Kornimate/medical-research-clean huggingface dataset:
wound infections following implant removal

Conditions: Surgical Wound Infection

Summary: in the netherlands about 18,000 surgical procedures with implant removal are annually performed after fracture healing, of which 30-80% concern the foot, ankle and lower leg region. for clean surgical procedures, the rate of postoperative wound infections (powis) should be less than 5%. however, rates of 10-12% following implant removal, specifically after foot, ankle and lower leg fractures are reported. currently, surgeons decide individually if antibiotics prophylaxis is given, since no guideline exists. this leads to undesirable practice variation. therefore, the investigators propose a double-blind randomized controlled trial (rct) in patients scheduled for implant removal following a foot, ankle or lower leg fracture, to assess the (cost-)effectiveness of a single gift of antibiotic prophylaxis. primary outcome is a powi within 30 days after implant removal. secondary outcomes are quality of life, functional outcome at 30 days and 6 months after implant removal and costs. with 2 x 250 patients a decrease in powi from 10% to 3.3% (expected rate in clean-contaminated elective orthopedic trauma procedures) can be detected (power=80%, 2-sided alpha=5%, including 15% lost to follow up). if the assumption of the investigators, that prophylactic antibiotics prior to implant removal reduces the infectious complication rate, is confirmed by this rct, this will offer a strong argument to adopt a single gift of antibiotic prophylaxis as standard practice of care. this will reduce the incidence of powis and consequently will lead to less physical and social disabilities and health care use. in addition, it will decrease the rate of use of empiric broad-spectrum antibiotics (and antibiotic resistance) prescribed upon suspicion or diagnosis of a powi. a preliminary, conservative estimation suggests yearly cost savings in the netherlands of €3.5 million per year.

see study protocol

Eligibility criteria:
inclusion criteria: * patients ≥18 years and ≤75 years of all ethnic backgrounds * implant removal following foot, ankle and/or lower leg surgery exclusion criteria: * removing and re-implanting osteosynthesis material in the same session * active wound infection or (plate) fistula * antibiotic treatment at time of elective implant removal for a concomitant disease or infection * a medical history of an allergic reaction to a cephalosporin, penicillin, or any other β-lactam antibiotic. * insufficient comprehension of the dutch language to understand the patient information to make an informed decision to participate. * kidney disease (egfr \<60 ml/min/1.73m\^2). * treatment with probenecide, anticoagulants (see spc) * pregnancy and lactation

Keywords: implant removal antibiotic prophylaxis postoperative wound infection orthopedics
the effects of nitrate, caffeine, and cold exposure on cardiovascular function.

Conditions: Nitrate; Caffeine; Cold Exposure

Summary: dietary inorganic nitrate supplementation may have positive implications on cardiovascular function. the aim of this project is to determine if nitrate supplementation can attenuate the effects that caffeine and cold exposure have on the cardiovascular system.

acute caffeine consumption and cold exposure elicit negative effects on the cardiovascular system. humans are regularly exposed to such conditions of increased cardiovascular strain, which may lead to elevated chronic cardiovascular risk. on the other hand, dietary inorganic nitrate supplementation is well established to improve cardiovascular function in healthy individuals. thus, acute nitrate supplementation may compensate for the negative effects that caffeine and the cold place on the cardiovascular system. these effects will be measured using peripheral blood pressure, pulse wave analysis, heart rate variability, forearm blood flow, flow mediated dilation, and blood and saliva markers.

Eligibility criteria:
inclusion criteria: * blood pressure \< 130 mmhg systolic and \< 85 mmhg diastolic. bmi between 18.5 and 29.9 kg/m2. females must be naturally menstruating (regular length cycle and menses) or using a form of combined hormonal contraception (for at least 6 months). exclusion criteria: * existing cardiovascular or metabolic conditions. experience any adverse reactions to experimental procedures or supplements. allergies to supplements or breakfast items. involved in any other studies. blood pressure \> 130 mmhg systolic and \> 85 mmhg diastolic.

Keywords: cardiovascular function flow mediated dilation
evaluation of stendo pulsating suit on microcirculation and central blood pressure in essential hypertension patients

Conditions: Essential Hypertension

Summary: the action of one stendo pulsating suit session will be evaluated on 24 patients referred to the hypertension consultations for essential hypertension treated but not stabilized. the effect of one stendo pulsating suit session system will be mainly assessed on the peripheral cutaneous microcirculation and on the central arterial pressure.

the role of the endothelium in micro-vascular system is mediated by synthesis and release of numerous substances that act on the smooth muscle fibres. the release of these products is modulated, in turn, by various circulating molecules, by the autonomic nervous system and by local mechanical factors such as shear stress. the essential hypertension is associated to increased risks of cardiovascular and stroke morbidity and mortality and constitutes a major cause of severe kidney failure. the essential hypertension is a complex and multi-factorial disease; the dysfunction of the endothelium is of a great importance in the physiopathology of this disease, concerning both the consequences of the increase of the blood pressure and the possible cause of the hypertension development. the stendo pulsating suit is expected to increase the cutaneous microcirculation measured by laser doppler laser flowmetry and potentially to decrease the central blood pressure. each patient will be his own witness and the clinical records will be assessed before, during when relevant, and after a pulsating suit session.

Eligibility criteria:
inclusion criteria: * patient referred to the hypertension hospital consultation for essential hypertension treated but not stabilized * patient with essential hypertension defined by a brachial arterial pressure of 140 ≤ systolic arterial pressure \< 180 mm hg and/or 90 ≤ diastolic arterial - pressure \< 110 mm hg * essential hypertension confirmed by an ambulatory measure of the arterial pressure during 24 hours before the pre-inclusion visit * patients aged more than 40 and less than 70 exclusion criteria: * patient with secondary hypertension * patient with diabetes * patient with complete arrhythmia with atrial fibrillation * patient with an advanced obstructive arterial disease * patient with a recent and progressive deep venous thrombosis

Keywords: essential hypertension central blood pressure microcirculation endothelium stimulation
immunogenicity and safety of a quadrivalent human papillomavirus (hpv) vaccine in patients with sle: a controlled study

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this trial is to study the effect of human papillomavirus (hpv) vaccination on the elevation of antibody titer to 4 serotypes of hpv in patients with systemic lupus erythematous and compare the antibody response with an equal number of age-matched healthy women.

genital infection with human papillomavirus (hpv) is one of the most common sexually transmitted infections in hong kong. most cases of hpv infection are asymptomatic. however, in some individuals, especially those patients who are immunocompromised, hpv infection is persistent and may result in genital warts, cervical smear abnormalities, cervical intraepithelial neoplasia (cin) and rarely cervical cancer. systemic lupus erythematosus (sle) is a disease that predominantly affects women of the childbearing age. patients with sle are at risk of persistent hpv infection. this is because of the immunosuppressive state induced by various treatments. the prevalence of abnormal pap smears and cervical squamous intraepithelial neoplasia (cin) in sle patients is higher than that in age-matched healthy women. thus, prevention of hpv infection is important in patients with sle to reduce the incidence of cin lesions and hence invasive cervical cancers in the long run. the quadrivalent hpv vaccine, gardasil is effective in reducing the occurrence of high-grade cin lesions and anogenital disease elated to hpv-16 and hpv-18 infection. vaccination of young women aged 16 to 23 years resulted in seroconversion rates of more than 99% for all the hpv types (6,11,16,18) and was well tolerated. there has been very little information regarding the efficacy of the quadrivalent hpv vaccine in immunocompromised hosts. the objectives of the current study are to evaluate the immunogenicity and safety of the quadrivalent hpv vaccine in a group of patients with sle in terms of antibody conversion. comparison will be made with an equal number of age-matched healthy women.

Eligibility criteria:
inclusion criteria: sle patients * female patients aged ≤ 35 years * fulfilling the american college of rheumatology (acr) criteria for the classification of sle * having received a stable dose of prednisolone and/or other immunosuppressive agents within 3 months of study entry * able to give written informed consent controls * women aged ≤ 35 years, matched those of sle patients recruited * no known chronic medical diseases * not receiving any long-term medications including herbs exclusion criteria: * history of allergy to hpv vaccines

Keywords: human papillomavirus vaccine lupus
emergency room firearm and medication safety intervention

Conditions: Suicide; Firearm Injury; Overdose

Summary: seventeen united states veterans die by suicide each day. nearly three-fourths of those veterans die from firearm injury or poisoning, and many seek care in va emergency departments (ed) prior to suicide attempts. in 2019, the va began screening all veterans seeking ed care for increased suicide risk. interventions that promote firearm and medication safety are recommended for veterans identified as at-risk. the investigators work will provide important information that will aid the development and testing of such an intervention for veterans who seek care in va eds. the investigators will interview at-risk veterans who recently sought va ed care to identify factors relevant to developing the intervention, and work with veterans and va healthcare staff to develop and test an intervention.

veterans will be recruited from the rocky mountain regional va medical center (rmrvamc) ed who are identified as having elevated suicide risk by vha's new suicide risk screening initiative. all veterans visiting vha eds are screened using an eight-item version of the columbia suicide severity rating scale (c-ssrs) screener, a valid predictor of future suicidal behavior. the c-ssrs screener assesses suicide risk using eight items about recent suicidal ideation and intent, preparatory behaviors, and action. deductive and inductive content analysis of qualitative interviews will occur in parallel with recruitment, and participants will be recruited until thematic saturation is achieved. veterans' visits (approx. 90 minutes) will be scheduled at their preferred times at rmrvamc within two weeks of discharge from the ed. sociodemographic and military service data will be collected using the rocky mountain mental illness research, education, and clinical center (mirecc) demographics survey. during this visit, individuals will participate in qualitative interviews to identify contextual factors that may inform development of va-based lethal means safety interventions.

Eligibility criteria:
inclusion criteria: * veteran * recent emergency room care * screen positive for elevated suicide risk exclusion criteria: * severe cognitive impairment * lack decisional capacity * unable to provide informed consent * lack reliable phone access * admitted to the hospital

Keywords: suicide
visual outcomes after bilateral surgical cataract phacoemulsification: acrysof toric iol implantation compared to monofocal iol implantation

Conditions: Cataract

Summary: the objectives of this study are to assess and compare bilateral uncorrected distance visual acuity and distance spectacle independence post bilateral implantation of acrysof toric intraocular lenses (iols) and monofocal iols. secondary outcomes will include cost of eyeglass purchased and patient vision-related quality of life.


Eligibility criteria:
inclusion criteria: * are willing and able to understand and sign an informed consent; * are willing and able to attend postoperative examinations per protocol schedule; * are ≥ 21 years of age, of either gender and any race; * have bilateral, age related, cataracts; * have planned cataract removal via phacoemulsification with implantation of an intraocular lens (iol); * are available to undergo second eye surgery within 6 weeks of the first eye surgery; * are in good ocular health, with the exception of cataracts; * are free of disease(s)/condition(s) listed in the "precautions" section of the acrysof toric and monofocal package inserts: choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, extremely shallow anterior chamber, medically uncontrolled glaucoma, microphthalmos, non-age-related cataract, proliferative diabetic retinopathy (severe), severe corneal dystrophy, severe optic nerve atrophy, irregular corneal astigmatism and color vision deficiencies. * have regular corneal astigmatism; * qualify for bilateral acrysof toric iols on the acrysof toric calculator (www.acrysoftoriccalculator.com) * are able to obtain pupil dilation ≥ 5.0 mm * are able to read and understand one of the following languages: dutch, french, german exclusion criteria: * previous corneal surgery and/or reshaping * abnormality, disease and/or conditions of the cornea (i.e. keratoconus, corneal dystrophy, keratitis, corneal scar, etc.), which would clinically contra-indicate the implantation of a toric intraocular lens * planned multiple procedures during cataract/iol implantation surgery * planned limbal relaxing incision (lri), excimer laser treatment or similar procedure prior to or during the course of the study * an ocular disease and/or condition that may compromise visual acuity levels (i.e. glaucoma, diabetic retinopathy, amblyopia, etc.) * pregnant, lactating or planning pregnancy during course of study. subjects who become pregnant during the study will not be discontinued; however, data may be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results. data will be collected on the crf as observations.

Keywords: intraocular lens toric
what is the prevalence of female pelvic floor disorders in minnesota?

Conditions: Prolapse; Urinary Incontinence; Fecal Incontinence; Bladder Pain Syndrome

Summary: to determine the prevalence of pelvic organ prolapse and urinary incontinence among women in minnesota using a short web-based self-administered questionnaire.

the study will be administered at the 2018 minnesota state fair at the driven to discover building. the study will be administered entirely for research purposes. all data will be self-reported (see attached survey). data collection will be through a web-based version of the epiq loaded into research electronic data capture redcap, a secure web-based system for data collection. data collection will occur over 6 half day sessions at the university of minnesota d2d building at the minnesota state fair grounds while the fair is running.

Eligibility criteria:
inclusion criteria: * women who are age 18 or older on the date they take the survey who are willing to take the survey. pregnant women may participate in the survey. exclusion criteria: * inability to provide consent to take the survey, and inability to speak and understand english.
ruxolitinib cream in participants with facial and/or neck atopic dermatitis involvement

Conditions: Atopic Dermatitis

Summary: this is a randomized, double blind, vehicle controlled phase 2 study with a 4-week open label extension in adolescent and adult participants with atopic dermatitis and head and/or neck involvement. it is intended to compare the efficacy and safety of ruxolitinib cream 1.5% bid versus vehicle cream, then further evaluate ruxolitinib cream as maintenance during the open label extension period.


Eligibility criteria:
inclusion criteria: * participants with diagnosis of ad for at least 6 months. * participants with an overall and a face and/or neck iga score of 2 or 3 at screening and baseline. * participants with ad affecting the following at screening and baseline: 1. ≥ 0.5% of the total bsa on the face and/or neck 2. up to a total of 20% bsa (face and/or neck plus other body areas) * willingness to avoid pregnancy or fathering children based on the criteria outlined in the protocol. * further inclusion criteria apply. exclusion criteria: * participants who have an unstable course of ad (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to baseline. * participants with concurrent conditions and history of other diseases such as immunocompromised; chronic or acute infection requiring systemic treatments; active acute skin infection; other concomitant skin conditions that may interfere with the evaluation of ad or compromise participant safety; other types of eczema; chronic asthma requiring high dose of inhaled corticosteroids. * any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. * previous treatment with systemic or topical jak inhibitors (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib). * participants who are pregnant (or who are considering pregnancy) or lactating. * laboratory values outside of the protocol -defined criteria * further exclusion criteria apply.

Keywords: atopic dermatitis adolescent adults in-home telemedicine
the duration of humoral immunity and the memory cell function after vaccination with 7-valent pneumococcal conjugate vaccine in cll

Conditions: Chronic Lymphocytic Leukemia (CLL)

Summary: patients with chronic lymphocytic leukemia (cll)have had very poor humoral responses to pneumococcal polysaccharide vaccine (ppv). the vaccine in which pneumococcal polysaccharide antigens are conjugated to protein (pcv) have been immunogenic in cll patients in our previous studies. the purpose of this study is to evaluate the duration of these vaccine-induced antibodies and the function of memory cells by giving a one dose of ppv-vaccine after several years of pcv-vaccination.


Eligibility criteria:
inclusion criteria: * cll patients and controls who have been vaccinated with pcv in our previous study exclusion criteria: * vaccinated with ppv-vaccine within the last 5 years, immunoglobulin substitution, corticosteroid treatment (equivalent of 20mg prednisolone per day)

Keywords: cll ppv pcv
knee injection rct

Conditions: Osteoarthritis

Summary: hypothesis: ketorolac injection is a cost-effective adjunct in the nonoperative treatment of knee osteoarthritis (oa) compared to steroids and viscosupplementation. aims/objectives: the objective of this randomized, controlled, double-blinded, prospective study is to assess the efficacy and cost-effectiveness of knee injection with ketorolac in the nonsurgical management of symptomatic oa compared to injections with corticosteroids and viscosupplements.

the purpose of this research study is to examine the effectiveness of intra-articular (inside the joint) ketorolac injection compared to injection with either corticosteroid or hyaluronic acid for the treatment of painful knee osteoarthritis. patients will be randomly assigned to receive either ketorolac (a nonsteroidal anti-inflammatory drug, methylprednisolone (a steroid), hyaluronic acid (a substance that is naturally present in the human body).

Eligibility criteria:
inclusion criteria: * patients over the age of 18 who present with 1) symptomatic knee oa and radiographic evidence of joint space narrowing and 2) are interested in knee injections for pain relief. exclusion criteria: * prior injections into the same knee within the past 6 months, * pregnant and/or lactating women, * inflammatory joint disease including rheumatoid or psoriatic arthritis, * concurrent use of anti-rheumatic drugs, * allergy or hypersensitivity to the study medications, * patients on an active pain management contract, * patients with insurance that requires pre-certification for any of the study drugs, * inability to make own decisions regarding the informed consent, * inability to read and/or understand english, * patients who are unable to return for follow-up or be reached by phone.

Keywords: osteoarthritis knee injection ketorolac
alternate-day buprenorphine administration. phase i - 3

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to determine if two times a subject's daily maintenance dose will hold for 48 hours without changes in agonist and antagonist effects.


Eligibility criteria:
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amelogenesis imperfecta

Conditions: Amelogenesis Imperfecta

Summary: amelogenesis imperfecta (ai) are a heterogeneous group of rare genetic diseases transmitted according to various mode of inheritance (x-linked, autosomal dominant, autosomal recessive) affecting the formation/mineralization of tooth enamel. these diseases exist in isolation with clinical manifestations limited to the oral cavity or may be associated to other symptoms in syndromes. many different genes (amelx, enam, enamelysin or mmp20, klk4, dlx3, fam83h, fam20a wdr72...) coding for enamel matrix proteins, enamel matrix degrading proteins, proteins involved in hydroxyapatite formation and growth and mineralization processes have been discovered responsible for the clinical phenotypes (hypoplastic, hypomineralized, hypomature) encountered in ai. genes involved in enamel formation but not yet identified in association with any form of ai include: amely, ameloblastin, tuftelin, amelotin, a pin protein, odam (odontogenic ameloblast associated). in this research protocol the investigators explore the phenotype including the enamel ultrastructure and the genotype of a cohort of patients presenting ai.


Eligibility criteria:
inclusion criteria: * patient presenting with ai * new patient or patient already known in the center * child (in his primary dentition) or adult * man or woman * having signed a consent form or accepted to participate to the study * patient affiliated to social security * validation of the inclusion by the principal investigator looking at the patient file exclusion criteria: * patient with acquired enamel defects * patient whose clinical diagnostic is not possible * patient whose clinical file does not contain teeth photos * patient who has not signed a consent form and accepted to participate to the study * patient who is not affiliated to social security. * non validation of the inclusion by the principal investigator looking at the patient file
bicuspid aortic valve stenosis transcatheter aortic valve replacement registry

Conditions: Bicuspid Aortic Valve

Summary: the objective of this study is to evaluate the procedural and clinical outcomes of patients with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.


Eligibility criteria:
inclusion criteria: 1. age≥18 years. 2. severe aortic stenosis with bicuspid anatomy. 3. nyha≥2 and/or syncope and/or angina. 4. patient judged by the heart team as indicated for tavr. exclusion criteria: 1. age \<18 years 2. asymptomatic patients 3. pure aortic regurgitation.