Kornimate/medical-research-clean huggingface dataset:
exchangeable zinc pool size and zn absorption from sprinkles and traditional foods in pakistani infants /toddlers

Conditions: Malnutrition

Summary: the broad objective is to improve zinc status in older infants and young children who are at risk of zinc deficiency because of combination of inadequate dietary zinc intake and high rates of diarrhea. as a sub-study within larger rct using zinc fortified sprinkles, the proposed study will measure the amount of zinc absorbed from a test meal of typical unfortified complementary foods consumed by pakistani infants, or the same complementary foods fortified by the addition of the zn-containing sprinkle.

in the nested study we aim to measure from a subgroup of recruited children in the main study, the amount of zinc absorbed from typical unfortified complementary foods consumed by pakistani infants, and compare it with the same complementary food fortified by the addition of the zn-containing sprinkles and multi vitamins. since ezp exchangeable zinc pool is considered to be the gold standard for estimation of the actual concentration of zinc in the plasma that is readily available for cellular function, we would also calculate the ezp in this subset of samples. the specific aim of the nested study will : 1. determine absorption of zinc (zn) from a test meal consisting of typical local food with addition of a multiple-micronutrient sprinkles product containing (10 mg of zn) vs absorption from the same meal without zinc supplementation to those with no micronutrient fortification. 2. compare size of exchangeable zn pool (ezp) for subjects who have been randomized to receive multi-micronutrient sprinkle (mn) only with those who were randomized to (mn+zn ) with control group. 3. children will be followed for growth monitoring for at least 2 years. 4. plasma zinc and phytates levels in the weaning diet will also be assessed.

Eligibility criteria:
inclusion criteria: * healthy infants between the ages of 9 and 12 months and on weaning diet for at least 3 months. * infants who are currently recruited in the main zinc gates study and consuming sprinkles sachet containing micronutrient and zinc . exclusion criteria: * infants with congenital anomalies * infants not on weaning diet * infants not consuming sprinkles sachet containing micronutrients

Keywords: zinc zn ezp (exchangeable zinc pools)multivitamin mn
post-marketing surveillance of long-term administration of donepezil hydrochloride -investigation of the clinical condition and safety in patients with alzheimer's disease-

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to investigate the following about donepezil hydrochloride administration in patients with mild or moderate alzheimer's disease in clinical practice: cognitive function, functional assessment staging (fast) score, adverse events/adverse drug reactions, and patient background.


Eligibility criteria:
inclusion criteria: patients diagnosed with alzheimer's disease by diagnostic and statistical manual of mental disorders (dsm-iv). patients diagnosed with mild or moderate alzheimer's disease, applicable to fast score 4 or 5. exclusion criteria: patients with history of hypersensitivity to component of aricept or piperidine derivative. patients registered for this survey before.
rlc followed by cr-chop in elderly patients with newly-diagnosed del

Conditions: Double-expressor Lymphoma

Summary: this is a prospective, single-arm, multicenter clinical study to evaluate the efficacy and safety of chidamide, rituximab combined with lenalidomide sequential immunochemotherapy in the treatment of newly diagnosed elderly double-expressor diffuse large b-cell lymphoma.

it is divided into 4 stages: screening period, induction therapy period, immunochemotherapy period and maintenance therapy period. the screening period was 28 days before the first dose. introduction treatment period: enrolled subjects received rlc regimen every 21 days for a cycle of 2 cycles. immunochemotherapy phase: cr-minichop regimen was administered after the completion of the introduction therapy phase. every 21 days for a cycle, treatment for 4 cycles. patients who achieved cr with induction therapy entered the maintenance treatment period, receiving 20 mg of chidamide d1,4,8,11 recommended 8 cycles. patients who did not achieve cr were discontinued from the study and treated at the discretion of their physician.

Eligibility criteria:
inclusion criteria: * 1. untreated dlbcl patients confirmed by histopathology 2. immunohistochemistry showed positive expression of myc and bcl2 protein (double expressor lymphoma, myc≥40%, bcl2≥50%) 3. age over 70 years old or age ≥65 years old and ecog score ≥2 points, both male and female 4. having at least one evaluable lesion, defined as having at least one lymphadenopathy with a maximum diameter \> 1.5 cm, or at least one extranodal lesion with a maximum diameter \> 1.0 cm, and at least two vertical diameters that can be accurately measured. 5. ecog ps≤3 6. expected survival time ≥3 months 7. voluntary participation in clinical research; fully understand and understand the study and sign the informed consent; willingness to follow and ability to complete all research steps. exclusion criteria: * 1. the pathological subtypes were pcnsl, pmbcl, ebv-positive dlbcl and hgbl 2. hemophagocytic syndrome accompanied the diagnosis 3. central nervous system involvement is secondary to lymphoma 4. are participating in other clinical studies, or the first study drug is administered less than 4 weeks after the end of treatment in the previous clinical study 5. hiv infection 6. major surgery was performed within 28 days prior to study start 7. any active infection that required systematic anti-infective therapy developed within 14 days prior to study initiation 8. the patients considered by the investigator to be unsuitable for participating in this study

Keywords: dlbcl del rituximab lenalidomide chidamide chemo-free
vitamin d and muscle metabolic function

Conditions: Healthy

Summary: the purpose of this study is to identify the magnitude of muscle lipid redistribution and muscle oxygen use in individuals 60 years old or older following combined treatment of vitamin d repletion and aerobic training compared to vitamin d repletion alone, aerobic training alone, or no treatment.

the investigators plan to recruit approximately 56 aged individuals with vitamin d insufficiency for a 13 week trial. all subjects will be 60 years of age or older. participants will be randomized to one of four groups: vitamin d (50,000iu/wk) + aerobic training (7 days during the 13th week); vitamin d (50,000iu/wk) + normal daily activity during the 13th week; placebo + aerobic training (7 days during the 13th week); or placebo + normal daily activity during the 13th week. following screening and informed consent process a physical activity questionnaire will be administered. a blood draw will then be conducted at baseline, midpoint and endpoint. collected blood for the purposes of this study will assess vitamin d status (25(oh)d), parathyroid hormone, ionized calcium, insulin, and a comprehensive metabolic panel. at baseline and endpoint muscle lipid will be assessed using magnetic resonance spectroscopy and muscle oxygen consumption will be determined using a novel hybrid diffuse optical instrument consisting of a near-infrared spectroscopy and a diffuse correlation spectroscopy. in addition, at each study time point 3 dietary recalls will be completed and physical activity will be measured using an accelerometer.

Eligibility criteria:
inclusion criteria: * age: 60 and older * bmi: 18.5-29 * communicates fluently in english exclusion criteria: * metal implant not suitable for mri * any form of hormone replacement therapy * engage in more than 1 hr/week of vigorous activity * participated in a high-intensity resistance or aerobic training program in the last 3 months * lower extremity injury or surgery in the past 3 months * foot sores or bone conditions severely limiting ability to move or perform exercise or joint pain made worse by mild exercise * diabetes, inflammatory bowel disease, renal disease or uncontrolled hypertension. * currently have or had a history of cardiovascular or pulmonary disease that would preclude the involvement in the performance of exercise * history of myopathy (including congenital myopathies) * history of neurological conditions related to spinal derangement, disk disease, peripheral neuropathies, tremor and rigidity * past medical history of hyperparathyroidism, kidney stones or rhabdomyolysis * currently receiving treatment for vitamin d deficiency * vitamin d level \>30ng/ml * currently smoking

Keywords: vitamin d 25(oh)d aerobic training near-infrared spectroscopy diffuse correlation spectroscopy mrs
utilization of autologous mesenchymal cells in posterolateral spinal fusion in degenerative spine disease

Conditions: Degenerative Disc Disease

Summary: subjects in whom a posterolateral fusion surgery has been planned and who meet the inclusion and exclusion criteria were proposed to receive a single-dose amsc treatment, in order to assess its safety and efficacy on posterolateral interbody fusion. after the surgery, the subjects were followed up as out-patients during 5 study visits for 12 months in total.

following informed consent collection at the screening visit and verification of all inclusion and exclusion criteria, eligible patients will undergo the procedure of bone marrow cell aspiration from iliac crest for the purpose of receiving autologous multipotent mesenchymal stem cells. the cells will be cultivated for 3 passages (for 3 - 4 weeks) in order to expand them to sufficient quantity. suspension of the cultured amsc will then be sterilely packed and transported to the surgery site. during the posterolateral spine fusion operation, 1.5 ml of cell suspension will be mixed with 5 cc of beta-tricalcium phosphate foam (vitoss™, orthovita) and 3.5 ml of patient's blood, and inserted between the transverse processes of the lumbar spine. all subjects will be hospitalized and followed up as per standard medical care rules used in the investigational site hospital for this type of intervention.

Eligibility criteria:
inclusion criteria: 1. established diagnosis of spinal degenerative disease indicated for lumbar spine surgery, 2. patients indicated for fusion therapy, 3. patients between 18-55 years, both sexes, 4. patients able to provide written informed consent. exclusion criteria: 1. previous lumbar spine surgery in the same segment of the spine, in order to achieve vertebral fusion, 2. osteoporosis, 3. diabetes mellitus, 4. pregnancy or breastfeeding, 5. women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contraceptive measures taken by their sexual partners, 6. fertile men not using proven contraceptive measures including effective contraception method in their partner (established oral contraception, intrauterine device, ligation of the uterine tube), 7. coagulopathy, 8. malnutrition, primary biliary cirrhosis, 9. skin infection at the site of bone marrow aspiration or at the site of spinal fusion, 10. gastrostomy, 11. any significant medical condition that would compromise the safety of the patient (e.g. recent myocardial infarction, congestive heart failure, renal failure, liver failure, systemic infection, recurrent thromboembolic disease .....), 12. alcohol or drug abuse, 13. cancer (compulsory clinical oncological screening), 14. ongoing or recent (last 3 months) systemic corticosteroid or immunosuppressive therapy.
the effect of high dose parenteral ascorbic acid on microcirculation in sepsis

Conditions: Sepsis; Septic Shock

Summary: the purpose of this study is to evaluate the effect of high-dose ascorbic acid on microcirculation in sepsis.

adult patients with septic shock were enrolled within 24 hours following admission to the central department of intensive care in lithuanian university of health sciences hospital kaunas clinics. participants were randomly assigned to a placebo or ascorbic acid group in a 1:1 ratio. they were resuscitated according to surviving sepsis campaign guidelines. additionally, they received an intravenous infusion of ascorbic acid either placebo. the dose of ascorbic acid was 200mg/kg/24h divided into four equal parts for 96 hours. sublingual microcirculatory measurements were obtained, using an incident dark field (idf) device.

Eligibility criteria:
inclusion criteria: * patients with sepsis or septic shock within the first 24 hours after icu admission. exclusion criteria: * age \< 18 years, * pregnancy, * advanced malignancy, * history of kidney stone, glucose-6-phosphate deficiency, hemochromatosis, or solid organ transplantation, * oral mucosal inflammation or injury or technical difficulties in obtaining sublingual images.

Keywords: sepsis microcirculation ascorbic acid
electromyography-triggered electrical stimulation on trunk balance and muscle thickness in sci patients

Conditions: Spinal Cord Injury Thoracic

Summary: the aim of this study was to investigate the effect of electromyography (emg) triggered electrical stimulation (es) applied to multifidus and erector spinae muscles on trunk balance in patients with complete thoracic spinal cord injury (sci). the fundamental questions that investigators want to answer are as follows: * \[question 1\]: "does multifidus and erector spinae emg es improve trunk balance in patients with complete sci?" * \[question 2\]: "does multifidus and erector spinae emg es improve muscle thickness in patients with complete sci?"

spinal cord injury results in loss of sensory and motor function below the level of injury, causing difficulty with unaided sitting and activities of daily living, especially at the thoracic level in sci patients. the paraspinal muscles that provide trunk balance are weakened in these patients. methods such as neuromuscular electrical stimulation and emg es are used to improve trunk balance and restore muscle function. this study aims to investigate the effect of emg es applied to the multifidus and erector spinae muscles on trunk balance in patients with complete thoracic sci.

Eligibility criteria:
inclusion criteria: * have traumatic sci and this injury occurred at least 3 months ago, * be between the ages of 18 and 65, * have a neurological injury level between thoracic 4 and thoracic 12 * be fully paraplegic according to the american spinal cord injury association (asia) impairment scale * be able to sit unsupported in a wheelchair exclusion criteria: * patients with a diagnosis of heart failure * malignancy * intracardiac defibrillators * epilepsy * open wounds * patients using trunk corsets

Keywords: spinal cord injury trunk balance electrical stimulation multifidus erector spinae
effect of ischemic strokes on recovery from intracerebral hemorrhages

Conditions: Hemorrhage; Intracerebral, Nontraumatic; Ischemic Strokes; Diffusion Weighted Imaging Lesions

Summary: intracerebral hemorrhage (ich) occurs when small arteries in the brain rupture due to weakening by age, high blood pressure, and/or elevated cholesterol. in addition to artery rupture, recent data suggests that patients with ich are also at risk for developing occlusion of arteries during the acute phase, called ischemic strokes. data suggests these ischemic strokes can negatively impact patient outcomes. diffusion weighted imaging (dwi) is a sequence on magnetic resonance imaging (mri) that is a sensitive marker for ischemic strokes in the brain. in this proposal, our primary aim is examine prospectively the effect dwi abnormalities have on functional outcomes in patients with ich. our hypothesis is that the dwi abnormalities found on mri of the brain lead to worse functional outcomes in patients with ich

diffusion weighted imaging (dwi) is a sensitive method to assess for secondary ischemia in patients with acute brain injury. by comparing the outcomes of patients with and without dwi abnormalities, we would able to assess the impact these lesions have on functional recovery in patients with ich. since no direct therapies exist for this disease, dwi abnormalities may be a novel target for intervention to improve outcomes. if traditionally assessed functional outcomes are not affected by dwi, the mechanism behind these lesions would still warrant further evaluation and potential treatment. detection of subclinical infarcts has emerged as a potential surrogate marker for subsequent risk of stroke, vascular dementia, and cognitive impairment. furthermore, the cause behind dwi lesions in acute ich may lead to better understanding the pathophysiologic interplay between ischemic and hemorrhagic strokes.

Eligibility criteria:
inclusion criteria: * patients \> 18 years and \< 80 years * spontaneous intracerebral hemorrhage documented by ct scan * less than 24 hours from time last seen normal to first medical evaluation * no prior clinical history of stroke (i.e. subarachnoid hemorrhage, ich, or ischemic strokes) exclusion criteria: * pregnancy * history of cancer * pre-admission mrs \> 2 * glasgow coma scale less than 5 * ich secondary to aneurysm, vascular malformation, mycotic aneurysm, primary or metastatic tumor, trauma, warfarin-related ich, acute-fibrinolytic associated ich, or coagulopathy * associated epidural or subdural hematoma * surgical intervention \< 48 hours from admission * hemodynamic instability (need for vasopressor therapy) * acute hypoxemic or hypercapnic respiratory failure * history of deep venous thrombosis * contraindications to mri based upon institutional safety checklist

Keywords: intracerebral hemorrhage ischemic stroke diffusion weight imaging abnormalities neurologic outcome
elasticity of the hoffa's fat pad in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis; Elasticity Imaging Techniques

Summary: knee osteoarthritis (oa) is a common problem in clinical settings. knee oa is well known for its association with the wear and tear of the cartilage and osteophyte formation. evidence has suggested the importance of the infrapatellar fat pad, known as hoffa's fat pad, during the development of knee oa. some studies have demonstrated the protective role of the infrapatellar fat pad, whereas others have suggested an inflammatory role such as increased fibrosis and proinflammatory cytokine levels. ultrasound is exceptionally convenient in the assessment of the musculoskeletal system, and elastography is a tool to evaluate tissue texture. therefore, in this study, we investigated the hoffa's fat pad in knee oa patients by using elastography.

this was an observation study that included a control group. we enrolled 20 patients with knee oa, as well as 10 healthy individuals. the western ontario and mcmaster universities osteoarthritis index (womac) and kellgren-lawrence x-ray grading were employed to determine disease severity. all the study participants received elastography assessment, including strain and shear wave elastography in the knee extension and flexion position. the strain elastography contained color mapping that enabled the calculation of the relative texture and strain ratio. the shear wave elastography revealed the qualitative velocity, which was measured 3 times. each patients with knee oa received elastography examination twice: once before hyaluronic acid injection and once 1 month after the injection.

Eligibility criteria:
inclusion criteria: oa group * kellgren-lawrence grading i-iv proved by knee x-ray healthy group * no knee pain or received injection during the past 1 year * no history of knee oa exclusion criteria: * history of knee surgery, trauma or malignancy * history of patellar tendinopathy or patellofemoral pain syndrome * refused informed consent
dreams-ot trial: delirium reduction through early activation in motivating and sleep promoting routines: a randomized controlled trial of occupational therapy for icu patients after coronary artery bypass graft (cabg) surgery

Conditions: Delirium, Postoperative

Summary: the goal of this randomized controlled trial (rct) is to compare the effectiveness of the dreams-ot intervention with standard care in reducing post-coronary artery bypass graft (cabg) delirium in patients undergoing cabg. the aims of the study are: * conduct a prospective randomized controlled trial comparing the effectiveness of the dreams-ot intervention with standard care in reducing post-cabg delirium in cardiothoracic intensive care unit (cticu) * to conduct a nested cost-effectiveness study the study team will compare intervention group and standard care group (control group) to see if there is a reduction in the incidence of delirium in patients 5 days post-cabg.


Eligibility criteria:
inclusion criteria: * patients deemed medically suitable for elective cabg surgery * patients aged 21 years and above * patients who are english or mandarin speaking. * patients who are able to provide consent exclusion criteria: * patients who speak other languages are excluded due to the language requirements of certain outcome measures. * patients with premorbid severe hearing impairment, severe cognitive impairment, progressive neurological disorders and psychological disorders will be excluded. * patients with surgical complications resulting in profuse bleeding from any invasive sites, septic shock unresponsive to maximal treatment, and those who are moribund or have an expected mortality within 48 hours will be excluded. * pregnant women will also be excluded from the study as well. * patients who develop delirium before initiation of the treatment are also excluded from the study.

Keywords: delirium coronary artery bypass grafting occupational therapy intensive care units randomized controlled trial
clinical investigation of acrysof® iq restor® +2.5 d multifocal intraocular lens (iol) model sn6ad2 [sv25t0]

Conditions: Cataracts

Summary: the purpose of this study is to compare the safety and efficacy of an investigational multifocal intraocular lens (iol) to an fda-approved monofocal iol.

participants 21 years and older in need of cataract extraction were consented and randomized in a 1:1 ratio at each investigative site to receive either the acrysof® iq restor® +2.5 d multifocal iol model sn6ad2 \[sv25t0\] or the acrysof® iq monofocal iol model sn60wf in both eyes. each participant completed a preoperative examination of both eyes, implantation of iol at the operative visit for each eye, and up to 7 postoperative visits, with monocular testing at day 1-2, day 7-14, and day 30-60, and monocular and binocular testing at day 120-180 following the second implantation. the first eye to be implanted was considered the primary eye. the second eye was implanted 7 and 30 days of the first. if the first eye was not implanted during surgery, the second eye was not eligible. if the second eye was not implanted during surgery, only the first eye was followed.

Eligibility criteria:
inclusion criteria: * diagnosis of bilateral cataracts * willing and able to complete all required postoperative visits * calculated lens power within the available supply range * planned cataract removal by phacoemulsification * potential postoperative visual acuity of 0.2 logmar or better in both eyes * preoperative astigmatism less than 1.0 diopter * clear intraocular media other than cataract in study eyes * preoperative best corrected distance visual acuity (bcdva) worse than 0.2 logmar * able to undergo second eye surgery between 7 days and 30 days of the first eye surgery * other protocol-defined inclusion criteria may apply exclusion criteria: * previous refractive surgery * inflammation or edema of the cornea * optic nerve atrophy * pregnancy * current participation in another investigational drug or device study * other protocol-defined exclusion criteria may apply

Keywords: intraocular lens monofocal multifocal