Kornimate/medical-research-clean huggingface dataset:
biofreedom ultra registry

Conditions: Coronary Artery Disease

Summary: over the past three decades, coronary stent struts have been made progressively thinner. thin strut drug-eluting stents (des) performed better than their thicker counterparts in a recent study. thinner struts discourage abnormal coronary flow after implantation and associated with greater flexibility, deliverability and better clinical outcomes. lower strut thickness may be particularly advantageous in small target vessels because thicker struts and smaller minimum in-stent lumen diameter are independent predictors of in-stent restenosis. biofreedom ultra is a thin strut (84μm), cobalt-chromium, carrier-free drug-coated stent with biolimus a9 drug. the biofreedom ultra stent is intended for percutaneous coronary intervention (pci) for high-bleeding-risk (hbr) patients treated with 1-month dual antiplatelet therapy. biofreedom ultra received ce mark in october 2020 supported by the leaders free iii trial which enrolled 400 hbr patients using the same inclusion criteria as the leaders free randomized trial. leaders free iii is a single-arm trial, with all patients treated using the biofreedom ultra stent. the data was compared to the biofreedom stainless steel drug-coated stent (dcs-sts) and bare-metal stent (bms) groups from leaders free. the primary safety endpoint of the trial was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis. the primary efficacy endpoint was clinically driven target lesion revascularization. the study found that the biofreedom ultra was non-inferior to the dcs-sts for safety and superior to the bms for efficacy. definite or probable stent thrombosis at 1 year in this hbr population was only 1%. recently, the biofreedom qca randomized trial compared the biofreedom ultra with the stainless steel version (dcs-sts) in an all-comer population. in this prospective, single-blind non-inferiority randomized (1:1) trial, biofreedom ultra was non-inferiority for late lumen loss at 9 months in comparison with dcs-sts.


Eligibility criteria:
inclusion criteria: this is an "all comers" registry and patient who will be enrolled have to meet following criteria: * patient must be at least 18 years of age * patient must have indication to percutaneous coronary intervention including: * stable angina or evidence of myocardial ischemia with stress echocardiography/ myocardial spect/exercise test, or * unstable angina / non st-elevation myocardial infarction, or * st-elevation myocardial infarction with de novo culprit lesion. * presence of one or more coronary artery stenosis \>50% with reference diameter 2.0-6.0mm which can be covered by one or multiple stents exclusion criteria: * known intolerance to any of the device components * inability to provide written informed consent * participating in other trial before reaching primary endpoint * planned surgery within 1 month of pci unless dual antiplatelet therapy is maintained throughout the peri-surgical period.

Keywords: biofreedom ultra drug-eluting stent percautaneous coronary intervention
utilizing consumer health informatics to support management of hypertension by clinical pharmacists in primary care

Conditions: Hypertension

Summary: the purpose of this research study is to test the feasibility, acceptability, and preliminary effectiveness of the use of a mobile pharmacist-led intervention that incorporates home bp monitoring and medication reminders with patients recruited from a primary care setting, as well as identify challenges and potential solutions to broader implementation of a mobile pharmacist-led home-based bp monitoring intervention in primary care clinics through key stakeholder interviews.


Eligibility criteria:
inclusion criteria: * have a smart phone compatible with mobile intervention * have been previously diagnosed with hypertension * have uncontrolled hypertension (systolic blood pressure \> 140 and/or diastolic blood pressure \> 90 on repeat measurement) * be under the care of a primary care physician at the recruitment clinic * be taking at least one antihypertensive medication * be english speaking exclusion criteria: * patients under the care of a clinical pharmacist for hypertension management, or under the care of a cardiologist * pregnant patients and anyone with the following unrelated, but serious medical conditions will also be excluded, as they may make blood pressure control difficult or necessitate frequent hospitalization: previous diagnosis of resistant hypertension; steroid dependent asthma or emphysema; cirrhosis or hepatic failure; stage c or d chronic heart failure; stage iv or v chronic kidney disease; and cancer (terminal or undergoing active chemotherapeutic or radiation therapy) * patients with other serious medical conditions (e.g., stroke, dementia) that may affect their ability to self-monitor blood pressure
safety and immunogenicity of a booster dose of -h5n1 influenza vaccine

Conditions: Avian Influenza

Summary: to assess persistence of antibody titers 17-18 months after primary immunization with two 0.5ml intramuscular (im) doses of h5n1 influenza vaccine containing h5n1 influenza antigen, as measured by hemagglutination inhibition (hi), single radial hemolysis (srh), and microneutralization (mn) test


Eligibility criteria:
inclusion criteria: * healthy subjects who previously participated in study v87p1, but did not receive the booster dose on day 202 exclusion criteria: * pregnant or breastfeeding * receipt of another vaccine or any investigational agent within the past 4 weeks * surgery planned during the study period

Keywords: h5n1 pandemic
school worksite weight gain prevention intervention study

Conditions: Obesity

Summary: the proposed site-level randomized trial will test the effectiveness of a work site intervention based on an ecological framework at preventing weight gain among high school employees in massachusetts. the investigators hypothesis is that the intervention will positively impact healthy dietary patterns and physical activity, perceived organizational commitment, coworker influences, social support, self-efficacy, and self-control, which in turn will positively mediate or moderate the positive associations between the intervention and the primary outcomes (change in weight, bmi, and waist circumference). if effective, the intervention is designed to be generalizable to high school settings across the country and has the potential to reduce the morbidity, mortality and economic costs of overweight and obesity in this important population.


Eligibility criteria:
inclusion criteria: * work at least 15 hours per week, or approximately half of the school week, * only work at one school participating in the study, * not be in a "leadership" position in the school (e.g. principals and vice-principals) * be able to stand up * speak english * plan to be employed at the school for the next 24 months exclusion criteria: * work less than 15 hours per week * work at more than one participating school * work in a "leadership" position (e.g. principal or vice-principal) * does not speak english * unable to stand up

Keywords: obesity workplace intervention diet exercise
insulinotropic effect of glp-1 and gip after dexamethasone

Conditions: Type 2 Diabetes

Summary: in this study we examine whether inducing insulin resistance by dexamethasone in healthy volunteers will lead to a decreased insulinotropic effect of the hormones glp-1 and gip.

in this study we are going to examine the insulinotropic properties of glp-1 and gip before and after the development of insulin resistance and/or glucose intolerance.the insulinotropic properties of glp-1 and gip are greatly reduced in type 2 diabetes. since the development of type 2 diabetes is preceded by insulin resistance and glucose intolerance we wanted to examine the insulinotropic properties of glp-1 and gip in the early stages of type 2 diabetes. to do this, we want to induce insulin resistance and/or glucose intolerance. this is achieved by 5 days of treatment with dexamethasone. subjects are studied on 4 different days in randomized order, with an oral glucose tolerance test (ogtt) and glucose clamps + infusions of glp-1, gip and nacl before and immediately after 5 days treatment with dexamethasone, 2mg bid. on day 1, 2 and 3 after the 5 days of dexamethasone, 2mg dexamethasone was given in the afternoon after the tests to ensure unchanged insulin resistance

Eligibility criteria:
inclusion criteria: * caucasians above 20 and below 45 years of age * normal glucose tolerance as assessed by the who criteria * first degree relative and at least 1 second degree relative with type 2 diabetes * normal haemoglobin * informed consent exclusion criteria: * liver disease (alat/asat \> 2 times normal value) * kidney disease (s-creatinin \> 130um and/or albuminuria) * heart disease (nyha ii, iii or iv) * treatment with medicine that cannot be paused * pregnancy of breast feeding

Keywords: incretin hormones glp-1 gip dexamethasone
interest of circulating endothelial biomarkers in vascular pregnancy complications

Conditions: Pre-Eclampsia

Summary: this is a prospective multicentric study including four clinical units of gynecology and obstetrics (3 public health hospitals and one private team), one research team in hematology and one center of clinical investigation (cic). the objective is to identify, beside the pregnancy, in a population of patients with a preeclampsia (pe), with fetus presenting with growth restriction (iugr) and a fetal demise (fd) a modification of circulating endothelial biomarkers compared with normal pregnancy. we want to understand better the physiopathology of preeclampsia and propose to patients with an endothelial dysfunction a early prevention of preeclampsia. patients will be tested 3 times : at the pregnancy events; then 8 weeks and 12 months after the birth. four groups will be constituted among patients: pe, iugr, fd and normal pregnancy. normal pregnancy will be tested as controls. the next pregnancy presenting in the unit to medical pregnancy follow up will be invited to participate. the main judgment criteria will be the levels of endothelial microparticles 8 weeks after the event. the study will last 3 years. the number of patient to include is 280.


Eligibility criteria:
inclusion criteria: * pregnant patients aged more than 18 years and more than 12 weeks of gestation for fd group, 20 weeks of gestation for pe or iugr group , presenting either: * pe (arterial pressure more than 140 mm hg and 90 mm hg) and at least a proteinuria evaluated on stick (one point) or 300 mg/24h. * iugr with biometries below 5° percentile according to the graphs of fetal echography college after 20 weeks of gestation. * fd after 12 weeks of gestation or with a cranio-caudal length of more than 45 mm. * normal pregnancy adjusted for gestational age and parity : patient should have no cardio-vascular past with a normal complication at the inclusion time and from which pregnancy remains uneventful until the term. the onset of premature delivery, hypertension or fetal growth restriction will exclude patients from the control group. * social security cover * written informed consent exclusion criteria: * foetal malformation * apls known * set back of patient consent

Keywords: identify in a population of patients with a pe, an iugr and a fd a modification of circulating endothelial biomarkers compared with normal pregnancy.
prospective, comparative, randomized, controlled trial on the efficacy of the treatment of gastroesophageal reflux infant with magnesium alginate

Conditions: Gastroesophageal Reflux; Regurgitation; Vomiting; Chronic Cough

Summary: the results on the efficacy of the formulations based on alginic acid are controversial. corvaglia et al demonstrated a significant reduction in reflux episodes in preterm infants by evaluation with ph-impedance analysis. this study concludes that the use of alginic acid reduces the acidity of the gastroesophageal reflux (ger) and has a non-systemic effect and a lesser presence of side effects compared to the use of h2-receptor antagonist(h2ra) and proton pump inhibitor (ppi).

primary outcomes this prospective, randomized, controlled trial aims to determine, in a population of infants within one year of life, suffering from gastroesophageal reflux (ger) the effectiveness of magnesium alginate. the clinical improvement of the patient will be evaluated based on the negativity of the symptom score (4.3.1), assessed using a validated questionnaire on symptoms of ger (i-gerq annex a). secondary outcomes to compare the efficacy of magnesium alginate on ger in infants compared with those of thickened feeding and reassurance, basing on questionnaire results.

Eligibility criteria:
inclusion criteria: * age \< 1 year * suggestive symptoms of gastroesophageal reflux (i-gerq score \> 7) * absence of clinical evidence of allergy to cow milk protein or other allergic disorder * no previous intake of thickened formulas, acid suppressants or drugs * all parents or guardians must sign a document of informed consent * patients affected by chronic disease * patients affected by hepatic or renal diseases * patients affected by cardiac diseases exclusion criteria: * patients affected by chronic disease * patients affected by hepatic or renal diseases * patients affected by cardiac diseases * inability or unwillingness to give informed consent * patients wth severe neurologic disease * patients affected by cow milk protein allergy * previous or ongoing intake of thickened formulas, acid suppressants or drugs

Keywords: ger alginate regurgitation questionnaire
haemodynamic and metabolism response during early rehabilitation in sedated patients

Conditions: Critically Ill Patients Under Mechanical Ventilation; Sedated Patients

Summary: despite several positive studies, benefits of early rehabilitation on recovery and motor performance improvement need to be demonstrate. a recent study finds that despite early rehabilitation, 1 survivor of 2 (52%) acquired an icu weakness. the low intensity exercises applied in intensive care is common and most patients stay in bed. under these conditions, the optimal choice of the rehabilitation technique for bedridden patient and its intensity should be studied. the objective of the study is to evaluate the cardiovascular and metabolic response of patients during four interventions: passive legs mobilization, passive cycloergometter, quadriceps neuromuscular electrical stimulation and functional electrical stimulation.


Eligibility criteria:
inclusion criteria: * mechanical ventilation * sedated * ramsay \< 4 exclusion criteria: * rehabilitation contraindication * patient with pacemaker * patient under volume assist control * fio2 \> 80% * patient under neuromuscular blockers * neurologic comorbidity

Keywords: early rehabilitation mechanical ventilation physiotherapy
endocrinology auto-triggered e-consults

Conditions: Diabetes Mellitus

Summary: diabetes currently affects 25.8 million people in the u.s. patients with diabetes are generally managed, at least initially, by a primary care practitioner (pcp). as the prevalence of diabetes continues to rise, pcps are under increased pressure to achieve recommended glycemic targets. failure to achieve these targets has been shown to increase clinical complications and cost of care. endocrinology referral is common for those patients not meeting a1c goals. unfortunately, access to specialty endocrinology care is limited and patients routinely wait weeks or months before being seen. electronic consultation (e-consult) is a new and innovative delivery model that has the potential to provide greater access to specialty care. the current system at massachusetts general hospital (mgh) allows pcps to electively place an e-consult to solicit specialist input. specialists in turn review the patients chart, relevant data and the clinical question and respond within the electronic medical record. e-consults have been well received by both patients and physicians, not only at mgh, but also across many centers in the us. with that said, the e-consult system remains in its infancy and current literature largely focuses on process metrics without hard clinical end-points. one way to optimize care for patients with diabetes is to automatically trigger an endocrinology e-consult for those not meeting a1c targets. the goal of this project will be to conduct a rigorous scientific evaluation of auto-triggered e-consults across massachusetts general hospitals affiliated primary care practices. the e-consults will be unsolicited and triggered based on inclusion criteria that include a1c and date of last pcp visit. this project will leverage an existing diabetes population health registry that is being used currently for ongoing diabetes care initiatives.


Eligibility criteria:
inclusion criteria: * diabetic patients with a pcp at massachusetts general hospital and hba1c between 8-10 who have seen their pcp in the office within 18 months exclusion criteria: * terminal illness * prior visit with mgh diabetes center * prior diabetes e-consult completed
bleeding pattern difference between levonorgestrel intrauterine system (lng-ius) and copper intrauterine devices (iuds) immediately inserted after abortion

Conditions: Contraception

Summary: to observe the bleeding patterns of post-abortion immediate insertion of ius compared to cu-iud over the first 6 months.


Eligibility criteria:
inclusion criteria: * reproductive women in good general health and requesting long-term contraception * applied the cu-iud or lng-ius immediately after first trimester surgical abortion * history of regular cyclic menstrual periods * written icf was obtained exclusion criteria: * suspected septic abortion and incomplete abortion, as well as missed abortion * the contraindications and warnings of the respective summary of product characteristics of mirena or prescribing information of cu-iuds must be followed

Keywords: bleeding pattern lng-ius cu-iud postabortion
engage4health: a combination intervention strategy for linkage and retention in mozambique

Conditions: HIV

Summary: purpose: to compare the effectiveness of a combination intervention strategy (cis), consisting of point of care (poc) cd4+ testing immediately following hiv diagnosis and accelerated art initiation for eligible participants delivered by facility personnel, and cellular appointment reminders delivered by study personnel, to the standard of care (soc) on linkage to and retention in hiv care at 12 months among adults testing positive for hiv in mozambique. additionally, the protocol will assess the incremental effectiveness of cis+ non-cash financial incentives (fi) compared to cis without fi on study outcomes.

design: two-arm cluster site-randomized trial with a pre-post intervention two-sample design nested in the intervention arm. study population: the study population is any adult who tests hiv positive at the hiv counseling and testing points participating in this study. the study unit (su), the level of randomization for the study, includes specific hiv counseling and testing points at primary health care clinics and the hiv care and treatment services located in the same health facility. a total of 10 su will be included. sample size: a total of 2,250 adults from the 10 study units will be included in the study, 750 in the soc arm, 750 receiving cis without fi and 750 receiving cis+fi. participants will be enrolled and followed for 12 months after enrollment.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * testing hiv positive at the largest-volume hiv point of testing (other than prevention of mother-to-child transmission or tuberculosis) at su with written proof of test result * agreeing to be referred to the hiv care services associated with the su * agreeing to provide locator information * agreeing to adhere to study procedures, including a baseline interview, interviews 1 and 12 months after study enrollment, and extraction of data from the hiv care and treatment electronic database * able to provide informed consent exclusion criteria: * being pregnant at study enrollment * planning on leaving the community where they currently reside in the next 12 months * enrolled in hiv care in the past 6 months at any clinic * initiated art (for any duration) in the past 6 months at any clinic * currently on art * does not speak or understand portuguese or xitswa/matswa

Keywords: hiv linkage retention
local anesthetic cream in younger patients undergoing lumbar punctures

Conditions: Malignant Neoplasm

Summary: this randomized clinical trial studies local anesthetic (emla) cream in younger patients undergoing lumbar punctures (lp). a local anesthetic cream may be effective for numbing the skin and reducing movement when applied prior to lumbar punctures and may reduce the amount of sedation necessary

primary objectives: i. to determine whether the application of a topical anesthetic (emla cream) to the lp site will decrease the total dose of propofol administered to pediatric oncology patients who are being sedated for lps compared to application of a topical placebo cream. secondary objectives: i. to determine whether the use of emla cream decreases complication rates from sedation. ii. to determine whether the use of emla cream decreases traumatic lumbar punctures. iii. to determine whether the use of emla cream shortens recovery time. iv. to determine practitioner and parent satisfaction with the use of emla cream. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients receive topical emla cream 60 minutes to 4 hours prior to the lp followed by standard sedation with fentanyl citrate and propofol. arm ii: patients receive topical placebo cream 60 minutes to 4 hours prior to the lp followed by standard sedation with fentanyl citrate and propofol. after completion of study treatment, patients are followed up within 1 week.

Eligibility criteria:
inclusion criteria: pediatric oncology patients undergoing a lumbar puncture in the pediatric sedation suite; patients may or may not be receiving intrathecal chemotherapy exclusion criteria: patients undergoing additional procedures during the same anesthetic such as bone marrow aspirate or biopsy will be excluded because they will likely require higher doses of propofol than those undergoing lp alone patients who are allergic to or not tolerant of emla cream, propofol, or fentanyl will be excluded patients who are pregnant will be excluded patients having their lps done by students will be excluded