Kornimate/medical-research-clean huggingface dataset:
evaluation of lymphocytic infiltrate, dendritic cells and cytokines expression in psoriatic lesion and normal skin before and after tnf alfa inhibitors therapy

Conditions: Moderate to Severe Psoriasis.; Absolute Number, Density of Immune Infiltrate and Dendritic Cells and Inflammatory Cytokines Expression Pattern.

Summary: the efficacy of tnf alfa inhibitors in the treatment of psoriasis has been documented in many studies. their effect on dendritic cells has been scarcely studied. tnf- α has a central role in dendritic cell biology, both for their maturity and mobilization of peripheral tissues to secondary lymphoid organs. the primary objectives of this study are: * to document absolute number, density of immune infiltrate and dendritic cells and inflammatory cytokines expression pattern (particularly ifn α and il-32) in psoriasic lesions vs normal skin of the same patient * to describe changes in such cell numbers and expression patterns upon 16 weeks treatment with tnf alfa inhibitors.


Eligibility criteria:
inclusion criteria: * male and female subjects \> 18 years of age, affected by moderate to severe psoriasis * subject has had clinical diagnosis of psoriasis for at least 12 months, stable plaque psoriasis for at least 2 months before screening (subjects with concurrent psoriatic arthritis may be enrolled). * subject is naıve to tnf-antagonist therapy and efalizumab. * subjects are considered eligible according to the following tuberculosis screening criteria: 1. have no history of latent or active tb prior to screening; 2. have no signs or symptoms suggestive of active tb upon medical history and/or physical examination; 3. within 1 month prior to the first administration of study medication, have negative diagnostic tuberculin skin test. * normal chest x-ray within 3 months prior to screening with no evidence of malignancy, infection, current or old tb. * subjects' screening and baseline clinical data must be within the normal limit, including the results of medical history, physical examination and laboratory evaluation (complete blood count, serum values for liver enzymes, bilirubin, glucose, albumin, creatinine and urine analysis). * willing and able to comply with the protocol requirements for the duration of the study. * women of childbearing potential must be using adequate birth control measure throughout the study and for 150 days (5 months) after study completion. exclusion criteria: * pregnant or breast-feeding women, or women who are planning pregnancy. * patients not suitable for tnf alfa inhibitors therapy

Keywords: psoriasis immune infiltrate dendritic cells cytokine expression
fluid overload quantification in septic shock

Conditions: Intensive Care Units; Shock, Septic

Summary: fluid management in septic shock patients remain a great challenge. insufficient fluid filling lead to hypovolemia, organ failure and increased death, whereas fluid overload was associated to an increased morbidity and mortality in several studies. several invasive and non invasive strategies have been developed during the past years to monitor the hemodynamic state of septic shock patients, but no method has been validated to objectively quantify fluid overload in septic shock patients. the body composition monitor (bcm) allow for measurement of total body water (tbw), extracellular water (ecw) and intracellular water (icw) volumes using bioimpedancemetry. the bcw is daily used in patients who undergo renal dialysis to assess the effectiveness of fluid removal. the bcm has never been validated in septic shock patients. the aim of the study is to investigate the accuracy of the bcm to measure the variation of the tbw during a fluid challenge of 500 ml of saline during the early phase of septic shock.

patients suffering from septic shock admitted in our critical care unit for less than 24 hours will be eligible. tbw, ecw and icw volumes will be measured using the bcm just before (t0), just at the end (t1) and 1 h after the end (t2) of a fluid challenge of 500 ml of saline. fluid responsiveness will be assessed using trans thoracic echocardiography (tte). tte will be performed at t0, t1 and t2. blood samples will be obtained at t0, t1 and t2 to dose biomarkers of endothelial dysfunction and of capillary leak. the effectiveness of fluid challenge on microcirculation will be investigated by measuring the tissue perfusion index of the urethral mucosa using the ikorus up device. patients will be followed until day 28 after admission in the critical care unit.

Eligibility criteria:
inclusion criteria: * patient aged from 18 to 80 years old * admitted to icu for septic shock for less than 24 h * fluid resuscitation decided by intensivist * patient affiliated to a social security system or recipient of a such system * patient/proxy not opposed to the study exclusion criteria: * subject with amputation of 1 or more limbs * body mass index \> 35 kg.m-2 ou \< 18 kg.m-2 * impossibility of setting up an arterial catheter for invasive blood pressure monitoring and / or a central venous catheter in the upper cava territory * patient with pacemaker and / or implantable cardioverter defibrillator * quality of cardio echo image insufficient to allow studied parameters measurement * moribund subject ( life expectancy expected less than 48 hours) * uncontrolled intracranial hypertension (intracranial pressure ≥ 20 mm hg by icp monitoring or by a pulsatility index ≥ 1.30 in the transcranial doppler) * patient under ecmo/ecls * legal incapacity or limited legal capacity * subject without health insurance * pregnant woman * subject being in the exclusion period of another study or provided for by the "national volunteer file"

Keywords: icu septic shock fluid overload quantification bioimpedancemetry capillary leak fluid responsiveness
artificial intelligence for automated diagnosis of breast cancer

Conditions: Breast Cancer Diagnosis

Summary: mammography is a two-dimensional imaging technique which involves the tissues overlapping under the projective image; dense glandular tissue above or below the lesion can reduce the visibility of the lesion. the trouble could be the interpretation of the image obtained which may lead to the inability to visualize a fist stage cancer and the probability that to a healthy person will be diagnosed a pathology that is not present (false positive). the introduction of an almost three-dimensional technique imaging called breast digital tomosynthesis (dbt) can overcome most limitations. in the last 5 years image analysis methods based on artificial intelligence (, ai) have also been massively introduced in breast cancer detection. the study is a prospective observational study based on artificial intelligence whose the mail goal is to develop a method to identify a lesion.


Eligibility criteria:
inclusion criteria: * patients who refer to the regina elena for diagnostic mammography tests * informed consent exclusion criteria: * presence of prostheses, artifacts, outcomes of a study in the breast intervention under the study
examining the feasibility of prolonged ketone concentrate supplement drink consumption in adults with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Hyperglycemia; Ketosis

Summary: brief summary: ketones are a source of energy and signaling molecule that are produced by the body when not consuming any food or consistently eating a low-carbohydrate "keto" diet. blood ketones can be used as a source of energy by the body, but they may also act as signals that impact how different cells in the body function. recently, ketone supplements have been developed that can be consumed as a drink. these supplements can raise blood ketones without having to fast or eat a "keto" diet. previous studies have shown that these supplement drinks can lower blood sugar without having to make any other dietary changes. drinking these ketone supplements may therefore be an effective strategy to improve blood sugar control and influence how cells function. to find out if it is feasible for people with type 2 diabetes to drink these ketones supplements regularly over 90 days, we will compare between two groups in this study: one group that will be asked to drink ketone supplements, and one group that will be asked to drink a placebo supplement.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes by a physician at least 1 year prior * stable use of glucose-lowering medications for at least three months * must be able to read and understand english in order to complete the study questionnaires exclusion criteria: * competitively trained endurance athlete * actively attempting to gain or lose weight * having a history of mental illness or existing neurological disease * having a history of cardiovascular events in the last two years, hypoglycemia, irritable bowel syndrome, or inflammatory bowel disease * are currently taking sglt2 inhibitors or insulin * are using more than 2 classes of glucose-lowering medication * currently following a ketogenic diet or regularly taking ketone supplements * unable to commit to a 90-day trial * being unable to follow remote guidance by internet or smartphone * currently taking natural or over-the-counter supplements specifically designed to lower blood glucose (e.g., berberine, bitter melon)
the effect of pre-emptive analgesia on the postoperative pain in children undergoing pediatric stomatology day surgeries

Conditions: Ankyloglossia; Oral Mucoceles; Supernumerary Teeth

Summary: the aim of this double-blinded, randomized, controlled trial was to test whether pre-emptive analgesia with ibuprofen suppository is effective for children undergoing pediatric stomatology day surgeries in the postoperative period.

the recruited patients were randomly assigned into either the pre-emptive analgesia group or the control group. after the induction of anesthesia was performed, the nurse delivered the ibuprofen suppository at the dose of 5-10 mg/kg for children of the pre-emptive analgesia group, and no measures were taken for the control group. all procedures of frenectomy, extraction of supernumerary teeth and excision of oral mucoceles were performed by a single surgeon. postoperative pain was assessed using the visual analogue scale (vas), the wong-baker faces pain rating scale (wbs), and the face, leges, activity, cry, and consolability (flacc) scale, and postoperative parental pain assessment (pppm) scale. the postoperative pain was measured 1, 4, and 24 hours after the surgery.

Eligibility criteria:
inclusion criteria: * an age of 3-8 years; undergoing upper labial frenectomy, lingual frenectomy, extraction of supernumerary teeth, excision of oral mucoceles and the written informed consent from the parents or guardians. exclusion criteria: * children or parents refusal for study participation; intellectual disability, major systemic diseases; allergy to ibuprofen and other medications used in the study protocol.

Keywords: pre-emptive analgesia pediatric stomatology day surgeries postoperative pain
interest of intravenous cholangiography with indocyanine green in the context of laparoscopic cholecystectomy for grade 1 and 2 acute gallstone cholecystitis

Conditions: Lithiasis; Cholecystitis, Acute; Cholangiopathy

Summary: acute lithiasis cholecystitis (alc) is the third most common cause of surgical emergency admission. the initial treatment of alc associates a medical support and a cholecystectomy, preferentially performed laparoscopically in the first 5 days of evolution. during the surgery, intraoperative cholangiography (cpo) using a contrast product is the "gold standard" to identify the bile ducts. however cpo is performed in approximately 30% of laparoscopic cholecystectomy. laparoscopic cholecystectomy for alc is associated with an increase in the rate of biliary ducts injuries compared with cholecystectomy for symptomatic vesicular lithiasis, evaluated at 0.8 % versus 0.1 %. its higher rate is related to local inflammation that alters the biliary anatomy and complicates the identification of the bile ducts. indocyanine green facilitates the visualization of extrahepatic biliary structures, which could reduce the risk of biliary wound and shorten the operating time.


Eligibility criteria:
inclusion criteria: * adults patient (\>18 years old) * patients requiring laparoscopic cholecystectomy for grade 1 or 2 acute gallstone cholecystitis according to tokyo recommendations confirmed by radiological morphological examination * acute lithiasis cholecystitis (alc) evolving for less than 5 days * patients affiliated to a social security scheme exclusion criteria: * antecedent of biliary tract surgery * antecedent of cholecystectomy * contraindication to laparoscopy * contraindication to surgery * cholecystectomy by laparotomy out of hand * grade 3 cholecystitis according to tokyo recommendations * acute alithiasis cholecystitis * cirrhosis * conversion for gangrenous alc * patient with an allergy to indocyanine green * pregnant or lactating woman, childbearing age without effective contraception * minor patient * physical or psychological state that does not allow participation in the study, patient under guardianship or curatorship or patient deprived of liberty by a judicial or administrative decision (according with articles l 1121-6 and l 1121-8 of the french public health code)

Keywords: acute lithiasis cholecystitis intraoperative cholangiography indocyanine green cholecystectomy
inflammation and treatment of bacterial vaginosis near term

Conditions: Bacterial Vaginosis

Summary: most studies demonstrate that untreated bacterial vaginosis increases the rate of preterm birth. despite this, there is no evidence that screening and treatment of asymptomatic bacterial vaginosis nor interpregnancy treatment of endometritis decreases the subsequent rate of preterm birth. however, treatment of symptomatic bacterial vaginosis has been associated with a modest reduction in subsequent preterm birth. potential mechanisms for this reduction include a decrease in peripheral maternal pro-inflammatory activation of the th1 inflammatory cascade with treatment, however this direct pathway has not been elucidated. the approved treatment for bacterial vaginosis during pregnancy consists of metronidazole 500mg bid for 7 days. a more complete understanding of the effect of metronidazole on maternal inflammation would be useful in designing strategies to reduce the rates of preterm birth. this study proposes to determine the effect of standard treatment of bv carriage on maternal serum markers of inflammation. this will be accomplished by giving patients with asymptomatic bv either the standard treatment of metronidazole or a placebo for 7 days. blood will be drawn to compare levels of interleukins 1 and 6 as well as tumor necrosis factor alpha.


Eligibility criteria:
inclusion criteria: * 32 weeks gestation or greater * multiparity * no history of preterm birth * english speaking * ability to provide informed consent * bacterial vaginosis by gram stain exclusion criteria: * acute infections at any site * active autoimmune disease * current anti-inflammatory use * symptomatic bacterial vaginosis * previous adverse reaction to metronidazole * reports ongoing ethanol consumption

Keywords: metronidazole bv pregnancy
oxygen toxicity of hbot in chronic brain injury

Conditions: Adult and Pediatric Chronic Cerebral Disorders

Summary: hypothesis: that hbot can be toxic in the low-pressure range.

the study is a retrospective review of the author's experience treating chronic brain injury with hbot, supplemented by cases communicated to the author, who developed untoward effects during or after their hbot. the object of the study was to affirm or refute the author's general impression that there was an optimal dose of hbot in chronic brain injury which was lower than the traditional dose applied in chronic non-central nervous system wounding. furthermore, when this lower dosage range was exceeded and approached the traditional doses for non-cns wounding oxygen toxicity would result. to address these impressions the study seeks to review the author's medical records and other patient/doctor communications to the author where side effects of hbot occurred in the treatment of chronic brain injury and abstract signs, symptoms, and the dose of hbot employed.

Eligibility criteria:
inclusion criteria: * cerebral disorder of greater than one year's duration exclusion criteria: * none

Keywords: brain injury brain disorders
risk stratification in severe treatment-naive, tricuspid regurgitation

Conditions: Functional Tricuspid Regurgitation

Summary: this registry is aimed to characterize patients with severe tricuspid regurgitation for the purpose of patient selection for interventional treatment and identify factors related to adverse outcomes.


Eligibility criteria:
inclusion criteria: severe functional tricuspid regurgitation exclusion criteria: prior surgery or congenital heart diseases with involvement of the tricuspid valve

Keywords: tricuspid regurgitation, tricuspid valve, percutaneous treatment, right ventricle
a study to assess the efficacy and safety of induction therapy with ro7790121 in participants with moderately to severely active crohn's disease

Conditions: Moderately to Severely Active Crohns Disease

Summary: this phase iii, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with ro7790121 in participants with moderately to severely active crohn's disease (cd).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cd * moderately to severely active cd * bodyweight \>= 40 kilogram (kg) * demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced cd therapy * males and females of childbearing potential must meet protocol criteria for contraception requirements exclusion criteria: * current diagnosis of ulcerative colitis (uc) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis * participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum) * diagnosis of short gut or short bowel syndrome * presence of an ileostomy, colostomy or ileoanal pouch * participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon * presence of abdominal or perianal abscess * presence of rectovaginal fistulas or perianal fistulas with \>3 openings * participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon * current diagnosis or suspicion of primary sclerosing cholangitis * pregnancy or breastfeeding, or intention of becoming pregnant during the study * past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed * history of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer * evidence of infection with clostridioides difficile (c. difficile; formerly known as clostridium difficile), cytomegalovirus (cmv), human immunodeficiency virus (hiv), hepatitis b (hbv), hepatitis c (hcv) * has evidence of active tuberculosis (tb), latent tb not successfully treated (per local guidance) or inadequately treated tb * has received protocol-specified prohibited medicines, including known exposure to any type of anti-tl1a therapy
early intervention in parent-professional cooperation in cerebral palsy

Conditions: Cerebral Palsy

Summary: cerebral palsy (cp) is the most common motor disability in children. it is due to damage that occurs during brain development in the fetus or infant. early treatment (before 2 years) will allow the child to promote brain plasticity to compensate for the effects of the lesion and reduce the severity of cp. the goals of early intervention are to increase motor, cognitive and communication skills, prevent complications and provide parental support. most authors agree to recognize the benefit of early care by emphasizing home intervention programs with active parental participation. to date, no recommendations exist in france for the management of cerebral palsy in children under the age of two. it is therefore necessary to conduct scientific studies in this population. based on published international studies, the precop program (precoce intervention in parent-professional cooperation in cerebral palsy) consists of individualized care adapted to the specific needs of each child, from the arrival of the infant at home, by a multidisciplinary team during the child's first two years.


Eligibility criteria:
inclusion criteria: * new born presenting on transfontanellar ultrasound and confirmed on brain mri (magnetic resonance imaging) at least one of the following brain lesions at high risk of cerebral palsy : * stage 3 intraventricular hemorrhage, requiring at least 2 subtractive lumbar punctures and/or the establishment of a ventriculoperitoneal bypass * stage 4 intraventricular hemorrhage * periventricular leukomalacia : extensive unilateral or bilateral * sequelae of perinatal anoxo-ischemic encephalopathy * extensive neonatal stroke * less than 3 months old (corrected age in case of prematurity) * hospitalized in neonatology or hospitalized in pediatric intensive care unit or within two months following return home (follow-up visit after initial hospitalization) * affiliate to social security * parental or legal representative consent to participate in the study (free and informed written consent) exclusion criteria: * children who have had an antenatal diagnosis of a pathology causing fear of the onset of developmental delay * children presenting with a congenital pathology with neonatal revelation, whether of metabolic, genetic or malformative origin * palliative care offered by the neonatology team (lata: limitation and discontinuation of active therapeutics) * children participating simultaneously in another screening and early care program (excluding the cocon program (soins précoces et coordonnés du nouveau-né vulnérable))

Keywords: early intervention program functional impact cerebral palsy children