Kornimate/medical-research-clean huggingface dataset:
dressing wear time after breast augmentation with prosthesis

Conditions: Surgical Site Infection

Summary: this study was designed to determine whether the duration of dressing wear following augmentation mammaplasty influence skin colonization and eventually surgical site infections rates.

augmentation mammaplasty is currently one of the most performed plastic surgery procedures. it is a clean operation, and surgical site infection (ssi) rates are low. however, a ssi, since a minor one, leads to the failure of the procedure. thus, minimizing ssi risks is imperative. the centers for disease control and prevention (cdc) provides recommendations concerning prevention of ssi.no recommendation is offered for some practices, either because there is a lack of consensus regarding their efficacy or because of the available scientific evidence is insufficient to support their adoption. cdc´s "guideline for prevention of surgical site infection" recommends protecting with a sterile dressing for 24 to 48 hours an incision that has been closed primarily. there is no recommendation to cover the incision beyond 48 hours. one major risk factor for ssi is the presence of bacteria at surgical site.thus, this trial was designed to verify the influence of dressing wear time on skin colonization.

Eligibility criteria:
inclusion criteria: * candidate to breast prosthesis implantation * body mass index under 30kg/m2 exclusion criteria: * pregnancy, delivery or breast feeding during the last 12 months * body mass index over 30kg/m2 * breast cancer history * previous breast surgery * hard smoking

Keywords: breast prosthesis implantation bandages skin colonization surgical site infection augmentation mammaplasty dressing wear time
resvida and fat oxidation

Conditions: Obesity

Summary: there is now a general consensus that the combination of excessive energy intake and a low capacity to oxidize fat will lead to muscular fat accumulation and insulin resistance. it is known for many years that physical exercise is the most powerful treatment to combat insulin resistance, but it is also known that it is difficult to get people to exercise. a major breakthrough has come from the nutrition field, with the finding that resveratrol, a natural polyphenolic compound, could serve as an "exercise mimetic" by protecting mice from many detrimental effects of diet-induced obesity. therefore the researchers would like to investigate if resvida can increase skeletal muscle mitochondrial function and fat oxidative capacity in obese subjects. the researchers hypothesize that an increased mitochondrial function together with an increased intrinsic activity will lead to a better control of fatty acid handling in muscle, upon a high-fat challenge.


Eligibility criteria:
inclusion criteria: * male sex * age 45-65 years * body fat percentage \> 25%, bmi 30-35 kg/m2 * sedentary * stable dietary habits * willingness to abstain from ingestion of resveratrol-containing foods * healthy exclusion criteria: * female sex * unstable body weight (weight gain or loss \> 3 kg in the last three months) * total body fat percentage \< 25% * fasting plasma glucose \> 6.1 mmol/l * hemoglobin \< 7.8 mmol/l * engagement in programmed exercise \> 2 hours total per week * impaired kidney and/ or liver function * first- or second-degree family member with type 2 diabetes mellitus * any medical condition requiring treatment and/ or medication use * intake of dietary supplements except vitamins and minerals * unwilling to restrict high-resveratrol containing foods * current alcohol consumption \> 20 grams/day * participation in another biomedical study within 1 month before the screening visit * a contraindication to mri scanning. these contraindications include patients with the following devices: * central nervous system aneurysm clips * implanted neural stimulator * implanted cardiac pacemaker or defibrillator * cochlear implant * insulin pump * or metal containing corpora aliena in the eye or brains

Keywords: impaired fat oxidation fat accumulation mitochondrial dysfunction mitochondrial biogenesis
reducing sedentary time in obese adults

Conditions: Sedentary Behavior

Summary: greater time spent in sedentary behaviors, independent of physical activity level, can increase risk of morbidity and mortality. objective assessments indicate that bariatric surgery patients spend large amounts of time in sedentary behaviors. the present study is the first to test whether a mobile health (mhealth) approach that employs widely adopted smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible and acceptable method of reducing sedentary time in these patients and other obese populations.


Eligibility criteria:
inclusion criteria: * bariatric surgery patients and other obese individuals will be considered * body mass index \>= 30 kg/m2 exclusion criteria: * report being unable to engage in daily activities and walk continuously for \>= 10 minutes without assistance * are currently involved in a physical activity intervention. * are unable to read or understand the study materials * are currently taking medications that cause dizziness and/or feeling faint when sitting or standing. * report any condition that in the opinion of investigators would preclude adherence to the intervention protocol including plans to relocate, history of substance abuse or other significant psychiatric problems, or terminal illness.

Keywords: sedentary behavior physical activity obesity mobile health smartphone
pituitary functions after traumatic brain injury (tbi) and/or subarachnoid hemorrhage (sah)

Conditions: Traumatic Brain Injury; Subarachnoid Hemorrhage; Hypopituitarism

Summary: this study performs assessments of pituitary functions by basal hormone levels in the acute phase after tbi and/or sah followed by detailed endocrine tests (insulin-induced hypoglycemia or growth hormone releasing hormone-arginine-corticotropin releasing hormone-leuteinizing hormone releasing hormone \[ghrh-arginine-crh-lhrh\] test) after 4 and 12 months.

recent data have demonstrated that hypopituitarism seems to be a frequent finding after traumatic brain injury (tbi) and/or subarachnoid hemorrhage (sah). however, most of these studies referred to retrospective evaluations. there are only few prospective data, and no longitudinal study routinely taking into account the assessment of anterior pituitary function in the acute phase after tbi or sah so far. we prospectively evaluate pituitary functions in patients in the acute phase after tbi or sah and a control group of patients with trauma not involving the brain. endocrine data included basal anterior pituitary lobe hormone, igf-1 and testosterone serum levels (immulite 2000) within the first 8 hours after tbi or sah. further endocrine evaluation was performed by means of either a combined ghrh-arginine-crh-lhrh test or an insulin-induced hypoglycemia test after 4 months and 12 months. to rule out an assay related bias with regard to gh and igf-1, all hormone levels were cross-checked by a supersensitive assay in another laboratory.

Eligibility criteria:
inclusion criteria: * tbi or sah * control group: injury without involvement of the brain/skull exclusion criteria: * pregnancy

Keywords: traumatic brain injury subarachnoid hemorrhage hypopituitarism
safety and efficacy of an allergen vaccine in grass-pollen allergy

Conditions: Hypersensitivity

Summary: the purpose of this study is to evaluate whether the use of a specific immunomodulatory principle (qbg10) together with conventional grass pollen allergen leads to a more rapid and more pronounced decrease of sensitivity against pollen than with the grass pollen allergen alone


Eligibility criteria:
inclusion criteria: * 18 to 65 years of age * mild to moderate seasonal allergic rhinoconjunctivitis due to sensitization against grass pollen as evident from history (≥ 2 years), and positive nasal provocation test (npt) and positive skin prick test (spt, wheal ≥ 3mm larger than diluent) to grass pollen extract * female participants must meet one of the following criteria: no reproductive potential due to menopause (one year without menses, in case of doubts serum fsh will be determined and must be \>40 u/ml), hysterectomy, bilateral oophorectomy, or tubal ligation. patient agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 1 additional months after the last immunization (hormone-based, or intrauterine device, or double barrier contraception, i.e. condom + diaphragm, condom or diaphragm + spermicidal gel or foam) * written informed consent * patient is willing and able to comply with all trial requirements exclusion criteria: * additional allergies (seasonal or perennial) of which the symptoms overlap temporally with the screening and treatment period * contraindication to allergen preparation * contraindication for nasal provocation test * contraindication for skin prick test * actual significant obstructive pulmonary disorder (fev1\< 70%) * pharmacological treatment that could affect allergic sensitivity during the trial * presence or history of significant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological, and psychiatric disease as judged by the investigator * serum test positive for hiv, hbv, or hcv * current diagnosis or history of malignancy; presence of suspicious lymphadenopathy or splenomegaly on physical examination * pregnancy or lactation * blood donation within 30 days before enrolment * history of abuse of alcohol or other recreational drugs * specific immunotherapy against pollen allergy within the last two years * intake of an investigational drug within three month before enrolment * intake of contraindicated medicaments for sit as betablockers, ace/atii inhibitors

Keywords: allergy grass pollen systemic immunotherapy
smartphone-app based prediction of large vessel occlusion

Conditions: Acute Stroke

Summary: the aim of this non-interventional study is to evaluate a german version of the triage stroke-score fast-ed performed by ambulance service personnel in a pre-hospital setting using a smartphone app (join-triage, allm).

the emergency service of the city of essen (nrw, germany), which is organised by the essen fire-department, will perform a prehospital triage stroke-score using a smartphone-app (join-triage, allm) when referring patients with suspected stroke to the university clinic essen. the triage stroke-score fast-ed (field assessment stroke triage for emergency destination), as well as the expected time of arrival will be transmitted by an additional smartphone-app in advance of the arrival (join, allm). patients will receive emergency workup to identify stroke etiology and presence of large vessel occlusion. final diagnosis, presence of large vessel occlusion and type of revascularisation treatment will be registered. sensitivity, specificity and further criteria for test quality will be calculated for the stroke triage by emergency service in field using the fast-ed.

Eligibility criteria:
all patients above the age of 18 with suspected acute stroke transferred to the university hospital essen. inclusion criteria: suspected acute stroke, age above 18 years and a digitally transmitted fast-ed by ems prior to admission. exclusion criteria: known symptom onset beyond 24 hours.

Keywords: prehospital triage
amg 745 in subjects with age-associated muscle loss

Conditions: Age-associated Muscle Loss

Summary: randomized, double-blind, placebo-controlled dose ranging study to evaluate the safety and efficacy of amg 745 in age-associated muscle loss


Eligibility criteria:
inclusion criteria: * limited exercise tolerance and rapid assessment of physical activity (rapa) score ≤ 3 * hand grip (dominant hand): men ≤ 30.3 kg, women ≤ 19.3 kg * walk speed ≤ 0.8 m/s (based on a 4 meter walk) exclusion criteria: * subject weight \> 137 kg (300 lbs), or body mass index (bmi) \> 32 kg/m2 * primary muscle disease or myopathy * recent immobilization, or major trauma to the legs within 6 months * knee or hip replacement within 12 months or lower extremity amputation * significant laboratory abnormalities * significant comorbidities or medical history * weight loss (intentional or unintentional) of \> 5 kg in 12 weeks * unable to complete an mri scan

Keywords: aging frailty sedentary immobilization atrophy muscle wasting physical activity
depuy attune total knee arthroplasty rsa study

Conditions: Osteoarthritis

Summary: the depuy attune knee system incorporates several key features aimed at improving kinematics of the knee joint, range of motion, and smoothness of use compared to existing total knee replacement technologies. as this is a newly approved medical device, clinical testing in patients using high precision diagnostics is important to evaluate the stability of implant fixation and in vivo function. we propose a multi-centre consecutive series study examining the stability of the attune posterior-stabilized knee design in 30 patients undergoing total knee arthroplasty for a follow-up period of 2 years. radiostereometric analysis (rsa) will be utilized to identify the micromotion of the tibial tray with respect to the surrounding bone. health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at follow-up intervals.


Eligibility criteria:
inclusion criteria: * symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty * between the ages of 21 and 80 inclusive * patients willing and able to comply with follow-up requirements and self-evaluations * ability to give informed consent exclusion criteria: * active or prior infection * medical condition precluding major surgery
assessment of the efficacy of stereotactic intracavitary instillation of 90yttrium colloid

Conditions: Neuroepithelial Cyst

Summary: neuroepithelial cysts are rare, representing less than 1% of the intracranial cysts. neuroepithelial cysts, are benign and mostly asymptomatic. these cysts are lined by thin columnar or low cuboidal epithelium. the csf-like contents of the cyst are due to secretion of the epithelial cyst wall. although mostly asymptomatic, symptoms can occur when the cyst enlarges; the specific symptoms vary according to the size (mass effect) and location of the lesion. radioactive phosphorus (32p) and 90yttrium colloid are isotopes that have been used. these are approved in the united states and europe. 32p is not available in canada. we want to use 90yttrium colloid. there is evidence in the scientific literature that treatment with 90yttrium colloid injected into the cyst is effective in preventing the cyst from growing, effective in causing the cyst to get smaller and in some cases the cyst disappears.

in brief, a single patient has been identified as having a cystic tumor by diagnostic imaging and clinical expertise and based on standards of excellence in clinical care will be offered participation in the study for the intracystic implantation of 90yttrium colloid. this patient will be followed closely for 4 weeks following 90yttrium colloid treatment and then receive standard of care (http://neurosurgery.medicine.dal.ca).

Eligibility criteria:
inclusion criteria: 1. cystic tumor 2. required treatment 3. adult over 17 years of age 4. willingness to provide informed consent exclusion criteria 1. solid tumor 2. treatment not required 3. child under 17 years of age 4. not willing to provide informed consent
circuit class training vs. individual, task specific training in chronic stroke patient

Conditions: Stroke

Summary: due to minimal volitional activation of the impaired arm, these individuals are less able to engage in activities of daily living (adl's). moreover, simultaneous use of the hand and arm are needed throughout adl's. the effects of these two approaches (circuit class training and individual task-specific training) on upper extremity function and activities of daily living (adl's) have not yet been clearly identified, and studies on its effects on chronic stroke patients are limited.

several research found that circuit training improved various functional parameters after stroke. and most of the circuit based tasks from the published studies were focused on the leg strength, walking speed, distance and balance etc. previous literature found that circuit class training is effective in improving upper extremity function in chronic stroke patients disregarding the type of stroke and the results of that study are not generalized for chronic stroke patients with upper extremity deficit. secondly, circuit class training and task-specific training are effective for improving upper limb function following a stroke but in the acute stage. in fact, there is no evidence in which comparison of these two approaches has been done in chronic stroke patients and thirdly, between these two approaches which approach is more effective towards improving upper limb function in chronic stage.

Eligibility criteria:
inclusion criteria: * mini-mental state examination score more than 24 * chronic stage (i.e. post-stroke duration of 6 months) * single episode of stroke * mas of 1 to 3 at upper extremity. * mrs of ≤ 3 at lower extremity. * mca stroke * scores 32 to 47 on fugl-meyer upper extremity scale (fma-ue) exclusion criteria: * orthopedic conditions that affect the ue function. * other neurological conditions, like pd, ms etc.

Keywords: spasticity motor function
reducing the frequency of follow up and task sharing in the treatment of uncomplicated severe acute malnutrition

Conditions: Severe Acute Malnutrition

Summary: this study will be conducted as a stratified cluster randomized trial. the unit of randomization will be the outpatient therapeutic feeding center. the 10 health centers will be stratified by size, and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance.

this study will be conducted as a stratified cluster randomized trial of a monthly schedule of follow up in the treatment of uncomplicated sam among children aged 6 to 59 months. the unit of randomization will be the outpatient therapeutic feeding center. the 10 health centers supported by international medical corps uk (imc-uk) will be stratified by size (± 1000 admissions per site per year), and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance. distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a weekly or monthly basis until discharge according to the random assignment of the site. caregivers in the monthly visit group will receive additional instruction at admission regarding home-based muac measurement and clinical surveillance. regardless of intervention assignment, all children with uncomplicated sam will receive standard medical care on admission as per national guidelines, and a home visit 2 months following discharge from the nutritional program. additional data collection, including coverage assessment and economic costing analysis will be used to address the secondary objectives related to the evaluation of coverage and cost-effectiveness, respectively.

Eligibility criteria:
inclusion criteria: * age from 6 to 59 months * muac \< 115 mm and/or grade 1-2 edema * absence of current illness requiring inpatient care exclusion criteria: * history of allergy to peanuts * any other condition in which, in the judgment of the field investigator, would interfere with or serves as a contraindication to protocol adherence or the ability to give informed consent
dolutegravir and clinical outcomes among art-recipients in brazil

Conditions: HIV Infections; Clinical Outcomes; Adverse Drug Event; Effect of Drugs

Summary: access to antiretroviral therapy (art) in low-income and middle-income countries has been scaled-up effectively over recent years. recently, the world health organization (who) guidelines changed to recommend the use of dolutegravir (dtg) combined with two nucleoside reverse transcriptase inhibitors (nrtis), tenofovir and lamivudine, for first-line art; however, there is still a need for further data on the outcomes of dtg-based regimens for people with hiv-1. this study aims to describe the outcomes of drug-naïve and experienced patients starting a dolutegravir (dtg)-based regimen in a large cohort of hiv - infected patients in brazil and compare to outcomes obtained from a retrospective control group of subjects who initiated non-dtg-based art.

code is a multicenter prospective observational study to describe and quantify the outcomes of patients starting dtg-based regimens. the investigators will follow art-naïve patients starting dtg-based regimens (group 1), patients on stable art regimens switching to dtg (any reason) (group 2), and art-experienced patients switching to dtg-containing regimens due to virological failure (group 3). in addition, for comparison purposes, the investigators will collect data on patients who started a non-dtg containing regimen (group 4) in the period for 2014-2016 and did not switch to dtg-based regimens (figure 1). enrolled patients will be followed for 36 months.

Eligibility criteria:
inclusion criteria: * • signed informed consent. * hiv infection documented by plasma hiv rna viral load, a rapid hiv test or any licensed elisa test; and confirmed by another test using a different method, including but not limited to a rapid hiv test, western blot, hiv culture, hiv antigen, or hiv pro-viral dna at any time prior to study entry. * age ≥ 15 years. * for women of child-bearing potential, willingness to use effective contraceptives. * starting use of dtg-based regimen, or being initiated on a non-dtg based art between 2014 - 2016. exclusion criteria: * • any previous use of art (drug-naïve group only). * current imprisonment, or compulsory detention (involuntary incarceration). for treatment of a psychiatric or physical illness.
pharmacokinetics, pharmacodynamics and safety of deb025 plus ribavirin in chronic hepatitis c genotype 2 and 3 treatment naïve patients

Conditions: Hepatitis C; Liver Disease

Summary: this study will explore the relationship of different deb025 doses in combination with rbv to pharmacokinetic, pharmacodynamic (i.e. viral load reduction) and safety profiles in chronic hepatitis c gt 2 and 3 treatment naïve patients.


Eligibility criteria:
inclusion criteria: 1. written informed consent must be obtained before any assessment is performed. 2. no previous treatment for hepatitis c (hcv) infection (i.e. hcv treatment-naïve) 3. chronic hepatitis c (g2 or g3) virus infection diagnosed exclusion criteria: 1. use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment. 2. history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes 3. hepatitis b surface antigen (hbsag) positive 4. human immunodeficiency virus (hiv) positive. -

Keywords: chronic hepatitis c deb025 alisporivir ribavirin therapy genotype 2/3 treatment naive patients