Kornimate/medical-research-clean huggingface dataset:
safety and tolerability of varying load and dose of isis 301012 in people with elevated ldl-cholesterol levels

Conditions: Hypercholesterolemia

Summary: the aim of this study is to assess the safety and tolerability of varying dose and load regimens of isis 301012 in people who have elevated ldl-cholesterol levels.


Eligibility criteria:
inclusion criteria: * bmi \>/= 25 to \</= 32 kg/m\^2 * fasting stable ldl-cholesterol \>/= 130 mg/dl (3.36 mmol/l) and triglycerides \< 400 mg/dl (4.55 mmol/l) * females not of childbearing potential exclusion criteria: * no endocrine, hematologic, renal, hepatic, metabolic, psychiatric, neurology, pulmonary or cardiovascular disease * subjects who test positive for hepatitis b, c or hiv * current diagnosis or known history of liver disease, such as acute or chronic hepatitis, liver cirrhosis, liver steatosis, or liver function abnormalities such as ast, alt, ggt, or total bilirubin \>/= 1.5 x uln at screening * a systolic blood pressure \>/= 160 mmhg or a diastolic blood pressure \>/= 95 mmhg on 2 occasions during screening * concomitant medications within 14 days of dosing, except hormone replacement therapy for post-menopausal women and acetylsalicylic acid or paracetamol dosed for fewer than five consecutive days * subject has taken any lipid-lowering drug within 30 days or five half-lives (of the lipid-lowering drug) whichever is longer, prior to screening * alcohol or drug abuse within 2 years of screening * donated blood (450 ml) within the 3 months prior to screening or suffered significant blood loss equal to a blood donor portion * subject smokes \> 10 cigarettes, or more than one pipe or one cigar per day

Keywords: ldl-cholesterol apob-100 apob-48
clinical research on the effect of different extents of internal limiting membrane peeling on macular hole closure and visual acuity

Conditions: Macular Holes

Summary: observing and describing the surgical effects of different extents of internal limiting membrane peeling combined with internal limiting membrane insertion for macular hole


Eligibility criteria:
inclusion criteria: * clear diagnosis of macular hole; * the minimum diameter of the macular hole is \>400 μm; * without serious systemic disease that make patients can not be operated; exclusion criteria: * suffering from severe retinal diseases such as: diabetic retinopathy, age-related macular degeneration, peripheral retinal detachment, pvr, etc.; * opacitas in the refractive medium can not perform angio-oct and visual acuity examination; * eye acute and chronic inflammation, such as acute contagious conjunctivitis, acute and chronic keratitis, acute dacryocystitis; * traumatic macular hole, secondary macular hole, high myopia macular hole, etc.; * having a history of vitrectomy surgery; * glaucoma in stage of preclinical, severe stenosis or closure;
naltrexone vs buprenorphine-naloxone for opioid dependence in norway

Conditions: Opioid Dependence

Summary: persons dependent on opioids like heroin, morphine, or codeine have a high risk of relapse, overdose and overdose death. this risk is elevated even further following discharge from treatment or correctional institutions where patients have been detoxified. at the moment, state-of-the-art treatment is based on maintaining the dependence on opioids by daily intake of opioid medications like methadone or buprenorphine. recently, a medication containing the blocking agent naltrexone was approved in the us; this does not maintain dependence but instead blocks heroin and other opioids for 28 days after intramuscular administration. this study will conduct a 12-week randomized comparison of naltrexone intramuscular suspension (xl-ntx) with daily buprenorphine-naloxone in omt. medication will start preceding discharge from a treatment or correctional facility to participating catchment regions in norway. the main hypotheses are that xl-ntx will do equally well as - or better than - omt on the proportion of biological samples negative for opioids, retention, self-reported use of alcohol and illicit drugs. following the 12-week randomized period, there will be a 36-week period where participants can receive the study medication of their choice. after the end of the study, data from national registry databases can be collected for a further 12 months on outcomes such as recidivism, mortality and morbidity.


Eligibility criteria:
inclusion criteria: * opioid dependence (dsm-iv tr) * age 18 or above * applied \& approved for norway's national omt program * discharge within 30 days of inclusion from a controlled environment; e.g. inpatient treatment or correctional (prison) facility * voluntarily seeking treatment for opioid dependence exclusion criteria: * pregnant or breast-feeding * acute or recurring severe psychiatric disorder, e.g. psychosis, suicidality * serious debilitation of liver or renal function (e.g. child-pugh level c) * use of excluded medication * known intolerance to study drugs or their ingredients * employment in firm manufacturing one of the study drugs or close relation to such person
tavr for aortic valve disease

Conditions: Aortic Valve Disease

Summary: transcatheter aortic valve replacement (tavr) has became an important treatment of severe aortic stenosis (as). several randomized clinical trials showed that tavr was non-inferior or superior to surgical aortic valve replacement (savr). however, many different issues have emerged: tavr in younger patients? valve leaflet thrombosis? transcatheter valve durability? coronary reaccess after tavr? tavr in bicuspid aortic valve? tavr in aortic regurgitation? etc. hence, a prospective, multicenter database is created to provide the real-word data for these questions.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of severe aortic stenosis or aortic regurgitation 2. patients undergo transcatheter aortic valve replacement exclusion criteria: patients refuse the clinical follow-up
compare the safety and efficacy of genoss® dcb and sequent® please in korean patients with coronary in-stent restenosis

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of paclitaxel-coated balloon (genoss® dcb) by demonstrating non-inferiority to in-segment late lumen loss at 6 months after the procedure in patients with in-stent restenosis (isr) compared with a product of the same category (sequent® please)

in a randomized controlled trials to compare with the same-category medical device (sequent® please), 82 patients with in-stent restenosis (isr) were recruited from a total of 7 institutions, and the enrolled subjects were 1: 1 through randomization. the ratio was assigned to the test group and the control group, and each of the test or control devices was assigned to receive the procedure. drug release "stents" for pci usually follow 9 months or 12 months, but the medical device for this clinical trial has a drug coated "balloon catheter" and the mechanism of action is different from the stent and the duration of follow up was set to 6 months.

Eligibility criteria:
inclusion criteria: * age ≥19 years old * patients with significant coronary artery stenosis including left main coronary lesion (\> 50% diameter stenosis on coronary angiography) * patients with stable angina pectoris, or unstable angina pectoris, and asymptomatic myocardial ischemia * patients suitable to receive coronary revascularization of any type * restenosis mehran type i-iii after stent implantation for the first time * patients with in-stent restenosis after 90 days of the stent implantation, and the degree of restenosis corresponds to mehran type i-ⅲ. * diameter of the stent with restenosis should be 2.0-4.0mm (included). length of the stenosis lesion should be no more than 40mm * in case of voluntarily deciding to participate in this clinical trial by signing the informed consent form exclusion criteria: * patients with infarct related artery (ira) lesions among patients with acute myocardial infarction * patients have restenosis lesions with thrombosis * patients with a history of cardiogenic shock * patients with total occlusion indicating timi 0 blood flow at the target lesion (mehran type iv stenosis) * patients with graft vessel lesion * patients who are contraindicated in aspirin, heparin, clopidogrel, ticlopidine, and paclitaxel * patients with renal insufficiency (egfr\<30ml/min) * pregnant or lactating women * the patients have a life expectancy of less than 12 months * patients who had reduced immunity or clinically significant abnormalities in the laboratory tests (hematological, serum biochemical, and urine tests) performed at the time of screening * patients who had clinically significant disorders in cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system, or mental illness that significantly affects this study * patients who are unsuitable for the study according to the investigator judges

Keywords: in-stent restenosis
evaluating control of hypertension - effect of social determinants

Conditions: Hypertension

Summary: this study evaluates the impact of a large-scale, national expansion of medicaid on hypertension incidence, screening, treatment, and management. social determinants of health will be assessed as moderators, and comparing states that did versus states that did not expand medicaid will also be evaluated.

the affordable care act (aca) enacted several provisions intended to improve healthcare for vulnerable populations,including expanding medicaid eligibility to those earning ≤138% of the federal poverty level (fpl). since the expansion was not required, as of march 2018, 32 states (and district of columbia) implemented the expansion and 18 did not. simulated models predicted the aca would improve health outcomes and reduce disparities for patients with hypertension, yet actual changes are not yet available. in addition, there is new interest in tracking and utilizing social determinants of health (sdh) in the primary care setting but there is currently little information on how this information will impact hypertension (htn) care, especially related to changes to health insurance availability. this study will build on current understanding of how health insurance impacts htn incidence, screening, treatment, and management by comparing states that did versus did not expand medicaid as part of the aca and seeks to understand the influence of sdh on these changes. the investigators will address the following specific aims: aim 1: compare htn incidence, prevalence of undiagnosed htn, and rates of htn screening, in medicaid expansion versus non-expansion states before and after the aca. aim 2: compare htn treatment (e.g., medication use), and management (e.g., htn control, systolic and diastolic blood pressure change, risk factors related to htn control) in medicaid expansion versus non-expansion states before and after the aca. aim 3: assess the extent to which rates of htn incidence, screening, and treatment effectiveness among patients who gained insurance versus those continuously insured or uninsured, pre-post aca, are moderated by individual-level sdh (e.g., race, ethnicity), in expansion states. aim 4: explore the interaction between community-level sdh (e.g., neighborhood racial segregation and deprivation) and htn incidence, screening, treatment, and management among patients who gained insurance relative to those who were continuously insured or uninsured, in expansion states. the findings from this project will be extremely relevant to policy and practice, informing further improvements in the us healthcare system to ensure access to healthcare for vulnerable populations.

Eligibility criteria:
inclusion criteria: * patients in intervention and control states aged 19-64 exclusion criteria: * patients outside of age range 19-64

Keywords: hypertension social determinants of health health insurance medicaid affordable care act
pilot trial of centeringpregnancy with mindfulness skills

Conditions: Premature Birth; Low Birth Weight; Postpartum Depression

Summary: in the u.s., rates of preterm birth and low birth weight have increased over the past 30 years. poor birth outcomes are especially high among racial/ethnic minority populations. maternal stress is an important factor that can lead to negative birth outcomes. thus, programs that reduce stress during pregnancy could improve birth outcomes. initial pilot work tested a mindfulness-based approach to stress reduction during pregnancy. women in the pilot study had lower stress and improved coping after the program. for the current study, mindfulness is added to an existing prenatal healthcare program called centeringpregnancy (cp). cp provides prenatal care through 10 group sessions. this study compares cp with a version of cp infused with mindfulness skills training. effects of the two versions of cp on psychological stress and coping, stress hormones, and birth outcomes will be tested. data will be collected from participants three times: twice during pregnancy and once after birth. medical records will provide data on birth outcomes and other health factors. the study will provide initial information about a mind-body program to reduce stress and improve birth outcomes. data from the study will inform the development of an r01 proposal for a larger study. the study will also help advance the long term goal of reducing health disparities.


Eligibility criteria:
inclusion criteria: * age 18 and over * enrolled to receive group-based prenatal healthcare from the san francisco general hospital (sfgh) outpatient midwifery clinic centeringpregnancy program exclusion criteria: * ineligible for centeringpregnancy due to the need for individualized prenatal care * type 2 diabetes * hiv * seizure disorder * serious mental health disorder * substance abuse or medical condition that would lead to inability to adhere to intervention guidelines * not fluent in english or spanish * previous formal training in meditation, yoga, or other mind-body practice * previous participation in centeringpregnancy

Keywords: mindfulness stress coping emotion depression group medical visits prenatal healthcare preterm birth birth weight postpartum depression cortisol neuroendocrine function blood pressure health disparities
harnessing neuroplasticity to enhance functional recovery during chronic recovery from upper extremity nerve repair

Conditions: Hand Transplantation; Peripheral Nerve Injuries; Neurologic Rehabilitation

Summary: this study adopts a strategy that has arisen from basic neuroscience research on facilitating adaptive brain plasticity and applies this to rehabilitation to improve functional recovery in peripheral nervous system injuries (including hand transplantation, hand replantation, and surgically repaired upper extremity nerve injuries). the technique involves combining behavioral training with transcranial direct current stimulation (tdcs)-a non-invasive form of brain stimulation capable of facilitating adaptive changes in brain organization.

this study will implement and evaluate an innovative program of post hand transplant rehabilitation; one that harnesses recent discoveries in neuroscience to facilitate long-term, experience-dependent adaptations within the brain's sensory and motor systems. the current approach to rehabilitation of function in allogeneic hand transplant recipients is largely the same as standard-of-care following hand replantation (re-attachment) and peripheral nerve repairs. this involves an eclectic combination of traditional therapies. in seeking to improve on this approach, there is potentially much to be gained by considering evidence that limb amputation not only impacts the peripheral nervous system but also the brain, and tailoring interventions accordingly.

Eligibility criteria:
inclusion criteria: * individuals whom have received a unilateral allogeneic transplantation proximal to the wrist and are at the chronic stage of recovery (approx. 12 - 18 months following surgery, when tinel's sign reaches the distal fingertips). * individuals whom have undergone a complete amputation the hand between the wrist and elbow followed by successful re-attachment and are at the chronic stage of recovery (approx. 12 - 18 months following surgery, when tinel's sign reaches the distal fingertips). * individuals whom have undergone repairs of the median, ulnar, or other related or nearby nerve(s) following complex volar forearm lacerations or other injuries between the distal wrist crease and the flexor musculotendinous junctions. individuals must be at the chronic stage of recovery (approx. 12 - 18 months following surgery, when tinel's sign reaches the distal fingertips). exclusion criteria: * individuals with significant/severe brain trauma * serious psychiatric conditions * chronic or severe neurological conditions. * current pregnancy * history of seizures or unexplained loss of consciousness * metallic implants above the chest * certain implanted medical devices.

Keywords: rehabilitation neuroscience transcranial direct current stimulation rehabilitation therapy neuroplasticity transplantation hand therapy constraint induced movement therapy peripheral nerve injuries tdcs cimt
impact of anticoagulants and antiplatelets in patients on transurethral resection of the prostate

Conditions: Benign Prostatic Hyperplasia; Prostate Cancer

Summary: benign prostatic hyperplasia(bph) is a common disease in urology among old men. if bph symptom cannot be controlled by drugs, then transurethral resection of the prostate (turp), is recommended. although the procedure is quit safe, these old men often take anticoagulants and antiplatelets to control cardiovascular diseases, which arose some concerns for their bleeding risk. the management of anticoagulation in patients undergoing surgical procedures is challenging because interrupting anticoagulation increases the risk of thrombotic events. at the same time, surgery and invasive procedures have associated bleeding risks that are increased by the anticoagulant administration. now, the recommendation about anticoagulants and antiplatelets discontinuation had no concrete evidence, especially in turp. furthermore, there is no relative studies done in taiwan population, which calls for further investigation.


Eligibility criteria:
inclusion criteria: * admitted to national cheng kung university hospital urology during the study * older than 20 years old * agree to participate this study * receiving transurethral resection of the prostate for benign prostatic hyperplasia or prostate cancer exclusion criteria: * poor expression ability and without close care givers to answer questions

Keywords: transurethral resection of the prostate anticoagulants platelet aggregation inhibitors
actigraphy and neonatal abstinence syndrome of hospitalized newborn in intensive care units

Conditions: Neonatal Abstinence Syndrome

Summary: the aim of this study is to analyse the correlation between actigraphy and lipsitz scoring system in neonatal opioid abstinence syndrome of hospitalized newborn in intensive care units

hospitalized newborn in intensive care units can receive opioids to manage pain or sedation. neonatal opioid abstinence syndrome can occur when newborn receive opioid treatment for a long time. many scoring systems, like lipsitz scoring system, are used to diagnose and manage neonatal abstinence syndrome but they are subjective. the majority of items in these scores are motor skills items. actigraphy allows to measure objectively the newborn motricity. this study will analyse the correlation between actigraphy and lipsitz scoring system.

Eligibility criteria:
inclusion criteria: * newborn \> 22 gestation weeks * hospitalization in neonatal intensive care unit at chu de caen. * opioids treatment \> 48 hours. exclusion criteria : * ante or post-natal brain injury diagnosis * upper arm motor deficit * palliative care
safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis receiving carotid endarterectomy

Conditions: Carotid Artery Stenosis

Summary: the purpose of this study is to explore the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis receiving carotid endarterectomy.

in this study, 100 patients with carotid artery stenosis receiving carotid endarterectomy are included in our center in china according to the principle of random, and parallel control. the experimental group receive basic treatment and remote ischemic conditioning for 200mmhg, 2 times per day for 6 consecutive days. the control group receive basic treatment and remote ischemic conditioning control for 60mmhg, 2 times per day for 6 consecutive days. two groups will be followed up for 90 days to evaluate the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis receiving carotid endarterectomy.

Eligibility criteria:
inclusion criteria: 1. age≥18 years, \<80 years, regardless of sex; 2. symptomatic or asymptomatic carotid artery stenosis. in symptomatic patients the degree of stenosis should more than 50% (based on north american symptomatic carotid endarterectomy trial collaborators (nascet) criteria), in asymptomatic patients the degree of stenosis should more than 70% (based on nascet criteria); 3. baseline mrs 0-2; 4. can cooperate with and complete brain magnetic resonance imaging (mri) examination; 5. signed and dated informed consent is obtained; exclusion criteria: 1. evolving stroke; 2. chronic complete occlusion of the carotid artery without obvious symptoms of cerebral ischemia; 3. severe dementia; 4. the causes of cardiogenic embolism, such as rheumatic mitral or aortic valve stenosis, artificial heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, left ventricular wall thrombosis or valve tumor, congestive heart failure, bacterial endocarditis, etc; 5. uncontrolled hypertension (defined as systolic blood pressure ≥ 180 mmhg or diastolic blood pressure ≥ 110 mmhg, despite medication taken at enrollment); 6. severe hepatic and renal dysfunction (defined as aspartate aminotransferase (ast) or alanine aminotransferase (alt) ≥3 times higher than the upper limit of the normal range, creatinine \>265umol/l (3mg/dl)); 7. the patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb. acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc; 8. pregnant or lactating women; 9. he/she is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission; 10. other conditions that the researchers think are not suitable for the group.

Keywords: remote ischemic conditioning carotid artery stenosis carotid endarterectomy