Kornimate/medical-research-clean huggingface dataset:
retrospective study of the impact of drug eluting stents

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine whether the use of drug eluting stents is associated with higher rates of death, myocardial infarction, and major bleeding. in addition, the overall economic costs of implanting drug eluting stents compared to bare metal stents will be assessed.

a major limitation of percutaneous coronary stenting compared to coronary artery bypass grafting surgery has been the significantly higher need for repeat revascularization due to restenosis occurring at or near the stent site. by eluting a potent anti-proliferative agent from a polymer coated stent in a time-controlled manner, it has been possible to markedly inhibit intimal proliferation that results from implantation of a bare metal stent, dramatically reducing the need for future target lesion revascularization. recent angioscopic and autopsy studies have demonstrated markedly delayed and incomplete endothelialization following drug-eluting stent implantation. these events are rarely observed following bare metal stent implantation. in addition, drug-eluting stents have been associated with hypersensitivity reactions, which may predispose patients to subacute thrombosis. finally, serial intra-coronary ultrasound studies demonstrate late stent mal-apposition, which is believed to create a possible nidus for thrombus formation. by means of examining several extensive administrative databases, this study will retrospectively examine approximately 9,800 consecutive patients who underwent either bare metal or drug eluting coronary artery stenting at sacred heart medical center, spokane, wa between march 1, 2001 and march 30, 2006. time frame of follow-up is at least 18 months. comparison: the strategy of implanting stents during three time periods will be compared to each other. in the first study period which occurred prior to commercial release of the cypher drug eluting stent, all patients received bare metal stents. the second study group will include all patients from the time frame between release of the cypher stent and the taxus drug eluting stent (approximately one year) after which a contractual decision was made to only utilize taxus stents. during second time frame of corresponding to availability of the cypher stent, about 30% of total stent cases received drug eluting stents predominately for "on label" indications. the third study group occurred during a time-frame when taxus drug eluting stents were implanted in about 90% of overall patients including many with "off label" indications.

Eligibility criteria:
inclusion criteria: * coronary artery stenting between march 1, 2001 and march 30, 2006 exclusion criteria: * implanted investigational drug eluting stents

Keywords: coronary artery disease drug eluting stent bare metal stent subacute thrombosis bleeding economic
a study to evaluate sleep quality in patients with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate sleep quality in patients with mild to moderate alzheimer's disease treated with anticholinesterase drugs in clinical practice.

this is an epidemiological (the study of health-related states or events in specific populations) study of patients with mild to moderate alzheimer's who have been treated previously with anticholinesterase drugs (class of drugs that act in the central nervous system) up to a maximum of fifteen days. the data for each patient will be recorded on two occasions; first at a baseline visit and then at a follow-up visit at 3 months. at the baseline visit, after the patient or his/her legal representative has given written informed consent, each participating neurologist will use the study questionnaire to collect patient sociodemographic characteristics (characteristics such as age, years of education, race, sex, religion, birthplace, income, occupation, geographic location, among others), medical history and diagnosis of alzheimer's disease. the neurologist will also record treatment for alzheimer's disease and concomitant hypnotic medications (simultaneous use of medications that induce sleep) and evaluate the patient using two scales: the pittsburgh sleep quality index (psqi) to record sleep disturbances and the epworth sleepiness scale to determine the level of daytime sleepiness. alzheimer treatment and concomitant hypnotic medications will be recorded again at the follow-up visit. patient sleep quality using the psqi and daytime sleepiness using the epworth scale will also be evaluated again at this visit.

Eligibility criteria:
inclusion criteria: * patients with a recent diagnosis of possible or probable alzheimer's disease (national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association (nincds-adrda criteria) within a maximum of 60 days before the baseline visit. * patients with mild or moderate alzheimer's disease, defined by a mini-mental state exam (mmse) score between 11 and 25. * patients whose caregivers are sufficiently informed of the patients' state and if possible live with the patient. * patients who are capable of attending a second clinic visit with their accompanying person 3 months later, based on the clinical practice of the investigator. * patients and/or legal representatives who have given and signed written informed consent. exclusion criteria: * patients who have psychotic manifestations. * patients who have clinically significant sleep disorder (sleep apnea syndrome, restless leg syndrome). * patients treated with memantine. * patients and/or legal representatives who refuse to give written informed consent to participate in the study.

Keywords: alzheimer's disease sleep quality anticholinesterase drugs
role of the sma during unimanual and bimanual movements preparation: the mirror movements paradigm

Conditions: Congenital Mirror Movements

Summary: the aim of the project is to study the role of secondary motor area (more precisely the supplementary motor area, or sma) during unimanual and bimanual voluntary movements externally (cue) or internally (subject's choice) triggered. in that view, we will study 3 experimental groups : * a group of healthy volunteers (control group) * the same group of healthy volunteers after a transient inactivation of the sma (by the aim of repetitive trans cranial magnetic stimulation or tms) * a group of patients suffering from congenital mirror movements who are suspected to present a dysfunction of the sma (according to our previous results) in each of these groups, by the aim of a serial reaction time task, we will study the influence of a sma stimulation on the excitability of the primary motor cortex (m1) during the preparation of a voluntary movement (unimanual or bimanual). this will allow us to assess the communication between the sma and m1 during movement preparation. using the same task in functional imagery, we will study the activation's pattern of primary and secondary motor areas during movement preparation. this multimodal approach should allow us to better understand the synergistic functioning of these different structures involved in movement preparation. an other interesting aspect will be to determine the role of these structures in movement lateralization. eventually, our results might allow us to precise to role of the motor preparation's dysfunction in the genesis of congenital mirror movements. in the first place, this study aims at a better understanding of the cerebral physiology of movement preparation (which is not well known) using the mirror movements paradigm as a dysfunction model (according to our previous results). according to our hypothesis, there is a strong link between the sma and m1 during movement preparation. this hypothesis will be assessed by the use of the same experimental task with combined neurophysiological and neuroimaging approaches, thus increasing the validity of the results obtained. a secondary aim of this protocol is to precise the role of motor planning dysfunction in patients with congenital mirror movements. a better understanding of the mechanisms responsible for this condition is necessary in a medium-term therapeutic prospect.


Eligibility criteria:
inclusion criteria: * patients aged from 15 years and 3 months to 82 years * patients with congenital mirror movements without additional manifestation or malformation * no contraindications for mri or tms study exclusion criteria: * inability to provide an informed consent * simultaneous participation in another clinical trial * treatment that modulate cortical excitability (for the tms part of the study only)

Keywords: congenital mirror movements sma movement preparation movement lateralization mri transcranial magnetic stimulation
randomized trial assessing the effectiveness of a pharmacist-delivered program for smoking cessation

Conditions: Tobacco Use Disorder; Smoking

Summary: this randomized trial compared the effectiveness of a three session pharmacist-delivered group program for smoking versus one 5 to 10 minute standard care session delivered over the telephone on 7-day point prevalence quit rates. participants in both groups were offered their choice of bupropion ir or nicotine patch at no cost. at 6 months after the established quit date, self-reported cessation was biochemically verified using tests for urinary cotinine.


Eligibility criteria:
inclusion criteria: * smoked one or more cigarettes daily for 7 days * somewhat ready to quit in the next 2 weeks (4 or more on a 10- point scale) * willing and capable of attending three scheduled sessions at the clinic * interested in participating in the study exclusion criteria: * planned to leave the area in the next 6 months * used pharmacotherapy for smoking cessation in the last 30 days * used other forms of tobacco in the last 30 days * schizophrenia * prior participation

Keywords: smoking cessation pharmacist-delivered
carotid revascularization with ev3 arterial technology evolution post approval study

Conditions: Carotid Artery Disease

Summary: the purposes of this study are: 1. to provide additional safety and effectiveness information on the commercial use of protégé™ gps™ and protégé™ rx carotid stent systems and the spiderfx™ embolic protection device. 2. to evaluate rare and unanticipated adverse events. 3. to evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.


Eligibility criteria:
inclusion criteria: * 18 years and above * informed consent * intent to use the protégé™ gps™ and protégé™ rx and spiderfx™ to treat carotid artery disease per instructions for use * meet instruction for use (ifu)/ centers for medicare \& medicaid services (cms)defined anatomical or clinical high risk criteria exclusion criteria: * subjects with contraindications as outlined in the instructions for use

Keywords: carotid artery disease embolic protection
a therapeutic equivalence study in subjects with primary open angle glaucoma or ocular hypertension

Conditions: Primary Open Angle Glaucoma; Ocular Hypertension

Summary: this is a randomized, investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.


Eligibility criteria:
inclusion criteria: * male or nonpregnant female aged 18 years or older with chronic open angle glaucoma or ocular hypertension in both eyes. * provide signed and dated informed consent in accordance with good clinical practice and local legislation prior to any study procedure. * be able and willing to follow study instructions and complete all required visits. * subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period. exclusion criteria: * subjects with angle closure glaucoma * females who are pregnant, breast feeding, or planning a pregnancy. * females of childbearing potential who do not agree to utilize an adequate form of contraception. * current, or past history of, severe hepatic or renal impairment * current, or history within 2 months prior to baseline of, significant ocular disease * functionally significant visual field loss * contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy * subjects currently in another clinical trial
a trial investigating the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 287 in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 287 in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * male or female, age between 18 and 64 years (both inclusive) at the time of signing informed consent. * subject who is considered to be generally healthy (with the exception of conditions associated with diabetes mellitus), based on the medical history, physical examination, and the results of vital signs, ecg and laboratory safety tests, as judged by the investigator. * body mass index between 20.0 and 34.9 kg/m\^2 (both inclusive). * type 2 diabetes mellitus (as diagnosed clinically) for ≥12 months (365 days). * no change in insulin treatment regimen during the last 90 days prior to screening. * current total daily insulin treatment between 0.3 and 1.0 (i) u/kg/day (both inclusive). exclusion criteria: * known or suspected hypersensitivity to trial products or related products. * female who is pregnant, breast-feeding, or intending to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by regulation or practice)(highly effective contraceptive methods are considered those with a failure rate less than 1% undesired pregnancies per year including surgical sterilisation,hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence or a surgically sterilised partner). females who are not postmenopausal can participate in the study if they use adequate contraceptive methods. postmenopausal is defined as women aged \ 40 iu/l or aged ≥ 52 years and being amenorrheic for less than one year and with serum fsh level \> 40 iu/l or aged ≥ 52 years being amenorrheic for more than one year. * receipt of any investigational medicinal product within 3 months before the screening visit of this trial. * history of deep leg vein thrombosis or repeated episodes of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children) as judged by the investigator. * recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days. * use of oral antidiabetic drugs (oads) or glp-1 receptor agonists (e.g. exenatide, liraglutide) within 3 months prior to screening.
a safety and performance pmcf investigation of the avance® solo npwt system in surgically closed incisions

Conditions: Incision, Surgical; Surgical Incision; Surgical Wound; Surgical Wound, Recent; Surgical Wound Dehiscence

Summary: the asolo-sci investigation is a post market clinical follow-up (pmcf) study to investigate the safety and performance of the avance® solo npwt system in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the instructions for use (ifu).

the asolo-sci investigation is designed as a prospective, open, non-comparative, pmcf study to investigate the safety and performance of the avance® solo npwt system in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the ifu in up to 34 patients (n=34). the asolo-sci investigation is a multicentre study that is expected to take place in approximately three european centres. the study treatment shall be stopped earlier (i.e. prior to 14 days), in the event study subjects withdraw their consent, or shall the principal investigator and clinical team deem the avance® solo npwt system to be no longer adequate for the study subject's wound. following termination of subject participation for whichever reason in the study, the patient shall be followed in accordance with the local standard of care in wound management and treatment. as a primary endpoint, the principal investigator and clinical team will evaluate whether the surgical incision remains closed, from baseline to study end at day 14.

Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 years of age. 2. signed written informed consent form. 3. low to moderate exuding surgically closed incisions suitable for sunpwt, according with the investigator´s judgement and the avance® solo npwt system instructions for use. 4. study subjects that are deemed capable and willing to comply with the protocol instructions. exclusion criteria: 1. known malignancy in the wound or margins of the wound. 2. untreated and previously confirmed osteomyelitis. 3. non-enteric and unexplored fistulas. 4. necrotic tissue with eschar present. 5. exposed nerves, arteries, veins or organs. 6. exposed anastomotic site. 7. known allergy/hypersensitivity to the dressing or its components. 8. known pregnancy or planning to become pregnant or breastfeeding at time of study participation. 9. participation in another investigative drug or device trial currently or within the last 30 days. 10. subjects not suitable for the investigation according to the investigator's judgement, clinical investigation plan and instructions for use.

Keywords: negative pressure wound therapy post market clinical follow-up vacuum assisted closure
effect of prolotherapy in knee osteoarthritis.

Conditions: Knee Osteoarthritis

Summary: patients with primary knee osteoarthritis will be included in the study, plain x-ray for the affected knee, followed by musculoskeletal ultrasound assessment will be done. the intervention: intra-articular injection and extra-articular injections of 25% dextrose. follow up will be done at 24 weeks after the last injection both clinically and ultrasonographically . aim: determine whether prolotherapy improves pain. stiffness and function of symptomatic knee osteoarthritis and determine ultrasonographic changes before and after prolotherapy.

sixty knees with primary knee osteoarthritis will be included in the study, clinical assessment will be done, then plain x-ray for the affected knee (s), followed by musculoskeletal ultrasound assessment will be done. the intervention: 1. a single intra-articular injection of 6 ml of 25% dextrose through infero-medial or infero-lateral approach will be done. 2. extra-articular injections will be done at major tender tendons and ligaments through 15 skin punctures using peppering technique and placing a possible total of 22.5 ml of 25% dextrose. * both intra and extra-articular injections will be done at 1, 5, 9, and 13 weeks intervals. follow up will be done at 24 weeks after the last injection both clinically and ultrasonographically .

Eligibility criteria:
inclusion criteria: * moderate and moderate to severe primary knee osteoarthritis (kl grade ii and iii) * consent obtained exclusion criteria: * early knee osteoarthritis (kl grade i) * severe knee osteoarthritis (kl grade iv) * causes of 2ry osteoarthritis: other rheumatological, metabolic and inflammatory joint diseases. * received oral or systemic steroids 1 year prior to the procedure * received intra-articular steroids or hyaluronic acid 1 year prior to the procedure * bmi \>45kg/m2 * poorly controlled diabetes mellitus, on anticoagulation therapy, history of cancer

Keywords: primary knee osteoarthritis, prolotherapy, musculoskeletal ultrasound
feasibility study: ulthera® system for the treatment of moderate to severe facial acne

Conditions: Facial Acne

Summary: this study will evaluate the effectiveness of ultherapy for the treatment of facial acne.

study subjects will be assigned to one of two treatment groups. both treatment groups will receive treatment in the center of the forehead/temples, medial cheeks, and chin regions using the 1.5mm and 1.0mm transducers. * for group a, both the 1.5mm and 1.0mm transducers will be used at 0.25j energy setting and 0.20j energy setting, respectively. * for group b, both the 1.5mm and 1.0mm transducers will be used at 0.18j energy setting and 0.15j energy setting, respectively. subjects will receive 3 ultherapy treatments administered 2 weeks apart. subjects will be required to return for follow-up assessments at 14, 30, 60, 90 and 180 days following the third ultherapy treatment. pre- and post-treatment photos will be taken. in addition, pre- and post-treatment lesion counts and sebum measurements will be obtained.

Eligibility criteria:
inclusion criteria: * male or female, aged 18 years and older. * subject in good health. * presence of clinically-evident facial acne of moderate to severe severity with at least 20 inflammatory lesions and 20-100 noninflammatory lesions. exclusion criteria: * presence of \>2 nodular lesions in the areas to be treated. * presence of any cysts in the areas to be treated. * presence of an active systemic or local skin disease that may affect wound healing. * use of alcohol-based topical solutions or "exfoliating" agents within 1 week prior to study participation. * history of frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections. * history of keloid scar formation. * significant scarring in areas to be treated. * significant open facial wounds or lesions. * presence of a metal stent or implant in the facial area to be treated.

Keywords: ulthera® system ultherapy™ treatment ulthera, inc.
virtual reality for postoperative pain management

Conditions: Surgery; Pain, Postoperative; Incision; Otolaryngological Disease

Summary: this trial studies an active virtual reality (vr) experience as a means for non-pharmacologic postoperative pain management among patients after head and neck surgery. investigators will assess differences in pain scores, analgesic use, and subjective patient experiences between patients participating in a vr activity and patients participating in the same activity using a smartphone.

management of postoperative pain after head and neck surgery is complex, and has received increased attention to improve patient recovery and quality of life. narcotic analgesics are frequently utilized in postoperative pain management, but these have risks including nausea, sedation, constipation, and dependence. multimodal analgesia can reduce narcotic use and improve recovery, but medical comorbidities may contraindicate the use of certain medications. non-pharmacologic measures for postoperative pain control may provide novel and cost-effective strategies to confront this complex issue. patients undergoing head and neck surgery will be randomly allocated to participate in an immersive experience in vr, or to participate in a similar experience on a two-dimensional screen using a smartphone.

Eligibility criteria:
inclusion criteria: * patients who have undergone head and neck surgery with an average pain score of 3 or greater out of 10 during the 24 hours preceding the screening * are able to provide informed consent * are not in the intensive care unit (icu) exclusion criteria: * symptoms concerning for an active respiratory infection including fever, cough, and shortness of breath or confirmed respiratory infection * active eye discharge * active nausea or vomiting * history of seizure, epilepsy, or hypersensitivity to flashing light * history of motion sickness or vertigo * have wound dressings on the head or neck that prevent comfortable and safe use of the virtual reality headset

Keywords: virtual reality