Kornimate/medical-research-clean huggingface dataset:
bronchial thermoplasty 10+ year study

Conditions: Asthma

Summary: to confirm the long-term efficacy and safety of bronchial thermoplasty (bt) at 10 years follow-up or beyond in subjects previously enrolled in any of the following boston scientific-sponsored, controlled pre-approval studies: air, risa and air2.

compare rates of severe asthma exacerbations of subjects during the first and fifth year after bt treatment with the proportion of subjects who experience severe asthma exacerbations during the 12 months period prior to enrollment. compare baseline hrct scans from subjects from the air2 study that enroll in bt 10+ study to examine if there are any clinically significant post-treatment respiratory changes following bt defined as bronchiectasis or bronchial stenosis.

Eligibility criteria:
inclusion criteria * subjects previously enrolled in air, risa or air2 * subjects who received active bt treatment and had last bt treatment at least 10 years and 6 weeks prior to enrollment * control/sham subjects with at least 10 years of long-term follow-up from index date plus 6 weeks * subject is able to read, understand and sign a written informed consent to participate in the study and able to comply with the study requirements exclusion criteria: * severe asthma exacerbation or chest infection in the past 4 weeks. subject entry into this study should be delayed until free from severe asthma exacerbation or chest infection for a minimum of 4 weeks.

Keywords: bronchial thermoplasty alair registry
study of efficacy and safety of secukinumab in japanese patients with active ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the purpose of this study was to assess the clinical efficacy, safety and tolerability of secukinumab subcutaneous injections up to 52 weeks in japanese patients with active as despite current or previous non-steroidal anti-inflammatory drugs (nsaids) and/or anti-tumor necrosis factor (tnf) α therapy. efficacy and safety data were used to support the registration of secukinumab in japan for the treatment of active as.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe as with prior documented radiologic evidence (x-ray or radiologist's report) fulfilling the modified new york criteria for as with active as assessed by basdai ≥ 4 (0-10) and spinal pain as measured by vas≥ 4 cm (basdai question #2) at baseline * patients should have been on nsaids at the highest recommended dose for at least 3 months prior to baseline with an inadequate response or failure to respond, or less than 3 months if therapy had to be withdrawn due to intolerance, toxicity or contraindications * patients who have been on a tnfα inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to baseline or have been intolerant to at least one administration of an anti-tnfα agent exclusion criteria: * patients with total ankylosis of the spine * patients previously treated with any biological immunomodulating agents except for those targeting tnfα * active ongoing inflammatory diseases other than as that might confound the evaluation of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis * known infection with hiv, hepatitis b or hepatitis c at screening or baseline

Keywords: ankylosing spondylitis secukinumab ain457h spondyloarthritis
effects of resistance exercise compared to whole-body electromyostimulation in young female dentists.

Conditions: Osteopenia; Cardiometabolic Conditions

Summary: due to their high workload and unfavorable working position, young female dentists are particularly at risk of cardiometabolic diseases and an early reduction in bone mineral density (bmd). with focus on the latter issue, short bouts of resistance exercise with high strain magnitude and velocity are commonly considered to be a feasible option to prevent bone loss in the early years of young adulthood. in parallel, whole-body electromyostimulation (wb-ems) a trainings technology able address all main muscle groups simultaneously, however with dedicated exercise intensity might be a time-effective, joint friendly and safe option to maintain bmd in people unable or unmotivated to exercise conventionally. in the present study, we aim to compare the effects of a single session of wb-ems versus high intensity, high velocity resistance exercise on biomarkers of bone formation (procollagen type 1 n propeptide, p1np) and resorption (c-terminal telopeptide of type i collagen, ctx-i). we hypothesize that no clinically relevant different effects on p1np and ctx-i were determined.


Eligibility criteria:
inclusion criteria: * female dental students (\>3rd semester) or licensed dentists * no competitive sports background for \>2 years * normal body mass (bmi\>18,5 and \<25 kg/m2) exclusion criteria: * more than one resistance exercise session per week (last 12 month) * whole-body electromyostimulation during the last 12 month * amenorrhea, oligomenorrhea

Keywords: biomarkers bone metabolism exercise whole-body electromyostimulation female dentists
the effect of oral and nasal feeding on cerebral small vessel disease

Conditions: Cerebral Small Vessel Diseases

Summary: nasogastric tube feeding (ngt) has been widely used in cerebral small vessel disease (csvd) patients with dysphagia but has a significant risk of complications. intermittent oro-esophageal tube feeding (ioe) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. this study aims to explore the clinical effect of ioe vs. ngt on csvd patients with dysphagia. compared to ngt, ioe, as an enteral nutrition support mode, in csvd patients with dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, adl, qol, pneumonia, and adverse events, which should be considered as the preferred approach.

nasogastric tube feeding (ngt) has been widely used in cerebral small vessel disease (csvd) patients with dysphagia but has a significant risk of complications. intermittent oro-esophageal tube feeding (ioe) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. this study aims to explore the clinical effect of ioe vs. ngt on csvd patients with dysphagia. this was a randomized controlled study with 60 csvd patients with dysphagia who received comprehensive rehabilitation therapy. patients enrolled were randomly divided into the observation group (with ioe, n=30) and the control group (with ngt, n=30). at admission and after treatment, video fluoroscopic swallowing study (vfss) and functional oral intake scale (fois), body mass index (bmi), serum albumin (alb), and hemoglobin (hb), modified barthel index (mbi) and world health organization quality of life assessment instrument brief version (whoqol-bref) were recruited to assess and compare dysphagia, nutritional status, activities of daily living (adl) and quality of life (qol). the incidence of pneumonia was recorded and compared.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cerebral small vessel disease; * must be able to cooperate with treatment and questionnaire investigation, (generally with a mini-mental state examination (mmse) score ≥ 24) ; * clinical diagnosis of dysphagia through the functional oral intake scale (fois) and video fluoroscopic swallowing study (vfss); * age between 40 and 70 years; * enteral nutrition support was required and feasible. * no history of prior stroke. exclusion criteria: * dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases; * complicated with severe liver and kidney failure, tumors, or hematological disorders; * simultaneously need to undergo other therapy that might affect the outcomes of this study; * pregnant or nursing females.
post-ercp pancreatitis severity indication (pepsi) study

Conditions: Pancreatitis

Summary: this study plans to directly address the problem of post-ercp pancreatitis to gauge the various factors involved in its development and genetic variability in the immune response to an isolated pancreatic insult. in addition, the investigators hope to study markers of the early immune response to this injury and to develop a risk-assessment model.

endoscopic retrograde cholangiopancreaticography (ercp) is an important diagnostic and therapeutic tool in the management of pancreatic and biliary diseases. however, it carries up to 10% risk of developing acute pancreatitis, 10% of which will be severe. current models to predict the severity of acute pancreatitis are incomplete and unable to prognosticate early in the course of the disease because they are based on biomarkers of late immune response. recent findings suggest that polymorphisms in the gene coding for mcp-1 (monocyte chemotactic protein-1) play an important role in the early immune response leading to either mild versus severe acute pancreatitis of various etiologies. this study plans to directly address the problem of post-ercp pancreatitis to gauge the various factors involved in its development and genetic variability in the immune response to an isolated pancreatic insult. in addition, we hope to study markers of the early immune response to this injury and to develop a risk-assessment model.

Eligibility criteria:
inclusion criteria: 1. all people presenting for ercp procedures. 2. males and females of 14 years of age and older. 3. willingness to participate in the study and sign the informed consent. (children will require a representative to sign the informed consent). 4. people in whom therapeutic pancreatic interventions are planned during the ercp procedure. 5. intact papilla exclusion criteria: 1. persons unwilling to sign the informed consent 2. disorientation secondary to irreversible organic brain damage. 3. hemoglobin of less than 11 gm/dl in children of 10 years of age to puberty and hemoglobin of 12 gm/dl in pubertal males and females. 4. mean corpuscular volume (mcv) of less than 77 in all children of 18 years or younger. 5. ercp scheduled for stent change 6. previous diagnosis of pancreatic cancer or cholangiocarcinoma 7. history of chronic pancreatitis 8. active acute pancreatitis prior to ercp (typical pain and amylase or lipase \>3 times unl)or smoldering pancreatitis 9. history of recurrent acute pancreatitis with chronic pain between acute attacks of \>5/10 more than 3 days per week. 10. previous sphincterotomy 11. post surgical anatomy 12. history of organ transplant 13. on medications for the treatment of hiv
cognitive behavioral therapy for insomnia in people with chronic obstructive pulmonary disease(copd)

Conditions: Insomnia

Summary: a two-phase research study is being conducted. in phase 1 of the study, the cognitive behavioral therapy intervention for insomnia was implemented in a small (n = 5) group of people with moderate to severe copd and insomnia. the intervention was pilot-tested to determine feasibility and acceptability, and the intervention will be refined as needed. in phase 2 of the study, a two-group randomized controlled study (n = 20) will be conducted to test the effects of the cognitive behavioral therapy for insomnia intervention on the primary outcomes of sleep quality and fatigue and the secondary outcomes of mood and functional performance. it is hypothesized that people with copd receiving cognitive behavioral therapy for insomnia will demonstrate significant improvements in sleep quality, fatigue, mood and functional performance as compared to people with copd who receive a wellness program. this research will yield valuable information regarding effective interventions aimed at mitigating problems such as poor sleep quality, fatigue and reduced ability to perform valued daily activities. this information will be used to increase the likelihood of long-term successful outcomes such as the ability to maintain productive roles in society for people with copd.


Eligibility criteria:
inclusion criteria: * subjects will have moderate to severe copd. severity of copd will be defined according to the new gold standards (moderate iia (moderate), 50% \< fev1 \< 80% predicted; moderate iib (severe) 30% \< fev1 \< 50%). 58 * insomnia. insomnia will be defined as difficulty initiating or maintaining sleep, waking up too early or poor quality sleep. 59 * subjects must be \> 45 years of age with no other major health problems * subjects must be clinically stable at the time of enrollment into the study without major exacerbation of copd within the previous two months. exclusion criteria: * evidence of restrictive lung disease or asthma. * evidence of a major sleep disorder other than insomnia (sleep apnea evidenced by apnea/hypopnea index of \> 10, periodic limb movement disorder, narcolepsy). * hypnotic, sedative, anxiolytic or antidepressant use. * pulse oximetry (sao2) reading of \< 90% at rest. * pulse oximetry (sao2) reading of \ 5 minutes. * significant sleep apnea (apnea/hypopnea index ≥ 10). * .acute respiratory infection within the previous 2 months. * class \> 2 functional status according to the new york heart association. * the presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis; evidence of alcohol or drug abuse, musculoskeletal or degenerative nerve disease. * a self-reported current diagnosis of major depression or psychiatric disease or a hospital anxiety and depression scale (hads) depression score of \> 11. * currently participating in pulmonary rehabilitation.
digital health navigation for latino patients with type ii diabetes

Conditions: Type 2 Diabetes

Summary: the goal of this clinical trial is to learn about digital literacy training in adult, latino patient with type ii diabetes. the main question it aims to answer is: can providing digital literacy training during a hospital admission can help patients with their after-hospital care by using the patient portal and telehealth? participants will receive digital literacy training by a digital navigator that focuses on the main patient portal functions. researchers will compare patients who receive digital literacy training to those who receive standard of care (educational sheet) to see if it impacts their use of the patient portal after discharge.

latinos have the second-highest age-adjusted prevalence and among the highest incidence of diabetes. latinos also experience worse glycemic control and diabetes-related complications, including diabetic retinopathy and chronic renal disease. these findings are concerning since latinos are the largest minority group in the u.s and will account for 25% of the population by 2045. digital tools, like patient portals and telemedicine, offer an opportunity to address some of the challenges that lead to these disparities, especially during care transitions. however, latinos, especially those who are spanish-speaking are less likely to use digital health tools. findings from previous health information technology work have highlighted barriers, including 1) digital access and literacy, 2) interface usability, 3) privacy, and 4) patient preference. one promising intervention to address digital literacy gaps is the use digital navigators. this study aims are to assess a digital health navigation intervention focused on increasing patient portal use after discharge among latino patients with type ii diabetes admitted to the general medicine inpatient floor.

Eligibility criteria:
inclusion criteria: * self-identified latino adult patients with type ii diabetes * admitted to general medicine floors at brigham and women's hospital * preferred language: english or spanish exclusion criteria: * critical illness * dementia, delirium, or other condition that limits ability to participate in education and consent process

Keywords: latinos
naps and pulses of bright light in shift workers

Conditions: Sleep

Summary: design: paired trials without and with naps and bright light. setting: real driving on a private road circuit. environmental controlled car. participants: 9 shift workers on tree shifts (morning-afternoon-night) measurements: sleepiness at the wheel was measured by ambulatory polysomnography and assessed using 30 seconds segments of recordings when the percentage of theta eeg was at least 50% (15 seconds) of the period recorded. subjects were also called to rate their sleepiness on the 7-point stanford sleepiness scale (sss). intervention: participants drove the same car on two similar 24 hours periods of work, with three pilots in each shift (morning, afternoon, night), separated by three weeks. during the baseline period, the subjects were told to manage their rest as they usually do in the real life. during the second experimental period, they had to rest lied in a dark room during two naps of 20 minutes and then exposed to bright light pulse (5000 lux) during 10 minutes.

results are submitted to publication

Eligibility criteria:
inclusion criteria: * a professional experience of at least one year exclusion criteria: * with an history of chronic disease,treatments (or toxic) * subjects with a suspicion of sleep disorders * snorers

Keywords: accidents shift work sleepiness naps bright light pulses sleep
effects of achieving sdai remission on joint space outcomes progression in early rheumatoid arthritis: an hr-pqct study

Conditions: Rheumatoid Arthritis

Summary: objectives: to elucidate the effects of achieving sustained simple disease activity index (sdai) remission in the progression of joint space outcomes using high-resolution peripheral quantitative ct (hr-pqct) in patients with early rheumatoid arthritis (era), and what the independent effects of erosion /jsw progression are on patient's function. hypothesis to be tested: effective control of inflammation in era patients who can achieve sustained sdai remission will have less progression of joint damage then patients who cannot achieve sustained sdai remission. design and subjects: 110 consecutive era patients will participate in this 1-year prospective, hospital-based, cohort study. study instruments metacarpophalangeal joints 2-4 will be measured using hr-pqct interventions all participants will receive 1-year tight-control treatment according to a standardized protocol aiming at sdai remission. physical function will be assessed by health assessment questionnaire (haq) at each visit. hr-pqct and radiographs will be performed at baseline, 6 (hr-pqct only) and 12 months. quantitative analysis of joint space width (jsw) and volume, erosion number and volume, and marginal osteosclerosis (bone apposition at the base of the erosion) will be evaluated by hr-pqct. radiographic progression will be scored using van der heijde-sharp (svdh) score. outcome measures: the primary outcome is the change in jsw and volume over a period of 12 months. main secondary outcomes include changes in the i) number and size of erosion, ii) svdh score and iii) haq over a period of 12 months. expected results: patients who can achieve sustained sdai remission will have less joint damage and functional loss compared


Eligibility criteria:
inclusion criteria: * fulfilled the 2010 acr/eular classification criteria for ra * have symptoms onset of less than 2 years, * have active disease (sdai \>3.3) exclusion criteria: * have severe clinical deformity at the 2nd, 3rd or 4th mcp joint which precluded a reliable hr-pqct examination and resulted in motion artefacts influencing the scanning accuracy * are pregnant or breast feeding

Keywords: early rheumatoid arthritis treat to target hrpqct joint space narrowing sdai remission
back to the traditional: anti-cox drugs can improve the outcome of covid-19 patients admitted to icu

Conditions: COVID-19 Disease

Summary: retrospective multicenter study to evaluate the data of covid-19 patients who were admitted to university hospitals in relation to their recent administration or maintenance on non-steroidal anti-inflammatory drugs (nsaid) prior to have covid-19 disease and to analyze it in relation to outcome of these patients.

the data contained in hospital registry were collected, categorized into demographic, previous medical history, the use of nsaid as maintenance therapy or its recent administration before diagnosis of covid-19 disease, presenting manifestations, laboratory and ct findings, applied therapies or interventions. outcomes will be categorized as survival and non-survival outcome. survivors will be subdivided as complete recovery or recovery with getting new morbidities. mortality was subdivided as total hospital and icu mortality. data will be statistically analyzed in relation to outcomes

Eligibility criteria:
inclusion criteria: * assured diagnosis of covid-19 by rt-pcr exclusion criteria: * no

Keywords: covid-19 nsaid aspirin mortality
evaluation of the revive se device for intra-arterial thrombectomy in acute ischemic stroke

Conditions: Stroke

Summary: the main objective of this study is to assess the safety and effectiveness of the revive se (self- expanding) neurothrombectomy device in subjects requiring mechanical thrombectomy when used according to its instruction for use (ifu).


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. clinical signs consistent with acute ischemic stroke 3. no pre-stroke functional dependence (pre-stroke modified rankin score ≤ 1) 4. nihss ≥ 6,, assessed within two hours before treatment with revive se 5. large (≥ 1.5mm) and proximal vessel occlusion (presenting tici score of 0 or 1) of mca (m1-m2), dica, or ba confirmed by ct/mr angiography that it is accessible to the revive se. 6. treatment initiated within 8 hours after symptom onset (first revive se pass made within 6 hours 7. subject or legally authorized representative has provided informed consent on data collection, and consent is documented exclusion criteria: 1. life expectancy of less than 90 days 2. neurological signs that are rapidly improving prior to or at time of treatment (nihss improves at least 4 points between subject presentation and treatment initiation) 3. subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke 4. prior use of any other mechanical device to treat this stroke (e.g., merci retriever, penumbra, solitaire, trevo, mindframe, phenox, stent) 5. known bleeding diathesis: 1. current use of oral anticoagulants (eg, warfarin sodium) with international normalized ratio (inr) \> 3; 2. administration of heparin or novel oral anticoagulants (noac, eg dabigatran, rivaroxaban) within 48 hours preceding the onset of stroke and have an abnormal activated partial thromboplastin time (aptt) at presentation; and/or 3. platelet count \< 100,000/mm3 6. glucose \<50 mg/dl (2.8 mmol, 2.6mm) 7. uncontrolled hypertension (sbp\>185 or dbp\>110) refractory to pharmacological management 8. known hypersensitivity or allergy to nitinol and/or radiographic contrast agents 9. pregnancy or lactating female 10. subject already enrolled in a clinical study involving experimental medication or device imaging exclusion criteria: 11. ct scan or mri with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor. 12. angiographic evidence of carotid dissection, or high grade stenosis (\> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or cerebral vasculitis 13. blood vessel with extreme tortuosity or other conditions preventing the access of the device.

Keywords: thrombectomy stroke revive se