Kornimate/medical-research-clean huggingface dataset:
fe absorption in mother and child pairs from wheat fortified with iron with and without phenolic containing beverages

Conditions: Anemia; Deficiency, Nutritional, With Poor Iron Absorption

Summary: in senegal, iron deficiency affects 39% of and 82% of women and children between 12 and 50 months indicating that iron deficiency is a major health problem. the government of senegal has implemented a flour fortification program including iron and folate. iron is a difficult mineral to add to foods efficiently due to its organoleptic properties and typical low bioavailability in man. the aim of this study is to determine iron absorption from fortified wheat flour consumed with a phenolic containing beverage in women and child pairs. the fortificants used will be ferrous fumarate and ferrous sulfate, and the effect of absorption inhibitors on the bioavailability from iron compounds not readily bioavailable is poorly investigated. the bioavailability of the different iron compounds will be determined using stable iron isotopes. sixteen pairs of women and children (n=34, children between 3-6 years, women between 18-45y) will be selected for participation in the study. after a screening, each women and child will receive 4 test meals consisting of a bread roll fortified stable isotopes with and without the tisane beverage. the first two test meals will be consumed on consecutive days. two weeks after the second test meal a blood sample will be taken from each women and child before the third meal administration. after the forth test meal administration, and again two weeks later, the last blood sampling will take place and the study will be conducted for the subjects (duration 30 days). the samples will be sent to zurich on dry ice for analysis for the following parameters: isotopic composition, h pylori infection, b vitamin status, vitamin a status. in all samples, hemoglobin and iron status as well as inflammation status (crp) will be determined.

in this study each subject will act as his own control and receive all interventions. iron absorption data from the different test meals will be therefore compared assessing within and subject effects (main outcomes). secondary outcomes will also investigate between subject effects and co variates of iron absorption.

Eligibility criteria:
inclusion criteria * mother and child are willing to participate in the study jointly specific inclusions criteria for mothers * body weight \< 65 kg * 17 ≤ bmi ≤ 25 (kg/m2) * non anemic (hb ≥ 11,0 g/dl) * generally healthy and no chronic illnesses * non pregnant * non lactating * no blood donation in the last 4 months * no consumption of vitamin and nutritional supplements during and 2 weeks prior the study start. inclusion criteria for children: * age 3-6 years * generally healthy and no chronic illnesses * no consumption of vitamin and mineral supplements during and 2 weeks prior the study start
moon onsite mri 10 years after acl reconstruction

Conditions: Osteoarthritis, Knee

Summary: in this study, a total of 219 subjects from the moon nested cohort will be studied at ccf, vanderbilt and osu, table 1. among them, some will have added mri during their 10-year visit for the moon study. some subjects who finished their 10-year visit for the moon onsite study already will be called back to have mri. proms and other information of these subjects will be collected through the moon study.

in this study, a total of 219 subjects from the moon nested cohort will be studied at ccf, vanderbilt and osu, table 1. among them, some will have added mri during their 10-year visit for the moon study. some subjects who finished their 10-year visit for the moon onsite study already will be called back to have mri. proms and other information of these subjects will be collected through the moon study. in addition, 30 age-, sex- and bmi-matched control subjects (10 from each site) will be recruited and scanned for mri. proms (koos, ikdc, marx, sf-36) will be collected from these controls. among the 10 controls recruited locally at ccf, five will also travel to osu and vanderbilt to be scanned at the other two sites for cross-validation among the three sites. there will be a separate consent for the 5 controls that will be traveling to each of the 3 sites for the scans. the remaining 25 controls will be tested at only their local site.

Eligibility criteria:
inclusion criteria: * enrolled in moon onsite study * 12-33 years old at baseline (22-45 years for this study); * acl tear during a sport; no previous knee injury; * no graft rupture during follow-up; * no history of surgery on the contralateral knee; * no mri contraindications exclusion criteria: * history of surgery on contralateral knee * afraid of enclosed spaces
observational prospective clinical investigation on monofocal toric intraocular lens

Conditions: Cataract; Astigmatism

Summary: evaluation, at least one-year long-term, of the clinical performance and safety of mini toric ready intraocular lens (iol), a monofocal toric intraocular lens.

observational prospective clinical investigation based on the medical records of patients who undergone uncomplicated cataract surgery with implantation of mini toric ready iol and on a clinical visit after at least one year from the surgery. eyes with corneal astigmatism ≥0.75 diopters were included. postoperative evaluations included monocular or binocular uncorrected and corrected distance visual acuity; contrast sensitivity measured after at least one-year postoperatively.

Eligibility criteria:
inclusion criteria: * eighteen years of age or older at the time of surgery and diagnosed with unilateral or bilateral cataracts; * preoperative total corneal astigmatism ≥0.75d; * unilateral or bilateral cataract removal by phacoemulsification; * clear intraocular media other than cataract; * willing and able to complete all required postoperative visits; * able to comprehend and sign a statement of informed consent consistent with local regulation for research in human subjects. exclusion criteria: * subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days before the surgery.

Keywords: cataract astigmatism monofocal iol toric iol
avalglucosidase alfa french post-trial access for participants with pompe disease (pta avalglucosidase)

Conditions: Glycogen Storage Disease Type II

Summary: this long-term open label safety and efficacy study is intended to follow up, and to provide post-trial access to enzyme replacement therapy (ert) with avalglucosidase alfa to patients with pompe disease in france who have completed study efc14028, lts13769, or act14132, from market authorization until reimbursement of avalglucosidase alfa in france or until december 2025, whichever comes first. - study visit frequency: every 2 weeks

treatment duration approximately 3 years and 6 months: until reimbursement of avalglucosidase alfa in france or until december 2025, whichever comes first

Eligibility criteria:
inclusion criteria: * patient with lopd or iopd who has previously completed study efc14028, lts13769, or act14132 in france, and reimbursement for avalglucosidase alfa is not yet granted in france. * the patient and/or their parent/legal guardian is willing and able to provide signed informed consent, and the patient, if \<18 years of age, is willing to provide assent if deemed able to do so. * the patient (and patient's legal guardian if patient is \<18 years of age) must have the ability to comply with the clinical protocol. * the patient, if female and of childbearing potential, must have a negative pregnancy test result \[urine beta-human chorionic gonadotropin (β-hcg)\] at enrollment. * sexually active female patients of childbearing potential and male patients are required to practice true abstinence in line with their preferred and usual lifestyle or to use 2 acceptable effective methods of contraception. exclusion criteria: * patient with life-threatening hypersensitivity (anaphylactic reaction) to one of avalglucosidase alfa's excipients. * patient who permanently discontinued avalglucosidase alfa in a previous clinical study * pregnant or breastfeeding female patient * the patient is concurrently participating in another clinical study of investigational treatment. * the patient, in opinion of the investigator, is unable to comply with the requirements of the study. * the patient has clinically significant organic disease (with the exception of symptoms relating to pompe disease), including clinically significant cardiovascular, hepatobiliary, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, precludes participation in the study or potentially decreases survival. * individuals accommodated in an institution because of regulatory or legal order; prisoners, or patients who are legally institutionalized. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
prevention of functional and cognitive impairment in hospitalized oncogeriatric patients

Conditions: Cancer; Hospital Acquired Condition; Debility; Aging

Summary: hospitalized older patients usually remain bedridden for many hours and this may lead to the appearance of unwanted negative consequences, such as cognitive or physical decline upon discharge. our study will analyze whether an intervention consisting of a multicomponent training programme applied to patients over the age of 60 who are hospitalized for acute medical conditions in an oncology department of a tertiary hospital improves functional capacity and cognitive function. a total of 50 hospitalized older adult patients will be recruited in the hospital universitario de navarra, pamplona, spain. the participants will be randomized and included in an exercise intervention (n = 25) or a control (n = 25) group (hospital usual-care). the intervention consists of a multicomponent exercise training programme that will take place for 3 consecutive days (2 sessions/day). the control group will receive usual hospital care, which will include physical rehabilitation when needed. functional and cognitive impairment after and during acute hospitalization in older adults are major determinants of the later need for health resources. if our hypothesis is correct and shows that a multicomponent, individualized and progressive exercise programme is an effective therapy for improving the functional capacity of acutely hospitalized older patients compared to usual care, a change in the current system of hospitalization may be justified in oncogeriatric patients with medical conditions


Eligibility criteria:
inclusion criteria: * age \> 65 years * barthel index ≥60 points * able to ambulate (with/without assistance) * sign the informed consent * able to communicate exclusion criteria: * expected length of stay \< 6 days * terminal illness * very severe cognitive decline (i.e., gds 7) * uncontrolled arrhythmias, acute pulmonary embolism, acute myocardial infarction or limb bone fracture in the past 3 months.

Keywords: multicomponent exercise oncogeriatric hospitalization
prognostic value of right ventricular myocardial strain in patients with acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: for a long time, the right ventricle has been the "forgotten chamber", but with the deepening of people's understanding of the disease, right ventricular dysfunction has become an important factor to evaluate the disease progression and late prognosis of patients with ami. right ventricular myocardial strain derived from two-dimensional speckle tracking echocardiography is a new method for early evaluation of regional and global right ventricular systolic function, and its repeatability is much higher than that of lvef. acute inferior myocardial infarction is often caused by occlusion of the proximal middle segment of the right coronary artery. many studies have confirmed that rvms is an independent predictor of poor prognosis in patients with aimi. however, 60% of the right ventricular systolic function is contributed by the left ventricle and interventricular septum, and the left anterior descending branch and the left circumflex branch are the main sources of blood supply to the left ventricle and interventricular septum, so in theory, non-rca occlusion can also lead to varying degrees of right ventricular dysfunction. however, there are few studies on the role of rvms in predicting the prognosis of ami patients caused by non-rca occlusion. therefore, the purpose of this study is to prospectively study the value of dynamic changes of rvms in predicting the prognosis of patients with acute myocardial infarction with different infarct-related vessels, in order to provide more clinical reference information for the diagnosis and treatment of ami.

in this study, 200 patients with acute myocardial infarction treated in peking university third hospital from march 2022 to march 2024 were enrolled in this study. the parameters of myocardial enzymes, blood lipids and echocardiography were collected at the acute stage, 2 weeks and 6 months after discharge, and were followed up for two year. the echocardiographic parameters and mace of patients with acute myocardial infarction with different infarction related vessels were compared. this shows the significance of right ventricular myocardial strain in predicting the prognosis of patients with acute myocardial infarction.

Eligibility criteria:
inclusion criteria: 1. males and females were between 35 and 85 years old; 2. coronary artery disease underwent emergency pci for nstemi or primary pci for stemi; 3. coronary artery type was right coronary dominance; 4. regular follow-up for 2 year. exclusion criteria: 1. patients who cannot complete 2d speckle tracking imaging; 2. patients with severe valvular disease, cardiomyopathy, or congenital heart disease; severe liver and kidney insufficiency or chronic respiratory disease; 3. previous pci or cabg; 4. coronary artery type: left crown dominance.
comparison of srk-t with kane formula for prediction of refractive outcome after phacoemulsification

Conditions: Cataract; Surgery; Phacoemulsification; Biometry; Intraocular Lens Power

Summary: cataract is a leading cause of blindness in the world. cataract surgery is one of the most commonly performed ocular procedures. we aim to compare the newer generation biometry formula; the kane formula with the commonly used srk-t formula for intraocular power calculation in uneventful phacoemulsification surgery to assess the post-operative refractive outcomes at one month post-surgery.

purpose: to compare post-operative refractive outcome with sanders retzlaff kraff theoretical (srk t) and kane formulae for intraocular lens (iol) power calculation in cataract patients study design: prospective, interventional study place and duration of study: department of ophthalmology, fauji foundation hospital, rawalpindi material and methods: a total of a 70 eyes, 35 in each group will be included in our study. the patients will be randomly divided into two groups. in cases of bilateral cataract, one eye will be included in each group for better control. iol power calculation in group a will be done with the srk-t formula and in group 2 with the kane formula. autokeratometry and a-scan ultrasound will be done for biometry. inclusion criteria will be uncomplicated cataract in both genders. exclusion criteria will be ocular trauma, uveitis, previous intraocular surgery, or any retinopathy. all patients will undergo phacoemulsification with foldable lens implantation by two experienced surgeons. post-operative refractive outcome will be evaluated at one month after surgery. the two groups will be compared. results: the results will be calculated by spss. conclusion: a conclusion will be drawn on the basis of our results.

Eligibility criteria:
inclusion criteria: * senile cataract (nuclear, cortical, posterior subcapsular, mature, hypermature cataract) * absence of other ocular pathology causing diminished visual acuity * patients above 40 years of age * astigmatism \> 2.5 diopters exclusion criteria: * retinal diseases * maculopathy * uveitis * complications during phacoemulsification * combined procedures * previous ocular surgery * trauma * secondary cataract
a study to assess the efficacy and safety of efgartigimod ph20 sc in adults with systemic sclerosis

Conditions: Systemic Sclerosis (SSc)

Summary: the main purpose of this study is to evaluate the effect and safety of efgartigimod ph20 sc compared to placebo in adults with systemic sclerosis. the study consists of a screening period, a treatment period of up to 48 weeks and a safety follow-up period. after the screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod ph20 sc or placebo. the total study duration can be up to approximately 15 months.


Eligibility criteria:
inclusion criteria: * is aged ≥18 years and the local legal age of consent for clinical studies * has diffuse or limited ssc diagnosis and fulfills the 2013 acr/eular classification criteria * has a positive antinuclear antibodies (ana) test result at the central laboratory with titer of at least 1:160 * has a health assessment questionnaire-disability index (haq-di) score of at least 0.5 or a patient global assessment (pga) score of at least 3 * has a modified rodnan skin score (mrss) score between 15 and 35 * the participant is anti-rna polymerase iii autoantibody negative at central laboratory and had the first non-raynaud's phenomenon manifestation less than 5 years before screening or the participant is anti-rna polymerase iii autoantibody positive at central laboratory and had the first non-raynaud's phenomenon manifestation less than 2 years before screening * has uninvolved or mildly thickened skin area in at least 1 injection site exclusion criteria: * isolated anticentromere antibodies (aca) seropositivity at the central laboratory * significant pulmonary arterial hypertension * severe digital vasculopathy within the past 3 months * skin thickening due to scleroderma mimics or localized scleroderma * scleroderma renal crisis within the past 6 months of participating to the study * another rheumatic autoimmune disease, except for secondary sjögren's syndrome or fibromyalgia
safety assessment of repeated administration of tk006 in patients with breast cancer-related bone metastases

Conditions: Breast Cancer

Summary: this is an open labelled study. it was designed to evaluate the safety of multiple-dosing of tk006 in patients with breast cancer-related bone metastases. this trial is the extension of a core study: phase 1 trial of a fully human monoclonal antibody of receptor activator for nuclear factor-κ b ligand (rnakl, tk006) safety, pharmacokinetics, and pharmacodynamics in patients with breast cancer-related bone metastases (nct 03239756).

this trial is the extension of a core study: phase 1 trial of a fully human monoclonal antibody of receptor activator for nuclear factor-κ b ligand (rnakl, tk006) safety, pharmacokinetics, and pharmacodynamics in patients with breast cancer-related bone metastases (nct 03239756). it's an open labelled study, aimed at evaluating the safety of repeated administration of tk006 in patients with breast cancer-related bone metastases. the qualified subjects would be those completed the entire observation in either 60 mg, 120 mg or 180 mg single dose arm at the core study. also, these patients should be well-tolerated with tk006 at the core study and are deemed to further benefit from this extension phase estimated by the researcher and sponsor. the subjects would receive 120 mg tk006 every 4-week over a period of 84 days. only safety profile and immunogenicity assessment would be assessed in this extension stage, and no further study on pharmacokinetics and pharmacodynamics would be done.

Eligibility criteria:
inclusion criteria: 1. patients provide written informed consent voluntarily. 2. 18\~65 years old, male or female. 3. patients who completed the entire observation in either 60 mg, 120 mg or 180 mg single dose arm at the core phase (nct 03239756). also, these patients should be well-tolerated with tk006 and would further benefit from continued treatment estimated by the researcher and sponsor. 4. ecog≤2. 5. albumin-adjusted calcium≥2.0mmol/l, ≤2.9mmol/ l. exclusion criteria: 1. women in pregnancy or nursing. 2. central nervous system metastasis that is symptomatic or require treatment. 3. patients with grade iii or iv adverse events considered related to tk006 at the core phase (nct 03239756). 4. patients with important organs dysfunction and not suitable for further treatment with tk006 judged by the researcher. 5. imaging confirmed progression in bone metastasis compared with core phase (nct 03239756). 6. previous or existing osteomyelitis or osteonecrosis of jaw, toothache or jaw diseases which are in active or require invasive operations, unhealed wound of oral surgery, or planned invasive dental operations during this trial. 7. patients who have been selected for the study of other test devices or test medicine. 8. other situations which are not suitable for participation judged by the researcher.
a pilot to evaluate the feasibility and efficacy of a multifaceted rehabilitation intervention

Conditions: Mobility Limitation

Summary: the goal of this study is to evaluate the efficacy of multifaceted rehabilitation program in veterans 65 years and older. this study will also examine the neuromuscular and cognitive attributes that contribute to clinically meaningful improvements in mobility; and determine whether a novel mode of cognitive training can enhance cognition among mobility limited primary care veterans 65 years and older.

this study is a randomized control pilot study. all participants will receive rehabilitative exercise addressing mobility skills. in addition, one group will be will receive additional cognitive training. randomization is stratified according to screening mobility and cognitive score.

Eligibility criteria:
inclusion criteria: * age 65-90 * history of fall in the past year or difficulty or task modification with climbing one flight of stairs or walking ½ mile (6 blocks) * community dwelling * ability to speak and understand english exclusion criteria: * presence of a terminal disease (e.g. receiving hospice services, metastatic cancer * major medical problem interfering with safe and successful testing (i.e. history of hip replacement with recurrent dislocation; uncontrolled hypertension, use of supplemental oxygen * myocardial infarction or major surgery in previous 3 months * planned major surgery (e.g. joint replacement) * baseline short physical performance battery score \ 10 * modified mini mental status examination score of ≤77 out of 100 * inability to safely complete the 400 meter walk test

Keywords: rehabilitation aging mobility skills cognitive training