Kornimate/medical-research-clean huggingface dataset:
restricting the use of artesunate plus amodiaquine combination therapy to malaria cases confirmed by a dipstick test: a cluster randomised control trial

Conditions: Malaria

Summary: effective use of rapid diagnostic test (rdt) and artemisinin-based combination therapy (act) depends on the accuracy and safety of rdt based treatment practices and on factors related to the health delivery system. we propose to study the accuracy and safety of rdt based diagnosis and treatment of febrile illness, health system determinants of effective use of rdts and the public health outcomes of rdt based act for malaria.a cluster randomised trial of rdt based versus clinical judgment based treatment of febrile illness on the incidence of malaria in \<48 month old children will be conducted. health centres will be randomly allocated to rdt based treatment or clinical judgment based treatment arm and children under 2years of age from the catchment area of each health centre will be followed for 2 years. the cost effectiveness of rdt based approach will be compare with the clinical judgement based treatment.

two-stage, four component study stage i - component a: accuracy of rdt and the outcome of treatment based on rdt results primary outcome:what is the sensitivity and specificity of paracheck cassettes in ghana to diagnose malaria? stage 1 - component b: delivery system determinants of effective rdt based act primary outcome: what are the delivery system determinants of effective rdt based act? stage 2 - component a: effects of restricted use of acts based on rdt results: a randomised controlled trial primary outcome: incidence of malaria (fever + any level of parasite density) in \< 48 month-old children stage 2 - component b: cost effectiveness analysis: primary outcome:what is the cost effectiveness of rdt based act for treatment of children under 4 years compared with act based on clinical judgement?

Eligibility criteria:
inclusion criteria: * all children aged less than 48mths reporting to health center with suspected malaria exclusion criteria: * children having chronic illnesses such as severe malnutrition and heart disease will be excluded from the study.

Keywords: malaria rapid diagnostic test artemisinin ghana
a trial to evaluate the ongoing skin safety of testosterone md-lotion formulations

Conditions: Hypogonadism

Summary: testosterone replacement treatment is the most effective way of treating hypogonadism in men. acrux has a propriety testosterone replacement product, testosterone md-lotion and this study will assess the occurrence of skin safety events for a further two months of continuous use of the testosterone md-lotion® (cutaneous solution) after completion of the mte08 (nct00702650) trial.


Eligibility criteria:
inclusion criteria: * hypogonadal males with a qualifying general medical health who have completed the mte08 trial up to and including day 120/121 in a compliant manner * were able to communicate with the trial staff, understand the trial information sheet and sign the written informed consent forms; were willing to follow the protocol requirements and comply with protocol restrictions and procedures exclusion criteria: * any clinically significant chronic illness or finding and/or laboratory testing that would interfere with the trial objectives or safety of the subject * any man in whom testosterone therapy was contraindicated, which included those with: * known or suspected carcinoma (or history of carcinoma) of the prostate or clinically significant symptoms of benign prostatic hyperplasia and/or clinically significant symptoms of lower urinary obstructions and with a international prostate symptoms score (ipss) score of greater than or equal to 19 * known or suspected carcinoma (or history of carcinoma) of the breast * severe liver disease (i.e. cirrhosis, hepatitis or liver tumours or liver function tests \>2 times the upper limit of the normal range values * active deep vein thrombosis, thromboembolic disorders or a documented history of these conditions * current significant cerebrovascular or coronary artery disease * untreated sleep apnoea * haematocrit of \>54% * untreated moderate to severe depression * men with clinically significant prostate exam or clinically significant elevated serum prostate specific antigen (psa) level (\> 4 ng/ml) or age adjusted reference range of psa values * men taking concomitant medications (prescribed, over-the-counter or complementary) that would affect sex hormone binding globulin (shbg) or testosterone concentrations (excluding testosterone md-lotion (cutaneous solution)) or metabolism such as warfarin, insulin, opiates, gonadotropin-releasing hormone analogues (gnrh), 5 alpha reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for physiological replacement doses), estradiol * men with uncontrolled diabetes (hemoglobin a1c \[hba1c\] greater than or equal to 10%) * subjects intending to have any surgical procedure during the course of the trial * subjects with a partner of child bearing potential who are not willing to use adequate contraception for the duration of the trial * subjects whose partners are pregnant
blue protocol and eko artificial intelligence are best (bea-best)

Conditions: Acute Respiratory Failure

Summary: this is an observational study that will be enrolling university of louisville patients who present to the emergency department in acute respiratory failure. this study will be to determine if the addition of eko ai-assisted lung auscultation examination to a standard of care pulmonary pocus + assists with acute respiratory failure diagnosis.

once identified and consented, the subject will undergo both pocus and ai-assisted lung auscultation using an eko core stethoscope. the pocus protocol described here is the standard of care for patients who present in acute respiratory failure to the emergency room and both groups will receive this standardized care during the study. upon hospital discharge, the final discharge diagnosis will be used as the ground truth for assessing the accuracy of the pocus protocol. the pocus exam and the ekoai exam may be performed wherever the subject is located in the hospital when first enrolled in the study. if possible, both exams should be performed immediately, in either order. they will be performed by the same examiner. both the pocus and the ekoai exam will be analysed by an investigator blinded to the final diagnosis.

Eligibility criteria:
inclusion criteria: * adults aged 18 years or older presenting to the ed or admitted to the hospital within 12 hours of enrollment * acute respiratory failure defined as new onset shortness of breath initiated within the last 7 days, and new or increasing need for oxygen therapy * the patient or patient's legal health care proxy consents to participation exclusion criteria: unwillingness to consent * patients with trauma as the cause of arf * patients with pneumothorax as the cause of arf * inability to perform pulmonary pocus or lung auscultation (e.g. dressing on the chest) * unwilling or unable to complete the minimum of 12 lung sound stethoscope recordings.
administration of biib028 to subjects with solid tumors

Conditions: Advanced Solid Tumors

Summary: safety and tolerability of biib028


Eligibility criteria:
inclusion criteria: * ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (phi) in accordance with national and local subject privacy regulations. * age greater than or equal to 18 years at the time of informed consent. * subjects with histological or cytological confirmed solid tumors who have failed standard therapies or for which no standard therapy is available. * anticipated survival of at least 3 months in the opinion of the investigator. * ecog performance status of less than or equal to 2. * lab values consistent with adequate renal hepatic and bone marrow function. * must utilize effective contraception. exclusion criteria: * pregnant (positive pregnancy test) or nursing women * prior treatment with hsp90 inhibitors at any time. * prior antitumor therapies including prior experimental agents, approved antitumor small molecules and biologics, or radiotherapy with in 28 days or \<3 half lives (whichever is longer). in addition,prior to enrollment, all asociated toxicities must have been resolved to eligibility levels. * concurrent severe or uncontrolled other medical disease (i.e, diabetes, hypertension, coronary artery disease, congestive heart failure), which in the opinion of the investigator and/ or the sponsor could compromise assessment of safety. * use of anticoagulants, except low dose warfarin. * history of seizure, previous significant head trauma (e.g., associated with loss of consciousness for more than 5 minutes), abrupt discontinuation of benzodiazepines, or use of potentially epileptogenic medication
vitalscan mcg rule-out multi-centre pivotal study - us

Conditions: Acute Coronary Syndrome

Summary: a prospective multi-centre observational study to validate the diagnostic accuracy of a transportable magnetocardiograph device for acute coronary syndrome (acs), focusing on rule-out capability, in patients who present to the emergency department with chest pain symptoms consistent with acs.


Eligibility criteria:
inclusion criteria: * patient presents to the ed with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with acs) * 18+ year old male or female * patient is willing and able to give written informed consent exclusion criteria: * st-segment elevation mi (stemi) * clear non-ischemic cause for symptoms (e.g. trauma) * hemodynamic instability on admission (e.g. bp\>220mmhg systolic \& \>110mmhg diastolic, \ 160bpm) * ventricular tachycardia or fibrillation that cannot be treated effectively * atrial fibrillation * thoracic metal implants * pacemaker or internal defibrillator * pregnancy (if after 20-week period)\* or lactation * patient unable to lie down (i.e. supine position) or stay still on the examination bed * patient unable to understand the informed consent process and/or has a poor understanding of english (e.g. english- speaking relative/translator not available) * patient unable to comply with the requirements of the protocol
randomized study of plasmapheresis or human immunoglobulin infusion in childhood guillain-barre syndrome

Conditions: Guillain-Barre Syndrome

Summary: objectives: i. compare the efficacy of plasmapheresis and human immunoglobulin infusion in minimizing morbidity and augmenting the pace of recovery in children with guillain-barre syndrome. ii. compare the potential risks, in terms of treatment related side effects and adverse clinical outcome, between these two treatment modalities.

protocol outline: this is a randomized, multicenter study. patients are randomized to receive either human immunoglobulin infusion (ivig) (arm i) or plasmapheresis (arm ii). arm i patients receive liquid heat-treated ivig for 4 days starting on day 1 and then another single infusion of ivig on day 7, 8, or 9. arm ii patients receive serial plasmapheresis treatments. the first exchange is given on day 1 and the remaining exchanges are given over the next 5-10 days. patients are followed at weeks 1, 2, 3, 4, 8, 12, and 24. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- guillain-barre syndrome (gbs): progressive weakness of two or more limbs; absence or reduced tendon reflexes; no atypical symptoms of gbs (e.g., miller-fisher variant); no pure sensory neuropathy; no prior history of gbs disability at least grade 3 according to guillain-barre study group grading scale (unable to walk 5 meters without assistance); must not have improvement of one or more disability grades prior to randomization in this study no paresthesias, numbness, or weakness that began more than 14 days before randomization in this study no cns involvement --prior/concurrent therapy-- biologic therapy: no prior treatment with plasmapheresis or infusion of human immunoglobulin (ivig) endocrine therapy: no concurrent corticosteroids or other immunosuppressants (except for concurrent medical conditions, e.g., asthma) radiotherapy: not specified surgery: not specified other: no concurrent mechanical ventilation --patient characteristics-- age: under 18 but with at least 3 months of independent walking hematopoietic: cerebrospinal fluid leukocyte count less than 50/mm3 hepatic: no liver failure renal: no kidney failure neurological: no other major neurologic diseases, other neuromuscular disorders, or cerebral palsy other: hiv negative; no contraindications to plasmapheresis or ivig; no severe uncontrolled infection; no known iga hypersensitivity; no other preexisting disease that would interfere with assessment of disability grades; no other causes of acquired weakness (e.g., poliomyelitis, botulism, or other etiologies); no diabetes; not pregnant

Keywords: guillain-barre syndrome demyelinating neuropathy neurologic and psychiatric disorders rare disease
small aortic annulus - a new solution to the old problem

Conditions: Aortic Valve Replacement

Summary: in this prospective single-center study included 60 patients with a severe degenerative aortic stenosis and small aortic annulus (\<21 mm) who underwent standard avr with stented bioprosthesis (group 1, n=30) and aortic valve reconstruction using autologus pericardium (ozaki procedure) (group 2, n=30)

aortic valve replacement (avr) in patients with a small aortic annulus is a challenging problem. implantation of a small aortic valve sometimes leads to high residual gradients, despite a normally functioning prosthesis. patients with a small aortic annulus, especially those with a large body surface area, are at higher risk of prosthesis-patient mismatch, which is associated with worse clinical outcomes and decreased survival. the purpose of this study was to compare the hemodynamic performance among the 2 management strategies (standard avr with stented bioprosthesis and ozaki procedure) in the context of a small aortic annulus (\<21 mm)

Eligibility criteria:
inclusion criteria: * severe degenerative aortic valve stenosis exclusion criteria: * redo operation, infective endocarditis

Keywords: aortic stenosis, aortic valve replacement, pericardium
fracture evaluated in emergency room by ultra sound

Conditions: Fracture; Ultrasonography

Summary: the purpose of this study is to compare fracture diagnostic, conventional x-ray versus ultrasound.

to compare fracture diagnostic, conventional x-ray versus ultrasound in an emergency room department.

Eligibility criteria:
inclusion criteria: * recent trauma to the wrist, ankle or fingers * clinical exam by er staff and x-ray indication. * informed concent exclusion criteria: * open fracture * wounds * unstable fractures requiring cast immobilisation before x-ray * multi traumatised patients
fasenra regulatory postmarketing surveillance in korea

Conditions: Asthma, EGPA(Eosinophilic Granulomatosis With Polyangiitis)

Summary: as part of a post approval commitment, the mfds has requested a study to characterize safety in patients who are treated with fasenra for severe eosinophilic asthma and/or eosinophilic granulomatosis with polyangiitis (egpa) by physicians in normal clinical practice settings. this study is designed to confirm or assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of fasenra under conditions of routine daily medical practice in korea.

this is a local, prospective, non-interventional, observational study is designed to evaluate safety and effectiveness of fasenra in real world clinical practice setting in korea. adult patients with severe eosinophilic asthma and/or eosinophilic granulomatosis with polyangiitis (egpa) who are initiating fasenra for the first time as indicated by the mfds will be included. at least 45 patients are followed for up 24 weeks and/or 48 weeks. patients will be treated as part of routine practice at korean healthcare centers by accredited physicians. each investigator will sequentially enroll patients who are initiating fasenra for the first time and receive at least one dose until the target number of patients per center is reached. the characteristics of the study population and the fasenra treatment schedule should be consistent with those described in the local product information at the time of enrolment (as the local product information may change). the study will enrol patients until the target number is reached. all patients will be evaluated for safety during fasenra use or for 30 days after their last dose of the surveillance drug if patients discontinued fasenra before 24 weeks. investigator's follow up of adverse events can be conducted by mail, phone calls, or e-mail for patients who discontinue early. the decision about the duration and discontinuation of treatment is solely at the discretion of the treating investigator with agreement of the patient.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 years and older 2. patients with severe asthma with an eosinophilic phenotype eligible for first time treatment with fasenra according to the indication as indicated in the locally approved prescribing information 3. patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: 1. hypersensitivity to the active substances or to any of the excipients 2. current participation in any interventional trial
role of proton pump inhibitors on the postoperative course following pancreaticoduodenectomy

Conditions: Pancreatic Cancer; Pancreas Cancer; Ampullary Cancer; Pancreas Neuroendocrine Tumor; Pancreatitis; Distal Extrahepatic Cholangiocarcinoma; Duodenal Cancer

Summary: the purpose of this study is to prospectively determine the effects of administering proton pump inhibitors (ppis) following pancreaticoduodenectomy on postoperative outcomes. the findings of this study will help in avoiding the widespread use of ppis during the immediate postoperative period following pancreatic surgery.


Eligibility criteria:
inclusion criteria: * all consecutive patients who will undergo pancreaticoduodenectomy with gastric/biliary reconstruction performed as definitive management for a benign or malignant disease at washington university/barnes-jewish hospital. * at least 18 years of age. * ability to understand and willingness to sign an irb approved written informed consent document. exclusion criteria: * \<18 years of age
the genetic effects on vitamin d supplementation

Conditions: Vitamin D Deficiency

Summary: vitamin d is essential for skeletal growth and bone health, deficiency causes rickets and osteomalacia. in the uk 29% of adults have vitamin d deficiency. it is recommended all adults take 10µg vitamin d supplement daily. genetic variations could alter vitamin d status by affecting vitamin d metabolism. systematic reviews found variations in vdr, gc and cyp2r1 genes are associated with vitamin d deficiency. this study aims to assess the effects between vitamin d supplementation and variations in vdr, gc and cyp2r1 genes on vitamin d status.

the study design is a quantitative, randomised control trial measuring vitamin d concentrations in blood serum. all participants will be given the recommended 10µg daily dose of vitamin d supplementation. participants will be grouped based on their genotype for each gene, as either low, medium or high-risk genotypes. the low-risk group will act as a control and the medium and high-risk groups will act as the intervention groups. participants will attend st mary's university's applied science laboratory twice. during their first visit participants will provide a 2ml capillary blood sample. blood samples are collected using lancets to prick participants' ear lobes. the serum is extracted from the blood samples, serum is stored at -80c until analysis. participants will be given 90 10µg vitamin d supplements and instructed to take one per day for 90 days. participants will also be instructed to not make any major changes to their habitual diet. during the second visit participants will provide 1 ml of saliva sample into the collection pot and a second 2ml sample of blood. serum samples will be analysed for vitamin d concentrations using 25(oh) vitamin d elisa kit. dna will be extracted from the saliva samples using psp salivagene dna kit following the manufacturer's protocol. dna will be genotyped for variations in the vdr, gc and cyp2r1 genes. data will be assessed to determine if variations in these genes influenced the effectiveness of vitamin d supplementation.

Eligibility criteria:
inclusion criteria: * healthy adults * female and male * 18-65 years * completion of physical activity readiness questionnaire (par-q). exclusion criteria: * below 18 years * above 65 years * individuals taking medications that could interact with vitamin d status * individuals regularly taking daily vitamin d supplementation during the 3 months before the intervention start date * major dietary changes in vitamin d intake during the intervention period
a comparison of air optix® colors versus freshlook® colorblends

Conditions: Myopia

Summary: the purpose of this study was to evaluate the overall comfort of air optix® colors compared to freshlook® colorblends in habitual wearers of the freshlook® colorblends .


Eligibility criteria:
inclusion criteria: * able and willing to sign the informed consent document. if under legal age of consent, legally authorized representative must sign also informed consent document. * able to achieve visual acuity of at least 20/30 (snellen) in each eye at distance with contact lenses and best corrected visual acuity (bcva) ≥ 20/25 in each eye. * manifest cylinder less than or equal to 0.75 diopters (within the previous year) in each eye. * successful wear of freshlook® colorblends spherical soft contact lenses in both eyes (in the protocol-specified colors) during the past three months for a minimum of 5 days per week and 8 hours per day. * history of at least 5 days of successful use with both lenses (minimum of 8 hours/day) of one of the protocol-specified lens care solutions/multi-purpose solutions (mps). * other protocol-specified inclusion criteria may apply. exclusion criteria: * any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study. * wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis). * monovision, monocular (only one eye with functional vision) or fit with only one lens. * history of intolerance or hypersensitivity to any component of the test articles. * use of any over-the-counter or prescribed topical ocular medications within the previous 7 days (excluding rewetting drops). * moderate or severe corneal edema, corneal vascularization, corneal staining, injection, tarsal abnormalities, "other" complications; and any corneal infiltrates. * current or history of ocular infection, severe inflammation, or disease within previous 6 months. * any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions. * participation in any investigational clinical study within previous 30 days. * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses color contact lenses myopia