Kornimate/medical-research-clean huggingface dataset:
safety study to assess growth in children with seasonal allergic and/or perennial allergic rhinitis treated with gw685698x aqueous nasal spray or placebo nasal spray

Conditions: Rhinitis, Allergic, Perennial and Seasonal

Summary: the purpose of this study is to assess any effect in children with seasonal and/or perennial allergic rhinitis by gw685698x aqueous nasal spray (versus vehicle placebo nasal spray) on growth using knemometry.


Eligibility criteria:
inclusion criteria: * females (ages 6 to 11) who have not begun menses. * males (ages 6 to 12). * tanner stage 1. * history of sar (seasonal allergic rhinitis) or par (perennial allergic rhinitis) of at least one year with either a current level of allergic rhinitis symptoms that warrants treatment and/or expected symptoms during a majority of the study period. * positive skin test to an appropriate seasonal or perennial allergen. exclusion criteria: * history of abnormal growth or gross malnutrition. * clinically significant laboratory abnormality. * history of any condition that may have substantially affected growth. * historical or current evidence of clinically significant, uncontrolled disease of any body system. * any asthma other than mild, intermittent asthma controlled by short-acting, beta-agonists. * recent major surgery and/or trauma to the legs. * history of adrenal insufficiency. * current or prior treatment with any medication that may have a potential for an ongoing effect on linear growth. * use of corticosteroids, by any route, within 4 weeks prior to visit 1. * any nasal condition or deformity that would impair nasal breathing or deposition of medication. * physical impairment that would affect the subject's ability to participate in the study.

Keywords: gw685698x seasonal allergic rhinitis perennial allergic rhinitis knemometry children
ex-vivo adhesion of bacteria to different contact lens materials

Conditions: Visual Acuity

Summary: this is a single-site, 4-visit, contralateral, dispensing, open-label, randomized study. each eligible subject will be randomized into one of two sequence groups to wear two lens types contralaterally (test on the right eye and control on left eye or vice versa).


Eligibility criteria:
inclusion criteria: * potential subjects must satisfy all of the following criteria to be enrolled in the study. 1. the subject must read, understand, and sign the statement of informed consent and receive a fully executed copy of the form. 2. appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. between 18 and 45 (inclusive) years of age at the time of screening. 4. be a current spherical soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report. 5. have a pair of spectacles with corrected vision of 20/40 or better in each eye or uncorrected vision is 20/40 or better in each eye 6. the subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 d in each eye. 7. the subject has a best-corrected visual acuity of 20/25 or better in each eye. exclusion criteria: * potential subjects who meet any of the following criteria will be excluded from participating in the study. 1. currently pregnant or breastfeeding. 2. any ocular or systemic allergies or diseases that may interfere with contact lens wear. 3. any autoimmune disease or use of medication, which may interfere with contact lens wear. habitual medications used by successful soft contact lens wearers are considered acceptable. 4. any ocular abnormalities such as entropion, ectropion, extrusions, chalazia, recurrent styes, history of recurrent corneal erosions. 5. any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, prk, lasik, etc.). 6. multifocal, toric or extended wear contact lens correction. 7. participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. 8. history of binocular vision abnormality or strabismus. 9. any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., hiv) by self-report. 10. employee or immediate family member of an employee of clinical site (e.g., investigator, coordinator, technician). 11. any ocular infection. 12. any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the efron scale (appendix g), any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. 13. any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
effects of pain neuroscience education using an infographic in basketball elite athletes

Conditions: Elite Basketball Athletes

Summary: the objective of this study is to analyze the effectiveness of a brief educational intervention supported by an infographic versus that supported by powerpoint on the understanding of pain in elite athletes. secondary objective: to analyze whether a greater understanding of pain has effects on the intensity, extent and characteristics of pain experienced in the year after the intervention.


Eligibility criteria:
inclusion criteria: * elite athletes over 18 years of age from the acb unicaja basketball team during years 2021-2022 exclusion criteria: -
non-prescription versus prescription topical treatments versus no treatment in the control of sweating

Conditions: Hyperhidrosis; Excess Sweating

Summary: the purpose of this study is to assess the effectiveness of the prescription treatment compared to the non-prescription treatment. it is hypothesized that the prescription treatment will have a significantly greater effect than the non-prescription treatment on decreasing excess sweating.

the objective of this study is to assess the effectiveness of the prescription treatment compared to the non-prescription treatment. it is hypothesized that the prescription treatment will have a significantly greater effect than the non-prescription treatment on decreasing excess sweating.

Eligibility criteria:
inclusion criteria: * age 21-30 years * males and females * the subjects are in good health. * the subjects have willingness and the ability to understand and provide informed consent for participation in the study. exclusion criteria: * subjects with primary hyperhidrosis * subjects who are unable to withstand prolonged heat exposure or who have self-reported history of cardiovascular or respiratory disorders. * subjects who are unable to give informed consent. * subjects with mental illness. * subjects who are pregnant or nursing. * subjects with systemic or local skin disease and/or infection that may interfere with the conduct of the study.
an open-label extension trial to assess the safety of long-term treatment of rotigotine in advance-stage parkinson's disease

Conditions: Parkinson's Disease

Summary: the objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic parkinson's disease.

this is the open-label extension to the randomized, double-blind, placebo-controlled sp650 trial that assessed the efficacy and safety and tolerability of the rotigotine patch in subjects with advanced-stage idiopathic parkinson's disease who are not well-controlled on levodopa.

Eligibility criteria:
inclusion criteria: * subjects who have completed six months of maintenance treatment in the sp650 double-blind trial exclusion criteria: * subjects who had an ongoing serious adverse event from the sp650 double-blind trial that was assessed as related to study medication

Keywords: rotigotine neupro
analgesic effect of gabapentin in total knee arthroplasty (tka)

Conditions: Postoperative Pain; Postoperative Sedation

Summary: pain is a major problem after tka. gabapentin may reduce acute postoperative pain. the investigators therefore investigate the effect of gabapentin as a perioperative analgesic.

pain is a major problem after tka. studies indicate that gabapentin may reduce acute postoperative pain. however, the optimal dose is unknown and there is constant controversy on analgesic versus side-effects. the investigators therefore investigate the effect of gabapentin as a perioperative analgesic in a dose-related manner and with a sample-size allowing evaluation of side-effects.

Eligibility criteria:
inclusion criteria: * primary, unilateral total knee arthroplasty (tka) * age 50-85 years * ethnic danes exclusion criteria: * treatment with gabapentins, systemic glucocorticoids, opioids, anxiolytic agents, antiepileptics or antidepressive agents (last 4 weeks) * history of depression or mania * history of alcohol or drug abuse * history of malignancy * history of epilepsia * bmi \> 40 * disease affecting central or peripheral nerve function * history of dementia * history of renal insufficiency * allergy to gabapentin * women with menstruation (last 2 years)
rate of malignant transformation and clinical characteristics among an oral lichen planus cohort: a retrospective center experience

Conditions: Oral Lichen Planus; Oral Carcinoma; Oral Carcinoma in Situ

Summary: the main objective of this paper will be to evaluate the rate of malignant transformation among a cohort of patients affected by oral lichen planus with long-term follow-up. secondary aims will be to study and describe the characteristics of these patients to identify potential risk factors for malignant transformation, and to evaluate the therapeutic effects and features to olp drgus.

oral lichen planus (olp) is a chronic inflammatory mucocutaneous disease of unknown etiology, primarily affecting the oral mucosa. global prevalence ranges from 1.01% to 3%, with an estimated 1.43% prevalence in europe. although olp can affect the scalp, nails, and skin, it most commonly manifests in the oral cavity. the disease primarily involves the stratified squamous epithelium of the mouth, and while its precise cause remains unclear, it is thought to result from a t-cell-mediated autoimmune response, triggered by microbial agents, chemicals, stress, or viral infections. t cells directly attack keratinocytes, causing epithelial damage, with both specific (t-cell activity) and nonspecific mechanisms (mmps, chemokines, and mast cells) contributing to disease progression. cd8+ and cd4+ t cells and langerhans cells play key roles in antigen presentation, while matrix metalloproteinases (mmps) and their inhibitors (timps) are involved in the breakdown of the basement membrane, leading to keratinocyte destruction. the main objective of this paper will be to evaluate the rate of malignant transformation among a cohort of patients affected by oral lichen planus with long-term follow-up. secondary aims will be to study and describe the characteristics of these patients to identify potential risk factors for malignant transformation, and to evaluate the therapeutic effects and features to olp drgus.

Eligibility criteria:
inclusion criteria: * clinical-histological diagnosis of oral lichen planus * patients who gave consensus to personal data treatment * minimum 6 months follow-up exclusion criteria: * patients who did not give consensus to personal data treatment * oral lichenoid lesions * patients with anamnesis of hematopoietic stem cells transplant * patients with a oscc at the first histological examination (i.e., namely: also oscc patients with a olp background were excluded)

Keywords: oral lichen planus malignant transformation oral carcinoma oral dysplasia
a study of neoadjuvant atezolizumab plus chemotherapy versus placebo plus chemotherapy in patients with resectable stage ii, iiia, or select iiib non-small cell lung cancer (impower030)

Conditions: Non-Small-Cell Lung

Summary: this is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (mpdl3280a) or placebo in combination with platinum-based chemotherapy in participants with resectable stage ii, iiia, or select iiib non-small cell lung cancer (nsclc) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status 0 or 1 * histologically or cytologically confirmed, resectable stage ii, iiia, or select iiib (t3n2 only) nsclc of squamous or non-squamous histology. staging should be based on the 8th edition of the ajcc/uicc staging system * evaluation by an attending thoracic surgeon to confirm eligibility for an r0 resection with curative intent * adequate pulmonary and cardiac function to undergo surgical resection * measurable disease as defined by recist v1.1 * adequate hematologic and end organ function * negative hiv test at screening * negative for active hbv and hcv at screening * adequate tissue for pd-l1 ihc assessment exclusion criteria: * nsclc with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma * mixed nsclc and small cell lung cancer histology * any prior therapy for lung cancer * malignancies other than nsclc within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated expected curative outcome * non-squamous nsclc histology with activating alk and egfr mutation * pregnant or lactating women * history of autoimmune disease * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active of active pneumonitis on screening chest computed tomography (ct) scan * prior treatment with cluster of differentiation 137 (cd137) agonist or immune checkpoint blockade therapies, anti-programmed-death-1 (anti-pd-1), and anti-pd-l1 therapeutic antibody * severe infection within 4 weeks prior to randomization * significant history of cardiovascular disease
samu save sepsis: early goal directed therapy in pre hospital care of patients with severe sepsis and/or septic shock

Conditions: Severe Septic Syndrome (Severe Sepsis and Septic Shock) Diagnosed and Treated by Mobile Intensive Care Unit

Summary: the purpose of this study is to determine whether an aggressive strategy of severe sepsis patients since pre hospital care, including early antibiotics administration, hemodynamic optimization, and opotherapy when indicated, could reduce mortality

major prognostic factor in sepsis management is rapidity of treatments implementation. in 2001, rivers observed a reduction in mortality through early hemodynamic optimization. in 2009, arnold emphasizes that establishing more early antibiotic therapy allowed a further reduction of mortality. in france, pre hospital care is based on mobile intensive care unit (micu) called smur. smur is consisting of a driver, a nurse and an emergency physician. actually in france, management of severe septic syndrome (severe sepsis and septic shock) are not standardized and based on a "conventional" strategy at the discretion of the emergency physician. antibiotics are given in only two cases: fulminans purpura and meningitis. hemodynamic optimization is not a standard of care and no recommendation exist for hemodynamic targets. an "aggressive" strategy based on early antibiotics administration, hemodynamic optimization and opotherapy when required could be initiated by smur since first contact with the patient before hospital admission. we assume that an "aggressive" strategy initiated during the first 60 minutes of prehospital stage compared to "conventional" strategy could allow to reduce mortality in severe sepsis patients.

Eligibility criteria:
inclusion criteria: all patients fulfilling the following criteria: * age ≥ 18 years * patient with suspected severe infection defined by the existence of a suspected infection and * hypotension before vascular fluid loading and/or * lactataemia greater than 4 mmol/l and/or * glasgow scale lower than 13 and/or * mottling score greater than 2 * patient with a septic shock exclusion criteria: * age \<18 years or unable * pregnant * severe concomitant pathology requiring urgent care(i.e.epilepsy) * status "not to be reanimated" life expectancy less than 6 months with no indication of reanimation support ( prior decision on care limitation). * fulminans purpura * true allergy to beta-lactam defined by an angioedema or by an anaphylactic shock during a prior exposure to beta-lactam. * patient who have already received hemodynamic optimization or antibiotic treatment before the micu's (mobile intensive care unit) care.

Keywords: severe septic syndrome mobile intensive care unit strategy antibiotics hemodynamic optimization
patients with behavioural symptoms and hospitalized in cognitive and behavioural units

Conditions: Alzheimer Disease

Summary: cognitive and behavioral units (cbus) have been created between 2008 and 2012 french national alzheimer plan for the management of behavior problems of patients suffering from alzheimer's disease or other related disorders and necessitating hospitalisation. this alzheimer plan is promoting the evaluation of these units through the observation of the behavioral and psychological symptoms of dementia (bpsd) evolution. as these units are new, it appears important to assess their long-term impact on patients care.

expected results the present study should allow to better understand the long-term impact of cbu on care of patients with alzheimer disease and bpsd. moreover, it should allow to identify patients improved by cbu.

Eligibility criteria:
inclusion criteria: * patient hospitalized on cbus * patient with the diagnostic criteria for disease related to dementia stage with a clinical demential rating ≥ 1 * patient with a caregiver who is fairly frequent contact with the patient in order to observe the appearance of behavior changes exclusion criteria: * patient living alone at home * patient with risk of death within one year

Keywords: cognitive and behavioral units alzheimer disease dementia
the use of reconstructive surgery for sexually mutilated women at the university hospitals of strasbourg

Conditions: Sexual Trauma

Summary: despite awareness since the 1980s and a legal framework to punish sexual mutilation, this tradition continues in many countries, particularly in africa but not only in the middle east, malaysia and indonesia. this custom, carried out among increasingly young little girls, exposes them to infectious, hemorrhagic and even death risks and sometimes significant obstetric complications. every year, 3 million girls and young women are sexually mutilated around the world, or one woman every 15 seconds. in recent years, a surgical repair technique has been created by a french urologist, professor foldès. this technique allows clitoral reconstruction. sensory reacquisition after this intervention may take a few months, but the functional results are quite good. there is little or no data concerning the use of reconstructive surgery for these mutilated patients consulting in sexology and the future of patients post-operatively or who have not had recourse to reconstructive surgery. the investigators then questioned the decision of these patients and their future.


Eligibility criteria:
inclusion criteria: * adult woman (≥18 years old) * having consulted sexology at the hus for sexual mutilation between 01/01/2011 and 12/31/2021. * having had clitoral repair surgery at the hus between 01/01/2011 and 12/31/2021 * not objecting, after information, to the reuse of their data for the purposes of this research exclusion criteria: * woman who expressed her opposition to participating in the study * impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.) * woman under judicial protection or under guardianship or curatorship.

Keywords: sexual mutilation
heredity of retinal vessel tortuosity

Conditions: Retinopathy of Prematurity

Summary: the purpose of this study is to asses the relative influence of genetic and environmental influence on the tortuosity of retinal arterioles in eyes of 218 healthy danish twins aged 20-46 years. we expect to find a high heredity for the variation in tortuosity. this knowledge can contribute to the elucidation of the pathology in retinal diseases.

all persons underwent an ophthalmic examination including refraction, slit lamp biomicroscopy and digital fundus photography. two independent graders (both with an md degree) made a visual grading of the severity of tortuosity of the retinal arterioles in the fundus images.

Eligibility criteria:
inclusion criteria: * samesex twin pairs of self-assessed good health exclusion criteria: * diabetes mellitus * hypertension * thyroid disease * cataract or other opacities of the refractive media * missing fundus photographs

Keywords: retinal vessels tortuosity
rpsa as a potential prognostic biomarker of pancreatic cancer

Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)

Summary: pdac (pancreatic ductal adenocarcinoma) represents 90% of pancreatic tumors. the prognosis of pdac remains poor at this time. its management is based on surgery for early stages, associated with neoadjuvant and adjuvant chemotherapy. however, around 80% of patients will relapse after surgery. there is a lack of efficient biological biomarkers of pdac, especially for prognosis. to date, ca19-9 is commonly used despite its lack of sensitivity and specificity. ribosomal protein sa (rpsa) is a transmembrane receptor localized at the cell surface but also in the cytosolic and nuclear regions. rpsa interacts with many proteins in the extracellular matrix (ecm), including laminin-1 and elastin. rpsa in involved in different cellular functions such as cell adhesion, migration, proliferation and differentiation. the expression of rpsa is increased in many cancers including breast, lung, prostate, pancreatic, etc. it could represent a molecular biomarker of tumor invasion and metastatic abilities. moreover, the concentration of rpsa could be measured in the serum of patients with pdac. recent data suggest that a modification of the rpsa concentration could be a prognostic biomarker of pdac.

the aim of this study is to explore the potential implication of rpsa as prognostic biomarker of pdac.

Eligibility criteria:
inclusion criteria : * patients treated at the reims university hospital for a resectable or potentially resectable pancreatic tumor, with or without neoadjuvant chemotherapy * adults (aged more than 18 years old) * patients who have signed the informed consent form exclusion criteria : * patients with a prior history of cancer (excluding basal cell carcinoma or in situ cervical cancer that received conventional cancer treatment). * minors * patients for whom pdac is not the retained diagnosis

Keywords: pancreatic ductal adenocarcinoma ribosomal protein sa (rpsa) prognosis biomarker