Kornimate/medical-research-clean huggingface dataset:
strict glycemic control by insulin infusion:observations on emergency department initiation

Conditions: Hyperglycemia

Summary: glycemic control can be safely achieved in surgical and medical intensive care unit settings and has been shown to improve short and long-term clinical outcomes. as such, insulin infusion protocols are routinely used in the icu setting. the investigators plan to establish the use of strict glycemic control in a heterogenous group of acutely ill patients in the ed setting. the investigators propose to study the aspects of implementing a strict glycemic control protocol in the ed.


Eligibility criteria:
inclusion criteria: * patients with blood glucose ≥130 mg% considered to be critically ill as defined by: apache ii score ≥9 (see appendix 1) or \>2 sirs criteria with lactate ≥ 4 or bp \< 90mmhg despite one liter of fluid or evidence of organ dysfunction (see appendix 1) exclusion criteria: * patients requiring urgent interventional procedure (e.g. cardiac catheterization, dialysis) or surgery performed outside of the ed.

Keywords: hyperglycemia glycemic control
carmedas: cost-effectiveness analysis of imaging strategies in symptomatic carotid stenosis

Conditions: Carotid Stenosis

Summary: purpose: the purpose of this clinical trial is to study the cost-effectiveness ratios of diagnostic strategies for the imaging assessment of symptomatic carotid stenosis. materials and methods: the diagnostic accuracies of doppler ultrasound (dus), contrast-enhanced magnetic resonance angiography (cemra) and computed tomography angiography (cta) were compared with digital subtraction angiography (dsa) in a multicenter study (carmedas; 206 patients assessable) and in a meta-analysis (for cemra and cta). the direct costs of each imaging method were calculated in 2 university medical centers. eight hypothetical models were studied with dus considered as the first-line imaging method and either cemra or cta or dsa as the second or third line method. the effectiveness criterion was the number of potential avoided strokes for each strategy and for 1000 patients.


Eligibility criteria:
inclusion criteria: carotid artery stenosis \> 50%

Keywords: carotid artery stenosis cost effectiveness magnetic resonance angiography computed tomography angiography digital subtraction angiography
a randomized controlled trial of a smartphone delivered treatment for suicidal thoughts and behavior

Conditions: Suicidal Ideation; Suicide Attempt

Summary: this study aims to evaluate the acceptability, safety, and efficacy of a smartphone-delivered intervention called therapeutic evaluative conditioning for suicide (tec-s) in reducing suicidal thoughts and behaviors (stb) among adults with recent and frequent suicide ideation.

the present study is a two-arm randomized controlled trial (rct) designed to evaluate the safety, acceptability, and efficacy of therapeutic evaluative conditioning for suicide (tec-s), a smartphone-delivered intervention aimed at reducing suicidal thoughts and behaviors (stb). participants in this study will be 60 adult participants (ages 18+) who report recent and frequent stb, residing within the greater-boston, ma area. participants will be randomized to receive either the control condition, which consists of 3x/daily ecological momentary assessment (ema) of emotions and stbs and optional inactive tec (n = 30), or the experimental condition, consisting of 3x/daily ema and optional active tec-s (n = 30). evaluative conditioning uses classical conditioning to alter attitudes. the aim of tec-s is to alter attitudes toward suicide and, in turn, reduce stb. emas will monitor stb, safety, and acceptability, and efficacy. weekly behavioral and self-report assays will assess hypothesized treatment mechanisms. the study's aim is to determine if the active tec-s condition reduces stb and to explore if altered attitudes toward suicide mediates this effect.

Eligibility criteria:
inclusion criteria: * adults ages 18+ * relatively frequent and recent (≥5 days within the past-month) active suicidal thoughts as assessed via sitbi-r. * willing and able to provide at least one emergency contact (name, phone number, relation). * owns an android or ios smartphone. * possesses at least occasional access to wi-fi-enabled internet for data down/uploads. * fluent in english and willing to provide informed consent. * living in the boston metropolitan area (i.e., \~50 mile radius around boston, ma) exclusion criteria: * recent (past 3-month) hypo/manic symptoms or homicidal ideation or lifetime psychosis spectrum diagnosis as assessed via mini 7.0.2. * recent acute suicide risk operationalized as affirmative responses to both below items during structured clinical interview and evaluation by the pi in consultation with mentors/advisor drs. wilhelm, kleiman, and/or bentley: * at any time in past week: ≥ 8/10 current intent to act on suicidal thoughts (0 \["not at all"\] to 10 \["extremely strong"\]); and * at any time in past week: thought of a specific suicide plan (i.e, known method/means and/or location) with access to lethal means * impaired vision (e.g., legal blindness), technological illiteracy, or intellectual disability that might impair ability to provide valid data and/or informed consent.

Keywords: suicide ecological momentary assessment (ema) therapeutic evaluative conditioning (tec)
russian study of the efficacy and safety of tarka in patients with hypertension

Conditions: Hypertension

Summary: this study will investigate antihypertensive activity and safety profile of tarka in russian hypertension patients by ambulatory blood pressure measurement (abpm)


Eligibility criteria:
inclusion criteria: * hypertension exclusion criteria: * sbp \> 180 mm hg, dbp \> 114 mm hg * subject has a hypersensitivity to trandolapril or verapamil

Keywords: hypertension tarka
juniper: a phase 2 study to evaluate the safety, biological activity, and pk of nd-l02-s0201 in subjects with ipf

Conditions: Idiopathic Pulmonary Fibrosis

Summary: a phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, biological activity, and pharmacokinetics (pk) of nd-l02-s0201 for injection in subjects with ipf.

all subjects were treated with nd-l02-s0201 or placebo for 24 weeks (a total of 12 doses). subject's participation in the study was approximately 40 weeks including a screening and baseline period of up to 6 weeks, a treatment period of 24 weeks (including the 2 weeks after the last study treatment), and a follow-up period of 10 weeks after end-of-treatment (eot).

Eligibility criteria:
inclusion criteria: * forced vital capacity (fvc) ≥ 45% of predicted. * diffusion capacity of the lung for carbon monoxide (dlco) corrected for hemoglobin ≥ 30% of predicted value * ratio of forced expiratory volume in 1 second (fev1) to fvc ≥ 0.70. exclusion criteria: * best, acceptable fvc from separate screening spirometry that differ by ≥ 200 ml. * respiratory exacerbation(s) or hospitalization for ipf exacerbation within 3 months before screening. * anticipated to receive a lung transplant during the subject's participation in the study. * active smoker or smoking cessation within 12 weeks before screening. * malignancy within the last 5 years, with the exception of curable cancer that has received adequate treatment. * evidence of any unstable or untreated, clinically significant disease or condition that, in the opinion of the investigator, might confound the interpretation of the study or place the subject at increased risk. * treatment with high dose corticosteroids, cytotoxic agents, unapproved ipf targeted therapy, and cytokine modulating agents within 8 weeks or 5 half-lives (whichever is longer) before screening * participation in an investigational study with the last dose of investigational product occurring within 8 weeks or 5 half-lives (whichever is longer) before screening. * pregnant or breastfeeding. * medical history of infection with hiv, hepatitis b, or hepatitis c. * history of alcohol abuse and/or dependence within the last 2 years. * history within the last 2 years of significant mental illness, or physical dependence on any opioid or illicit drugs. other protocol defined inclusion/exclusion criteria could apply.
comparison of scoring balloon and conventional balloon predilation before drug coated balloon for de novo lesion in patients with high bleeding risk

Conditions: Coronary Artery Disease

Summary: this study is designed to investigate whether scoring balloon (non-slip element, nse) predilation compared to non-compliant (nc) balloon predilation for de novo lesion in patients with high bleeding risk and planning to receive drug-coated balloon (dcb) treatment will lead to lower change in minimal lumen area (mla) at 6 months by intravascular ultrasound (ivus).

this is a pilot study that aim to enroll 60 subjects with high bleeding risk. all patients with coronary artery stenosis suitable for dcb treatment will undergo 1:1 randomization either to nse predilation or nc balloon predilation using a randomization schedule. all subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo ivus before dcb treatment. data and images will be collected during the index procedure, and at the predefined 6-month ivus follow-up visit.

Eligibility criteria:
inclusion criteria: * de novo lesion, suitable for intravascular ultrasound (ivus) and fractional flow reserve (ffr) test; * coronary artery disease (cad) patients with high risk of bleeding exclusion criteria: * previous coronary artery bypass graft (cabg) patients * stent implantation in the target vessel * estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m2 * acute st segment elevation myocardial infarction (stemi) within 48 hours * contraindications to contrast media, antiplatelet therapy, or paclitaxel * cardiac shock * pregnancy * expected life less than 12 months
composition and collection feasibility of gut microbiota in children with and without obesity

Conditions: Childhood Obesity

Summary: adults with obesity have an imbalance of bacteria in their intestines which may contribute to weight gain and diseases related to obesity. restoring the balance of these bacteria (the "microbiota") could help reduce weight and related diseases. however, little is known about this imbalance in children with obesity. this research study will map out the compositions of the gut microbiota of children and compare them with those of children who have healthy weights and different degrees of obesity. this project will also measure the amounts of fatty acids in the stools which are an indication of how efficiently the intestines absorb calories from food. if an imbalance is detected in children with obesity, then this information can help researchers test ways to restore the gut microbiota with hopes of reducing weight and some of its related health problems.


Eligibility criteria:
inclusion criteria: 1) patients aged 5-12 years exclusion criteria: 1. patient who have received either oral or parenteral antibiotics in the last 3 months 2. patients who have a diagnosed immunodeficiency 3. patients who are on medications that modulate the immune system including systemic prednisone and biologics 4. patients who have a gastrointestinal condition which is known to alter the gut flora such as inflammatory bowel disease, chronic diarrhea, celiac disease and eosinophilic gastroenteritis diseases 5. patients who have taken proton pump inhibitors in the last 3 months 6. patients who have taken probiotics in the last 6 months.
comparing accuracy between cuffless wrist worn and cuffed ambulatory bp monitoring devices

Conditions: Blood Pressure

Summary: wrist worn devices can help record blood pressure (bp) throughout the day. as such devices are becoming increasingly affordable, they could help improve awareness, early diagnosis, and treatment of high and uncontrolled bp. the goal of continuum bp is to evaluate how bp readings from two different types of wrist-worn cuffless devices available on the market (aktiia and healthstats bpro evo) compare with bp taken using an ambulatory bp monitor which records readings over 24h using a standard upper arm cuff. this interventional study will recruit balanced numbers of male and female participants within different age group, who will sequentially wear the aktiia bracelet and the heathstats bpro evo for a period of 24h, alongside the cuffed ambulatory bp monitor. if wrist worn devices are found to measure bp reliably, future research will assess if artificial intelligence can use continuous bp readings from these devices to learn patterns and changes in bp; and develop digital twin models to guide better, more precise bp management for individuals.


Eligibility criteria:
inclusion criteria: 1. participant is aged ≥21 years and \<85 years at the time of screening visit. 2. able to speak and understand english. 3. able and willing to give informed consent. 4. independent and mobile. 5. willing and able to wear devices/no upper limb restrictions. exclusion criteria: 1. individuals who are or have been involved in interventional research within a period of 3 months. 2. vulnerable individuals including those with mental ill-health or who are care dependant. 3. individuals with serious comorbidities or end organ damage (e.g., previously diagnosed heart failure with new york heart association class iii/iv, verbal or documented evidence of renal failure or history of dialysis, stroke or myocardial infarction within the last 1-year, previous stroke with residual deficit); and doctor diagnosed hyperthyroidism. 4. individuals with arterio-venous fistula; or reduced peripheral perfusion identified by a history of raynaud's syndrome or a pulse pressure of \ 3s in the dominant arm. 5. individuals with heart rhythm disorders e.g., persistent atrial fibrillation and those who have tachycardia \> 120 after 5 minutes of rest. 6. individuals with skin irritation injury or damage. 7. self-reported pregnancy. participation will be withdrawn in the event of pregnancy following enrolment. 8. life threatening or terminal illness with limited lifespan of \<12months. 9. obesity (body mass index 35kg/m2 or higher) or arm/wrist circumferences outside the range highlighted in each device's specification. 10. those with very high office bp (greater than stage 3 hypertension). 11. interarm difference \>15mmhg in systolic bp and \>10mmhg in diastolic bp. 12. where the pi thinks that it would be technically difficult to obtain or interpret blood pressures measurements.
erythropoietin and early iron supplement and retinopathy of prematurity

Conditions: Retinopathy of Prematurity

Summary: to evaluate the possibility that erythropoietin with early iron supplementation may induce retinopathy of prematurity or worsen this disease. in addition risk factors for the development of rop will be checked.


Eligibility criteria:
inclusion criteria: * all premature infants with birth weight of 1250 grams or less exclusion criteria: * none

Keywords: erythropoietin iron retinopathy of prematurity
study of a prothrombin complex concentrate for rapid reversal of coagulopathy induced by vitamin k antagonists in japanese subjects

Conditions: Acute Major Bleeding; Reversal of Coagulopathy

Summary: the purpose of this study is to evaluate efficacy and safety of a prothrombin complex concentrate (pcc), be1116. be1116 will be used for the rapid reversal of coagulopathy induced by vitamin k antagonists in japanese subjects who require immediate correction of international normalized ratio (inr) due to a major bleed or emergency surgery.


Eligibility criteria:
inclusion criteria: * male and female japanese subjects greater than or equal to 20 years * subjects currently on vitamin k antagonist (vka) therapy * inr greater than or equal to 2 within 3 hours before start of be1116 infusion * urgent reversal of vka therapy for a surgical or invasive medical procedure is required within 24 hours of the start of be1116 infusion, or presentation with an acute major bleed exclusion criteria: * subjects for whom administration of i.v. vitamin k and vka withdrawal, alone, can adequately correct the subject's coagulopathy before the infusion of be1116 * subjects in whom lowering the inr to within the normal range is not a treatment goal * use of anticoagulants other than vkas (or expected use within 1 day) * medical history for which pccs are contraindicated * history of thromboembolic event within 3 months of screening * congenital or acquired abnormality of hemostasis other than receipt of vkas * administration of whole blood, plasma, plasma fractions, or platelets within 2 weeks prior to the start of be1116 infusion * for subjects with intracranial hemorrhage (ich): * glasgow coma score (gcs) \< 7 * intracerebral hematoma volume \> 30 cm3 as assessed by computed tomography (ct) scan * for subdural hematomas: maximum thickness ≥ 10 mm, midline shift ≥ 5 mm, or acute subdural hematomas (based on neurosurgeon review) * for subarachnoid hemorrhage: any evidence of hydrocephalus, or hunt and hess scale \> 2, or concomitant subdural hematoma * infratentorial ich location * epidural hematomas * intraventricular rupture of hemorrhage * requires surgical intervention
acetaminophen and impaired musculoskeletal adaptations to exercise training

Conditions: Sarcopenia; Osteoporosis; Aging

Summary: the purpose of this study is to determine if taking the pain reliever acetaminophen (acet) interferes with some of the benefits of weight lifting on muscles and bone density in older men.

the commonly used pain relievers acetaminophen and ibuprofen may impair musculoskeletal adaptations to progressive resistance exercise training by inhibiting exercise-induced muscle protein synthesis. to test the hypothesis that acetaminophen and ibuprofen would diminish training-induced increases in fat-free mass, untrained men (n=26) aged ≥ 50 years participated in 16 weeks of high-intensity progressive resistance exercise training and bone-loading exercises and were randomly assigned to take acet (1000 mg), ibuprofen (400 mg) or placebo 2 hours before each exercise session. the primary outcome was the change in total body fat-free mass measured by dual-energy x-ray absorptiometry (dxa) at baseline and week 16. our primary interest was in the comparison of the acetaminophen and placebo groups.

Eligibility criteria:
inclusion criteria: * average use of acetaminophen and non-steroidal anti-inflammatory drugs (nsaids) \[including aspirin\] less than 3 days per month * not currently engaged in moderate-to-vigorous weight-lifting exercise * non-smoker * willing to participate in a supervised exercise program for 9 months exclusion criteria: * relative or absolute contraindications to regular use of acetaminophen or nsaids including known allergy or intolerance to either drug,history of peptic ulcer or gi bleeding, anemia, asthma with bronchospasm induced by aspirin or other nsaids, moderate or severe renal impairment, known hepatobiliary disease * contraindications to exercise testing and training including congestive heart failure class iii or iv, uncontrolled hypertension and unstable cardiovascular disease * thyroid dysfunction * orthopedic problems that limit the ability to perform vigorous exercise or increase the likelihood of the use of pain medications * drugs known to alter bone metabolism * allergy to lidocaine * diabetes mellitus requiring pharmacologic therapy
boss study: a study of fuzeon using the needle-free biojector 2000 in patients with hiv-1 infection

Conditions: HIV Infections

Summary: this study will evaluate the signs and symptoms associated with fuzeon injection (90mg sc) using the b2000 needle-free injection device, in hiv-1 positive patients experienced to fuzeon treatment, but having difficulty tolerating long-term (\>4 weeks) administration of fuzeon with the standard needle and syringe. patients will be randomized to the b2000 device or the standard needle and syringe for 4 weeks; all patients will use the b2000 device for the next 4 weeks. the anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients \>=16 years of age; * current or former fuzeon user who may benefit from needle-free administration of fuzeon; * naive to use of the b2000 device; * positive test results for human immunodeficiency virus infection. exclusion criteria: * patients naive to fuzeon; * inability to self-inject fuzeon, or no reliable caregiver to administer injections; * evidence of active, untreated, opportunistic infections.
efficacy of yoga for postpartum depression

Conditions: Depression, Postpartum

Summary: the aim of this project is to compare the efficacy of an 8-week yoga intervention, relative to a wait-list control (wlc) condition, for improving psychological functioning and health-related quality of life in depressed postpartum women. it was hypothesized that the yoga intervention would be significantly more efficacious than the wait-list control condition in reducing symptoms of depression and anxiety, and improving health-related quality of life, at the end of the 8-week yoga intervention.


Eligibility criteria:
inclusion criteria: * score of 12 or greater on the 17-item hamilton depressing rating scale * participant must reside within a 30 mile radius of the yoga studios * ≥ 6 weeks postpartum if delivery was either complicated and/or involved a cesarean section exclusion criteria: * current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, alcohol or drug abuse/dependence (except nicotine), or anorexia in the past year * acute suicidal or homicidal risk * current mental health treatment, including psychotropic medications or psychotherapy with a certified therapist * st. john's wort or fish oil * practiced yoga at a studio with a certified yoga instructor within the past month * significant medical disorder (e.g., seizure disorder) that is contraindicated for exercise in postpartum women

Keywords: yoga complementary and alternative medicine interventions treatment postpartum depression
inferior vena cava retrievable filters: spanish register

Conditions: Vena Cava Filters

Summary: spanish registry of retrievable vena cava filters. this registry is sponsored by the spanish society of vascular and interventional radiology (servei) and conducted by the research group gitmi (group of research in minimally invasive techniques) of the university of zaragoza (spain). a software tool hosted on the official website of servei and the journal intervencionismo will be used for data collection a(https://estudios.watsoncme.com).

this is an prospective observational study of patients that have been implanted a inferior vena cava filter with intention to be retrieved. patients are recruited when the filter is implanted, and the investigators observe when is it finally retrieved (dwell time), if retrieval is possible or not, and if there is any complication at the retrieval of the filter.

Eligibility criteria:
inclusion criteria: * indicated inferior vena cava filter implantation * signed informed consent exclusion criteria: * permanent filters (including retrievable filters intended to be used as permanent ones) * impossibility of follow-up (3, 6 and 12 months) * life expectancy less than a year * patient refusal to be included in the study, at any time

Keywords: retrievable inferior vena cava filters pulmonary embolism