Kornimate/medical-research-clean huggingface dataset:
evaluation of tnf-alpha antagonists (infliximab) withdrawal in sarcoidosis

Conditions: Sarcoidosis

Summary: in severe refractory sarcoidosis not responding to conventional immunosuppressive treatment, the third-line tumor necrosis factor (tnf)-alpha inhibitor infliximab is an alternative. treatment duration is not known, although it has been suggested that relapse rates after withdrawal could be high. we hypothesize that a prolonged course of tnf-alpha would be better for maintaining remission in sarcoidosis. the population consists of histologically-proven adults sarcoidosis patients who were treated with infliximab and are in remission for at least 6 months with less than or equal to 10 milligrams of steroids (prednisone). the present study is a phase 3, prospective, randomized, parallel groups, comparative, open-labelled 2 arms study superiority trial comparing a stop to a remain strategy. patients will be randomized in the 2 groups in a 1:1 ratio.

the screening visit takes place between 60 days and until the baseline visit. the investigator will first check that the patient meets the inclusion criteria and does not present exclusion criteria. before enrolment and randomization, all patients will receive comprehensive information and provide written consent. visit schedule: * baseline visit * follow-up visits in the remain arm: visits will be performed each 4-8 weeks depending on the infliximab interval. in the stop arm, visits will be performed every 8 weeks, and in case of relapse (until m12+/- 2 weeks).

Eligibility criteria:
inclusion criteria: * age superior or equal to 18 years * clinical and radiological presentation consistent with sarcoidosis * presence of non-caseating granulomas in at least one organ * exclusion or other causes of granulomas * infliximab treatment for at least 6 months * steroid dosage \< or equal to 10 mg/day for at least 6 months * no activity of the disease (epost score 0) for at least 6 months * normal ace (angiotensin converting enzyme) and serum calcemia level * signed informed consent * affiliated to the national french social security system * as infliximab is the most used tnf-alpha antagonists, we decided to include only patients treated with infliximab to increase the homogeneity. exclusion criteria: * pregnancy or breast-feeding * positive igra (interferon gamma release assays) test without previous antituberculous antibiotherapy * active infection * patients with moderate to severe heart failure (nyha class iii/ iv) * severe liver function disorders * alcoholism * severe kidney function disorders * pre-existing blood dyscrasias * history of cancer in the 5 years before enrolment (except for cutaneous non melanoma cancers) * concurrent vaccination with live vaccines during therapy * inability to understand information about protocol * adult subject under legal protection or unable ton consent * absence of effective contraceptive method for men and women for duration of the study and 6 months after the end of participation * concomitant participation to another biomedical research (only category 1 trial according to the french law)
comparing maximal and half-maximal suction pressure applied during water exchange in colonoscopy

Conditions: Minimally Sedated Patient Undergoing Colonoscopy

Summary: this prospective, randomize, controlled trial will compared maximal to half-maximal suction pressure applied during water exchange in patients undergoing minimally sedated colonoscopy. we test the hypothesis that maximal suction pressure is more efficient and causes shorter insertion time.


Eligibility criteria:
inclusion criteria: * patients undergoing minimally sedated colonoscopy performed by yhh exclusion criteria: * known history of obstructive lesions of the colon, * allergy to meperidine, * massive ascites, * past history of partial colectomy, or * refusal to provide written informed consent.

Keywords: cecal intubation time water exchange pain
mindfulness for burnout prevention in primary care providers

Conditions: Burnout, Professional

Summary: burnout syndrome is one of the major challenges for health systems worldwide. this study strives to evaluate the feasibility and effectiveness of an 8- versus 2-week mindfulness-based self-care program on burnout symptoms and psychological and biological variables.

the development of stepped-care interventions allows for the development of new strategies within mindfulness-based approaches, classically described as a weekly two-hour commitment which lasts eight weeks. such approaches might reach larger and stratified groups, more suitable for usage in brazilian health-system context. for such evaluations, the investigators will use a 3-arms randomized clinical trial design, with sociodemographic and labor variables, such as age, sex, number of offspring, adherence to the program, adherence to the mindfulness practices, burnout clinical subtype questionnaire -(bcsq-36), maslach burnout inventory (mbi-gs), mindfulness attention awareness scale (maas), freiburg mindfulness inventory adapted for brazil (fmi-br-13), five-facet mindfulness questionnaire (ffmq-br). dna methylation will be measured by methylase-reaction, and bdnf (brain-derived neurotrophic factor) will be quantified by elisa-sandwich. the primary outcome will be the effectiveness of such programs on different clinical subtypes of burnout symptoms (frenetic, under challenged and worn-out). the secondary outcome will be mindfulness levels, and adherence to the program and to the mindfulness practice, and on inflammation and epigenetic variables.

Eligibility criteria:
inclusion criteria: * active primary care providers exclusion criteria: * acute disease (physical or mental) * schizophrenia or other psychotic symptoms * concomitant use of medication causing attentional, cognitive or concentration impairments * having practiced mindfulness or other contemplative techniques in the previous 12 months of the study.

Keywords: mindfulness-based self-care health workers epigenetics
a phase i study of immunotherapy with gsc -loaded dendritic cells in patients with recurrent glioblastoma

Conditions: de Novo Glioblastoma

Summary: mono-center, un-controlled, open label, first in human, clinical trial. approximately 20 patients (in order to achieve 12 valuable patients). the expected accrual time would range between 12 and 18 months. follow-up, including clinical, immune and radiological monitoring will end two years after the initial surgery of the last patient enrolled. the primary objective will be to assess the activity of immunotherapy in terms of its effect on immune response. in particular we will investigate the effect of treatment on effector cells including cd8 t cells, nk cells and natural killer t (nkt) cells. the sample size of 12 eligible patients was identified on ethical and practical considerations, rather than by a formal sample size calculation.


Eligibility criteria:
inclusion criteria: * age ≥18 and ≤70 years; * histological diagnosis of de novo gbm (i.e. not secondary gbm); * gross total resection as evaluated by mri performed within 72 hours from surgery; * karnofsky performance status (kps) ≥60 at the time of first progression; * written informed consent. exclusion criteria: * pregnancy or breast feeding; * participation in other clinical trials with experimental drugs simultaneously; * mandatory treatment with corticosteroids or salicylates in anti-inflammatory dose; * presence of sub-ependymal diffusion of the tumor; * presence of multi-focal gbm lesion; * haematology: leukocytes (wbc) \< 3x103/μl, absolute lymphocyte count\< 0.5x103/μl, absolute neutrophil count (anc) \< 1x103/μl, hemoglobin\< 9 g/dl, platelets\< 50x103/μl within two days prior to leukapheresis; * ast (sgot)/alt (sgpt) ≥3 x institutional upper limit normal (uln) at the time of leukapheresis; * serum creatinine\>1.5 uln or calculated creatinine clearance \< 60 ml/min at time of surgery; * documented immune deficiency; * documented systemic autoimmune disease; * positivity for hbv, hiv, hcv, treponema pallidum; * allergies to any component of the dc vaccine; * other active malignancy.
post-approval study of the treo abdominal stent-graft system

Conditions: Abdominal Aortic Aneurysm

Summary: the purpose of this study is to determine the long-term performance of the treo abdominal stent-graft as a treatment for patients with infrarenal abdominal aortic aneurysms or aorto-iliac aneurysms.

this is a prospective, multi-center, non-randomized, single-arm, post-market, non-interventional study of treatment with the treo abdominal stent-graft in subjects with infrarenal abdominal aortic aneurysms or aorto-iliac aneurysms. the study will include a minimum of 300 subjects treated with the treo abdominal stent-graft at up to 55 investigational sites in the us. the primary objective is the collection of real world safety and effectiveness outcomes of the treo abdominal stent-graft system in an all-comers population eligible for the endovascular treatment of aaa in routine clinical practice, with emphasis on subjects that experience a device stent-strut or barb fracture.

Eligibility criteria:
inclusion criteria: * willing and able to comply with all study procedures and visits. * written informed consent to participate in the study. * patient's aneurysm can be treated with the treo abdominal stent-graft system. * adequate data (medical records/imaging studies) available to analyze the primary endpoints for patients enrolled retrospectively. exclusion criteria: • medical, social or psychological problems that, in the opinion of the investigator, preclude patient from receiving treatment with the treo abdominal stent-graft system.

Keywords: aaa abdominal aortic aneurysm treo evar
multiple sclerosis produces cardiovascular subclinical dysfunction

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms), debilitating disease involving primarily the central nervous system, may cause cardiovascular dysfunction, due to autonomous nervous system dysfunction, physical invalidity, increased oxidative stress, and systemic inflammatory status, but the detailed mechanisms are not elucidated. the investigators aimed to assess left and right ventricular (lv and rv) function, left atrial (la) function, arterial function, and atrial-ventricular-arterial coupling in patients with ms, compared to control subjects. lv systolic and diastolic function and rv function were assessed by 2d- and 3d- echocardiography, tissue doppler, and speckle tracking echocardiography. la function was assessed by la volume index and la strain. arterial remodeling and stiffness were assessed by intima media-thickness, pulse wave velocity, and parameters of wave intensity and endothelial function


Eligibility criteria:
inclusion criteria: 1. age between 18 and 65 years; 2. patients with confirmed ms diagnosis, both newly diagnosed or already under immunomodulatory treatment; 3. informed consent signed. exclusion criteria: 1. ms treated with mitoxantrone; 2. patients with known cardiovascular disease; 3. presence of other neurological conditions; 4. any renal, pulmonary, hepatic or hematological disease; 5. diabetes mellitus; 6. any degree of arterial hypertension; 7. pregnancy; 8. and difficult acoustic window
axonics sacral neuromodulation system registry study

Conditions: Urinary Retention; Urinary Urge Incontinence; Urgency-Frequency; Fecal Incontinence

Summary: to assess the post-market clinical outcomes with use of the axonics sacral neuromodulation system(s).

the study will be a prospective, multi-center, single-arm, post-market registry study. participant outcomes will be compared to their baseline, with participants serving as their own control. the study is expected to complete enrollment in approximately 24 months and follow the patients per protocol for 1 year. the study was conducted at approximately 30 centers in the united states and canada.

Eligibility criteria:
inclusion criteria: 1. patients scheduled to be trialed with the axonics external trial system (ets), or patients scheduled to receive an axonics implantable neurostimulator (ins) or axonics fs implant 2. willing and capable of providing informed consent 3. capable of participating in all testing associated with this clinical investigation exclusion criteria: for all indications: 1. any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints 2. any psychiatric or personality disorder at the discretion of the study physician 3. history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone 4. a female who is breastfeeding 5. a female with a positive urine pregnancy test for oab \& ur: 6. current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture) 7. current symptomatic urinary tract infection (uti) for fi only: 8. rectomucosal prolapse or congenital anorectal malformation

Keywords: overactive bladder, bladder control, bowel control
expediting myasthenia gravis (mg) diagnostic evaluation: a novel, proof-of-concept for undiagnosed, symptomatic patients that uses social media targeting and self-assessment

Conditions: Myasthenia Gravis; Neuromuscular Manifestations; Neuromuscular Diseases

Summary: this is a fully remote, site-less, prospective, observational study enrolling adults in the united states (excluding u.s. territories) with undiagnosed neuromuscular symptoms. the main study objective is to evaluate the feasibility of a social media recruitment campaign tied to a participant reported symptom survey and self-administered physical assessment tool to influence undiagnosed participants to seek care for suspected myasthenia gravis (mg).

participants with undiagnosed neuromuscular symptoms will be targeted via social media paid advertisements to recruit them to our study landing page (weblink: https://bit.ly/unearthrootcause). two assessment tools were developed by the study team: the impact of daily living (idl) survey and the mg exercise assessment. both tools were designed using supporting literature, accepted guidelines, and a rigorous review via a panel of practicing neurologist key opinion leaders experienced in treating mg patients. adult participants who don't have specific diagnosed neurologic conditions will first be screened for eligibility based on the results of the idl survey which will query participants on the presence or absence of habits/symptoms characteristic of mg. those who qualify will complete the mg exercise assessment in which participants are provided video instructions to perform a series of 10 physical tests to examine if specific muscle groups undergo inducible fatigue. the results of the mg exercise assessment are reviewed by a neurologist to determine if participants would benefit further from an in-person neurologist evaluation for mg by a provider. each participant is provided with a report of the neurologist's evaluation. participants will be followed for 1 year through bimonthly communications to determine if and when they followed up with a clinician and if they received a confirmed diagnosis of myasthenia gravis.

Eligibility criteria:
inclusion criteria: * reside within the 50 states of the united states at the time of enrollment * age 19 or older if reside in nebraska or alabama, age 21 or older if reside in mississippi, age 18 years or older if reside in any other state * active email account * fluency in english (spoken / written), as demonstrated by the ability to read and sign the informed consent form exclusion criteria: * live in an overseas territory of the united states * inability or unwillingness to provide written informed consent * diagnosed myasthenia gravis * diagnosed multiple sclerosis * have speech impairment, eye/arm/leg weakness due to diagnosed brain cancer, or stroke

Keywords: social media myasthenia gravis
studies of biomarkers in female lower urinary tract symptoms

Conditions: Disorder of the Lower Urinary Tract

Summary: to determine the sensitivity and specificity of urinary ngf, pge2, il-6, egf or combinations in diagnosing different urodynamic diagnoses.

abstract background/purpose: urodyamic study is an objective method to evaluate female patients with lower urinary tract symptoms (luts). however, this method includes place a urinary catheter, thus prevents it as a routine method to evaluate and follow up patients with luts. therefore, it is necessary to find a simple and objective method to help in evaluating female patients with luts. several kinds of biomarker had been reported in diagnosing patients with overactive bladder; however, the sensitivity remained poor. the aim of this study is to find a useful biomarker, biomarkers, or combinations, with the aid of urodynamic study, to objectively and precisely in evaluating the female patients with luts. patients and methods: we will perform a prospective study to recruit 300 female patients with luts at the outpatient clinic of department of obstetrics and gynecology of national taiwan university hospital and far eastern memorial hospital. all patients will be asked to complete oabss, udi-6 \& iiq-7 questionnaires, voiding diary, 20-min pad test and urodynamic studies. urinary nerve growth factor, prostaglandin e2, interleukin-6 and epidermal growth factor were also measured. besides, we will also recruit 30 female patients without luts in our outpatient clinic, and they will be asked to complete the above questionnaire and examinations except pad test and urodynamic studies. possible results: with the comparison of the above parameters between non-luts and luts patients, we can answer the questions that (1) the mean values of urinary ngf, pge2, il-6, egf in different urodynamic studies, (2) the sensitivity and specificity of urinary ngf, pge2, il-6, egf or combinations in diagnosing different urodynamic diagnoses.

Eligibility criteria:
inclusion criteria: * female patients with lower urinary tract symptoms exclusion criteria: * acute cystitis

Keywords: lower urinary tract symptoms biomarkers urodynamic studies
fractional exhaled nitric oxide (feno) result prediction factors in children with allergic diseases

Conditions: Asthma; Allergic Rhinitis; Atopic Dermatitis

Summary: in about 800 children with allergic diseases (asthma, allergic rhinitis, atopic dermatitis) the investigators will retrospectively and cross-sectionally analyze the influence/correlation of diagnosis, treatment methods, allergy status (skin prick test results), lung function tests results on/with the concentration of nitric oxide in exhaled breath.

in about 800 children with allergic diseases from our outpatient clinic (asthma, allergic rhinitis, atopic dermatitis) we will retrospectively and cross-sectionally analyse the influence/correlation of diagnosis, treatment methods, allergy status (skin prick test results), lung function tests results on/with the concentration of nitric oxide in exhaled breath.

Eligibility criteria:
inclusion criteria: * children with asthma (allergic), and/or allergic rhinitis and/or atopic dermatitis exclusion criteria: * other chronic diseases * asthma exacerbation * pregnancy

Keywords: asthma allergic rhinitis atopic dermatitis children lung function skin prick tests feno
comorbidities of epilepsy

Conditions: Epilepsy

Summary: epilepsy is the second commonest chronic neurological disorder in developed countries, comorbidity refers to the co-occurrence of two conditions with a greater frequency than found in the general population


Eligibility criteria:
inclusion criteria: * patients diagnosed as primary epilepsy either newly diagnosed or on aeds * aged above 18 years old * males and females exclusion criteria: * patients diagnosed as secondary epilepsy (post stroke, trauma, tumor, encephalitis, etc). * patients diagnosed as epilepsy syndrome
calprotectin i serum as a diagnostic marker

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: lower respiratory tract infection is the most common cause of acute exacerbations of chronic obstructive pulmonary disease (aecopd). patients diagnosed with pneumonia in addition to an aecopd experience more severe clinical and laboratory disease manifestations, increase in-hospital morbidity and worse outcome. clinicians have sought for new biomarkers that together with clinical assessments can improve the diagnostic accuracy of pneumonia in patients with aecopd.the aim of the present study is to compare the accuracy of calprotectin with procalcitonin (pct), c-reactive protein (crp) and white blood cell count (wbc).


Eligibility criteria:
inclusion criteria: * clinically confirmed acute exacerbation of chronic obstructive pulmonary disorder (aecopd) * copd diagnosis previously confirmed by spirometry according to the gold criteria. exclusion criteria: * known malignant disease * bronchiectasis * chronic bacterial colonisation of the airways * treatment with an immunosuppressive drug or long-term treatment with antibiotics. * not examined with a chest x-ray at admission

Keywords: biomarkers sensitivity and specificity clinical deterioration
evaluation of the efficacy of 0.08% tacrolimus nanoencapsulated aqueous solution spray vs. 0.1% free tacrolimus commercial ointment in the treatment of oral lichen planus

Conditions: Oral Erosive Lichen Planus

Summary: the goal of this clinical trial is to assess the efficacy of different formulations of the drug tacrolimus in treating patients with oral lichen planus. the main questions it aims to answer are: * does the nanoencapsulation of tacrolimus in an aqueous solution, used as a spray, improve the effectiveness of treating oral lichen planus lesions compared to the commercially available tacrolimus ointment? * which tacrolimus formulation can keep participants free of lesions for longer periods? researchers will compare a spray of 0.08% tacrolimus nanoencapsulated aqueous solution against a 0.1% free tacrolimus commercial ointment to determine which formulation is more effective. participants will: * apply one of the proposed tacrolimus formulations twice a day for 1 month. * visit the clinic once every 2 weeks for checkups and tests, with follow-ups extending up to 3 months.


Eligibility criteria:
inclusion criteria: * individuals with a clinical and histopathological diagnosis of erosive/ulcerative/atrophic and symptomatic oral lichen planus, according to the criteria established by the american academy of oral and maxillofacial pathology exclusion criteria: * history of oral cancer; * history of allergic reactions to tacrolimus or any other component of the formulas; * history of organ transplant or have a systemic condition that induces significant immunosuppression; * be pregnant or lactating.

Keywords: oral lichen planus tacrolimus
brighter bites/legacy produce rx program

Conditions: Child Obesity

Summary: the purpose of this study is to assess the effectiveness of the produce prescription program at improving weight status and obesity-related health outcomes of participants, to examine the impacts of the program on household food insecurity and nutrition security, to examine the impacts of the program on participating adolescents' dietary behavioral outcomes, their home nutrition environment and feeding practices and to examine the impacts of the program in reducing healthcare use and associated costs


Eligibility criteria:
inclusion criteria: * must be a patient at one of the four legacy community health school-based clinics in galena park, texas * bmi greater than or equal to 85th percentile * reside within a 10-mile radius of houston food bank * medicaid recipients or low-income uninsured * parents must be able to read and write in english or spanish to complete surveys * patient and parents must confirm their willingness to complete the participant's well-child visit for the entire period of the study (approximately one year). exclusion criteria: * currently participating in brighter bites * with a family member/sibling currently participating in brighter bites