Kornimate/medical-research-clean huggingface dataset:
assessing health related quality of life in hypersensitivity pneumonitis

Conditions: Hypersensitivity Pneumonitis; Chronic Hypersensitivity Pneumonitis; Interstitial Lung Disease; Extrinsic Allergic Alveolitis; Health-related Quality of Life

Summary: the objective of this study is to administer and validate a disease specific health related quality of life (hrqol) survey for patients with chronic hypersensitivity pneumonitis (chp).

the objective of this study is to administer and validate a disease-specific health related quality of life (hrqol) survey for patients with chronic hypersensitivity pneumonitis (chp). the survey items have been developed and revised from prior qualitative research with chp patients. potential participants will be recruited from wcmc, the pulmonary fibrosis foundation (pff) registry and outside physician referral for the study. participants will be asked to sign informed consent. at the initial visit participants will be asked to complete the survey and two additional pros needed for concurrent validity testing. participants will then be asked to complete the hrqol survey under study a second time 2 weeks after the initial visit for test-re-test reliability testing. pulmonary function testing and six minute walk test results will be collected. pertinent demographic and clinical information will be collected from the patients and their medical records or registry data (if a pff registry participant). all information will be entered into a redcap database for secure data management and storage. psychometric testing will be performed on the overall survey instrument and the individual items in order to test validity and reliability. the goal is that the survey developed will be a reliable and valid measurement tool for use in both clinical practice and research settings.

Eligibility criteria:
inclusion criteria: 1. 18 years old or older 2. understand and sign the informed consent document 3. documented diagnosis of hp made and confirmed at an ild center via expert consensus or in multidisciplinary discussion a. diagnosis based upon a minimum of a medical history, physical examination, pulmonary function testing, and computerized tomography (ct) scan. pathology will be reviewed if available but is not required. 4. hp must be the primary pulmonary disease 5. anticipated ability to complete follow up survey within 2 weeks of initial survey completion 6. participants recruited from the pff registry must have agreed to be contacted for ancillary research studies. exclusion criteria: 1. non-english speaking (patient must be able to speak and read english fluently but it does not have to be their primary language) 2. inability to complete questionnaire due to cognitive impairment 3. patients who have not been seen by or communicated with their provider in over 2 years
spire maestro hand exoskeleton for rehabilitation post stroke

Conditions: Stroke

Summary: the research team will develop a novel training tool to improve finger joint coordination, to address the unmet need in the current rehabilitation, thereby enhancing hand function and contributing to improved independence and quality of life for veterans with stroke.

the research team will determine feasibility of training using ca and ta controllers in subacute stroke. specifically, we will examine if joint coordination improves over a training session. the investigators will compare the extent of improvement for each controller and impairment severity.

Eligibility criteria:
inclusion criteria: * adult veterans with a stroke 1-6 months ago * ability to move fingers (chedoke-mcmaster hand section stage 2-4) exclusion criteria: * inability to follow 2-step commands * severe muscle tone prohibiting proper placement of the fingers (modified ashworth scale, mas=5 out of 5) * change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment

Keywords: soft robotics robotic exoskeleton neurologic rehabilitation physical medicine and rehabilitation rehabilitation exercise
a 5-year postmarketing safety study of xalcom in patients with open angle glaucoma or ocular hypertension

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: to estimate the frequency of patients with ocular/periorbital adverse events. to identify any possible long-term adverse consequences of increased iris pigmentation and to follow serious adverse events throughout the study period.


Eligibility criteria:
inclusion criteria: * patients with open angle glaucoma and/or ocular hypertension requiring a reduction of iop who were insufficiently responsive to topical betablockers exclusion criteria: * previous and current treatment with any topical ophthalmic drug containing prostaglandins; any condition in which treatment with the betablocking agent, timolol, was contraindicated.
the effect of phytosterol esters of omega-3 (vayarol) versus omega-3 acids ethyl esters in reducing triglyceride levels

Conditions: Patients With Hypertriglyceridemia

Summary: the primary objective is to determine the efficacy of phytosterol esters of omega-3 (vayarol) versus omega-3 acids ethyl esters in reducing triglyceride levels in hypertriglyceridemia patients with fasting triglyceride levels ≥ 200 and \< 500 mg/dl.


Eligibility criteria:
inclusion criteria: 1. male or female, age \> 18 years 2. triglycerides ≥ 200 mg/dl and \< 500 mg/dl 3. ability to give written informed consent exclusion criteria: 1. female patient who are pregnant or breastfeeding or planning to become pregnant 2. fasting plasma glucose (fpg) levels \> 110 mg/dl 3. type 2 diabetes mellitus that is poorly controlled (glycosylated hemoglobin \[hbalc \] \>8.0% 4. patients who are under use of lipid altering drugs excluding use of simvastatin, atorvastatin, and rosovastatin for 6 weeks or more 5. patients who are under use of products containing omega-3 fatty acids or other dietary supplements with potential lipid altering effects 6. history of bariatric surgery or currently on weight loss drugs. 7. uncontrolled hypertension (bp\>140/90) 8. subjects with secondary causes of hypertriglyceridemia: alcoholism, dysglobulinemia, thyroid disease that is poorly controlled (tsh\ 5.5) 9. subjects with an abnormal level of liver enzymes (twice the normal level) 10. suffered from ischemic event such as myocardial infarction, cerebrovascular accident and angina pectoris in the last 6 months 11. uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins such as cushing syndrome 12. gastrointestinal disease that may influence lipid metabolism such as celiac, crohn, colitis or other malabsorption problem 13. subjects who have had any malignancy. subjects who have had basal cell carcinoma that have been disease free for at least 3 years are eligible for the study. 14. consumption of one fish serving (200 grams) or sea food x2 a week or more. 15. hiv infection by history 16. history of hypersensitivity or allergy to fish, fish oil or soy 17. bmi≥35 18. weight change \> 3 kg during the run-in period 19. any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient
the effect of intranasal insulin administration on cognitive function after cardiac surgery.

Conditions: Cognitive Decline; Heart Diseases; Delirium

Summary: decline in cognitive function after surgery occurs most commonly in older patients and patients undergoing major surgeries, such as heart surgery. postoperative cognitive dysfunction (pocd) may last a prolonged period of time while postoperative delirium (pod) is a more acute disturbance in attention, awareness and cognition. the cause of pocd and pod are not fully understood, however some of the pathophysiology of pocd is similar to that of alzheimer's disease (ad). insulin given intravenously during heart surgery has been shown to preserve short and long-term memory function after the operation. clinical trials further demonstrated that insulin given via the nose (intranasal) improves memory performance of patients with ad or cognitive impairment suggests that intranasal insulin also could be a therapeutic option for pocd and pod. this study is designed to examine the effect intranasal insulin on pocd and pod. the goal is to investigate whether administration of intranasal insulin during and after heart surgery improves cognitive function postoperatively.


Eligibility criteria:
inclusion criteria: • elective open heart surgery requiring cardiopulmonary bypass exclusion criteria: * inability to provide informed consent * allergy to insulin * pregnancy * mother tongue other than english or french * visual or hearing impairment interfering with the ability to complete cognitive tests.
use of the tdt for prevention of anastomotic leakage after laparoscopic anterior resection for rectal cancer

Conditions: Anastomotic Leakage; Rectal Neoplasms

Summary: the rate of anastomotic leakage after laparoscopic anterior resection（lar） for medium \& low rectal cancer is still high. the transanal drainage tube (tdt) was thought to be useful for deduce the rate. there were several studies, but most of them were not randomized controlled trial (rct) studies. there was only one rct study with enough samples, but it was designed for open anterior resection, and the patients underwent diverting stoma were excluded, so there was the selection bias. lar now is thought to been with the same effect, and it is safe and feasible. so a rct investigation for the use of tdt for prevention of anastomotic leakage after lar for medium \& low rectal cancer is needed.

patients were randomly assigned to two groups, the tdt and non-tdt group after the laparoscopic lar and dst procedure was decided during operation. randomization was obtained through a computer-generated random number sequence allocation. surgeon blinding was performed to ensure all the intraoperative decisions made by the surgeon were not interfered with by the grouping. all the operative procedures fully complied with the guideline for the diagnosis and treatment of colorectal cancer and the technique of total mesorectal excision (tme). the preservation of the left colonic artery was judged by the surgeon according to his own experiences and assessment of the patient's conditions. when the anastomosis was accomplished, the discretion of ds construction was made by the surgeon based on assessing the risk factors of al. pelvic drainages were used in all cases in this study. after completion of the anastomosis and further ds construction if necessary, the surgeon would be notified to implement the intervention based on the randomizing results.

Eligibility criteria:
inclusion criteria: all consecutive 18 to 80 years old individuals diagnosed as primary rectal adenocarcinoma with the lower edge of the tumor less than 10 cm from the anal verge were considered eligible; with the classification of american society of anaesthesiologist (asa) of i, ii, or iii; laparoscopic lar+ with double stapling technique (dst) was planned to perform for the patients. all the preoperative procedures should comply with the guideline for the diagnosis and treatment of colorectal cancer. exclusion criteria: the emergency operation for rectal cancer with obstruction, bleeding, or perforation would be excluded. patients with inflammatory bowel disease (ibd), familial adenomatous polyposis (fap), recurrent rectal cancer, or synchronous cancer would not be suitable. patients with preoperative radiotherapy were excluded. patients who underwent other types of surgeries for rectal cancer, including hartmann's procedure, abdominoperineal resection (apr), intersphincteric resection ( isr), et al. were excluded intraoperatively

Keywords: transanal drainage tube anastomotic leakage laparoscopic anterior resection rectal cancer
evaluation of the efficacy and safety of lebrikizumab (ly3650150) in moderate to severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. the study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.


Eligibility criteria:
inclusion criteria: * male or female adults and adolescents (≥12 years and ≥40 kg) * chronic atopic dermatitis (according to american academy of dermatology consensus criteria) that has been present for ≥1 year before the screening visit * eczema area and severity index (easi) score ≥16 at the baseline visit * investigator global assessment (iga) score ≥3 (scale of 0 to 4) at the baseline visit * ≥10% body surface area (bsa) of atopic dermatitis involvement at the baseline visit * history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable exclusion criteria: * prior treatment with dupilumab or tralokinumab * treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit * treatment with any of the following agents within 4 weeks prior to the baseline visit: * immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, ifn-γ, janus kinase inhibitors, azathioprine, methotrexate, etc.) * phototherapy and photochemotherapy (puva) for ad * treatment with the following prior to the baseline visit: * an investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer * cell-depleting biologics, including to rituximab, within 6 months of baseline * other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever is longer * treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study * uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma * evidence of active acute or chronic hepatitis * history of human immunodeficiency virus (hiv) infection or positive hiv serology * history of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin * pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Keywords: eczema dermatitis dermatitis, atopic skin diseases
mental health consequences of covid19 infection in the french rmd cohort

Conditions: Covid19; Systemic Autoimmune Disease; Inflammatory Rheumatism; Auto Inflammatory Diseases

Summary: this observational, cross-sectional, national, comparative study, including rmd patients followed in hospital centres of the fai²r rare diseases healthcare pathway network and specialist private practitioners caring for patients suffering from inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory diseases. the objective of the study is to compare rmd patients with covid 19 infection (cases) to rmd patients who have not had covid 19 infection (controls) on their mental health.


Eligibility criteria:
inclusion criteria: patient case: * patient with inflammatory rheumatism, systemic autoimmune or autoimmune disease * with confirmed covid-19 infection (at least one month prior to study inclusion) * study information given to the patient * patient affiliated to social security patient control: * patient with inflammatory rheumatism, systemic autoimmune disease or autoimmune disease. * not having had a confirmed covid-19 infection * study information given to the patient * patient affiliated to social security exclusion criteria: * opposition to participation in the study by the patient and/or his legal representative * adult patient not able to understand the implications and rules of the study * protected adults under guardianship or curatorship
comparison of urinary flow study

Conditions: Urinary Retention

Summary: the purpose of this research study is to compare the urinary flow speed of two different female catheters in patients that use intermittent catheters to empty their bladder. the "14 fr two eyelet coloplast female speedicath urinary catheter" will be compared to the "14 fr coloplast micro zone luja female catheter." participants will have one study visit that should take about an hour and will also receive a follow-up telephone call about one week after the visit.

the purpose of this crossover study is to compare the urinary flow speed of two different female catheters manufactured by coloplast, the "14 fr two eyelet coloplast female speedicath urinary catheter" vs "14 fr coloplast micro zone luja female catheter" in patients that use intermittent catheters to empty their bladder. patients will be randomly assigned to group a or group b using a closed-envelope randomization method. group a will self catheter with luja, backfill with sterile fluid volume equal to amount of urine collected, then self-catheter with speedicath. group b will self catheter with speedicath, backfill with sterile fluid volume equal to amount of urine collected, then self-catheter with luja. outcomes will be measured with office uroflow device.

Eligibility criteria:
inclusion criteria: * female * regular use of intermittent catheters to empty bladder, for at least 1 month before enrolment * age 18 years or older * required to adhere to the intervention procedure and not participate in any other clinical studies throughout the duration of this study exclusion criteria: * severe urinary tract abnormalities (e.g. excessive production of urinary mucus/sediments/debris) * hypersensitive to the ingredients in the catheters being tested * recent surgery, within 3 months * currently being treated for urinary tract infection * being pregnant or breastfeeding * non-english speaking

Keywords: catheter intermittent catheterization bladder
superficial cervical plexus block for pacemaker insertion

Conditions: Pacemaker Insertion; Regional Block; Pain

Summary: the purpose of this study is to investigate clinical outcomes from two current standard of care pain control procedures performed for patients undergoing pacemaker insertion.


Eligibility criteria:
inclusion criteria: * age 18-100 years old * registered patients at mayo clinic in florida scheduled to undergo primary insertion of pacemaker exclusion criteria: * emergency placement of pacemaker * sub-pectoral placement of pacemaker * patients with history of chronic pain * patients with anatomical abnormality or disruption to the pacemaker insertion site or site of block placement * patients with allergy to local anesthetic
wound dressings for split-thickness skin graft donor sites in patients undergoing surgery

Conditions: Pain; Perioperative/Postoperative Complications

Summary: this study is to determine what dressing would work best to heal and keep from hurting, the split-thickness skin graft donor site which will be done as part of the patient's surgical procedure. currently there is a dressing that is transparent and it is placed on the wound after surgery and wrapped with gauze and an elastic bandage. two days after the surgery the gauze and elastic bandages are removed and the area is left with the transparent dressing. sometimes the dressing needs to be changed because it leaks. on the fifth day this dressing is removed and the wound is left open to air. the dressing researchers are studying is a dressing that has been used for different types of wounds, as well as this type of wound. it is applied in the same manner; however, it is left in place until it falls off independently, usually around post-operative (post-op) day 10.

primary objectives: i. which dressing type and technique is most effective in minimizing pain and inflammation and promoting epithelialization in patients who have had surgery which requires the use of an anterior thigh split-thickness skin graft? outline: patients are randomized to 1 of 2 arms. arm i: patients receive transparent film dressing (otolaryngology service) or xeroform petroleum gel impregnated gauze dressing (surgical oncology service) after surgery. arm ii: patients receive native collagen wound dressing after surgery.

Eligibility criteria:
inclusion criteria: * population of otolaryngological or surgical oncology patients experiencing an autologous split-thickness skin graft as part of their surgical procedure * patients will have a glasgow coma score of 15 (or 10 with a tracheostomy) * patient donor sites will be limited to the anterior thigh * patients will be free of documented circulatory deficits, neuropathy, or mental illness which prohibits their ability to independently consent or respond to questions regarding pain * patients will be able to give consent independently * patients will be able to read and write in english exclusion criteria: * patients unable to give independent consent for any reason * skin graft donor sites other than the anterior thigh * patients with a concurrent diagnosis of diabetes, peripheral vascular disease, and/or paresthesias or paralysis of the lower extremities * patients who are unable to complete a self-report pain scale * patients who are prisoners * patients who are known active alcoholics * patients on steroids or other medications known to affect healing
reliability and validity of cciso for diagnosis of autism spectrum disorder

Conditions: Autism Spectrum Disorder; Global Developmental Delay; Language Disorder

Summary: the investigators designed the child-caregiver interaction observation scale（ccios）to assess social communication behaviors, stereotyped behaviors for children with autism spectrum disorder(asd) via a 20-min video of interactions between a caregiver and a child. the original ccios coding scheme consists 23 items. the score range for each item is 0-4, with higher scores being indicative of more atypical behavior. the aim of the study is to determine items for inclusion in the final ccios coding scheme through exploration of item correlations, establish the cutoff score of ccios for asd and evaluate the reliability and validity of ccios. the reliability evaluation include test-retest reliability and inter-rater reliability. dsm-5 criterion is used as the gold standard. validity is assessed by determining the correlation and consistency between ccios and dsm-5 criterion.

the investigators designed the child-caregiver interaction observation scale（ccios）to assess social communication behaviors, stereotyped behaviors for children with autism spectrum disorder(asd) via a 20-min video of interactions between a caregiver and a child. the original ccios coding scheme consists 23 items. the score range for each item is 0-4, with higher scores being indicative of more atypical behavior. the investigators conduct this study to determine items for inclusion in the final ccios coding scheme through exploration of item correlations, establish the cutoff score of ccios for asd and evaluate the reliability and validity of ccios. it is of importance to accurately distinguish children with asd from those with global developmental delay (gdd) and language disorder (ld) without asd, sometimes, it's very difficult in children with mental ages below 2 years. this differentiation has strong implications for treatment recommendations and may also inform long-term prognosis. in this study, the investigators planned to recruit 60 children with asd and 60 children with gdd/ld aged from 18 months to 48 months. the reliability evaluation include test-retest reliability and inter-rater reliability. dsm-5 criterion is used as the gold standard. validity is assessed by determining the correlation and consistency between ccios and dsm-5 criterion.

Eligibility criteria:
inclusion criteria: * the asd/gdd/ld diagnosis is made based on the criteria of asd/gdd/ld in diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) ; * age 18 months - 48 months; exclusion criteria: * visual, audi-tory and physical disabilities