Kornimate/medical-research-clean huggingface dataset:
corynebacterium spp bone and joint infection: retrospective study of microbiological, diagnostic and therapeutic features

Conditions: Corynebacterium Infections

Summary: corynebacterium spp have been considered as innocuous commensals of human skin, but are now accepted as important opportunistic pathogens responsible for various nosocomial infections, especially implicating foreign materials. in particular, they accounted for up to 10% of prosthetic joint infection (pji), and are mostly identified in chronic forms of bone and joint infections (bji). however, little is known about the pathophysiological pathway implicated in corynebacterium bji, species distribution and antimicrobial susceptibility, and the management of these difficult-to-treat clinical entities. this study aims to report a retrospective cohort of patients with corynebacterium spp bji, aiming to : i) describe microbiological characteristics of the implicated clinical isolates, including species identification and antimicrobial susceptibility (and especially according to previous antimicrobial exposure); ii) assess pathophysiological mechanisms associated with bji chronicity, including biofilm formation and bone cell invasion, to better understand mechanisms of corynebacterium spp and to evaluate their ability to distinguished colonizing and infective isolates; iii) describe the medical (nature and duration of antimicrobial therapy) and surgical management of these patients; and iv) evaluate the patient outcome according to this management strategy, and highlight risk factor for treatment failure in order to improve patient's management.


Eligibility criteria:
inclusion criteria: * adult patients (i.e age ≥ 18-year-old) with microbiologically proven corynebacterium bone and joint infection, with or without implant exclusion criteria: * diabetic foot osteomyelitis * pressure ulcer-associated osteomyelitis

Keywords: antimicrobial susceptibility biofilm formation bone and joint infection corynebacterium spp osteoblast outcome prosthetic joint infection
ultrasound (us) measurement of sarcopenia in the elder subject

Conditions: Sarcopenia

Summary: sarcopenia is a generalized, progressive and multifactorial muscle impairment, causing multiple pathologies and their consequences such as falls, fractures, dependence, worsening of cognitive disorders and death. interventions to combat the progression of sarcopenia should be introduced as soon as clinically suspected, based on functional tests to measure muscle strength. diagnostic confirmation of sarcopenia can be done using several validated methods of estimating muscle mass: magnetic resonance imaging (mri), computed tomography (ct), biphotonic absorptiometry (dexa) or bio-impedanceometry. their availability in clinical routine remains limited due to their high costs and/or lack of accessibility depending on the place of practice. on the other hand, there are certain pitfalls for carrying out these various examinations, in connection with several common clinical problems in the study population: mobility disorders and neurodegenerative disorders disabling for transport and access to the examination table for imaging examinations, hydration disorders distorting measures for bio-impedancetry. previous studies suggest that ultrasound may be as effective a tool as previous methods for diagnostic confirmation of sarcopenia. because of its non-invasive and non-irradiating nature, its affordability, its short duration of realization, its availability and its low constraints of realization, the ultrasound could help to remove some of the current limits to the diagnostic confirmation of sarcopenia. the investigators hypothesis is that ultrasound can be used to implement a simple and reliable protocol for assessing sarcopenia in the elderly. it could also be used to detect sarcopenia at an early stage ("presarcopenia") while the decrease in muscle mass is not yet accompanied by a decrease in skeletal muscle strength.


Eligibility criteria:
inclusion criteria: * age 75 or older * sarc-f \> 4 * decrease in muscle strength: grip strength \<27 kg for men and \<16 kg for women; and/or chair stand test \< 15 seconds * patient affiliated or beneficiary of a social security plan * patient who has signed informed consent beforehand exclusion criteria: * neurocognitive disorder preventing the expression of informed consent * lack of a measurement site (muscle resection or amputation) * impossibility or contraindication to strict dorsal and/or ventral decubitus * any associated neuromuscular pathology that may alter muscle composition and trophicity * wearing a pacemaker * any state of water inflation or dehydration * history of surgery on the studied lower limb less than 6 months old * patients protected by law under guardianship or under curate, or unable to participate in a clinical study under article l. 1121-16 of the french code of public health
asthma, smoking, emotional deficits

Conditions: Asthma; Emotional Disorder; Alexithymia

Summary: the objective of the study is to determine whether poor control of asthma is related to an emotional deficit such as alexithymia. the hypothesis is that there is a correlation between the severity of asthma, its control, and the degree of emotional deficits.


Eligibility criteria:
inclusion criteria: * men and women (\> 18 years). * asthma (mild, moderate, severe). * beneficiary of social security exclusion criteria: * pregnant women * patients who oppose their participation in the study * multiple drug users (psychoactive substances). * patients with severe psychiatric antecedents and comorbidities. * patients with cancer * patients with cognitive impairment * patients with speech, hearing, visual, and praxic disorders. * any chronic and especially respiratory pathology other than asthma (copd, bronchiectasis), which can alter the study. * patients not speaking french * persons protected by law
investigation of the effect of degarelix in terms of prostate volume reduction in prostate cancer patients

Conditions: Prostate Cancer

Summary: this was a phase 3b clinical study in prostate cancer patients which aimed to compare the current standard therapy of a gonadotrophin releasing hormone (gnrh) agonist, goserelin (3.6 mg; plus anti-androgen flare protection, bicalutamide), to a novel gnrh antagonist, degarelix (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in prostate volume. the hypothesis was that degarelix could decrease prostate size at least as effectively as the combination of a gnrh agonist with an anti-androgen for flare protection.


Eligibility criteria:
inclusion criteria: 1. patient has given written informed consent 2. patient is 18 years or older 3. patient has histologically confirmed prostate cancer 4. patient has a serum prostate-specific antigen (psa) level at screening \>2 ng/ml 5. the prostate size is \>30 cubic centimetres (cc), measured by trus 6. patient has had a bone-scan within 12 weeks before inclusion 7. patient must be able to undergo transrectal examinations 8. patient has an estimated life expectancy of at least 12 months exclusion criteria: 1. any previous treatments for prostate cancer 2. previous trans-urethral resection of the prostate (turp) 3. is not considered a candidate for medical castration 4. use of urethral catheter 5. is currently treated with a 5-alpha reductase inhibitor 6. is currently treated with an alpha-adrenoceptor antagonist 7. treatment with botulinum toxin a (botox) 8. require radiotherapy during the trial 9. history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema 10. hypersensitivity towards any component of the investigational products or excipients 11. previous history or presence of another malignancy 12. a clinically significant disorder 13. a corrected qt interval over 450 msec 14. mental incapacity or language barrier precluding adequate understanding or co-operation 15. receipt of an investigational drug within the last 28 days proceeding screening 16. previous participation in any degarelix trial
hepatitis b patients under oral nucleos(t)ide treatment with intermittent assessment of kidney function

Conditions: Hepatitis B, Chronic

Summary: patients with chronic hepatitis b who are under oral antiviral treatment for at least 6 months at study start will be monitored once yearly for kidney function changes within their routine outpatient visit. therefore urine samples will be collected and some additional blood test will be done within the routine blood sampling.

this non-interventional, long-term observational cohort study will evaluate demographic, clinical, biochemical and virological parameters of outpatients with chronic hepatitis b who are under oral antiviral treatment with an approved nucleos(t)ide for \> 6 months at study inclusion. during their routine outpatient visits annually an assessment of their kidney function especially for a proximal tubular dysfunction will be performed and their comedication will be explored. patients included in the study are followed up for 5 years.

Eligibility criteria:
inclusion criteria: * chronic hepatitis b virus infection * indication for an antiviral treatment due to the recent german hepatitis b guidelines and oral intake of an approved nucleos(t)ide for a minimum of 6 months at inclusion * alt \< 2 x unl (upper normal limit) at study inclusion * age 18 - 89 years * signed informed consent form exclusion criteria: * coinfection with hepatitis d virus (hdv), hepatitis c virus (hcv) or human immunodeficiency virus (hiv) * comorbidities that will hinder the study performance (e.g. malignancies, relevant psychiatric disorder) * hepatocellular carcinoma or hepatic metastases * legally incapacitated patients
cohort multiple randomized controlled trials open-label of immune modulatory drugs and other treatments in covid-19 patients - sarilumab trial - corimuno-19 - sari

Conditions: Corona Virus Infection

Summary: the overall objective of the study is to determine the therapeutic effect and tolerance of sarilumab in patients with moderate, severe pneumonia or critical pneumonia associated with coronavirus disease 2019 (covid-19). sarilumab is a human igg1 monoclonal antibody that binds specifically to both soluble and membrane-bound il-6rs (sil-6rα and mil-6rα) and has been shown to inhibit il-6-mediated signaling through these receptors. the study has a cohort multiple randomized controlled trials (cmrct) design. randomization will occur prior to offering sarilumab administration to patients enrolled in the corimuno-19 cohort. sarilumab will be administered to consenting adult patients hospitalized with covid-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. patients who will chose not to receive sarilumab will receive standard of care. outcomes of sarilumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.


Eligibility criteria:
inclusion criteria: 1. patients included in the corimuno-19 cohort 2. patients belonging to one of the 2 following groups: * group 1: patients not requiring intensive care unit at admission with moderate and severe pneumopathy according to the oms criteria of severity of covid pneumopathy. moderate cases : cases meeting all of the following criteria: * showing fever and respiratory symptoms with radiological findings of pneumonia. * requiring between 3l/min and 5l/min of oxygen to maintain spo2 \>97% severe cases cases meeting any of the following criteria: * respiratory distress (≧30 breaths/ min); * oxygen saturation≤93% at rest in ambient air; or oxygen saturation ≤97 % with o2 \> 5l/min. * pao2/fio2≦300mmhg * group 2: patients requiring intensive care unit based on criteria of severity of covid pneumopathy. * respiratory failure and requiring mechanical ventilation * no do-not-resuscitate order (dnr order) exclusion criteria: * patients with exclusion criteria to the corimuno-19 cohort. * known hypersensitivity to sarilumab or to any of their excipients. * pregnancy * current documented bacterial infection * patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication: * absolute neutrophil count (anc) ≤ 1.0 x 109/l * haemoglobin level: no limitation * platelets (plt) \< 50 g /l * sgot or sgpt \> 5n
endometrial safety study

Conditions: Postmenopause

Summary: the study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).


Eligibility criteria:
inclusion criteria: * postmenopausal women between 40 and 65 years of age with hormone therapy indication (symptoms and need for treatment) * non-hysterectomized women. exclusion criteria: * usual exclusion criteria for hormone therapy apply.

Keywords: postmenopausal symptoms e.g. hot flushes sweating episodes vaginal dryness
experiences, outcomes and unmet needs of caregivers of children with cerebral palsy

Conditions: Cerebral Palsy Infantile; Caregiver

Summary: cerebral palsy (cp ) is one of the most prevalent motor disabilities in childhood, significantly impacting both children and their caregivers. this study explores the experiences, psychological well-being, and unmet needs of caregivers of children with cp. using an explanatory sequential design (quan → qual), first it will be assessed burden, stress levels, and quality of life of caregivers through standardized questionnaires (pedsql-fim , zbi , pss-14 ).

before the recruitment begins, the principal investigator will present the project to the pediatric service of the arnau de vilanova university hospital of lleida (huav). during medical consultations, the pediatric service will inform eligible participants about the study. if the caregiver agrees to participate, they will give consent for the pediatric service to share their contact details with the research team. the investigators will then contact the participant to explain the project in detail, schedule a first meeting to sign the informed consent, and complete the initial questionnaires. the informed consent will include the first author's contact information so that participants can address any questions or concerns about the study. additionally, participants who sign the informed consent will be asked to provide their contact information for potential follow-up regarding the qualitative interview. in the first meeting, participants who meet the inclusion criteria and have signed the informed consent will be directed to a study homepage hosted on the university's website. this website will provide a link to redcap (research electronic data capture), a secure platform specifically designed for collecting research data (pedsql-fim, zbi, pss-14). participants' sociodemographic data will include descriptive information such as age, sex, household income, among others

Eligibility criteria:
inclusion criteria: * \>18 years old * being a caregiver of a child with cerebral palsy * spanish/catalan speaking * willing to talk about their experiences and be audio/video-recorded. * accept and sign the informed consent form

Keywords: caregivers cerebral palsy mixed-method research quality of life parenting stress
a postmarketing study of plecanatide in breast milk of lactating women treated with trulance®

Conditions: Chronic Idiopathic Constipation

Summary: this is a multi-center, open-label study evaluating pharmacokinetics of trulance® (plecanatide) in breast milk of lactating women treated with trulance

this is an open-label study in lactating women who have been prescribed trulance® by their healthcare provider. the study will assess the pharmacokinetics of plecanatide and its active metabolite in breast milk of lactating women treated therapeutically with trulance. subjects will be screened prior to admission for baseline assessments. following final qualifications, the morning dose of trulance will be administered under supervision from study personnel and serial samples of breast milk will be collected via breast pump.

Eligibility criteria:
inclusion criteria: * females ≥ 18 years of age * has been breastfeeding or actively pumping for at least 4 weeks * has been prescribed trulance by a healthcare provider and has taken it for a minimum of 14 consecutive days before anticipated baseline visit * has the ability to understand and communicate the requirements of the study and is willing to continue breastfeeding or regular pumping in order to maintain milk supply for the duration of the study * weaning must not be underway exclusion criteria: * has clinically significant medical or psychiatric condition (as determined by the medical monitor) other than the medical condition being treated with trulance * has mastitis or other condition that would prevent the collection of milk from one or both breasts. * has participated in an investigational drug study within the 90 days prior to cru admission

Keywords: breast milk lactating
the effects of cerebral collateral circulation on the outcome of leukoaraiosis in high-risk population

Conditions: Leukoaraiosis

Summary: this study observed the relationship between cerebral collateral circulation and the prognosis of leukoaraiosis in high-risk population. cerebral collateral circulation and leukoaraiosis levels will be evaluated and followed up by magnetic resonance examination. the participants' clinical performance caused by leukoaraiosis will be assessed by a series of scales.

1. case collection information is sent daily to clinical trial supervisors. 2. the clinical trial team meets once a week to monitor the quality of clinical trials. 3. the severity of the leukoaraiosis will be evaluated by a scale. the patients whose score is more than 2 will take additional magnetic resonance examination including magnetic resonance angiography (mra) and arterial spin labeling (asl). and their cognitive ability will be evaluated by a series of scales including mini-mental state examination (mmse) and montreal cognitive assessment (moca) and gait by the short physical performance battery (sppb). the blood sample will be taken for biochemical detection and hair and nail samples for trace element detection. 4. data were analyzed by regression analysis.

Eligibility criteria:
inclusion criteria: * physical examinees or out-patients * the mri scale score ≥ 2 exclusion criteria: * history of stroke * history of malignant tumor * history of connective tissue disease * pregnant, trying to become pregnant or within 6 weeks after delivery * serious infections

Keywords: cognitive impairment
blood pressure augmentation in large-vessel occlusion stroke study

Conditions: Ischemic Stroke; Blood Pressure

Summary: an open label, prospective, single center, pilot trial to assess feasibility and tolerability of short term blood pressure augmentation to minimize infarct progression in acute lvo stroke patients undergoing endovascular therapy.

the trial is planned to include 40 subjects with acute lvo stroke who meet the eligibility criteria. in stage 1 of the study, the investigators will monitor beat-to-beat blood pressure and other hemodynamic parameters in 20 patients receiving standard of care therapy. for the second stage, the investigators will enroll an additional 20 patients who will receive blood pressure augmentation therapy using intravenous fluids and phenylephrine or norepinephrine infusion. the investigators will increase baseline systolic blood pressure by 20% to at least 160 mmhg until blood vessel recanalization is achieved or the thrombectomy procedure is completed. the study will assess how quickly a target blood pressure can be reached in the acute stroke setting, and furthermore the ability to successfully maintain these blood pressure targets throughout the intervention and avoid hypotension during conscious sedation or general anesthesia. the primary research hypothesis of the trial is that treatment failure defined as an inability to achieve and maintain blood pressure targets despite the use of maximum tolerable doses of vasopressors (phenylephrine or norepinephrine) occurs in less than 20% of cases. in addition, the study will evaluate the recruitment feasibility and preliminary safety of blood pressure augmentation.

Eligibility criteria:
inclusion criteria: 1. age is ≥18 years 2. patients presenting with anterior circulation acute ischemic stroke 3. enrollment within 24 hours of stroke onset 4. treatment with endovascular thrombectomy 5. arterial occlusion on cta or mra of the ica, m1 or m2 6. mismatch - using ct or mri with a tmax \>6 second delay perfusion volume and either ct-rcbf or dwi infarct core volume. 1. mismatch ratio of greater than 1.8, and 2. absolute mismatch volume of greater than 15 ml, and 3. infarct core lesion volume of less than 70 ml exclusion criteria: 1. baseline sbp\>200 mm hg 2. intracranial hemorrhage (ich) identified by ct or mri 3. inability to access the cerebral vasculature in the opinion of the neurointerventional team 4. contraindication to imaging with mr 5. a history of a left ventricular heart failure (nyha class ≥ iii, or ef \< 50%) or angina (either unstable or ccs grade ii) involving symptoms at rest or with ordinary physical activity 6. acute myocardial infarction in the past 6 months 7. signs or symptoms of acute myocardial infarction, including electrocardiogram find-ings, on admission 8. elevated serum troponin concentration on admission (\>0.1 μg/l) 9. suspicion of aortic dissection on admission 10. participation in any investigational study in the previous 30 days 11. treatment with monoamine oxidase inhibitors (mao-i) within last 7 days

Keywords: induced hypertension blood pressure augmentation large-vessel occlusion thrombectomy endovascular therapy
clinical trial to compare rejointm to sodium hyaluronate injection for knee osteoarthritis cartilage defects

Conditions: Defect of Articular Cartilage; Knee Osteoarthritis

Summary: the purpose of this study is to evaluate the effectiveness of rejointm for the knee osteoarthritis patients with cartilage defects comparing to sodium hyaluronate injection.

this is a randomized, single-blind,phase ii clinical trial. at least 28 subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects will be randomly distributed 1:1 to the treatment group or the control group after signing the icf and screening tests.the treatment will accept rejointm at the first and fourth week,and sodium hyaluronate injection at the second and third week.the control group will accept sodium hyaluronate injection weekly ,and four injections in total.the duration of the therapy is 48 weeks. in addition, external control will be added if necessary.

Eligibility criteria:
inclusion criteria: * 18-70 years old, koa couse ≤ 10 years * kellgren-lawrence ⅰ-ⅲ * vas core \>6， more than 4 months * signed informed consent from the subject * cartilage defect 2-6cm2 exclusion criteria: * pregnancy test positive. * subject infected with hepatitis c, hiv or syphilis. * subject enrolled in any other cell therapy studies within the past 30 days. * subject deemed to be not suitable for the study by the investigator

Keywords: adipose-derived mesenchymal progenitor cells artz