Kornimate/medical-research-clean huggingface dataset:
atrial fibrillation clopidogrel trial with irbesartan for prevention of vascular events (active i)

Conditions: Atrial Fibrillation; Cardiovascular Disease

Summary: the purpose of this study was to determine if irbesartan compared to placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with atrial fibrillation (af) and with at least one major risk of vascular events.

active i was one of the 3 separate but related trials of the active program conducted in af patients at risk of vascular events. patients were enrolled first into one of the 2 parallel trials of the active program evaluating clopidogrel: * active a comparing clopidogrel + acetylsalicylic acid (asa) and asa alone * active w comparing clopidogrel + asa and oral anticoagulant (oac). then those satisfying additional criteria related to blood pressure and angiotensin receptor blocking agents were re-randomized in the two active i arms according to a separate randomization list.

Eligibility criteria:
inclusion criteria: should fulfill the eligibility criteria for active a or active w trial and: * have a systolic blood pressure of at least 110 mmhg * not already receiving an angiotensin receptor blocking agent, unless they are willing and able to be changed to another antihypertensive agent * no previous intolerance to angiotensin receptor blocking agents * no proven indication for angiotensin receptor blocking agents, unless an angiotensin converting enzyme (ace) inhibitor can be substituted exclusion criteria: patients will be excluded from active study if any of the following are present: * requirement for clopidogrel (such as recent coronary stent procedure) * requirement for oral anticoagulant (such as prosthetic mechanical heart valve) * prior intolerance to acetylsalicyclic acid (asa) or clopidogrel * documented peptic ulcer disease within the previous 6 months * prior intracerebral hemorrhage * significant thrombocytopenia (platelet count \<50 x 10(9)/l) * psychosocial reason making study participation impractical * geographic reason making study participation impractical * ongoing alcohol abuse * mitral stenosis * pregnant or nursing woman or woman of child bearing potential and not on effective birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study * severe comorbid condition such that the patient is not expected to survive 6 months * patient currently receiving an investigational pharmacologic agent * requirement for chronic (\> 3 months) non-cyclooxygenase-2 (non-cox-2) inhibitor nonsteroidal anti-inflammatory drug (nsaid) therapy unless willing enrolled in active a

Keywords: atrial fibrillation cardiovascular disease angiotensin ii blocker
study evaluating the potential impact of a hemorrhagic risk stratification score in patients with mild head trauma

Conditions: Head Injury Trauma

Summary: head injuries are a common reason for consultation in emergency departments. the clinical severity of head injury is assessed using the glasgow coma scale (gcs). between 71% and 97.5% of patients with head trauma seen in the emergency department are considered minor, that is to say with an initial gcs 13 and the consequences are quite variable. three to 10% of patients will have short, medium or long-term health consequences. according to the studies, there are between 2.1 and 8% of intracranial bleeding immediate or delayed (up to one month), with about 1% of them, the need to resort to neurosurgery. following a minor head trauma, it is recommended, in the absence of clinical signs of severity, to realize a brain scan (cerebral computerized tomography scan (ct scan): reference imaging examination) within 6h (between 4 hours and 8 hours according to studies), a hospital surveillance of 24h, with the realization of a control scanner within 12 hours to 24 hours in case of treatment by anticoagulants or antiaggregation. in december 2015, journal of the american medical association published an article evaluating two clinical algorithms across the atlantic, the new orleans criteria (noc) and the canadian ct head rule, to identify a group of patients with a very low risk of severe brain damage. the performance of this score is unquestionably, however, it does not include patients treated with antiplatelet or anticoagulant drugs; risk factors having a decisive impact on the incidence of intracranial bleeding. in this context, various studies have been carried out retrospectively in angers to assess the incidence and risk factors of the occurrence of an immediate or delayed intracerebral hemorrhage in patients with minor head trauma with or without anti-thrombotic treatment.


Eligibility criteria:
inclusion criteria: * patient \> 18 years old * head injury * glasgow coma scale \> or = 13 exclusion criteria: * refusal of participation, * indication of a scanner for a reason other than minor head injury * follow-up not possible * pregnant woman or breastfeeding * patients in life-threatening emergency situations.
left ventricular unloading to improve outcome in cardiogenic shock patients on va-ecmo

Conditions: Cardiogenic Shock

Summary: prospective, multi-center, randomized (1:1), controlled trial of impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation vs. veno-arterial extracorporeal membrane oxygenation alone for the treatment of cardiogenic shock.

in the past years extensive efforts in developing treatment strategies for patients with cardiogenic shock have been performed. one promising such strategy is active unloading of the left ventricle while simultaneously supporting the circulatory system with veno-arterial extracorporeal membrane oxygenation. recently, in a multinational, multicenter, retrospective registry, it has been shown that this approach might be associated with lower mortality . the investigators now seek to extend the evidence on this topic and to test this approach in a prospective, randomized, controlled, multicenter trial. a power calculation has been conducted based on the data from the registry. n=198 patients with cardiogenic shock will be randomized 1:1 to be either treated with an impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation or with veno-arterial extracorporeal membrane oxygenation alone. a blinded interim analysis will be performed, which might lead to an adjustment of the enrollment target. the primary endpoint of this study will be death from any cause 30 days after randomization.

Eligibility criteria:
inclusion criteria: severe cardiogenic shock due to severe left ventricular dysfunction: * systolic blood pressure \<90 mmhg or need for catecholamines to maintain such blood pressure * signs of impaired organ perfusion with at least one of the following: altered mental status or cold, clammy skin or oliguria with urine output \<30 ml/h * arterial lactate \>5 mmol/l exclusion criteria: * post-cardiotomy cardiogenic shock. * cardiogenic shock due to acute rejection in heart transplant recipients. * obstructive cardiogenic shock (e.g. cardiogenic shock due to fulminant pulmonary embolism) * cardiogenic shock due to other causes (e.g. bleeding, hypothermia) * pre-existing impella treatment. * onset of shock \>12 hours. * mechanical complication of acute myocardial infarction. * prolonged resuscitation (\>60 minutes). * severe peripheral artery disease with infeasibility for impella or veno-arterial extracorporeal membrane oxygenation implantation. * age \ 80 years. * other severe concomitant disease with life expectancy \<6 months. * participation in another trial with an intervention or pregnancy.

Keywords: active left ventricular unloading va-ecmo impella cardiogenic shock
effect of agave syrup, placebo, and no treatment on nocturnal cough and sleep quality for coughing infants/toddlers and their parents

Conditions: Cough

Summary: cough is a frequent symptom in children and infants and is one of the most common reasons parents visit a healthcare provider for their child. the us food and drug administration has issued a warning that over-the-counter cough and cold medicines including antihistamines, decongestants, anti-tussives, and expectorants should not be administered to children younger than 2 years of age due not only to lack of proven efficacy, but also because of important safety concerns. honey, another method of soothing cough cannot be used in children \<1 year due to concerns for infantile botulism. a preparation from agave syrup has been created to address the need for an infant cough syrup. although no studies have formally evaluated the use of agave nectar for nocturnal cough associated with upper respiratory infections, the demulcent effect and sweet taste of agave nectar may provide some relief from cough in children.


Eligibility criteria:
inclusion criteria: * otherwise healthy male or female infant who is 2 to \<48 months of age. * presents with a non-specific acute cough for 7 or fewer days' duration. * parents/legal authorized representative reporting at least moderate cough and cold symptoms. * parent/legal authorized representative was in the home with the child on the night prior to enrollment and plans to be in the home with the child on the night when study treatment will be administered * parent/legal authorized representative who is willing and able to comply with study requirements. exclusion criteria: * previous participation in this clinical trial * gestational age at birth \<35 weeks. * signs or symptoms of a more treatable disease (eg, asthma, pneumonia, laryngotracheobronchitis, sinusitis, allergic rhinitis). * diagnosis of influenza, bronchiolitis or respiratory syncytial virus (rsv). * history of reactive airways disease, asthma, or chronic lung disease. * use of any medication or honey to treat cough within 6 hours of bedtime on the evening prior to or on the day of enrollment. * presence of any significant disease including immunodeficiency, hepatic, renal,cardiovascular, or hematologic disease or any other health condition that, in the opinion of the investigator, would preclude participation in the study. * known allergy to agave nectar or grape flavoring

Keywords: cough nocturnal cough agave sleep quality childhood cough
the use of cck vs ps in revision tkas

Conditions: Aseptic Loosening of Prosthetic Joint; Instability of Prosthetic Joint; Reimplantation for Periprosthetic Joint Infection; Femoral Revision Indicated; Tibial Component Revision

Summary: this study aims to compare the clinical impact of constrained condylar versus posterior stabilized knee (ps) bearings on patient satisfaction and surgical outcomes including mid-term survivorship among patients undergoing revision total knee arthroplasty.

the primary purpose of this study is to determine whether a difference exists in clinical patient reported outcomes between cck or ps bearings following rtka. a secondary goal of the study is to compare both bearings in survivorship free of revision surgery as well as other surgical complications including instability, in early to mid-term follow-up.

Eligibility criteria:
inclusion criteria: * patients between 18-80 years of age * patients who are undergoing both femoral and tibial component revisions, or isolated femoral component revisions with a retained tibial component that is compatible with ps or cck bearings * patients who are at least 6-weeks out from primary tka surgery, with complete pre-operative and post-operative knee radiographs obtained at standard of care perioperative visits (ap/lateral and patellar views) * patients undergoing rtka for indications including aseptic component loosening, flexion or extension coronal or sagittal instability, component malalignment, arthrofibrosis, patellar maltracking, reimplantation following single or two-stage exchange revision for prosthetic joint infection or bearing surface wear when femoral or tibial component revision is indicated. * the use of revision total knee arthroplasty systems which have ps and cck bearing options including different degree options of coronal and rotational constraint (to be individually randomized per constrained option): * zimmer biomet persona, nexgen, or vanguard * smith and nephew legion * djo / enovis empowr * stryker triathlon * link symphoknee * depuy attune sion criteria: exclusion criteria: patients undergoing rtka with a hinged implant, or pre-operatively determined to require cck bearing rtka, \> 80 years of age, or those requiring rtka less than 6-weeks from the primary tka, patients undergoing rtka for bearing exchange only rtka, isolated tibial component rtka patients with pre-operative diagnosis of extensor mechanism disruption or collateral ligament incompetence or with a compromised soft tissue envelope requiring pre-pre-operative plastic surgery evaluation and planned soft tissue coverage. -

Keywords: revision total knee replacement cck ps coronal instability sagittal instability
a study of the safety of atezolizumab in participants with locally advanced or metastatic non small cell lung cancer in argentina

Conditions: Carcinoma, Non-small-cell Lung

Summary: this is a study of the safety and effectiveness of atezolizumab in participants with metastatic non-small cell lung cancer (nsclc) who have disease progression during or following platinum-containing chemotherapy. participants also will have progressed on an appropriate approved targeted therapy if their tumor has epidermal growth factor receptor (egfr) or anaplastic lymphoma kinase (alk) gene abnormalities treated in common clinical practice settings in argentina.


Eligibility criteria:
inclusion criteria: * signed an informed consent form submitted to the administración nacional de medicamentos alimentos y tecnología médica (anmat) * locally advanced or metastatic (stage iiib, stage iv, or recurrent) non-small cell lung cancer (nsclc) * have received at least one dose of atezolizumab as per local label and clinical practice exclusion criteria: * contraindicated atezolizumab therapy
hyperaldosteronism in pregnancy predicted impacts (h.a.p.p.i. trial)

Conditions: Primary Hyperaldosteronism; Hypertensive Disorder of Pregnancy

Summary: primary hyperaldosteronism confers a higher risk of cardiovascular complications compared to essential hypertension. preliminary data is controversial in regards of excessive maternal fetal and neonatal excessive risks in pregnancy. this study aims at establishing the prevalence of pha in an population with a recent episode of hypertensive disorder of pregnancy (hdp). the goal is to determine if a universal screening for pha after a hdp is worthed. the investigators also wish to evaluate the complication rate in pregnant women with pha compared to women without pha. this is a prospective cohort study where all eligible women will be screened for pha after a hdp episode in the last pregnancy. we will then compare pha women to non pha women according to pregnancy complications.

this is a pilot study to evaluate feasibility and proof of concept. this is a prospective multicenter cohort study. two university centers will participate (sherbrooke and montreal). participants will be recruited from post-partum obstetric medicine clinic in two tertiary care centers. they will be included if they presented a hypertensive disorder of preganncy (hdp) in their last pregnacy (from 4 weeks to 24 months after delivery). women with pheochromocytoma, cushing syndrome, secondary hyperaldosteronism, and those who are currently pregnant will be excluded. all participants will be screened for pha (with an aldosterone/renin ratio) and if the screening test is positive, they will be referred to a specialist to confirm the diagnosis. data will be collected from the participants and their babies' charts. demographic data, obstetrical data, delivery data, maternal/fetal/neonatal complications, and diagnostic of pha data will be collected. a convenient sample size of 200 women will be used. if the prevalence of hpa is 5% or more, this would justify a larger study. primary outcome: establish the prevalence of pha in women with a hypertensive disorders of pregnancy in last pregancy. secondary outcome include: 1. to compare maternal, fetal and neonatal outcomes among women diagnosed with primary hyperaldosteronism (pha) and pregnant women without pha. 2. to establish the prevalence of pha for each sub-type of hypertensive disorder of pregnancy 3. to compare maternal, fetal and neonatal outcomes among women diagnosed with primary hyperaldosteronism (pha) before pregnancy and pregnant women diagnosed with pha after pregnancy.

Eligibility criteria:
inclusion criteria: * between 4 and 24 weeks post-partum women who had a hypertensive disorder during their latest pregnancy. exclusion criteria: * ongoing pregnancy * diagnosed pheochromocytoma * diagnosed cushing syndrome * diagnosed secondary hyperaldosteronism

Keywords: pregnancy outcome prevalence
the active trial: a prospective randomised control trial of the h1 implant versus total hip replacement

Conditions: Osteoarthritis, Hip; Inflammatory Arthritis

Summary: the goal of this randomised controlled trial is to compare the success of two types of hip replacement in patients with hip arthritis. the main question it aims to answer is whether a new type of hip replacement (called a hip resurfacing) can be as successful as an existing hip replacement (called a total hip replacement). patients will be given either the new hip resurfacing or the existing total hip replacement and researchers will compare their function, complication rate and physical activity.

the h1 implant is a cementless, ceramic hip resurfacing arthroplasty (hra) device. the intended purpose of the h1 implant is to provide an artificial substitute for a disease-damaged hip joint to replace the articulating surfaces of the hip while preserving the underlying femoral head and natural femoral neck. this is standard for a resurfacing hip prosthesis. this study will randomise patients to receive either the h1 implant or a primary cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement (thr). composite clinical success (ccs) scores, physical activity levels and patient reported outcome measures (proms) will be compared for the two groups. the primary objective of the study is to determine whether the h1 implant is non-inferior to cementless thr in terms of ccs. the key secondary objective is to determine whether the h1 implant is superior compared to cementless thr in terms of physical activity and proms. other secondary objectives are to compare the h1 implant and thr with respect to: safety, through collection of all device-related, operative site-related and systemic adverse events; and noise generation, through patient survey.

Eligibility criteria:
inclusion criteria: * patient requires unilateral primary hip arthroplasty due to primary osteoarthritis, osteoarthritis secondary to e.g. trauma, avascular necrosis or developmental hip dysplasia, or inflammatory arthritis. * patient is willing to comply with study requirements. * patient plans to be available through 10 years postoperative follow-up. exclusion criteria: * patient has a bmi greater than 40 kg/m². * patient has active infection or sepsis (treated or untreated). * patient has insufficient bone stock at the hip (\>1/3 necrosis of the femoral head or large and multiple cysts) or in general as in severe osteopenia or osteoporosis (t-score \< -2.5 as measured with bmd). * patient is not skeletally mature. * patient meets the contraindication criteria of the control device. * patient already has another lower limb arthroplasty or arthrodesis or will require a further lower limb arthroplasty or arthrodesis within the subsequent 2 years. * patient lacks capacity to consent. * patient is unable to understand the native language of the country where their procedure is taking place

Keywords: hip resurfacing ceramic
axitinib for the treatment of advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic hcc * failure of one prior antiangiogenic therapy including sorafenib, bevacizumab and brivanib. * child-pugh class a or b (score 7 only) disease. exclusion criteria: * prior treatment of advanced hcc with more than one prior first-line systemic therapy. * any prior local therapy within 2 weeks of starting the study treatment. * presence of hepatic encephalopathy and/or clinically relevant ascites. * presence of main portal vein invasion by hcc.

Keywords: hepatocellular carcinoma
combidex uspio - ultra-small superparamagnetic iron oxide

Conditions: Uterine Neoplasms; Cervix Neoplasms; Bladder Neoplasms; Prostatic Neoplasms

Summary: the purpose of this study is to test whether or not a new contrast agent called combidex, a contrast agent formulated from ultra-small superparamagnetic iron oxide (uspio) improves the ability of magnetic resonance imaging (mri) to see lymph nodes in the pelvis. it might also help doctors tell whether or not cancer has spread to these lymph nodes. it might allow radiotherapy to be delivered more accurately.


Eligibility criteria:
inclusion criteria: * histologically confirmed endometrial, cervix, prostate (ct1-ct3) or bladder cancer * no distant metastases * informed consent exclusion criteria: * confirmed prostate carcinoma and psa less than or equal to 4 or greater than 100 * radical surgery or prior cryosurgery for prostate carcinoma, previous rt, hormonal manipulation or chemotherapy * biopsy-proven lymph node involvement * endometrium or cervix carcinoma who have undergone recent pelvic surgery with the exclusion of d\&c or biopsy * bladder carcinoma with recent pelvic surgery with the exclusion of turbt * previous or concurrent cancers other than superficial basal or squamous cell skin carcinoma unless disease-free for at least 5 yrs * contraindication to mr imaging * hip prosthesis * major medical or psychiatric illness * patients with known allergy to dextran or iron-containing compounds * patients with cirrhosis or hemochromatosis * patients receiving another mr contrast within 2 hrs prior to the ferumoxtran-10