Kornimate/medical-research-clean huggingface dataset:
the dynamic interplay between bleeding phenotype and baseline factor level in moderate and mild hemophilia a and b

Conditions: Hemophilia

Summary: there are large inter-individual differences in the bleeding pattern of patients with moderate or mild hemophilia. the major determinant of bleeding phenotype is the level of coagulant factor viii or ix. in hemophilia a, studies addressing the association between factor viii level and the clinical bleeding pattern yield conflicting results. in hemophilia b such studies have not yet been performed. the primary aim of this project is to analyze the association between factor viii and factor ix levels and the bleeding phenotype. the secondary aim is to analyze potential differences in phenotype between hemophilia a and b. the project is a multicentre observational cohort study. we will include 230 patients with moderate or mild hemophilia a or b (fviii/fix 0.02-0.35 iu/ml) who are 12 to 55 years old. the main cohort study consists of clinical data collection, one blood sample and an online questionnaire for patients. data will be collected on the nature and duration of all bleeding episodes, disease and treatment characteristics, physical activity level and musculoskeletal status. one blood withdrawal will be performed for centralized laboratory assays for fviii or fix levels (both one-stage and chromogenic assays) and genetic analysis for the most prevalent prothrombotic mutations. the online questionnaire for patients focuses on bleeds experienced in the past. a subset of 50 patients aged 24 years or older with mild and moderate hemophilia a will be investigated in more detail by longitudinal data collection including analysis of physical joint status, mri imaging of joints and biomarkers for joint damage. this longitudinal observation will consist of two time points that lie two years apart, allowing us to identify any changes that occur over the observed time period with respect to joint status.


Eligibility criteria:
inclusion criteria: * moderate or mild hemophilia a (fviii:c 0.02-0.35 iu/ml) or hemophilia b (fix:c 0.02-0.35 iu/ml) * age from 12 up to and including 55 years exclusion criteria: * other clotting disorder * participation in another trial with an investigational product * comorbidity affecting the musculoskeletal status * clinically relevant inhibitor status at present or in the past * hemophilia b leyden * use of anticoagulants
physical training and blood pressure in high risk youths

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Obesity

Summary: to determine the effects of physical activity on blood pressure and body fat in children varying in ethnicity, gender, and health status.

design narrative: there were two specific aims. the first was to test the hypothesis that controlled physical training (pt) reduced blood pressure, at rest and in reaction to forehead cold and exercise stressors, in 8-9 year olds who were high in both blood pressure and body fatness. subjects were divided equally on gender and blood pressure and body fatness. subjects were divided equally on gender and ethnicity (black/white). both resting and reactive blood pressure were correlated with left ventricular mass and were predictive of future essential hypertension. the underlying hemodynamic regulators of blood pressure, cardiac output and the total peripheral resistance, were measured with impedance cardiography to explore hemodynamic mechanisms through which training had a favorable influence on blood pressure and left ventricular mass. the second aim tested the hypothesis that physical training reduced percent body fat, as measured with dual energy x-ray absorptiometry (dexa). children above the 70th percentile in both blood pressure and fatness were randomly assigned, within ethnicity and gender, to a physical training or waiting list control group. after the physical training group underwent four months of training, all subjects were retested and these data were used to test the primary hypotheses. the initial control subjects then performed four months of physical training, after which they were retested. the data from this second phase were added to the data of the initial physical training group to explore interactions of training with gender and ethnicity. the initial physical training group was brought back four months after cessation of training to see if the changes elicited by the training were reversible. to document the stimulation provided by the training, heart rate was monitored during training sessions. to observe the time course of changes between the full lab testing sessions, skinfolds and resting blood pressure were measured monthly. diet and free living physical activity were assessed to help explain changes in body composition. aerobic fitness was measured with treadmill tests of maximal oxygen consumption.

Eligibility criteria:
no eligibility criteria
management of malignant pleural effusion - indwelling pleural catheter or talc pleurodesis

Conditions: Pleural Effusion, Malignant; Lung Neoplasms

Summary: prospective study of the effect of talc pleurodesis vs. indwelling pleural catheter in treatment of patients with malignant pleural effusion

randomized prospective study that will include 120 patients with malignant pleural effusion with high rate of accumulation; less than one month, the patients will be divided randomly for two groups, each group 60 patients, the first group will undergoes talc pleurodesis, the second group will undergoes indwelling pleural catheter insertion. the two groups will be followed up for one year, starting at the time of intervention, after 14 days of intervention, after 30 days of intervention, once monthly for one year. the patients will be evaluated according to the rate of complication; need for further intervention in each group, improvement of the quality of life, respiratory improvement, radiological evaluation based on chest xray findings, rate and duration of admissions that are related to pleural effusion during the year of study.

Eligibility criteria:
inclusion criteria: 1. patients with recurrent symptomatic pleural effusion, the diagnosis was obtained by : - positive cytology for malignant cells in the fluid. * patients well known for malignancy, with exudative pleural effusion with no alternative diagnosis. * pleural biopsy - surgically obtained - with diagnosis of pleural malignancy * microscopic intraoperative findings suggestive of pleural malignancy. 2. patients who underwent prior to involvement in the study, draining of the pleural fluid with symptomatic improvement. 3. patients with rate of fluid accumulation less than 30 days. 4. patient who signed informed consent about being involved in the study. exclusion criteria: 1. patients under the age of 18 years. 2. female patients who are pregnant or nursing. 3. patients with rate of pleural effusion accumulation is more than 30 days. 4. patients who didn't show clinical improvement post proper draining of the fluid 5. patients who are hemodynamically or respiratory unstable. 6. patients with empyema. 7. patients who are non functioning/ not active according to the performance status. 8. the type of malignancy which cause the malignant pleural effusion is lymphoma. 9. patient who underwent pneumonectomy at the side of the fluid. 10. previous pleurodesis at the side of pleural effusion. 11. chylothorax in the initial pleural tapping.

Keywords: malignant pleural effusion,talc pleurodesis,quality of life
population pharmacokinetic modeling to optimize the dosage of the piperacillin / tazobactam combination in patients with sepsis in intensive care

Conditions: Resuscitation Patients With Sepsis

Summary: population pharmacokinetic modeling mathematically describes the pharmacokinetics of a drug and the variables likely to influence it in a "typical" patient population. we propose to model a bayesian estimator, taking into account the individual factors that influence exposure to the piperacillin / tazobactam combination in a target population of sepsis, to allow for early assessment of serum piperacillin / tazobactam concentration profiles. optimization of dosing regimens. indeed, pharmacokinetic tools of this type are already regularly successfully applied for other classes of antibiotics or immunosuppressants whose therapeutic index is narrow. they reduce the toxic risk and optimize the effectiveness of these treatments.


Eligibility criteria:
inclusion criteria: * major patient (age ≥18 years) male or female. * patient hospitalized in intensive care for sepsis, involving (i) a suspected or proven infection; (ii) a systemic inflammatory response; (iii) dysfunction of at least one organ, according to the international consensus "sepsis-3". * patient with an arterial catheter that can be used for blood sampling by the time the first dose of piperacillin / tazobactam is administered. * patient for whom treatment with piperacillin / tazobactam, alone or in combination with another antibiotic, is prescribed according to the following modalities (drug spc): scheduled antibiotic treatment for at least 48 hours in iv infusion of 4 g of piperacillin and 0.5 g tazobactam over 3 hours, every 6 hours or every 8 hours. * patient affiliated to a social security scheme. * patient informed and given his non-opposition. if the patient is unable to do so (emergency situations) the non-opposition will be obtained from the patient's representative. exclusion criteria: * treatment with piperacillin and / or tazobactam within 7 days prior to evaluation. * patient with a history of allergy to penicillins or β-lactams. * kidney function of kdigo score = 3 (3 times baseline plasma creatinine or plasma creatinine ≥ 354μmol / l or extra-renal clearance, or diuresis \<0.3ml / kg / h for ≥ 24h or anuria for ≥ 12h) to not include patients at very high risk of extra-renal clearance within 48 hours. * hypersensitivity to the active substances, to any other antibacterial agent of the penicillin class or to any of the excipients. * history of severe allergic reaction to any other β-lactam. * patient being treated with extrarenal treatment. * patient being treated with extracorporeal circulation (ecmo). * hepatic insufficiency patient with child c. cirrhosis. * patient who refused to participate or refused participation by the representative. * person deprived of liberty by an administrative or judicial decision. * person under tutorship or curatorship. * pregnant or nursing woman.
dlbcl treatment in children and adolescents

Conditions: Diffuse Large B-cell Lymphoma

Summary: we compared the efficacy and safety of modified nhl-bfm-90 regimen and r-chop/chop regimen in pediatric (aged 0-14 years) and adolescent（aged 15-18 years）dlbcl patients in a single institution during a 20-year period. we compared the efficacy and safety of modified nhl-bfm-90 regimen and r-chop/chop regimen in pediatric (aged 0-14 years) and adolescent（aged 15-18 years）dlbcl patients in a single institution during a 20-year period. to our best knowledge, no reports have been previously published regarding the comparison.

diffuse large b-cell lymphoma (dlbcl) is an aggressive lymphoma that accounts for approximately 10%-20% of pediatric and adolescent non-hodgkin's lymphomas (nhls). the incidence increases with age, with 37% of nhls patients being adolescents aged. poor survival has been demonstrated in adolescents and young adults compared to children with dlbcl. however, the associazione italiana ematologia oncologia pediatrica (aieop) lnh-97 study showed that age was not a poor prognostic factor in children and adolescents with burkitt lymphoma (bl) and dlbcl. a conclusion as to whether adolescent age is an independent risk factor has not been reached. at present, the preferred protocols for adolescent dlbcl patients have not been standardized. adolescents with cancer have been designated as a vulnerable population, positioned between children and the adult population. treatment strategies differ between adults and pediatric patients. the pediatric strategy for dlbcl was developed in parallel by the berlin-frankfurt-münster (bfm) and french-american-british/lymphomes malins b (fab/lmb) groups. the combination of rituximab plus cyclophosphamide, adriamycin, vincristine, and prednisone (r-chop) or r-chop-like chemotherapy regimens are the standard therapy for the treatment of adult patients with dlbcl. there is currently a lack of studies that have compared the treatment outcomes in adolescent patients with dlbcl who were administered pediatric or adult regimens. hence, we retrospectively analyzed the clinical characteristics and prognostic factors in dlbcl patients, especially the efficacy and safety of the pediatric regimen (modified nhl-bfm-90) and adult regimen (r-chop/chop), between pediatric and adolescent dlbcl patients.

Eligibility criteria:
inclusion criteria: 1. patients who were pathologically diagnosed with dlbcl 2. patients under 18 years of age. exclusion criteria: 1. was administered prior chemotherapy; 2. patients who could not receive chemotherapy due to severe immunodeficiency or other diseases. 3. patients with primary central nervous system lymphomas.

Keywords: children, adolescent, treatment, modified nhl-bfm-90, r-chop
efficacy and outcomes of neodymium-doped yttrium aluminum garnet (nd: yag) laser capsulotomy performed by optometrists

Conditions: Posterior Capsule Opacification Obscuring Vision

Summary: the purpose of this study is to formally assess the efficacy and outcomes of optometrist-performed neodymium-doped yttrium aluminum garnet (nd: yag) laser capsulotomy procedures.

participants will undergo a pre-procedure examination to establish baseline findings and to determine if they meet the inclusion criteria. participants will undergo the nd: yag laser capsulotomy procedure and will be examined at 1 hour, 1 day (if necessary), 1 week, 1 month, and 3 months following the procedure. follow-up examinations will evaluate visual acuity improvement and possible post-procedure complications. the complication rate following the laser capsulotomy procedure is typically minimal.

Eligibility criteria:
inclusion criteria: 1. ability to provide written informed consent; 2. at least 18 years of age, male or female; 3. prior cataract surgery; 4. diagnosed with posterior capsule opacification obstructing vision; 5. best-corrected visual acuity less than 20/40 or visual acuity with glare that reduces by 2 lines or more on an etdrs visual acuity chart or significant effect on activities of daily living exclusion criteria: 1. history of underlying ocular disease (not including mild/moderate non-proliferative diabetic retinopathy or incidental findings) 2. previous myopic refractive error greater than 6.00 diopters 3. complications following previous ocular procedures (i.e. intraocular lens decentration) 4. ocular surgery other than uncomplicated cataract or uncomplicated refractive surgery
use music therapy in autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: music therapy is an established form of creative art therapy. by using music as a specific medium of communication, expression and adapting it to the individual resources and abilities of the patient, music therapy can be beneficial in activating and supporting mental and psycho-physical recover .

students with developmental disabilities often have challenges in the areas of communication and social/emotional learning, which can lead to social isolation, problematic behaviors, and deficits in academic learning.these students have been found to respond well to the incorporation of music in intervention programs, in terms of both gains in communication skills and stronger social functioning . they respond more favorably and appropriately to music than other sensory stimuli

Eligibility criteria:
inclusion criteria: * 1.age :3_7 2.gender : both sex will be included in the study 3.iq ≥75 4.children who will dignosed by an expert phoniatricist as having asd exclusion criteria: * 1.age \>3 \<7 2.iq \<75 . 3. children having other cause of delayed language development
evaluation of the samsung labgeo ivd-a20 chf test in a point-of-care setting

Conditions: Congestive Heart Failure

Summary: to establish the performance characteristics of the samsung labgeo ivd-a20 chf test in intended use settings, by comparing test results of the a20 chf test with results obtained from an fda-cleared comparator assay.


Eligibility criteria:
inclusion criteria: * chf subjects: 21 years of age or greater, with clinically confirmed chf or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure. * subjects with potentially confounding comorbidities: non-chf subjects 21 years of age or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (copd) * healthy subjects: apparently healthy subjects greater than 45 years of age, with no prior history of cardiac-related disease. exclusion criteria: * apparently healthy subjects with a history of mi, chf or other cardiac-related disease; * subjects with acute decompensated heart failure currently on nesiritide therapy; * subjects having participated in another experimental drug, biologic, or invasive device study within 30 days prior to signing informed consent for this study, or enrolled concurrently in any other investigative study; and * subjects unable to or refusing to provide written informed consent.

Keywords: chf
clareon toric study (t2-t9)

Conditions: Aphakia; Corneal Astigmatism

Summary: the purpose of this post-market study is to describe the long-term safety and performance of clareon toric intraocular lenses (iols).

subjects will attend up to 12 scheduled visits (one preoperative visit, up to two surgical visits, and up to 9 postoperative visits) over the course of the study (3 years follow-up). the overall study duration is expected to be approximately 4 years. this study will be conducted in canada.

Eligibility criteria:
key inclusion criteria: * able to understand and sign the informed consent form. * willing and able to attend all scheduled study visits as required per protocol. * cataract in one or both eyes with planned extraction by conventional phacoemulsification. * astigmatism in the operative eye(s). * other protocol-defined inclusion criteria may apply. key exclusion criteria: * women of childbearing potential, currently pregnant, intend to become pregnant during the study, or nursing. * history of retinal detachment, age-related macular degeneration, glaucoma, diabetic retinopathy, or any pathologic changes associated with the optic nerve. * clinically significant corneal disease that may, according to the investigator's medical opinion, adversely affect visual outcomes. * clinically significant dry eye that would affect study measurements based on the investigator's expert medical opinion. * history of prior intraocular or corneal surgery. * other protocol-defined exclusion criteria may apply.
pharmacokinetics (pk) and safety evaluation of daptomycin in children ages 3-24 months with proven or suspected gram-positive infections or peri-operative subjects receiving prophylactic antibiotics

Conditions: Gram Positive Bacterial Infection

Summary: this is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 3 months to 24 months who have proven or suspected infections that are caused by a specific group of bacteria (called gram-positive bacteria)or perioperative subjects that are receiving prophylactic antibiotics .


Eligibility criteria:
inclusion criteria: 1. written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care; 2.1 male or female between the ages of 3 months and 24 months, inclusive; 3. able to comply with the protocol for the duration of the study; 4.1 clinically stable with no evidence of hemodynamic instability (defined as a requirement for inotropic or vasodilatory support to manage blood pressure) in the 24 hour window prior to first dose, and no history or evidence of renal or hepatic compromise; 5.1 suspected or diagnosed bacterial infection for which the subject is receiving standard antibiotic therapy; including prophylactic use of antibiotics peri-operatively; 6. a calculated creatinine clearance rate (clcr) ≥ 80 ml/min/1.73m2 as determined by the schwartz equation at baseline; 7. creatine phosphokinase (cpk) levels less than 2x uln (upper limit of normal) at baseline; 8.1 presence of two patent intravenous lines (or comparable means of venous or arterial access)prior to dosing on study day 1. a single intravenous line (or comparable means of venous access) is acceptable for both drug administration and sample collection if reasonable effort to gain a second line is unsuccessful. the line must be flushed as described in appendix b of the protocol prior to obtaining pk samples. pk sample can be obtained from a peri-operatively placed arterial line. arterial pk samples should be indicated on the crf. exclusion criteria: 1. investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry; 2. known allergy/ hypersensitivity to daptomycin; 3.1 history of clinically significant, renal, hepatic, autoimmune disease or primary immune deficiency; 4. deleted 5. subjects with clinically significant abnormal laboratory test results (including ecgs), as determined by investigator; 6. administration of rifampin within 7 days of study drug administration; 7. deleted 8. subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of investigator); 9. deleted; 10.1 planned administration of intramuscular injection within 12 hours following study administration unless approved by the medical monitor; 11. deleted 12.1 guillian-barre or spinal cord injury; 13. history of or current rhabdomyolysis.

Keywords: gram positive infection concurrent antibiotic treatment