Kornimate/medical-research-clean huggingface dataset:
study of the efficacy and safety of sti-5656 (abivertinib maleate) in subjects hospitalized with covid-19

Conditions: Covid-19

Summary: study to assess the safety and efficacy of sti-5656 (abivertinib maleate) plus soc versus soc in subjects hospitalized with covid-19

this is a phase 2, open-label, randomized 2-arm multicenter study to assess the safety and efficacy of sti-5656 (abivertinib maleate) administered orally plus standard of care (soc) versus soc in hospitalized subjects with rt-pcr confirmed sars-cov-2 infection and covid-19 pneumonia (documented radiographically). only hospitalized patients are eligible for this study.

Eligibility criteria:
inclusion criteria: * confirmed infection with sars-cov-2 per world health organization (who) criteria (including positive rt-pcr nucleic acid test of any specimen \[eg, respiratory, blood, urine, stool, or other bodily fluid\]) within 7 days of randomization * hospitalized with covid-19 pneumonia (documented radiographically) and oxygen saturation \<94% on room air or subject requires supplemental oxygen * able to swallow capsules * willing to follow contraception guidelines * subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity. however, if obtaining written informed consent is not possible, other procedures as provided in the march 27th, 2020 fda guidance on conduct of clinical trials of medical products during covid-19 pandemic, question 10, may be used exclusion criteria: * known cardio-pulmonary resuscitation within 14 days prior to randomization * pregnant or breast feeding * suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with sars-cov-2) * alanine aminotransferase (alt) ≥ 3x upper limit of normal (uln) and total bilirubin \> 2x uln * qtcf prolongation \>480 milliseconds * uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (nyha grade 3 or 4). exception: subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll * treatment with a strong cytochrome p450 (cyp3a4 inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug) * received anti-rejection or immunomodulatory drugs (eg, anti-cytokines, btk inhibitors, jak inhibitors, pi3k inhibitors) within 30 days before randomization on study * concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable) * any condition that confounds the ability to interpret data from the study * relevant renal impairment (egfr \<60 ml/min) * any significant medical condition, laboratory abnormality or psychiatric illness that would interfere or prevent the subject from participating in the study
metformin to reduce heart failure after myocardial infarction

Conditions: ST Elevation Myocardial Infarction (STEMI); Coronary Artery Disease; Heart Failure; Diabetes

Summary: the investigators will evaluate the effect of metformin therapy during 4 months in non-diabetic patients following st-elevation myocardial infarction on left ventricular ejection fraction as measured with cardiac magnetic resonance imaging, compared to placebo.

in this trial, the investigators will evaluate the effect of metformin therapy following st-elevation myocardial infarction (stemi) in a total of 380 non-diabetic patients. this trial is a randomized, double blind, controlled trial. the intervention, which consist of metformin 500mg twice daily or placebo twice daily, will commence within three hours after the percutaneous coronary intervention, and will be continued for 4 months. the primary endpoint is the difference between the two intervention groups (metformin vs placebo) in left ventricular ejection fraction, as measured with magnetic resonance imaging after 4 months. the investigators hypothesize that metformin therapy results in a significantly higher ejection fraction in this population.

Eligibility criteria:
inclusion criteria: * the diagnosis acute mi defined by chest pain suggestive for myocardial ischemia for at least 30 minutes, the time from onset of the symptoms less than 12 hours before hospital admission, and an ecg recording with st- segment elevation of more than 0.1 mv in 2 or more leads. * successful primary pci (post-procedural timi 2/3); * at least one stent sized ≥ 3.0 mm; * eligible for 3t cmr imaging; * verbal followed by written informed consent. exclusion criteria: * rescue pci after thrombolytic therapy; * need for emergency coronary artery bypass grafting; * creatinin \>177 μmol/l measured pre-pci; * younger than 18 years; * mechanical ventilation; * diabetes; * prior myocardial infarction; * contra-indication to metformin (see safety); * the existence of a life-threatening disease with a life-expectancy of less than 6 months.

Keywords: metformin st elevation myocardial infarction (stemi) coronary artery disease heart failure diabetes
study comparing two types of psychotherapy for treating depression and substance abuse

Conditions: Alcohol Abuse; Cannabis Abuse; Major Depressive Disorder; Substance-Related Disorders

Summary: the purpose of this study is to determine whether integrated cognitive behavioral therapy or twelve step facilitation therapy is most effective for treatment of dually diagnosed veterans with depressive and substance use disorders.

depression is the most frequent co-occuring mental health disorder among adults with substance use disorders, and such comorbidity is often associated with poorer treatment outcomes. although there is an urgent need for effective treatments specific for dual-diagnosis adults, few studies have been conducted to address this need. comparison: this study will compare substance use and depression symptoms of individuals in two different psychotherapy groups: integrated cognitive behavioral therapy and twelve step facilitation therapy. symptoms and substance use will be compared during the active treatment phase (24 weeks) and for one year following the end of the active treatment.

Eligibility criteria:
inclusion criteria: * individuals diagnosed with one or more substance use disorders (alcohol, cannabis, and or stimulant abuse/dependence) and an independent co-occurring depressive disorder (major depression or dysthymia) will be included. exclusion criteria: * individuals with substance induced mood disorders and individuals experiencing persistent psychotic symptoms. * those with life threatening or unstable medical illness, neurological disorders, or inability to read will be excluded. * individuals currently prescribed steroids, disulfiram, or long acting benzodiazepines will be excluded.

Keywords: alcohol abuse/dependence alcohol use disorders cannabis abuse/dependence depression dual diagnosis dysthymia stimulant abuse/dependence substance use disorders
dermacyd ph_desilsty_fr (lactic acid) - compatibility - stay on frutal

Conditions: Hygiene

Summary: primary objective: to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product dermacyd phdesilstyfr.


Eligibility criteria:
inclusion criteria: * phototype skin i,ii, iii e iv integral skin test in the region * willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; exclusion criteria: * lactation or gestation * use of antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection * disease which can cause immunosuppresion, such as diabetes, hiv * personnel history of atopy * history of sensitivity or irritation for topic products * cutaneous active disease (local and/or general) which can modify the study results * use of new drugs and/or cosmetics during the study * cutaneous reactive * previous participation in studies using the same product in test * volunteer which has immunodeficiency congenital or acquired * relevant history or confirmation of alcohol or other drugs abuse * intolerance detected or suspected for some component of the sample tested * medecin or sponsor employees or their close family. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
follow up study of patients on fingolimod who were enrolled in the original biobank study (cfty720dde01)

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: the purpose of this single visit extension study is to explore immune status in rrms patients treated for at least 48 months with fingolimod. long-term changes in t cell counts will be compared to short-term changes in immune status (baseline to month 6) after treatment start with fingolimod as assessed in the original biobank study (cfty720dde01).


Eligibility criteria:
inclusion criteria: 1. written informed consent before any assessment was performed. 2. randomized in study cfty720dde01 and received at least one dose of study drug (fingolimod) and completed the study. 3. continuous intake of fingolimod after end of study cfty720dde01 with a maximum treatment interruption of 3 months in total before entering this study. 4. parallel participation at study cfty720dde02 (pangaea nis) was allowed. exclusion criteriat: 1. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hcg) laboratory test. 2. patients with onset of an acute relapse had to postpone their evaluation until deemed stable from relapse by treating physician, but at least for 1 month since end of relapse. 3. patients that received immunomodulating or immunosuppressive ms treatments other than fingolimod since completion of study cfty720dde01 as for example: natalizumab,alemtuzumab, dimethyl fumarate, teriflunomide, intravenous immunoglobulins,mitoxantrone, methotrexate, azathioprine or experimental immunomodulating-immunosuppressive therapies.

Keywords: fingolimod biomarker multiple sclerosis relapsing-remitting multiple sclerosis
revitive for the treatment of patients with venous insufficiency

Conditions: Venous Insufficiency; Oedema; Varicose Veins

Summary: to investigate the efficacy of an electrical stimulation (using the revitive ix device) in treating patients with venous insufficiency.

this is a pilot randomised control trial to assess the efficacy of a neuromuscular electrical stimulation device to improve venous blood flow and patients' symptoms in patients with chronic venous insufficiency. the revitive ix device is a neuromuscular electrical stimulation device that gives wide pulse pattern electrical stimulation via foot pads. a cycle of treatment consists of a 30 minute programme of 15 varying waveforms that last a minute each. twenty patients with venous insufficiency will be screened according the eligibility criteria. patients will be randomised to either treatment or control (sham device) group. patients are advised to use the device 30 minutes a day, everyday, for 6 weeks. compliance will be monitored with a data logger and diary card. primary outcome measure: a) improvement in venous haemodynamics. secondary outcome measures: 1. improvement in lower limb oedema 2. improvement in clinical symptoms 3. reduction in lower limb pain and discomfort 4. improvement in quality of life measures 5. device satisfaction.

Eligibility criteria:
inclusion criteria: * ability to understand the study and provide meaningful written informed consent for the study. * willing, able, and committed to participate in the procedures for the full length of the study. * all ethnic groups, male or female above the age of 18 years. * diagnosis of chronic venous insufficiency (c2-c5 ceap classified) * be of non-childbearing potential; or using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the device. * blood pressure currently under moderate control (\<160/100mmhg) * no current foot ulceration. exclusion criteria: * has insufficient ability to understand the subject information sheet, consent form and verbal instruction. * has an unstable condition (eg psychiatric disorder, a recent history of substance abuse or otherwise thought to be unreliable or incapable of complying wight he requirements of the clinical investigational plan (cip). * has any metal implants. * pregnant. * has a cardiac pacemaker, aicd or other implanted electrical device. * has an existing dvt. * has an acute medical condition other than chronic venous insufficiency. * has recent lower limb injury or lower back pain. * has current foot ulceration or other skin ulcers. * has cardiovascular disease. * has foot deformities. * has any disorder that, in the opinion of the investigator, might interfere with the conduct of the study. * has an abpi \< 0.8.

Keywords: electrical stimulation venous insufficiency post thrombotic syndrome varicose veins
near patient microbial testing in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: to identify whether home monitoring of multiple physiological parameters and biomarkers in sputum could provide advanced warning of an infective exacerbation or treatment failure before changes in patient-reported symptoms.

1. to determine if longitudinal profiling of sputum from cystic fibrosis patients allow accurate prediction of exacerbations in a study of a larger group and can we confirm the 7+ day early warning system works in this larger group. 2. is one biomarker sufficient to predict exacerbations - what is the accuracy? are two or more biomarkers required to achieve an accuracy of greater than 95%? 3. can we now accurately determine how many hospital bed days a home testing/wellness monitoring device would save? what is the business case for healthcare providers to adopt our future test for home use? we estimate a 50% saving. can this be confirmed? 4. when used in the clinic, how many hospital days would our test save through faster determination of treatment efficacy? what is the business case for adopting our future test as a point of care test on the ward in cystic fibrosis centres? could this be the new revolutionary tool that we anticipate? 5. we forecast a 50% reduction in costs to treat cystic fibrosis patients in disease severity bands 2-a to 5. can we provide evidence for this to support further investment?

Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis based on genetic testing and/or sweat chloride levels. * chronic infection with pseudomonas aeruginosa. * patients able to produce daily sputum samples. * current history of at least two pulmonary infective exacerbations in the past 12 months. * able to give written informed consent exclusion criteria: * unable to provide written informed consent * patients unable to produce daily sputum samples * fewer than two infective pulmonary exacerbations in 12 months
the effect and safety of low dose nebulized epinephrine in croup

Conditions: Croup; Epinephrine, Administration, Inhalation

Summary: croup is common illness presenting emergency department with dyspnea. the main treatment for croup is nebulized l-epinephrine and steroid. the study for the dose of nebulized l-epinephrine is restricted that the study of comparision between racemic epinephrine and l-epinephrine. the investigators conducted this study to compare the effectiveness of low dose l-epinephrine with conventional dose l-epinephrine.


Eligibility criteria:
inclusion criteria: * croup children between 6 month and 5 years old * westley croup score between 3 and 11 exclusion criteria: * underlying lung or heart disase * contra indication to dexamethasone * immune deficient state * preterm birth * previous intubation or apnea history

Keywords: croup, dose, epinephrine
external cooling in septic shock patients

Conditions: Septic Shock

Summary: the rapidity of the resolution of cardiovascular failure has a strong impact on septic shock patients' outcome. the aim of this multicenter randomized controlled trial is to determine whether external cooling might accelerate improvement in cardiovascular function.

patients suffering from septic shock need fluid resuscitation and vasopressor therapy for restoring cardiovascular function. corticosteroids and activated protein c have been both proposed for vascular tone improvement. while external cooling is largely used in icu febrile patients, benefits and risks of fever treatment during sepsis have been rarely studied. surveys show that external cooling is usual care applied by nurses themselves without medical order. the control of thermal balance might decrease cardiac output and oxygen consumption, and reduce serum lactate concentration. however some animal studies have suggested that fever might be essential for host defence. this trial compares two strategies of fever management on vasopressor dependence in septic shock patients. in the treatment group, external cooling is applied to normalize the body temperature between 36°5 c and 37°c, while control patients receive any fever treatment. the goal for mean arterial pressure is the same in the two groups and vasopressor withdrawal is determined by similar algorithm.

Eligibility criteria:
inclusion criteria: * documented or suspected infection * body temperature \> 38.3°c * persistent hypotension despite fluid resuscitation and need for vasopressor infusion to maintain mean arterial pressure \> 65 mmhg. * invasive mechanical ventilation * intravenous sedation exclusion criteria: * temperature \> 41°c * age \< 18 years * pregnancy * continuous renal replacement therapy * paracetamol or nsai administration within 6 hours before inclusion * need for paracetamol and/or nsai therapy during the study period * burns or lyell syndrome

Keywords: vasopressor epinephrine norepinephrine cooling fever icu
sc il-1ra in sah - phase iii trial (scil)

Conditions: Subarachnoid Hemorrhage

Summary: this phase iii trial will establish whether il-1ra, with sub-cutaneous (sc) administration twice daily for up to 21 days post aneurysmal subarachnoid haemorrhage (asah), improves clinical outcome as measured by ordinal shift in mrs at 6 months. patients with sah transferred to a neurosurgical centre will be identified and approached for study participation. following consent, patients will be randomised to receive either il-1ra or placebo for a maximum of 21 days from onset of symptoms. patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment. blood samples for plasma il-6 will be obtained prior to randomisation and at day 3-5 post randomisation for il-6 \& il-1 measurement. safety will be measured at 30 days post randomisation and outcome assessed at 6 months post randomisation.


Eligibility criteria:
inclusion criteria: 1. patients with ct positive spontaneous sah admitted to a participating neurosurgical centre where written informed consent can be obtained and study drug can be administered within 72 hours of ictus. 2. no concomitant health problems that, in the opinion of the pi or designee, would interfere with participation, administration of study drug or assessment of outcomes including safety. 3. willing and able to give informed consent or consent available from a patient representative for trial inclusion including agreement in principle to receive study drug and undergo all study assessments. 4. male or female aged 18 years or above. exclusion criteria: 1. unconfirmed or uncertain diagnosis of spontaneous sah. 2. known active tuberculosis or active hepatitis. 3. known active malignancy. 4. known still's disease 5. neutropenia (anc \<1.5 x 109/l ). 6. abnormal renal function (creatinine clearance or estimated glomerular filtration rate (egfr) \< 30 ml/minute) documented in the last 3 months prior to this sah. 7. live vaccinations within the last 10 days of this sah. 8. previous or concurrent treatment with il-1ra known at the time of trial entry or previous participation in this trial. 9. current treatment with tnf antagonists. 10. known to have participated in a clinical trial of an investigational agent or device in the 30 days prior to ictus. 11. known to have participated in a clinical trial of an investigational agent or device within 5 half-lives (of the previous agent or device) prior to ictus. 12. known to be pregnant or breast feeding or inability to reliably confirm that the patient is not pregnant 13. clinically significant serious concurrent medical condition, pre morbid illnesses, or concurrent serious infection, at the pi's (or designee's) discretion, which could affect the safety or tolerability of the intervention. 14. known allergy to il-1ra or any of the excipients listed in the drug smpc 15. known allergy to other products that are produced by dna technology using the micro-organism e. coli (e.g. e.coli derived protein). 16. current treatment with il-6 or il-1 inhibitors or drugs affecting the il-1 axis. 17. history of dress syndrome.

Keywords: aneurysmal
act mali: treatment of malaria based on combination therapies

Conditions: Malaria

Summary: test the hypothesis that repeated administration of artesunate/amiodaquine, artesunate/sulfadoxine-pyrimethamine and arthemeter-lufemantrine for the treatment of consecutive episodes of uncomplicated malaria reduces the incidence of uncomplicated falciparum malaria and malaria attributable anemia


Eligibility criteria:
inclusion criteria: * body weight \> 5kg * residence in the investigator site area for the duration of the trial * axillary temperature ≥ 37,5°c at day 0 * confirmed plasmodium falciparum infection,with parasitemia range from 2000 to 200000 asexual parasites /µl of blood exclusion criteria: * danger signs or signs of severe malaria * other severe illnesses * allergy to one of the drugs * pregnant women the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.