Kornimate/medical-research-clean huggingface dataset:
liposomal anthracyclin in the treatment of elderly all

Conditions: Acute Lymphoblastic Leukemia

Summary: phase ii multicentric study comparing vad regimen with continuous infusion over 96 hours of doxorubicin, vincristine and dexamethasone to a 90 minutes infusion of equivalent doses of dox li-peg, bolus infusion of vincristine and dexamethasone

patients aged 55 years or over will be assessed for response to steroids from day -7 to day 0 during steroid therapy, ph status will be determinated : patients with ph+ ve all will be treated according to the another french protocol while patients with ph-ve all will be included in the "caelyx" protocol and randomly allocated to induction with vad or with vadox-li-peg (caelyx). a second course of induction therapy with vad+ cyclophosphamide of vadox-li-peg+ cyclophosphamide(according to the initial randomization arm) will then be given to all patients. consolidation therapy included 2 courses of vad or of vadox-li-peg , according to the initial random allocation, followed by two courses of cytarabine,cyclophosphamide and thioguanine. during induction and consolidation therapy, doxorubicin and liposomal pegylated doxorubicin pharmacokinetics will be assessed in all patients. treatment of occult cns invasion includes skull radiotherapy and 6 intrathecal injections(steroïds+methotrexate) a two years maintenance course with 6 mercaptopurine and methotrexate will then be offered to all patients.

Eligibility criteria:
inclusion criteria: * 55 years of age and older * ecog performance \ /=3 * vih negative * absence of previous all treatment * informed consent signed * sgpt and bilirubin \< 4x upper limit of normal * normal creatinine for age * cardiac state compatible with anthacyclin exclusion criteria: * all with philadelphia chromosome * all3 * cml blasts crisis * cardiac insufficiency and/ or left ventricular ejection fraction \< 50% * evolutive infection * presence of other evolutifs cancer or ongoing treatment * mental status incompatible with inform consent

Keywords: all chemotherapy pharmacokinetics of doxorubicin (pegylated or not) elderly all
study of low-grade systemic inflammation in adult patients with phenylketonuria

Conditions: Phenylketonuria

Summary: patient suffering from phenylketonuria have chronic hyperphenylalaninemia. hyperphenylalaninemia is known to be toxic to central nervous system and cardiovascular system in particular through oxydative stress. in this context, research of low grade systemic inflammation through cytokine assay appears legitimate. the primary outcome of this study is to describe inflammation profile of patients with phenylketonuria.

phenylketonuria (pku) is a metabolic hereditary disease due to lack of activity of phenylalanine hydroxylase. this lack of activity whom origin is genetic, results in chronic hyperphenylalaninemia, toxic to central nervous system and cardiovascular system. without treatment, pku is responsible for mental retardation in children. pku is subject to systematic screening at birth and if diagnosis is confirmed a specific diet controlled in phenylalanine is prescribed for infant. this diet allows a neurodevelopment as closed as healthy infant. despite this diet, neurological and systemic complications are more often reported at adult age. it is therefore recommended to follow patient regularly in order to search for those complications. in a pku murine model, it has been shown (cf references) that a low grade systematic inflammation exists and was reversible after dietetic treatment using glycomacropeptide (through a probiotic effect of this protein naturally phenylalanine free). existence of this low grade systematic inflammation, evaluated by plasmatic cytokine screening (tnf alpha il2, il6, il10, ifngamma, il1alpha, il1beta and protein c reactive) has not been proven in humans to date. primary outcome of this study is to characterize this low grade systemic inflammation profile in patient with pku.

Eligibility criteria:
inclusion criteria (patient with pku) * age \>/= 18 years old * phenylketonuria diagnosis * fasting condition * registered with a social security system * patient consent inclusion criteria (healthy volunteer) * age \>/= 18 years old * no metabolic condition * fasting condition * paired to patient with phenylketonuria already included according to age, sex and bmi class * registered with a social security system * volunteer consent exclusion criteria, common to healthy volunteer and patient with phenylketonuria * pregnant and lactating women * subject to legal protection measures. * chronic or acute inflammatory disease * fever on inclusion * undergoing anti inflammatory treatment * surgery in the previous months * diabetes * included in other therapeutic trial

Keywords: low grade inflammation cardiovascular phenylketonuria
interrupters of vascular damage in malignant hypertension

Conditions: Malignant Hypertension

Summary: the pathophysiology of malignant hypertension is poorly understood. the objective of this translational research project is to evaluate the relationship between activation of vasoactive systems (renin-angiotensin and endothelin systems), angiogenic signal deficiency (vegf and sflt-1) and the occurrence of malignant hypertension episodes in humans.

the pathophysiology of malignant hypertension is poorly understood. the current dogma is based on an overwhelming renin-angiotensin-aldosterone system activation, leading to arterial hypertension that overcomes target organ auto-regulatory mechanisms and leads to subacute microvascular lesions. however, some patients present with normal or lowered renin in the acute phase of malignant hypertension, suggesting other pathophysiological pathways. malignant hypertension was reported following anti-vegf treatment, suggesting that this pathway may be involved. recent unpublished animal data highlight 1/ the possibility of severe deregulation of the vegf (vascular endothelial growth factor) system in malignant hypertension 2/ the possibility of compensation of the vasculotoxic effects of vegf deficiency by inflammasome components. these systems have never been studied together in human hypertension. investigators will analyze the angiogenic, vasoactive and vegf systems through blood and urine sampling. these samples will be collected at the time of malignant hypertension diagnosis and repeated one month later in 30 patients. the same tests will be performed in 15 patients with severe non-malignant hypertension, constituting the control group.

Eligibility criteria:
inclusion criteria: patients group : * patients included in the hama cohort * who is willing to take part in the ivama project control group : * grade 2 or 3 hypertension with office blood pressure measurement (above 160 and/or 100 mmhg for systolic and diastolic) * persistence of blood pressure above 160 / 100 mmhg on the average of 3 "attended" blood pressure measurements exclusion criteria: patients group : * age \< 18 years old * patients with chronic renal failure of stage 3 or higher. * patients with any type of diabetes * patient in per partum * patients who cannot freely give their consent, or patients who refuse to participate * chronic dialysis patient control group: * evidence of subacute involvement of one of the following target organs: brain, kidney, eye, heart, thrombotic microangiopathy. target organ impairment is defined in the inclusion criteria for the "patients" group. * presence of known chronic kidney insufficiency of grade 3 or higher * chronic dialysis patient * diabetes of any type * patients who cannot freely give their consent, or patients who refuse to participate

Keywords: malignant hypertension severe hypertension hypertensive emergency pathophysiology angiogenic system inflammasome
immunogenicity, safety and tolerability of two doses of adjuvanted and non-adjuvanted swine origin a/h1n1 monovalent influenza vaccine in healthy subjects 18 or more years of age

Conditions: Pandemic Influenza

Summary: this present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of an adjuvanted and not-adjuvanted new swine-origin influenza a/h1n1 virus monovalent subunit vaccine in healthy adult and elderly subjects. a booster dose will be administered 12 months after the first vaccination.


Eligibility criteria:
inclusion criteria: 1. males and females 18 years of age and above on the day of enrollment; 2. individuals in good health 3. individuals are able to comply with all study procedures 4. willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response. exclusion criteria: 1. individual not able to comprehend and to follow all required study procedures; 2. history or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study; 3. any serious chronic or progressive disease according to judgment of the investigator 4. history of any anaphylaxis, serious vaccine reactions, to any excipients. 5. adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to day 1; 6. receipt of another investigational agent within 4 weeks prior to enrollment, or before completion of the safety follow-up period in this or in another study; unwilling to refuse participation in another clinical study through the end of this study; 7. any other vaccines within 4 weeks prior to enrollment or who are planning to receive any vaccine within 4 weeks from the study vaccines; only exception being plain seasonal influenza vaccines which are allowed until 1 week prior to and after 1 week study vaccinations. 8. receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks; 9. axillary temperature ≥ 38°c or oral temperature ≥ 38.5°c within 3 days of intended study vaccination; 10. known or suspected impairment/alteration of immune function, for example resulting from a receipt of immunosuppressive therapy within 60 days prior to visit 1; 11. history of progressive or severe neurological disorders; 12. surgery planned during the study period that in the investigator's opinion would interfere with the study visits schedule; 13. female of childbearing potential, not used any acceptable contraceptive methods for at least 2 months prior to study entry; 14. female pregnant or nursing (breastfeeding) mothers or females of childbearing potential do not plan to use acceptable birth control measures during the first 3 weeks after vaccination; 15. members of the research staff or their relatives.

Keywords: pandemic influenza vaccine
to optimize the therapeutic pathway of peginterferon treatment in patients with chb based on ifna2p.ala120thr /isgs.

Conditions: Hepatitis B

Summary: the study is to guide clinical cure of peginterferon alfa-2a treatment in patients with chronic hepatitis b based on the detection of interferon gene mutation (ifna2p.ala120thr) and interferon-stimulated genes (isgs) detection gene spectrum.

it is estimated that more than 400 million people are infected with hepatitis b virus (hbv) globally.how to make more patients with chronic hepatitis b get clinical treatment through the existing anti-viral treatment is an urgent problem to be solved.this study is a random, multi-center and open experiment,the collaborators includes the second people's hospital of zhongshan city, the eighth people's hospital of guangzhou city, and the first people's hospital of foshan city. patients with chronic hepatitis b who were treated with nas for over 1 year,hbsag quantification≤1500 iu/ml, hbeag negative and serum hbv dna quantification \ 0.05 were divided into two groups. after informed consent , patients were grouped according to their treatment intentions,in one group, patients continued nas for another 48 weeks. in another group , patients were treated with peg-interferon-2a and nas for 48 weeks.patient's bmi, genotype, family history, smoking history, drinking history, other medical history, suspected transmission channels, types and time of use were recorded in this study.moreover, patients were assessed every 12 weeks,included liver and kidney function, blood routine, hbv cccdna, hbeag quantification, hbsag quantification, pgrna and so on.in addition,liver imaging examination and liver hardness test were assessed every six months. in this study, we will analyze whether clinical cure rates differed between patients with chronic hepatitis b treated with peginterferon alfa-2a and nas;bisedes,the baseline interferon variant site variants and changes in interferon-stimulated gene profile expression were analyzed to determine whether they could be used as molecular markers to predict clinical cure with interferon.

Eligibility criteria:
inclusion criteria: * age between 18 and 60 years old; * hbsag positive, hbsag quantification≤1500 iu/ml; * serum hbv dna quantification \<100 iu/ml; * hbeag negative. exclusion criteria: * treated with interferon in the past six months; * liver cirrhosis or hcc and other associated tumors; * women during pregnancy or lactation; * with liver disease caused by other causes; * combination infection of hiv or other immunodeficiency diseases; * with diabetes, autoimmune diseases and other organ dysfunction or failure; * combination of other serious complications (infection, hepatic encephalopathy,gastrointestinal bleeding, hepatorenal syndrome, etc.); * others who cannot be treated with interferon; * anyone cannot return to the hospital for follow-up and follow-up visits regularly as planned

Keywords: chronic hepatitis b ifna2p.ala120thr /isgs
etiology of acute exacerbations of chronic obstructive pulmonary disease (aecopd) in japan

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this prospective, epidemiological, cohort study is to evaluate the lung microbiome in stable-state chronic obstructive pulmonary disease (copd) in japanese participants


Eligibility criteria:
inclusion criteria: * participants must be able and willing to comply with the requirements of the protocol. * participant must be aged greater than or equal to (\>=)40 years to to less than or equal to (\<=)80 years at the time of signing the informed consent form (icf). * participants must have a record of a clinical diagnosis of copd, acos or cb. * participants must have moderate to severe airflow limitation based on spirometry: fev1 percent predicted normal \>=30 to \<=80 percent (%) and post-bronchodilator fev1/forced vital capacity (fvc) ratio \<0.7. * participants must be symptomatic at screening, defined as having a cat score \>=10. * participants must have a documented history of at least 1 lrti treated with antibiotics and/or oral/systemic corticosteroids. * participants must be current or former tobacco (cigarette) smokers with a smoking history of \>=10 pack-years. * participants may be male or female. for female participants: a female participant is eligible to participate if she is not pregnant or breastfeeding. women of non-childbearing potential can also participate. a woman of childbearing potential must have had a highly sensitive negative urine pregnancy test. * participants should be able to provide a spontaneous or induced sputum sample of \>=0.2 grams (g) at the screening visit. exclusion criteria: * participants with a diagnosed respiratory disorder other than copd, acos or cb. * participants with a diagnosis of alpha-1 antitrypsin deficiency as the underlying cause of copd. * participants who have received antibiotics within 1 month of screening or have received antibiotics for more than 30 days within 90 days prior to screening; except for those who have received and are currently receiving long-term treatment with low-dose macrolide: erythromycin \<=600 milligrams (mg) per (/) day or clarithromycin \<=200 mg/day. * participants who have received systemic corticosteroids (oral/intravenous/intramuscular) for more than 14 consecutive days within 90 days prior to giving informed consent. * participants who are unable to use or to comply with daily completion of the ediary.

Keywords: asthma-copd overlap syndrome acute exacerbations of chronic obstructive pulmonary disease acute exacerbation and respiratory infections in copd-japan chronic bronchitis chronic obstructive pulmonary disease exacerbation microbiome quantitative polymerase chain reaction (qpcr) 16s ribosomal ribonucleic acid (16s rrna) metagenomic analysis sputum
dtdi during a sbt to predict extubation failure in preterm infants

Conditions: Premature

Summary: weaning from mechanical ventilation is a critical issue and the diaphragmatic disfunction has been demonstrated to play an important role in extubation failure. the aim of present investigation is to evaluate diaphragmatic excursion velocity during in patients undergoing spontaneous breathing trial through tissue doppler analysis in both inspiration and expiration.


Eligibility criteria:
inclusion criteria: * premature infants with gestational age \<32 weeks and supported by invasive mechanical ventilation ≥48 hours * all the indications for extubation are met：cough or vomiting due to spontaneous breathing and sputum aspiration; ventilator parameters in recent 24 hours: map \ 7.25, (paco2\ 90% * a successful sbt * parents or legal guardians sign informed consent to attend this study exclusion criteria: * accidental extubation * chest ct or bronchoscopy during hospitalization indicated congenital airway dysplasia * complex congenital heart disease * congenital metabolic diseases, neuromuscular diseases * severe brain injury * surgical mechanical ventilation * give up before extubation; * pneumothorax or pleural effusion * no consent is signed

Keywords: tissue doppler imaging premature infants extubation diaphragm
homeless veterans and peer whole health coaching

Conditions: Acute Care Service Utilization; Mental Health Status; Physical Health Status; Housing

Summary: use of acute care services (e.g., hospitalizations, emergency department visits) contributes substantially to the cost of healthcare for veterans. homelessness is a robust social determinant of super utilization of acute care. the goal of this project is to test if peer specialists trained in whole health coaching can reduce homeless veterans' frequent use of acute care.

ten percent of patients account for up to 70% of acute care costs. among these "super-utilizer" patients, homelessness is a robust social determinant of acute care utilization. through a field-based dashboard and clinical aids, the hot spotter analytic program assists patient aligned care teams (pact) with targeting and tailoring care for the highest-need homeless veterans. however, many veterans identified by the analytics do not engage in supportive services that reduce risk for acute care utilization. peer specialists (ps) are a high-value workforce that can facilitate veterans' engagement in care. yet, there is a need to enhance the ps role with a structured approach that can capitalize on known facilitators of care engagement among homeless veterans. whole health coaching (whc) is one such approach. by focusing on patients' values and goals rather than treatment of specific conditions, whc reduces patients' stigma regarding their care needs and increases patient activation and well-being, which can increase engagement in supportive services. the goal of this project is to integrate use of hot spotter analytics with peer specialists trained in whole health coaching (ps-whc) and evaluate whether this approach reduces homeless veterans' frequent use of acute care. using a hybrid type 1 design at the palo alto, bedford, and north little rock vas, the investigators will test whether receipt of ps-whc (vs. enhanced usual care; euc) predicts (1a) lower acute care utilization, (1b) better health-related outcomes, and whether (1c) the effects of ps-whc on 1a and 1b are mediated by increased (i) patient activation and well-being, and (ii) access to supportive services. aim 2: conduct a process evaluation to inform va's potential widespread implementation of hot spotter analytics + ps-whc on pacts. aim 3: conduct a budget impact analysis to determine the impact on total costs of va care due to implementing ps-whc.

Eligibility criteria:
inclusion criteria: veterans who: * are on va's homeless registry, which comprises those who utilized any va homeless programs and services in the past 2 years * are enrolled on a patient aligned care team (or "pact") at a study site * had a hot spotter qualifying event in two or more quarters in the past year will be eligible for participation exclusion criteria: * veterans who have a suicidal and/or behavioral flag in their medical record and those who are too cognitively impaired to understand the informed consent process and other study procedures will be excluded

Keywords: homeless persons costs and cost analysis mental health peer support
the effects of polymyxin-b protects on sepsis induced kidney dysfunction: a randomized clinical trial

Conditions: Gram-Negative Bacterial Infections; Sepsis

Summary: aim of the study is to verify whether polymyxin-b hemoperfusion protects from renal dysfunction in patients with severe sepsis from gram negative infection.

acute renal failure (arf) is a frequent complication in sepsis, in nearly to 50% of the cases, and the mortality rate is higher, compare to patients with arf alone (70% vs 45%). clinical and experimental studies demonstrated the key role of apoptosis, or programmed cell death, in the induction of tubular and glomerular injury in the course of sepsis. indeed, it has been shown that inflammatory cytokines and lipopolysaccharide (lps) cause renal tubular cell apoptosis via fas- and caspase-mediated pathways. in addition, lps is able to alter the normal expression pattern of sodium, urea and glucose renal transporters and to modulate tubular polarity by changing the expression of tight junction proteins with consequent back-leakage of tubular fluid in the interstitial spaces and enhancement of the inflammatory process. therefore a novel extracorporeal therapy to remove circulating lps, using the polymyxin-b fiber (pmx-b) cartridge was developed. the pmx-b cartridge is an extracorporeal hemoperfusion device and consists of a polystyrene-based, fibrous adsorbent on which the polymyxin b antibiotic is covalently immobilized as a ligand to adsorb endotoxin. aim of this study is to verify whether the removal of lps, using the pmx-b hemoperfusion system, protects from acute renal failure, reduces the need for renal replacement therapy (rrt) and consequently improves the outcome in severe sepsis from gram negative infection.

Eligibility criteria:
inclusion criteria: * endotoxemia associated to severe sepsis exclusion criteria: * age \< 18 years old * organ transplantation * hemorrhagic shock * thrombophilia * chronic renal failure * cardiogenic shock * apache ii score \> 30 * lack of consent

Keywords: acute renal failure lipopolysaccharide tubular apoptosis polymyxin-b fiber severe sepsis from gram negative infection