Kornimate/medical-research-clean huggingface dataset:
building electronic tools to enhance and reinforce cardiovascular recommendations - heart failure (better care-hf)

Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction

Summary: building electronic tools to enhance and reinforce cardiovascular recommendations - heart failure (better care-hf) is a pragmatic, cluster-randomized, three-arm intervention trial that will compare the effectiveness of two targeted clinical decision support (cds) intervention tools (best practice alert (bpa) and automated in-basket massage) to inform providers when a patient with heart failure and reduce ejection fraction (hfref) is not on appropriate medical therapy, as compared to usual care.

an estimated 68,000 deaths per year nationwide can be attributed to gaps in care for patients with heart failure and reduced ejection fraction (hfref), with the majority being due to lack of mineralocorticoid receptor antagonists (mra). despite proven benefits in randomized trials, class i guideline recommendations, and published clinical performance measures, patients with hfref are often not on guideline-directed medical therapy (gdmt). while successful interventions for improvement in prescription of gdmt have often included multidisciplinary approaches with dedicated staff, the relatively high cost of hiring additional personnel has led to an interest in electronic health record (ehr)-based interventions. prior studies on ehr-based interventions in this arena have mainly been conducted in the inpatient setting, which is limited to one encounter during acute hospitalization, a setting often complicated by renal dysfunction or hypotension that can limit prescription of mra. the development and study of outpatient ehr-based alerts for hfref gdmt are needed. two types of outpatient ehr-based interventions include best practice alerts (bpa) and automated in-basket messages. both of these methods have limited data, with some studies showing benefit and others demonstrating provider fatigue and burnout. to our knowledge, there is no study that has directly compared these different types of ehr-based interventions. better care - hf is a pragmatic, cluster-randomized, three-arm intervention trail that will compare the effectiveness of two targeted cds intervention tools (bpa and automated in-basket message) as compared to usual care on the primary outcome of mra prescription at end of study period.

Eligibility criteria:
inclusion criteria: * cardiologist visit * transthoracic echocardiogram with the most recent ef \>= 40% exclusion criteria: * hypotension: sbp \< 95 * hyperkalemia: most recent k \> 5.1, or any k \>5.5 * renal dysfunction: egfr \< 30 * ventricular assist device * hospice care * cardiac amyloid

Keywords: best practice alert [bpa] in-basket message mineralocorticoid receptor antagonists [mra] guideline-directed medical therapy [gdmt] clinical decision support
endovascular abdominal aortic aneurysm repair by interventional cardiologists

Conditions: Endovascular Abdominal Aortic Aneurysm Repair (EVAR)

Summary: registry for endovascular repair of abdominal aortic aneurysm performed primarily by interventional cardiologists


Eligibility criteria:
inclusion criteria: * patients with abdominal aortic aneurysm amenable for endovascular repair exclusion criteria: * pregnant patients * patients less than 18 years old.

Keywords: endovascular abdominal aortic aneurysm repair (evar) abdominal aortic aneurysm (aaa)
sms technology for the promotion of diabetes education and self-management in egypt

Conditions: Diabetes Mellitus

Summary: this study was conducted at the teaching hospital of misr university for science \& technology. it aimed to examine the use of sms technology in educating and monitoring diabetic patients in egypt, and assess the impact of educational text messages on their glycemic control and self-management behaviors. participants were randomized into an intervention and a control group. intervention patients received an instruction booklet as well as daily educational and weekly reminder messages to better control their diabetes. control patients received the same instruction booklet but no sms messages. both group patients took an hba1c test at the beginning and end of the study period and were asked to measure their blood glucose once a week and record their readings into a monitoring table over 12 weeks. the primary outcome was the change in hba1c levels, which was expected to be greater among intervention patients at the end of the study. secondary outcomes included blood glucose levels, treatment and medication adherence, diabetes self-efficacy, rate of hospital/er visits, frequency of blood glucose measurement, among others.


Eligibility criteria:
inclusion criteria: * has diabetes * owns a mobile phone * can read sms messages or lives with someone that can read for them. exclusion criteria: * cannot read or not sms familiar and lives alone

Keywords: sms text messaging diabetes self management glycemic control mhealth mobile health diabetes education
patient registry of intrathecal ziconotide management(prizm)

Conditions: Patients With Severe Chronic Pain

Summary: the objectives of this study are to evaluate the effectiveness, long-term safety, tolerability, satisfaction with treatment, and health-related quality of life (hrqol) associated with intrathecal prialt use for severe chronic pain of varying etiologies.


Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age at the time of study entry. * patient who has severe chronic pain, whom it therapy is warranted, and who is intolerant of, or refractory to other treatments, such as systemic analgesics, adjunctive therapies, and/or it morphine. * patient is planned to be initiated on it prialt as the sole agent in the pump at a participated site. * patient has not received prialt treatment administered continuously via medtronic synchromed® ii pump within the past 30 days. * patient has a life expectancy \>6 months as determined by the physician. * patient is able to read, understand, and voluntarily sign the irb-approved informed consent document prior to the performance of any study-specific procedures. * patient is able to understand and complete required assessments. exclusion criteria: * patient has a known hypersensitivity to prialt or any of its formulation components. * patient has a pre-existing history of psychosis. * patient has infection at the microinjection site, uncontrolled bleeding diathesis, or known spinal canal obstruction that impairs circulation of cerebrospinal fluid. * patient is being initiated with prialt in conjunction with other it agents. * patients with any other concomitant treatment or medical condition that, in the opinion of the clinician, would render it administration hazardous.
dna microarray study of pancreas cancer

Conditions: Pancreas Cancer

Summary: pancreas cancer and precancerous cysts can be difficult to diagnose. sometimes biopsies do not show cancer when cancer is actually present. we hypothesize that genetic differences exist in tissue that is malignant compared to nonmalignant. when patients present with a pancreas mass or cyst, we biopsy it by fine-needle aspiration during upper endoscopy with ultrasound guidance. we would like to use tissue obtained via endoscopic ultrasound guided fine needle aspiration to perform dna microarray analysis, and compare the differences in gene expression level in the benign tissue compared to cancerous tissue in order to improve our diagnostic capabilities. dna microarray measures gene expression level rather than germline mutations. the true diagnosis will be based on cytology, surgical pathology, or clinical followup. the performance of the microarray test as a diagnostic test will be compared to the performance of cytology.


Eligibility criteria:
inclusion criteria: * adults aged 18 or older who are able to give informed consent who present for an endoscopic ultrasound to evaluate a pancreas mass or cyst or for suspicion of cancer. exclusion criteria: * unable to give informed consent, pregnant or nursing, contraindication to endoscopic ultrasound, no mass or cyst found on ultrasound

Keywords: pancreas cancer pancreas cyst dna microarray
use of an interactive 3d tool during consultation for breast reconstruction surgery

Conditions: Breast Cancer

Summary: the purpose of this study is to find out whether using an interactive 3d tool during a standard surgical consultation can lead to greater patient satisfaction with the information provided about breast reconstruction options than the standard consultation alone. the study researchers will also assess whether women whose surgical consultation includes the use of the 3d tool are more satisfied with their breasts and with the decisions they made about their reconstruction procedure.


Eligibility criteria:
inclusion criteria: * ≥18 years old * presenting at msk for initial breast reconstruction consultation * planning to undergo mastectomy at time of consultation * english spoken as primary language * able to provide informed consent without a legally authorized representative exclusion criteria: * prior breast reconstruction * prior breast reconstruction consultation with a plastic surgeon

Keywords: reconstruction surgery interactive 3d tool consultation 21-318
minnesota heart survey - mortality and morbidity

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction; Death, Sudden, Cardiac

Summary: to continue surveillance of coronary heart disease (chd) mortality and morbidity in the seven county metropolitan minneapolis/st. paul (twin cities) areas.

background: the minnesota heart survey (mhs) is among the few population-based longitudinal studies to monitor and explain trends in coronary heart disease (chd) mortality and morbidity, the leading cause of death and disability in the united states. it encompasses a large and well-defined community, the minneapolis/st. paul (twin cities) metropolitan area of minnesota, comprising a population of 2.3 million (1990 census) for almost two decade the minnesota heart survey has made contributions to understanding 1) the components of the decline of coronary heart disease mortality including incidence rate, hospitalized attach rate, case fatality, and population levels of chd risk factors; and 2) the methodology of disease surveillance in a time when classification and diagnostic technologies are constantly changing. design narrative: the minnesota heart survey continues surveillance of coronary heart disease (chd) mortality and morbidity in the seven county metropolitan minneapolis/st. paul (twin cities) areas through the year 2002. the study will also monitor trends in acute myocardial infarction (ami), evaluate the effect on ami diagnosis of the widespread use of new biomarkers (troponins), perform a validation study to the previous standard, and evaluate out-of-hospital sudden cardiac death (scd) through an autopsy study a combination of different techniques will be used for surveillance. chd deaths will be obtained from death certificate data from the minneapolis department of public health. census data will be used to construct the appropriate denominators. a major focus is based on in-hospital chd morbidity and mortality. data from the minnesota hospital and health care partnership, which originally receives data from 22 of the 23 area hospitals, will be used to identify and validate acute myocardial infarction (ami) cases. census data will again be used to obtain the appropriate denominators. an important issue in assessing time trends in hospitalized ami attack rate is the changing definitions used to identify cases over time. a specific issue in this regard is the increasing use of troponin levels that are more sensitive than previously used ckmb levels to identify cases. thus, a validation study will be conducted comparing these two methodologies on the same subjects. the goal of the study is to obtain correction factors so that time trends in ami attack rates are not influenced by differences in diagnostic criteria. a new important area of investigation is that of out of-hospital sudden cardiac deaths (scd). autopsy studies of 100 cases per year (about 300 total) will be conducted to describe risk factors for scd. in addition, comparisons will be made between a control group of 600 persons in the risk factor study. .

Eligibility criteria:
no eligibility criteria
pharmacogenomic study in patients of lung, colorectal and head/neck cancers receiving chemotherapy

Conditions: Lung Cancer; Colorectal Cancer; Head and Neck Cancer

Summary: the purpose of this study is to look at several genes that might determine how the body processes the drugs used to treat lung, colorectal and head and neck cancers. the goal of this examination is to help investigators determine the proper dosage to give future cancer patients or to better predict which future patients will respond to particular drug therapies.

this study is to establish a pilot pharmacogenomic program in identifying genetic variation to predict the safety, toxicity and/or efficacy of drugs. dna will be extracted from patients' peripheral blood to study snps in dpd, ts, mthfr, ugt1a1, cyp3a4, cyp3a5, gstm1, gstt1, gstp1, ho-1, ercc1, xpd, xrcc1 and egfr genes. the results of genetic study will be compared to treatment efficacy and toxicity. the ultimate goal is to use genotype profiles to provide individualized cancer treatment to improve outcome and decrease toxicity.

Eligibility criteria:
inclusion criteria: * lung, colorectal and head and neck cancer patients that have received or plan to receive chemotherapy as part of their treatment exclusion criteria: * colorectal cancer patients that have never received or will not receive chemotherapy as part of their therapy * head and neck cancer patients that have never received or will not receive chemotherapy as part of their treatment * patients with cancer types other than colorectal or head and neck * unable to give informed consent
acceptability and feasibility of simultaneous screening for viral hepatitis b, c and hiv among drug users and vulnerable populations, in non-conventional structures "outside the walls" by dual screening method rtds and fibroscan®

Conditions: Viral Hepatitis

Summary: the "scanvir" concept aims to achieve barriers to hcv screening and treating of marginalized patients. the concept is applicable to other various populations and territories and should effectively improve hcv patient's health outcomes. the main objective of the scanvir project was to evaluate the feasibility, acceptability and reproducibility of a "test, treat and cure" strategy for pwids and vulnerable populations during dedicated days in addiction care centers.

according to the french recommendations, eliminating hepatitis c virus by 2025 could be a realistic public health goal in this country. a total of 71,466 patients had treatment initiation between 2015 and 2019. it is estimated that 100 000 people are still infected in 2019. to meet these ambitious objectives, effective screening policies should be intensified and access to treatment promoted through new care strategies for patients who escape the usual care pathways i.e. people who inject drugs (pwids), prisoners, migrants and vulnerable populations. pwids represent a large proportion of patients to be screened and treated. it's still not possible to accurately evaluate the number of drug users who are infected with hcv (45 000 people estimated). drug users sharing needles and syringes have poor access to treatment. dealing with pwids in addiction care centers (csapa and caarud in france) is one way to promote hcv testing, and to keep them in the care pathway. this population requires dedicated models that reduce barriers to care: harm reductions policies, access to therapy in real time and follow-up for the detection of reinfection. so the investigator designed and applied a new innovative concept to test, treat and cure pwids in their own environment, called the scanvir program, initially tested in four french departments with a regional and now national extension.

Eligibility criteria:
inclusion criteria: * adult 18 and over * patient frequenting an unconventional structure "outside the walls" or referred by a professional in the care sector * patient not opposed to research exclusion criteria: * age under 18 * patient opposed to research

Keywords: hcv eradication marginalized patients
to demonstrate the superiority of imp (0.3% and 1% opa-15406 ointment) versus the vehicle in pediatric patients with ad

Conditions: Atopic Dermatitis (AD)

Summary: a multicenter, randomized, double-blind, vehicle-controlled, parallel group trial to demonstrate the superiority of 0.3% and 1% opa-15406 ointment to vehicle in pediatric subjects with ad. this trial consists of the 0.3% opa-15406 group, the 1% opa-15406 group, and the vehicle group.

1. screening period is defined as the interval between the day of obtaining informed consent and the day of the baseline visit (0-30 days). the investigator performs a screening examination after obtaining informed consent from the subject's legal guardian (and, if possible, after obtaining consent from the subject). 2. assessment period (4 weeks double blind treatment period) is defined as the period between the day of baseline visit and the end of week 4 visit (or the end of withdrawal visit). subjects who meet the inclusion criteria and do not meet the exclusion criteria at the baseline visit will be assigned to receive 0.3% or 1% opa-15406 ointment or comparator (vehicle \[placebo\]). the allocated imp will be administered to the treatment area from the day of baseline visit twice-daily for 4 weeks. after the baseline visit, examinations will be performed at weeks 1, 2, and 4. if a subject discontinues the imp administration between the day of baseline visit and the day of the week 4 visit, a withdrawal visit will be performed for that subject. 3. trial period(4 weeks double blind treatment) the trial period for an individual subject is the period from the day of obtaining the written informed consent from the subject's legal guardian to the day of the week 4 visit or withdrawal visit. for subjects who miss the week 4 visit or withdrawal visit, the termination date, will be the date, as determined by the investigator, when the subject is withdrawn from the trial. the trial period does not include a follow-up period for ae. 4. 24 weeks, open label, long term treatment period to be eligible for long term treatment, subjects must complete the randomized, double-blind treatment. subjects must be judged by their investigators to have the potential for clinical benefit by longer-term exposure to opa-15406, they can continue to receive 0.3% or 1% opa-15406 open treatment for up to 24 weeks based on the inform consent of the subjects.

Eligibility criteria:
inclusion criteria: 1. sex: either male or female. age: 2 to 14 years, inclusive (at time of obtaining informed consent) (only for 4 weeks double blind treatment). 2. diagnosis of ad based on the criteria of hanifin and rajka (see appendix 1). 3. atopic dermatitis affecting ≥5% to ≤40% of bsa (excluding scalp) at the screening and baseline visit(only for 4 weeks double blind treatment). exclusion criteria: 1. subjects who defined as ad or contact dermatitis rapid deterioration, within 28 days prior to the baseline visit.
feasibility of a mindfulness intervention for endometriosis surgery

Conditions: Endometriosis; Pain; Mindfulness

Summary: endometriosis is a common cause of pelvic pain in women which has been historically under-studied and under-diagnosed. the goal of this research is to pilot-test the feasibility and acceptability of a manualized, single-session brief mindfulness-based intervention (bmbi) among participants with endometriosis-related chronic pelvic pain (ecpp) who undergo surgical treatment, and gather preliminary data necessary for future studies assessing bmbi's impact on outcomes in surgically-treated ecpp. this pilot study will enroll 10-20 adult participants with ecpp to receive either a bmbi adjunctive to treatment as usual (tau; n=5-10) or education with tau (n=5-10) prior to their ecpp surgery. the central hypothesis is the bmbi is feasible to deliver pre-operatively, acceptable to patients, and may help improve acute post-surgical outcomes through more adaptive stress coping and pain processing, enabled by mindfulness training.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. diagnosis or probable diagnosis of endometriosis 3. candidate for surgical procedure for endometriosis 4. english speaking 5. have access to wifi and email exclusion criteria: 1. prior formal mindfulness training 2. unable to consent
impact of pycnogenol® on gingival inflammation

Conditions: Periodontitis

Summary: this randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial is designed to evaluate the impact of the regular consumption of a polyphenol-containing maritime pine (pinus pinaster) bark extract (pycnogenol®) on clinical signs of gingival inflammation in a cohort of periodontal aftercare patients

polyphenols are natural compounds produced by plants that have various functions, such as defence against microbial pathogens or protection against uv light. based on their antioxidant activity, a soothing or preventive effect of polyphenols on various inflammatory diseases has been suspected. there is evidence of an anti-inflammatory effect of polyphenols in manifest periodontitis as well as antibacterial properties of these compounds. in addition, it is discussed that dietary polyphenols intervene in mechanisms involved in the pathophysiology of arteriosclerotic changes and their progression. this randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial is designed to evaluate the impact of the regular consumption of a polyphenol-containing maritime pine (pinus pinaster) bark extract (pycnogenol®) on clinical signs of gingival inflammation in a cohort of periodontal aftercare patients

Eligibility criteria:
inclusion criteria: * number of teeth ≥ 10 * age ≥ 35 ≤ 90 years * body mass index (bmi) ≥ 20 ≤ 30 * history of periodontal disease and inclusion in a regular scheme of supportive periodontal therapy (regularly repeated subgingival biofilm removal 2-4 x/year) * minimum of 10% probing sites displaying bleeding on probing exclusion criteria: * manifestation of inflammatory oral mucosal diseases other than gingivitis * xerostomia (stimulated salivary flow ≤ 0.1 ml/minute) * inability to perform regular oral home care * inability to follow the study protocol due to intellectual or physical handicaps * history of malignancy, radiotherapy, or chemotherapy for malignancy in the past 5 years * current pregnancy * acute infections such as hiv * manifestation of metabolic bone disease * use of antibiotics and/or anti-inflammatory medications within 4 weeks prior to screening. * current orthodontic therapy