Kornimate/medical-research-clean huggingface dataset:
multi centre trial of dsmm for newly diagnosed multiple myeloma up to 60 years

Conditions: Multiple Myeloma

Summary: the study is evaluating whether risk-stratification by the means of a chromosomal aberration provides a tool to discriminate between standard and high risk. risk-adapted therapy is based on allogeneic stem-cell transplantation for high-risk subjects instead of a second autograft in patients with deletion of chromosome 13 who have an hla-identical stem cell donor available.

the dsmm v protocol is to compare a consolidation treatment for standard-risk patients not displaying del(13) at initial diagnosis following two cycles of high-dose melphalan 200 mg/m² each supported by autologous stem cell retransfusion with interferon versus peg-interferon. patients with del(13) are screened for availability of a fully hla-matched related or unrelated donor. if patient's informed consent is obtained additionally, he is scheduled to undergo an allogeneic sct following the first cycle of high-dose melphalan. all other subjects are to proceed to a second course of high-dose melphalan similar to the standard-risk group. initial cytoreduction is foreseen with four cycles of anthracycline-dexamethasone combination followed by combination therapy with ifosfamide/epirubicine/etoposide for stem-cell collection.

Eligibility criteria:
inclusion criteria: * primary diagnosis of multiple myeloma * salmon-and-durie stage ii or iii * less than or equal to 60 years * signed informed consent exclusion criteria: * relevant comorbidities * unable to adhere to study protocol * pregnancy * not received subject's informed consent

Keywords: primary treatment allogeneic stem-cell transplantation high-dose therapy cytogenetics
prospective liver tumor (prolit) database

Conditions: Hepatocellular Carcinoma; Evidence of Liver Transplantation

Summary: the investigators propose a prospective, web-based database (developed within the framework of quickbase, intuit) which will allow an evaluation of the data for patients with a liver tumour who receive a liver transplant. each site will continue to transplant according to their own criteria for inclusion on the waiting list. each center will be responsible to enter a short list of data points at time of listing, transplant, and at 1 and 2 years post transplant. data will be gathered prospectively through a web-based anaonymized database, and outcomes analyzed yearly x5 for tumour recurrence and patient survival.

a previous retrospective study evaluated the unos database of liver transplant recipients for use of total tumor volume (ttv) and alphafetoprotein (afp) as criteria for selection of candidates for liver transplantation. the results confirmed a prior publication demonstrating that tumors modestly beyond milan size limitation and irrespective of tumor numbers can achieve excellent outcomes, while providing important insight into which tumors within milan criteria remain with a high likelihood of recurrence (high afp). the work has now been published in hepatology. the investigators propose a prospective evaluation of these composite criteria, using data from patients receiving a liver transplant in order to have a larger population. centers will continue to transplant according to their own criteria for inclusion on the waiting list. data will be gathered prospectively through a web-based database (quickbase, intuit) and outcomes analyzed yearly for 5 years follow-up for tumour recurrence and patient survival. each center will be responsible to enter a short list of data points for their patients at time of listing, time of transplant, and yearly post transplant. data points have been kept to a minimum in the hope that this will encourage participation in this database. the database will be set up with 3 levels of access: 1. data entry only (one at each site) 2. review site data and composite data from other sites(one at each site) 3. review all sites and aggregate (for analysis and publication) sites will only be able to edit and review their own patient data. they will be able to view aggregate data from other sites from which all identifiers have been removed. data will not be used to manage patient care in any way. the data will be used only to evaluate outcomes of patients who had a liver tumour at the time of their liver transplant.

Eligibility criteria:
inclusion criteria: * patients with hepatocellular carcinoma listed for liver transplantation

Keywords: selection criteria liver transplantation hepatocellular carcinoma
efficacy of temporary positive expiratory pressure (tpep) in chronic hypersecretion

Conditions: Chronic Hypersecretions

Summary: mechanical devices to increase the individual's bronchial hygiene are commonly used in patients with chronic retention of secretions and abnormal cough reflex. in this clinical context a new technology (namely tpep® - temporary positive expiratory pressure) has been recently developed with the aim to improve the respiratory condition in patients suffering from chronic respiratory diseases. this trial has the aim to assess the clinical efficacy of tpep in patients with chronic hypersecretion and airways obstruction, but with a normal competence of the cough reflex

this is a single-blind multicentre controlled randomized trial with consecutive recruitment. randomization list by blocks will be available. group comparison will be made between active therapies including tpep added to conventional mabt (intervention) or mabt alone (control). active therapy will last 10 consecutive daily sessions in both groups. primary outcome efficacy comparison on change in: a.arterial oxygenation (as assessed by pao2/fio2 ratio and/or sato2 index) secondary outcomes efficacy comparison on change in: 1. sputum characteristics 2. daily sputum volume 3. perceived sensation 4. lung functions (as assessed by spirometry and rm strength)

Eligibility criteria:
inclusion criteria: * chronic hypersecretion as defined by \> 30 ml/die sputum production (7) * chronic airway obstruction (by definition) * copd, bronchiectasis, asthma, cystic disease, etc. with or without chronic respiratory failure * adulthood * smoking or non-smoking habit * peak cough expiratory flow \> 150 l\*min-1 (5) * willingness to participate exclusion criteria: * childhood * presence of acute exacerbation * severe concomitant cardiovascular diseases * concomitant neoplastic diseases * non compliance/adherence to tpep * concomitant use of chronic mechanical ventilation * use of amynophyllines and/or any active drugs (e.g. n-acetyl-cysteine)

Keywords: chronic bronchitis copd bronchiectasis
predicting breast cancer with the brave system

Conditions: Breast Mass; Breast Cancer

Summary: breast cancer predominates among cancer diagnoses in canadian women. it accounts for around 25% of new cases and contributes to 13% of all cancer-related deaths. in 2020, almost 27,400 canadian women were diagnosed with breast cancer and 5,000 of them died from it. mammography is still the preferred method for screening for breast cancer. although progress has been made over the years, mammography does have its drawbacks. these include physical discomfort for patients, exposure to x-rays and reduced effectiveness in dense breasts. the study team is therefore interested in developing a new breast cancer detection method, the brave method. the brave method, short for "bra-based visco-elastography", uses the high contrast of elastic stiffness in malignant breast tumors to detect possible cancer cases without the need for x-rays or breast compression. the first phase, carried out on a small scale pilot study, aimed to assess the method's ability to distinguish a breast with no abnormalities from one with confirmed cancer. the second phase (current phase), carried out on a larger scale, aims to confirm the sensitivity and specificity of the method in detecting malignant lesions, i.e. to determine whether the method is capable of distinguishing between several types of breast masses.

this study has two objectives, which will be studied in two separate groups. 1. to measure the sensitivity and specificity of brave in identifying malignant lesions in a cohort of 300 women. 2. to assess the impact of breast density on the ability of brave to discriminate malignant breast lesions. the research team aim to recruit 300 women requiring follow-up imaging. half will have lower breast density (categories a or b) and the other half will have higher breast density (categories c or d). participants will need to attend a single visit lasting approximately 75 minutes, where they will be asked to wear the study's bra and complete the examination process. other data will also be collected in the medical file to enable the team to confirm: the density of the breast, and the results and dates of mammography imaging or other tests related to breast cancer.

Eligibility criteria:
inclusion criteria: * ≥18 years old * able and willing to provide signed informed consent in french or english * recent mammogram (\< 6 months) * breast mass newly identified by palpation, mammography, sonography, or mri and have been referred for additional imaging or evaluation. specific inclusion criteria: group 1 - normal mammographic breast density (nmbd): breast density a or b group 2 - elevated mammographic breast density (embd): breast density c or d exclusion criteria: * pregnant or breast-feeding women * breast implants or prior surgery/biopsy to breasts * any disease or condition limiting the capacity to complete the examination process * any previous or prescribed treatment against cancer

Keywords: breast mass breast cancer mammogram imaging
intensive case diabetes management (icdm) to prevent readmission

Conditions: Diabetes

Summary: the purpose of this study is to assess whether intensive case management interventions by a diabetes team, led by an endocrinologist and certified diabetes educator, can prevent \<31 day readmission in previously identified high risk patients with diabetes.the procedures of the study will focus on managing the patient's diabetes and diabetes education while in the hospital, decreasing the patient's risk for hypoglycemia and hyperglycemia in the hospital, and assist in the patient's diabetes management plan for a safe discharge.


Eligibility criteria:
inclusion criteria: * patients admitted with a diagnosis of diabetes, patients with a previous history of pharmacy expert system (pes) alert, enrollment in research must be within 24 hours of admission exclusion criteria: * patients transferred from institutionalized care, patients who already plan to move to institutionalized care, patients with severe co-morbidities (e.g. terminal cancer), patients admitted for surgery within 24 hours, patients who are unwilling or unable to give written consent (e.g. dementia), patients who are homeless, patients previously admitted to the diabetes endocrine service

Keywords: inpatient diabetes management prevent <31 day readmission in patients with diabetes cdes role in transition of care of inpatients with diabetes
common variants in candidate genes and premature mi risk

Conditions: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction

Summary: to examine the impact of an interaction between common genetic susceptibility markers and environmental exposures on risk for early onset myocardial infarction in cases with myocardial infarction and matching controls.

background: inherited factors play a role in the pathogenesis of myocardial infarction (mi), and there is growing interest in identifying common genetic susceptibility markers that interact with common environmental exposures to contribute to the occurrence of myocardial infarction (mi) in the population. design narrative: the study had a case-control design. the preliminary data addressed the contribution of common genetic and environmental factors to the risk of mi among women under 45 years of age. those data showed that common polymorphisms in genes coding for two clotting factors, coagulation factor v and coagulation factor ii, were risk factors for mi only among cigarette smokers in this sample. these relationships, and others observed, provided strong evidence of gene-environment interactions between thrombotic and atherosclerotic factors in early-onset mi. one intent was to determine whether the risk of early-onset mi was related to interactions between environmental factors (e.g., cigarette smoking, exercise, alcohol consumption) and common polymorphisms in genes coding for thrombotic factors (coagulation factor v, coagulation factor ii, plasminogen activator inhibitor-1, and beta-fibrinogen) and atherosclerotic factors (the adhesion molecule e-selectin and metalloproteinase stromelysin-1; the lipid metabolism enzymes paraoxinase, lipoprotein lipase, cholesterol ester transfer protein; and the apolipoproteins apolipoprotein e and apolipoprotein b). additionally, there were plans to determine whether the risk of early-onset mi was related to interactions between plasma lipoprotein(a) levels (which were largely genetically determined) and environmental risk factors and/or polymorphisms in the candidate genes. interactions among candidate polymorphisms were also assessed. newly-diagnosed cases of mi and controls will be interviewed in person to assess medical and behavioral characteristics related to mi risk. a venous blood sample will be obtained and processed into aliquots of plasma and white cells. dna extracted from the white cells will be tested using the polymerase chain reaction (pcr), pcr/restriction fragment length polymorphisms (rflp), and oligonucleotide ligation assays to determine the genotypes of interest. plasma will be tested for lipid, lipoprotein, and homocysteine concentrations. analyses will address both the overall association between the genotypes and mi risk, along with posited gene-environment and gene-gene interactions.

Eligibility criteria:
no eligibility criteria
effects of adaptive servoventilation in patients with systolic heart failure and sleep-disordered breathing

Conditions: Heart Failure, Congestive; Sleep Apnea Syndromes; Adaptive Servoventilation

Summary: prospective, follow-up registry of heart failure patients with or without sleep-disordered breathing (sdb). to test the hypothesis that treatment of nocturnal central sleep apnea with cheyne-stokes respiration by adaptive servoventilation (asv) improves symptoms, cardiac performance and event-free survival.

the study is intended to investigate therapeutic effects of adaptive servoventilation in patients with sleep-disordered breathing and chronic heart failure. these effects include short-/long-term effects on * symptoms and quality of life * physical and cardiac performance (6min walking test, cardiopulmonary exercise testing) * echocardiographic parameters * arrhythmias * nt-probnp * respiratory stability (blood gases, rebreathing test, ve/vco2-slope in cardiopulmonary exercise testing) * compliance with asv therapy * event free survival (death, heart transplantation, assist device implantation) all of these data are also obtained in patients who basically meet the inclusion criteria but in whom sleep-disordered breathing was excluded by means of cardiorespiratory polygraphy or polysomnography and in patients with sleep-disordered breathing who do not undergo adaptive servoventilation for various reasons.

Eligibility criteria:
inclusion criteria: * stable heart failure nyha ≥ ii * ef ≤ 45% * without sleep-disordered breathing (apnea-hypopnea-index \<5/h) and those with moderate to severe central sleep apnea (apnea-hypopnea index ≥ 15/h) with or without adaptive servoventilation therapy exclusion criteria: * cardiac resynchronization or pacemaker implantation within the last 6 months * significant copd with an forced expiratory one-second capacity relative to vital capacity (fev1/vc)\< 70% (gold iii) * respiratory insufficiency requiring long-term oxygen therapy * daytime hypercapnia at rest (pco2 \> 45 mmhg) * current ventilation therapy * cardiac surgery, pci, myocardial infarction, unstable angina, tia or stroke within 12 weeks prior to randomization * acute myocarditis within 6 months prior to randomization * pregnancy

Keywords: heart failure, congestive sleep apnea syndromes adaptive servoventilation prognosis cheyne-stokes respiration
surfactant levels in the lungs of covid-19 patients

Conditions: To Assess Surfactant Levels in Lung Fluid

Summary: name of study: surfactant levels in the lungs of covid-19 patients background * infection with sars-cov-2 may induce respiratory failure. * covid-19 associated respiratory failure may require ventilatory support. * sars-cov-2 uses alveolar type ii cells for virus replication. * alveolar type ii cells are responsible for surfactant production and lack of surfactant causes respiratory failure in preterm neonates. * lack of surfactant may play role for respiratory failure in covid-19 patients design exploratory prospective study design without therapeutic intervention of any kind. lung fluid will be donated as part of standard care procedures. hypothesis surfactant is measurable in tracheal secretions by mid-infrared ftir spectroscopy determined surfactant spectra. surfactant is reduced in covid-19 patients requiring ventilator support as compared to non- covid-19 patients. dysfunctional surfactant in covid-19 patients regain its function when respiratory function improves. population main population is patients with covid-19 pneumonia that requires ventilatory support. outcome measures primary outcome is the level of surfactant in lung fluid as obtained by tracheal suction. sample size in total 30 patients will be included: twenty covid-19 patients and 10 non-covid-19 patients.


Eligibility criteria:
inclusion criteria: 1. patients positive for coronavirus 2 (sars-cov-2) and 2. respiratory failure requiring mechanical ventilation support or respiratory failure requiring oxygen supplementation and 3. age \> 18 years and 4. permission from next of kin exclusion criteria: inability to obtain ts or bl as determined by clinical judgement by responsible clinician. patients with known surfactant dysfunction (such as mutations in the sftpb or abca3 gene). imminent expected death within 24 hours. stage 4 severe chronic kidney disease or requiring dialysis. liver failure. anticipated transfer to another hospital within 72 hours. participation in another study which in the opinion of the investigator would prevent enrollment for safety purposes.
clopidogrel vs. aspirin in patients with s. aureus bacteremia

Conditions: Staphylococcus Aureus Endocarditis; Staphylococcus Aureus Septicemia; Staphylococcus Aureus Bloodstream Infection

Summary: this is an open-label randomized controlled trial which will enroll patients with s. aureus bacteremia who are already taking aspirin for secondary prevention of cardiovascular events. we will randomize patients to continue their aspirin or change clopidogrel which is also approved for secondary prevention. unlike aspirin, clopidogrel may have activity against s. aureus. we wish to determine if changing to clopidogrel will improve outcomes in s. aureus bacteremia in people who otherwise would have a reason to be taking it. this study is an approved sub-study of the staphylococcus aureus network adaptive platform (snap) trial (nct05137119). if positive, this study will support a second rct in people who do not currently have an indication for clopidogrel.


Eligibility criteria:
the participant must meet all inclusion and exclusion criteria for the snap platform (nct05137119) and also the following inclusion and exclusion criteria: inclusion criteria: * patient is taking aspirin for secondary prevention of cardiovascular disease (coronary, cerebrovascular, or peripheral vascular disease) exclusion criteria: * active bleeding (allowing up to 3 days from platform entry to randomize in the event anti-thrombotic therapy is resumed) * anticipated major cardiac surgery, neurosurgery, or spine surgery within the next 3 days * pregnancy * known receipt of clopidogrel, prasugrel, or ticagrelor within the last month * allergy to clopidogrel * concomitant receipt of oral xa inhibitor

Keywords: s. aureus bactremia s. aureus bloodstream infection s. aureus endocarditis aspirin clopidogrel
a phase ii clinical study of ac-201 tablets in subjects with plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the purpose of the study is to evaluate the efficacy and safety of ac-201 tablets compared with placebo in subjects with moderate-to-severe plaque psoriasis

ac-201 is a highly selective dual inhibitor of tyk2 and jak1, which are targeting the signal transduction of a variety of cytokines in psoriasis. this study is to evaluate the efficacy and safety of ac-201 tablets in subjects with moderate-to-severe plaque psoriasis. the efficacy will be determined by the superior percentage of subjects achieved psoriasis area and severity index (pasi) 75 (greater than or equal to 75% improvement in pasi) compared with placebo. the treatment of ac-201 will be up to 12 weeks and followed by a 4-week safety follow-up, and total duration will be up to 16 weeks. adverse events, clinical laboratory assessments, electrocardiograms (ecgs), vital signs, physical examinations, concomitant medications will be monitored throughout the study. meanwhile, pharmacokinetics and pharmacodynamics will be analyzed.

Eligibility criteria:
inclusion criteria: -stable plaque psoriasis (defined as no morphological or severity changes for ≥ 6 month) and meet the following disease severity at screening and baseline: total pasi score ≥ 12, and total spga ≥ 3, and total bsa ≥ 10% -candidate for phototherapy or systemic treatment for plaque psoriasis exclusion criteria: * other form of psoriasis (e.g., erythrodermic, pustular or guttate) * current or history for drug-induced psoriasis (e.g., psoriasis induced by beta blockers, calcium channel blockers, antimalarial drugs, or lithium) * history or risk of tuberculosis (tb) * have received tyk2 inhibitor and lack of efficacy deemed by investigator * topical medications/treatments for psoriasis within 2 weeks prior to administration of any study medication * systemic medications/treatments for psoriasis within 4 weeks prior to administration of any study medication * has received biological treatment (e.g., anti-tnfα, anti-il12/23, anti-il17) for psoriasis less than 5 half-lives of treatment prior to administration of any study medication