Kornimate/medical-research-clean huggingface dataset:
satisfaction with multifocal vs accommodating lens implants 2 years after surgery

Conditions: Cataract

Summary: this study will examine patient satisfaction and spectacle independence using a survey in patients who have undergone uncomplicated cataract surgery with a presbyopia-correcting lens at least 2 years prior to administration of the survey.

purpose: to compare patient-reported satisfaction with a multifocal vs an accommodating presbyopia-correcting at least two years following implantation of either type of implant. number of study subjects: 200 (half with multifocal and half with accommodating lens implants) in this study, we will send a secure, online questionnaire to patients who have previously undergone cataract surgery at least two years previously. patients will receive an email invitation, and by clicking the embedded link and verifying their identity with date of birth and phone number, they will be directed to a survey. the survey will ask the following types of questions: * overall satisfaction with the surgery * would they do the same surgery again? * would they choose the same (elective) lens implant again? * for what types of activities (reading newspaper, driving, driving at night, fine print) do they require glasses to see clearly? * do they experience glare and halo symptoms? * how bothered is the patient by these symptoms? these data will be stored on a secure server. statistical analysis will be done by a statistician, using a student's t-test to determine statistical significance of any difference between patients with different types of lens implants. no intervention will be planned with patients, other than analyzing the survey results. all patient identifying (demographic) information will be carefully protected according to hipaa and hitech standards.

Eligibility criteria:
inclusion criteria: * patients with uncomplicated bilateral cataract surgery with either multifocal or accommodating lens implants performed at least 24 months previously * patients with or without astigmatic keratotomy or other simultaneous procedures may be included, so long as exclusion criteria are not met. exclusion criteria: * patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that, in the best judgment of the investigator, could affect their satisfaction with surgery * patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered iol, cystoid macular edema, etc.) * patients with ≥ grade 1 posterior capsule opacity at their last visit

Keywords: cataract satisfaction
deploying digital prosthetic interface technology and exercise in dysvascular amputees

Conditions: Diabete Type 2; Amputation

Summary: the study will test a new approach to the design and implementation of socket and liner technology in individuals who lost a lower limb secondary to diabetes mellitus type ii (herein referred to as dysvascular amputees). the technology-based intervention will be combined with an exercise program designed to improve the health status of dysvascular amputees.

the study will test the hypothesis that the use of a digital approach to the design and implementation of socket and liner technology (herein referred to as "digital prosthetic interface technology") leads to better health of the residuum (compared to traditional socket and liner technology). this hypothesis will be tested by recruiting a group of dysvascular amputees (herein meant to refer to individuals who lost a lower limb secondary diabetes mellitus type ii) and by randomizing them to either receiving a digital prosthetic interface technology or a traditional socket and liner system. furthermore, the study will assess if the digital prosthetic interface technology improves adherence to an exercise program and results in better clinical outcomes. to test this hypothesis, an exercise intervention will be deployed by relying on coaching and mobile health technology to encourage adherence to a walking program targeting dysvascular transtibial amputees. this exercise intervention is an extension of pilot work that demonstrated the suitability of mobile health technology to implement an exercise-based intervention program in dysvascular amputees.

Eligibility criteria:
inclusion criteria: * unilateral transtibial amputation within the past 4-16 months * etiology secondary to complications of diabetes mellitus (dm) type ii * current use of a prosthesis, with at least 2 months prior use * k2 or k3 level (as determined using the amputee mobility predictor assessment tool) * own a smartphone exclusion criteria: * amputation due to cancer or macrotrauma or acute hemorrhage * bilateral amputation * medically or surgically unstable contralateral lower extremity as determined by medical criteria (e.g., critical limb ischemia) * severe residual limb pain that limits function preventing participation in an exercise-based program * medical conditions that would interfere with subject's participation in regular sustained exercise * anthropometric characteristics that are not compatible with the technology used to scan the residuum and manufacture the liner and socket (e.g., a residuum circumference greater than 32 inches would not be compatible with the device used to scan the residuum) * current pregnancy
randomized trial of high dose influenza vaccine in long term care setting

Conditions: Influenza

Summary: the purpose of the study is to compare the performance of two currently available influenza (flu) vaccines. this study will try and determine if the high dose flu vaccine provides protection that is the same or better than that of regular dose flu vaccine. both the regular dose and the high dose flu vaccines are approved by the fda for use in older adults.

influenza and pneumonia are the fifth leading cause of death in the united states, the leading cause of vaccine preventable death, and the leading cause of infection related deaths among nursing home residents(nace, drinka et al.2010). each year, an estimated 36,000 individuals die from seasonal influenza and over 90% of these deaths occur among older adults, primarily the frail older adults residing in ltc settings(fiore,uyeki et al. 2010).vaccination is the most effective means of preventing influenza (nichol and treanor 2006). despite increasing success in immunizing ltc residents though, outbreaks continue to occur annually with case fatality rates ranging between 5-55% (nace 2008). older adults have a reduced response to influenza vaccination, in part due to age related immunosenescence (keitel, atmar et al. 1121; skowronski, tweed et al. 2008). it is widely recognized that more effective vaccine options are needed for frail older adults. one option is to increase the hemagglutinin (ha) dose in influenza vaccines in an effort to increase antibodies to hemagglutinin. to date, no studies have evaluated the effectiveness of the hdiv among ltc residents.

Eligibility criteria:
inclusion criteria: * residents of one of the participating ltc sites * 65 years or older at the time of consent * require assistance in two or more instrumental activities of daily living and/or one or more activities of daily living as identified by facility staff exclusion criteria: * age less than 65 years * life expectancy less than 6 months * history of allergic reaction to influenza vaccine, its components, or eggs * history of severe allergic reaction to latex * history of guillian-barre syndrome * actively undergoing chemotherapy * actively undergoing radiation therapy * use of prednisone (or other steroid) at prednisone-equivalent dosages of 10mg or higher within the past 14 days * serious current immunosuppression or immunosuppression expected in the next 6 weeks * any condition that, in the opinion of the investigator,might interfere with the evaluation of study objectives

Keywords: influenza in long term care setting high dose inactivated influenza vaccine standard dose inactivated influenza vaccine
diamel in the treatment of polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to assess the efficacy of diamel administration in the treatment of polycystic ovary syndrome. the duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks.


Eligibility criteria:
inclusion criteria: * two of the following criteria: * oligo or anovulation * polycystic ovary diagnosed by ultrasound technique * clinical signs of hyperandrogenism * signed informed consent exclusion criteria: * personal history of other causes of hyperandrogenism: hyperprolactinemia, suprarenal tumors, ovary tumors, suprarenal hyperplasia, hypercortisolism. * patients under other experimental treatment * treatment with ovulation inducers and/or insulin sensitizers within 60 days before treatment * treatment with vitamins within 7 days before treatment * treatment with dietary supplements within 60 days before treatment * non-compensated intercurrent diseases: diabetes mellitus, thyroid disease, hypertension

Keywords: dietary supplement diamel polycystic ovary syndrome female infertility
effects of breathing exercises on women with primary dysmenorhea

Conditions: Dysmenorrhea

Summary: the aim of this study is to examine the effects of breathing exercises in women with primary dysmenorrhea.

primary dysmenorrhea (pd) is the most common gynecological disorder and constitutes a serious health and economic problem. pd is defined as painful menstrual cramps in the lower abdomen during or a few days before the menstrual period with no detectable organic disease. breathing exercises are an effective method for pain relief. however, breathing exercises need to be examined in pd management.

Eligibility criteria:
inclusion criteria: * having pd symptoms according to the primary dysmenorrhea consensus criteria, * having menstrual pain intensity of 4 or higher according to the visual analog scale in the last 6 months, * having a regular menstrual cycle (28±7 days) * volunteering to participate in the study. exclusion criteria: * being pregnant or suspected of pregnancy, * using oral contraceptives or antidepressants in the last 6 months, * using intrauterine devices, * having a history of other gynecological diseases * having pulmonary, neurological and/or systemic disease, * having undergone abdominal or cardiothoracic surgery within the last year.
a study to assess safety and efficacy of perampanel in indian participants as an adjunctive treatment in partial onset seizures with or without secondary generalized seizures in participants with epilepsy aged 12 years or older

Conditions: Partial Onset Seizures; Epilepsy

Summary: the purpose of this study is to assess the safety of perampanel in the treatment of partial onset seizures in participants of age 12 years and older with epilepsy.


Eligibility criteria:
inclusion criteria: * participants prescribed perampanel for the adjunctive treatment of partial onset seizures based on independent clinical judgment of treating physicians. exclusion criteria: * participation in another study involving administration of an investigational drug or device whilst participating in this observational study. * hypersensitivity \[allergic\] to perampanel.

Keywords: e2007 fycompa perampanel prospective partial onset seizures epilepsy seizures
caregiver assessments of the quality of home hospice care

Conditions: Advanced Cancer

Summary: the objectives are to administer the family evaluation of hospice care (fehc) questionnaire and the texas revised inventory of grief (trig) to caregivers previously enrolled into the parent grant and conduct supplemental analyses to: 1. examine cross-ethnic differences in the caregivers' quality of hospice care assessments. 2. investigate the association between parenteral hydration status of the patient and the quality of care assessments provided by the caregivers after death. 3. examine the association between levels of grief (as measured by the trig) and the quality of hospice care assessments provided by the caregiver.

after the death of their loved-ones, caregivers will be asked to report on the care received by their care recipient and the quality of practical and emotional care provided to them by hospice by completing the 25-minute fehc questionnaire over the phone. caregivers will also be asked 16 additional questions to assess their attitudes and beliefs about hydration at the end of life, and a brief questionnaire to assess past and current levels of grief (trig). the additional questions on hydration and grief can easily be completed in less than 10 minutes over the phone. the entire interview should take no more than 35 minutes to complete. bereaved caregivers who have participated in the parent grant and have lost their loved one within 3-23 months will be mailed a letter from drs. bruera and torres inviting them to participate in the voluntary supplemental after-death survey. the letter will include a brief description of the research study and appropriate contact information for the caregiver to call if she/he is interested in participating. the letters then will be followed up by a phone call from dr. torres to verify receipt of the letter. if the caregivers express their interest in participating in the study, they will be asked a few screening questions over the phone to verify their eligibility. once found eligible for the study, a telephone verbal consent will be obtained. dr. isabel torres will conduct the phone interviews with 128 primary caregivers who had previously completed the parent grant protocol.

Eligibility criteria:
inclusion criteria: 1. bereaved family caregivers who completed their participation in the parent protocol (2006-0494) and have lost their loved one within 3-23 months. 2. caregivers who participated in the parent grant met the inclusion/exclusion criteria of the parent grant. exclusion criteria: 1. bereaved family caregivers who did not complete their participation in the parent protocol or any other caregiver who was never enrolled in the parent protocol (2006-0494).

Keywords: caregiver questionnaire home hospice care family evaluation of hospice care fehc the texas revised inventory of grief trig cross-ethnic differences parenteral hydration grief
simuversity medical center: pain and opioid management training in diverse patient populations

Conditions: None Volunteer

Summary: this study aims to compare the effectiveness of the new educational activity/game (a novel, engaging digital-training plus interaction with virtual patients to practice skills) in meeting clinical learning objectives and outcomes compared to traditional didactic (powerpoint slide-based training and text-base case scenarios) approaches to provider and student education and satisfaction.

management of chronic pain and opioid use/misuse is challenging for clinicians and students, especially when working with diverse and underserved patient populations, and very few low-cost, flexible, highly-engaging, and effective learning resources are available to help the healthcare workforce best learn to manage these unique health concerns. gamification holds promise as a user-friendly, fun, engaging and effective teaching strategy, especially for healthcare applications. simuversity medical center is an immersive 3d gaming platform that will engage students and practicing clinicians in a unique and captivating learning experience focused on pain and opioid management in diverse patient groups. simuversity medical center is an innovative platform solution to education and training in specialty topics in healthcare. this novel learning platform will permit learners to explore a 3d virtual hospital space and can interact with objects, virtual colleagues/trainers and virtual patients (imbued with artificial intelligence) to learn and practice new clinical skills. the platform is built for ease-of-use with simple character controls that non-game-savvy learners find intuitive and easy. the graphical interface is clean and clear and the software runs on all modern computing platforms. the control intervention consists of traditional powerpoint slide-based training and text-base case studies for review. this study aims to compare the effectiveness of the new educational activity/game (a novel, engaging digital-training plus interaction with virtual patients to practice skills) in meeting clinical learning objectives and outcomes compared to traditional didactic (powerpoint slide-based training and text-base case scenarios) approaches to provider and student education and satisfaction.

Eligibility criteria:
inclusion criteria: 1. ages 18-80 years 2. english-speaking 3. graduate-level health professional students and faculty at the medical university of south carolina 4. willingness to volunteer to play the new educational game and complete questionnaires regarding satisfaction, knowledge acquisition, value, ease of use and ability to meet learning objectives exclusion criteria: 1. age outside the predefined range 2. not a student or faculty at musc 3. not willing or able to participate in the learning activity or complete study related questionnaires.

Keywords: educational methods educational software
efficacy of platelet rich plasma in the treatment of hemiplegıc shoulder pain

Conditions: Shoulder Pain; Shoulder Impingement; Hemiplegia, Infantile; Shoulder Subluxation; Spasticity, Muscle

Summary: in this study assessing whether platelet rich plasma injections(prp) are effective in the management hemiplegic shoulder pain, 55 patients with hemiplegic shoulder pain was recruited to this randomized controlled study. patients were randomized into two groups, first getting prp injections, and other group taking sham injections.


Eligibility criteria:
inclusion criteria: * inclusion criteria were being an adult stroke patient with more than two weeks of shoulder pain and restriction, and not having a history of stroke before the recent incident. exclusion criteria: * patients with aphasia, severe cognitive or psychiatric disorders, history of trauma, recent injection (\ 3) were excluded from the study

Keywords: shoulder pain hemiplegia shoulder subluxation spasticity stroke
ketamine for postherpetic neuralgia with depression

Conditions: Depression Disorders; Herpetic Neuralgia

Summary: this clinical trial examines the antidepressant efficacy and safety of a single low-dose intravenous esketamine combined with oral duloxetine in patients with postherpetic neuralgia and depression (duration more than 1 month). in this prospective, randomized, double-blind, placebo-controlled parallel study, eligible patients were randomized into two groups: one received esketamine plus duloxetine, and the other got placebo plus duloxetine. both groups underwent standard pain management and neuro modulation therapy. the primary outcome was the hospital anxiety and depression scale - depression( hads-d)score at 2 weeks post - infusion, with various secondary outcomes assessed over multiple time points. data were collected through in-person interviews and telephone follow-ups.


Eligibility criteria:
inclusion criteria: * diagnosed with herpetic neuralgia, with a disease course exceeding 1 month, and an hads-d score ≥8 (15) upon admission. * diagnosed with depression based on the dsm-v and icd-11 criteria. * aged between 18 and 65 years old. * bmi \<30 kg/m². exclusion criteria: * unable to cooperate with questionnaires. * allergic to ketamine. * history of other mental disorders such as anxiety. * severe hypertension and serious dysfunctions of heart, lung, liver, or kidney.

Keywords: herpetic neuralgia depression ketamine
a study to evaluate the efficacy of mk0719 in the prevention of postoperative dental pain (0719-002)

Conditions: Pain, Postoperative

Summary: this study is being conducted to evaluate the safety and tolerability of the drug and to evaluate its efficacy compared to placebo and to ibuprofen in the prevention of postoperative dental pain in male patients. this is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (full information is available to trial participants).


Eligibility criteria:
inclusion criteria : * patients in generally good health who are scheduled to have 2 or more third molars removed, at least 1 of which is partially or completely embedded in bone and is a mandibular impaction exclusion criteria : * patient has a history of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient

Keywords: postoperative dental pain
sex hormones & serum sclerostin level

Conditions: Bony Sclerosis; Testicular; Hormone, C

Summary: the aim of this study is to determine whether plasma sclerostin levels is affected by sex hormones during menstrual cycle. blood samples will be obtained at the beginning (between 2-5th day), mid (between 11-13th day) and end (between 21-23th day) of menstrual cycle. serum sclerostin, estradiol, progesterone and testosteron levels will be measured blindly by only one investigator

this study is a prospective, observational, single-center study. ethical approval was obtained from the institutional review board. this study will be completed with 40 premenopausal healthy volunteer women. an intravenous cannula will be inserted into the antecubital vein. blood samples will be obtained at the beginning (between 2-5th day), mid (between 11-13th day) and end (between 21-23th day) of menstrual cycle. serum will be collected and will be centrifuged for 15 minutes at 1000xg within 30 minutes of collection. aliquots of plasma will be added to ependorf tubes and stored at -20°c. plasma sclerostin levels will be measured using a human sclerostin elisa kit (cusabio, catalog no: csb-e13146h, newark, de, usa). all assays will be performed according to the manufacturer's instructions. the minimum detectable concentration of human sclerostin is typically \<0.012 ng/ml. intra-assay precision is less than 8%. estradiol and progesterone levels will be analyzed in serum samples using an electrochemiluminescence immunoassay (elecsys pth, elecsys-estradiol ii; roche diagnostics, mannheim, germany) and the cobas 601 analyzing system (roche diagnostics). free testosteron levels will be analyzed in serum samples using an ria (radio immun assay) (dsl 4900 testosterone, free, active® ria assay kit, beckman coulter) and the dsl 4900 berthold technologies multi crystal lb 2111 model gama counter.

Eligibility criteria:
inclusion criteria: * premenopausal women * healthy * volunteer exclusion criteria: * endocrinopathies * bone disease (osteoporosis, osteomalacia, paget disease etc) * women who used hormonal drug within last six months * cognitive disorders

Keywords: sclerostin estradiol progesterone testosteron sex hormones
a phase i - ii safety study of filgrastim (neupogen) to improve left ventricular function after severe acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the objective is to obtain initial information regarding the safety and efficacy of the use of filgrastim in the setting of acute myocardial infarction. the secondary objectives are to obtain information regarding the mobilization of relevant stem cell progenitor cells by filgrastim in this setting and to obtain further clinical information that may be helpful in the assessment of safety and efficacy of this drug as utilized. it is a one center, randomized, placebo controlled, dose escalation, blinded study. it will be 2:1 randomization with 9 patients total. filgrastim 10 mcg/kg/day will be administered sq for 5 days vs. placebo. primary endpoint is death /or myocardial rupture or change in left ventricular ejection fraction from baseline to 30 days. 9 pts. have already completed the first phase of the trial using filgrastim 5 mcg/kg/day.


Eligibility criteria:
inclusion criteria: acute myocardial infarction within 6 hours of symptoms exclusion criteria: -