Kornimate/medical-research-clean huggingface dataset:
oral lactoferrin supplementation for prevention of sepsis in preterm neonate

Conditions: Neonatal Sepsis

Summary: hypothesis: orally ingested lactoferrin has effects on promotion of growth and differentiation of the immature gut; also it has immunomodulatory properties, so it will prevent serious infections in preterm infants. the aim of the study is to: * evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis. * compare two dose regiment of lactoferrin supplementation. * study effect of lactoferrin supplementation on serum iron stores. it is a prospective, randomized, double blind, placebo-controlled study, it will include 180 preterm neonates admitted to the neonatal intensive care units of of ain shams university hospitals and manshiet el bakry hospital. •group a: who will receive oral lactoferrin supplementation in a dose of 100 mg/day. •group b: who will receive oral lactoferrin supplementation in a dose of 150 mg/kg/ twice daily. •group c (controls): who match the subjected neonates, will receive placebo in form of distilled water.


Eligibility criteria:
inclusion criteria: 1. neonates with a birth weight between 500g and 2500g. 2. neonates with a ≤ 36 weeks of gestation counting from the first day of the last menstrual period. 3. preterm neonates born in, or referred to the neonatal intensive care units of one of the participating hospitals in the first 48 hours of life. exclusion criteria: 1. neonates with underlying gastrointestinal problems that prevent oral intake. 2. neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities). 3. neonates with a family background of cow milk allergy. 4. neonates who will not have the chance to complete the study time (who will be referred to another hospitals). 5. neonates whose parents decline to participate. 6. neonates with early onset sepsis.
registry and clinical observation of children with diarrhoeal disease

Conditions: Diarrhea

Summary: this study based on the actual clinical diagnosis and treatment of data, evaluate the clinical characteristics of children with diarrhea therapeutic effect and security, and establish the platform to childhood diarrhea registration, long-term accumulation of clinical data, develop the clinical characteristics and therapeutic effect of childhood diarrhea, safety monitoring data, and provide reliable data support for the clinical application.

to evaluate the causes, clinical manifestations, treatment plans and clinical outcomes of diarrhoeal disease in children in a real diagnosis and treatment setting。 evaluate the effect of different treatment schemes in actual clinical application,the clinical use of nutrition-supported zinc in oral rehydration fluids,the influencing factors of clinical efficacy, including the demographic characteristics and clinical characteristics of the children, as well as drug combination regimens, etc. to evaluate the clinical use of antibiotics,the clinical effects of different probiotics in the treatment of diarrhoeal disease in children,the effectiveness, safety and economy of the dose course of the clinical application of clostridium butyricum bivariate living agents, the medical costs and resource consumption of treatment for diarrhoeal diseases in children.

Eligibility criteria:
inclusion criteria: * under the age of 18 * children diagnosed with diarrhea, including: 1. acute diarrhea: infectious, such as viral bacteria, and non-infectious, such as improper diet and climate factors 2. persistent chronic diarrhea: including the following diseases: 1. food allergy, food intolerance, indigestion, etc.; 2. inflammatory bowel disease (ibd); 3. diarrhoeal irritable bowel syndrome; 4. antibiotic associated diarrhea (aad); 5. others: chronic hepatitis associated diarrhea, metabolic diseases associated diarrhea (such as diabetes mellitus with diarrhea), pancreatic exocrine dysfunction (cystic fibrosis), etc 3. volunteered to participate in this study and signed the informed consent or the guardian signed the informed consent exclusion criteria: 1. class a infectious diseases associated with diarrhoea (cholera, plague) 2. children with congenital heart disease, immune deficiency, malformation of digestive tract, or with severe dysfunction of heart, lung, liver and kidney。 3. children receiving long-term immunosuppressive therapy (except children with ibd)。 4. children with gastrointestinal surgery and tumor; 5. in addition to the above, the researchers determined that there were other children who were not suitable to participate in the study。

Keywords: probiotics children
octa and retinal angiomatous proliferation

Conditions: Age Related Macular Degeneration

Summary: to investigate, using optical coherence tomography angiography, the retinal vascular features in patients affected by rap.

retinal vascular anomalous complex represents a distinct form of neovascularization in patients with age-related macular degeneration. the study investigated the changes in retinal vascular network using optical coherence tomography angiography, a novel and non invasive diagnostic technique that allows to better understand the pathophysiologic mechanism of this neovascularization.

Eligibility criteria:
inclusion criteria: * age older than 65 years * diagnosis of retinal angiomatous proliferation and reticular pseudodrusen * absence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases. * absence of significant lens opacities, low-quality oct-a images. exclusion criteria: * age older than 80 years * absence of diagnosis of retinal angiomatous proliferation and reticular pseudodrusen * presence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases. * presence of significant lens opacities, low-quality oct-a images.
posterior plating versus anterior to posterior screws in fixation of posterior column in pilon fractures

Conditions: Tibial Fractures

Summary: management of comminuted distal tibia fracture (pilon fracture) is still a challenging field. it is recently done guided by the new four column theory of distal tibia. several approaches were advocated to address and fix each column. fixation of posterior column is still a wide debate among orthopedic surgeons. this study is conducted to compare outcomes between two modalities for the management of posterior column fracture in pilon fractures.

the aim of this work is to assess and compare results of anterior to posterior screws versus posterior buttress plate in management of posterior column fracture in pilon fracture as regards functional, radiological outcomes and possible complications. optimal treatment of comminuted pilon fractures requires precise anatomical reduction. several methods have been advocated to manage complex pilon fractures, but an optimal fixation technique remains controversial. on the basis of the anatomical characteristics of the ankle joint a four-column classification to guide the treatment of comminuted pilon fractures was proposed. the four-column classification can be summarized as follows: lateral column( the distal fibula), posterior column( the posterior part of the intermalleolus line with the distal tibial shaft), anterior column (the anterior part of the intermalleolus line with the distal tibial shaft) and medial column(the medial one-third of the tibial plafond with the distal tibial shaft). a posterolateral incision is typically used to reduce and fix the posterior malleolar fragment to the tibial metaphysis which can be also done through the anterior incision using anterior to posterior screws.

Eligibility criteria:
inclusion criteria: * two, three and four column pilon fracture exclusion criteria: * pathological fractures. * pediatric age group with open physis.
collateral ligation in failing fistulas

Conditions: Hemodialysis Access Failure

Summary: arteriovenous fistulas (avfs) for hemodialysis often fail to become usable due to failure to mature (ftm). the most common cause is narrowing of the artery or vein (stenosis). another potential cause is the presence of collateral or side branch veins that steal blood flow from the main fistula channel. some believe that occluding these veins might help maturation of those failing avfs. to evaluate if this actually works, patients with ftm will be randomly assigned to side branch vein ligation (or not), and rates of avf maturation of the two groups will be compared.

arteriovenous fistulas (avfs) for hemodialysis often fail to become usable due to failure to mature (ftm). the most common cause is stenosis of the artery or vein. another potential cause is the presence of collateral or side branch veins that steal blood flow from the main fistula channel. the utility of ligating these veins to improve maturation of those failing avfs is controversial. to evaluate this, 35 patients presenting for fistulograms for evaluation of avfs with ftm, found to have side branch veins will be prospectively enrolled. after management of stenoses (if present), they will be randomly assigned to ligation of the venous side branches or not. maturation rates for each group will be prospectively assessed. for patients assigned to the control group who have persistent failure to mature, a cross-over intervention will be performed and side branch ligation will be offered.

Eligibility criteria:
inclusion criteria: - patients with upper extremity autogenous avf presenting with ftm with evidence of collaterals on ultrasound and/or clinical exam. exclusion criteria: * age under 18 years * pregnant women * prior endovascular or surgical procedure in the fistula after its creation (with the exception of surgical superficialization or mobilization) * clinical evidence of infection associated with the avf * uncorrectable coagulopathy (international normalized radio \>2.5, platelet count \<50.000/μl) * absence of significant venous side branches on angiogram (defined as those that arise in the initial 10 cm, including the future cannulation zone, and have maximal diameter greater than or equal to one third of the widest diameter of the fistula's main venous channel in this segment).

Keywords: hemodialysis fistula failure to mature collateral vein
ocrelizumab effects on the metabolome in ms

Conditions: Multiple Sclerosis

Summary: in this observational study, the investigators aim to recruit 50 patients over an 10-12 month period. the investigators will recruit patients with relapsing-remitting ms (based on 2017 mcdonald criteria) beginning treatment with ocrelizumab and fulfilling study inclusion and exclusion criteria. participants recruited in this study will be participants in the johns hopkins ms precision medicine center of excellence bio-banking protocol which requires collection of serum and plasma at 6-monthly intervals and hence will have blood collection performed prior to ocrevus start and then at 6, 12, 18 and 24 months following ocrelizumab initiation as part of the bio-banking protocol. all recruited participants will provide written informed consent. the investigators will collect demographic and clinical characteristics at baseline and update these at follow-up visits. these will include disease duration, co-morbidities, relapses, treatment status and history. the investigators will also collect physiological variables - height and weight at each visit. all recruited patients will return for follow up visits at 6,12, 18 and 24 months post-ocrelizumab initiation. at each visit patients will undergo the following evaluations - edss, msfc, sdmt, fatigue scale (mfis), quality of life measure (ms-qol), depression scale (beck depression inventory, 2nd version) and block food frequency questionnaire. the investigators will then utilize plasma collected at the various time points to perform global metabolomics analysis. this will yield measures of various metabolites in the circulation, including amino acids and metabolites of the amino acids. the investigators will utilize this data to determine the change in the circulating metabolome produced by treatment with ocrelizumab. following this the investigators will assess changes in the various clinical measures collected - disability (edss, msfc), cognition (sdmt), mood (bdi-ii), fatigue (mfis) and quality of life (ms-qol) with ocrelizumab treatment and correlate these with the changes noted in the metabolome. this approach will allow us to determine whether the metabolic changes are associated with/ could underlie the changes noted in clinical measures.


Eligibility criteria:
inclusion criteria: * between 18-75 years of age * diagnosis of relapsing remitting multiple sclerosis (rrms) based on 2017 mcdonald criteria * initiating treatment with ocrelizumab based on decision of the treating physician * able to return for visits every 6 months to johns hopkins ms center exclusion criteria: * presence of additional neuroinflammatory or neurodegenerative disorder * steroids within the past 30 days * other significant metabolic comorbidity - eg: uncontrolled hypothyroidism or diabetes * likely to switch therapy in the following year * previous treatment with rituximab or other chemotherapy agents
exercise in patients with end stage kidney disease

Conditions: Renal Failure

Summary: this study will be conducted over a 3 year time period. this is a trial of an exercise intervention vs. standard of care in patients receiving chronic dialysis. the specific aims will be to determine feasibility of patient recruitment, adherence to the exercise program, and efficacy of the intervention on patient important outcomes. the exercise intervention will be delivered to randomized participants for 12 months, and consist of the prescribed use of nordic walking poles, online resources for exercise in the home, regular use of a pedometer to monitor progress, and regular verbal encouragement to exercise (monthly) by dialysis unit staff. both groups will receive the same standard of care co-interventions including individualized dialysis prescriptions and health-care interactions according to practices at their centre.


Eligibility criteria:
inclusion criteria: 1. all ambulatory adult patients with end stage kidney disease 2. treatment with peritoneal dialysis or hemodialysis for greater than six months 3. able to understand english or french 4. abuse to use nordic walking poles 5. able and willing to provide informed consent exclusion criteria: 1. any absolute contraindication to exercise \[unstable angina, uncontrolled hypertension (systolic or diastolic blood pressure greater than 180 mmhg (millimeters of mercury) or greater than 110 mmhg, respectively), deemed not suitable for exercise by the treating physician\] 2. baseline step count greater than 8000 steps a day 3. planned living donor kidney transplant 4. potential for recovery of renal function 5. patients who feel unsafe using nordic walking poles in place of their mobility aid 6. participation in another interventional trial that may affect the results of this study

Keywords: renal failure hemodialysis peritoneal dialysis exercise
epomi study: erythropoietin in myocardial infarction

Conditions: Myocardial Infarction

Summary: epomi is a randomized, open-label, parallel phase ii clinical study that will evaluate the effects of a single erythropoietin administration on infarct size and cardiac remodeling in patients with acute myocardial infarction. eligible patients will be randomly assigned to receive conventional therapy and single infusion of 1000u/kg of epoetin beta or conventional therapy alone. infarct size and cardiac remodeling parameters will be assessed by cardiac magnetic resonance imaging (mri) within 3-7 days of the randomization and repeated 3 months later.


Eligibility criteria:
inclusion criteria: * st-segment elevation myocardial infarction \<6h * infarct related artery : proximal circumflex artery , proximal and mid left anterior descending artery, 1st segment of the right coronary artery * timi 0 or 1 before angioplasty * successful pci defined by residual stenosis \< 50% and timi 2 or 3 flow grade * body weight : \[50-110\] kg * informed, written consent exclusion criteria: * age \< 18 * pregnant, or parturient or breast-feeding women; * sexually active women without efficient contraception; * inability to fully cooperate with the study protocol * pre-treatment with fibrinolysis ; * previous q-wave myocardial infarction or previous aorto-coronary bypass; * history of deep vein thrombosis or pulmonary embolism; * contraindication to aspirin or clopidogrel ; * cardiogenic shock ; * cardiac resuscitated before angioplasty ; * past or active erythropoietin therapy; * contraindications to erythropoietin therapy: uncontrolled hypertension, known hypersensitivity to benzoic acid, chronic liver insufficiency, hemoglobin\> 16g / l, thrombocytosis, refractory anemia with excess of blasts; * renal insufficiency (creatinine clearance \<30ml/mn.); * active malignancies * any contraindications to magnetic resonance imaging: pacemaker and automatic cardiac defibrillator, hearing aid, neurostimulator, infusion pump etc metallic splinters in the eye, ferromagnetic haemostatic clips in the central nervous system cochlear implants, claustrophobia; * allergy to gadolinium ; * patient refusal / patient not having provided written informed consent.

Keywords: acute st elevation myocardial infarction
conservative treatment in lateral epicondylitis

Conditions: Lateral Epicondylitis

Summary: conservative treatments follow the vast majority of treatments in lateral epicondylitis. in this research, we aimed to elucidate the treatment outcomes of patients via epicondylitis bandage, wrist dorsiflexion splint, and kinesio tape groups by sequential randomization and to compare treatment outcomes.


Eligibility criteria:
inclusion criteria: * patients who were ≥18 years of age, and had no history of elbow surgery. * participants should have pain and sensitivity, with symptom duration less than 12 weeks. * patients with a positive result in one of the provocation tests (maudsley's test-resisted middle finger extension extensor carpi radialis test), resisted wrist extension, or passive stretching of the wrist extensors (mill's test) were included. exclusion criteria: * patients under 18 years of age, * patients who did not consent to participate in the study, * those who had previous surgery on the elbow, * presence of cervical spondylosis and radiculopathy, * presence of endocrine disease, * presence of autoimmune disease, * presence of concomitant entrapment neuropathy or polyneuropathy, * pregnancy, * presence of systemic inflammatory disease, * presence of acute trauma, * presence of deformity in the upper extremity, * presence of metabolic disease, * presence of elbow arthritis, * presence of allergy to kinesio tape and orthoses, * having received treatment for lateral epicondylitis in the past (exercise, injection, nsaids).
technology-assisted conscientiousness therapy for people with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this is a validation study of a conscientiousness-based phone app intervention strategy to help people with their health management and employment.

the primary objective is to establish whether people with ms with low conscientiousness benefit from a cognitive-behavioral, phone app intervention. also enrolled are healthy individuals over the age of 60. this group's response to the intervention will be compared to the ms sample. the investigators also aim to determine the acceptability and utilization of the conscientiousness-coach phone application and intervention. it is anticipated that the conscientiousness-coach phone app intervention will result in fewer negative work events and increased work accommodations in those treated, relative to the control group. in exploration of other secondary outcomes, the investigators also expect that the treatment will result in increased self-report trait conscientiousness itself, increase in structured leisure activities, reduction in depression, and reduction in anxiety. this is a prospective longitudinal design with an experimental manipulation (i.e., a randomized-controlled trial). there will be an initial assessment with neuropsychological testing, the buffalo vocational monitoring survey (bvms), and several self-report measures, and a post-test assessment after three months and six months with these same instruments, excluding the neuropsychological assessment. the bvms will also be administered at 0 months, 3 months, and 6 months to further assess post-treatment effects.

Eligibility criteria:
inclusion criteria: * has a diagnosis of multiple sclerosis or is over 60 years of age. * if an ms patient: is above 18 years of age. * no history of substance dependence/abuse, psychiatric disorders, or any neurological disease other than ms * if an ms patient: has a neo-ffi conscientiousness score that is one standard deviation or more below the healthy adult mean (t=40) exclusion criteria: • does not meet one or more of the above inclusion criteria

Keywords: neuropsychology multiple sclerosis conscientiousness mobile application smartphone application employment quality of life
effect of warfarin in the treatment of metachromatic leukodystrophy

Conditions: Metachromatic Leukodystrophy

Summary: objectives/purpose: to determine the safety and efficacy of a vitamin k (vit k) antagonist (warfarin) in treating metachromatic leukodystrophy (mld).

hypothesis: vit k has an essential role in biosynthesis of sulfatides and other sphingolopids in the brain. administering warfarin, a vit k antagonist, may ameliorate the phenotype in mld by decreasing t he amount of sphingolipid storage in the neuronal cells. study design prospective: we will enroll eligible consenting subjects into the study. the study will not include a control group and the families and treating physicians are informed administration of the drug. 1. duration of treatment: 4 weeks 2. pharmacological intervention: the patients will receive warfarin 1.5 mg at the beginning of the study period. the dosage then will be adjusted to the inr values on weekly basis. 3. clinical evaluation: the patients will undergo clinical assessment prior to starting the treatment and at the end of the treatment period. the clinical assessment will also include administration of gross motor function measure (gmfm), a clinical toll for evaluation of motor development in children. 4. urine sulfatide quantification: urine samples for quantification of the sulfatide level will be collected at the time of enrollment, after 2 weeks and at the end of treatment period. 5. blood monitoring: the patients will undergo blood test for pt/inr at baseline and afterwards, at weekly bases for 4 weeks. the inr will be kept in a safe range of 2-2.5. if the inr is greater than 4.0 the dosage of warfarin will be lowered and another blood draw will be performed in 3 days.

Eligibility criteria:
inclusion criteria: * children with mld, 1 to 10 years of age who have received and failed bone marrow transplantation or are excluded from the treatment due to delayed diagnosis or any other reasons. exclusion criteria: * any children with mld who are eligible for and might receive abmt. * any children with mld who suffer with a bleeding disorder, moderate to severe anemia or any other hematological disorders. * any contraindications systemic for anti-coagulation

Keywords: mld