Kornimate/medical-research-clean huggingface dataset:
needle-aspirated compression dressing following ostomy reversal

Conditions: Colostomy Stoma; Ileostomy - Stoma; Surgical Site Infection; Wound Complication

Summary: negative pressure wound dressings have been studied and shown to have applications in decreasing rates of surgical wound infections. this study studies the effect of a low cost needle-aspirated negative pressure compression dressing on rates of wound infection at prior ostomy site in patients undergoing ostomy reversal surgery.

negative pressure wound therapy (npwt) will be studied in colorectal surgery patients undergoing ostomy reversal surgery. the immediate goal is to compare primary wound closure against primary closure with needle-aspirated compression dressing, and determine if risk of potential ostomy site wound infections is decreased. the investigators would also like to evaluate if this compression dressing can increase prevalence of complete wound closure by 12 weeks (last planned clinic visit). npwt using a continuous suction device was shown to decrease surgical site infection (ssi) at ostomy reversal sites undergoing primary closure. there is a lack of published literature studying npwt dressings without an associated suction device. the investigators will be using a low-cost simple needle-aspirated suction technique to provide negative pressure under a tegaderm/gauze dressing, at the time of placement. patients will be consented and randomized into a negative pressure group, or a control group consisting of the same dressing under normal pressure. all adult patients undergoing ostomy reversal surgery who consent to the study will be included. exclusion criteria include prior recurrent skin infections, prior stoma-site infection, or large parastomal hernia. patients in the negative pressure group will have the pressure under the dressing measured immediately prior to removal on post-operative day 2.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * presence of a loop or end colostomy or ileostomy * consenting to study and to ostomy reversal exclusion criteria: * altered mental status or patients unable to sign the informed consent form * vulnerable patient populations such as prison and ward patients * patients who are discovered before or during surgery as unable to undergo placement of compression dressing will be excluded. * patients with visible protrusion/evidence of large parastomal hernia * history of recurrent skin \& soft tissue infections * history of previous stoma site infection or complications * patients with extensive comorbidities (such as cancer involving stoma site, uncontrolled diabetes, etc), crohn's patients and abdominal wall fistula patients * patients in who primary closure of wound is deemed inappropriate by the operating surgeon, requiring a different method of stoma site wound management

Keywords: negative pressure wound therapy
power walking on quality of life in post cabg patient undergoing phase 2 cardiac rehabilitation

Conditions: Coronary Artery Disease

Summary: to determine the effect of power walking on quality of life in post cabg population undergoing phase 2 cardiac rehabilitation


Eligibility criteria:
inclusion criteria: * male and female subject * age will be from 50 to 70 * four weeks after cabg surgery patient are eligible to participate * patient able to walk on treadmill with cardiac symptoms stable or absent * appropriate hr response to exercise exclusion criteria: * those patients with contraindications to exercise or clinical risk factors, such as musculoskeletal, neurological, pulmonary or metabolic disorder were all excluded from the study.
safety and efficacy of pg101 for dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: to evaluate the safety and efficacy of 0.25% pg101 and 1.0% pg101 topical gel suspension compared to placebo when administered two times daily for 14 days in subjects diagnosed with dry eye syndrome

the topical product pg101 is expected to be efficacious in treating the symptoms of dry eye such as discomfort, dryness, grittiness, burning, stinging, photophobia, lid friction, mucus discharge and hyper-tearing. two concentrations (0.25% and 1.0%) are included in the study to determine if there is a dose response effect.

Eligibility criteria:
inclusion criteria: * be male or female of any race, at least 18 years of age * have provided verbal and written informed consent * be able and willing to follow instructions, including participation in all study assessments and visits * have a reported history of dry eye syndrome * have a history of use or desire to use eye drops for dry eye * if a woman of childbearing potential, have a negative pregnancy test at visit 1 and be using an adequate method of birth control throughout the study period * have a best corrected visual acuity of +0.70 logmar or better in both eyes exclusion criteria: * have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters * be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis) at visit 1 * be a woman who is pregnant, nursing or planning a pregnancy * have a known allergy and/or sensitivity to the test article or its components * have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study * be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of visit 1

Keywords: keratoconjunctivitis sicca dry eye
clinical trials of two helichrysum infusions in adults

Conditions: Hypertension; Hyperlipidemias; Inflammation; Hyperglycemia; Hypercholesterolemia; Microbial Colonization; Overweight and Obesity

Summary: the study evaluates the effects of helichrysum italicum and helichrysum arenarium on different components of the metabolic syndrome. the components of metabolic syndrome will be measured at baseline and four weeks after daily consumptions of either helichrysum italicum or either helichrysum arenarium, and after two weeks of washout. in addition, stool samples will be also taken at baseline and after four weeks of daily consumtion of either helichrysum italicum or either helichrysum arenarium.

helichrysum arenarium (ha) has a long tradition in european ethno-medicine as a medicinal plant with many known activities; eu monograph supports its use for the digestive disorders, feeling of fullness and bloating, and, importantly, it re-ports no side effects. assessment report of the european medicines agency committee on herbal medicinal products supports its stimulatory role in the bile flow and in the release of cholesterol to the bile. ha has also been used in chronic liver inflammatory disease and as a scavenger of free radicals. similar to ha helichrysum italicum (hi) is widely used in traditional medicine. lately, much attention has been given to natural antioxidants and their ability to delay the progression of chronic diseases related to the formation and the activity of reactive oxygen species and other free radicals. herbs are very often used to prepare recreational tea and are thereby important sources of antioxidants in different cultures. in traditional medicine, hi is also used in diet, mainly for the preparation of infusions in treating respiratory and digestive conditions. therefore,the ail of our study is to evaluate the effects of helichrysum italicum and helichrysum arenarium on different components of the metabolic syndrome in adults presenting at least two components of metabolic syndrome and yet not receiving any medication. the components of metabolic syndrome (lipid profile, blood pressure, antrophometry, inflammation status, glucose levels) will be measured at baseline and four weeks after daily consumptions of either helichrysum italicum or either helichrysum arenarium, and after two weeks of washout. in addition, stool samples will be also taken at baseline and after four weeks of daily consumtion of either helichrysum italicum or either helichrysum arenarium.

Eligibility criteria:
inclusion criteria: * stable weight in the last 3 months * bmi more than 25 * clinical diagnosis of at least two components of metabolic syndrome, exclusion criteria: * consumption of dietary supplements * medications for any component of metabolic syndrome

Keywords: metabolic syndrome herbal infusions diet microbiota
a study of teduglutide (revestive®) in participants with short bowel syndrome (sbs) in canada

Conditions: Short Bowel Syndrome (SBS)

Summary: the main aim of this study is to assess the effectiveness and side effects of teduglutide (revestive®) in real-world clinical practice setting in adult participants with intestinal failure due to short bowel syndrome (sbs-if) in canada. this study is about collecting existing data only; participants receive teduglutide (revestive®) by their doctors according to the clinical practice but not as part of this study. no new information will be collected during this study. the study will be conducted using data from the takeda onepath patient support program (psp) or takeda global pharmacovigilance.


Eligibility criteria:
inclusion criteria: * participants more than or equal to (\>=) 18 years of age at first dose of teduglutide diagnosed with intestinal failure due to short bowel syndrome as a result of intestinal resection. note: as "sbs as result of major intestinal resection" is a criterion for teduglutide treatment reimbursement, it is assumed that all participants receiving teduglutide in the psp have sbs-if as a result of intestinal resection. * stable participants with sbs-if who were dependent on parenteral support prior to teduglutide treatment initiation, and were treated with teduglutide during the study period with at least 6 months of follow-up data available before the end of the study period. * participants who have provided informed consent for secondary use of data for research. exclusion criteria: - participants with active gastrointestinal malignancy or a history of gastrointestinal malignancy in the past 5 years before start of treatment.
postpartum continuous glucose monitoring (cgm) study

Conditions: Gestational Diabetes

Summary: this research study is being done to assess if using a glucose sensor (also known as a continuous glucose monitor) after childbirth can help identify women who are at risk of developing diabetes after having diabetes during pregnancy or gestational diabetes. currently, screening for diabetes after childbirth is performed with an oral glucose tolerance test 6-12 weeks after delivery, but this is burdensome. this study will use a glucose sensor worn on the skin for 10 days. the data from the sensor will be compared to the standard oral glucose tolerance test. this is a single site study at the icahn school of medicine at mount sinai. the research team plans to enroll 50 participants aged 18years or older into the study. participation in the study is expected to last up to 20 weeks and involves 4-5 visits depending on if enrollment is in the 3rd trimester of pregnancy or immediate postpartum. study procedures include 1. consent \& screening. 2.sensor placement and download after 10 days of wear. 3. a second sensor placement 2-5 days before oral glucose tolerance test (ogtt).


Eligibility criteria:
inclusion criteria: * include diagnosis of gestational diabetes during a current or recent pregnancy * age 18 or older. exclusion criteria: * include known pregestational diabetes, * known skin adhesive allergy which would prevent subject from wearing a cgm, * chronic glucocorticoid use which is planned to be ongoing after labor and delivery discharge.

Keywords: gestational diabetes oral glucose tolerance test glucose sensor
symplicity htn-3 renal denervation in patients with uncontrolled hypertension

Conditions: Uncontrolled Hypertension

Summary: the symplicity htn-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. bilateral renal denervation will be performed using the symplicity catheter - a percutaneous system that delivers radiofrequency (rf)energy through the luminal surface of the renal artery.

the symplicity htn-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. bilateral renal denervation will be performed using the symplicity catheter - a percutaneous system that delivers radiofrequency (rf)energy through the luminal surface of the renal artery.

Eligibility criteria:
inclusion criteria: * individual is ≥ 18 and ≤ 80 years old at time of randomization. * individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 2 weeks prior to screening) that is expected to be maintained without changes for at least 6 months. * individual has an office systolic blood pressure (sbp) of ≥ 160 mmhg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit exclusion criteria: * individual has an estimated glomerular filtration rate (egfr) of \< 45 ml/min/1.73 m2 * individual has an ambulatory blood pressure monitoring (abpm) 24 hour average sbp \< 135 mmhg * individual has type 1 diabetes mellitus * individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, cpap, bipap) other than nocturnal respiratory support for sleep apnea. * individual has primary pulmonary hypertension. * individual is pregnant, nursing or planning to be pregnant.

Keywords: uncontrolled hypertension renal denervation
special drug use-results survey to evaluate safety and efficacy of cosentyx in pediatric patients with psv, psa, or gpp

Conditions: Psoriasis Vulgaris; Psoriatic Arthritis; Pustular Psoriasis

Summary: this was a multicenter, centrally registered observational study without a control group. this observational study was a specified drug use-results survey conducted under gpsp to collect information on safety and efficacy during the observation period (52 weeks after the start of treatment with this drug) in pediatric patients with psoriasis vulgaris, psoriatic arthritis, or pustular psoriasis who received this drug.

for patients who discontinued or completed this drug before the end of the observation period, the investigator recorded adverse events that occurred within 30 days after the day following the last administration of this drug, or the day of discontinuation of the survey (the day when discontinuation of the survey was judged), whichever is later, in the crf. if a patient withdraw consent, information was collected during the observation period up to the date of consent withdrawal.

Eligibility criteria:
inclusion criteria: * patients who have obtained written consent from their legally acceptable representative to cooperate in this survey before the start of treatment with this drug * patients aged less than 18 years at the start of treatment with this drug * patients newly treated with this drug for any of the following diseases: psoriasis vulgaris, psoriatic arthritis, pustular psoriasis exclusion criteria: * prior treatment with this drug * participation in an interventional study (e.g., a clinical trial) at the time of starting this drug.

Keywords: psoriasis vulgaris psoriatic arthritis pustular psoriasis nis japan cosentyx pediatric
project aspire efficacy pilot: achieving superior parental involvement for rehabilitative excellence

Conditions: Parental Language Behaviors

Summary: the purpose of the proposed exploratory research protocol is to investigate the feasibility and efficacy of project aspire, a parent-directed intervention aiming to increase parental skills and enrich children's early language environments and ultimately improve child outcomes in children with hearing loss from low-income backgrounds.

we will test the curriculum's efficacy in increasing parental knowledge and skills with a pilot study funded by a u.s. department of education institute for education sciences goal 2 grant. we hypothesize that parents who complete the aspire curriculum with an early intervention therapist will demonstrate enhanced understanding of their child's listening and language needs. this deeper understanding will support behavior changes that improve the language-learning environment through increased parental engagement and linguistic input. knowledge increase and changes to the language environment will be apparent in comparative pre- vs. post-intervention assessment scores. in addition, child outcomes will demonstrate improved listening and spoken language trajectories. to encourage behavior change and help parents track their progress, the curriculum will be coupled with "linguistic feedback" gathered by the language environment analysis (lena) recorders and software. with linguistic feedback, ei therapists and parents will be able to track the family's progress through skill building and set goals for behavior change. this feedback and goal setting will allow parents to translate their knowledge into behavior changes that enrich their child's early language environment.

Eligibility criteria:
inclusion criteria: * child is under 4.5 years old * child uses at least one amplification device (hearing aid, cochlear implant, baha) * child has adequate amplification (at least 30 db in one ear) * parent speaks conversational english * family's communication choice includes spoken language * family is considered low-ses according to income and education proxies exclusion criteria: * child is younger than 6 months of age * parent does not speak conversational english * child is over 4.5 years of age * family is considered high-ses according to income and education proxies

Keywords: hearing loss language behavior change early intervention home visiting
olive oil and soybean 1 oil based intravenous lipid emulsions, liver chemistry and clinical outcomes

Conditions: Parenteral Nutrition Associated Liver Disease

Summary: background: intravenous lipid emulsions (ivle) are an essential component of parenteral nutrition (pn). omega-6 reducing strategies may improve outcomes, including reduced pn associated liver disease. objective: the primary objective was to compare serum alkaline phosphatase (alp), among surgical and medical patients provided with either intralipid or clinoleic lipid emulsions. design: in this quasi-experimental study the medical records of surgical and medical adult patients were reviewed from 3 canadian hospitals that received pn with either soybean oil (intralipid) or predominantly olive oil (clinoleic) based lipid emulsions for at least 7 consecutive days.

a few small studies have shown that a predominantly olive oil based ivle is well tolerated and safe, however the clinical relevance of this ivle is uncertain as no clear benefit in outcomes has been observed in small randomized clinical trials. given the limited data available for the adult population reporting on the experience with olive oil based ivle, we designed a quasi-experimental study to review our experience with clinoleic compared to intralipid. the primary objective was to compare the impact of intralipid and clinoleic ivle on serum alkaline phosphatase (alp), pre-pn to after one week of pn (i.e. between day 8 to 16 post-pn initiation), while controlling for the ordered lipid dosing. secondary objectives were to assess if there were differences between the ivles on the remaining liver function tests, lipid dosing, incidence of infectious complications, length of stay in hospital and 30- day mortality. this retrospective quasi-experimental chart review was conducted in 3 tertiary care hospitals in calgary, ab between july 01, 2012 to june 30, 2013 and july 01, 2014 to june 30, 2015. standard soybean oil-based therapy, intralipid was the only available ivle in calgary, ab until july 2013, at which time predominantly olive oil clinoleic was approved as an alternative in the hospital formulary, accounting for the dates chosen for the study. ethics approval from the conjoint health research and ethics board at the university of calgary was obtained prior to the initiation of the study.

Eligibility criteria:
inclusion criteria: * admitted to hospital who received pn with intralipid or clinoleic ivles for at least 7 consecutive days. exclusion criteria: * baseline liver disease * home pn prior to admission * alp and total bilirubin (tb) not available within 3 days prior to pn start as well as between days 8 to 16 post pn start * receipt of diprivan 1%® (propofol 116 - astrazeneca canada inc., mississauga, canada) during pn support period * enteral nutrition providing greater than 600 kcal daily for longer than half of time period on pn * oral intake of greater than 50% of hospital meal tray contents for longer than half of the pn support time period
a study to investigate the safety, tolerability, and efficacy of bxc-i17e single and multiple dose sc injection in patients with moderate to severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to assess the safety, tolerability, and preliminary efficacy of a single and multiple sc dose of bxc-i17e in patients with moderate to severe atopic dermatitis (ad)


Eligibility criteria:
inclusion criteria: 1. patients (males or females) aged 18 years or older. 2. patients have documented history of moderate to severe ad, that has been present for at least 1 year 3. history of inadequate response to a stable regimen of tcss or tcis as treatment for ad 4. patients must agree to apply stable doses of additive-free, basic bland emollient lotions twice daily for at least 7 days before the baseline visit. 5. willingness and ability to comply with clinic visits and study-related procedures. 6. patients should be able to read, understand, and be willing to sign the icf exclusion criteria: 1. presence of any of the following laboratory abnormalities * hemoglobin \< 11 g/dl * wbc \< 3.5 × 103/μl * platelet count \< 125 × 103/μl * neutrophils \< 1.75 × 103/μl * ast/alt \> 1.5 × uln * total bilirubin \> uln * creatinine \> uln * creatine phosphokinase \> uln 2. positive test for hepatitis b surface antigen, and/or hepatitis c antibody 3. active dermatologic conditions that may confound the diagnosis of ad 4. prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study 5. significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the patient's participation in this study 6. treatment with tcs, and/or tci, within 1 week prior to the baseline visit. 7. known history of human immunodeficiency virus (hiv) infection 8. pregnant or breastfeeding women

Keywords: atopic dermatitis