Kornimate/medical-research-clean huggingface dataset:
osimertinib study in indian patients

Conditions: Non Small Cell Lung Cancer (NSCLC)

Summary: this is a prospective, single-arm, multicenter, phase-iv study investigating the safety of osimertinib in indian adult patients.

this is a prospective, single-arm, multicenter, phase-iv trial investigating the safety of osimertinib in indian adult patients with locally advanced or metastatic egfr-t790m mutation-positive nsclc. prior to data collection, all patients must sign an informed consent form (icf) allowing data collection and source data verification in accordance with local requirements and sponsor policy. patients with metastatic egfr t790m mutation-positive nsclc, who are eligible to osimertinib treatment as per locally approved prescribing information and ratified by an independent clinical judgment of treating physician will be evaluated for the inclusion into the current phase-iv study based on eligibility criteria. egfr t790m positivity on plasma or tissue biopsy on pcr-based platform will be considered appropriate test. egfr t790m must be performed after progressive disease on last line of therapy (on or after egfr tki therapy). in order to enroll approximately 60 patients, it is expected that approximately 70 patients will be screened.

Eligibility criteria:
inclusion criteria: 1. patient of either gender and ≥18 years of age 2. patients with metastatic egfr t790m mutation-positive nsclc, as detected by an appropriate test, who have progressed on or after egfr tki therapy by an independent clinical judgment of treating physician based on locally approved prescribing information 3. each patient must sign an informed consent form (icf) exclusion criteria: 1. patient with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug. 2. pregnant and/or lactating women 3. patients participating in any current or future interventional trial will not be enrolled in the current study

Keywords: non small cell lung cancer (nsclc)
genomewide search for loci underlying metabolic syndrome

Conditions: Metabolic Syndrome X; Cardiovascular Diseases; Heart Diseases; Obesity; Hypertension; Hyperinsulinism; Insulin Resistance

Summary: to identify the genes involved in the metabolic syndrome.

background: metabolic syndrome, characterized by clustering of multiple metabolic abnormalities including abdominal obesity, dyslipidemia, hyperinsulinemia, hyperglycemia, and hypertension, is one of the most important risk factors for cardiovascular disease and stroke. genetics play a significant role in determining the individual susceptibility to metabolic syndrome and the inter-individual variation in its associated phenotypes, though these genetic factors remain largely unknown. the long-term goal is to identify the metabolic syndrome susceptibility genes and their functional variants. design narrative: the goal of the research is to study the underlying phenotypic structure of the metabolic syndrome and to systematically search for genetic loci predisposing to the metabolic syndrome using the genome scan approach. the specific aims are: (1) to screen about 10,000 sibling pairs aged 40 to 64 years in anqing, anhui china, on intermediate phenotypes of the metabolic syndrome including body mass index, waist and hip circumference, serum lipid profiles (triglyceride, hdl-, ldl-, and total cholesterol), fasting serum glucose and insulin level, and blood pressure; (2) to study the underlying phenotypic structure of the metabolic syndrome in the about 10,000 ascertained sibling pairs using factor analysis; (3) to select and genome scan 800 nuclear families from the pool of the ascertained sibling pairs using weber screening set 10 markers. each selected nuclear family contains a "proband" and \>=3 other family members. the values of the three most significant factors for metabolic syndrome in the factor analysis (see specific aim 2) will be used to classify "proband" status for each subject. a "proband" is defined as having \>=2 out of 3 factor values falling into the same side of the 10/90 percentile tails of the corresponding age- and sex-adjusted population distributions; (4) to test for linkage in the genome-scanned families on intermediate phenotypes and factors of metabolic syndrome using the unified haseman-elston method. in addition to the univariate test, linkage analysis will be performed using a novel multivariate version of the unified h-e method, which has recently been proposed and shown to be significantly more powerful than the univariate test for traits with common genetic determinants; (5) to perform expansion or replication linkage studies on loci identified in the genome scan in 300-400 additional families with \>=1 proband with a denser set of markers.

Eligibility criteria:
no eligibility criteria
a psychosocial program impact evaluation in jordan

Conditions: Stress, Psychological; Mental Health Impairment

Summary: the study aims to deliver a robust pre-post evaluation of the wellbeing impacts of an innovative, brief, and scalable psychosocial intervention, delivered to refugee youth living in urban settlements in jordan. the study was conducted using two waves of data collection: the first featured an intervention and a matched control group, the second featured a full randomized control trial.

this study will provide a robust evaluation of the mercy corps 'advancing adolescents, no lost generation' program that targets stress alleviation in refugee youth (12-18 years) with specific measures of psychosocial stress, biological stress, and cognitive function.

Eligibility criteria:
inclusion criteria: * eligible and enrolled in mercy corps advancing adolescents program * syrian refugee and jordanian host-community youth residing in 4 urban centers in northern jordan exclusion criteria: * not available for study recruitment (started sessions or deferred sessions before study start date).

Keywords: stress insecurity mental health
cognitive-behavioral therapy for irritability in adolescents with high functioning autism spectrum disorder

Conditions: Autism; Autism Spectrum Disorder (ASD; Asperger's Disorder; Pervasive Developmental Disorder (PDD-NOS)

Summary: in addition to the core symptoms, children and adolescents with autism spectrum disorder (asd) often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, and aggression. this is a pilot study of cognitive-behavioral therapy, also known as anger control training, in adolescents with high-functioning asd. cbt teaches children to recognize antecedents and consequences of problem behavior and to use emotion regulation and problem-solving skills to reduce irritability, aggression and noncompliance. this form of cbt has been well-studied in typically developing children with disruptive behavior and we are investigating if this treatment can be feasible and helpful, with appropriate modifications, for irritability and disruptive behavior in asd.


Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of autistic disorder, asperger's disorder, or pdd-nos * presence of disruptive behaviors such as irritability and anger outbursts * iq above 80 * unmedicated or on stable medication exclusion criteria: * medical or psychiatric condition that would require alternative treatment

Keywords: autism irritability disruptive behavior aggression behavior therapy cognitive behavioral therapy
assessment of tele-expertise for the interpretation of mri among neonates with high risk of neurological sequelae

Conditions: Hypoxia, Brain

Summary: the purpose of the study is to determine whether tele-expertise would be more effective and more cost-effective for the interpretation of mri among neonates with high risk of neurological sequelae


Eligibility criteria:
inclusion criteria: * less than 28 days of life * mandatory to have a medical advice in paediatric neuroradiology for interpretation of brain mri exclusion criteria: * none
a dose range finding study of jnj-38518168 in patients with active rheumatoid arthritis in spite of treatment with methotrexate

Conditions: Rheumatoid Arthritis

Summary: the purpose of this dose range finding study is to assess the effectiveness, safety and tolerability of jnj-38518168 at doses of 3, 10, and 30 mg/d compared with placebo in patients with active rheumatoid arthritis (ra) despite concomitant methotrexate (mtx) therapy.

this is a randomized (the study medication is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), multicenter, placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each group of patients will be treated at the same time), dose range finding study of jnj-38518168 in patients with active ra despite concomitant mtx therapy. the study will consist a screening period, a 24-week placebo-controlled period and a 4-week follow-up period between the last dose and the last visit. the duration of participation in the study for an individual patient will be up to 34 weeks (including screening). the patients will be assigned to 1 of 4 treatment groups in a 1:1:1:1 ratio to placebo and jnj-38518168 (3 mg or 10 mg or 30 mg). safety assessments and evaluations to determine the efficacy of jnj-38518168 to reduce the signs and symptoms of ra will be performed at study visits. safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * has had rheumatoid arthritis for at least 6 months prior to the date of signing the informed consent at screening * must be positive for either anti-cyclic citrullinated peptide antibody or rheumatoid factor in serum at screening * must have active rheumatoid arthritis (at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline and serum c reactive protein greater than or equal to 0.80 mg/dl at the time of screening * has been treated with and tolerated methotrexate treatment at dosages from 10 to 25 mg/week inclusive, for a minimum of 6 months with stable dose for at least 8 weeks prior to the date of signing the informed consent at screening exclusion criteria: * has inflammatory diseases other than rheumatoid arthritis, including but not limited to adult onset still's disease, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, and lyme disease that might confound the evaluation of the benefit of study agent therapy * has current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled * has ever received any approved or investigational biologic agent for a rheumatoid indication * has been treated with any nonbiologic disease modifying antirheumatic drugs within 4 weeks prior to the first administration of study agent

Keywords: rheumatoid arthritis swollen and tender joints methotrexate immunology dose range finding study
the effect of accelerated rehabilitation after anterior cruciate ligament reconstruction with and without suture tape reinforcement

Conditions: ACL Injury

Summary: the aim of our study is to evaluate the effect of accelerated rehabilitation post acl reconstruction with and without augmentation on graft healing and return to normal activity clinically by scoring system and radiologically.

acl reconstruction is the most commonly performed knee ligament reconstruction and employs a variety of surgical techniques. however, despite high success rates, it is still challenged by residual laxity and graft rupture. while the majority of patients who undergo aclr will have good to excellent results, a subset of patients is at a higher risk for graft failure. for those that require revision surgery, the second operation often fails. anterior cruciate ligament injuries account for 50% of knee ligament injuries for high school-aged adults. the most commonly used autografts for aclr are the hamstring tendons (ht) and the bone-patellar tendon-bone (bptb). however, questions remain about how patients with either an ht or a bptb autograft recover knee muscle strength postoperatively. to help address and prevent future acl failures, new repair and reconstruction techniques have been employed that incorporate suture augmentation. the goal of augmentation is to protect the newly repaired or reconstructed ligament during rehabilitation. despite advances in anterior cruciate ligament (acl) reconstruction surgical techniques and rehabilitation, recent studies report that between 20% to 50% of those with acl reconstruction do not return to the same sports after surgery and 10% to 70% of those who resume preinjury sports participate at a reduced level or with significant functional impairments. anecdotal evidence from patient report and clinical observation suggests that an inability to return to sports after acl reconstruction can be partially attributed to a fear of reinjuring the knee.

Eligibility criteria:
inclusion criteria: * age from 15 to 50 years old. * with or without meniscal injury. * isolated acl injury without any other ligament injury. * recent and chronic injury. exclusion criteria: * multiligament injury. * deformed knee (genu varus or valgus). * previous acl reconstruction or repair. * older than 50 years old and younger than 15 years old. * failed acl reconstruction or repair -

Keywords: rehabilitation
pilot study with gft505 (80mg) in atherogenic dyslipidaemic patients with abdominal obesity

Conditions: Atherogenic Dyslipidaemia; Abdominal Obesity

Summary: the purpose of this study is to evaluate the efficacy of gft505 80mg in reducing serum triglycerides (tg) and increasing high density lipoprotein cholesterol (hdl-c) levels compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of gft505 during 28 days.

the study period per patient is 7 to 14 weeks: a screening period (1 to 8 weeks) will precede a 4-week double-blind treatment period and a 2-week follow-up period. during the screening period, patients will be asked to start or continue adequate diet and exercise and to stop their lipid-lowering medication (for not treatment-naïve patients). for patient taking any lipid-regulating medication, a minimum of 8-week wash-out from lipid-regulating therapies (fibrates, statins, ...) is required.

Eligibility criteria:
inclusion criteria: * male or post-menopausal female. * waist circumference ≥102cm for male, ≥ 88cm for female. * atherogenic dislipidaemia inadequately controlled despite therapeutic lifestyle change (tlc) recommendations (diet and exercise). * 150≤ fasting tg ≤ 600 mg/dl (1.69 ≤ fasting tg ≤ 6.78 mmol/l) at v2. * fasting hdl-c ≤ 40 mg/dl (≤ 1.03 mmol/l) for male, hdl-c ≤ 45 mg/dl (≤ 1.16 mmol/l) for female at v2. exclusion criteria: * body mass index (bmi) ≥ 40 kg/m². * blood pressure \> 160 / 95 mmhg. * type i or type ii diabetes mellitus.

Keywords: atherogenic-dyslipidaemia ppars
switching study from warfarin to rivaroxaban

Conditions: Venous Thrombosis

Summary: the study objective is to investigate the pharmacodynamics (effects of a drug product) when switching the treatment from warfarin to rivaroxaban. 84 young, healthy subjects will participate; they will be treated following a randomized, parallel-group (treatments a, b, and c), placebo-controlled (treatment b), and single-blind (treatments a and b) design. the first two groups (a, b) will receive warfarin for approximately one week to adjust their blood coagulation values to a specific level, i.e. to maintain an inr (international normalized ratio) of 2.0 - 3.0. this range is commonly used for long-term anticoagulant treatment. the first group (a) will receive rivaroxaban for four days, the second group (b) will take placebo. on the last day, all subjects in groups a and b will receive vitamin k to neutralize the effects of warfarin. the third group (c) will not undergo prior treatment with warfarin but will receive rivaroxaban for four days.


Eligibility criteria:
inclusion criteria: * 18 to 45 years of age; * normal body weight: bmi (body mass index) between 18 and 29 kg/m2; * pharmacogenetics: subjects who are homozygous for the wildtype allele 2c9\*1 and who are carriers of the c-allele at positions 6484 and 7566 of the vkorc1 (vitamin k epoxide reductase) gene, respectively exclusion criteria: * relevant deviation from the normal range in the clinical examination; * relevant deviation from the normal range in clinical chemistry, hematology or urinalysis; * resting heart rate in the awake subject below 45 bpm (beats per minute) or above 90 bpm; * systolic blood pressure below 100 mmhg or above 140 mmhg; and diastolic blood pressure above 85 mmhg; * relevant pathological changes in the ecg (electrocardiogram) such as a second or third-degree av block, prolongation of the qrs (qrs complex in ecg) complex over 120 msec or of the qt / qtc-interval over 450 msec (qt interval in ecg, qtc interval corrected for heart rate); * subject is tested to be hiv-1/2ab, p24ag, hbsag or hcv-ab positive; * known coagulation disorders (e.g. von willebrand's disease, haemophiliac); * known disorders with increased bleeding risks (e.g. periodontosis, hemorrhoids, acute gastritis, peptic ulcer); * known sensitivity to common causes of bleeding (e.g. nasal); * recent or planned surgical or diagnostic procedures at the central nervous system (cns) or eye; * subjects with hyperlipidemia (coumadin / warfarin warning)

Keywords: rivaroxaban xa-factors warfarin thrombosis embolism
the anemia control program: high or low iron supplementation

Conditions: Iron Deficiency Anemia; Cognitive Development; Motor Development

Summary: the purpose of this clinical trial was to determine if high-iron or low-iron formula, containing an average of 12.7 mg/l or 2.3 mg/l respectively, had differing effects on iron status in infancy and on development longitudinally.

for a detailed description of the clinical trial setting and procedures in infancy, please refer to the following: walter t, pino p, pizarro f and lozoff b. prevention of iron-deficiency anemia: comparison of high- and low-iron formulas in term healthy infants after six months of life. j pedr 1998:132:635-40.

Eligibility criteria:
inclusion criteria: * birth weight \>= 3.0 kg * single birth * no major congenital anomalies * no major birth or neonatal complications * no emergency c-section * no jaundice requiring phototherapy * no hospitalization for more than 5 days * no chronic illness * no iron therapy * already started to received some bottle feedings by 6 months of age exclusion criteria: * residence outside identified neighborhoods * another infant \<12 months in household * infant in daycare * unstable, illiterate, or psychotic caregiver

Keywords: iron deficiency anemia cognitive development motor development
efficacy of early intravenous high-dose vitamin c in post-cardiac arrest shock.

Conditions: Cardiac Arrest

Summary: among patients admitted after an out-of-hospital cardiac arrest (ohca) in intensive care unit (icu), almost two thirds of patients will develop in the first hours a post-cardiac arrest (ca) shock. this post-ca shock, combines cardiac and hemodynamic failure, generally resulting in multi-organ failure and early death in up to 35% of patients. experimental data suggest that intravenous ascorbic acid (vitamin c) may attenuate inflammation and vascular injury related to sepsis or surgery. preclinical and clinical studies also provide safety data of high dose intravenous vitamin c (\> 200mg/kg/day) with no significant adverse event reported and favorable impact on outcome. experimental data also suggest beneficial effect of vitamin c in post-ca management with improvement of shock and multi-organ failure with potential benefit on neuroprotection and outcome. the study is a phase ii multicenter prospective controlled open-label trial randomized in two parallel groups : * expérimental group: standard of care care for post-ca shock + vitamin c (vit-c) 200mg/kg/d iv (started as early as possible, no later than 1 h after randomization + thiamin (vit b1) 200mg every 12 h during 3 days. * control group: standard of care care for post ca shock according international guidelines. patient number to be enrolled : 234, study duration :24 months and 28 days, inclusion duration : 24 months, patient participation : duration : 28 days


Eligibility criteria:
inclusion criteria: * patients still comatose (glasgow coma scale \< 8) after an ohca of presumed cardiac origin with rosc \< 60 min; * and treated with a norepinephrin or an epinephrin continuous infusion during at least 30 min before randomization to maintain mean arterial pressure (map) ≥ 65 mmhg. exclusion criteria: * patients still comatose (glasgow coma scale \< 8) after an ohca of presumed cardiac origin with rosc \< 60 min; * and treated with a norepinephrin or an epinephrin continuous infusion ≥ 0.2µg/kg/h, within 4 hours after ohca, during at least 30 min/h to maintain mean arterial pressure (map) ≥ 65 mmhg. exclusion criteria: * minor or pregnant women; * ohca from evident extracardiac cause (trauma, bleeding, poisoning, etc.); * interval between racs and randomization \> 6 hours; * extracorporeal circulatory assistance requirement in the first 4 hours after ohca; * history of urolithiasis, oxalate nephropathy or hemochromatosis; * glucose-6-phosphate deshydrogenase deficiency; nephrolithiasis, hyperoxalyurie * patients already treated with vit-c; known vit-c deficit; * inclusion in another study; * pre-existent severe chronic kidney disease (glomerular filtration rate \< 30ml/min); * treatment limitationsor moribound * patient with derpived freedom or with legal protective measures. * patient not covered by french national health insurance
administration of anti-sars-cov-2 convalescent plasma in hospitalized, non-icu patients with covid-19

Conditions: COVID-19

Summary: the purpose of this study is to assess the efficacy and safety of the administration of anti-sars-cov-2 convalescent plasma in covid-19 patients who are sick enough to warrant hospitalization, but not yet admitted to the icu (prior to the onset of overwhelming disease including a systemic inflammatory response, sepsis, and/or ards).

this study is a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of anti-sars-cov-2 convalescent plasma in covid-19 patients. after confirmation of covid-19, patients that meet the eligibility requirement and provide informed consent will be randomized in a 2:1 ratio to anti-sars-cov-2 convalescent plasma (1 unit of approximately 250 ml) or placebo (1 unit albumin 5%, approximately 250 ml). we will evaluate the ability of anti-sars-cov-2 convalescent plasma vs. placebo control to decrease disease progression (measured by the who ordinal scale for clinical improvement) during the 28 days following administration to hospitalized, non-icu patients. if patient is discharged from the hospital prior to day 28, day 28 assessment will be by phone.

Eligibility criteria:
inclusion criteria: * patients ≥18 years of age * hospitalized with covid-19-related acute respiratory symptoms * initial covid-19 severity status on the who ordinal scale for clinical improvement = 3 ("hospitalized, no oxygen therapy) or 4 ("hospitalized, on oxygen by mask or nasal prongs") * laboratory-confirmed covid-19 * first signs of infection occurring no more than 14 days prior to enrollment exclusion criteria: * receipt of pooled immunoglobulin in the past 30 days * contraindication to transfusion or history of prior reactions to transfusion blood products * admission to intensive care unit at any point during hospital course prior to enrollment

Keywords: anti-sars-cov-2 plasma