Kornimate/medical-research-clean huggingface dataset:
deep brain stimulation for parkinson's disease trial

Conditions: Parkinson's Disease

Summary: the purpose of this trial is to evaluate the effect of deep brain stimulation in the the globus pallidus (gpi) and the subthalamic nucleus (stn) on motor, neuropsychological and psychiatric function, and quality of life in patients with parkinson's disease.

medical therapy is the mainstay of treatment for patients with parkinson's disease (pd). after several years of drug therapy, however, a large proportion of patients experience worsening of their parkinsonism and develop incapacitating motor fluctuations and dyskinesias. to deal with this, attention has been directed to surgical procedures, such as deep brain stimulation (dbs). recently, stimulating the areas of the brain that control movement, the globus pallidus (gpi) and subthalamic nucleus (stn), has been proposed as a therapy for treating many of the disabling symptoms associated with pd and drug-induced side effects. the major aim of this 5-year study is to carry out a prospective, double blinded, randomized, clinical trial of dbs for medically intractable pd. the study will evaluate the effect of dbs in the gpi and stn on motor, neuropsychological and psychiatric function, and quality of life in patients with pd. the study also will address two key issues: 1) whether there are differences between unilateral gpi-dbs and stn-dbs and 2) which patients are the best candidates for bilateral dbs.

Eligibility criteria:
inclusion: * clinical diagnosis of idiopathic parkinson's disease based on the presence of at least 2 of the cardinal motor signs (akinesia/bradykinesia, rigidity, tremor, and gait/balance disorder) and a clear response to levodopa therapy. * hoeh \& yahr staging iii or worse "off " medication periods. * intractable, disabling motor fluctuations, dyskinesias, or freezing episodes. * unsatisfactory clinical response to maximal medical management or previous surgical treatment. * stable on parkinson's medications for at least 30 days with total l-dopa equivalence varying no more than +/- twenty percent during the 30 day period. * absence of cognitive, or psychiatric or other co-morbidities that might interfere with the patient's ability to understand and sign the informed consent form. exclusion: * clinically significant medical history that increases pre- / post operative complications (cardiac or pulmonary disease, uncontrolled hypertension, diabetes...). * secondary or atypical parkinsonism as suggested by: i. history of stroke, encephalitis, exposure to toxins or neuroleptics. ii. neurologic signs of upper motor neuron or cerebella involvement, supranuclear gaze palsy, or significant autonomic dysfunction. iii. mri scan with evidence of significant brain atrophy, lacunar infracts, or iron deposits in the putamen. * dementia as indicated by a mattis dementia rating scale (drs) less than 116 or dsm-iv criterion for dementia. * clinically significant psychiatric disorder meeting structured clinical interview for the dsm-iv criteria for an active anxiety, depressive, or psychotic disorder.

Keywords: parkinson's disease pd deep brain stimulation dbs
transcutaneous auricular vagus nerve stimulation in dry eye

Conditions: Dry Eye Disease

Summary: objective: to evaluate the effect of transcutaneous auricular vagus nerve stimulation (tavns) for the patients with dry eye disease. methods: the investigators enrolled 256 patients at beijing tongren hospital. patients completed questionnaires at baseline, 1 month, 3 months, and 6 months. osdi score, tbut, schirmer i, cfs, sf36, deq5, and psychological status to evaluate the therapeutic effects. a difference of p \< 0.05 was considered statistically significant.


Eligibility criteria:
inclusion criteria: 1. age \>=18 and age \<=65. 2. complaint of ded symptoms for 6 months or longer at screening. 3. ocular surface disease index (osdi) score of 25 or higher. 4. tear film breakup time (tfbut) of 5 seconds or less. 5. schirmer i test without anesthesia of 5 mm or more at 5 minutes. 6. tcfs score of 4 or higher. exclusion criteria: 1. history systemic autoimmune diseases and ocular/periocular malignancy. 2. clinically relevant slitlamp findings or abnormal lid anatomy. 3. active ocular allergies and active infection. 4. pregnant or lactating women.

Keywords: tavns dry eye rct
alpha as a predictive biomarker

Conditions: Pain

Summary: the investigators will use non-invasive recordings of brain activity to measure pain as a proxy to self-report. participants will undergo testing for about 3 hours on two separate days. the testing will involve experiencing painful heat.

neurophysiological investigations of pain have suggested that electroencephalograph (eeg) measures of peak alpha frequency might provide a means of pain assessment. in healthy subjects, increased peak alpha frequency is strongly correlated with pain self-reports after exposure to acute noxious heat. conversely, chronic pain patients compared to healthy control display decreased peak alpha frequencies higher in alpha power. measures of peak alpha frequency also show a negative relationship with disease duration, suggesting that peak alpha frequency may not only index ongoing pain but also disease progression. the overall aim is to determine the predictive accuracy, reliability, and specificity of eeg alpha activity in acute pain and a model of neuropathic pain in healthy subjects.

Eligibility criteria:
inclusion criteria: * able to speak, read, and write english * between 21 and 44 years of age * able to understand and willing to comply with all study procedures and is available for the duration of the study * free of an acute or chronic pain condition * not history of psychiatric or neurologic condition exclusion criteria: * unable to undergo eeg, assessed on an individual basis * history of unstable major psychiatric disorder (self-report) * history of chronic pain (self-report) * more than 14 alcoholic drinks per week on average (self-report) * active \[within 6 months\] substance or alcohol abuse (self-report and urine toxicology) * use of opioids (self-report and urine toxicology) * history of major depressive disorder (self-report) * pregnant or lactating (women only), based on (self-report and urine test) * anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study * uncontrolled (systolic blood pressure \> 175 mmhg or diastolic blood pressure \>105 mmhg) or unstable hypertension

Keywords: eeg healthy subjects
finding solutions to thrive after birth asphyxia in africa

Conditions: Birth Asphyxia

Summary: neonatal encephalopathy (ne) is the third leading cause of under 5-year mortality and contributes substantially to long-term neurological morbidity worldwide. in low-income countries (lics), families often lack the resources to care for affected children. for those with disabilities, stigma is high, and social and emotional impacts are substantial. improving our understanding of ne in lics is crucial if intervention strategies are developed. providing access to an affordable and easy-to-administer treatment after birth may improve survival, early brain development and later outcome, maximizing developmental potential. the primary objective of this study is to investigate the feasibility, safety and tolerability of administering sildenafil as a neuroprotective/neurorestorative strategy to improve early brain development in a cohort of children with ne in uganda.


Eligibility criteria:
inclusion criteria: * male and female neonates meeting the criteria for birth asphyxia * gestational age ≥ 36 weeks and birth weight ≥ 1800 g; * admitted to kawempe hospital or nsambya hospital within 48 hours of life; * need for continued resuscitation after birth and/or 5-minute apgar score ≤5; * evidence of neonatal encephalopathy by an abnormal neurological exam (modified sarnat score of 2-3 or abnormal aeeg). exclusion criteria: * absent heart rate at 10 minutes/imminent death * neonates with major congenital malformations * neonates with grade 3 aki (serum creatinine rise ≥3x lowest previous creatinine or creatinine \> 2.5 mg/dl = 221 mcmol/l or receipt of dialysis) * neonates with intraventricular and/or intraparenchymal hemorrhage on cranial ultrasound (cus) performed on day 1-2 of life * mother living permanently outside 20km radius of kawempe hospital or nsambya hospital * neonates whose parents are unwilling or unable to give informed written consent to enter the study
the effect of the prostate cancer foundation screening guidelines for black men on intention to screen in faith-based communities

Conditions: Prostate Cancer Screening

Summary: to learn about barriers to prostate cancer screening in black, faith-based communities. investigators will use the information collected in this study to create a prostate cancer education program that is relevant to black men within the church and improve prostate cancer screening.

primary objective to determine barriers to prostate cancer screening in black faith-based communities through focus group assessments which will inform a culturally relevant prostate cancer education and early detection program.

Eligibility criteria:
inclusion criteria: * self-reported identification of black/ african american * willingness to participate in the study with signed and dated informed consent exclusion criteria: * non-english proficiency * unwillingness to participate in the study or inability to sign and date an informed consent
lactate level and gastrointestinal bleeding

Conditions: Patient Compliance

Summary: acute gastrointestinal bleeding is a common emergency with significant morbidity, mortality, and cost. appropriate risk stratification of patients presenting with acute gastrointestinal bleeding aids in the triage of patients to determine need for hospital admission and the need for emergency endoscopic intervention. increased blood lactate levels are common in critically ill patients. our study will evaluate the usefulness of lactate measurements on resources utilisation ( intensive care unit admission, length of hospital stay) and other patient-oriented outcomes ( need for transfusion and endoscopy) in patients with acute gastrointestinal bleeding.

the present study is a prospective cross sectional study aimed to assess whether venous blood lactate on hospital presentation is predictive of need for interventions and short term outcomes (eg prbc transfusion, icu admission ) in patients with acute gib who presented to ed of assuit university hospital between september 2019 and june 2022. the study included 300 patients with acute gib. out of those patients; 200 patients had elevated blood lactate and 100 patients had normal blood lactate. it was found that mean age of patients with elevated lactate was significantly higher in comparison to those with normal lactate. there were no significant differences between both groups as regard risk factors for bleeding (use of anti-coagulants, aspirin), use of nsaids was higher among patients with normal lactate while history of prior ugib was higher among patients with elevated lactate. the most frequent presentations among the studied patients were hematemesis and melena. both groups had insignificant differences as regard laboratory data, endoscopic findings and interventions. patients with elevated lactate had prolonged hospital stay, higher frequency of blood transfusion, icu admission and mortality in comparison to those with normal blood lactate. based on the current study, predictors of mortality among patients with ugib were old age , lc, elevated lactate and variceal bleeding. so we could say that elevated blood lactate can be predictive for interventions and short term outcomes in patients with acute gib ,however, further and similar studies with multi-center settings would be more reliable and accurate.

Eligibility criteria:
inclusion criteria: * patients presenting with acute gastrointestinal bleeding, inclusive of both upper and lower sources * patients ≥18 years old exclusion criteria: * patients with tumor bleeding * patients with post procedure or surgical site bleeding * patients with active systemic infection * patients wit post-cardiopulmonary resuscitation state
a phase i clinical, dose escalation study of the safety, tolerability and pharmacokinetics of donepezil patch in healthy male subjects

Conditions: Alzheimer Disease

Summary: study of the safety, tolerability and pharmacokinetics with single dose of donepezil patch in healthy male subjects.


Eligibility criteria:
inclusion criteria: * bmi : more than 20 ㎏/㎡, less than 26 ㎏/㎡ * systolic blood pressure : more than 90, less than 140 (mmhg) * diastolic blood pressure : more than 60, less than 100 (mmhg) exclusion criteria: * evidence of clinically significant, severe, active, or unstable gastrointestinal, renal,hepatic, respiratory, hematological, endocrine, or cardiovascular system disease. * a history of skin disease or skin graft * hypersensitivity to donepezil or piperidine derivatives or any of the excipients. * a known or suspected history of drug or alcohol dependency or abuse * patients who have participated in another clinical study within 60 days. * whole blood within 60 days, apheresis within 30 days, transfusion within 30 days * heavy caffeine intake(more than 5 units/day) * heavy alcohol intake(more than 21 units/week) * heavy smoker(more than 10 cigarette/day) * abnormal clinical laboratory values which are judged clinically significant by the investigator. * any condition that would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study.
direct application of selective laser trabeculoplasty in open angle glaucoma

Conditions: Glaucoma

Summary: the trial objectives are to establish the safety \& efficacy of using a dltp laser to perform laser trabeculoplasty to reduce intraocular pressure (iop) in patients with open angle glaucoma (including pigmentary \& exfoliative glaucoma), that did not achieve adequate iop control by conventional therapy.

this is a single site outpatient feasibility study assessing the safety \& efficacy of the dltp laser in the ability to reduce iop in patients with open angle glaucoma (oag). the investigational site will accrue patients with uncontrolled oag. these eyes will be treated with the direct application of direct laser trabeculoplasty (dltp)/ direct selective laser trabeculoplasty automated device (dslt). only one eye per patient is to be treated with the investigational device during the study. the laser parameters used will be like these used in the selective trabeculoplasty (slt) device (ce/fda approved), but all laser beams will be applied in about one-second, through the peri-limbal. subjects will be evaluated preoperatively and postoperatively at 1 hour, 2 hours (and hourly to 4 hours in the event of an iop elevation in the immediate postop course), 1 day, 1 week, and 1, 3, 6 months. patients will be followed out to 6 months.

Eligibility criteria:
inclusion criteria: * patient is aged 18 years or older, with 2 sighted eyes. * eye to be treated have average iop \*22 mmhg, measured at 2 pretreatment visits. * eye to be treated either exhibits: * poorly controlled open angle glaucoma including pigmentary \& exfoliative glaucoma * patient would be considered eligible for conventional laser trabeculoplasty. * patient is willing to participate in the 6-month study and to adhere to the follow-up schedule. * patient is willing to review and sign a consent form. exclusion criteria: * evidence of glaucoma other than open-angle glaucoma; * severe para-central or generalized field defect; * any ocular condition that precluded adequate visualization and treatment of the trabecular meshwork. * prior glaucoma surgery other than laser trabeculoplasty or peripheral iridotomy. * patient has mental impairment such that he/she could not understand the protocol or is not in a position to provide written informed consent. * patient is pregnant. * patient might require other ocular surgery within the 6-month follow-up period. * patient has a medical history that suggested the potential for complications from direct selective trabeculoplasty (dslt) * having concurrent treatment with systemic steroids. * patient is under 18 years old

Keywords: slt, ltp, dslt non contact trabeculoplasty laser intraocular pressure
a pk study to evaluate pur0200 and a reference product in healthy subjects

Conditions: Healthy

Summary: the purpose of this study is to compare drug blood levels of multiple formulations of inhaled pur0200 to each other and to the reference product with and without oral charcoal.

the purpose of this study is to compare 5 different formulations of pur0200 to the reference product. all formulations will be inhaled. in 6 of the 7 study periods either pur0200 or the reference product will be inhaled under fasting conditions without oral charcoal. in the 7th study period, half of the subjects will receive reference with oral charcoal and the other half will receive reference product without oral charcoal.

Eligibility criteria:
inclusion criteria: * healthy male or female subject * age between 18 and 50 (inclusive) years * non-smokers or ex-smokers (stopped at least 6 months ago) * fev1 ≥80% of the predicted value * completion of 3 training inhalations exclusion criteria: * pregnant and/or nursing women. positive pregnancy test at entry visit or on hospitalization day 0 of each study period. * fertile women without reliable contraception * participation in any research study within 3 months prior to entry visit, or simultaneous participation in another clinical study * blood donation or blood loss within last 3 months * treatment with any investigational study drug (i.e. drug not yet approved) in the last 3 months before entry visit * intake or administration of any prescribed systemic or topical medication including over the counter (otc) medication or natural food supplements (e.g. vitamins, garlic, or ginger capsules) within 2 weeks before entry visit * current or history of drug abuse within 5 years before entry visit * alcohol abuse * regular consumption of beverages or food containing methylxanthines (i.e. coffee, tea, cola, caffeine containing sodas, chocolate) equivalent to more than 500 mg methylxanthines\* per day * presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases * major surgery of the gastrointestinal tract except for appendectomy, or any pulmonary surgery * clinically significant illness (including upper or lower respiratory infection and/or candidiasis of the mouth and throat) within 4 weeks before entry visit * any acute or chronic disease which might interfere with inhalation, absorption, distribution, metabolism or excretion of the drug special diet due to any reason, e.g. vegetarians * positive serologic findings for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), and/or hepatitis c virus (hcv) antibodies * excessive physical activity (more than 4 times per week for more than 90 minutes) within the last 6 months and during the study

Keywords: pharmacokinetics
clareon toric vs eyhance toric

Conditions: Cataract; Aphakia

Summary: the primary purpose of this study is to compare the clareon/clareon toric intraocular lenses (iols) to the eyhance/eyhance toric iols in binocular best corrected distance visual acuity (bcdva) at 3 months postoperative.

this study will enroll adults 22 years of age and older diagnosed with cataracts in both eyes with planned bilateral cataract removal by routine small incision phacoemulsification surgery. subjects will attend up to 7 scheduled visits: a screening visit, two operative visits, and four post-operative visits. the expected individual duration of participation in the study is 3 months.

Eligibility criteria:
key inclusion criteria: * planned bilateral cataract removal by routine small incision phacoemulsification surgery; * planned implantation of either test or comparator iol (per randomization) in at least one eye with approximately 1.00 - 3.00 diopter (d) of preoperative corneal astigmatism; * predicted postoperative astigmatism of ≤ 0.5 d in both operative eyes based on a toric calculator; * other protocol-specified inclusion criteria may apply. key exclusion criteria: * any disease or pathology, other than cataract, that (in the investigator's opinion) may reduce potential best corrected distance visual acuity (bcdva) to a level worse than 0.2 logarithm minimum angle of resolution (logmar); * clinically significant (in the investigator's opinion) corneal pathology, dry-eye or ocular surface disease that would adversely affect a) the biometry measures and/or toric calculations and b) the visual outcome; * history of previous intraocular or corneal surgery (including laser-assisted in situ keratomileusis (lasik)); * any other planned ocular surgical procedures including but not limited to limbal relaxing incision (lri), astigmatic keratotomy, lasik, and retinal laser treatment within the study time frame; * other protocol-specified exclusion criteria may apply.

Keywords: cataracts phacoemulsification iol
a phase 2 study to evaluate the safety and efficacy of yra-1909 in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a multicenter, randomized, double-blind phase2 study to evaluate the safety and investigate the efficacy of yra-1909 in patients with rheumatoid arthritis who are on a stable dose of methotrexate(mtx) and who have an inadequate response to mtx(mtx-ir).


Eligibility criteria:
inclusion criteria: * 19 years to 80 years * subjects with onset ra classified by acr/eular 2010 revised classification criteria at least 12 weeks prior to screening * subjects meet the acr 1992 revised criteria for the classification of global functional status in ra class i, ii or, iii at screening exclusion criteria: * subjects meet the acr 1992 revised criteria for the classification of global functional status in ra class ⅳ at screening * any of the following laboratory values at screening: 1. patients with severe liver impairment (ast or alt \> 2 times the upper limit of normal) 2. patients with renal disease,immunodeficiency disease and peptic ulcer 3. patients with pleural effusion and ascites