Kornimate/medical-research-clean huggingface dataset:
chronic obstructive pulmonary disease transcription factor and cytokine study

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease transcription factor and cytokine study.

chronic obstructive pulmonary disease (copd) is the 4th leading cause of death in the united states. it is projected to be the leading cause of death by 2020. as many as 24 million americans are estimated to suffer from impaired lung function. of those more than 12 million were actually diagnosed with copd, and over 118,000 deaths were attributed to copd in 2004. copd has been linked with an increased risk for lung cancer. both airway obstruction, defined by abnormal pulmonary function tests (pfts), and ct scan diagnosed emphysema were shown to be independent risk factors for lung cancer. treatment for copd includes cessation of environmental exposures (i.e. smoking), dampening the inflammatory response, symptoms control and, for a small subgroup, surgical approaches and lung transplant. nevertheless, the effectiveness of these treatment options to change the natural history of this disease is very limited. recent evidence suggests a new role for macrolides as immune-modulators in patients with copd, although the mechanisms are not clearly determined. the investigators hypothesize that in patients with copd, treatment with azithromycin will show reduced inflammatory markers, transcription factors changes, and lung function changes consistent with reduced inflammation.

Eligibility criteria:
* key inclusion criteria: list primary criteria for study inclusion (i.e. do not need to enter entire list of inclusion criteria). 1. patient must be 50 years old or older. 2. patient must have a smoking history of at least 20 pack-years 3. patient must have stable copd, gold 0, i and/or iia. 4. ct of chest with evidence of emphysema * key exclusion criteria: list primary criteria for study exclusion (i.e. do not need to enter entire list of inclusion criteria). 1. fev1 \< 70%. 2. exacerbations (defined as use of oral steroids or antibiotics) in the previous month. 3. cardiovascular disease defined as abnormal ekg, known or suspected coronary artery disease or congestive heart failure. 4. diabetes mellitus 5. renal disease 6. liver disease 7. lung cancer 8. etoh use of more than \>6 beers \>4 mixed drinks daily

Keywords: copd, pulmonary disease
investigating the effects of a museum intervention on the psychological and cardiac health of older adults

Conditions: Atrial Fibrillation Recurrent; Aging

Summary: in a recent report, the world organization for health provided some evidence that artistic and cultural activities can support the health and well-being of the population. our previous research suggests that the effect of museum visits on well-being and stress might be tied to relaxing proprieties of contact with art objects, especially when the artwork is viewed with an introspective and self-reflexive approach. this study addresses the effect of a well-being museum intervention of six weeks on cerebral activity associated with artwork contemplation during a museum visit and assesses how it affects the psychological and cardiovascular health of older adults with and without atrial fibrillation. the well-being intervention will engage the participant in a series of 6 visits, in groups of 10, oriented on his feelings, impressions, and interpretations of artworks. this well-being museum intervention will be compared to visits typically provided in the museum, in a cross-over single-blinded design.


Eligibility criteria:
inclusion criteria: * men/women aged 50 and over, * presenting normal or corrected vision and hearing, * with or without controlled atrial fibrillation, * no specific expertise in visual arts (official degree or training relating to the visual arts), * occasionally attended museums and exhibitions (≤ 6 times per year). exclusion criteria: * score \> 5/15 on the geriatric depression scale, * score on the telephone version of the mmse \< 19, * psychiatric or neurological diagnosis, * presence of major functional limitations likely to affect the individual's ability to stand and walk independently.

Keywords: museum visits neurocognition stress cardiovascular functioning
tradeoff between spatial and temporal resolution

Conditions: Deafness

Summary: in this study, investigators will examine how temporal rate processing might be affected when the width of neural excitation narrows. the manipulation of neural excitation width will be achieved for example by changing electrode configurations or stimulating single versus multiple electrodes simultaneously. investigators will then measure if the extent to which rate processing is affected by spatially restricted stimulation can predict a subject's overall speech recognition and predict also whether the subject is likely to benefit from a focused electrode configuration. lastly, investigators will introduce and test a novel current focusing strategy where current focusing is applied in a channel specific manner and quantify if this intervention improves speech recognition. the primary endpoint of the study is speech recognition, and the secondary endpoint is psychophysical sensitivity to stimulation rate change.


Eligibility criteria:
inclusion criteria: * native speakers of english * cochlear nucleus cochlear implant users or advanced bionics users * postlingually deafened * has had device experience for at least one year * can be child or adult at the time of enrollment exclusion criteria: * none
the preformed metal crowns placed using the hall technique versus the conventional restoration

Conditions: Dental Caries; Caries; Dentin

Summary: the aim of this study is to compare the survival rate of the conventional restorations with the hall technique in carious primary molars.

comparing the survival rate of the conventional restorations with the hall technique in carious primary molars.

Eligibility criteria:
inclusion criteria: * patients aged five to eight years at the time of dental treatment, * patients attending follow-up appointments * patients with compomer restoration and hall restoration in their teeth * patients with matching the extent of caries in the two groups exclusion criteria: * patients not attending follow-up appointments * patients without both treatment
insulin resistance and cognitive dysfunction in obese adolescents: pilot study

Conditions: Obesity

Summary: obese adolescents will be evaluated for insulin resistance and cognitive dysfunction.

the short-term goal of this project is to conduct a feasibility study at winthrop university hospital to determine how well extremely obese (bmi \> 99%tile corrected for age) children and adolescents can be recruited into an exercise program and evaluated in an efficient fashion, and to identify particular strategies (e.g., medical examination feedback) that can serve as potential benefits to research subjects and their families. in addition investigators will evaluate the effect of the exercise program on physical fitness, insulin resistance, and neurocognitive functioning as well as the relationship between insulin sensitivity and neurocognitive function among adolescents who participate in the exercise program. the long-term goal of this project is to evaluate a large, multi-ethnic sample of adolescents, 14 to 19 years of age, to systematically assess cognitive function and school performance, fitness and examine the relationship between performance on those outcome variables and a variety of biomedical and psychosocial factors that may directly or indirectly influence brain function and test-taking performance. high body mass index (bmi) among children and adolescents continues to be a public health concern in the united states. the most recent figures from the national health and nutrition examination survey (nhanes) for 2007-2008 report that 18.1% (95% ci, 14.5%-21.7%) of 12- through 19-year-old adolescents were at or above the 95th percentile of bmi for age. children with high bmi often become obese adults, and obese adults are at risk for many chronic conditions. high bmi in children may also have immediate consequences, such as elevated lipid concentrations and blood pressure. it now appears that neurocognitive dysfunction is also more common in obese children and adolescents. in a large population study of 2,519 children, 8 to 16 years of age, a brief neuropsychological assessment showed a statistically significant, albeit modest relationship between cognitive test scores and bmi that persisted after adjusting for confounding variables. obesity is also associated with several conditions which known to affect brain function, including sleep apnea, insulin resistance, hypertension, and chronic inflammatory factors (e.g., by these variables cannot be determined, unfortunately, because those variables were not measured. it is important to note, however, that there is not complete agreement on linkages between obesity and cognition.

Eligibility criteria:
inclusion criteria: * male and female subject's ages 14 to 19 years old, extremely obese (bmi ≥ 99th percentile). * clearance by pediatric cardiologist, including evaluation of v02max. exclusion criteria: * male and female less than 14years of age or more than 19 years of age. * patients with type 1 or type 2 diabetes * patients with serious medical conditions. * anyone who is deemed inappropriate by pediatric cardiologist during clearance evaluation.
dobutamine on the cardiac conduction system

Conditions: Arrhythmias, Cardiac

Summary: our hypothesis is that dobutamine will act in a similar fashion to isoproterenol with respect to cardiac conduction. our goal is to study the effects of dobutamine on cardiac conduction and refractoriness during an electrophysiology study (eps). at the end of most eps isoproterenol is commonly administered in an effort to change the conduction properties of the heart. in our practice we have been using dobutamine for this purpose for many years. dobutamine has never been rigorously studied for this indication however. we designed this study to systematically study the effect of various doses of dobutamine on the parameters of cardiac conduction and refractoriness that are commonly measured during an eps. we are specifically looking to compare the effect that dobutamine has on the sinus node with the effect it has on the atrioventricular node. patients undergoing an eps at long island jewish hospital will be recruited and consented. measurements of various conduction parameters will be taken at baseline as is standard protocol for an eps. dobutamine will then be administered at doses of 5mcg/kg/min, 10mcg/kg/min, 15mcg/kg/min and 20mcg/kg/min. at each of these dosages the same conduction parameters will be measured. a comparison will then be made between the conduction parameters at baseline and when the dobutamine is administered.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, ages 18-80 4. patients must be diagnosed with a condition that necessitates an eps. they must also be deemed to be in good enough medical health to be eligible to safely undergo an eps. medical eligibility will be determined by the attending electrophysiologist performing the eps. 5. for females of reproductive potential a negative pregnancy tes exclusion criteria: patients with a resting left ventricular outflow gradient \> 30mmhg patients with severe aortic stenosis patients with prior sustained ventricular tachycardia or ventricular fibrillation patients who are not able to consent for themselves patients with a prior allergic reaction to dobutamine or any of its compounds including sulfites pregnant patients patients receiving b-blockers
agreement and accuracy of different devices for biometry measurements in patients with cataract

Conditions: Cataract; Cornea; Surgery

Summary: the rationale of this study is to compare repeatability, reproducibility and agreement of three different as-oct devices and pentacam. the investigational devices are approved biometry and keratometry devices to perform biometric/keratometric measurements preoperatively before cataract surgery. the measurements are used to calculate the needed iol power. measurements with all four devices will be performed 3 times consecutively by two trained observer. the order of the observer, the order of devices as well as the eye (left/right) is randomized. examinations will be implemented in accordance with the approved investigational plan on subjects and includes: repeated biometry/keratometry with four different devices

the rationale of this study is to compare repeatability, reproducibility and agreement of both, as-oct(s) and pentacam. in our department three different as-oct devices and a hr scheimpflug imaging device are currently in use for clinical routine to measure the cornea. among refractive and anterior segment surgeons, there is no preferred and accepted method for accurate measurements of the corneal curvature. the four diagnostic tools are based on different technical and physical imaging principles and to date only limited information on their comparability exist. one advantage of asoct represents faster imaging speed when compared to scheimpflug imaging. thus, imaging misalignment, segmentation errors and defocus aberration can most likely be avoided by as-oct. chen et al demonstrated that hr scheimpflug imaging measurements of cct were systematically higher than the measurements provided by fd as-oct. further, repeatability, reproducibility and agreement of as-oct and scheimpflug imaging device will be assessed during follow-up.

Eligibility criteria:
inclusion criteria: * age-related cataract * age 40 and older (females of childbearing age will be interviewed if pregnancy is possible) exclusion criteria: * contact lens wear within 5 days * pathologic changes of the cornea, eye lid or conjunctiva on slit- lamp examination * history of corneal ocular surgery * microphthalmus * recurrent intraocular inflammation of unknown etiology * blind fellow eye * uncontrolled systemic or ocular disease
exactech proximal humerus fracture plate system post market clinical follow-up

Conditions: Proximal Humeral Fracture; Fracture Dislocation; Non-Union Fracture

Summary: the objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the equinoxe proximal humerus fracture plates over time. this study will follow subjects for a period of up to 10 years post-surgery.


Eligibility criteria:
inclusion criteria: * patient is indicated to receive equinoxe proximal humerus fracture plate or has previously underwent primary surgery with equioxe proximal humerus fracture plate * patient is willing to participate by complying with pre- and postoperative visit requirements * patient is willing to agree to be followed for up to 10 years following their index surgery * patient is willing and able to review and sign a study informed consent form exclusion criteria: * osteomyelitis of the proximal humerus or scapula * inadequate or malformed bone that precludes adequate support or fixation of the prosthesis * patient's age, weight, or activity level would cause the surgeon to expect early failure of the system * the patient is unwilling or unable to comply with the post-operative care instructions * alcohol, drug, or other subtance abuse * any disease state that could adversaly affect the function or longevity of the implant * patient is pregnant * patient is a prisoner * patient has a physical or mental condition that would invalidate the results
maine lung cancer coalition: using chws for the annual lung cancer screening reminder

Conditions: Lung Cancer

Summary: this research study will test whether support from a community health worker (chw) to address barriers to annual ldct screening will result in an increased number of patients who receive the annual screening as per the recommended standard of care compared to passive outreach using a reminder letter.

this research study is a randomized controlled trial comparing phone outreach by a trained community health worker (chw) following a reminder letter to the reminder letter alone for patients who are at least a month overdue to have a routine annual low dose ct scan (ldct) screening for lung cancer. chws will be able to identify and address barriers to accessing screening for those patients randomized to that arm of the study. outcomes that will be measured include scheduling and completing the ldct as well as agreeing to a referral for tobacco treatment.

Eligibility criteria:
inclusion criteria: * 30 or more pack years of tobacco use * if no longer using tobacco, no more than 15 years since last use * at least 13 months since last low dose ct scan screening exclusion criteria: * development of serious medical condition that would preclude treatment of lung cancer if found * death since baseline screen

Keywords: screening
laparoscopic essure device removal

Conditions: Contraception

Summary: in recent years, several symptoms have been attributed to essure, including pelvic pain and other general symptoms. consequently, an increasing number of patients request essure removal for alleged adverse reactions to the device. study objective: to evaluate the quality of life of patients who underwent essure_ device removal and morbidity of this surgery. design: prospective observational cohort study. setting: academic hospitals of la conception, marseille, and arnaud-de-villeneuve, montpellier, france. patients: women who underwent essure_ device removal by salpingectomy, between february 2017 and august 2018. methods : the following information have been collected during preoperative clinics: demographic data, medical history, clinical symptoms attributed to the essure device, time between essure sterilization and early symptoms, time between the beginning of symptoms and surgical removal. follow-up visits have benne scheduled at one month and three months post-operation. the evolution of symptoms was collected during the follow-up visit at three months based on clinical reports and a dedicated questionnaire. evaluation of quality of life have been evaluated thanks to sf36 and had questionnaires. alle these patients will be contacted by phone call to assess to evolution of symptoms and to complete sf 36 and had questionnaires. hypothesis : recovery of symptoms due to essure device and improvement of quality of life after surgery.


Eligibility criteria:
inclusion criteria: * age \>18 years old * symptoms related to essure device * salpingectomy for essure removal exclusion criteria: - exclusion criteria were failure to perform a complete removal of the essure and second surgery to remove fragments left behind from a previous procedure.

Keywords: essure device removal quality of life
injection site tolerability of multiple dose treatment with long-acting injectable risperidone administered via deltoid muscle in chronic schizophrenia patients.

Conditions: Schizophrenia

Summary: the purpose of this study is to examine the discontinuation rate of schizophrenia patients receiving multiple sequential 2 ml injections of long acting injectable risperidone (an atypical antipsychotic medication) when administered into the deltoid muscle once every 2 weeks.

this is an open-label, multiple-dose, multicenter study in chronic schizophrenia patients, who are receiving long-acting injectable risperidone 25 or 37.5-mg injections into the gluteal muscle, and clinically require a higher dose. the study consists of a pretreatment screening phase, an 8-week, open label treatment phase during which patients will receive 4 sequential 2 ml injections with long-acting injectable risperidone (37.5 or 50 mg) administered every 2 weeks into the deltoid muscle in alternate arms (right versus left) for each visit; and a post treatment phase consisting of end of study evaluations upon completion of all the study procedures on day 57 or at early withdrawal. the study hypothesis is that repeated injections of long-acting injectable risperidone into the deltoid muscle will be safe and well tolerated as assessed by the percent of patients who discontinue after at least 2 injections. safety was assessed using adverse events (including occurrence of extrapyramidal symptoms as assessed by the extrapyramidal symptoms rating scale), clinical laboratory tests (hematology, serum chemistry, urinalysis, and pregnancy testing), vital signs, physical examinations, electrocardiograms, and injection site evaluation. the patients will receive 4 injections with long-acting injectable risperidone (37.5 or 50 mg) administered as 1 injection every 2 weeks into the deltoid muscle.

Eligibility criteria:
inclusion criteria: * chronic schizophrenia of any subtype, according to dsm-iv criteria * under current treatment with long-acting injectable risperidone 25 mg or 37.5 mg gluteal injections in an adequate study for at least 2 injections, and in need of a dose increase of long-acting injectable risperidone for clinical reason * informed consent signed by the patient * patient is otherwise healthy on the basis of a prestudy physical examination and medical history. exclusion criteria: * no dsm iv axis i diagnosis other than schizophrenia * no pregnant or breast feeding women * no female subject of childbearing potential without adequate contraception * no history of severe drug allergy or hypersensitivity * no patients with inadequate mass in the deltoid regions to receive the intramuscular drug injections.

Keywords: schizophrenia risperidone long acting injectable intradeltoidal injection
safety and bioactivity of axt107 in subjects with diabetic macular edema

Conditions: Diabetic Macular Edema (DME)

Summary: this study is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg axt107 in approximately 18 subjects (up to 6 subjects per dose) with diabetic macular edema (dme).

upon providing informed consent, subjects will be sequentially enrolled into the study. decision regarding dose escalation will be based on the recommendation from the data monitoring committee (dmc). the first 3 eligible subjects will receive the low dose of axt107 injection. after the 3 low dose subjects complete a 7-day follow-up, the dmc will review their safety data. if an acceptable safety profile is determined by the dmc, 3 additional subjects will be enrolled to receive the mid dose of axt107 injection. upon completion of a 7-day follow-up, review of the safety data, and determination of an acceptable safety profile by the dmc for the mid dose subjects, 3 additional subjects will be enrolled to receive the high dose of axt107 injection.

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older with diabetic macular edema (dme) diagnosis secondary to diabetes mellitus type 1 or 2 * best corrected visual acuity (bcva) early treatment diabetic retinopathy study (etdrs) letter score of 65 to 23 in the study eye * willing and able to comply with clinic visits and study-related procedures * provide signed inform consent exclusion criteria: * any signs of high risk proliferative diabetic retinopathy in the study * previously-treated patients who are not responders to anti-vegf * panretinal laser photocoagulation within 6 months and macular laser photocoagulation with 3 months of screening in the study eye note: other inclusion/exclusion criteria apply.

Keywords: asclepix macular edema dme eye diseases retinal diseases axt107 diabetes duration of action dose escalation diabetic retinopathy retinal degeneration