Kornimate/medical-research-clean huggingface dataset:
induction, consolidation and intensification therapy for patients younger than 66 years with previously untreated cd33 positive acute myeloid leukemia (aml)

Conditions: Acute Myeloid Leukemia

Summary: this is a prospective, open, non-randomized, non-controlled, phase ii, clinical trial for treatment of newly diagnosed aml patients, younger than 66 years. trial is based on: * induction: flai + gemtuzumab-ozogamicin (flai-go). * consolidation: intermediate dose arac + ida (idac+ida) +/- one course of high dose arac (hdac) * intensification: allo-bmt, asct * maintenance: arac a) primary endpoints: * feasibility, efficacy (cr+pr rate) and toxicity of flai + gemtuzumab-ozogamicin. * rfs, dfs and os. b) secondary endpoints: * evaluation of minimal residual disease by wt1 (and other biologic markers) expression and monitoring. * evaluation of prognostic clinical relevance of biological features at onset. * feasibility and outcome of consolidation with bmt.


Eligibility criteria:
inclusion criteria: * age 18-65 years. * who ps grade 0-2 (appendix b) or karnofsky \> 70. * aml according to the new who criteria, i.e., % of bm blasts ≥ 20%. nb. this % should be assessed on a bm aspiration or on a bm biopsy * all fab subtypes except m3. * cd33 positivity (\> 20%). it is mandatory to perform an immunotyping of the bm blasts in particular the determination of cd33 positivity, which will be used as a inclusion factor. * previously untreated (except ≤ 14 days of hydroxyurea) primary or secondary aml (including aml after mds). * adequate renal and liver function, i.e., creatinine \< 2 mg/dl and bilirubin, alt/ast ≤ 3 times the upper limit of normal. * written informed consent exclusion criteria: * blast crisis of chronic myeloid leukemia. * aml supervening after other myeloproliferative diseases. * aml de novo or secondary previously pretreated. * concomitant malignant disease. * active central nervous system (cns) leukemia. * active uncontrolled infection \[nb severe systemic infection should be excluded\]. * concomitant severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease. * cardiac ejection fraction of 50% or less. * severe pulmonary dysfunction (ctc grade 3-4). * severe concomitant neurological or psychiatric disease. * history of alcohol abuse. * hiv positivity. * pregnancy. * man and woman not agreeing to the adequate contraceptive precautions during study period and for at last 24 months after stop of therapy. * any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Keywords: induction chemotherapy fludarabine gemtuzumab ozogamicin
a long-term safety study of once-daily travatan

Conditions: Glaucoma, Open-angle; Ocular Hypertension

Summary: long term safety study of travatan in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
adult patients of any race and either sex with chronic angle-closure glaucoma.

Keywords: glaucoma poag oag oht
evaluation of the strategy of "one-stop" endovascular treatment for concomitant coronary artery disease and aortic atherosclerotic disease

Conditions: Coronary Artery Disease; Aortic Atherosclerotic Disease

Summary: the study is a prospective, randomized, controlled, exploratory trail to evaluate the strategy of "one-stop" endovascular treatment for concomitant coronary artery disease and aortic atherosclerotic disease.

60 patients will be allocated randomly in a 1:1 ratio into one-stop strategy group or staging strategy group. in one-stop strategy group, percutaneous coronary intervention (pci) will be performed on the same operating room immediately after the endovascular aortic repair (evar); in staging strategy group, pci will be performed several days after evar. the safety and effectiveness will be assessed between two groups 1 year after the operation. the economic index will be evaluated as well as.

Eligibility criteria:
inclusion criteria: * aged from 18 years to 75years, male or female; * aortic atherosclerotic disease with indication of evar; * coronary heart disease with indication of pci; * provided informed consent. exclusion criteria: * acute aortic dissection * acute coronary syndrome * dysfunction of coagulation system * patients with gastrointestinal hemorrhage * known allergy to contrasts or antiplatelet drugs * renal dysfunction (gfr≤60ml/min) * patient with multi-branch coronary preferred cabg

Keywords: coronary artery disease aortic atherosclerotic disease one-stop endovascular aortic repair percutaneous coronary intervention
efficacy of risk assessment for sudden cardiac death in patients with hypertrophic cardiomyopathy

Conditions: Hypertrophic Cardiomyopathy

Summary: hypertrophic cardiomyopathy (hcm) is a heart disease characterized by hypertrophy of the left ventricular myocardium and is most often caused by mutations in sarcomere genes. the structural and functional abnormalities cannot be explained by flow-limiting coronary artery disease or loading conditions. the disease affects at least 0,2% of the population worldwide and is the most common cause of sudden cardiac death (scd) in young people and competitive athletes due to fatal ventricular arrhythmia, but in most patients, however, hcm has a benign course. therefore, it is of utmost importance to properly evaluate patients and identify those who would benefit from a cardioverter-defibrillator (icd) implantation.

hypertrophic cardiomyopathy (hcm) is a heart disease characterized by hypertrophy of the left ventricular myocardium and is most often caused by mutations in sarcomere genes. the structural and functional abnormalities cannot be explained by flow-limiting coronary artery disease or loading conditions. the disease affects at least 0,2% of the population worldwide and is the most common cause of sudden cardiac death (scd) in young people and competitive athletes due to fatal ventricular arrhythmia, but in most patients, however, hcm has a benign course. therefore, it is of utmost importance to properly evaluate patients and identify those who would benefit from a cardioverter-defibrillator (icd) implantation. this study assesses the accuracy of the hcm scd-risk calculator, recommended by european society of cardiology guidelines, in patients treated in the ist department of cardiology of poznan university of medical sciences from 2005 to 2018. the study group consisted of 252 patients aged 20-88 (mean 53,8 ± 15,1, median 54); 49,6% were men. the protocol consisted of medical history collection (including a questionnaire), physical examination and additional tests such as echocardiography with the assessment of global longitudinal strain and average strain, cardiac magnetic resonance, ambulatory ecg monitoring, control of implantable devices and exercise testing.

Eligibility criteria:
inclusion criteria: 1. hypertrophic cardiomyopathy, 2. minimum 18 years, 3. questionnaire, 4. assessment of hcm scd-risk calculator at the beginning of the observation, 5. regular visits in cardiology outpatient clinic, 6. agreement to participate in the study exclusion criteria: 1. poorly controlled hypertension (systolic pressure on the next two visits in the cardiology outpatient clinic \>180 mmhg), 2. haemodynamically significant valvular heart disease or valve replacement condition, 3. past myocardial infarction (haemodynamically significant changes found in coronarography), 4. heart transplant, 5. insufficient amount of data from the subject and additional tests allowing for further analysis, 6. lack of consent to participate in the study.

Keywords: sudden cardiac death risk assesment hcm risk-scd calculator
reduction of catheter-associated urinary tract infection with a daily nursing review of the indication

Conditions: Urinary Tract Infections; Urinary Tract; Accessory

Summary: the purpose of this study is to determine whether the daily nurse review of the indication of the urinary catheter compared to the everyday care of the working staff is effective to reduce the rate of catheter-associated urinary tract infection in adults hospitalized.

healthcare-associated infection (hai)in hospitalized patients are very frequent, especially the catheter-associated urinary tract infection, which prolongs the hospital stay and costs, and is about 3 times more likely to die during hospitalization than patients not infected. the measures of aseptic insertion and closed systems of collection, as well as the rational use of the probe reduce the risk for infection. a checklist that contains the agreed indications of catheter, related to obstruction, incontinence, skin lesions in sacral region, monitoring or surgical procedures allows the daily review of the indication of the probe. if the patient doesn´t meet at least one of the criteria, should be recommended the withdrawal of the catheter.

Eligibility criteria:
inclusion criteria: * inpatient with a permanent urinary catheter (balloon catheter) * urinary catheter placed in the hospitalization (previous day) or at admission exclusion criteria: * urinary tract infection diagnosis at time of the insertion * spinal cord injury or neurogenic bladder at admission

Keywords: urinary tract infections catheter-associated urinary tract infections prevention and control controlled clinical trial
efficacy of human coronavirus-immune convalescent plasma for the treatment of covid-19 disease in hospitalized children

Conditions: Hospitalized Children; Covid-19 Infection

Summary: this is a multicentered, open-label, randomized controlled phase 2 trial to evaluate the safety and efficacy of providing human coronavirus-immune convalescent plasma as treatment for covid-19 disease in hospitalized children in the context of the covid-19 pandemic.

sars-cov-2 viral infection resulting in covid-19 disease has recently been designated by the world health organization as a global pandemic. outbreak forecasting and mathematical models suggest that the number of covid-19 cases will continue to rise over the coming weeks and months. there is an urgent public health need for rapid development of novel interventions. this protocol aims to use passive antibody therapy via convalescent plasma from sars-cov-2-infected patients who have developed antibody immunity, covid-19 convalescent plasma (c19-cp), as treatment for hospitalized children with covid-19 disease at pediatric academic hospitals across canada. the unknown role for convalescent plasma in treating covid-19 necessitates further study.

Eligibility criteria:
inclusion criteria: 1. age 0 to \<19 years old 2. hospitalized with symptoms compatible with covid-19 illness 3. laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen prior to randomization. 4. abo compatible convalescent plasma available exclusion criteria: 1. onset of symptoms began \>12 days before screening 2. history of adverse reactions to blood products or other contraindication to transfusion 3. refusal of plasma for religious or other reasons 4. acute heart failure with fluid overload 5. any condition or diagnosis, that could in the opinion of the site principal investigator interfere with the participant's ability to comply with study instructions, or put the participant at risk 6. anticipated discharge within 24 hours note: the intent of this exclusion criteria is to only include participants with acute covid-19 infections. this protocol is not intended to include participants with post-infectious complications. in cases where the distinction is not clear, participant eligibility will be discussed with the study steering committee prior to enrollment.

Keywords: covid-19 hospitalized children convalescent plasma therapy
post marketing observational study of reformulated benefix

Conditions: Hemophilia B

Summary: the primary objective of this observational study is to collect safety data on reformulated benefix as prescribed in routine clinical practice conditions in france. the secondary objectives are to collect data on the clinical course of individuals treated with reformulated benefix and on the ease of reformulated benefix.

no sampling

Eligibility criteria:
inclusion criteria: * subjects with hemophilia b already receiving or starting treatment with reformulated benefix. * subjects who have dated and signed the informed consent form. exclusion criteria: * ongoing treatment of hemophilia b by a product other than reformulated benefix. * participation in the european prospective registry of patients with hemophilia b treated with benefix (wyeth protocol 3090a-101039).

Keywords: hemophilia b observational post marketing study
effect of oral health education on oral health status, treatment needs and barriers to care

Conditions: Dental Caries; Gingivitis

Summary: jordanian children have very poor oral hygiene parameters, and this is reflected as very high caries prevalence and poor gingival health conditions. this study will focus on children at social homes in the community in order to establish a baseline reference about their oral health status, treatment needs, and barriers to dental care. also, to report the efficacy of oral health education using audio-visual aids and frequent motivation on oral health status, treatment needs and barriers to care among children at social homes in jordan.

the oral health status (ohs) for children and adults is a reflection of the whole body general health status as well as the overall quality of life. jordanian children have very poor oral hygiene parameters, and this is reflected as very high caries prevalence and poor gingival health conditions. orphans and children who come from broken homes are suspected to have poorer oral health conditions from their peers in the public due to the different parameters that can affect their general health in whole and oral health in particular, and this could affect their quality of life. these parameters can be related to socioeconomic status, psychological and behavioral conditions, access to care and other factors. the role of tooth brushing in decreasing dental caries and enhancing the gingival health is well-established in the literature, and oral health education programs have proven to be effective in improving the oral health knowledge, attitude and behavior of children. these programs could be regarded as an effective measure to enhance the oral health status and establish good routines in childhood which is vital for optimum oral health and provision of lifelong protection against caries. this study will focus on children at social homes in the community in order to establish a baseline reference about their oral health status, treatment needs, and barriers to dental care. also, to report the efficacy of oral health education using audio-visual aids and frequent motivation on oral health status, treatment needs and barriers to care among children at social homes in jordan.

Eligibility criteria:
inclusion criteria: * healthy children living in social homes among age group specified exclusion criteria: * children with poor behavior

Keywords: oral health status dental treatment needs barriers to dental care children at social homes
a novel limb cryocompression system for prevention of chemotherapy induced peripheral neuropathy - expansion study

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: the study conducted on cancer patients is designed to test safety and efficacy of limb hypothermia in cancer patients using the new paxman limb cryocompression system (plcs). ultimately this will lead to the development of a therapy regime that will help to prevent chemotherapy-induced neuropathy in cancer patients.

the study will consist of 80 cancer patients, recruited from the national university hospital and curie oncology. based on an established optimal temperature and pressure of limb cryocompression, cancer patients will undergo cryocompression over multiple cycles of chemotherapy to establish safety and efficacy of repeated therapy. cryocompression of the limbs will be administered using cooling wraps attached to a cooling device. the limbs will be cooled from the digits to the elbow/knee.

Eligibility criteria:
inclusion criteria: * age 21- 80 years. * signed informed consent from patient or legal representative * scheduled to receive weekly paclitaxel chemotherapy * patients may receive other chemotherapy drugs alongside taxane e.g. platinum/herceptin. exclusion criteria: * open skin wound or ulcers of the limbs * history of raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes * pregnant woman * a score of more than 5 in total neuropathy score (tns) at baseline for cancer patients

Keywords: chemotherapy-induced peripheral neuropathy cryocompression
predictive risk stratification through t variability in icd patients without pacing indications

Conditions: Sudden Cardiac Death

Summary: the aim of the study is to assess the negative predictive value of the t amplitude variance as a method for risk stratification for patients with an increased risk for scd.


Eligibility criteria:
inclusion criteria: patient has been prescribed the implantation of an sorin group ovatiotm dr 6550 / vr 6250 system according to relevant currently-approved guidelines * chf since \> 3 months and * lvef \< 35% and * nyha class ii or iii or * prior myocardial infarction since more than 4 weeks and * lvef \< 30% exclusion criteria: * documented spontaneous sustained ventricular tachycardia * prior implant of any device for ventricular cardiac pacing * existing indication for permanent ventricular pacing * myocardial infarction within 4 weeks prior to enrollment * arrhythmogenic rv-dysplasia * brugada syndrome * long qt syndrome * performed within 3 months prior to enrollment or scheduled (within 3 months) cardiac revascularization (interventional or surgical) * any indication for crt accordingly to the relevant currently-approved acc/aha1 or esc35 guidelines for the implantation of a crt system. * excisting or planned administration of amiodarone - initiation of amiodarone therapy during the run of the study will lead to immediate exclusion of the patient * permanent chronic atrial fibrillation / flutter * patient is unable to attend the scheduled follow-up visits at the participating centre * patient is already included in another ongoing clinical study * patient is unable to understand the objectives of the study * patient refuses to cooperate * patient is unable or refuses to provide informed consent * patient is minor (less than 18-year old) * patient has life expectancy of less than 1 year * patient is pregnant.

Keywords: risk stratification method, negative predictive value, fast ventricular arrhythmias, icd the negative predictive value of the t amplitude variance as a method for risk stratification for patients with an increased risk for scd.
dutch national itb study in children with cerebral palsy

Conditions: Cerebral Palsy; Spasticity

Summary: the objective of this study is to determine the efficacy and safety of treatment with intrathecal baclofen for severe spasticity in children with cerebral palsy.

spasticity in cerebral palsy (cp) is a serious problem leading to pain, sleep disturbance, increased expenditure of energy and/or interference with positioning, transfers, dressing and body hygiene. in later stages, secondary phenomena, such as contractures, decubitus and heterotopic calcifications of joints or tendons may create large treatment problems. a substantial group of children with severe cp does not respond to regular treatments, such as physical therapy, orthopaedic surgery or oral medication. an effective treatment option for intractable spasticity is the continuous delivery of intrathecal baclofen (citb). in 2000, the american academy for cerebral palsy and developmental medicine (aacpdm) published a systematic review on the body of evidence about intrathecal baclofen (itb) for spasticity in individuals with cp. it appeared that only a small and uncertain number of children had been studied. except for two case-reports, none of the studies solely concerned children. the research methodology employed in three quarters of the available studies was not capable of confirming treatment effect. the aacpdm underlined the need for further high-level research in the form of prospective, randomized trials that use valid and reliable outcome measures in well described and homogeneous groups. in 1998 the dutch study group on child spasticity designed the dutch national study on the effectiveness and safety of itb for refractory spasticity in children with cerebral palsy. the dutch national itb study included four phases: 1\] the selection phase, 2\] the double-blind, placebo-controlled dose-escalation test treatment phase, 3\] the prospective, randomized, open-label implantation phase and 4\] the follow-up phase.

Eligibility criteria:
inclusion criteria: * age between 4 and 16 years * spastic diplegia or tetraplegia as part of cp * insufficient response to oral spasticity-reducing medication * in a mixed cp syndrome, spasticity has to be the most prominent sign * spasticity results in a decrease in the quality of life of the child and/or its caregivers * sufficient motivation for participation in the study including availability for follow-up * magnetic resonance imaging of the brain rules out progressive causes of spasticity exclusion criteria: * hypersensitivity to baclofen * contraindications for general anaesthesia * insufficient general health * intractable epileptic seizures * infection of the lumbar skin * a systemic infection

Keywords: cerebral palsy spasticity child baclofen intrathecal injection
intervention study in overweight patients with copd

Conditions: Pulmonary Disease, Chronic Obstructive; Obesity; Weight Loss; Life Style; Overweight

Summary: symptoms of chronic obstructive pulmonary disease (copd) and high body mass index (bmi) overlap. the investigators are trying to find out if a program proven to help people lose a modest amount of weight and increase their physical activity will improve copd symptoms for those with a high bmi. the program uses a series of video sessions and self-study handouts focused on healthy eating and increasing physical activity, and encourages participants to monitor their weight, diet, and physical activity for one year. for those who want to, they will be able to work with a health coach to help meet weight and activity goals. we hope that the program will lead to improved exercise tolerance, body weight, dyspnea, generic health-related quality of life, and major cardiovascular risk factors (central obesity by waist circumference, framingham risk score, and blood pressure) through 12 months of follow-up. to be in the study, participants will need to have copd, high bmi, history of smoking, shortness of breath, and be at least 40 years old.


Eligibility criteria:
inclusion criteria: * 40 years or older at time of eligibility screening; * body mass index 25.0-44.9 kg/m2 (also see figure 2); * smoked more than 10 pack-years of cigarettes; * shortness of breath; * copd; * able to participate fully in all study protocol/procedures including written informed consent process. exclusion criteria: * inability to speak, read, or understand english; * active weight loss interventions; * expected weight loss because of alternate explanations, such as from illness; * unable to ambulate to weight scale for weight measurement; * safety and/or adherence concerns due to severe physical or mental health issues or life expectancy \<18 months; * pregnant, lactating, or planning to become pregnant during the study period; * participation in other intervention studies.

Keywords: randomized controlled trial diet exercise obesity overweight chronic obstructive pulmonary disease lifestyle