.


Eligibility criteria:
inclusion criteria: * diagnosis of adenocarcinoma of the stomach * stage iv disease not amenable to curative surgery. * disease status must be that of measurable disease as defined by recist criteria * performance status of 0 or 1 on the ecog scale and adequate organ function. * signed informed consent from patient exclusion criteria: * prior palliative chemotherapy for advanced disease. * known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment. * concurrent administration of any other tumor therapy * inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (nsaids) 2 days before, the day of, and 2 days after the dose of alimta plus cisplatin. * inability or unwillingness to take folic acid, vitamin b12 supplementation, or dexamethasone.
doxycycline effects on inflammation in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: doxycycline is known to exhibit immune modulatory activities beyond its antibacterial effects. in particular, doxycycline is a potent inhibitor of matrix metalloproteinase 9, which is a protease derived largely from neutrophils. recent studies demonstrate a significant correlation between pulmonary disease severity and sputum concentrations of mmp-9 in patients with cf. in addition, sputum mmp-9 levels are associated with airway remodeling in cf. the goal of this study is to determine the therapeutic potential of doxycycline in modulating host airway inflammation in patients with cf. specifically, the study will characterize the pk /pd of doxycycline, evaluate the safety of short term therapy, and explore the concentration effect relationship between doxycycline exposure and sputum biomarker levels.

this study will consist of a prospective, open-label, randomized, controlled trial conducted in 24 patients with cystic fibrosis. twenty subjects will be stratified in a 1:2 ratio based on baseline fev1 into mild (\> 70%) or moderate (40-70%) pulmonary disease in order to control for disease severity within each dose level. the subjects will be randomized in blocks of four to receive no drug, 40mg, 100mg, or 200mg daily for 28 days. sputum samples will be obtained in all groups by induction with hypertonic saline at baseline, 8, 24, and 48 hours following the first dose and then weekly for 4 weeks. sputum will also be collected at two follow up visits after the treatment period at weeks 5 and 6. in the doxycycline group, serial blood samples (5 ml) for determination of doxycycline concentrations will be obtained before and at 0, 0.5, 1, 2, 4, 12, 24, and 48 hours following the 1-hr infusion of a single iv dose. once daily dosing of doxycycline will resume immediately following the 48-hour blood sample and will continue until day 28. additional levels will be obtained pre-dose, and 1, 2, and 3 hours after doses administered on days 14 and 28. a sample of blood will be obtained at baseline, and at days 28 for inflammatory marker analyses.

Eligibility criteria:
inclusion criteria: * age greater than 18 years * clinically stable (fev1 within 10% of baseline) * fev1 \> 40% predicted exclusion criteria: * use of clinically significant concomitant drug therapy such as long-term use of nonsteroidal anti-inflammatory drugs or corticosteroids * known hypersensitivity to doxycycline * pregnancy or attempting to conceive, breast feeding, initiation of or change in hormonal method of contraception within 4 weeks of baseline or during the study * use of systemic antibiotics (except oral azithromycin) within 4 weeks of baseline * use of doxycycline within 60 days of baseline * known history of gastrointestinal bleeding or gastrointestinal ulceration.
school influenza vaccine vs standard of care with nested trial of 2 parent notification intensities

Conditions: Immunizations; Vaccination; Influenza; School Health

Summary: purpose of the study. the purpose of the project is to evaluate the feasibility, acceptability, and cost effectiveness of providing influenza vaccine in schools to children in grades kindergarten through 6th grade. hypothesis 1: school based influenza vaccination (siv) will increase the overall rate of influenza vaccination in school children. hypothesis 2: higher intensity parent notification about school based influenza vaccination does not increase immunization rates compared to low intensity. hypothesis 3: school based vaccination from the perspective of mass vaccinators is cost neutral.

background. the acip (american committee on immunization practices) has now recommended influenza vaccination for all children 6 months to 18 years of age. while many school-aged children will be vaccinated in the medical home, the large number of children for whom the vaccine is now recommended exceeds the capacity of many primary care settings. schools have been recommended as potential sites for influenza vaccination, yet little is known about the feasibility, implementation requirements, costs, or effectiveness of school-based influenza vaccination (siv) programs. this project will implement and rigorously evaluate the feasibility, acceptability, billing and reimbursement components, costs, cost-effectiveness, and overall effectiveness of an siv program that targets diverse populations and different intensity of interventions.

Eligibility criteria:
inclusion criteria: children in grades k through 5 enrolled in schools that agreed to participate in the randomized trial of school based influenza vaccine exclusion criteria: children and schools not enrolled in school based influenza vaccine program children in participating schools in grades other than kindergarten through 5th grade. -

Keywords: seasonal influenza vaccine school-based clinics economic analysis of school based influenza vaccine delivery pediatric influenza vaccine rates influenza vaccine information for parents
banana flower extract in the efficacy verification program of hair and body health care

Conditions: Hair Loss

Summary: to assess banana flower extract supplement on hair and body health care


Eligibility criteria:
inclusion criteria: * healthy adults aged above 20 years old exclusion criteria: * subject who is not willing to participate in this study. * patients with diseases of the skin, liver, kidney. * subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder. * female who is pregnant or nursing or planning to become pregnant during the course of the study. * the students taught by the pi. * subjects who have wounds on the scalp and subjects who have used drugs to treat the scalp, received hair transplants or other scalp treatments within six months
study of paclitaxel/carboplatin with or without bavituximab in previously untreated non small-cell lung cancer

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this is a randomized, open-label, multicenter, phase 2 study comparing paclitaxel/carboplatin with or without bavituximab in patients that have previously untreated locally advanced or metastatic non-small cell lung cancer (nsclc).


Eligibility criteria:
key inclusion criteria: * adults over 18 years of age with a life expectancy of at least 3 months. * histologically or cytologically confirmed stage iiib or stage iv non-squamous nsclc that has not been previously treated with systemic chemotherapy. * measurable disease by response evaluation criteria in solid tumors (recist, version 1.1). * adequate hematologic, renal and hepatic function. * pt / inr ≤ 1.5 × uln, aptt ≤ 1.5 × uln and d-dimer ≤ 3 × uln. key exclusion criteria: * squamous cell, small cell, or mixed histology. * known history of bleeding diathesis or coagulopathy. * cavitary tumors or tumors abutting large blood vessels. * bleeding: clinically significant bleeding, such as gross hematuria, gi bleeding and hemoptysis, within 12 months of screening. * venous thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism) within 6 months of screening. * ongoing therapy with oral or parenteral anticoagulants. * concurrent estrogens, anti-estrogens or progesterone compounds. * grade 2 or higher peripheral neuropathy. * radiotherapy within 2 weeks preceding study day 1. * symptomatic or clinically active brain metastases. * major surgery within 4 weeks of study day 1. * uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease). * symptomatic coronary artery disease, cerebrovascular accident,transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of screening.

Keywords: nsclc lung cancer non small cell lung cancer bavituximab monoclonal antibody
endoscopic versus radiologic biliary drainage for perihilar malignant obstruction

Conditions: Perihilar Cholangiocarcinoma; Jaundice, Obstructive

Summary: this retrospective monocentric study aims at comparing multimodality endoscopic biliary drainage versus percutaneous radiologic biliary drainage in case of perihilar malignant obstruction. data from patients admitted in the nancy university hospital, france, between january 2016 and march 2022 with jaundice and perihilar obstruction will be retrospectively collected.


Eligibility criteria:
inclusion criteria: * hospitalization between january 2006 and march 2022 * perihilar obstruction * indication of biliary drainage exclusion criteria: * distal biliary obstruction * perihilar obstruction without indication of biliary drainage

Keywords: ercp eus-guided biliary drainage percutaneous transhepatic biliary drainage hilar obstruction
telemedicine education for rural children with asthma

Conditions: Asthma

Summary: the investigators will implement an interactive school-based telemedicine education program for rural low-income, minority children with asthma, their caregivers, and school nurses in the delta region of arkansas. specific aims: 1. the investigators will examine changes in asthma symptoms control and other health outcomes such as activity levels and family/child emotional health in the intervention group compared to a usual care group. 2. the investigators will examine changes in asthma knowledge, self-efficacy, and quality of life in the intervention participants and their caregivers compared to a usual care group.

the investigators will conduct a prospective study to examine the impact of an interactive, telemedicine asthma intervention among children living in the rural delta region of arkansas.

Eligibility criteria:
inclusion criteria: * study participants will be english-speaking children ages 7-17 years with physician-diagnosed asthma and/or active symptoms in the previous 12 months. * active symptoms include one or more of the following: * experience daytime wheezing, shortness of breath, and/or coughing two or more times a week for the last 4 weeks; * nighttime wheezing, shortness of breath and/or cough more than once a week; * take asthma medication more than two days a week; * have been treated in a hospital or emergency department two or more times in the last two years for asthma symptoms; * have been treated in a hospital or emergency department two or more times in the last two years for asthma symptoms have episodes of asthma-like symptoms when playing/exercising. * potentially eligible participants will be screened using an asthma screener to confirm eligibility. exclusion criteria: * children with significant underlying respiratory disease other than asthma (such as cystic fibrosis) or significant co-morbid conditions (such as severe developmental delay or cerebral palsy) will be excluded from the study. * the primary caregiver and child will be asked questions via telephone interview about how asthma affects the child every day. children with no telephone number or contact telephone number will be excluded.

Keywords: asthma low-income quality of life children
anti-inflammatory effect of atorvastatin in atherosclerotic plaques assessed by fdg-pet imaging

Conditions: Atherosclerosis; Inflammation

Summary: the purpose of this study is to determine whether hmg-coa reductase inhibitor, atorvastatin attenuates inflammation in atherosclerotic plaques detected by 18f-fluorodeoxyglucose(fdg) pet.


Eligibility criteria:
inclusion criteria: * subjects with accumulation of fdg-pet in carotid artery or aorta exclusion criteria: * ldl cholesterol level (calculated by using friedewald formula) higher than 180 mg/dl or less than 120 mg/dl * subjects currently taking hmg coa-reductase (statins) or fibrates * symptomatic coronary artery diseases * symptomatic cerebrovascular diseases * subjects suffered from myocardial infarction or stroke within 6 months * subjects underwent percutaneous vascular interventions or vascular operations within 6 months * diabetic patients with poor glycemic control (hba1c\>8.5) * hypertensive patients with poor blood pressure control * subjects with neoplasms * subjects with systemic inflammatory diseases

Keywords: atherosclerotic plaques hypercholesterolemia hmg-coa reductase inhibitor statin lipid-lowering therapy