Kornimate/medical-research-clean huggingface dataset:
validity and inter-rater reliability of a novel bedside referral tool for spasticity

Conditions: Spasticity, Muscle; Muscular Diseases; Musculoskeletal Disease; Muscle Hypertonia; Muscle Spasticity; Neuromuscular Manifestations; Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations

Summary: the purpose of this study is to improve spasticity diagnosis through development of a simple physical examination guide for primary care providers to identify patients who would benefit from being referred to a movement disorders neurologist for a spasticity evaluation.

the aim of this study is to improve spasticity (a form of muscle rigidity) diagnosis through development of a simple physical examination guide for primary care providers/clinicians. this guide will assist in the identification of patients who would benefit from being referred to a movement disorders neurologist for spasticity evaluation and subsequent treatment. the examination tool will be tested for bedside implementation in all consenting participants residing in tennessee state veteran's home, which is a long-term care facility in murfreesboro, tn. each of the 140 residents will receive one neurological examination and two physical examinations guided by the referral tool. a medical record review will also be performed.

Eligibility criteria:
inclusion criteria: * males or female subjects of any race, aged 18 and above * resident of the selected long-term care facility * the subject, or if appropriate their medical decision maker, is willing and able to provide written informed consent. exclusion criteria: * subjects for whom participation in the study may cause medical harm
examining the association between pre-existing sleep disturbance and postoperative delirium

Conditions: Delirium

Summary: the investigators are performing this research study to understand the role of sleep disturbance on the incidence/severity of delirium after surgery. the investigators will study the brain using a polysomnography device (psg), which records the brain's electrical activity during sleep.

during this study, psg recordings will be collected and a sleep questionnaire will be administered to participants on the night before surgery in order to establish level of preexisting sleep disturbance. delirium assessments will be conducted during the postoperative period. on postoperative days 0 and 1, blood will be collected for analysis. further cognitive, quality of life and pain questionnaires will be administered perioperatively.

Eligibility criteria:
inclusion criteria: * over 60 years of age * inpatient and scheduled for surgical procedure at mgh exclusion criteria: * blindness, deafness or the inability to speak english * inability to provide informed consent objective drop criteria * post-operative intubation greater than 24 hours
generic travoprost versus brand name travoprost in patients with primary open angle glaucoma or ocular hypertension

Conditions: Glaucoma, Primary Open Angle; Ocular Hypertension

Summary: the purpose of this study is to compare the efficacy and tolerance of generic travoprost with its brand name formulation. in this open label, randomized, crossover study, the primary outcome will be intraocular pressure and the secondary outcome will be tolerance to the drops, as measured by a subjective questionnaire. patients will be randomized to receive either brand name or generic travoprost during the first visit. at the second visit 3 weeks later, their intraocular pressure will be measured and a questionnaire will be completed on the tolerance of the medication. patients will then receive the other formulation of travoprost. at the third and final visit, another 3 weeks later, their intraocular pressure will be measured and a questionnaire will be completed on the tolerance of the second medication.


Eligibility criteria:
inclusion criteria: * be apt to give consent * have a diagnostic of primary open angle glaucoma or ocular hypertension requiring treatment exclusion criteria: * angle closure glaucoma or having benefited from a peripheral iridotomy * known allergies to travoprost or to one of the ingredients * current usage of other glaucoma drops other than travoprost * current usage of topical corticosteroids * pregnancy * breast feeding * monophthalmic * having benefited from glaucoma surgery including trabeculectomies, implant drainage devices, and selective laser trabeculectomies * active intraocular inflammation * ocular surface disease that interferes with accurate measuring of the intraocular pressure * any clinically significant ocular disease that could interfere with the study

Keywords: drugs, generic generic equivalency
sars-cov-2 safety study for the treatment of covid-19

Conditions: SARS-CoV-2

Summary: sars-cov-2 produced strong pluripotent stem cells and brain cells to protect telomere chromosomes to maintain acid deoxyribonucleic (adn) molecules.

sars-cov-2 produced strong pluripotent stem cells and brain cells to change and disappear defective cells in virus variants, covid-19 disease. pluripotent stem cells produced strong cells serve as a repair system, replacing damaged cells, defective cells and dead cells. chemistry: sars-cov-2 does not use any chemicals, no colors and no additives and no preservatives. toxicology: sars-cov-2 product is not adverse effect, non-toxic and no pharmacal toxicology. sars-cov-2 is not placebo drug

Eligibility criteria:
inclusion criteria: * sars-cov-2 exclusion criteria:
prognostic value of central and brachial ambulatory blood pressure monitoring in ersd patients treated with hemodialysis

Conditions: End Stage Renal Disease

Summary: this is a prospective cohort study which aims to explore the significance of brachial and central ambulatory blood pressure monitoring in predicting cardiovascular risk in patients with end stage renal disease who are treated with hemodialysis. enrolled patients will receive a 48-hour central and brachial ambulatory blood pressure monitoring at its first-time dialysis after enrollment. and their cardiovascular events and deaths at first and third year will be followed-up.

the protocol of this study was approved by the local ethical review board. the including criteria: 1) esrd treated with hemodialysis for more than 3 months prior to study enrollment; 2) agree to participate the study and sign informed written consent; 3) available for long-term follow-up. the excluding criteria: 1)chronic atrial fibrillation or other cardiac arrhythmia; 2) nonfunctional arteriovenous fistula in the contralateral brachial area of the one used for dialysis; 3) myocardial infarction, angina pectoris and ischemic stroke during the previous month; 4) congestive heart failure class iv based on the new york heart association classification; 5) malignancy or any other condition with poor prognosis; 6) antihypertensive treatment during one month prior to enrollment. after enrollment, every patient will receive a question-based interview to obtain medical history and the following examinations and tests: anthropometric parameters measurement including body height, weight; biochemical tests including vein blood and urine. at the first-time dialysis after enrollment, patients will receive 48-hour central and brachial ambulatory blood pressure monitoring using a well validated and commercial device mobil-o-graph (iem, germany). brachial blood pressure are measured for each patient before every dialysis for at three month. then one-year and three-year cardiovascular events and deaths will be followed-up. the primary outcome measures are as follows: deaths and cardiovascular events including nonfatal myocardial infarction, unstable angina, stroke, hospitalization for heart failure, or resuscitated cardiac arrest.

Eligibility criteria:
inclusion criteria: * patients with end-stage renal disease treated with hemodialysis for more than 3 months prior to study enrollment; * agree to participate the study and sign informed written consent; * available for long-term follow-up. exclusion criteria: * chronic atrial fibrillation or other cardiac arrhythmia; * nonfunctional arteriovenous fistula in the contralateral brachial area of the one used for dialysis; * myocardial infarction, angina pectoris and ischemic stroke during the previous month; * congestive heart failure class iv based on the new york heart association classification; * malignancy or any other condition with poor prognosis; * antihypertensive treatment during 1 month prior to enrollment.

Keywords: central blood pressure ambulatory blood pressure monitoring blood pressure variability
effect of recombinant human epo on the postoperative neurologic outcome in pediatric moyamoya patients

Conditions: Moyamoya Disease; Pediatrics; Cerebrovascular Disorders

Summary: this study evaluates the effect of recombinant human erythropoietin (rhuepo) on the neovascularization of pediatric moyamoya disease patients. rhuepo will be administrated during perioperative period of the first revascularization surgery. primary outcome (incidence of good postoperative mca territory revascularization by cerebral angiography) will be evaluated after 3-6 month of revascularization surgery.


Eligibility criteria:
inclusion criteria: * pediatric moyamoya patients scheduled for the first revascularization surgery exclusion criteria: * hypersensitivity or contraindication to rhuepo * history of unstable hypertension, hypertensive encephalopathy, thrombosis * primary intracerebral hemorrhage (ich), subarachnoid hemorrhage (sah), arterio-venous malformation (avm), cerebral aneurysm, or cerebral neoplasm * history of seizure * hemoglobin \>16 mg/dl * prolonged pt (pt \> 15.5 seconds, pt inr \> 1.2) or prolonged aptt (\> 40 seconds) * thrombocytopenia (platelet count \ 400,000/microl), neutropenia (absolute neutrophil count (anc) \< 1500/microl) * abnormal kidney function (creatinine\> 2.0 mg/dl, history of dialysis) * abnormal hepatic function (aspartate transaminase\> 80 unit/l, alanine aminotransferase\> 80 unit/l)
effect of retatrutide compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone (transcend-t2d-1)

Conditions: Diabetes Type 2

Summary: the purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with type 2 diabetes and inadequate glycemic control. the study will last about 11 months and may include up to 11 visits.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes (t2d) * have hba1c ≥ 7.0% to ≤ 9.5% * are naïve to insulin therapy and have not used oral or injectable antihyperglycemic (diabetes) medication for at least 90 days prior to screening * are of stable weight for at least 90 days prior to screening * have a body mass index (bmi) ≥ 23.0 kilograms per meter squared (kg/m\^2) exclusion criteria: * have type 1 diabetes (t1d) * have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening * have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening * are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * have an estimated glomerular filtration rate (egfr) \<15 milliliters/minute/1.73 meter squared (ml/min/1.73 m\^2) as determined by the central laboratory * have a prior or planned surgical treatment for obesity * have new york heart association functional classification iv congestive heart failure * have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening * have a known clinically significant gastric emptying abnormality * have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years * have any lifetime history of a suicide attempt * had chronic or acute pancreatitis * have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (men) syndrome type 2 * have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.

Keywords: glucose metabolism disorders metabolic diseases endocrine system diseases
graft thrombosis after endovascular aortic repair - a single center experience with the cook zenith alpha spiral-z®

Conditions: Aorta Aneurysm

Summary: the purpose of this study is to assess the extent of thrombosis in the zenith alpha spiral-z® stent graft.

cook medical has reported thrombus formation with or without occlusion of the zenith alpha spiral-z®. the purpose of this study is to measure the extent of thrombus formation and occlusion of these stent graft limbs in patients with aortic aneurysms treated at st. olavs hospital in 2017, 2018 and 2019. information is collected from the norwegian registry for vascular surgery (norkar), electronic patient journal and the picture archiving and communication system (pacs). the total number of included patients is estimated to be approximately 100.

Eligibility criteria:
inclusion criteria: * patients that have received endovascular treatment with the zenith alpha spiral-z® for an aortic aneurysm * the endovascular procedure was performed at st olavs hospital from january 2017 until december 2019 exclusion criteria: * none

Keywords: stents thrombosis
screening and treating asymptomatic bacteriuria every trimester and preterm birth

Conditions: Preterm Birth; Asymptomatic Bacteriuria in Pregnancy

Summary: this study is evaluating whether screening of a pregnant woman for asymptomatic bacteriuria in each trimester for early detection and treatment of bacteriuria will reduce the incidence of preterm birth in harare.

asymptomatic bacteriuria is common in pregnancy. if the disease is not detected early in pregnancy and treated it often progresses to an acute symptomatic disease, pyelonephritis which is associated with adverse pregnancy outcomes including preterm birth. it is recommended that every woman be screened for asymptomatic bacteriuria by urine culture test at initial antenatal care visit so that the disease is if identified is treated early to prevent preventable complications of the disease in pregnancy. culture test is expensive and therefore unavailable at several primary care settings especially in low resource settings where majority of pregnant women register and visit for antenatal care. in zimbabwe antenatal care at primary care clinics is not including screening for asymptomatic bacteriuria. majority who present with symptoms are empirically treated. in this study the griess nitrite test, an effective inexpensive screening test for asymptomatic bacteriuria is used. the test detects nitrite in urine which is associated with presence of nitrate reducing uropathogens, commonly the gram negative bacteria. all the positive samples will then be further tested by culture for bacteria identification, quantification and antibiotic sensitivity. a randomized controlled trial research design is being used. participants are randomly allocated to intervention group or control group. urine samples will be collected and tested 3 times for each recruited participant in the intervention arm. treatment will be initiated for positive result according to sensitivity test. control group will only be subjected to routine existing antenatal care. participants will be recruited before 22 weeks gestation and followed on for second contact by 28 weeks and third contact by 36 weeks. follow up will be stopped on delivery for noting gestation at delivery, whether preterm or term.

Eligibility criteria:
inclusion criteria: * pregnant women registering at study site. * woman is able to identify her date of last menstrual period. * gestation of pregnancy is between 6 and 22 weeks. * woman is asymptomatic for bacteriuria * woman voluntarily signs the consent form exclusion criteria: * pregnant woman ill and unwell * pregnant woman unwilling to sign consent form * woman who had antibiotic treatment 2 weeks before recruitment * woman on long term antibiotic treatment * woman who fails to identify date of last menstrual period * woman symptomatic for urinary tract infection

Keywords: asymptomati bacteriuria, griess nitrite test, preterm birth
detecting lung infections through vibration

Conditions: Lung Infection

Summary: the purpose of this study is to test a lung air vibrator device for vibrating air inside the lung. this exploratory diagnostic trial will test a novel and non-invasive means of detecting lower airway infections using exhaled breath sample.

this study has two phases. once the subject has consented phase 1 will start by the subject breathing air out of their lungs into the device. next, the subject will simply breathe through the mouthpiece with the machine turned on and take samples of exhaled air. in phase 2, the subjects will breathe air out of their lungs into the device for 15 minutes. next, the subject will simply breathe through the mouthpiece with the machine turned on and take samples of exhaled air for 15 minutes.

Eligibility criteria:
inclusion criteria: * age 18-50 exclusion criteria: * history of major respiratory compromise (except cystic fibrosis if included within cystic fibrosis cohort)

Keywords: cystic fibrosis
study of axial mobility exercises in parkinson disease

Conditions: Parkinson Disease

Summary: objectives: i. compare the benefit of exercise versus usual care (no exercise) on impairments and functional limitations in patients with parkinson disease.

protocol outline: this is a randomized study. patients assigned to the axial mobility exercise program participate 3 times a week for 10 weeks. the program consists of individualized exercises specifically directed toward restoration of axial mobility in the context of functional tasks. patients assigned to the control group receive standard care (no exercise).

Eligibility criteria:
protocol entry criteria: --disease characteristics-- stage 2 or 3 parkinson disease (hoehn/yahr scale) able to ambulate independently able to function independently in home moderate rigidity no moderate or severe tremor --prior/concurrent therapy-- concurrent stable pharmacologic regimen required --patient characteristics-- cardiovascular: no unstable angina other: no psychiatric or medical contraindication to exercise, e.g., dementia, hip fracture; no other neurologic disorder, e.g., stroke, multiple sclerosis; resides within 30 miles of duke university

Keywords: parkinson disease neurologic and psychiatric disorders rare disease
a study to assess the efficacy and safety of pt009 compared to pt005 on copd exacerbations over a 52-week period in subjects with moderate to very severe copd (sophos)

Conditions: Chronic Obstructive Pulmonary Disorder

Summary: this is a phase iii randomized, double-blind, parallel group, multi-center, 52-week copd exacerbation and lung function study with pt009 320/9.6 μg, pt009 160/9.6 μg and pt005 9.6 μg, all administered bid.

this is a phase iii randomized, double-blind, parallel group, multi-center, 52-week copd exacerbation and lung function study. subjects will undergo a 1- to 4-week screening period. subjects who successfully complete the screening period will be randomized to one of the following three treatment groups: pt009 320/9.6 μg, pt009 160/9.6 μg and pt005 9.6 μg, all administered bid. following randomization, subjects will enter the treatment period and undergo additional treatment visits over 52 weeks.

Eligibility criteria:
inclusion criteria: 1. give their signed written informed consent to participate 2. at least 40 years of age and no older than 80 years of age 3. copd patients who are symptomatic 4. must be receiving one or more inhaled bronchodilators as maintenance therapy 5. must have a documented history of copd exacerbations exclusion criteria: 1. current diagnosis of asthma 2. copd due to α1-antitrypsin deficiency 3. known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, pulmonary resection or lung volume reduction surgery during the past 6 months. 4. long-term-oxygen therapy (≥ 15 hours a day).

Keywords: copd
influence of hrs9531 on pharmacokinetics of metformin in healthy subjects

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the influence of hrs9531 injection on pharmacokinetics of metformin in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent; 2. male subjects aged 18-45 years on the date of signing informed consent (inclusive); 3. body weight ≥50 kg, body mass index (bmi) within the range of 20.0-30.0 kg/m2 (inclusive); 4. hba1c\<6.0%. exclusion criteria: 1. chronic or severe medical history of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., or those with existing systemic diseases mentioned above, and judged by the investigator to be unsuitable to participate in this study; 2. obvious gastric emptying abnormalities or gastrointestinal diseases in the past, or had undergone gastrointestinal surgery (except for gastrointestinal polyps, appendix, and haemorrhoidectomy) 3. past history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (men2), a history of pancreatitis or symptomatic gallbladder stones; 4. surgery within 6 months prior to dosing, planned to undergo surgery during the study period; 5. participation in clinical trials of any drug or medical device in the 3 months or 5 half-lives, whichever longer, prior to dosing; 6. blood donation history or blood loss ≥400 ml within 3 months or ≥200 ml within 1 month before dosing, or received blood transfusion within 3 months before dosing; 7. allergic constitution includes severe drug allergy or history of drug allergy; 8. hepatitis b surface antigen (hbsag), hiv antibody, hepatitis c virus antibody (hcvab), treponema pallidum specific antibody detection, positive; 9. abnormal laboratory test results or abnormal examinations considered unsuitable to participate in this trial; 10. history of hypoglycaemia; 11. the investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.
clinical validation of inferread lung ct.ai

Conditions: Lung Cancer

Summary: lung cancer is the second most common cause of cancer-related death in men and women. early pulmonary nodule screening is an effective means to prevent lung cancer, which is no less important than the diagnosis and treatment of lung cancer. early lung cancer screening has been investigated and applied as a medical practice. inferread lung ct.ai by infervision is a dedicated post processing application that generates cade marks as an overlay on the original ct series intended to aid the radiologist in the detection of pulmonary nodules. this study was designed to evaluate radiologists' performance in detecting actionable nodules on chest ct when aided by inferread.


Eligibility criteria:
inclusion criteria: * lung cancer screening eligible patients exclusion criteria: -