Kornimate/medical-research-clean huggingface dataset:
feasibility study to evaluate the use of patient reported complications after digital consent

Conditions: Breast Cancer; Complication of Surgical Procedure

Summary: patient report complication data to our best knowledge has not been studied yet in electronic consent. this study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. this data will then be used to improve the consent process and evaluate whether the patient initiated follow up (pifu) model is effective or if it leads to underreporting of problems.

at the time of consent, patients are informed of possible post-operative complications. it is often not known whether these complications actually occur, whether there are others which go unreported and the extent, both quantitatively and qualitatively, of the complications. patient reported complication data, to our best knowledge has not been previously studied. this study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. in this case, consent is to be sought digitally; the digital consent form includes a procedure specific list of recognised complications but these might not reflect actual patient experience. if prc data collection is feasible and reliable, this technique could be scaled to create a consent feedback loop, enabling operative outcome data to be collected from all patients, to be be used to improve the consent process for subsequent patients. awareness of post-operative patient complications is important and it is an nhs (national health service) requirement that complications are discussed within regular clinical governance (mortality/morbidity) audit departmental meetings. currently this process relies on clinicians obtaining and reporting these complications. the move towards patient initiated follow up (pifu) models may be leading to underreporting of problems. potentially patient reported complications would allow for a more comprehensive understanding of the benefits and consequences of the various surgical procedures. this in turn might help facilitate 'shared decision making' and allow treatment decisions to be tailored to the individual patients.

Eligibility criteria:
inclusion criteria: * consent form 1- adult patients who have the capacity to consent for themselves. * female adult aged 18years or above * diagnosed with early invasive breast cancer suitable for breast conserving surgery * undergoing wide local excision of the breast and sentinel lymph node biopsy. * participant must be able to fill out an electronic questionnaire or take part in a phone questionnaire. * participant is willing and able to give informed consent for participation in the study. exclusion criteria: * unable to consent for themselves or do not wish to participate. * patients who need an interpreter.
the treatment of clavicular fractures

Conditions: Displaced, Midshaft Clavicular Fractures

Summary: patients with a displaced, shortened, midshaft clavicular fracture are randomized in two groups: conservative or operative treatment. the conservative arm is treated with a sling for 6 weeks. the operative arm is treated with osteosynthesis, within 2 weeks. patients are clinically and radiologically evaluated during 1 year. a economical analysis is also done.


Eligibility criteria:
inclusion criteria: * 18 to 65 year * 100% displaced midshaft clavicular fracture * shortening * male: 18mm * female: 14mm exclusion criteria: * pregnancy * pathological fracture * open fracture * history of frozen shoulder * ipsilateral fracture of shoulder or scapula * neurovascular injury * contraindication to anaesthesia
observational study of meloxicam in mexican patients with rheumatic diseases

Conditions: Arthritis, Rheumatoid

Summary: observational study to evaluate the efficacy and safety of meloxicam (mobicox®) in mexican population with rheumatic diseases


Eligibility criteria:
inclusion criteria: * age of 12 or older and rheumatologic disease exclusion criteria: * hypersensitivity to meloxicam * hypersensitivity to other non-steroidal anti-inflammatory drugs (nsaids) * history of asthma, angioedema or urticaria secondary to nsaids * pregnancy or lactation * recent or current history of peptic ulcer disease, severe renal failure and severe hepatic failure
description of the copper concentration in breast milk in women treated for wilson's disease

Conditions: Wilson's Disease

Summary: wilson's disease is a rare genetic disease, affecting less than 1,500 people in france. the transmission is autosomal recessive linked to an anomaly of the atp7b gene on chromosome.this gene codes for an atpase-type transmembrane protein involved in the transport of copper through the cell plasma member.this gene codes for an atpase-type transmembrane protein involved in the transport of copper through the cell plasma member. if there is no mutation, this atpase incorporates copper into apo-ceruloplasmin to be released into the blood serum. the mutation of the atp7b gene results in a defective biliary excretion of copper, leading to its accumulation in the liver, but also in other organs such as the eye or the brain. advances in treatment have dramatically changed the prognosis for wilson's disease, making the desire for pregnancy more confident. the consensus is to maintain treatment during pregnancy, reducing the dosage to limit teratogenicity as well as the risk of fetal copper deficiency.the mammary gland is the primary site of copper metabolism in lactation, and atpase 7b is the primary effector. it has been shown in a mouse model of wilson's disease (atp7b - / - mouse) with treatment, that mothers accumulate copper in the liver but also in the mammary gland. however, a recent study showed that the copper level in breast milk was normal in 18 wilsonian patients treated with d-penicillamine, trientine salts or zinc salts, suggesting that breastfeeding is possible in these patients without risk to the development of the infants.the problem of breastfeeding newborns for patients with wilson's disease is therefore associated with a risk of copper deficiency in the newborn due to insufficiently rich breast milk in copper due to drugs. in addition, the passage into breast milk of treatments is not sufficiently known. these factors make breastfeeding not currently recommended for wilsonian mothers,however, many patients wish to breastfeed and some of them breastfeed their newborns despite the risk of breastfeeding


Eligibility criteria:
criteria for inclusion : * patient aged 18 years or over. * wilson's disease fulfilling the criteria for the leipzig score * pregnancy in progress whatever the term. * express consent to participate in the study. * affiliate or beneficiary of a social security system. criteria for non-inclusion : * liver transplant patient * no affiliation to social security system * vuinability to give free and informed consent * patient benefiting from a legal protection measure
predicting meniscal tears outcomes after physical therapy treatment

Conditions: Meniscus Tear

Summary: the aim of this multicenter non-controlled study is to develop a multivariable prediction model of pain/disability improvements in patients with meniscal tears, after a physical therapy treatment based on therapeutic exercise and education.

a multivariable prediction model for the improvement in shoulder pain and disability will be developed based on the following predictors: * body mass index \[kg/m2, fractional polynomials fp2\]. * smoking \[years, linear relationship\]. * employment status \[3 categories\]. * maximum education degree \[4 categories\]. * previous performance of physical exercise \[2 categories\]. * baseline disability (measured with the knee injury and ostoarthritis outcome score) \[fractional polynomials fp2\]. * baseline pain intensity (measured with a numeric pain rating scale) \[fractional polynomials fp2\]. * pain duration \[weeks, linear relationship\] * pain catastrophizing (measured with the pain catastrophizing scale) \[linear relationship\]. * patient's expectations (measured with the musculoskeletal outcomes data evaluation and management system) \[linear relationship\].

Eligibility criteria:
inclusion criteria: * degenerative meniscal tears (medial and/or lateral), diagnosed by magnetic resonance imaging. * traumatic meniscal tears (medial and/or lateral), diagnosed by magnetic resonance imaging, originated 6 months ago or more. * pain intensity equal or greater to 3 points in a numeric pain rating scale, or a degree of disability in the koos questionnaire greater or equal to 15%. * pain lasting 3 months ore more. * adequate comprehension of written and spoken spanish exclusion criteria: * knee ligament injuries at the moment of recruitment. * presence of hip or ankle pathology that makes it impossible to peform knee therapeutic exercises. * history of fracture in the lower limb within the last year. * history of surgery in the lower lim within the last year. * presence of cancer, fibromyalgia, neurological and/or other systemic diseases. * cognitive impairment that makes it impossible to perform therapeutic exercise.

Keywords: physical therapy therapeutic resistance exercise education prediction model
online pilates in individuals with chronic low back pain

Conditions: Low Back Pain; Chronic Pain

Summary: the purpose of this study is to evaluate the effects of the pilates method, performed online, in individuals with chronic low back pain. this is a randomized controlled trial consisting of two arms.

low back pain is one of the main causes of disability in the world, and physical inactivity is associated with its development. in this sense, pilates can be used both in the treatment and preventively for this symptomatology. thus, the aim of this study is to evaluate the effects of the pilates method, performed online, in individuals with chronic low back pain. this is a randomized controlled trial involving men and women between 18 and 60 years of age with a history of non-specific chronic low back pain and a minimum pain intensity equal to 3 points on the numeric pain scale. research participants will perform a pre-intervention (ev1) and post-intervention (ev2) assessment, both online. pain sensation, functional performance, kinesiophobia and perception of global change will be the outcomes evaluated through the following instruments: numerical pain scale, roland morris questionnaire, tampa scale for kinesiophobia and patient global impression of change scale. participants included in the study will be randomized into two groups with separate interventions, both lasting eight weeks: online pilates group and control group. the control group will receive information about self-management of low back pain, pain education, and changes in lifestyle habits; the pilates group, besides having access to the same information as the control group, will undergo 16 pilates sessions performed online (2 times/week). the statistical analysis will be done through the independent t test and the mann-whitney test to investigate the differences between the groups (pilates online x control), while the paired t test and the wilcoxon test will be applied to evaluate the effect of the time variable (pre x post), considering a significance level of 5%.

Eligibility criteria:
inclusion criteria: * men and women with a history of chronic nonspecific low back pain (for more than 12 weeks) and minimum pain intensity of 3 on numerical pain rating scale. exclusion criteria: * symptoms related to serious pathologies (such as fever, changes in sensibility, weight loss, constant pain); * recent history of spinal fracture, cancer, inflammatory diseases, nerve root involvement, spinal pathologies (such as ankylosing spondylitis, herniated disc with radiculopathy, advanced osteoporosis, spondylolysis, spondylolisthesis); * central neurological diseases (such as parkinson's and stroke), psychiatric (such as depression or schizophrenia); * autoimmune diseases; * orthopedic surgery in the last year; * severe cardiovascular diseases; * decompensated metabolic diseases; * pregnancy.

Keywords: low back pain exercise movement techniques exercise chronic pain telerehabilitation
ttvr early feasibility study

Conditions: Tricuspid Regurgitation

Summary: the objective of this early feasibility study is to gain early clinical insight into the performance of the intrepid transcatheter tricuspid valve replacement (ttvr) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

multi-center, prospective, non-randomized, investigational, and pre-market.

Eligibility criteria:
inclusion criteria: * heart team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement * subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local heart team * subjects with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the echocardiography core lab assessment of a qualifying transthoracic echocardiogram (tte) and transesophageal echocardiogram (tee) * new york heart association (nyha) function class ii or greater * subject anatomically suitable for the intrepid ttvr delivery system including transfemoral access * subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits * subject meets the legal minimum age to provide informed consent based on local regulatory requirements exclusion criteria: * estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions * anatomic contraindications for intrepid™ ttvr (e.g., annular dimensions) * evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus * implanted with venous stents (iliac and/or femoral) or inferior vena cava (ivc) filter or congenital abnormalities of the ivc that would preclude ability for transfemoral access of delivery system * echocardiographic evidence of severe right ventricular dysfunction * left ventricular ejection fraction (lvef) \<30 as measured by resting echocardiogram within 30 days of the index procedure * need for emergent or urgent surgery * untreated clinically significant coronary artery disease requiring revascularization * carcinoid tricuspid regurgitation
study of survival duration for donor skin cells in skin biopsy wounds

Conditions: Normal Female Volunteers

Summary: the goal for this study is to examine the persistence of growth arrested,allogeneic,male-donor keratinocytes and fibroblasts when applied as product hp802-247 to the surface of acute excisional wounds in health female volunteers, as measured using y-str for detection of y-chromosome.


Eligibility criteria:
inclusion criteria: * provide written informed consent. * female, 18 years of age or older. * any race or skin type, provided that there are no tattoos within 5 cm of the wound target, and the gentian violet surgical marker produces a clearly visible mark on the skin. * willing to make all required study visits and, in the opinion of the investigator, able to follow instructions. * willing to undergo the repeated biopsy procedures. * willing to undergo verification of sex chromosome status. exclusion criteria: * males, or phenotypic females bearing y-chromosome genetic material \[e.g., 46,x,(r)y; 46,x,der(x)t(x;y); sex reassignment surgery\]. * contraindications or hypersensitivity to the use of the study medications or their components (e.g., history of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, or amphotericin b). * history of keloid formation or hypertrophic scarring. * participation in any interventional clinical trial within 30 days prior to screening. * history of prolonged bleeding, bleeding into joints, easy bruising following minor trauma, clotting factor deficiency, or current use of anticoagulants or platelet inhibitors. * any medical condition which, in the opinion of the co-investigator, may interfere with normal wound repair. * current therapy with drugs or biologics intended to function as immuno-suppressants, chronic (\> 10 days) oral corticosteroids, or any concomitant medication which, in the opinion of the co-investigator, may interfere with normal wound repair.
high intensity interval training in pcos

Conditions: Polycystic Ovary Syndrome

Summary: study objective is to determine the effect of high intensity interval training on psychological wellbeing, anthropometrics and quality of life in females with polycystic ovarian syndrome


Eligibility criteria:
inclusion criteria: * females 18 to 45 years of age * diagnosed with pcos based on rotterdam criteria * ferriman and gallway score of \>8 for hirsutism exclusion criteria: * use of hormonal contraceptives or iuds for contraception * taking metformin \<3 months prior to the inclusion * breast feeding mothers * type i or ii dm * hypo/hyperthyroidism * regular high-intensity endurance or strength training (defined as ≥ 2 sessions of vigorous exercise per week), physical ailments/injuries that limited exercise performance.
progress of mild alzheimer's disease in participants on solanezumab versus placebo

Conditions: Alzheimer's Disease

Summary: to test the idea that solanezumab will slow the cognitive decline of alzheimer's disease (ad) as compared with placebo in participants with mild ad.


Eligibility criteria:
inclusion criteria: * meets national institute of neurological and communicative disorders and stroke/alzheimer's disease and related disorders association (nincds/adrda) criteria for probable ad * has a modified hachinski ischemia scale score of less than or equal to 4 * has a mini-mental state examination (mmse) score of 20 through 26 at screening visit * has a geriatric depression scale score of less than or equal to 6 (on the staff-administered short form) * has had a magnetic resonance imaging (mri) or computerized tomography (ct) scan performed within the past 2 years that has confirmed no findings inconsistent with a diagnosis of ad * has a florbetapir positron emission tomography (pet) scan or cerebrospinal fluid (csf) result consistent with the presence of amyloid pathology at screening exclusion criteria: * does not have a reliable caregiver who is in frequent contact with the participant (defined as at least 10 hours per week), will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications * meets national institute of neurological disorders and stroke/association internationale pour la recherche et l'enseignement en neurosciences (ninds/airen) criteria for vascular dementia * has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than ad), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study; or has a life expectancy of \<2 years * has had a history within the last 5 years of a serious infectious disease affecting the brain or head trauma resulting in protracted loss of consciousness * has a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen posttreatment * has a known history of human immunodeficiency virus (hiv), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions * has received acetylcholinesterase inhibitor (acheis), memantine and/or other ad therapy for less than 4 months or has less than 2 months of stable therapy on these treatments * has received medications that affect the central nervous system (cns), except treatments for ad, for less than 4 weeks * has a history of chronic alcohol or drug abuse/dependence within the past 5 years * has a visit 1 mri with results showing \>4 amyloid-related imaging abnormality (aria), -hemorrhage /hemosiderin deposition (aria-h) or presence of aria-e (edema/effusions)
esomeprazole to reduce organ failure in sepsis

Conditions: Sepsis; Septic Shock

Summary: sepsis is a severe disease with a high mortality rate and lack of efficacious therapies. proton pump inhibitors (ppi) are drugs widely used to inhibit acid secretion by gastric cells and with a high safety profile. carta and rubartelli (irccs san martino - genova) have recently reported that ppi, such as esomeprazole, inhibit tnf-alfa and il-1ß secretion. moreover, they showed that a single administration of ppi protects mice from endotoxic shock with no adverse effects. ppi-sepsis is a randomized, double blind, controlled against placebo clinical trial to test if high-doses esomeprazole in septic patients reduces the severity of organs failure. in parallel, the investigators will evaluate ex vivo in monocytes from septic patients: redox state and response to inflammatory stimuli; atp release; metabolic changes and ph; cytokine production; the effects of ppi on these parameters.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * admitted to intensive care unit or emergency department * sepsis or septic shock * able to express informed consent. for unconscious patients, current laws will be applied as requested by ethical committee. exclusion criteria * able to express informed consent and deny it * known allergy or intolerance to study drug * little chance of survival, as defined by a saps ii score more than 65 point * concomitant acquired immunodeficiency syndrome * on immunosuppressant or long-term corticosteroid therapy * receiving lifesaving drugs known to have a strong interference with esomeprazole * sepsis or septic shock since over 36 hours * severe hepatic dysfunction * pregnant or breastfeeding

Keywords: proton pump inhibitor esomeprazole sepsis septic shock organ failure sofa mortality
factors associated with the acne severity among transmen population: a cross-sectional study

Conditions: Acne; Transgenderism

Summary: the goal of this observational cross-sectional study is to identify factors associated with severity of acne in thai transmen receiving masculinizing hormone therapy. the main questions it aims to answer are: * what are the factors associated with severity of acne in transmen? * does masculinizing hormone therapy associate with the severity of acne in transmen? participants will be asked to complete an online questionnaire and allow to take pictures of their face for acne assessment purpose.


Eligibility criteria:
inclusion criteria: * transmen who visited the gender variation (genv) clinic of ramathibodi hospital * transmen who received masculinizing hormone therapy (testosterone) * transmen who completed an online questionnaire and intentional submit their facial photographs exclusion criteria: * refusal to participate * incomplete questionnaire * missing photos * diagnosis of any disorders of sexual differentiation which may have peculiar hormonal effect

Keywords: diet, female-to-male transgender, masculinizing hormone therapy, risk factors