Kornimate/medical-research-clean huggingface dataset:
study of obeldesivir to treat nonhospitalized adults with acute respiratory syncytial virus (rsv) infection

Conditions: RSV Infection

Summary: the goal of this clinical study is to learn more about the study drug, obeldesivir (odv; gs-5245), and how safe and effective it is in treating nonhospitalized adults with acute respiratory syncytial virus (rsv) infection. the researchers want to see if obeldesivir can help participants' symptoms get better faster. the primary objectives of this study are to evaluate the efficacy of odv in reducing the duration of symptoms and to evaluate the safety and tolerability of odv in nonhospitalized adult participants with acute rsv infection.


Eligibility criteria:
key inclusion criteria: * exhibits at least 1 of the following risk factors for severe rsv disease: 1. age ≥ 60 years 2. moderate or severe chronic obstructive pulmonary disease (copd) with a history of exacerbation during the preceding 12 months. 3. asthma with a history of ≥ 1 exacerbation during the proceeding 12 months 4. one or more of the following chronic lung diseases: * i) bronchiectasis * ii) interstitial lung disease (eg, idiopathic pulmonary fibrosis) * iii) pulmonary hypertension 5. chronic cardiovascular disease exclusive of hypertension * rsv infection confirmed ≤ 3 days before randomization * new onset or increased from baseline of ≥ 2 of the following signs and or/symptoms, and at least 1 sign/symptom of moderate severity a screening, and onset ≤ 3 days before randomization. * rsv vaccine status: * individuals whose only risk factor is age ≥ 60 years must not have received any doses of a vaccine for rsv. key exclusion criteria: * currently requiring or expected to require hospitalization within 48 hours after randomization. * documented previous infection and/or hospitalization for rsv during the current respiratory virus season. * documented to be positive for influenza a or b virus, and/or severe acute respiratory syndrome coronavirus 2 (sars-cov-2) ≤ 7 days prior to randomization. * concurrent infections requiring treatment with any antimicrobial therapy ≤ 7 days prior to randomization. * individuals with a history of cystic fibrosis. * undergoing dialysis, known history of moderate or severe renal impairment within the preceding 6 months prior to randomization. * pregnant at screening. * received any approved or authorized, direct-acting antiviral drug or monoclonal antibody against rsv \< 28 days or \< 5 half-lives, whichever is longer, before randomization. * received an investigational product \< 28 days or \< 5 half-lives, whichever is longer, before randomization. note: other protocol defined inclusion/exclusion criteria may apply.
an efficacy study of a single dose treatment of pro-513 for subjects suffering a migraine attack

Conditions: Migraine; Photophobia; Phonophobia

Summary: the purpose of the study is to show the efficacy of a single dose of pro-513 for treating subjects suffering moderate pain form a migraine attack, with or without aura. the study is also intended to show the effectiveness of pro-513 for associated symptoms of nausea, photophobia, and phonophobia due to a migraine attack.


Eligibility criteria:
inclusion criteria: * male and female subjects * 18-65 years of age * primary diagnosis of migraine attack with aura or migraine attack without aura * migraine history of averaging at least 1 migraine attack per month but averaging not more than 6 migraine attacks per month over the prior year * female subjects must use an effective form of birth control * listing of additional inclusion criteria are available through the sponsor exclusion criteria: * excluding subjects with a history of other serious events causing secondary headaches * excluding subjects with a current medical condition that could interfere with the overall study intent or affect the absorption, distribution, metabolism, or excretion of the study medication * excluding subjects with a history or current medical condition that could confound the study results or use of a concomitant medication that could interfere with the study drug * listing of additional exclusion criteria are available through the sponsor

Keywords: migraine photophobia phonophobia aura
reinterpretation of cnv with unknown significance: a 5-year retrospective analysis

Conditions: Genetic Disease; CNV; Genetic Counseling; Array CGH

Summary: we aim to assess the usefulness of systematic reinterpretation of cnv of unknown significance. to investigate this question we will study all cnv of unknown significance detected between 2010 and 2017.

array-cgh is a front-line technique in many genetic indications in both prenatal and postnatal settings. it allows the detection of chromosomal rearrangements (duplication or deletion for example) in routine. the interpretation and classification of these copy number variations or cnvs is essential but complex. it requires a systematic and methodical analysis of the variation in the context of the scientific literature. when these revisions do not meet either pathogenicity or benignity criteria, they are referred to as variation of unknown significance (or vus). they account for a significant proportion of the revisions up to 75% (palmer et al., 2013). the detection of vus does not, in most cases, allow for a diagnosis and often requires the use of other, costly techniques. the human impact may also be significant in the absence of possible genetic counselling (e.g. in the context of a future pregnancy). reanalysis of an vus is of major interest for at least two reasons : (1) the first, if it is classified as benign, makes it possible to close the investigation of the variant, to consider other leads without ulterior motives, and to reassure the patient about the absence of pathogenicity of the variant. (2) if the vus is ultimately pathogenic, this makes it possible to name the disease for the patient, to specify genetic counselling, to avoid further long and costly investigation and possibly to propose treatment. currently, vus can be reanalysed by the laboratory at the request of the prescribing physician or possibly another physician. however, no systematic reanalysis procedure is currently in place. although these variations of unknown meanings are frequent and represent an important issue, to our knowledge, no systematic database study has been carried out. some similar work has nevertheless been carried out over a shorter period or on an ad hoc basis, showing an interest in this type of approach (palmer et al., 2014). indeed, it seems essential to determine the interest of reanalysing such variations in several modes: diagnostic, economic and human.

Eligibility criteria:
inclusion criteria: * signed consent for array-cgh (authorization for the conservation of a biological sample and its subsequent use to continue investigations); * array-cghcarried out at the genetics laboratory in nancy between 1st january 2010 and 31th december 2017 (considering the date of validation of the report); * identification of variations of unknown clinical significance. exclusion criteria: * none
definition of ards in qinghai province: verification of berlin definition plateau criteria

Conditions: ARDS; High Altitude

Summary: the severity stratification criteria for acute respiratory distress syndrome (ards) in xi'ning qinghai province (mean altitude: 2200m) were clarified according to the oxygenation index (pao2/fio2).

this study is a single-center retrospective study. according to the berlin diagnostic standard, ards patients admitted to the department of severe medicine, affiliated hospital of qinghai university from january 2018 to december 2018 were divided into three groups: mild (153mmhg \< pao2/ fio2 ≥ 230 mmhg), moderate (76mmhg \< pao2/ fio2 ≥ 153 mmhg) and severe (pao2/ fio2 ≥ 76 mmhg). the icu mortality, 28-day mortality, non-ventilator time in icu, icu hospitalization time and non-i hospitalization were observed respectively. the difference of cu time and total hospitalization days.

Eligibility criteria:
inclusion criteria: * 18 years of age * meet the diagnostic criteria of ards * receive invasive mechanical ventilation exclusion criteria: * receive a large number of hormone shock therapy in a short period of time * death within a short period of time (\< 24 h) after mechanical ventilation * no chest imaging data * data missing
exposure to antibiotics and incidence of bacteraemia caused by resistant bacteria

Conditions: Bacteremia

Summary: the primary objective of the study is to identify the risk factors of community-acquired bacteremia to resistant bacteria. as the secondary objectives, the study aims * to describe the episodes of epidemiology of bacteremia (community-acquired and nosocomial) with inpatient patients in aphp. * to research a potential correlation between the incidence of community-acquired bacteremia of studied germs and the evolution of antibiotics consumption in general population in île de france region. * to distinguish three categories of community-acquired bacteremia: real community-acquired infections, infections beginning in community (patients discharged a community care center within 3 months), the nosocomial infections (patients discharged a health center within 7 jours). describe the epidemiology of resistance and the differential impact of individual exposure to antibiotics in these three categories. * to identify, according to pathogens, a temporal threshold from which a prior stay in a health center or had would impact on the occurrence of a community-acquired bacteremia with a resistant bacterium. * to describe prospectively for follow-up of 1 year for hospitalized patients for a community-acquired or nosocomial bacteremia: mortality at one month and 3 months, re-hospitalization for an infectious episode and isolated bacteria during this later episode.

the investigators will study in particularly individual exposure to antibiotics: exposure in 3 months ou in 12 months, cumulative exposure, hospital- and community-acquired exposure, etc.

Eligibility criteria:
inclusion criteria: for bacteraemia cohort: all inpatient patients in a hospital of aphp between january 2010 and december 2018 with at least one haemoculture positive. * presence of at least a bacteremia as primary diagnosis, related diagnosis and associated diagnosis: a40 (streptococcus), a41 (staphylococcus, bgn, anaerobes, others), a32.7 (listeria), a39.4 (meningocoele), a42.7 (actinomyces), a02.1 (salmonella), a54.8 (gonocoque), a48.0 (clostridium). * and/or in biological data presence of at least a haemoculture positive to staphylococcus aureus, klebsiella pneumoniae, escherichia coli, acinetobacter baumannii, enterococcus faecium, enterococcus faecalis, enterobacter cloacae, pseudomonas aeruginosa, streptococcus sp., salmonella sp., clostridium difficile. for control cohort: patients cared in a hospital of aphp between 2010 and 2018 without infection. - patients without infection of cim-10 bacteraemia as primary diagnosis, related diagnosis and associated diagnosis, without haemoculture positive in microbiology. exclusion criteria: - patients aged \< 18 years

Keywords: bacteremia resistant bacteria antibiotic
safety and efficacy study of dexmethylphenidate in children with adhd

Conditions: ADHD

Summary: the purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for adhd (mph) and placebo in children ages 6-12 diagnosed with adhd.


Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of adhd * males and females aged 6-12 exclusion criteria: * inability to understand or follow instructions * is pregnant * diagnosis of tic disorder * history of seizure disorder

Keywords: adhd, children
plasma concentrations of prophylactic cefazolin in pediatric patients undergoing cardiac surgery with cpb

Conditions: Surgical Site Infection

Summary: surgical site infection (ssi) is a serious operative complication that may be associated with any surgical procedures. it increases morbidity and mortality after cardiac surgery. plasma concentration of prophylactic antibiotic, routinely cefazolin, is altered by effects of cardiopulmonary bypass. this study is conducted to measure the plasma concentrations of cefazolin to determine its adequacy in pediatric patients undergoing elective cardiac surgery with cardiopulmonary bypass including its correlation with the incidence of postoperative ssi.


Eligibility criteria:
inclusion criteria: 1. age \< 7 years old 2. undergoing elective cardiac surgery with cardiopulmonary bypass 3. receive cefazolin as prophylactic antibiotic exclusion criteria: 1. known or family history of penicillin or cephalosporins allergy 2. coexisting liver or renal disease 3. previous infection or received any antibiotics within 4 weeks 4. previous surgery with median sternotomy 5. predicted cardiopulmonary bypass time of less than 30 minutes or more than 150 minutes 6. severe hemodynamic instability during the operation, requiring mechanical circulatory support
a phase 1/2 study of oral sb1518 in subjects with chronic idiopathic myelofibrosis

Conditions: Myelofibrosis; Myeloproliferative Disorders; Polycythemia Vera; Essential Thrombocythemia

Summary: the study consists of two phases: the first portion of the study is a phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of sb1518 when given as a single agent orally once daily in subjects with chronic idiopathic myelofibrosis (cimf) regardless of their jak2 mutational status. the second portion of the study is a phase 2 study to define the efficacy and safety profile of single agent sb1518 at the recommended dose in subjects with cimf.


Eligibility criteria:
inclusion criteria * subjects with cimf (including post et/pv mf) requiring therapy, including: * eastern cooperative oncology group (ecog) performance status 0-2 * men of reproductive potential who can agree to practice effective contraception during the entire study period and for one month after the last study treatment * women of child-bearing potential who have a negative pregnancy test within 14 days prior to the first dose of study drug and can agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists * subjects who are able to understand and willing to sign the informed consent form exclusion criteria * subjects with uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. subjects receiving antibiotics for infections that are under control may be included in the study unless the antibiotic is a cyp3a4 inducer/inhibitor * subjects known to be hiv-positive * subjects with known active hepatitis a, b, or c, or latent hepatitis b * women who are pregnant or lactating * subjects with prior radiation therapy to more than 20% of the hematopoietic marrow (prior radiation to spleen is allowed)

Keywords: sb1518 chronic idiopathic myelofibrosis myeloproliferative disorders polycythemia vera essential thrombocythemia jak2 inhibitor
validating cardiac mri biomarkers and genotype-phenotype correlations for dmd

Conditions: Muscular Dystrophy, Duchenne

Summary: this study will collect mri from healthy volunteer boys and boys with duchenne muscular dystrophy (dmd) to help researchers identify and validate cardiac mri biomarkers to better understand the health of the heart and changes in heart health over time in boys with dmd. currently, there is a lack of sufficiently well characterized cardiac mri biomarkers that can serve as endpoints for detecting on-target and/or off-target cardiac effects during clinical drug trials for boys with dmd. consequently, the first objective is to identify and characterize several cardiac mri biomarkers for boys with dmd.

the second objective is to use their well-characterized cardiac mri biomarkers and define their sensitivity for detecting early cardiac involvement. the final objective is to use these validated cardiac mri biomarkers to better understand the genotype-phenotype correlation in boys with dmd, which to date remain tenuous. the investigators propose a pilot study to explore cardiac genotype-phenotype correlations in boys with dmd and outlier phenotypes using approaches they have pioneered for skeletal muscle.

Eligibility criteria:
inclusion criteria: * healthy boys or pediatric patients with dmd age 7 to 21 * able \& willing to complete an approximately 75-minute (or less) mri exam without sedation or mechanical ventilation * drug regimen (if applicable) stable for at least 3 months prior to participation exclusion criteria: * renal insufficiency (gfr\<40 ml/min/m2) * non-mri compatible implants (e.g. neurostimulator, pacemaker, implanted cardioverter defibrillator) * claustrophobia that prevents an mri exam * known allergy to mri contrast agents * serum potassium level of \>5.0 mmol/l * signs and symptoms of heart failure
lot consistency clinical trial of bivalent hpv vaccine in 9 to 30 years old healthy females

Conditions: HPV Infection

Summary: the purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of bivalent hpv (type 16,18) vaccine (pichia pastoris) in healthy female subjects aged 9 - 30 years, and demonstrate the non-inferiority of the candidate hpv vaccine manufactured at commercial scale compared with a pilot scale.


Eligibility criteria:
inclusion criteria: * 9-30 healthy female able to provide legal identification. * written informed consent had to be obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent had to be obtained from a parent or legal guardian of the subject and, in addition, the subject had to sign and personally date a written informed assent). * women of child-bearing age(wocba): subject had to have a negative urine pregnancy test, no plan to be pregnant in 7 months, and agree to use adequate contraceptive precautions during study period. exclusion criteria: * subject has received a marketed hpv vaccine or participated in an hpv vaccine clinical trial. * history of abnormal cervical screen test result (asc-us or worse) or history of genital warts. * history of severe allergic reaction that required medical intervention. * history of allergic disease or reactions likely to be exacerbated by any component of the study vaccines. * pregnant or breastfeeding, or within 6 weeks after the end of pregnancy. * fever prior to vaccination (auxiliary temperature ≥37.3 °c). * hypertension (physical examination systolic blood pressure 140mmhg and or diastolic blood pressure 90mmhg. * received live attenuated vaccine within 15 days before vaccination or subunit or inactivated vaccine within 7 days. * received immunoglobulin and/or blood product 3 months prior to the first vaccination. * acute diseases or acute stage of the chronic diseases within 3 days preceding the vaccination. * according to the judgment of the investigator, subject has or had any other symptoms, medical history and other factors that are not suitable for participating in this clinical trial.
when distance is an act of love: exploring the use of video diaries for family members of intensive care patients

Conditions: Coronavirus; Anxiety Depression

Summary: due to covid-19, intensive care (icu) patients are not allowed visitors or have severely restricted visiting. after being admitted to icu most patients are unconscious or extremely weak and therefore cannot speak on a phone or video call to a family member. before these visiting restrictions, family members of patients admitted to icu as a result of being critically ill were already known to suffer significant psychological distress and may now face increased distress given they are unable to visit a loved one. previous research demonstrates that keeping a paper diary has been found to be helpful for icu patients and families. when lockdown measures were announced, nhs scotland introduced video diaries as an emergency measure to try to support communication with families and reduce distress. vcreate is an nhs trusted secure video messaging service that helps patients, families and clinical teams stay connected throughout their care journey. the use of video diaries may have a positive impact for family members but there is a risk that they could also have negative effects for some people. there is a need to explore both icu healthcare professionals and family members' experiences of using video diaries. at the same time it is also important to test the feasibility and acceptability of measures of distress and psychological well-being on family members during and after their experience of video diaries. in doing so, some initial recommendations about video diaries can be made and a larger subsequent study planned to test their effect on family members and healthcare professionals.


Eligibility criteria:
inclusion criteria: - (i) family members in lothian aged ≥16 years receiving a video diary for an icu patient who stays in icu for ≥24 hours or more. if the patient dies, family members will be invited to continue in the study. (ii) icu healthcare staff in nhs lothian who have experience of using the video diary to support family members during lockdown. exclusion criteria: prisoners family members lacking capacity to consent family members aged under 16 years
a trial of shr-1905 in subjects with severe uncontrolled asthma

Conditions: Asthma

Summary: this study is a phase 2 study of shr-1905 in subjects with severe uncontrolled asthma. the purpose of the study is to evaluate efficacy and safety of shr-1905 in subjects with severe uncontrolled asthma.


Eligibility criteria:
inclusion criteria: 1. male or female aged between 18 and 75 years (inclusive) 2. weight ≥ 40 kg 3. meet the diagnostic criteria for asthma and have a medical history of at least 1 year 4. treatment with a total daily dose of either medium or high dose inhaled glucocorticoids (ics) for at least 6 months before screening, with a stable use for 3 months before randomization 5. at least one additional maintenance asthma controller with stable use for at least 3 months before randomization 6. at least 2 exacerbations within 12 months before screening 7. no birth plan and must agree to take effective contraceptive methods 8. sign informed consent form voluntarily for the trial exclusion criteria: 1. any clinically important pulmonary disease 2. any disease other than asthma that may affect lung function 3. any disease other than asthma related to elevation of eosinophils 4. any immunodeficiency disease 5. any clinically important serious cardiovascular diseases unstable or uncontrolled 6. uncontrolled hypertension 7. uncontrolled diabetes mellitus 8. any clinically important infections within 4 weeks before randomization 9. any major surgery within 3 months before randomized, or any surgical plan during the study, or any treatment that may affect the evaluation of the subjects considered by the investigator 10. any parasitic infections within 6 months before randomization 11. malignancy diagnosed within 5 years before randomization 12. abnormal laboratory tests during screening and baseline 13. positive infectious disease test 14. prolonged qtc interval or other clinical significant abnormal findings in ecg at screening that may cause safety risk to the subject 15. current smoker or smoking cessation for less than 6 months at screening, or smoking history ≥10 pack- years 16. drug or alcohol abuse 17. allergy history to any biologicsl or other agent that investigator think the subject should not participate in the study 18. subjects who are pregnant or breastfeeding, or plan to become pregnant during the study 19. participated in other clinical trials and used investigational drugs containing active ingredients within 4 weeks or 5 half-lives before screening 20. any other circumstance inappropriate for participating in the clinical trial considered by the investigator