Kornimate/medical-research-clean huggingface dataset:
photographic library of moderate to severe psoriasis subjects treated with infliximab (study p05047)

Conditions: Psoriasis

Summary: this is a national, multi-center, observational, prospective photographic atlas study in subjects who are treated with infliximab for moderate-to-severe psoriasis in daily clinic according to local country regulations and reimbursement.

subjects will enter this study using a non-probability sampling method.

Eligibility criteria:
inclusion criteria: * male or female, age \>=18 with moderate-to-severe psoriasis. * patient for whom the physician has decided to initiate psoriasis treatment with infliximab in accordance with the terms of the european labeling. * patient must demonstrate his/her willingness to participate in the observational study by signing a written consent. exclusion criteria: * patient unable to understand and answer a self administered questionnaire. * no specific non-inclusion criteria will be applied to eligible patients. * contradiction and/or precaution listed in the summary of product characteristics.
development and validation of an enhanced prediction score for postoperative acute renal failure after liver resection

Conditions: Acute Renal Failure

Summary: post-operative acute renal failure is a severe post-operative complication and is associated with high mortality. the enhanced prediction score, including pre-as well as intra-operative predictors accurately predicted arf following hepatic surgery. this prediction score allows early identification of patients at high risk of arf and may support decision-making for protective kidney treatment.

to enhance and validate an already pre-existing score accurately predicting post-operative acute renal failure (arf) after hepatic surgery we will enhance a pre-existing score predicting arf based on pre-operative as well as intra-operative predictors. development process: we will identify the strongest predictors of arf in a multivariable logistic regression model followed by a stepwise backward logistic regression analysis and bootstrapping. validation process: we will perform an internal validation by calibrating the prediction model as well as by k-fold cross validation (c statistics) and bootstrapping. additionally, we will calculate the discrimination by the area under the curve (auc). decision curve analysis: furthermore we will perform a decision curve analysis to evaluate the clinical consequences of both prediction scores whether a patient with increased arf risk would post-operative benefit of a treatment on the icu.

Eligibility criteria:
inclusion criteria: * \> 18 years * scheduled for liver surgery * benign as well as malignant diseases exclusion criteria: * liver trauma * incomplete data sets * pre-operative chronic renal failure requiring hemodialysis

Keywords: development pre- and intra-operative predictors acute renal failure liver surgery prediction score validation clinical consequences decision curve analysis predictors of acute renal failure after liver resection
effect of volume and type of fluid on postoperative incidence of respiratory complications and outcome (crc-study)

Conditions: Respiratory Failure; Acute Respiratory Failure Requiring Reintubation; Pulmonary Edema; Pneumonia; Hypoxia; Acute Kidney Injury

Summary: intraoperative intravenous fluid management practice varies greatly between anesthesiologists. postoperative fluid based weight gain is associated with major morbidity. postoperative respiratory complications are associated with increased morbidity, mortality and hospital costs. the literature shows conflicting data regarding intraoperative fluid resuscitation volume. no large-scale studies have focused on intraoperative fluid management and postoperative respiratory dysfunction. hypotheses: primary - liberal intraoperative fluid resuscitation is associated with an increased risk of 30 day mortality secondary - liberal intraoperative fluid resuscitation is associated with increased likelihood of postoperative respiratory failure, pulmonary edema, reintubation, atelectasis, acute kidney injury and peri-extubation oxygen desaturation.


Eligibility criteria:
inclusion criteria: * ages 18 upwards * tracheally intubated at the beginning of the procedure and extubated at the end of the procedure exclusion criteria: * cases where the subject had additional surgeries within the previous four weeks * ages under 18

Keywords: fluids intraoperative respiratory outcomes surgery anesthesia
copd in the time of covid-19

Conditions: COPD Exacerbation; COPD

Summary: this cross-sectional observational study will collect information about changes in exacerbation frequency and behaviour amongst a clinical cohort of severe or complex copd clinic patients. this will be done through a combination of telephone survey and access to electronic heath records.

this study will be a cross-sectional observational study utilising a telephone survey. after obtaining informed verbal consent participants will be asked to recall their symptoms, exacerbation events and exacerbation medication usage over the periods of 01/03/20 - 14/03/20 (pre-lockdown) and then 15/03/20 to 30/04/20 (lockdown). a structured survey will follow on from this asking questions regarding behaviour including self-isolation, shielding, other household contacts, visitors to the home, arrangements for shopping, changes in smoking behaviour (including that of other smokers in the household), medication changes, self-reported change in use of preventer medication, self-reported change in walking/activity levels and self-reported changes in anxiety levels. baseline clinical data will subsequently also be collected from the comprehensive respiratory review previously performed in the complex copd clinic (comprising both hospital and gp records.) this will include previous aecopd phenotyping (eosinophil levels, sputum culture and viral pcr), previous lung function testing, prescribed medication, bmi and smoking status and history. previous aecopd events will be counted and graded based on gp antibiotic or steroid prescriptions and hospital admissions. participants will be contacted once as part of the main study following verbal informed consent (via telephone). this will be a brief survey as described above, lasting approximately 20 minutes. a second similar survey will take place up to 12 months after the initial contact to evaluate longitudinal changes associated with the lockdown (further details on this will be submitted as an amendment at a later date due the shifting and unpredictable nature of the covid-19 pandemic and lockdown, this will be prior to initiating these second calls). additional clinical data will be collected from healthcare records to quantify disease severity. participant postcodes will be collected to link results with changes in local air pollution as recorded or estimated during the covid-19 lockdown.

Eligibility criteria:
inclusion criteria: 1. confirmed clinical diagnosis of copd 2. ability to provide informed verbal consent via english language telephone consultation 3. adults aged over 40 years exclusion criteria: 1. patients currently admitted to hospital 2. unwilling/unable to provide informed consent

Keywords: copd aecopd covid-19
the effects of different exercise modalities in adolescents with type 1 diabetes using aid systems

Conditions: Type 1 Diabetes

Summary: objective: the overall objective of this study is to assess the efficacy of the current recommended guidelines for physical activity (pa) in response to acute moderate intensity continous exercise (mice) and high intensity interval exercise (hiie) among adolescents with type 1 diabetes (t1d) using automated insulin delivery (aid) systems (minimed 780g and tandem control-iq). methods: this study will be a two-period, cross-over, clinical trial with between and within cohort comparisons of two different exercise modalities among a total of 24 age-, sex-, and insulin-dose-matched adolescents with t1d (12 using minimed 780g and 12 using tandem control-iq). endpoint: the primary endpoint is sensor-derived time in range (3.9 mmol/l-10.0 mmol/l) around exercise

participants included in the study will perform a cardiopulmonary exercise testing (cpet) before the exercise study visits, to prescribe subsequent exercise intensity thresholds. participants will have a canula placed in a antecubital vein for plasma sampling during the test. participants will undertake two exercise visits each including a bout of exercise on a stationary bicycle of either one of two exercise modalities; i.) high-intensity interval exercise with sprints at \~85% of vo2max (hiie); ii.) moderate intensity continuous exercise at \~60% of vo2max (mice). participants will arrive at the research facility, steno diabetes center copenhagen, in the afternoon. as per the current recommended guidelines, the mice-session will be announced to the aid systems 60 minutes in advance, whereas the hiie-session will not be announced. participants will have a canula placed in a antecubital vein for plasma sampling. participants will rest for 60 minutes, exercise for 45 minutes and rest again for 75 minutes before leaving the research facility. during exercise participants will be fitted with a spirometry face mask to compute ventilatory thresholds and indirect calorimetry (vyaire vyntus® cpx, intramedic a/s) and a telemetry chest strap (polar h10) for integrated hr heart rate (hr) measurements with the spirometry device. in the mice session: after 15 minutes post-exercise rest the temporary target/exercise mode is turned off. around each study visit (24 hours prior until 24 hours after), sensor glucose as well as sleep and physical activity will be recorded. sensor glucose will be measured by participants' own devices. sleep and physical activity level will be assessed with a wrist-worn accelerometer, actigraph wgt3x-bt (actigraph, pensacola, fl). study days will be separated by at least three days.

Eligibility criteria:
inclusion criteria: * age 13-17 years old * type 1 diabetes \> 1 year * use of tandem t:slim x2 control-iq or medtronic minimed 780g with connected continous glucose monitor \> 3 months * hba1c below 75 mmol/l exclusion criteria: * use of anti-diabetic medicine other than insulin * breastfeeding, pregnancy or planning to become pregnant * lack of compliance with key study procedures at the discretion of the investigator
skin barrier assessment in pregnancy and at birth

Conditions: Pregnancy Related; Allergy; Atopic Dermatitis Eczema; Asthma in Children; Food Allergy

Summary: this is a prospective birth cohort study assessing the role of maternal and environmental factors on the development of allergic diseases in children. pregnant mothers will be enrolled and we will examine her skin barrier with skin tape strips (sts) and transepidermal water loss (tewl), along with blood work. we will then follow her offspring and perform similar testing, along with detailed questionnaires inquiring about exposures such as use of detergents and soaps, sunlight exposure, and pollution exposure. when the infant is around 12 months old, we will contact the family via telephone to see if the child developed any allergic conditions within their first year of life, such as eczema, food allergy, or wheezing. a final questionnaire will be performed.


Eligibility criteria:
inclusion criteria: inclusion criteria of the pregnant women: • pregnant women at any stage of a singleton pregnancy. inclusion criteria of the infant: • infant is the offspring of a woman enrolled in the study. exclusion criteria: exclusion criteria of all subjects: * use of systemic immunosuppressive drugs including oral steroids within 30 days of skin barrier assessment * has received total body phototherapy (e.g., ultraviolet light b \[uvb\], psoralen plus ultraviolet light a \[puva\], tanning beds \[\>1 visit per week\]) within 30 days of skin barrier assessment * use of topical corticosteroids, topical immunomodulatory agents, or topical antibiotics on the extremity being evaluated within 7 days of skin barrier assessment * use of systemic antibiotics, antiparasitics, antivirals, or antifungals within 7 days, or antihistamines within 5 days of skin barrier assessment * has taken a bleach bath within 7 days of skin barrier assessment * use of emollients on the extremity being evaluated within 24 hours of skin barrier assessment * has taken a bath or shower on the day of the skin barrier assessment exclusion criteria of the pregnant women: * pregnant women with high risk pregnancies. * pregnancy is from an egg donation. * pregnant women pregnant with more than one fetus. * pregnant women with psychiatric and developmental co-morbidities that would render them unable to provide informed consent or perform study-related procedures. * aids and hiv infection. * a fetus with chromosomal or congenital abnormalities, a heritable hematological disorder like thalassemia or sickle cell disease in the mother. exclusion criteria of the infant: * infant is delivered earlier than 34 weeks gestation. * infant is born with a significant birth defect or medical condition where enrollment in this study is not in the infant's best interest.
brachial plexus block vs. general anesthesia for anesthesia anxiety before orthopedic upper extremity surgery

Conditions: Orthopedic Disorder; Anxiety; Upper Extremity Injury; Surgery

Summary: surgical procedures and anesthesia applications are situations in which people do not feel safe due to the current vital risks. anxiety is a natural reaction that occurs in such situations, it manifests itself with worry and fear. increased anxiety before surgery is associated with pathophysiological responses such as hypertension and dysrhythmia. intense preoperative anxiety can increase morbidity, the need for anesthetic medication, and postoperative analgesia. for this reason, many questionnaire studies have been conducted to measure the degree of preoperative anxiety and to reveal its causes. the amsterdam preoperative anxiety and information scale (apais) test has two parts that measure anxiety and the need for information about anesthesia and surgery. the apais-a (anxiety) part is the test that measures strain and shows whether the patient has anxiety about anesthesia or surgery. the apais-i (information) part estimates whether the person needs information. in the literature, the effects of general and spinal anesthesia techniques on preoperative anxiety levels have been compared for some specific surgical methods such as c-sections and perianal region surgeries. however, no study has been reported between peripheral nerve block and general anesthesia techniques. this study aimed to determine the effects of regional and general anesthesia methods on preoperative anxiety levels and the factors affecting these scores in patients who will undergo upper extremity surgery.

146 patients (asa i-ii-iii) aged 18-75 years who were to undergo orthopedic upper extremity surgery were randomized and divided into two groups. 26 patients were dropout for different reasons (60 patients in each of the bpb block and general anesthesia groups). one of the brachial plexus blocks was performed according to the level to be operated on to the bpb group, and general anesthesia was performed on the ga group. preoperative anxiety of the patients was measured using the apais test. the patients' preoperative anxiety score was the primary outcome measure. postoperative numerical rating scale values were a secondary outcome measure.

Eligibility criteria:
inclusion criteria: * ages of 18-75 * asa i-iii * patients who will undergo orthopedic upper extremity surgery exclusion criteria: * clinically known local anesthetic allergy * morbid obesity (body mass index\> 35 kg m2) * clinically diagnosis of opioid, alcohol and substance dependence * clinically diagnosis of psychiatric disease * coagulopathy * patients with asa iv-v * illiterate patients

Keywords: brachial plexus block general anesthesia orthopedic surgery preoperative anxiety upper exremity surgery
the effect of sponge versus no-sponge placement of mitomycin-c on the outcomes of trabeculectomy with ex-press glaucoma filtration device

Conditions: Primary Open Angle Glaucoma

Summary: the primary focus of this study is to assess intraocular pressure and complication rates between patients who receive mitomycin-c using a sponge versus no-sponge.


Eligibility criteria:
inclusion criteria: 1. men or women aged 18 years and older at screening. 2. diagnosis of chronic angle-closure glaucoma or open-angle glaucoma, phakic or pseudophakic, with visual field or optic disc changes characteristic of glaucoma. 3. suitable candidate for trabeculectomy with ex-press glaucoma filtration device with mmc in the superonasal quadrant in the study eye which the physician deems as medically necessary. 4. capable and willing to provide consent exclusion criteria: 1. unable or unwilling to provide consent 2. any previous ocular surgeries in the study eye preventing placement of the trabeculectomy with ex-press glaucoma filtration device with mitomycin-c in the superonasal quadrant 3. any previous glaucoma drainage devices in the study eye 4. any abnormality other than glaucoma in the study eye that could affect applanation tonometry. 5. presence or history of any abnormality or disorder that could interfere with the study procedure or prevent the successful completion of the study. 6. presence or history of uveitis within 10 years or any other ocular infection or inflammation within 14 days before day 1. 7. any significant unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. 8. known pregnancy or breastfeeding physical and laboratory findings 9. conjunctival scarring precluding a superonasal implantation location. 10. vitreous in the anterior chamber. 11. abnormality preventing reliable applanation tonometry in the study eye.

Keywords: primary open angle glaucoma trabeculectomy mitomycin-c express mini-shunt
comparing an intraoperative vs. a standard wavefront device

Conditions: Cataract

Summary: comparison of intraoperative measured wavefront data with pre- and post-operative wavefront data.

different technologies are in use for measuring wavefront aberrations, such as hartmann-shack wavefront aberrometry, tscherning aberrometry, laser raytracing and automatic retinoscopy. while hartmann-shack wavefront aberrometry, the most widespread of these techniques, uses a lenslet array to record distortions of light bundles coming from a single source form the retina, tscherning aberrometry uses a matrix of pinholes. laser ray tracing in contrast measures the aberration of a laser beam at different locations. all three systems compare distorsions of the measured light beams with a perfect optical system to calculate the wavefront errors. repeatability of wavefront devices was studied in young healthy subjects and different devices have been compared to each other. these results do not represent the typical cataract patient. several factors, such as tear film instability and pupil size, have an influence on the measurements and these factors may change significantly with age. intraoperative measured data could help to get a better information about wavefront aberrations.

Eligibility criteria:
inclusion criteria: * cataract * age 21 and older * able to understand the patient information * willing to follow the instructions and attend all follow-up visits * willing to sign informed consent prior to surgery exclusion criteria: * relevant other ophthalmic diseases that are likely to reduce the refractive outcome, such as pseudoexfoliation syndrome, traumatic cataract, severe corneal scars * previous ocular surgeries on the study eye * patients who are not able to cooperate, with eccentric fixation or insufficient ability to fixate (tremor, nystagmus) * pregnant or lactating women (pregnancy testing will be performed preoperatively on women of reproductive age)

Keywords: cataract wavefront measurement
effects of training and detraining on postmenopausal breast cancer survivors

Conditions: Breast Neoplasm Female

Summary: the present study aimed to verify the effects of resistance exercise training and successive detraining on body composition, lipid profile, muscle strength, oxidative stress, and inflammatory markers of postmenopausal breast cancer survivors undergoing tamoxifen treatment.

the present study aimed to verify the effects of 12 weeks of resistance exercise training and successive 12 weeks of detraining on body composition (body mass, body mass index, fat mass, and fat-free mass), lipid profile (triglycerides, total cholesterol, ldl-cholesterol, hdl-cholesterol), muscle strength (1rm test), oxidative stress (thiobarbituric acid reactive substances,non-protein thiols, catalase activity, and superoxide dismutase), and inflammatory markers (interferon γ, tumor necrosis factor α, interleukin 6 , adiponectin, and interleukin 4) of postmenopausal breast cancer survivors undergoing tamoxifen treatment.

Eligibility criteria:
inclusion criteria: * 1) age between 40 and 65 years; 2) stage 0-iiia breast cancer; 3) submission to axillary lymphadenectomy); 4) completion of chemotherapy and radiation therapy at least 6 months before the study; 5) lack of participation in supervised physical exercise programs in the six months before the beginning of the research; 6) absence of a problem and/or musculoskeletal limitation that would prevent the performance of the proposed exercises; 7) release by a medical professional to participate in the physical training program; 8) residency in uberlândia exclusion criteria: * missing more than 20% of the exercise sessions; unable to perform the proposed training protocols; change in drug therapy during the intervention.

Keywords: breast cancer immune function inflammation resistance exercise oxidative stress menopause