Kornimate/medical-research-clean huggingface dataset:
evaluation of pupillary distension reflexes, as a tool for the monitoring of analgesia for patients in intensive care.

Conditions: Failure of Respiratory Function

Summary: sedation-analgesia is an important therapy for patients in resuscitation. it requires a surveillance, in order to avoid excessive or insufficient dosages of sedative or nonmorphinics, sources of side effects. yet, means of surveillance are limited in resuscitation care : variations of blood pressure and heart rate are not very sensitive criterias. clinical scales to measure the sedation and analgesia level were proposed for patients in resuscitation, including the richmond (rass) sedation scale and the behavioural pain scale (bps). the study of pupillary dilatation's reflex (rdp) due to a nociceptive stimulation is a tool proposed for the monitoring of the analgesia peroperative for patients under general anaesthetic. yet, there isn't any study that measured the analgesia threshold by pupillometry for patients in resuscitation receiving a sedation-analgesia. the main goal of this study is to measure the minimum intensity of a painful stimulation (tetanus), leading to a 10% raise of rdp in a cohort of patients in resuscitation care receiving sedation-analgesia continuously.

secondary goals will be to bring this measures back to the pain score bps and the pupillary diameter measured during a painful care (tracheal aspiration), as well as morphinics dosage.

Eligibility criteria:
inclusion criteria: * intubated and mechanically ventilated patients receiving by continuous intravenous an hypnotic sedation (midazolam or propofol) associate with a morphine type drug (fentanyl, sufentanil, rémifentanil, or morphine) since at least 6 hours and for a predictable duration over 24 hours. * both gender * adult over 18 years exclusion criteria: * neuromuscular pathology that does not allow the use of clinical scales in order to measure sedation-analgesia : tetraplegia, resuscitation neuromyopathy, curares. * intracranial hypertension (intracranial pressure over 20 mmhg) whatever the cause (traumatique, vasculaire, tumorale). * dysautonomia altering the pupillary dilatation's reflex (rdp) : old diabetes with diabetic retinopathy, multiple sclerosis, systemic amylose. * treatment in progress which may affect the pupillary dilatation's reflex (rdp) : antiemetic (droperidol, métoclopramide), alpha-2 agoniste (clonidine). * ocular pathology * opiate addiction * refusal by a patient * pregnant women

Keywords: pupillary reflexes analgesia sedation
a study to provide continued access to mitapivat for participants who previously completed an agios-sponsored mitapivat study

Conditions: Pyruvate Kinase Deficiency; Anemia, Hemolytic

Summary: the purpose of this study is to provide continued access to mitapivat for participants who completed an agios-sponsored mitapivat study (antecedent) and do not have commercial access to mitapivat.

participants will continue the mitapivat dose regimen that they were receiving at the final visit of their antecedent study.

Eligibility criteria:
inclusion criteria: * has completed an agios-sponsored adult pyruvate kinase (pk) deficiency study of mitapivat within 1 day of enrollment in this rollover study; * is unable to obtain mitapivat treatment due to country regulations or lack of commercial access; * was deriving clinical benefit from mitapivat treatment at the completion of the antecedent study, in the opinion of the investigator; * for women of childbearing potential, must be abstinent of sexual activities that may result in pregnancy as part of their usual lifestyle or agree to use 2 forms of contraception, 1 of which must be considered highly effective, from the time of providing informed consent, throughout the study, and for 28 days after the last dose of study drug. the second form of contraception can be an acceptable barrier method; * written informed consent from the participant before any study-related procedures are conducted and willing to comply with all study procedures for the duration of the study; * agrees not to participate in other interventional clinical studies, including other studies of mitapivat, during participation in this study. exclusion criteria: * has discontinued treatment with mitapivat before completing the antecedent study; * known allergy or other contraindication to mitapivat or its inactive ingredients (microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, mannitol, opadry ii blue \[hypromellose, titanium dioxide, lactose monohydrate, triacetin, and fd\&c blue #2\]); * any medical, hematologic, psychological, or behavioral condition(s) or prior or current therapy that, in the opinion of the investigator, may confer an unacceptable risk to participating in the study also excluded are: * participants who are institutionalized by regulatory or court order * participants with any condition(s) that could create undue influence (including but not limited to incarceration, involuntary psychiatric confinement, and financial or familial affiliation with the investigator or sponsor).
efficacy of ciclesonide inhaled once daily versus other corticosteroids used for treatment of mild asthma in children (4 to 11 years) (by9010/ca-101)

Conditions: Asthma

Summary: the aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. the study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). the study will provide further data on safety and tolerability of ciclesonide.

the drug being tested in this study is called ciclesonide. ciclesonide is being tested to treat children who have mild asthma. the study enrolled 240 patients. participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need): * ciclesonide 100 µg * ciclesonide 200 µg * placebo (dummy inactive inhalation) - this is a metered-dose inhaler that looks like the study drug but has no active ingredient. all participants were asked to take two puffs from a metered-dose inhaler once daily, in the evening, for up to 12 months. this multi-center trial was conducted in canada, hungary and south africa. the overall time to participate in this study was 12 months preceded by a baseline washout period of 3 to 4 weeks. participants made multiple visits to the clinic including a safety follow-up visit within 30 days of the last treatment.

Eligibility criteria:
main inclusion criteria: * outpatients * symptoms consistent with the diagnosis of asthma for at least 12 months * forced expiratory volume in one second (fev) at least 80% of predicted * participants who have a history of reversible airway obstruction * good health with the exception of asthma main exclusion criteria: * history of life-threatening asthma * a hospitalization for asthma within the last 3 months, or more than two hospitalizations for asthma within the last year * concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids * participants suffering from relevant lung diseases causing alternating impairment in lung function (e.g. chronic bronchitis or emphysema) * prematurely born children (\<36 weeks of gestation) * smokers * pregnancy (or intention to become pregnant during the course of the trial), breast feeding or lack of safe contraception by female of child-bearing potential

Keywords: asthma ciclesonide exacerbation
biorepository and registry for plasma exchange patients

Conditions: Antibody-mediated Rejection; NMO Spectrum Disorder; TTP; CIDP

Summary: patients who have immune mediated diseases commonly undergo plasma exchange (plex) procedures to remove pathological substances, typically believed to be antibodies. at our facility about 400 of these procedures are performed annually on 40-60 different patients. these procedures are considered within the standard of care for these patients and are covered by insurance. this study will not influence the treatment plan for subjects who participate in this study. the goal of the study is to collect and cryopreserve blood biospecimens (plasma, serum, pbmcs) for current and future studies. any patient undergoing plasma exchange procedures will be eligible for the study. patients or the legally authorized representative (lar) will be consented for the study as soon as feasible after the are referred to degowin for plasma exchange. the immediate objective of the study is to examine antibody levels (igg/igm) and baff levels in the blood of these patients over the course of the plasma exchange treatments. specimens and clinical data will be collected such that other immune factors that may regulate b cell survival, proliferation and antibody secretion can be studied. another goal of the study is to isolate and cryopreserve pbmcs at different points during the patient's treatment. this would allow the study of immune cells that may mediate these diseases. the study will also follow pathological antibodies over time in these patients so biospecimens can be obtained even after the completion of their course of plasma exchange treatments. the collection of biospecimens and clinical information from these subjects will help us understand the impact of plasma exchange on both normal and pathological immune factors in a variety of patients undergoing these procedures.


Eligibility criteria:
pts undergoing plasma exchange therapy are eligible to be in this protocol

Keywords: plasma exchange plasmapheresis
visual outcomes following bilateral implantation of the vivity toric intraocular lens

Conditions: Cataract Senile; Intraocular Lens Complication

Summary: the objective of this study was to evaluate the clinical and patient reported outcomes after bilateral implantation of the acrysof™ iq vivity™ toric intraocular lens.

this is a prospective interventional case series of 30 patients who underwent cataract surgery and bilateral implantation of the acrysof™ iq vivity™ toric intraocular lens. this study is represented by an asian cohort of patients and the study evaluations were focused not only on clinical visual outcomes but also on "real-life" patient reported outcomes such as dysphotopsias, spectacle independence and daily visual tasks all of which were measured at 1 month and up to 3 months postoperatively. the objective would be to provide insight into the performance of this intraocular lens in asian patients.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * bilateral significant cataracts * bilateral significant corneal astigmatism exclusion criteria: * previous refractive surgery * amblyopia * strabismus * any ocular co-morbidity which could impact on final visual acuity * pre-existing zonular weakness * capsular instability or compromise

Keywords: cataract surgery intraocular lens non-diffractive extended depth of focus
immunization against tumor cells in sezary syndrome

Conditions: Cutaneous T-cell Lymphoma; Sezary Syndrome

Summary: this research is being done to look at the safety and value of a vaccine for a cancer found in the blood and skin known as cutaneous t-cell lymphoma (ctcl) and sezary syndrome. in the laboratory, researches found that special white blood cells, called dendritic cells (dcs), are able to stimulate the immune system (groups of cells that protect the body from germs and diseases) in a way that helps your body fight cancer. autologous (from your own body) dcs will be prepared (mixed together) in the laboratory with your cancer cell (sezary cells) to allow your dcs to pick up parts of your sezary cells to make the vaccine for you.

although the etiology of ctcl is not completely understood, immunologic factors appear to play an important role. dendritic cell (dc)-tumor cell vaccines have several features that suggest applications for the immunotherapy of human tumors. importantly, dc-tumor cell immunization has the potential to simultaneously stimulate cd4+ and cd8+ t cell-mediated immunity against multiple tumor antigens. the vaccine will be prepared from the subject's own blood, obtained during leukapheresis. from leukapheresed blood, monocyte-derived dcs and malignant lymphocytes will be isolated. the dcs will then be loaded with lymphocyte-derived tumor antigens. formulations and release criteria must be met before vaccine can be administered. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of sezary syndrome * must be willing to discontinue concomitant medications for ctcl, including: \*oral steroids above 10 mg - 30 day washout, unless subject has addison's disease or adrenal insufficiency, \*puva or uvb - 2 week washout, sunbathing, tanning beds, etc. and for the duration of the study, \*electron beam - for the duration of the study, \*chemotherapeutic agents - 30 day washout, \*bexarotene capsules or other oral biologics - 3 week washout, \*topical nitrogen mustard - 2 week washout, \*extracorporeal photopheresis - 4 week washout and for the duration of the study. * must be at least 18 years of age and must be able to understand the written informed consent. * subjects must have no evidence of active infection. subjects with active infections (whether or not they require antibiotic therapy) may be eligible for continuation of therapy after complete resolution of the infection. subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatment. exclusion criteria: * subjects with autoimmune disease, hiv, and/or hepatitis * subjects who are pregnant or lactating

Keywords: cutaneous t-cell lymphoma (ctcl) sezary syndrome mycosis fungoides vaccine
nivolumab in the real world: analysis of the expanded use in spanish patient

Conditions: Non Small Cell Lung Cancer

Summary: the investigators will be retrospectively review the case note of patients registered in the eap of nivolumab. a standard anonymous data collection form will be used to collect data and to analyze it. patients with advanced non-small cell lung cancer previously treated and included in the spanish expanded access programme of nivolumab.

this study will help to understand the efficacy of nivolumab in the real world setting within the spanish expanded access programme. the main objective of this study is to evaluate nivolumab efficacy in terms of overall survival (os), progression free survival (pfs), overall response rate (orr) and safety in the clinical practice. the efficacy variables will be assessed for patients (squamous vs non-squamous) who received second line therapies or third lines and subsequent lines and also, long responders will be evaluated.

Eligibility criteria:
inclusion criteria: 1. squamous or non-squamous, non small cell lung cancer (nsclc), stage iiib/iv (histologically or cytologically confirmed), relapsed after 1 prior platinum-based systemic treatment and who received treatment within the spanish expanded access programme of nivolumab (eap) 2. alive patients must have signed and dated an irb/iec-approved written informed consent form in accordance with regulatory and institutional guidelines. this must be obtained before the performance of any protocol-related procedures that are not part of normal subject care exclusion criteria: 1. alive patients who do not want to sign and date an irb/iec-approved written informed consent form 2. patients who were accepted in the eap but do not receive treatment
mhealth application for anticoagulation care in atrial fibrillation

Conditions: Atrial Fibrillation; Anticoagulants; Circulating, Hemorrhagic Disorder

Summary: this study will assess the benefits of using a mobile health application designed for shared decision aid in anticoagulation therapy in patients with atrial fibrillation (af). the aim is to improve their treatment adherence and time in therapeutic international normalized ratio (inr) range. the results of this study have the potential to lead to a sustainable and resource-efficient strategy for better prevent thromboembolic events in patients with atrial fibrillation.

atrial fibrillation is a common disease, with important burden on morbidity and mortality and a challenging management. its incidence and healthcare costs have increased over the decades. one of the most important features of this arrhythmia is its stroke risk, which can be reduced with the use of anticoagulants. deciding about anticoagulation therapy is complicated due to frequent competing comorbidities and potential harms of the therapy itself. to achieve better outcomes in preventing stroke, it is paramount that decisions about atrial fibrillation treatment be shared between providers and patients. mobile health is empowering individuals to assume a more active role in monitoring and managing their chronic conditions and therapeutic regimens. also, health professionals are being provided with fast and point-of-care information, which can facilitate decision-making. therefore, this study will investigate the effects of an mhealth application idealized to aid shared decision and improve anticoagulation care in atrial fibrillation. adults with atrial fibrillation will be recruited from anticoagulation outpatient clinics and basic health units and randomized to either (1) an intervention group in which the mhealth application will be used during the consultations or (2) a control group receiving the usual care with anticoagulation. it is hypothesized that the intervention group will achieve better anticoagulation outcomes.

Eligibility criteria:
inclusion criteria: * adults \>=18 years * diagnostic of atrial fibrillation * indication of oral anticoagulation by their physician, based on risk scores * ability to speak, hear and understand portuguese * able to receive and read text messages through a cell phone exclusion criteria: physical impairments that prevent completion of the intervention, cognitive impairments that jeopardize informed consent and/or intervention comprehension and not fluent in portuguese.

Keywords: mobile health
safety and immunogenicity of a novel h5n1 influenza vaccine in healthy adults age 18-49 years

Conditions: Influenza

Summary: this study will evaluate the safety and immunogenicity of vax161b \[stf2.ha5 h5n1\], a recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of doses.

the purpose of this study is to test an investigational vaccine known as "vax161b". vax161b is a vaccine for the influenza a virus subtype h5n1 avian influenza virus (bird flu). in this study, the subject will receive the vax161b vaccine at one of five doses to see which does might be the best. vaxinnate want to find out how safe these vaccines are and how well they are tolerated by people who receive them. to measure how effective each type of vaccine is, vaxinnate will test the ability of the body to develop an immune response, which means how well the body recognizes and defends itself against the influenza virus.

Eligibility criteria:
inclusion criteria: * male or female aged 18 - 49 years inclusive * give written informed consent to participate * healthy, as determined by medical history, physical examination * comprehension of the study requirements * willing to provide multiple blood specimens collected by venipuncture. exclusion criteria: * subjects who have a psychiatric illness, a chronic illness that would interfere with participation or interpretation of results * clinically significant abnormal liver function tests * positive serology for hbsag or hcv antibodies * impaired immune responses * history of anaphylactic type reaction to injected vaccines * history of drug or chemical abuse in the year prior to screening * history of guillain-barré syndrome * history of chronic obstructive pulmonary disease or history of other lung disease

Keywords: influenza vaccines h5n1
morphofunctional, gene, inflammation molecules and oxidative stress analysis in kidney tissue of covid-19 patients

Conditions: COVID-19; Kidney Injury; Gene Amplification; Oxidative Stress; Inflammatory Response

Summary: the involvement of the kidneys in patients infected with the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) at the outset of the pandemic was associated with high mortality rates worldwide. this was in part due to the generation of an inflammatory process and exacerbated oxidative stress. the present study was initiated to investigate the relationship between morphofunctional changes and gene expression in the kidney tissue of deceased mexican patients prior to the initiation of vaccination. the investigator designed a single-center, prospective, cohort study, to analyze and relate the morphofunctional changes and gene expression of inflammatory and oxidative stress molecules in the kidney tissue of men who died from severe covid-19. a total of 40 percutaneous renal biopsies from deceased patients with severe acute respiratory syndrome coronavirus 2 infection were included in the study and divided into two a groups. one group was preserved in trizol to obtain rna and total protein, while the remaining sample was fixed in formalin to be examined by staining with hematoxylin and eosin. the histopathological analysis was conducted by an experienced pathologist. the expression of molecules was evaluated by real-time polymerase chain reaction assay (nphs2, slc9a1, cx3cl1, havcr1, slc22a17, sod2, egf, timp2, hmox1, fabp1, and so forth). the following biomarkers were analyzed: interleukin-6, arginase-1 (arg-1), dipeptidyl peptidase-4 (dpp-4), gstt1, type i gamma-glutamyltransferase (ggt1), occludin (ocl), cyp3a4, and claudin-8 (cl-8). additionally, western blot analysis was conducted on claudin-5 (cl-5), occludin, hsp70, nuclear factor erythroid 2-related factor-2 (nrf-2), superoxide dismutase-2 (sod-2), nicotinamide adenine dinucleotide phosphate dehydrogenase 1 (nqo1), gamma glutamylcysteine synthase (γ-gcl), and receptor for advanced glycation end products (rage). the estimated glomerular filtration rate (egfr) was calculated using the chronic kidney disease epidemiology collaboration (ckd-epi) equation, with the subjects divided into two groups based on their egfr: \>60 or \<60 ml/min/1.73 m². the statistical analysis was conducted using the stata program and graphpad software, version 10.2.3.


Eligibility criteria:
inclusion criteria: * not having at least one creatinine measurement. * family members will not accept to participate. exclusion criteria: * specimens with sub-optimal quality for analysis.