Kornimate/medical-research-clean huggingface dataset:
trial of malaria seasonal iptc combined with community case management

Conditions: Malaria

Summary: malaria is a major public health problem. 250 million cases annually leads to approximately 1 million deaths. over 80 per cent of these deaths occur among african children under age five. the main interventions covered treatment with artemisinin combination therapies (act), long lasting bednets distribution and rapid diagnosis tests (rdt) to improve malaria diagnosis. this has led in senegal to a substantial decrease in the incidence of malaria, in 2009. however the recent overall decline hides the fact that malaria incidence remains very high in the south of senegal. that's why home-based management (hmm) for malaria is being introduced in selected areas. intermittent preventive treatment (ipt) by monthly administration of a therapeutic dose of antimalarials can achieve a very high degree of protection from attacks of clinical malaria in children. the purpose of this project is to evaluate the effectiveness of combining iptc with hmm in southern senegal the study objectives are to : * assess the tolerance of iptc using sp+aq when it is administered for a longer period in areas with a longer transmission season, * assess the added benefit that ipt with the association of sulfadoxine-pyrimethamine + amodiaquine can offer in populations where a rapid and early care with home management of malaria is already established. * determine the cost benefit ratio of the addition of iptc with hmm. a cluster randomized controlled trial has been designed to evaluate the effectiveness of adding seasonal iptc with sulfadoxine-pyrimethamine plus amodiaquine (sp+aq) for 5 months per year, in villages where home-based management of malaria is implemented. all villages in saraya district, excluding 7 villages with a health post, will be eligible to participate. saraya villages will be combined to form 24 clusters which will be randomized to receive hmm from a community volunteer, or iptc plus hmm. trained volunteer community medicine distributors (cmd) will provide hmm. the primary endpoint will be the incidence of clinical malaria with fever or history of fever and parasitaemia with density of at least 3000/ul. secondary outcomes will include the safety, the tolerability, the coverage and acceptability of the intervention. both the recurrent and capital costs to the health service of training staff and delivering the interventions will be estimated. both direct and indirect costs to users of the services (children and their families) will also be assessed.


Eligibility criteria:
inclusion criteria: * age between 3 to 120 months * consent participation given by parents or guardians * willing to remain in the study area in the next 6 months exclusion criteria: * known allergy to the study investigational drug * any underlying chronic or severe condition. * participant under treatment with sulfamides

Keywords: iptc community case management home management for malaria
utilizing augmented artificial intelligence for aminoacidopathies

Conditions: Inborn Errors of Metabolism

Summary: the objective of the study was to interpret metabolic profiles of plasma amino acid (paa) and compare reference intervals (ri) of paa data from pakistan with data from other countries using clinical laboratory integrated reports (clir). one-year data (reference and cases data) of twenty-two paa, analyzed by ion exchange high performance chromatography at biochemical genetics laboratory (bgl) of aga khan university pakistan, was compiled in a comma-separated values (.csv) file and uploaded on clir software using aaqp (amino acid in plasma) application for statistical analysis. among total of 2081 paa profiles, 92% (n=1913) were completely normal with all paa values falling within the age-specific reference range. a concordance of 98.8% was noted between the reporting done by the bgl at aku and then after applying clir tools.


Eligibility criteria:
inclusion criteria: all plasma samples during 1 year received at biogenetic lab exclusion criteria: subjects with age greater than 16 years

Keywords: clinical laboratory integrated reports (clir) inherited metabolic disorders (imds)
a clinical trial to explore the safety and efficacy of injections of macugen when given every 6 weeks in subjects with amd

Conditions: Age-Related Macular Degeneration (AMD)

Summary: the purpose of this study is to explore the safety and efficacy of macugen given as maintenance therapy in patients who have had initial success with another amd treatment. patients must have 1, but not more than 3 prior treatments for neovascular amd.


Eligibility criteria:
inclusion criteria: * subfoveal cnv secondary to amd * at least 1 but not more than 3 prior treatments for amd exclusion criteria: * subfoveal scar or subfoveal atrophy * significant media opacities, including cataract, which might interfere with visual acuity

Keywords: age-related macular degeneration (amd) pegaptanib sodium subfoveal cnv macugen
a prospective clinical evaluation of the total vascular access (tva) flex-1 device protocol flex-1-001

Conditions: Chronic Kidney Disease (CKD)

Summary: the primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the flex-1 device for the creation of an arteriovenous fistula (avf) in patients requiring chronic hemodialysis.


Eligibility criteria:
inclusion criteria: * eligible for a native surgical arteriovenous fistula, as determined by the treating physician. * adult (age \>18 years old). * advanced chronic kidney disease (ckd), stage 4 or 5 electing for hemodialysis. * written informed consent obtained

Keywords: chronic kidney disease arteriovenous fistula (avf) hemodialysis vascular access endovascular avf (endoavf)
the effect of stress on the residual gastric volume

Conditions: Arthritis Knee

Summary: in our institution, many patients undergo staged bilateral total knee arthroplasty at weekly intervals, and most of the patients are older adults with degenerative arthritis. as recommended, the older adult patients who undergoing total knee arthroplasty drink carbohydrate-containing fluid (400 ml) 2 hours prior to surgery. in this type of surgery, there are additional points to consider when applying the fasting guidelines. this is because, in addition to the factor of advanced age, which can affect gastric emptying time, the patient's physical, medical, and psychological conditions at the first and the second operation may be different. for example, the effect of the acute pain that occurs after the first total knee arthroplasty and subsequent opioids administered on gastric motility cannot be ignored. however, to date, there have been no studies examining the association of stress (emotional and surgical) and residual gastric volume of older adult patients with staged bilateral total knee arthroplasty and whether there is a difference according to the stage when carbohydrate-containing fluid is ingested. in the present study, the investigators will evaluate the effect of emotional stress, surgical stress, pain, and the use of opioids on the residual gastric volume in older adults undergoing staged-bilateral total knee arthroplasty.


Eligibility criteria:
inclusion criteria: * patients scheduled for staged bilateral total knee arthroplasty aged ≥ 65 * american society of anesthesiologists physical status classification 1, 2, and 3 * body mass index \< 35 kg/cm2 * patients administered carbohydrate-containing fluid 2 hours prior to surgery exclusion criteria: * previous surgery of the upper gastrointestinal tract * achalasia * diabetes
role of activated charcoal in decreasing blood urea, creatinine and phosphorous

Conditions: Chronic Kidney Disease stage3

Summary: the study aims to explore the ability of oral activated charcoal to adsorb uremic toxins limiting the progression of chronic kidney disease and delaying the need for hemodialysis in patients with ckd stages iii and iv. to compare its effect with the effect of dry seeds as absorbents of uremic toxins

in recent years, chronic kidney disease(ckd) has become a worldwide public health issue. the main factors affecting the prognosis of patients with chronic kidney disease are its complications, including cardiovascular and cerebrovascular diseases, malnutrition, inflammation, atherosclerosis syndrome, and anemia. the accumulation of uremic toxins, such as indoxyl sulfate and p-cresyl sulfate, is implicated in the progression of renal failure and cardiovascular disease. for many patients, chronic kidney disease (ckd) is a progressive condition marked by deteriorating renal function ultimately leading to end-stage renal disease (esrd) and many patients refuse to start chronic hemodialysis. therapeutic approaches that decrease the level of uremic toxins are a rational method for inhibiting this progression. many researches have been done aiming to find alternatives for chronic hemodialysis either for economic issues or psychological issues especially in elderly patients, as example: * gum arabic in the remedy and amelioration of kidney dysfunction and end-stage renal disease * skin as excretory root for urea, increasing sweat from sweat glands can support kidney function by excreting a good amount of what kidneys naturally excrete. * the oral charcoal adsorbent reduces serum levels of indoxyl sulfate through adsorption of indole converted from dietary tryptophan in the gastrointestinal tract decreasing serum creatinine and urea level . in this study, the clinical data supporting the role of oral activated charcoal in a dose of 30gm/ day for slowing the progression of ckd will be reviewed. in this study, a trial will be done using dry seeds (lentils as an example) as an absorbent for uremic toxins comparing its effect with the effect of oral activated charcoal.

Eligibility criteria:
inclusion criteria: patients with ckd stages iii and iv patients with age more than 18 years old exclusion criteria: patients on regular hemodialysis patients with age less than 18 years old
yoga for breast cancer

Conditions: Women With Stage I or II Breast Cancer Undergoing Active Radiation Therapy

Summary: the purpose of this study is to examine the use of eischens yoga for 8 weeks in one cohort of 20 women with stage i and ii breast cancer receiving radiation therapy treatment, while a second cohort of the same type of and number of patients who, instead of yoga will receive standard supportive therapy, questionnaire measuring cancer-related quality of life (fact-g instrument) and fatigue (brief fatique inventory) will be given to patients at several points.


Eligibility criteria:
inclusion criteria: * stage i and ii breast cancer patients undergoing active radiation therapy * above the age of 18 * must sign informed consent form * must speak english * only women are eligible exclusion criteria: * patients with medical restrictions that may interfere with yoga participation per their physicians' decision * those who have smoked in the last 6 months because smoking can interfere with the breathing and relaxation techniques of yoga. * those who have regularly taken yoga in the last 6 months, because they would not come to the intervention with the same baseline as other participants.
metformin's effect on drug metabolism in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: type 2 diabetes is a major public health concern. it is widely established that type 2 diabetes in linked to activated innate immunity and increased levels of c-reactive protein and interleukin-6 (il-6) in plasma. studies in humans and in liver cells has shown that il-6 downregulates important drug metabolizing enzymes in the liver (cytochrome p450 (cyp) enzymes). more than half of the most prescribed drugs are eliminated by biotransformation of these enzymes. the investigators have previously shown that initiating glucose-lowering treatment (e.g. metformin, sulphonylureas and insulin) leads to decreased therapeutic efficacy of the blood-thinning vitamin-k antagonist warfarin. due to the non-specific effect of glucose lowering drugs, the investigators hypothesize that this is caused by the glucose-lowering effect rather than drug-drug interactions caused by the individual drugs. based on the proposal that reversal of increased plasma glucose affects drug metabolism, the investigators will perform a clinical pharmacokinetic trial. the purpose of the study is to elucidate whether initiation of glucose-lowering treatment causes altered drug metabolism among patients with type 2 diabetes. the study will include newly diagnosed and untreated type 2 diabetes patients who will ingest a 6-drug cocktail consisting of probes for specific cyp enzymes. plasma and urine will be drawn over 6 hours to determine concentrations of the drugs and their metabolites. patients will then initiate metformin treatment and to assess both short- and long-term impact of glucose-lowering, the same 6-drug cocktail will be ingested, and concentrations measured, after three weeks and three months. to help understand the mechanism and the putative involvement of inflammation, markers of inflammation such as cytokines, transcription factors, etc. will also be assesses.


Eligibility criteria:
inclusion criteria: * type 2 diabetes, not treated metformin. * hemoglobin 1ac (hba1c): ≥48 mmol/mol * age: 18-75 years * body mass index (bmi) ≤ 40 kg/m2 * estimated glomerular filtration rate (egfr) \> 60 ml/min * alanine aminotransferase (alat), bilirubin and hemoglobin within reference range or clinically insignificant differ from this. exclusion criteria: * acute or chronic infection or inflammation * active cancer * glutamic acid decarboxylase (gad)-antibodies * known hypersensitivity to one or several of the drugs * intake of medications which can influence the safety of the patient or the results of the study * alcohol consumption above the limits recommended by the danish health authorities (men 14 units/week, women 7 units/week) * participation in other trials with interventions. * women: positive pregnancy test at inclusion or on one of the test-days.
allogeneic ucb therapy with epo in children with cp

Conditions: Cerebral Palsy

Summary: this randomized controlled study aims to evaluate the efficacy and safety of allogeneic umbilical cord blood therapy combined with erythropoietin for children with cerebral palsy.

cerebral palsy (cp) is a group of neurodevelopmental conditions with abnormal movement and posture resulted from a non-progressive cerebral disturbance. it is the most common cause of motor disability in childhood. most therapies are palliative rather than restorative. umbilical cord blood (ucb) and erythropoetin (epo) may be used as restorative approach for children with cp. many experimental animal studies have revealed that ucb is beneficial to improve and repair neurological injuries. epo is also known to have neuroprotective effects. based on animal studies and some clinical trials, ucb is suggested as a potential therapy for children with cp. epo is combined to add synergistic effects to ucb therapy.

Eligibility criteria:
inclusion criteria: * diagnosed with cerebral palsy * age of ≥10 months and ≤6 years * mismatch in hla-a, b, and dr ≤2, and total nucleated cell count ≥3x107/kg. if the cell count is less than given values, more than 1 unit could be used. * hemoglobin ≤13.6 g/dl * decision of participation in the study by and acquisition of informed consent from the subject's representative * willingness and ability to be hospitalized according to the schedule specified in the protocol and continue the study for 12 months after study entry exclusion criteria: * current aspiration pneumonia * known genetic disease * history of hypersensitivity reaction to any study drugs pertinent to the study * history of participation in any other study with stem cell * prior treatment with epo within 3 months prior to study entry * known coagulopathy with family history of thrombosis or medical history of recurrent thrombosis * patient with severe seizure disease who has clinical convulsion despite combination therapy with 3 or more agents * uncontrolled hypertension defined as systolic blood pressure \>115 mmhg and/or diastolic blood pressure \>70 mmhg * hepatic impairment defined as asparate aminotransferase (ast) \>55 iu/l and/or alanine aminotransferase (alt) \>45 iu/l * renal impairment defined as creatinine (cr) ≥1.2 mg/dl * absolute neutrophil count ≤500/dl * presence of diagnosed or suspected malignant tumor and/or hematologic malignancy * non-compliance with study visits specified in the protocol or unwillingness of care-giver due to lack of understanding of the patient

Keywords: cerebral palsy umbilical cord blood erythropoietin rehabilitation
the effects of unilateral and bilateral mirror therapy on upper extremity function of stroke at acute stage.

Conditions: Stroke, Acute

Summary: objective: to comparing the effects of unilateral and bilateral mirror therapy on upper extremity function of stroke at acute stage. we hypothesize there are different effects between unilateral and bilateral mirror therapy on stroke patients at acute stage. method: patients with unilateral stroke and the onset within one month will be recruited and then randomly allocated to one of the three groups (including unilateral mirror therapy, bilateral mirror therapy, and conventional occupational therapy). patient will receive 20 consecutive sessions of intervention (5 time per week, totally 4 weeks) and assessments before and after the intervention within one week. in each intervention session, patients will receive 30 minutes unilateral or bilateral mirror therapy depending on their allocated groups and then 30 conventional occupational therapy. the patients recruited in the conventional occupational therapy group will receive 60 minute conventional therapy. the outcome measures at pre- and post-treatment will including the fugl-meyer assessment for upper extremity (fma-ue), the modified ashworth scale (mas), the jamar hydraulic hand dynamometer, the chedoke arm and hand activity inventory (cahai), the revised nottingham sensory assessment (rnsa), and functional independence measurement (fim).


Eligibility criteria:
inclusion criteria: * unilateral stroke onset within 1 month * the score of mini-mental state examination (mmse) is more than 24 * the score of fugl-meyer assessment for upper extremity (fma-ue) is between 18 to 56 * the score of modified ashworth scale (mas) is less than 3 * willing to receive 3-5 sessions of the intervention per week, total 20 sessions consecutively * willing to sign informed consent exclusion criteria: * unstable vital sign or complicating with other symptoms of neurological disease * auditory or visual function impairment * complicating with perceptual impairment (e.g., apraxia, neglect, or visual agnosia) * receiving botulinum toxin injection within 3 months * complicating with wernicke's or broca's aphasia

Keywords: stroke unilateral mirror therapy bilateral mirror therapy acute stage motor function of upper extremity
fitting evaluation of hydrogel and silicone hydrogel sphere design contact lenses

Conditions: Myopia

Summary: the aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.

this is a 40-subject, double masked, randomized, bilateral, non-dispensing fitting trial comparing hydrogel and silicone hydrogel lens materials. it is anticipated that this study will involve 2 visits for each lens pair, as follows: visits: v1 (lens dispensing), v2 (1 hour post lens settling). each subject will be randomized to wear each pair bilaterally in a series of three short fitting comparisons.

Eligibility criteria:
inclusion criteria: * a person is eligible for inclusion in the study if he/she: * is between 18 and 40 years of age (inclusive). * has had a self-reported visual exam in the last two years. * is an adapted soft cl (contact lens) wearer who is not wearing any of the study lenses. * has a cl spherical prescription between - 1.00 and - 6.00 (inclusive) * has a spectacle cylinder up to 0.75d (diopter) in each eye. * can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logmar) or better in each eye. * can achieve a distance visual acuity of 20/30 (0.18 logmar) or better in each eye with the study contact lenses. * has clear corneas and no active ocular disease. * has read, understood and signed the information consent letter. * patient contact lens refraction should fit within the available parameters of the study lenses. * is willing to comply with the wear schedule. * is willing to comply with the visit schedule. exclusion criteria: * a person will be excluded from the study if he/she: * has never worn contact lenses before. * currently wears rigid gas permeable contact lenses. * has a history of not achieving comfortable cl wear (5 days per week; \> 8 hours/day) * has a cl prescription outside the range of - 1.00 to - 6.00d * has a spectacle cylinder ≥1.00d of cylinder in either eye. * has contact lens best corrected distance vision worse than 20/25 (0.10 logmar) in either eye. * presence of clinically significant (grade 2-4) anterior segment abnormalities. * presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. * slit lamp findings that would contraindicate contact lens wear such as: * pathological dry eye or associated findings * pterygium, pinguecula, or corneal scars within the visual axis * neovascularization \> 0.75 mm in from of the limbus * giant papillary conjunctivitis (gcp) worse than grade 1 * anterior uveitis or iritis (past or present) * seborrheic eczema, seborrheic conjunctivitis * history of corneal ulcers or fungal infections * poor personal hygiene * has a known history of corneal hypoesthesia (reduced corneal sensitivity) * has aphakia, keratoconus or a highly irregular cornea. * has presbyopia or has dependence on spectacles for near work over the contact lenses. * has undergone corneal refractive surgery. * is participating in any other type of eye related clinical or research study.