Kornimate/medical-research-clean huggingface dataset:
a repeatability study of fatty acid uptake using pet/mr imaging in patients with t2dm and non-diabetic control subjects

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to evaluate the overall variation in the assessment of fatty acid uptake and blood flow in adipose tissue and skeletal muscle in the fasted and postprandial states by evaluating the repeatability of whole-body three-dimensional kinetic (4d) combined positron emission tomography and magnetic resonance imaging (pet/mri) readouts in participants with type 2 diabetes mellitus (t2dm), and non-diabetic control participants. each volunteer participates 4 scanning sessions.

a total of approximately 13 t2dm and 6 control subjects (a total of 19 subjects) are planned to be enrolled to achieve 11 t2dm and 5 control subjects to complete the study, assuming a 15% drop-out rate. the test-retest repeatability of the ratio of ftha uptake rates in subcutaneous adipose tissue (sat) to skeletal muscle is measured using the intra-class correlation coefficient (icc). assuming an icc of 0.85, with a 5% two-sided type i error rate, a sample size of 16 completers will yield approximately 90% power to detect an icc statistically significantly greater than 0.4 (usually considered as a criterion for moderate agreement). the total radiaooin burden for tshi sitdu yis 27.4 msv. the study is approved by the local ethical committtee and fimea.

Eligibility criteria:
inclusion criteria: * have a body mass index (bmi) between 25 to 40 kilograms per meter squared (kg/m²), * for participants with a confirmed type 2 diabetes diagnosis: the condition must be managed either by diet and exercise alone or on a stable dose of metformin * for nondiabetic subjects: participants must agree to keep their diet and physical activity habits stable throughout the study * female participants must be post-menopausal and male participants exclusion criteria: * poorly controlled diabetes * unstable body weight within 30 days prior to screening. * for non-diabetic control subjects: evidence of diabetes or prediabetes at screening. * having worked as a metal worker or welder * history of alcohol or drug abuse within 5 years of the screening * currently participating, or previous participation in another clinical trial within 30 days prior to the screening visit, or previous participation in another pet imaging study within 12 months.
cognitive assessment of elderly primary care patients

Conditions: Mild Cognitive Impairment

Summary: most primary care physicians do not screen older patients for cognitive impairment. identification of cognitive impairment may result in earlier referral for diagnostic work-up and earlier treatment and better patient outcomes. the purpose of this study is to determine whether physicians who receive the results of a cognitive screen use this information in treatment plans and whether this results in better cognitive outcomes for the older patients.

current trends in healthcare suggest that in the coming decade most older patients will obtain services solely through the general practice/family practice sector of healthcare. effective and optimal management of older patients with multiple complex medical conditions and compromised cognitive functioning will be a challenge for the primary care physician (pcp). early identification of older patients with cognitive deficits should allow early referral for diagnostic work-up and earlier treatment and better patient outcomes. the goal of this study is to investigate the utility of providing cognitive testing in the pcp office. pcps will be randomized to either treatment as usual (tau) or cognitive report (cr). the study hypotheses are (1) patients of physicians in the cr group will have improved clinical outcomes i.e. cognitively impaired patients in the cr group will have a slower rate of progression of cognitive deficits over two years than cognitively impaired patients in the tau group; (2) pcps in the cr group will order dementia screening tests, refer to specialists and prescribe anticholinesterase inhibitors more frequently than pcps in the tau group.

Eligibility criteria:
inclusion criteria: * age 65 or over * plan to remain a patient of this physician for two years * mmse score greater than 18 exclusion criteria: * diagnosis of dementia, alzheimer's disease, huntington's disease, vascular disease or other dementing disorder * mmse score of 18 or less * sensory deficit e.g. limited vision or hearing precluding cognitive testing

Keywords: cognitive decline cognitive impairment
media impact on preschool behavior

Conditions: Aggression; Prosocial Behavior

Summary: this study tests the hypothesis that modifying the media diet of preschool children so that they watch more prosocial programming and less violent programming will result in decreased aggression and increased prosocial behavior.


Eligibility criteria:
inclusion criteria: * 2.5-4 years of age * watches tv regularly * english speaking exclusion criteria: * no tv * non english

Keywords: tv violence dvds behavior preschool children
treatment of smoking among individuals with ptsd

Conditions: Cigarette Smoking; Nicotine Dependence; Post-traumatic Stress Disorder; Tobacco Use Disorder

Summary: this study will examine the effect of combining prolonged exposure, a cognitive-behavioral treatment program for post-traumatic stress disorder (ptsd) with medication (varenicline) and counseling treatments for smoking cessation. subjects will be randomly assigned to a 3-month treatment of either: 1) varenicline and smoking cessation counseling alone, or 2) prolonged exposure, varenicline, and smoking cessation counseling. assessments will be completed at the end of treatment and 6-month follow-up. we hypothesize that, at the end of treatment and at follow-up, abstinence rates and decrease in cigarettes smoked will be greater among participants who receive the combined treatment for both ptsd and smoking.


Eligibility criteria:
inclusion criteria: * male or female treatment-seeking cigarette smokers between 18-75 years old who smoke an average of ≥10 cigarettes/day during past year; * current diagnosis of chronic ptsd (symptom duration \> 3 months) with clinically significant trauma-related symptoms (pss-i \>= 20) * live a commutable distance to the university of pennsylvania and agree to follow-up visits; * agree not to use other forms of smoking cessation treatment or treatment for ptsd during the study period; * if taking sris or other medications at intake, have been on stable medication and dose regimen for past 3 months and agree to maintain current regimen if possible; * demonstrate the capacity to provide informed consent; * speak and read english. exclusion criteria: * history of drug or alcohol abuse or dependence in past 3 months or any unwillingness to not smoke marijuana during the first 13 weeks of the study; * current and continuing intimate relationship with a physically or sexually abusive partner; * current suicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment; * prior serious suicide attempt, as judged by the evaluator to have a high degree of lethality; * current or past history of psychosis (bipolar disorder or schizophrenia); * history of significant cardiovascular disease or uncontrolled hypertension in past 6 months; * women who are pregnant, likely to become pregnant (i.e., sexually active and not using contraception), or nursing.

Keywords: smoking cessation anxiety behavior therapy varenicline
a rct of psychosocial interventions facilitating positive psychological adaptation in breast cancer

Conditions: Breast Cancer Female

Summary: to test the effects of a 10-wk stress management interventions vs. a 5-wk control condition on positive psychosocial adaptation in women being treated for breast cancer. participants assigned to either of the stress management groups will show better positive psychosocial adaptation compared to those in the control group.


Eligibility criteria:
inclusion criteria: * aged between 20 and 70 years * newly diagnosed breast cancer patients in stages i, ii, or iii (with no prior history of cancer) * literate, without significant cognitive impairments * capable of writing and expressing themselves in chinese exclusion criteria: * major psychiatric disorders (such as schizophrenia), personality disorders, and substance addiction (excluding smoking) * currently participating in other breast cancer-related psychotherapy studies
pdt study for exudative amd with pcv

Conditions: Age Related Macular Degeneration

Summary: the purpose of this study is to evaluate and conduct an exploratory comparison of the efficacy and safety of indocyanine green angiography (icga) guided photodynamic therapy (pdt) and fluorescein angiography (fa) guided pdt for exudative age-related macular degeneration (amd) accompanied with polypoidal choroidal vasculopathy (pcv).

pdt with verteporfin has been proven beneficial for patients with amd. the laser spot size is decided based on fa finding (fa guided pdt). icga is needed to detect pcv lesions, such as polypoidal lesions or abnormal network vessels. in clinical practice, pdt based on icga (icga guided pdt) has and is being conducted for the treatment of amd with pcv. however, there are no reports on the outcomes of prospective research of pdt for pcv in japanese patients. furthermore, there are no reports comparing fa guided pdt and icga guided pdt. we propose to conduct this clinical research in order to investigate the efficacy and safety of pdt for pcv in japanese patients, and to compare results of fa guided pdt and icga guided pdt.

Eligibility criteria:
inclusion criteria: * japanese patients aged 50 years old or older * exudative amd with subfoveal pcv * eyes with pcv meets the definite criteria of pcv issued from japanese study group of polypoidal choroidal vasculopathy * pcv lesion with subfoveal hemorrhage or exudation * lesion size (gld) of less than 12 mps disc area measured by fa and ia. * decimal bcva of 0.1-0.5 at baseline period. exclusion criteria: * patients who have rpe tear, vitelliform retinal dystrophy, and central serous chorioretinopathy. * patients who have other ocular disease with irreversible va * study eyes unable to be taken fundus photos of cnv * study eyes received surgery operation within 2 months of the participation to this study or nd:yag operation within one month * pathological myopia * pcv with cleary identified subsensory retinal cnv (on the rpe) at the baseline examination * study eyes which have received any treatments for cnv, such as pdt, transpupillary thermotherapy, laser photocoagulation, and so on. * patients who have any physical problem for using angiography or pdt (such as systemic debility, significant diabetes mellitus, significant heart disease, and so on) * medical history of porphyria, porphyrin sensitivity, or hypersensitivity to sunlight or bright light. * patients with medical history of hypersensitivity to ingredients of visudyne * patients with medical history of hypersensitivity to ingredients of fluorescein or indocyanine green injection * patients with hypersensitivity to iodine * patients judged inappropriate for this study by the investigator

Keywords: amd pcv pdt
amped outcomes registry of post-ed pain management

Conditions: Soft Tissue Injuries; Gouty Arthritis; Fractures; Ureteral Colic; Dysmenorrhea

Summary: study aims to assess patient-recorded outcomes of pain control medications prescribed in the er after visits for specific painful injuries/illnesses.

multicenter, observational, prospective, out-of-hospital registry collecting clinical, satisfaction, quality of life, and healthcare resource utilization from subjects discharged after ed care for a specific acute pain syndrome with a clinician-determined analgesic regimen. subjects are stratified by diagnosis and by regimen based on the treating clinician's judgment. the registry study is independent of ed care and clinician's decision-making.

Eligibility criteria:
inclusion criteria: * eligible subjects will meet the following criteria: 1. eligible diagnoses: musculoskeletal etiologies: acute extremity fractures sprains/strains acute gouty arthritis visceral etiologies: renal colic dysmenorrhea 2. age gte 18 years; 3. decision to discharge from ed to community already made; 4. decision to give sprix, opioid, or sprix + opioid rescue already made; 5. treating clinician deems patient appropriate for continued analgesic management as an outpatient for the next 3-5 days; 6. patient has ready touch-tone (mobile or land line) telephone access, provides number (and back-up number, if possible) and agrees (verbal or written consent as mandated by site) to answer and comply with brief ivr questionnaires daily for next 4 days. exclusion criteria: * eligible subjects will meet none of the following criteria: 1. patient admitted or placed on observation status from ed; 2. patient unwilling or unable to comply with telephonic follow-up; 3. fracture that requires surgical repair (even if at a later date); 4. patient has diagnosis of any chronic pain syndrome; 5. patient already routinely takes nsaid or opioid agent; 6. treating clinician has reasonable suspicion of drug-seeking behavior or noncompliance; 7. nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor).

Keywords: pain control fractures sprains strains dysmenorrhea kidney stones gouty arthritis opioids nsdaids emergency department patient reported outcomes
acupuncture for the treatment of medication-dependent hypotension in heart failure

Conditions: Congestive Heart Failure; Hypotension

Summary: acupuncture is believed to increase blood pressure in people who struggle with low blood pressure. this is a common problem facing people with heart failure, and sometimes these people need to take medications to artificially increase their blood pressure. this study is designed to determine if using acupuncture in people with heart failure can improve their blood pressure enough to not require medications to artificially increase blood pressure.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years old * chronic congestive heart failure (systolic or diastolic) * medication list includes midodrine or fludrocortisone, either taking as scheduled or as needed exclusion criteria: * history of acupuncture of any kind in the last 3 months * acute decompensated heart failure, as indicated by clinical picture at time of enrollment * currently on a mechanical device (lvad, tah, ecmo) * history of hepatorenal syndrome, adrenal insufficiency, for which midodrine and fludrocortisone respectively is specifically being used to treat that condition * lack of suitable locations for which to place acupuncture seeds

Keywords: acupuncture midodrine fludrocortisone randomized controlled trial
cardiovascular health study (chs) events follow-up study

Conditions: Cardiovascular Diseases; Coronary Disease; Cerebrovascular Accident; Diabetes Mellitus; Heart Diseases; Hypertension; Heart Failure, Congestive

Summary: to support follow-up for the cardiovascular health study (chs) of coronary heart disease and stroke risk factors in adults 65 years or older.

background: the cardiovascular health study (chs) is an nhlbi-funded cohort study of risk factors for coronary heart disease (chd) and stroke in adults 65 years or older. in the early 1990s, 5888 participants underwent examinations that included traditional risk factors and measures of sub-clinical disease. during follow-up, many exam components were repeated, and cvd events were ascertained. the national heart, lung, and blood institute has extended chs contract funding (1) to implement a model for a transition from contract-funding to investigator-initiated research and (2) to enhance access to chs data for future papers and ancillary studies by chs and non-chs colleagues. the events follow-up study will provide a foundation for the transition. current and future papers and ancillary studies using chs data or stored specimens will have additional power and can be conducted more efficiently if a service events-core continues to collect and adjudicate cvd events and deaths in a standardized fashion. design narrative: structurally, the primary aims are: (1) to evaluate the incidence rates of and risk factors for cvd in older adults, including comparisons between blacks and whites, men and women, young old and old; (2) the evaluation of prognosis in inception cohorts of older adults with new-onset conditions such as heart failure (hf) and atrial fibrillation; and (3) the evaluation of associations between risk-factor change and the incidence of subsequent events. questions of interest include: what are the determinants of the low chd incidence in women 80 yrs and older? do older black women also have a low chd incidence? what are the determinants of chd, hf, and stroke in adults 80 and older? are risk factors different between men and women, whites and blacks? do traditional risk factors and measures of sub-clinical disease continue to be powerful predictors of chd, hf and stroke in those 80 and older? in this study, the investigators expect to make over 20,000 phone calls to identify 6000 hospitalizations, 1000 deaths, 3000 events for detailed review, and 1500 new events, including 370 chd, 300 stroke, and 450 hf. these new events represent an increase in the number of cvd events of 29% to 35% in whites and an increase of 40% to 49% in blacks. the data and specimens collected in chs represent a major national resource for the study of health, aging, and cardiovascular disease in older adults. additional events follow-up will not only provide the opportunity to address the aims of this study, but also enhance the power of current and future chs papers and ancillary studies by chs and non-chs colleagues.

Eligibility criteria:
no eligibility criteria
chronic pain onesheet clinical trial

Conditions: Chronic Pain

Summary: the purpose of the study is to determine whether and how having access to the chronic pain onesheet clinical decision support tool in epic affects the ordering, prescribing, goal-setting, risk monitoring, and outcome measuring behavior of participating primary care providers (pcps) in visits with patients with chronic pain conditions. the investigators will also assess whether access to the chronic pain onesheet results in pcps making chronic pain treatment decisions that are more concordant with the centers for disease control and prevention (cdc) guideline for prescribing opioids for chronic pain.

the chronic pain onesheet (onesheet) is an electronic health record (ehr) based clinical support tool developed and built in epic. the onesheet is a dashboard designed to assist pcps in treating patients with chronic pain conditions by providing an overview of patient information needed by pcps when treating these patients. the dashboard does not provide new information to pcps. instead, it works by aggregating and structuring information already being collected, available in other places in the medical record. by aggregating and structuring this information more conveniently, the goal of the onesheet is to make important information in clinical decision-making more readily available and reduce the time pcps need to spend locating this information. the study aimed to determine whether and how having access to the chronic pain onesheet activity in epic affects the ordering, prescribing, goal-setting, risk monitoring, and outcome-measuring behavior of participating pcps in visits with patients with chronic pain conditions. the investigators also assessed whether access to the chronic pain onesheet results in pcps making chronic pain treatment decisions that are more concordant with the cdc guideline for prescribing opioids for chronic pain. to test this, researchers conducted a two-arm pragmatic randomized controlled trial (rct), enrolling pcps across two health systems. the randomization occurred at the pcp level; the analysis occurred at the patient-visit level. the pcps signed an informed consent form, while the data from patient visits was obtained through a waiver of informed consent. the investigators assessed outcomes by analyzing ehr usage log files and pcp ordering records extracted from the healthcare systems' clinical data warehouses.

Eligibility criteria:
inclusion criteria: * primary care provider (including family medicine, internal medicine, med-peds, and general medicine) * can prescribe medication (i.e., doctor of medicine (md), nurse practitioner (np), physicians assistant (pa)) * sees patients at a primary care clinic at one of the two participating hospital systems exclusion criteria: * does not practice primary care * does not regularly see patients at a primary care clinic at one of the two participating hospital systems * cannot prescribe medication

Keywords: clinical decision support chronic pain care behavioral economics provider behavior
efficacy and safety study of netarsudil 0.02% ophthalmic solution compared to ripasudil hydrochloride hydrate 0.4% ophthalmic solution in japanese subjects with primary open angle glaucoma or ocular hypertension

Conditions: Primary Open Angle Glaucoma; Ocular Hypertension

Summary: a phase 3 study comparing the efficacy and safety of netarsudil ophthalmic solution 0.02% qd to ripasudil hydrochloride hydrate ophthalmic solution 0.4% bid, for treatment of primary open-angle glaucoma or ocular hypertension over a 4-week period.


Eligibility criteria:
inclusion criteria: * 20 years of age or older * diagnosis of poag or oht in both eyes (poag in one eye and oht in the fellow eye was acceptable) * medicated intraocular pressure (iop) ≥ 14 mmhg in at least one eye and \< 30 mmhg in both eyes at screening visit * for poag eyes, unmedicated (post washout) iop ≥ 15 mmhg and \< 35 mmhg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. at second qualification visit iop ≥ 15 mmhg and \< 35 mmhg at 11:00 and 16:00 hour (in the same eye). * for oht eyes, unmedicated (post washout) iop ≥ 22 mmhg and \< 35 mmhg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. at second qualification visit iop ≥ 22 mmhg and \< 35 mmhg at 11:00 and 16:00 hours (in the same eye) * best-corrected visual acuity (bcva) +0.7 log mar or better (20/100 snellen or better or 0.20 or better in decimal unit) in each eye * willingness and ability to give signed informed consent and follow study instructions exclusion criteria: * clinically significant ocular disease * retinal diseases that may progress during the study period * pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles * previous glaucoma intraocular surgery * refractive surgery in either eye * ocular hyperemia score of moderate (+2) or severe (+3) at qualification visit #2 * ocular trauma * ocular infection or inflammation * any corneal disease that may confound assessment * evidence of corneal deposits or cornea verticillata * known hypersensitivity to any component of netarsudil ophthalmic solution 0.02%, ripasudil hydrochloride hydrate ophthalmic solution 0.4%, or to topical anesthetic. * mean central corneal thickness \>620 um * any abnormality preventing reliable goldmann applanation tonometry of either eye (e.g. keratoconus) * cannot demonstrate proper delivery of the eye drop * clinically significant systemic disease * participation in any investigational study within 30 days prior to screening * women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.

Keywords: glaucoma, primary open-angle glaucoma ocular hypertension