Kornimate/medical-research-clean huggingface dataset:
comparison of colonoscopy adenoma detection yield

Conditions: Adenoma Colon

Summary: a prospective randomized comparison of colonoscopy adenoma detection yield of (i) standard colonoscopy (sc), (ii) artificial intelligence (discovery) aided colonoscopy, and (iii) artificial intelligence (discovery) and permanently mounted balloon (g-eye®) aided colonoscopy.

multi-center, three-arm, randomized, controlled, open-label study. total of up to 1320 patients will be randomized, including up to 10% for subject drop-out, 440 to each of the three following arms (groups): group 1 (1st arm): patients will receive standard colonoscopy (sc) group 2 (2nd arm): patients will receive colonoscopy aided by the discovery artificial intelligence software (dc) group 3 (3rd arm): patients will receive colonoscopy aided by the discovery artificial intelligence software and the g-eye® balloon (gdc) the purpose of this study is to compare between the diagnostic yield of standard colonoscopy, discovery aided colonoscopy, and discovery \& g-eye® aided colonoscopy.

Eligibility criteria:
inclusion criteria: 1. screening and surveillance population for adenoma and crc. 2. the patient must understand and sign a written informed consent for the procedure. exclusion criteria: 1. subjects with inflammatory bowel disease; 2. subjects with a personal history of hereditary polyposis syndrome; 3. subjects with suspected chronic stricture potentially precluding complete colonoscopy; 4. subjects with diverticulitis or toxic megacolon; 5. subjects with prior colonic surgery (exclusion appendectomy) 6. subjects with a history of radiation therapy to abdomen or pelvis; 7. pregnant or lactating female subjects; 8. subjects who are currently enrolled in another clinical investigation. 9. subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator. 10. subjects with recent (within the last 3 mounts) coronary ischemia or cva (stroke) 11. any patient condition deemed too risky for the study by the investigator
incidence of episodes of (dis)connected consciousness among emergency patients admitted in the resuscitation room

Conditions: Critical Illness; Near-Death Experience; Consciousness, Loss of; Quality of Life; Emergencies

Summary: this observational study aims to describe the incidence of episodes of disconnected consciousness (including near-death experience (nde)) and episodes of connected consciousness in patients admitted to the resuscitation room, who survived a critical condition and who meet at least one of these criteria during their stay in the resuscitation room: (1) deep sedation, (2) intubation, (3) cardiopulmonary resuscitation, or (4) (non-drug-induced) glasgow coma scale score = 3. we also investigate the potential (neuro)physiological markers and biomarkers. in order to help determine the potential risk factors of such episodes, cognitive factors such as dissociative propensity are also investigated. unexpected visual and auditory stimuli will be displayed. in addition, we assess the evolution of memory, as well as short- and long-term consequences on quality of life, anxiety, and attitudes towards care. memory of patients who did not meet the above-mentioned criteria are also investigated. a group of 15 healthy participants will be invited to test the stimuli display. finally, (neuro)physiological parameters of a subsample of dying patients are also investigated.


Eligibility criteria:
inclusion criteria: * patients admitted in the resuscitation room of our university hospital * french speaking exclusion criteria: * refusal * chronic disorder of consciousness * deafness * blindness * dementia * hemineglect * aphasia

Keywords: dream
improving parent understanding of instructions about asthma care

Conditions: Asthma

Summary: asthma has an especially great impact on poor urban children and their families. in addition to higher asthma prevalence and morbidity, those in low ses urban areas are at risk for low health literacy. low health literacy is associated with poorer asthma outcomes. the provision of a written asthma action plan has been shown to help with asthma management and to reduce hospitalizations and er visits. poor urban families who may have low literacy may need an alternative asthma action plan to convey the treatment plan. this pilot study proposes to investigate whether a plain language asthma action plan can improve parent understanding and adherence with medication instructions, compared to standard written materials, among parents of children with asthma. this is an rct in which parents of children with asthma will be randomized to either receive a pictogram-based low literacy asthma action plan, or a standard action plan (aaaai), to examine whether those who receive the low literacy plan have improved asthma action plan knowledge when presented with a hypothetical scenario. a second part of the study is to examine whether providers who are given the pictogram-based low literacy asthma action plan will be more likely to counsel about certain aspects of asthma management (eg. need for daily medications even when sick, spacer use, confusion between everyday and rescue inhaler)compared to providers who receive use a standard action plan (aaaai). this is an rct in which pediatric providers are randomized to counsel a hypothetical patient using the pictogram-based action plan or the standard action plan (aaaai).


Eligibility criteria:
parent study: inclusion criteria: * primary caregiver / parent / legal guardian of child 2-12 years old * child with diagnosis of asthma exclusion criteria: * parent not english or spanish-speaking provider study: inclusion criteria: * health providers who care for children with asthma

Keywords: asthma health literacy parent knowledge of appropriate action plan steps
prevent tool study: late effects clinic

Conditions: Cardiovascular Disease; Childhood Obesity

Summary: the purpose of this study is to test the feasibility of a novel, health information technology behavior change tool in a single clinic setting. the prevent tool is the first electronic health record (ehr)-compatible tool that both tailors evidence-based behavior change strategies and incorporates community-level data specific to each patient into routine care. the central hypothesis is that prevent will improve patient's attitudes towards behavior change recommendations, increase adherence to recommended behavior change and improve cardiovascular health. fifty adolescents will be randomized to intervention or wait-list, routine care control to assess the preliminary effectiveness of prevent. qualitative and quantitative methods will be used among patients, parents and providers to examine barriers to current and future implementation of the prevent tool to inform adoption and maintenance.


Eligibility criteria:
inclusion criteria: patient eligibility criteria: * adolescents 12 to 19 years * prior diagnosis of pediatric cancer (diagnosed \<21 years of age) * not receiving active therapy for their cancer * receiving care from the pediatric hematology/oncology staff and physicians at st. louis children's hospital or the st. louis children's specialty care center (cscc) * at risk for poor cardiovascular health (cvh) (bmi greater than or equal to 85th percentile) provider eligibility criteria -all providers and staff (physicians, nurses, clinic staff, clinical research associates) in the pediatric hematology/oncology program at st. louis children's hospital and the cscc parent eligibility criteria -a parent or legal guardian of a study participant. the parent or legal guardian must have been present at the clinic visit in which the prevent tool was administered to the study participant.
a new anthrax vaccine administered by the intramuscular (im) route in healthy adults

Conditions: Anthrax

Summary: this study will provide preliminary safety and comparative immunogenicity data for the e.coli derived rpa vaccine administered by intramuscular (im) injection at day 0 and month 1.doses will range from 5 μg to 100 μg rpa, and at each dose-level, rpa will either be combined with phosphate-buffered saline (pbs) or adsorbed to alhydrogel.

this is a safety study with an open-label part (2 groups), followed by a dose-ranging part evaluating safety and immunogenicity using a double-blind, sequential-group design with randomization and placebo-control within each of the 6 groups. volunteers in each dose group will receive two im injections at day 0 and month 1

Eligibility criteria:
volunteers are eligible for this study if they meet all the following criteria: * citizens of the u.s. * age 18 to 40 years. * for women, a negative serum pregnancy test will be required at study entry and within 24 hours prior to each vaccination, as well as verbal assurance that adequate birth control measures are applied prior to initial vaccination and for 3 months after the last vaccination. * good health as determined by medical history, physical examination, and clinical judgment. * normal baseline clinical laboratory values at screening including: * complete blood count (cbc) including: * white blood cell count: 3.8 -10.8 * red blood cell count (mill/mcl) * male: 4.20 - 5.80 * female: 3.80 - 5.10 * hemoglobin (g/dl) * male: 13.2 - 17.1 * female: 11.7 - 15.5 * hematocrit (%) * male: 38.5- 50.0 * female: 35.0 - 45.0 * platelet count: 140 - 440 (thous/mcl) * differential * urine dipstick for protein and blood: negative or trace. if either is ≥ 1+, obtain complete urinalysis (ua). if microscopic ua confirms evidence of hematuria or proteinuria ≥ 1+, the volunteer is ineligible. * negative serology for hiv infection (elisa test). * cpk within normal limits * hepatic function tests including ast, alt, alk phos. * total bilirubin, bun, serum creatinine, serum electrolytes * availability for at least 13 months of follow-up from the time of the screening visit. * successful completion of the test of understanding defined as 90% correct with three opportunities to take test. errors will be reviewed with volunteer after each test. * commitment for trial participation and signature of the approved consent form.

Keywords: anthrax
sleep promotion program primary care

Conditions: Sleep; Sleep Disturbance; Insufficient Sleep

Summary: investigators developed a brief, scalable, behavioral sleep promotion program (spp) for adolescents with short sleep duration and sleep-wake irregularity, which relies on two individual sessions and smart phone technology to deliver evidence-based strategies. this r34 will test the feasibility and initial effectiveness of the spp program and provider training via pilot randomized controlled trial (rct, n=50) comparing spp to sleep psychoeducation, a brief session on healthy sleep habits. participants will be adolescents (12-18 years) with short sleep duration, sleep-wake irregularity, and depression.


Eligibility criteria:
inclusion criteria: youth: * able and willing to provide informed assent (with consent from parent/guardian) * ages 12-18 * currently a patient at kids plus pediatrics * currently depressed * report short sleep duration (\ =2 hours parents: parents must be age 18 or older and the parent/guardian of an enrolled youth participant and must have at least 10 hours face-to-face interaction with the youth participant per week. exclusion criteria: youth: * significant or unstable medical conditions * diagnosis of sleep apnea, narcolepsy, restless leg syndrome, nightmare disorder, or periodic limb movement disorder * diagnosis of ptsd, bipolar disorder, a psychotic disorder, or substance use disorder * currently engaged in cognitive and/or behavioral therapy that aims to improve sleep * changes in medications in the month prior to screening * active suicidality requiring immediate treatment * unable or unwilling to comply with study procedures * have any physical or mental condition that would preclude study participation. parents will be excluded if they: * express active suicidality that requires immediate treatment; * have any physical or mental condition that would preclude study participation; or * are unable or unwilling to comply with study procedures.
pyrotinib plus vinorelbine versus lapatinib plus capecitabine

Conditions: Breast Cancer

Summary: pyrotinib plus vinorelbine versus lapatinib plus capecitabine

this is a retrospective study aiming to explore the efficacy and safety of pyrotinib plus vinorelbine versus lapatinib plus capecitabine in patients with previously treated her2-positive metastatic breast cancer.

Eligibility criteria:
inclusion criteria: * her2+ mbc patients scored +3 by immunohistochemical (ihc) analysis or scored +2 and the result of fluorescence in situ hybridization was positive. * patients were previously treated with trastuzumab in the advanced setting and a taxane in any setting. * patients received lapatinib (750-1,250 mg/day) plus capecitabine (1,500-2,000 mg/m2) or pyrotinib (320-400 mg/day) plus vinorelbine (25mg/ m2 intravenously or 60 mg/m2 orally on days 1 and 8 per 21 days) for at least one cycle, starting from jun 2015 to jan 2021. * patients had complete medical records. all data were retrospectively collected from medical records of individual institutions. exclusion criteria: * incomplete medical history

Keywords: pyrotinib lapatinib vinorelbine
efficacity of a standardized hypnotic message during the application of a qutenza (capsaicin) 8% patch

Conditions: Pain

Summary: qutenza® is a skin patch with a high concentration of capsaicin (8%) which is the component responsible for spicy peppers. qutenza® is indicated for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other analgesics. acute pain experienced during and after the procedure can be relieved by local cooling methods and oral analgesics but the pain remains intense. the hypothesis is that hypnosis via a standardized hypnotic message would increase the local tolerance of the treatment when applying the patch qutenza®. to date, there are no studies that can confirm or refute this hypothesis.


Eligibility criteria:
inclusion criteria: * patient who have already received at least a qutenza® patch * treatment for patient in failure to conventional treatments for neuropathic pain other than diabetics * age \>18 years * eastern cooperative oncology group (ecog) performance status \<3 * patient must be affiliated to a social security system * ability to provide written informed consent * patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study exclusion criteria: * patient with psychotic disorders * patient with hearing disorders * patient not understanding the french language * age \< 18 years * patient requiring analgesic premedication before applying the patch qutenza® * patient with a history of hypersensitivity to capsaicin or any of the excipients of the patch * patient deprived of liberty or under supervision

Keywords: capsaicin qutenza® hypnosis peripheral neuropathic
a registry based randomized-controlled trial of an upper limb exergaming intervention for children and adolescents with spinal muscular atrophy

Conditions: Spinal Muscular Atrophy

Summary: this is a multisite randomized controlled registry-based trial to evaluate the efficacy of an 8-week home-based exergaming intervention as compared to usual care on occupational satisfaction of children and youth (8-18 years old age) with spinal muscular atrophy (sma).

this multisite randomized controlled registry-based trial will evaluate the efficacy of a home-based exergaming intervention, as compared to usual care, on occupational satisfaction of children and youth (aged 8-18 years old) with sma. participants in the intervention arm will play the exergame, tales from the magic keep™ on the azure kinect platform, 3 times per week, for at least 20 minutes, over 8 weeks (total 8 hours), and continue to access their regular physical activities and rehabilitation services. those in the usual care arm will continue to access their regular physical activities and rehabilitation services. occupational satisfaction will be assessed using the canadian occupational performance measure (copm) at 8 weeks.

Eligibility criteria:
inclusion criteria: * confirmed genetic diagnosis of 5q sma * age at screening: aged 8-18 years old * participant is able to stay seated independently without support for at least 10 seconds * participants has a score of at least 2 points in entry item a of the rulm (i.e., "can raise 1 or 2 hands to the mouth but cannot raise a 200 g weight in it to the mouth") * treated with disease-modifying therapy * signed icf exclusion criteria: * inability to comply with study procedures according to the site investigator, prior to randomization * severe scoliosis or contractures that would interfere with gameplay or with successful completion of functional assessments, as confirmed by the clinical evaluator * planned orthopedic surgery 6 months prior to or throughout intervention and follow-up period (16 weeks post randomization) * inability to read in english or french

Keywords: spinal muscular atrophy rehabilitation exergaming pediatrics randomized-controlled trial
laboratory-based hypnosis intervention on pain responsivity in adolescents with sickle cell disease

Conditions: Sickle Cell Disease

Summary: the purpose of this study is to test the effects of a laboratory-based hypnosis session compared to an attention control condition on peripheral blood flow, autonomic stress responses, and acute pain responses in adolescents (ages 12-21) with sickle cell disease, and examine how perceived disease-related stigma may affect these responses.


Eligibility criteria:
inclusion criteria: * a diagnosis of sickle cell disease * age 12-21 years old * fluent in english (the intervention will be delivered in english) * participant is cognitively able to provide informed signed consent or assent * participant is cognitively able to follow instructions exclusion criteria: * under 12 years of age or over 21 years of age * not fluent in english * pain medication prescription has changed or if they have been hospitalized for a vaso-occlusive episode within 30 days of study participation. * diagnosis of a condition (e.g., neurological disorder affecting peripheral sensation, skin abnormality over the stimulus site, obstructive sleep apnea, diabetes, ischemic heart disease) or cognitive impairment that may affect data integrity or the ability to complete study procedures.

Keywords: adolescence autonomic nervous system hypnosis pain sickle cell disease
the effects of endurance and strength training in subjects with asthma

Conditions: Asthma

Summary: emerging evidence suggests that regular exercise can complement medical treatment for asthma. furthermore there are no specific recommendation on how plan exercise training. to the best of current knowledge, there isn't enough evidence of the effect of a strength training in subjects with asthma. therefore the aim of this study is to evaluate the short and long term effects of a strength and endurance training compared with endurance training alone in subjects with asthma.

to the best of current knowledge, there isn't enough evidence of the effect of a strength training in subjects with asthma. aim of the study is evaluate the short (after pulmonary rehabilitation) and long term (after 12 months) effects of a strength and endurance training compared with endurance training alone in improving quality of life and disease control in subjects with asthma of global initiative for asthma (gina) stage from 4 to 5.this is a prospective randomized control trial. subjects with diagnosis of asthma according to the gina guidelines admitted to a reference centre for inpatient pulmonary rehabilitation will be randomly assigned to study or control group.

Eligibility criteria:
inclusion criteria: * diagnosis of asthma step 4 to 5 under optimal medical treatment for at least 6 months according to gina guideline * symptomatic despite being on treatment: asthma control test (act) score ≥ 20 ≤24 * able to perform and complete with studies procedures (feno, cpet, six minute walking test (6mwt), mvs. exclusion criteria: * diagnosis of chronic obstructive pulmonary disease (copd) according to the global initiative for obstructive lung disease (gold) guidelines criteria * smokers or ex-smokers with pack/years ≥10 * body mass index (bmi) ≥30 * change in asthma medications in the last 30 days * cognitive impairment (mini-mental state examination score \<22) * history of oncological, neurological, cardiovascular diseases, musculoskeletal impairment and/or medical diseases precluding exercise testing and pulmonary rehabilitation

Keywords: asthma resistance training endurance training quality of life
early progressive strength training to patients with unicompartmental knee replacement

Conditions: Knee Osteoarthritis

Summary: the purpose and study hypotheses: the purpose of the study is to investigate the effect of progressive resistance training in the early postoperative phase on patients who has had unicompartmental knee replacement. the hypotheses are that this group compared to a control group will achieve greater muscle strength and functional ability in terms of gait and working capacity. study design: the subjects will be randomized into two groups; intervention and control. intervention group: strength training two times a week supervised by a physiotherapist. control group: training at home, following extradited guidelines. endpoint: primary endpoint is two months postoperative. the following test will be used: muscle power test (by a power rig), instrumented gait analysis using a combined accelerometer and gyro-sensor in; 6 min. walk test, stair climbing test, 20 meter walking test and block step test. furthermore, the questionnaire koos will be used for monitoring every 2 weeks. sample size: the power calculation is based on an expected improvement in muscle power by 25%. the risk of a type 1 error is set to 5 %, and the power is set to 80%. the calculations showed that 24 patients are needed in both groups, but 30 patient will be included in both groups to account for dropouts. perspectives: this study is, to our knowledge, the first study to investigate the effect of strength training after unicompartmental knee replacement. moreover it has , to our knowledge not been. at the moment no guidelines for rehabilitation exist, and research showed that this group of patients has a decreased function in their daily living compared with the background population. if, as expected, cases have an overall increased function compared to controls, this study can provide a basis for future rehabilitation.


Eligibility criteria:
inclusion criteria: * medial osteoarthrosis in knee assigned to unicompartmental knee replacement * 18+ years. exclusion criteria: * rheumatoid arthritis * neuro muscular conditions * alcohol or drug abuse * cognitive problems * patients not fluid in the danish language * walking disability caused by other than in condition in question

Keywords: osteoarthrosis unicompartmental knee replacement knee resistance training muscle power gait analysis gait physiotherapy gyro sensor