Kornimate/medical-research-clean huggingface dataset:
exacerbations among patients receiving breztri (eros study)

Conditions: Pulmonary Disease; Chronic Obstructive; Retrospective Studies

Summary: eros was a retrospective analysis of people with copd using the more2 registry®. inclusion required ≥1 severe, ≥2 moderate, or ≥1 moderate exacerbation while on other maintenance treatment. primary outcomes were the rate of copd exacerbations and healthcare costs for those that received bgf promptly. the effect of each 30-day delay in initiation of bgf was estimated using a multivariable negative binomial regression model.

eros was a retrospective real-world evidence claims analysis study, assessing the relationship between the timing of breztri aerosphere following an exacerbation and the appearance of subsequent disease exacerbations of people with copd. the study used administrative claims data in the us sourced from the inovalon more2 registry® between july 2019 and march 2022. inclusion required one of the following qualifying exacerbation events: ≥1 severe, ≥2 moderate, or ≥1 moderate exacerbation while on other maintenance treatment, be age ≥40 at the index date, and have ≥90 days of continuous enrollment following the index date. primary outcomes were the rate of copd exacerbations and healthcare costs for those that received bgf promptly. the effect of each 30-day delay in initiation of bgf was estimated using a multivariable negative binomial regression model. statistical analyses included both descriptive and multivariable approaches- negative binomial regression models to estimate the effect of each 30-day delay on the number of exacerbations and a gamma model with a log-link to estimate the effects on the incremental increase in copd-related costs.

Eligibility criteria:
inclusion criteria: * ≥ 1 prescription fill for bgf on or following july 24th, 2020 (breztri approval date); * evidence of any of the following exacerbation patterns within the 12-month period preceding the initiation of bgf, all index exacerbation events must occur following bgf approval: (1) one moderate exacerbation (the exacerbation must occur following approval of breztri) with presence of other inhaled therapy, (2) two moderate exacerbations (the second exacerbation must occur following approval of breztri) without the presence of other inhaled therapy, or (3) severe exacerbation- inpatient copd hospitalization * ≥ 12 months of continuous enrollment preceding the index exacerbation date * ≥ 90 days of continuous enrollment following the index exacerbation date * age ≥ 40 years on the index exacerbation date exclusion criteria: * presence of closed triple therapy during the baseline period * initiation of bgf 4/1/2022 or later * presence of an enrollment gap of more than 14-days from index exacerbation date to bgf initiation date

Keywords: copd delayed therapy exacerbations triple therapy
impact of noninvasive with expiratory washout on respiratory rate of patients with acute hypercapnic respiratory failure

Conditions: Noninvasive Ventilation

Summary: this study will determine if niv using the vela investigational mask with expiratory washout of the upper airway more effectively reduces respiratory rate in acute patients with hypercapnic respiratory failure. patients admitted to hospital with acute respiratory failure (arf) will be assessed for hypercapnic arf by normal hospital protocols. patients requiring noninvasive ventilation (niv) will be set up on niv as prescribed per standard of care. enrollment onto the investigation will occur after the patient has been allowed to stabilize on niv . patients that meet the inclusion/exclusion criteria will be approached for consent. investigation participants will receive two masks in random order; 1. niv for one hour with the investigational mask (vela) 2. niv for one hour with the standard mask (nivairo). participants will have their physiological respiratory parameters recorded.

this is a simple study. patients who are already on noninvasive ventilation (niv) for acute respiratory failure will be approached for the study within the first 24 hours on niv therapy. the study will be conducted as described above. after the study patients will be able to choose which mask they continue their niv on. they will continue niv as part of their normal hospital care.

Eligibility criteria:
inclusion criteria: * have type ii acute respiratory failure (arf) and have been prescribed niv * arterial blood gas (abg) partial pressure of arterial carbon dioxide greater or equal to 6.0 kilopascals (45 millimeters of mercury) * arterial blood gas acidity greater or equal to 7.35 prior to bilevel commencement * on niv for 24 hours or less * negative covid-19 test * are 18 years or older exclusion criteria: * contraindicated for niv * on niv in emergency department/ ward for more than 24 hours, within the last 48 hours * niv is likely to fail and/or intubation be required, at the doctor's discretion * cpap or bilevel pressure of 25 centimeters of water or more is required * unable to tolerate niv for the duration of the investigation * do not fit the investigational mask or the standard mask * pregnancy (tested under standard care) * agitated * unable to understand the consent process
effect of thoracic mobilization on lumbar radiculopathy

Conditions: Lumbosacral Radiculopathy

Summary: the purpose of the study will be to: * to investigate the effect of thoracic mobilization on back and leg pain in patients with lumbosacral radiculopathy. * to investigate the effect of thoracic mobilization on functional disability in patients with lumbosacral radiculopathy. * to investigate the effect of thoracic mobilization on proprioception in patients with lumbosacral radiculopathy.

to investigate the effect of thoracic mobilization on back and leg pain, functional disability and proprioception in patients with lumbosacral radiculopathy. 1-thirty four patients of both sexes with unilateral chronic lumbar radiculopathy at l4-l5 or/ and l5-s1 levels will participate in this study. the patients will be diagnosed as having lumbar radiculopathy based on careful clinical examination by neurologist . the diagnosis will be confirmed by ct scan or mri. patients will be recruited from the outpatient clinic of faculty of physical therapy, cairo university and private clinics. patients in this study will be randomly divided into two groups. * group (i) which will include 17 patients who will receive manual mobilization exercises in addition to selected physical therapy . * group (ii) which will include 17 patients who will receive selected physical therapy. the treatment will conducted 3 sessions per week for 6 weeks.

Eligibility criteria:
inclusion criteria: 1. patients with unilateral chronic lumbosacral radiculopathy at l4- l5 or / and l5-s1 levels confirmed by mri. 2. the age of patients will be ranged from 30 to 45 years. 3. duration of pain will be more than 12 weeks. 4. patients with a positive straight leg raising (slr) test. 5. patients with sufficient cognitive abilities that enables them to understand and follow instructions . 6. patients had to report an average pain level of more than five on the visual analogue scale (vas) and a lumbar spine range of motion (rom) of at least 50% of the accepted normal range. 7. patients with body mass index\< 30kg/m2 exclusion criteria: 1. cauda equina syndrome. 2. ankylosing spondylitis, thoracic deformities (pectus carinatum, excavatum), spina bifida, fractures, postoperative spinal conditions, diabetes, inflammatory processes. 3. previous inner ear infection or vestibular disorder with unresolved balance disturbance, history of head trauma with residual neurological deficits. 4. spinal tumor. 5. previous lumbar surgery. 6. sever musculoskeletal disease. 7. peripheral mononeuropathies or polyneuropathy. 8. obesity . 9. pregnancy.
clinical trial with riluzole in spinocerebellar ataxia type 2 (atril)

Conditions: Spinocerebellar Ataxia Type 2

Summary: atril is a multi-centric, double-blind randomized, two-arm controlled study. 42 spinocerebellar ataxia type 2 (sca2) patients, both gender, at least 18 years of age will be included. riluzole 50 mg will be administered (per os) twice a day, versus one group with placebo for 12 months. riluzole (rilutek®) is a benzothiazole drug, market approved, for amyotrophic lateral sclerosis (als). it delays the onset of ventilator-dependence or tracheostomy in selected patients and may increase survival. scale for the assessment and rating of ataxia (sara) will be used at m0, m6 and m12. to assess primary criterion, the percentage of patients with a decrease of at least 1 point of the sara score between the inclusion visit, and visit 3 (months 12) will be calculated.

inherited cerebellar ataxias are genetically heterogeneous neurological disorders. they are characterized by ataxic gait and cerebellar dysarthria that progresses over time with loss of ambulation and speech. the mutations by expansions of cag triplets in the genes atxn1 (sca1), atxn 2 (sca2), 3 (sca3), cacna1a (sca6), atxn 7 (sca7), and tbp (sca17) are responsible for 50% of hereditary forms there is no curative or preventive treatment. this phase iii study is a multi-centric, double-blind randomized, two-arm controlled study (one group with 50 mg riluzole twice a day versus one group with placebo), to measure the efficacy of treatment with riluzole in sca2 patients during 12 months. amelioration is defined by a 1 point decrease of the sara score.

Eligibility criteria:
inclusion criteria: * genetically diagnosed sca2 (cag triplet in atxn2 ≥ 33) * at least 18 years of age * signature of informed consent * covered by social security * sara score ≥ 5 and ≤ 26 * age at onset ≤ 50 years old exclusion criteria: * treated with riluzole prior to the study * hepatotoxic medication * hypersensitivity to the active substance or to any of the excipients * serious systemic illnesses or conditions known for enhancing the side effects of riluzole * contraindications for mri examination * participation in another therapeutic trial (3 months exclusion period) * pregnancy or breastfeeding * non abstinence or absence of effective contraception for women * inability to understand information about the protocol * persons deprived of their liberty by judicial or administrative decision * adult subject under legal protection or unable to consent * other ataxic syndromes than sca2

Keywords: spinocerebellar ataxia-sca2 sara (scale for the assessment and rating of ataxia) score riluzole (rilutek)
coconut oil in cardiovascular disease

Conditions: Chronic Coronary Artery Disease

Summary: the purpose of this study is to evaluate the supplementation with extra virgin of coconut oil combined with a nutritional counseling in reducing anthropometry and improves the lipid profile in patients with chronic coronary disease.

the universe of patients with coronary artery disease (cad) has been increasing steadily worldwide. and associated intimately with certain cardiovascular risk factors such as dyslipidemia , decreased hdl-c , hypertension , diabetes mellitus and obesity. the quality of the fat in the diet influences the incidence of obesity and dyslipidemia. a high intake of saturated fat in different populations is associated with elevated serum cholesterol concentration and cardiovascular mortality. however, studies have shown that extra virgin coconut oil (cocos nucifera l.) despite being characterized by its high content of saturated fat was not associated with obesity and dyslipidemia in populations that had their high consumption . and this is due to the high proportion of medium chain triglycerides , especially lauric acid in proportions ranging from 45-50 % , and the presence of factors antioxidants like vitamin e and polyphenols. our hypothesis is that extra virgin coconut oil associated with a nutritional treatment has an effect on weight reduction and control of dyslipidemia contributes to control in secondary prevention in patients with coronary artery disease. all participants will be informed about the research and they must sign a consent form . volunteers will be divided into two groups : a group receiving dietary treatment for 6 months and the other beyond the dietary treatment during the 6 months starts to receive supplementation with coconut oil extra virgin from 3 months, both groups evaluated monthly . at each visit , weight assessment , compliance with diet and blood pressure measurement is performed. in addition , the blood will also be collected for determination of glucose, insulin, total cholesterol, ldl-cholesterol , hdl-cholesterol, triglycerides , apolipoprotein a and b. the results will be analyzed by the statistical program.it is expected that the results obtained, the extra virgin coconut oil can be used as a coupled secondary prevention in patients with coronary artery disease.our hypothesis is that extra virgin coconut oil associated with nutritional treatment has an effect on weight reduction and control of dyslipidemia contributes to control in secondary prevention in patients with coronary artery disease.

Eligibility criteria:
inclusion criteria: presenting chronic coronary artery disease (myocardial infarction and/or stable angina exclusion criteria: angioplasty and/or coronary artery bypass grafting and previous cardiovascular event \ the 2mg/dl and liver disease.

Keywords: chronic coronary artery disease coconut oil extra virgin index of diet quality nutritional treatment
rate of allergic contact dermatitis and cosmetic outcomes

Conditions: Allergic Contact Dermatitis; Osteoarthritis, Hip; Osteoarthritis, Knee

Summary: the patients from the department of orthopaedics center for joint replacement will be asked to participate in the study. these patients will be randomized to one of three wound closure products, sylke adhesive dressing, exofin skin glue, or suture strip plus. participants will be asked to take a photograph of the incision 4 days after surgery to submit via mychart for review by the wvu department of dermatology team. all patients will be evaluated at their regular 2-week, 6-week, and 3-month post-operative visits where clinical photographs will be submitted for independent review by the wvu department of dermatology team to assess outcomes.


Eligibility criteria:
inclusion criteria: * willing and able to sign the informed consent * patients presenting to the wvu medicine center for joint replacement who have a primary tka or tha surgery scheduled * patients with surgical wounds closed by 2-0 vicryl and barbed, running v-loc suture (assessed in or) * active mychart account and the ability to take and upload a photo in that system exclusion criteria: * patients scheduled for a revision tha or revision tka * tha used for treatment of a fracture * patients participating in other studies that might have involve medications such as antibiotics
safety, tolerability and efficacy on low density lipoprotein cholesterol (ldl-c) of evolocumab in participants with human immunodeficiency virus (hiv) and hyperlipidemia/mixed dyslipidemia

Conditions: Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection

Summary: the study is divided into 2 parts. the first part of the study will be double-blinded and will last for 24 weeks. during this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (qm) or placebo qm. the second part of the study is a 24-week open label extension period. during this time all participants will receive evolocumab qm. the clinical hypothesis is that subcutaneous evolocumab qm will be well tolerated and will result in greater reduction of low density lipoprotein cholesterol (ldl-c), defined as percent change from baseline at week 24, compared with placebo qm in human immunodeficiency virus (hiv)-positive participants with hyperlipidemia or mixed dyslipidemia.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age * known hiv infection with stable hiv therapy for ≥ 6 months * cluster of differentiation 4 (cd4) ≥ 250 cells/mm\^3 for ≥ 6 months * hiv viral load ≤ 50 copies/ml at screening and ≤ 200 copies/ml for ≥ 6 months * subject on stable lipid-lowering therapy for ≥ 4 weeks prior to randomization and not expected to change during the duration of study * for subjects with known clinical atherosclerotic cardiovascular disease (ascvd), fasting ldl-c of ≥ 70 mg/dl or non-high density lipoprotein cholesterol (non-hdl-c) ≥ 100 mg/dl. for subjects without known clinical ascvd: fasting ldl-c of ≥ 100 mg/dl or non-hdl-c of ≥ 130 mg/dl * fasting triglycerides ≤ 600 mg/dl (6.8 mmol/l) exclusion criteria: * taking a combination of background lipid-lowering therapy and hiv therapy known to have significant drug-drug interaction * new york heart association (nyha) iii or iv heart failure, or last known left ventricular ejection fraction (lvef) \< 30% * known opportunistic infection/acquired immunodeficiency syndrome (aids) defining illness within 1 year prior to randomization * myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months * type 1 diabetes, new-onset or poorly controlled type 2 diabetes * uncontrolled hypertension * taken a cholesteryl ester transfer protein inhibitor in the last 12 months * moderate to severe renal dysfunction * persistent active liver disease or hepatic dysfunction (stable chronic hepatitis c of at least 1 year duration prior to randomization is allowed) * malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or stage 1 prostate carcinoma) within the last 5 years prior to randomization other exclusion criteria may apply.

Keywords: hyperlipidemia dyslipidemia proprotein convertase subtilisin/kexin type 9 (pcsk9) inhibition hiv infection cluster of differentiation viral load
a randomized, double-blind, placebo-controlled, clinical trial to evaluate the safety, tolerability, efficacy, and pharmacodynamics for the treatment of covid-19.

Conditions: Covid19

Summary: a randomized, double-blind, placebo-controlled, clinical trial to evaluate the safety, tolerability, efficacy, and pharmacodynamics of adx-629 administered orally for the treatment of covid-19


Eligibility criteria:
inclusion criteria: * is a male or female greater than or equal to18 years of age at screening; * is willing and able to sign and date (or has a legally authorized representative willing to sign and date) a written (or electronic) informed consent form or provide equivalent consent per food and drug administration guidelines on covid-19 clinical trials; * has a documented, laboratory-confirmed severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection as determined by polymerase chain reaction, a sars-cov-2 antigen test, or another commercial or public health assay, within 3 days (72 hours) of randomization; * has covid-19 of moderate severity, as defined by the following: positive testing by standard reverse transcription polymerase chain reaction assay or equivalent testing; symptoms of illness with covid-19, which could include any of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, or new loss of taste or smell; clinical signs suggestive of illness with covid-19, such as respiratory rate greater than or equal to 20 breaths per minute, saturation of oxygen greater than 93% on room air at sea level, or heart rate greater than or equal to 90 beats per minute; and no clinical signs indicative of severe or critical severity. exclusion criteria: * has an niaid ordinal scale score \<5; * is on high-flow oxygen or any form of noninvasive ventilation, excluding continuous positive airway pressure (cpap) alone for sleep disorders (e.g., obstructive sleep apnea); * has significant cardiovascular disease, defined by myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism within 3 months prior to randomization; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy; symptomatic peripheral vascular disease; new york heart association class 3 or 4 congestive heart failure; grade 3 hypertension (diastolic blood pressure greater than or equal to 100 mmhg or systolic blood pressure greater than or equal to 160 mmhg); history of congenital prolonged qt syndrome, or known dyslipidemia; * is currently taking any investigational products, other than the study drug; * has any other condition that, in the opinion of the investigator, could interfere with (or for which the treatment might interfere with) the conduct of the clinical trial or interpretation of the clinical trial results or that would place the subject at undue risk by participating in the clinical trial.
impact of serious pediatric illness on parent and sibling health

Conditions: Family Members of: Newborns Extremely Premature; Family Members of: New Pediatric Oncology Patients; Family Members of: Critical Congenital Heart Defect Patients; Family Members of: Children Severe Neurological Impairment

Summary: to estimate the impact of having a child with serious illness (si) on the health and healthcare of other members of the child's family.

although standard pediatric practice, when caring for a child with serious illness, is to provide support to the child's parents and any siblings, little quantitative information exists regarding what could be considered the "collateral impact" on other family members of having a child with serious illness in the family. this study seeks to provide such information, using existing claims data from the health insurance company, cigna, to identify children with serious illness and then examining the health and health care of their family members. the investigators hypothesize that, compared to control families without a sick child, parents and siblings of children with serious pediatric illness (spi) will have more new mental and physical health diagnoses, more new prescriptions, increased levels of emergency department (ed) and acute care services, and reduced levels of use of recommended chronic disease management for pre-existing conditions and of preventative services.

Eligibility criteria:
inclusion criteria: * cigna customers as follows: 1. neonatal intensive care unit (nicu) cohort: infants born at 30 weeks gestational age or less, or with a birthweight less than 1500 grams. 2. critical congenital heart disease (cchd) cohort: newborns with critical congenital heart defects who undergo surgery by 12 months of life. 3. oncology cohort: patients with new onset (not relapses) pediatric oncologic diagnoses including liquid, solid, and brain cancer. 4. severe neurological impairment (ni) cohort: patients with severe neurologic impairments, associated with substantial functional impairment, relentless progressive deterioration, or substantially shortened life-spans. * for each index patient in a particular spi cohort, investigators randomly identified up to four children of the same ages as the index patient but who do not have the specific spi. the matching by age was as follows: in months if \ or = 3 years. cigna then identified all family members, using both definitions of "family members" described above. exclusion criteria: -