Kornimate/medical-research-clean huggingface dataset:
indoor air filtration and young adults health study

Conditions: Cardiopulmonary Diseases

Summary: this study aims to explore the cardiopulmonary health effects of indoor air purification and other indoor environmental conditions among young healthy college students in beijing, china.

the present randomized, double-blind crossover study was conducted to investigate the cardiopulmonary health effects of air purification among 81 young healthy college students in beijing, china. real or sham purification was performed in the dormitories for 4 days, following a 15-day wash-out period in the intervals. during the study periods, the investigators collected indoor exposure levels of size-fractionated particulate matter (pm), black carbon (bc), noise, ozone, nitrogen dioxide, carbon dioxide, volatile organic compounds, temperature, relative humidity, illumination, and microorganism. biological specimens (i.e., morning urine, fasting venous blood, exhaled breath condensate, and nasal mucus) were also collected and examined. some important individual factors including demographical information (age, sex, height, weight, etc.), physical activity, sleep condition, mood and cognition, and food intake were also gathered using questionaire or anthropometric measurements, in order to control for the potential confounding effects. for further data analyses, air pollutants, noise, and other exposures would be controlled as confounders when addressing the health effects associated with air purification, and would also be used to explore their effects on cardiopulmonary health. the interaction effects of air pollutants, noise, and other exposures on cardiopulmonary health would also be explored.

Eligibility criteria:
inclusion criteria: * living in beijing for more than one consecutive years; * college students between 18-28 years; exclusion criteria: * current or past smokers; * body mass index (bmi) over 28.0 kg/m2. * alcohol addict; * having thoracic surgery history; * history of diagnosed chronic disease; * hepatitis b / hepatitis c virus patient / carrier; * unwilling or unable to provide informed consent or cooperate with all research related procedures.
vunakizumab in adults with spondyloarthritis

Conditions: Spondyloarthritis (SpA)

Summary: this prospective, single-arm, multicenter study is aimed to explore the efficacy and safety of vunakizumab in adults with spondyloarthritis. the primary endpoint is the proportion of adults with spondyloarthritis achieving ankylosing spondylitis assessment score (asas) 40 at week 16 in the treatment of vunakizumab.


Eligibility criteria:
inclusion criteria: 1. patients older than 18 years when signing the informed consent; 2. patients diagnosed with spondyloarthritis (excluding psoriatic arthritis) and are eligible for biologic therapy; 3. the subjects voluntarily signed informed consent before the start of any procedures related to the study, were able to communicate with the investigators smoothly, understood and were willing to strictly abide by the requirements of the clinical research protocol to complete the study. exclusion criteria: 1. patients with severe hypersensitivity reaction to the active ingredient or any excipient of vunakizumab; 2. fertile women (defined as all women with the physical requirements for pregnancy) and men who are pregnant or who are unwilling or unable to use highly effective birth control during the study and within 20 weeks after last receiving the study drug; 3. active infection with important clinical significance; 4. patients with moderate to severe heart failure (nyha class ⅲ/ⅳ); 5. patients with malignant tumors who were receiving treatment or were not receiving treatment; 6. concomitant with other inflammatory diseases or severe autoimmune diseases, including but not limited to inflammatory bowel disease, which may affect the efficacy and safety evaluation according to the investigator's judgment; 7. any other condition that the investigator considers would prevent the subject from adhering to and completing the study protocol.
the vesalio neva stent retriever registry study for treatment of large vessel occlusion strokes

Conditions: Acute Ischemic Stroke

Summary: a prospective, open label, 90-day study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the neva stent retrievers.

this is a prospective, open label, multi-center registry designed to assess the safety, performance and efficacy of the neva stent retriever in the treatment of large vessel occlusion strokes. up to 400 subjects at up 20 sites will participate in the study.

Eligibility criteria:
inclusion criteria: only subjects already treated with the neva devices can be considered for enrollment. 1. clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups: 1.1. subject has failed iv t-pa therapy 1.2. subject is contraindicated for iv t-pa administration 2. age ≥18 3. nihss score ≥ 6 4. pre-stroke mrs score of ≤ 1 5. intracranial arterial occlusion of the distal intracranial carotid artery or middle cerebral artery (m1/m2), anterior cerebral artery (aca), posterior cerebral artery (pca), basilar artery, or vertebral artery demonstrated with dsa. 6. thrombectomy procedure can be initiated within 24 hours from symptom onset (defined as time last known well \[tlkw\]) 7. imaging inclusion criteria: 7.1. non-contrast ct selection (if ct perfusion or mri not utilized): aspects 6-10 if treatment started 0-6 hours from tlkw aspects 8-10 if treatment started 6-24 hours from tlkw 7.2. ct perfusion core ≤50 cc 7.3. mri dwi core ≤50 cc 8. subject or legal representative is able and willing to give informed consent within 48 hours after the intervention. exclusion criteria: 1. pre-existing medical neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. aricept). 2. cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing myocardial infarction, concern for pre- treatment pulmonary aspiration. 3. clinical symptoms suggestive of bilateral stroke or stroke in multiple territories 4. cerebral vasculitis 5. history of severe allergy to contrast medium. 6. known allergy to neva materials (nitinol, stainless steel) 7. suspicion of aortic dissection, septic embolus, or bacterial endocarditis 8. systemic infection 9. significant mass effect with midline shift 10. evidence of intracranial tumor (except small meningioma) 11. inability to deploy neva device for at least one pass for any other reason 12. life expectancy less than 6 months 13. any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
brazilian registry for clinical presentation of individuals with covid-19 (sars-brazil)

Conditions: Covid19; SARS-CoV Infection

Summary: this is a registry-based cohort study of all adult patients (≥18 years) with confirmed or suspected sars-cov-2 infection. the main goal is to describe mortality incidence, demographic characteristics, coexisting conditions, treatments, outcomes among sars-cov2 infected patients. a secondary goal is to identify biological factors (omics - genomic, proteomic and metabolomics characterization) associated with severity conditions for these patients.

registry on characteristics and outcomes of hospitalized and non-hospitalized sars-cov2 infected patients in brazil.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years); * confirmed or suspected sars-cov2 infection exclusion criteria: * patient who expressed opposition to participation in the study

Keywords: covid-19 sars-cov2 infection intensive care unit oxygen supplementation invasive ventilation mortality
a study of extending relugolix dosing intervals through addition of itraconazole or ritonavir in prostate cancer patients

Conditions: Prostate Cancer; Prostate Cancer Metastatic; Prostate Adenocarcinoma

Summary: researchers leading this study hope to learn about the safety of combining the study drug relugolix with another study drug called itraconazole or ritonavir in prostate cancer. this study is for individuals who have advanced prostate cancer and plans to have medical castration (the use of medications or chemicals to lower hormone production in the testicles). your participation in this research will last up to 1 month. the purpose of this research is to gather information on the safety and effectiveness of relugolix in combination with ritonavir or itraconazole. the goal of this research is to find out if combining two medications (relugolix and itraconazole or relugolix and ritonavir) could possibly lead to using less relugolix, which is an expensive drug.


Eligibility criteria:
inclusion criteria: * must have histologically or cytologically confirmed prostate cancer with plans to start medical castration therapy. * age 18 or older. because no dosing or adverse event data are currently available on the use of relugolix in combination with itraconazole or ritonavir in patients \<18 years of age, children are excluded from this study. * eastern cooperative oncology group performance status ≤2 (karnofsky ≥60%) * participants must satisfy the following laboratory criteria: * testosterone \> 200 ng/dl * qtc within normal limits * aspartate transferase (ast)/alanine transaminase (alt) \< 3x upper limit of normal * ability to take oral medication and be willing to adhere to the medication regimen. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * need for combination systemic therapy for prostate cancer including docetaxel and/or second-generation androgen receptor pathway targeted agents (i.e. abiraterone, enzalutamide, apalutamide, darolutamide, etc). * concurrent therapy with strong interacting drugs with cyp3a4 and p-gp (see appendix list of strong inhibitors or inducers) due to concerning possible drug-drug interactions with itraconazole, ritonavir and relugolix. potential drug-drug interactions will also be reviewed by study investigators prior to enrollment. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to relugolix, itraconazole or ritonavir. * patients receiving treatment with another investigational drug or other intervention within 3 expected half-lives of the agent. * serious or uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements. * new york heart association class iii of iv congestive heart failure * known gastrointestinal malabsorption. * active psychiatric illness/social situations that would limit compliance with protocol requirements.

Keywords: prostate cancer
comparison of the analgesic efficacy and duration of analgesic effect of pericapsular nerve group block block application with peng block and pulse radiofrequency ablation in chronic hip pain

Conditions: Hip Pain Chronic

Summary: comparison of the analgesic efficacy and duration of analgesic effect of peng block application with peng block and pulse radiofrequency ablation in chronic hip pain.

patients with chronic hip pain will be divided into two groups, and after providing the necessary information, informed consent forms will be obtained for inclusion in the study from both groups. the 'verbal numerical rating scale (vnrs)' will be assessed before the procedure. patients to undergo peng block and peng block with pulse radiofrequency ablation will be monitored prior to the procedure. after the procedure, they will be monitored for 3 hours under observation. at the third hour after the procedure, before leaving the operating room, and at the 1st and 3rd months, patients will be contacted by phone, and the 'verbal numerical rating scale (vnrs)' will be evaluated. this will allow the comparison of the effects of peng block and peng block with pulse radiofrequency ablation on pain management in chronic hip pain.

Eligibility criteria:
inclusion criteria: * patients with chronic hip pain aged 18-80 asa i-iii patients exclusion criteria: * patients with allergies to the medications used, severe cardiac, renal, pulmonary, liver, and endocrine diseases, patients with uncontrolled blood sugar levels (diabetes mellitus), patients who have used anticoagulant medications in the last five days, patients with bleeding or clotting disorders, those with implanted medical devices such as pacemakers and defibrillators, patients with infections at the procedure site, patients with psychiatric disorders or communication difficulties, patients with missing data, and patients who do not wish to undergo regional block are defined as exclusion criteria.

Keywords: hip pain chronic radiofrequency ablation peng block vnrs (verbal numerical rating scale)
from opinion to evidence: multi-site evaluation of custom dynamic orthosis best practices

Conditions: Foot Injury

Summary: this study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (cdos) influences outcomes following traumatic lower extremity injury.

this study is designed to evaluate how different configurations of two types of carbon fiber custom dynamic orthoses (cdos) influence outcomes following traumatic lower extremity injury. in this study, adult participants who still experiencing deficits including weakness and/or immobility more than two years post traumatic lower extremity injury will be randomized and fit with either modular or monolithic cdo. participants will then be evaluated without a cdo and with the cdo in three configurations in a randomized order: a proposed optimal benchmark configuration, a variation with the device in more dorsiflexion, and a variation with the device in greater plantarflexion. multiple well-established tests will be used to compare outcomes between the different configurations.

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 65 * 2 or more years from a traumatic injury below the knee * ability to be fit with an orthosis * any of the following: * weakness of ankle plantarflexors (\<4/5 on manual muscle test) * limited pain-free ankle motion (dorsiflexion (df) \<10° or plantarflexion (pf) \<20°) * mechanical pain with loading to hindfoot/midfoot (\>=4/10 numerical pain rating scale) * fusion or candidate for fusion of the ankle or hindfoot * candidate for amputation secondary to ankle/foot injury and impairment exclusion criteria: * pain greater than 8/10 at rest * ankle weakness or spasticity as a result of spinal cord injury or central nervous system pathology * use of an orthosis including the knee * non-ambulatory * surgery on study limb anticipated in next 4 months * medical or psychological conditions that would influence functional testing (e.g., severe traumatic brain injury, stroke, heart disease, vestibular disorder) * neurologic, musculoskeletal, or other conditions limiting function of the contralateral extremity * uncorrected visual or hearing impairments * pregnancy * non-english speaking * bmi \> 40

Keywords: ankle foot orthosis carbon fiber gait biomechanics physical performance
capecitabine and interferon-alpha in metastatic renal cell carcinoma patients with failure on interleukin-2 based regimens

Conditions: Carcinoma, Renal Cell

Summary: the aim of this study is to determine preliminary efficacy of capecitabine and interferon-alpha in second-line after interleukin-2 based regimens in patients with mrcc


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed renal carcinoma * ct-confirmed metastatic sites * must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion measured as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral ct scan * disease progression after il-2 * age 18 or older * ecog performance status 1-3 * life expectancy ≥ 2 months * wbc ≥ 3,000/mm3 * platelet count ≥ 100,000/mm3 * hemoglobin ≥ 7.5 g/dl * creatinine ≤ 1.5 mg/dl (2.0 mg/dl in post-nephrectomy patients) * total bilirubin ≤ 1.5 mg/dl * ast ≤ 3.0 times normal * alkaline phosphatase ≤ 2.5 times normal (10 times uln in presence of bone metastases) * not pregnant or nursing * no history of autoimmune * no history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., new york heart association class iii or iv) * no cns metastases by neurologic exam and/or mri * no history of seizure disorders * no local and/or systemic infections requiring antibiotics within 28 days prior to study entry * no other malignancy * written informed consent

Keywords: kidney cancer, capecitabine, interferon
physician radiation exposure during radial access cardiac catheterization using a rad board

Conditions: Radiation Exposure to Operator

Summary: radiation exposure to operator is an occupational hazard of invasive cardiologists. during radial access for diagnostic catheterization, a new radio-dense arm board is advertised to reduce operator radiation exposure. the investigators randomize patients to a new radio-dense armboard versus a standard radio-transparent armboard during diagnostic catheterization and measure radiation exposure to the operator. both groups have a radio-dense pelvic shield in place. the investigators hypothesize that operator radiation dose will be decreased by use of the radio-dense armboard.

hypothesis: compared to standard shielding with a lead pelvic drape alone, using a radio-opaque arm board in addition to the pelvic drape will decrease operator radiation exposure during radial access cardiac catheterization by at least 30%. study design this is a randomized, prospective study where patients will be randomized by random numbers in sealed envelopes to standard shielding (pelvic drape alone, the "no-board group") or to experimental shielding (pelvic drape plus radiation board, the "board group"). a robust radiation safety monitoring program is in place. patient exposure is measured by the catheterization laboratory equipment and recorded. lindauer microstar nanodot badges worn at waist level above the radiation lead will be used to measure operator radiation exposure. a new nanodot will be used for every case. radiation exposure to the operator's nanodot will be measured immediately after each procedure by a technician blinded to study assignment. all patients 18-89 years old presenting to geisinger medical center for diagnostic cardiac catheterization will be evaluated for the study. all interventional or diagnostic cardiologists and fellows that will be performing the cardiac catheterization procedure also will be study subjects. approximately 215 geisinger patients who satisfy inclusion and exclusion criteria will be included. approximately 6 interventional cardiologists, 2 diagnostic cardiologists and 10 fellows will be included in this study.

Eligibility criteria:
inclusion criteria: operators: interventional or diagnostic interventional attendings and fellows, operators willing to participate. patients: age 18-89 years old requiring catheterization at geisinger medical center using radial access exclusion criteria: * patients with cabg, requiring extensive imaging, with operator switch during the procedure * patients in whom the procedure took unusual time because of anatomic issues, and need to switch to alternative access.

Keywords: radiation radiation injury occupational risk
replication of the heads up atopic dermatitis trial with registry data

Conditions: Atopic Dermatitis

Summary: the goal is the replication of the primary outcome (easi 75 at week 16) of the heads up trial (blauvelt, a, teixeira, h, simpson, e et al (2021) doi:10.1001/jamadermatol.2021.3023) and the evaluation of the patient reported outcomes (poem, dlqi and recap) in a head-to-head comparison of upadacitinib versus dupilumab treatment in moderate-to-severe atopic dermatitis (ad).

atopic dermatitis (ad) is an inflammatory, multifactorial skin disease characterized by eczematous skin lesions, severe itching, and negative consequences on quality of life. the goal of this study is the replication of the primary outcome (eczema area and severity index (easi) 75 at week 16) of the heads up trial and the evaluation of the patient reported outcomes (patient-oriented eczema measure (poem), dermatologic quality of life index (dlqi) and recap of atopic eczema (recap)) that were not assessed in the heads up trial but are part of the recommendations by the harmonising outcome measures for eczema (home) initiative (williams, hc, schmitt, j, thomas, ks et al (2022) doi:10.1016\\j.jaci.2022.03.017) regarding core outcome sets in atopic dermatitis clinical trials. the core outcome set as defined by home encompasses the following domains (core outcome instruments): clinical signs (easi), patient-reported symptoms (poem and peak itch), long term control (recap) and quality of life (dlqi). the data basis is the treatgermany registry (https://treatgermany.org/). treatgermany is a national clinical registry for patients with moderate to severe ad. the physician and patient-reported outcomes are collected in about 60 clinics and private practices during routine care. data of more than 2,400 patients is currently documented.

Eligibility criteria:
inclusion criteria: * chronic ad with onset of symptoms at least 3 years prior to baseline * meets uk working party criteria * easi score ≥ 16 * ≥ 10% body surface area (bsa) of ad involvement at baseline ("therapy start") visit exclusion criteria: * contraindications according to upadacitinib or dupilumab labeling

Keywords: observational target trial emulation dupilumab upadacitinib
human milk fortifier - growth evaluation

Conditions: Premature Birth

Summary: it it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.


Eligibility criteria:
inclusion criteria: * birth weight ≤1500 g and/or gestational age ≤32 weeks (determined by maternal dates, fetal ultrasound, dubowitz/ballard examination or a combination thereof) * male or female * tolerating an enteral intake of human milk, donor milk or a combination at ≥100 ml/kg/d for ≥ 24 h * subject is anticipated to receive human milk, donor milk or a combination for ≥ 3 consecutive weeks after having achieved full fortification with volume intake contained between 150 and 180 ml/kg/d. * written informed consent has been obtained from the legal representative(s). exclusion criteria: * infants with current systemic disease * infants with a history of systemic disease * any congenital anomalies of the gi tract that significantly interfere with nutrition and growth or previous gi surgery. * small size for gestational age (sga) - body weight ≦ 5th percentile for that gestational age. * infants diagnosed with any inherent metabolic disease. * infants diagnosed with any chromosomic disease. * receiving any commercial formula supplementation to breast milk. * receiving steroids at the time of enrollment. * participation in another nutritional clinical trial that may affect outcomes of this study.
a study of iressa in relapsed and refractory small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: the purpose of this study is to determine the disease control rate at trial closure and after the first stage of the study in patients with relapsed or refractory sclc and measurable disease treated with gefitinib


Eligibility criteria:
inclusion criteria: * provision of written informed consent * histologically confirmed, relapsed or refractory sclcr * aged 18 or over and a life expectancy of more than 2 months exclusion criteria: * any evidence of clinically active interstitial lung disease * other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ.