Kornimate/medical-research-clean huggingface dataset:
surefire precision infusion system registry

Conditions: Hepatocellular Carcinoma

Summary: this project involves the collection and analysis of retrospective and prospective data on patients diagnosed with hepatocellular carcinoma (hcc) in which the surefire precision infusion system was used/will used be to deliver transarterial chemoembolization with doxorubicin-eluting beads (deb-tace). the purpose is to compare tumor and medical response in a real-world setting as well as identify potential areas for future clinical research.

conventional transarterial chemoembolization with lipiodol/doxorubicin (ctace) is known to prolong survival compared to supportive therapy in certain patients with unresectable hcc, including patients with unilateral portal vein invasion (pvi). the best results for ctace occur when the dose is delivered in a highly targeted manner into the tumor. dense accumulation of embolic spheres or lipiodol into the tumor as documented by computed tomography (ct) has been shown to have improved outcomes. however, with standard endhole catheters, achieving maximum delivery of embolic agents is significantly limited by the development of stasis, non-target delivery and subsequent non-target injury. thus, when this procedure is performed with endhole catheters, there is significant variability in the delivery of the agent that is entirely dependent on the flow pattern of the target tumor. therefore, current techniques result in various degrees of embolization with variability in dosages and angiographic endpoints. deb-tace is a relatively new modality associated with favorable systemic doxorubicin exposure/toxicity and liver-specific toxicity compared to ctace. it is currently utilized for: (1) patients who have unresectable hcc; (2) patients who meet the milan criteria and are currently on liver transplantation lists; and (3) downstaging patients into milan criteria for possible liver transplantation.

Eligibility criteria:
inclusion criteria: * patients who have undergone or will undergo deb-tace for hcc delivered by the surefire® precision infusion system * patients aged 18 years or older * diagnosis of hcc * has a discrete hepatic artery(s) feeding the vessel with diameter(s) of the vessels ≥ 1.5 mm exclusion criteria: * contraindications for doxorubicin administration * vessels providing flow to the tumor that are \< 1.5 mm in diameter(s) * patients who are unable to provide informed consent

Keywords: hepatocellular carcinoma deb-tace
promoting nutrition and physical activity in family child care

Conditions: Diet, Healthy; Physical Activity; Obesity, Childhood

Summary: the cheer study takes advantage of a natural experiment happening in south carolina (sc). the south carolina department of social services implemented new healthy eating and physical activity standards through a state-wide policy for family child care homes that participate in the abc grow healthy program. thus, cheer is a quasi-experimental, two-group, pre-test/post-test design study.

the overall goal of the study is to evaluate new healthy eating and physical activity standards targeting family child care homes in south carolina. to accomplish this goal, we are assessing the effects of the standards on the dietary intake and physical activity levels of racially diverse low-income children in family child care homes. the specific aims of the "cheer" study are as follows: aim 1. evaluate the extent to which the new regulatory standards impact children's dietary intake assessed via direct observation in homes and 24-hour recalls with parents, and physical activity and sedentary behavior assessed via accelerometry. aim 2. evaluate the extent to which the new regulatory standards impact children's body mass index computed from researcher-measured height and weight. secondary aim. evaluate the extent to which family child care homes in the sc abc child care program comply with the new healthy eating and physical activity regulatory standards, compared to family child care homes not participating in the program. we hypothesize that most homes will comply with the new standards, yielding improvements in children's healthy eating and physical activity levels. as an exploratory aim, we will examine the effects of the standards on children's weight status.

Eligibility criteria:
inclusion criteria: * having a child in care between the ages 2 and 4 years at recruitment * the family is planning to stay in the same care arrangement for the next few years exclusion criteria: * family planning to leave the care arrangement in next few years
pharmacodynamics, pharmacokinetics, safety and tolerability of pth analog tablets in postmenopausal women

Conditions: Postmenopausal Osteoporosis

Summary: this study is designed to provide information about the bone anabolic properties and absorption profile of unigene's pth analog when administered as oral tablets over a period of 24 weeks to postmenopausal women with osteoporosis.

the choice of a 24-week treatment period was based on published studies of pth which demonstrate its potential to produce a statistically significant increase in bmd in patients with postmenopausal osteoporosis within that observation period.

Eligibility criteria:
inclusion criteria: * healthy postmenopausal women (45-80 years old) with a diagnosis of osteoporosis exclusion criteria: * use of estrogen or hormone replacement therapy * use of bisphosphonates, strontium ranelate or denosumab * use of parathyroid analogues or other bone metabolic agents * medical conditions which might alter bone metabolism * any known clinically significant disease affecting calcium metabolism or history of metabolic disorders including paget's disease, osteogenesis imperfecta, or osteomalacia * impairment of thyroid function

Keywords: osteoporosis bone diseases, metabolic bone diseases bone density conservation agents
posterior tibial transcutaneous neurostimulation in idiopathic overactive bladder

Conditions: Overactive Bladder

Summary: overactive bladder is a clinical diagnosis affecting up to 17% of women. the existing medical treatment, anticholinergics, has many side effects and is sometimes ineffective. neurostimulation of the posterior tibial nerve is a validated 3rd-line therapy, after failure of perineal re-education and medication. studies on tens have shown a real impact on patients quality of life and encourage its use in routine clinical practice. tensi+ medical device is a treatment for overactive bladder. it is non-invasive, placed over the posterior tibial nerve pathway and sends electrical stimulation via electrodes located on the skin. discreet and without side effects for users, this treatment is indicated as 3rd-line treatment for people suffering from idiopathic overactive bladder with no contraindications. the aim of this study is to assess the quality of life of patients using this device, both before use and after at least 3 months of use.


Eligibility criteria:
inclusion criteria: * patients treated for overactive bladder * patients using the tensi+ for at least 3 months exclusion criteria: * neurological disease that may explain overactive bladder * patient having received anticholinergic drug treatment during neurostimulation. * have one or more contraindications to wearing the device: pacemaker, defibrillator, wearing a mechanical implant near the electrode placement area, ankle joint problems, damaged skin, cognitive impairment.

Keywords: neurostimulation
perichondrium autograft in refractory necrotizing scleritis

Conditions: Necrotizing Scleritis

Summary: necrotizing scleritis with severe ischemia is refractory to conventional treatment because of avascular necrosis. the investigators assessed the therapeutic efficacy and safety of autologous perichondrium transplantation in patients with severe ischemic necrotizing scleritis, and analyzed the therapeutic effects.

ischemic necrotizing scleritis patients who showed persistent and progressive scleral melting were included in this study. perichondrium tissue was harvested from the patient's ear cartilage and transplanted to reconstruct the scleral defect after the necrotic tissue removal.

Eligibility criteria:
inclusion criteria: 1. impending perforation or perforation state of sclera; 2. graft melting following previous surgery; 3. bacterial or fungal infection of sclera or graft after previous surgery; 4. discomfort due to protrusion of scleral calcification with ischemic necrosis 5. broad avascular area larger than 10 mm in diameter exclusion criteria: 1. asymptomatic patients 2. smaller scleral defect less than 10 mm in diameter 3. shallow scleral defect

Keywords: scleromalacia perforans necrotizing scleritis perichondrium
bispecific antibody in finding tumor cells in patients with colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: diagnostic procedures, such as radionuclide imaging using bispecific antibody, may help find colorectal cancer cells and learn the extent of disease. purpose: this phase i trial is studying how well a bispecific antibody works in finding tumor cells in patients with colorectal cancer.

objectives: * assess the pharmacokinetics and tissue distribution of anti-cea x anti-hsg bispecific monoclonal antibody tf2 in patients with colorectal cancer. outline: this is a multicenter study. patients receive iodine i 131-labeled anti-cea x anti-hsg bispecific monoclonal antibody tf2 (\^131i-tf2) iv over 10-20 minutes on day 1. patients also undergo whole-body external scintigraphy at various times during the study. blood samples are collected at baseline and periodically after \^131i-tf2 infusion for pharmacokinetic studies and \^131i-tf2 biodistribution by elisa and radioactivity measurements.

Eligibility criteria:
disease characteristics: * histologically confirmed colorectal cancer * radiological documentation of disease is preferred, but not required patient characteristics: * karnofsky performance status 70-100% * life expectancy ≥ 3 months * wbc ≥ 3,000/mm³ * neutrophil count ≥ 1,500/mm³ * platelet count ≥ 100,000/mm³ * serum creatinine normal * bilirubin ≤ 1.5 times upper limit of normal (uln) * ast/alt \< 2 times uln * not pregnant or nursing * fertile patients must use effective contraception during and for 1 month after completion of study therapy * no medical conditions that might prevent full participation in protocol-required testing or follow-up * no institutionalized patients (e.g., in prisons or mental health institutions) prior concurrent therapy: * no concurrent chemotherapy or treatments that would compromise the safety and efficacy of protocol assessments

Keywords: stage i colon cancer stage ii colon cancer stage iii colon cancer stage iv colon cancer stage i rectal cancer stage ii rectal cancer stage iii rectal cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer
a study of the safety and effectiveness of infliximab for the treatment of psoriatic arthritis

Conditions: Arthritis, Psoriatic

Summary: the purpose of this study is to determine if infliximab is safe and effective in the treatment of psoriatic arthritis. infliximab (remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

this is a phase iii, multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled study designed to determine the safety and effectiveness of infliximab in the treatment of patients with psoriatic arthritis. this is an experimental medical research study. a total of 200 people in north america and europe participated in this study during the 17 month study period. patients will receive infusions of either placebo or 5 or 10 mg/kg infliximab (remicade) at weeks 0,2, 6, 14, 16, 18, 22, 30, 38, and 46. safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. patients will receive either placebo or 5 mg/kg induction infusions (weeks 0, 2 and 6) followed by maintenance infusions every 8 weeks until week 46. in the placebo group, patients may early escape at week 16 and crossover at week 24 to infliximab;. in the 5mg/kg group, dose escalation if needed at week 38.

Eligibility criteria:
inclusion criteria: * diagnosed psoriatic arthritis for \>= 6 months * active arthritis with \>= 5 tender and 5 swollen joints * active psoriasis exclusion criteria: * have other inflammatory diseases, including but not limited to, rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or lyme disease * received any systemic immunosuppressives within 4 weeks prior to enrollment in the study

Keywords: psoriatic arthritis infliximab remicade
a study to assess the effect of rho-kinase inhibitor ar-12286 ophthalmic solution 0.5% and 0.7% in patients with uncontrolled advanced glaucoma with prior failed trabeculectomy or tube shunt

Conditions: Advanced Glaucoma

Summary: a. to evaluate the ocular hypotensive efficacy of the rho-kinase inhibitor (ar-12286 0.5% and 0.7%) ophthalmic solutions in glaucoma patients with failed prior glaucoma filtering surgery and uncontrolled iop who are facing further surgical intervention. patients will be treated for 6 months in this initial trial. b. to evaluate the efficacy of ar-12286 in enabling treated patients to delay or avoid the necessity of further surgical intervention.


Eligibility criteria:
inclusion criteria: 1. patients older than 18 years of either sex. 2. patients with open-angle glaucoma with prior glaucoma filtering surgery. 3. iop above the target range or visual field progression. 4. have given written informed consent, prior to any investigational procedures. 5. ability to attend for the 6-month duration of treatment. exclusion criteria: 1. closed angle glaucoma (primary or secondary). 2. known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics. 3. ocular medication of any kind within 30 days of base-line visit, with the exception of ocular hypotensive medications and/or lubricating drops for dry eye (which may be used throughout the study). 4. any abnormality preventing reliable applanation tonometry of the treated eye. 5. clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study. 6. participation in any investigational study within the past 30 days. 7. inability to perform reliable visual field testing. 8. unwilling to sign the consent form approved by the institutional review board (irb) of the new york eye and ear infirmary. 9. self-reported poor compliance to treatment. 10. reluctance to return for scheduled follow-up visits. 11. patients not able to understand the nature of the study.
device-related central nervous system infections in adult intensive care units in brazil

Conditions: Central Nervous System Infections

Summary: resistant microorganisms are public health problems because they affect the treatment of infectious diseases and the survival of patients. neurosurgical procedures with placement of intracranial pressure monitoring and external ventricular drainage devices are related to increased morbidity and mortality. in brazil, there are several multicenter studies demonstrating the prevalence and types of resistant microorganisms, however, there is a lack of data related to central nervous system infections associated with invasive devices, which can have a direct impact on prevention and treatment policies.

neurosurgical procedures with placement of devices are related to increased morbidity and mortality. a study shows that the incidence of device-related central nervous system infection can reach 27%. a meta-analysis published in 2015, which included 35 studies, showed an incidence of 11.4 per 1000 catheters-day. this is a prospective cohort study, including adult patients, in the icus of hospitals participating in the impacto mr platform, who have a catheter device for monitoring intracranial pressure or external ventricular shunt, with infection densities and microbiological profile being evaluated; risk factors; clinical management; costs involved and short- and long-term clinical outcomes

Eligibility criteria:
inclusion criteria: * all patients over 18 years of age admitted to the icu in the selected hospitals during the study period, using intracranial pressure monitoring catheters and/or external ventricular shunt. exclusion criteria: * diagnosis of brain death.

Keywords: central nervous system infections catheters
ventilation strategy reduces postoperative atelectasis

Conditions: Pulmonary Atelectasis

Summary: atelectasis is common during and after general anesthesia. the investigators hypothesized that a ventilation strategy with a combination of 1) continuous positive airway pressure (cpap) or positive end-expiratory pressure (peep) and 2) a reduced end-expiratory oxygen fraction (feto2) before commencing mask ventilation with cpap after extubation would reduce the area of postoperative atelectasis.

during general anesthesia, the combination of reduced functional residual capacity (frc), high inspiratory oxygen fraction (fio2), and airway closure are the main factors implicated in the atelectasis, shunt and shunt-like effects that account for the majority of the impaired oxygenation seen during general anesthesia. previous studies have shown that formation of atelectasis during preoxygenation and induction of anesthesia can be avoided by adding a continuous positive airway pressure (cpap) followed by a positive end-expiratory pressure (peep).during emergence from anesthesia, high concentrations of oxygen predispose to atelectasis formation. even a recruitment maneuver, followed by ventilation with 100% oxygen with a peep/cpap of 10 cm h2o until extubation, failed to improve postoperative oxygenation compared with that achieved with zero end-expiratory pressure (zeep).this failure may have been caused by the presence of lung regions with high oxygen concentrations. the investigators hypothesized that by inducing and discontinuing anesthesia during cpap/peep and deliberately reducing fio2 after extubation, postoperative atelectasis would be reduced compared with standard protocols. to test our hypothesis, the investigators studied 1) a control group with no cpap/peep and a fio2 of 1.0 while breathing spontaneously after extubation, and 2) an intervention group that was on cpap/peep of 6 cmh2o from induction to extubation and that received an fio2 of 1.0 until extubation and then an fio2 of 0.3 via a facemask while on cpap after extubation.

Eligibility criteria:
inclusion criteria: 1. adult patients up to 75 years of age. 2. american society of anesthesiologists (asa) physical status class i-iii. 3. be able to climb two flight of stairs without stopping. 4. spo2 of ≥ 94% when breathing air in the supine position. 5. a body mass index (bmi, weight in kilograms divided by the square of the height in meters) of \< 31. exclusion criteria: 1. patients with chronic obstructive pulmonary disease. 2. smokers. 3. ex smokers if smoked more than 5 pack years. 4. overt heart failure 5. known or predicted difficult intubation.
early ra vascular randomised controlled study

Conditions: Early Rheumatoid Arthritis

Summary: to investigate the effect of two tight-control treatment strategies, aiming at 1) 2011 american college of rheumatology/european league against rheumatism (acr/eular) definition of remission compare with 2) minimal disease activity (disease activity index in 28 joints \[das28\] \<2.6), on arterial stiffness in early rheumatoid arthritis (ra) patients. to compare the effect of two treatments on arterial stiffness in early rheumatoid arthritis

one hundred ra patients with active disease (das28 \>/=3.2), duration of symptoms less than 2 years, and are disease modifying anti-rheumatic drug naive will participate in this 5-year prospective, hospital-based, open-label, randomized, controlled trial. all participants will receive 1-year tight-control treatment. one hundred patients will be randomly assigned to two arms. treatment will be adjusted according to a standardized protocol every 3-monthly aiming at remission defined by the 2011 acr/eular definition (group 1, n=50, simplified disease activity score \[sdai\] ≤3.3) or minimal disease activity (group 2, n=50, das28\<2.6). a follow up visit will be conducted at the 5th year to evulate long term effect on vascular outcomes between the two groups.

Eligibility criteria:
inclusion criteria: * fulfilled the 2010 acr/eular classification criteria for ra * have symptoms onset of less than 2 years * have active disease (das28\> 3.2) * are positive for rheumatoid factor or anti-cyclic citrullinated protein antibodies exclusion criteria: * have a history of overt cardiovascular diseases * are on aspirin, or hmg-coa reductase inhibitors (statins) or angiotensin-converting-enzyme inhibitor (acei) * have severe renal impairment defined as a glomerular filtration rate of less than 30 ml/min/1.73m2 * have been previously treated with tumor necrosis factor alpha (tnfa) inhibitors or other biological dmards * on glucocorticoids at a dose \>10mg/day

Keywords: early rheumatoid arthritis arterial stiffness sdai remission group minimal disease activity remission group