Kornimate/medical-research-clean huggingface dataset:
estimating usual iodine intake from spot urinary iodine concentrations

Conditions: Iodine Deficiency

Summary: the overall objective of this study is to develop a reliable method to obtain habitual iodine intakes from spot urinary iodine concentration (uic) and to assess the prevalence of inadequate iodine intake in school-age children and women of reproductive age. we will evaluate different methods to estimate iodine intake from uic and estimate the prevalence of inadequate and excess iodine intake in uic studies conducted in populations with low, adequate and high iodine intakes using the the established estimated average requirement (ear)/tolerable upper intake level (ul) cut-point method.


Eligibility criteria:
inclusion criteria: * lived in study area \>= 12 months * no reported intake of amiodarone * no history of thyroid dysfunction / goiter (past \& present) * no exposure to iodine containing contrast agents within the last 12 months second arm: women aged 18 - 49, exclusion / inclusion criteria apply, plus non-pregnant, non-lactating.

Keywords: iodine
quality of life and target achievement after treatment of patients with stable angina pectoris

Conditions: Stable Angina Pectoris

Summary: the purpose of this study is to, in patients with stable angina pectoris, assess the additional benefit of pci on top of optimized medical treatment, physical training and smoking cessation with regard to quality of life, achievement of target of treatment and clinical events such as death, acute myocardial infarction, stroke and revascularization.

patients with stable angina pectoris with a significant coronary stenosis will be randomized to optimized medical treatment, physical training and smoking cessation or to optimized medical treatment, physical training, smoking cessation and complimentary treatment with pci. all patients will be followed up at six months and at one and five years regarding symptoms, blood lipids, systemic blood pressure, physical training status, smoking habits, and maximal exercise ecg. achievement of target of treatment will be measured by questions regarding the patients' expectation of the treatment at baseline and at a 6 month follow-up. the questions at 6 months will be based on the interviews at inclusion. furthermore quality of life will be measured with three different measuring instrument; sf-36 short form, seattle angina questionnaire (saq), and eq-5d. these instruments will be given to the patients at baseline, at six months and at the five year follow up.

Eligibility criteria:
inclusion criteria: * stable coronary artery disease * angina pectoris with at least angina class 2 according to canadian cardiovascular society (ccs) * angiographic verified stenos in a native vessel * accepted for pci exclusion criteria: * instable coronary artery disease or ami withín two months * ccs class iv * stenosis in left main and/or proximal lad * nyha- iii-iv * fall in blood pressure during exercise test \> 10mm hg, measured two times * contraindication or allergy against clopidogrel or asa * unable to communicate verbal or i writing * unwillingness to participate in the study * participating in an other study

Keywords: stable coronary artery disease quality of life target achievement physical training percutaneous coronary intervention
mechanical ventilation in severe brain injury: the effect of positive end expiratory pressure on intracranial pressure

Conditions: Intracranial Hypertension; Critical Illness; Brain Injuries; Lung Injury; Respiratory Failure; Positive-Pressure Respiration, Intrinsic

Summary: the purpose of this study is to collect physiologic data from patients with severe brain injury who require mechanical ventilation in order to describe the impact of ventilation, specifically positive end expiratory pressure (peep), on intracranial pressure (icp).


Eligibility criteria:
inclusion criteria: * patients with severe brain injury (gcs 8 or less) * receiving mechanical ventilation * receiving intracranial pressure monitoring exclusion criteria: * esophageal varices * esophageal trauma * recent esophageal surgery * coagulopathy (platelets \ 2 ) * other contraindication for esophageal manometry * already receiving peep \> 15 cmh2o at enrollment * intracranial hypertension (defined as icp \> 20 mmhg) * decompressive hemi-craniectomy
biomarkers in samples from young patients with neuroblastoma

Conditions: Neuroblastoma

Summary: rationale: studying samples of tissue and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research study studies biomarkers in samples from young patients with neuroblastoma.

objectives: primary * to analyze the expression of ror1 on the surface of primary neuroblastoma cells. * to investigate the therapeutic potential of anti-ror1 monoclonal antibodies (mabs), bispecific antibodies, and immunotoxins in in vitro and in vivo models of neuroblastoma. outline: archived bone marrow and tumor tissue samples are analyzed for ror1 expression by flow cytometry, western blotting, qpcr, and ihc.

Eligibility criteria:
disease characteristics: * diagnosed with neuroblastoma * with or without n-myc amplification * primary tumor samples as frozen tissue in liquid nitrogen or -80 degrees c * bone marrow samples from high-risk patients as peripheral blood mononuclear cells (pbmc) that have been cryopreserved with dmso as viable cells to be used for flow cytometry or slides of bone marrow that can be used for immunohistochemistry patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: localized resectable neuroblastoma recurrent neuroblastoma regional neuroblastoma stage 4s neuroblastoma localized unresectable neuroblastoma
a study comparing two monofocal, aspheric, hydrophobic acrylic intraocular lenses: the alcon clareon® and the abbott medical optics pcb00

Conditions: Cataract Extraction; Phacoemulsification; Glistenings; Intraocular Lens Implant; Hydrophobic Acrylic; Cataract Surgery; Light Scatter; Patient Satisfaction; Patient Related Outcome Measures

Summary: this is a bilateral randomised controlled study to compare visual performance, refractive outcome, forward light scatter, patient satisfaction and objective measurement of glistenings following insertion of two monofocal, aspheric, hydrophobic acrylic intraocular lenses (iols). a new product is compared with an established one.


Eligibility criteria:
inclusion criteria: * bilateral cataracts * good visual potential * ability to understand informed consent and objectives of the trial * not-pregnant * not breast feeding * no previous eye surgery * corneal astigmatism less than 1 diopter in both eyes exclusion criteria: * age-related macula degeneration * glaucoma * previous retinal vascular disorders * previous retinal detachment or tear * any neuro-ophthalmological condition * any inherited retinal disorder or pathology * previous strabismus surgery or record of amblyopia * previous transient ischaemic attacks, cerebrovascular events or other vaso-occlusive disease * already enrolled in another study * exclusion criteria relate to clinical contraindications for femtosecond laser assisted cataract surgery, such as: * significant corneal opacities * small pupils following pharmacological dilatation * patients unable to lie sufficiently flat so as to be positioned underneath the laser machine

Keywords: cataract cataract extraction interocular lens implant glistenings phacoemulsification hydrophobic acrylic light scatter patient related outcome measures
cybercycling to reduce therapeutic side effects and improve quality of life in aya cancers

Conditions: Adolescent and Young Adult Cancers

Summary: only a few clinical trials evaluating the potential benefits of exercise have been conducted in adolescents and young adults (aya) with cancer and, no prior studies have evaluated the potential effects of 'cybercycling' (exergaming on a stationary bike) in aya cancer survivors. therefore, the study aims to conduct a pilot trial to determine feasibility (adherence, user acceptance) and to explore potential effects of a 'cybercycling' exercise program on fitness, body composition, quality of life, sleep and cognition.

objectives specific aim 1: to evaluate the feasibility (adherence; user acceptance: exercise tolerance, enjoyment and motivation) of performing an adaptive, moderate intensity, aerobic exercise program on a 'cybercycle' compared to control (stretching/resistance bands) in adolescent and young adults (aya) with cancer. (exploratory) aim 2: to explore the effects of an adaptive, moderate intensity aerobic exercise program using a 'cybercycle' compared to control (stretching/resistance bands) on changes in fitness, body composition, quality of life (qol), fatigue, sleep and cognition. study design/overview: this study is a randomized trial in 20 adolescent and young adult (aya) cancer survivors (15-30 years old) which will comparing two intervention arms: 1) aerobic exercise on a 'cybercycle' (stationary cycling with exergaming/videogaming); and, 2) a stretching/resistance band 'control' condition.

Eligibility criteria:
inclusion criteria: * histologically confirmed cancer * completed primary treatment * approved to be contacted by the treating oncologist/nurse practitioner * meet screening criteria exclusion criteria: * patients unable to provide informed consent * patients not available for follow-up testing * patients with any pre-existing medical conditions that would be a contraindication to exercise.

Keywords: aya exercise cancer cybercycling
pk/pd investigation of modufolin (arfolitixorin) in plasma, tumor and adjacent mucosa adjacent mucosa in patients with colon cancer

Conditions: Colonic Neoplasms

Summary: the purpose of this study is to compare the concentration of four different metabolites in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different doses of modufolin (arfolitixorin) and levoleucovorin (isovorin®), respectively (60 and 200 mg/m2).

the purpose of this study is to compare the concentration of \[6r\] 5,10-methylene-thf, 5-formyl-thf, 5-methyl-thf and thf in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different does of modufolin® and levoleucovorin (isovorin®), respectively (60 and 200 mg/m2).

Eligibility criteria:
main inclusion criteria: * operable colon cancer amenable to curative surgery. * performance status of 0 to 1 * informed consent form * patients must be at least 18 years of age. main exclusion criteria: * any concurrent other anti-tumor therapy * any prohibited concomitant medication within 30 days of surgery * pregnancy or breast-feeding. * second primary malignancy

Keywords: colon cancer 5,10-methylenetetrahydrofolate rectal neoplasms colorectal neoplasms intestinal neoplasms gastrointestinal neoplasms digestive system neoplasms gastrointestinal diseases therapeutic uses pharmacokinetics pharmacodynamics
evaluation of role of transient elastography (fibroscan) in differentiating patients of acute severe viral hepatitis and acute on chronic liver failure

Conditions: Acute Severe Viral Hepatitis; Acute on Chronic Liver Failure

Summary: transient elastography is novel non-invasive method for assessment of hepatic fibrosis in patients with chronic liver disease, by measuring liver stiffness. transient elastography is a user friendly technique that can be easily performed at bedside or in outpatient clinic with immediate results and good reproducibility. liver stiffness values ranges from 2.5 to 75 kpa with lower values \<6kpa suggest no fibrosis where as higher values above 14kpa suggests cirrhosis. in the present study the investigators hypothesis that the investigators can differentiate aclf and acute severe viral hepatitis based on fibroscan as patients with underlying fibrosis with superadded inflammation would have higher fibroscan value than when patient have only inflammation with no underlying fibrosis and hence the investigators can avoid unnecessary test in such subgroup.

transient elastography is a novel non-invasive method that for the assessment of hepatic fibrosis in patients with chronic liver diseases, by measuring liver stiffness. acute on chronic liver failure: acute hepatic insult manifesting as jaundice and coagulopathy, complicated within 4 weeks by ascites and/or encephalopathy in patients with previously diagnosed or undiagnosed chronic liver disease. acute severe hepatitis: acute severe hepatitis which is characterized by serum bilirubin \> or = 10.0 mg/dl and international normalized ratio (inr) \> or = 1.5. patients with acute severe viral hepatitis or acute on chronic liver failure will be enrolled in this prospective study after taking informed written consent. all patients will be evaluated at baseline as per standard protocol which include evaluation of etiology of disease and tests to exclude underlying liver disease which includes ultrasound/computed tomography and if necessary upper gastrointestinal endoscopy and liver biopsy if imaging shows any signs of underlying liver disease. the patients will be followed up for 1 month, all patients will undergo fibroscan at the time of admission and thereafter at 1week and 4th week .

Eligibility criteria:
inclusion criteria: * patient's age 18-70years. * patients with a diagnosis of acute severe viral hepatitis or acute on chronic liver failure. * patients willing for informed consent and follow up for 1 month. exclusion criteria: * patients with gross ascites, hepatic encephalopathy. * patient fail to give written consent.

Keywords: aclf avh fibroscan transient elastography
open-label natalizumab safety extension study

Conditions: Multiple Sclerosis

Summary: the primary objective of this study is to determine the safety and the immunogenicity of extended treatment with natalizumab when administered at a dose of 300 mg intravenously (iv) to subjects with multiple sclerosis (ms) who have completed natalizumab studies c-1801, c-1802, or c-1803.


Eligibility criteria:
inclusion criteria: * must give written informed consent. * must be an ms subject who has completed natalizumab study c-1801, c-1802 or c-1803 exclusion criteria: * history of, or available abnormal laboratory results, indicative of any significant disease that would preclude treatment. * history of severe allergic or anaphylactic reactions or known drug hypersensitivity * a clinically significant infectious illness within 30 days prior to study entry.
ict-supported multidimensional approach for frailty screening in community-dwelling individuals aged ≥ 65 years

Conditions: Frail Elderly Syndrome

Summary: sunfrail+ is a prospective observational cohort study aimed to carry out a multidimensional assessment of community-dwelling older adults, through an it platform, which allows to connect the items of the sunfrail frailty assessment tool with a cascading multidimensional in-depth assessment of the bio-psycho-social domains of frailty. it is a multicentric study. seven centres will administer sunfrail questionnaire to 100 older adults each and, according to the specific "alerts" triggered by the answers provided, older adults will be subjected to one or more validated in-depth tests in order to perform further diagnostic or dimensional evaluations.


Eligibility criteria:
inclusion criteria: * age ≥65 years; * living at home; * accessing participating centres for social and healthcare services other than those covered by this study; * ability to sign the informed consent exclusion criteria: * age \<65 years; * residents in care facilities (hospital, nursing home); * have overt frailty or disability; are already enrolled in home care; are unable to understand the study aims and sign the informed consent
functional neuroimaging of cortical plasticity in the human visual system

Conditions: Stroke; Blindness; Vision

Summary: the study's objective is to measure changes in human visual cortex organization that may arise as a result of injury to the visual pathways. subjects with retinal or cortical injury will be studied and compared to appropriate controls. functional magnetic resonance imaging methods are used to monitor cortical topography in time. the main aims of the study are to determine: 1) what are the patterns of cortical reorganization that are seen spontaneously after injury, and 2) whether rehabilitative training can promote adaptive reorganization enhancing recovery.


Eligibility criteria:
inclusion criteria: * stable lesion of the visual pathways resulting in a visual field scotoma. exclusion criteria: * inability to undergo magnetic resonance imaging, * inability to comply with basic instructions, * inability to perform the behavioral tasks required, * patients with chronic progressive neurological or psychiatric disorders, * patients that are pregnant, or breast feeding.

Keywords: plasticity reorganization cortical fmri rehabilitation
study of fordadistrogene movaparvovec in early stage duchenne muscular dystrophy

Conditions: Muscular Dystrophy, Duchenne

Summary: the study will evaluate the safety and dystrophin expression following gene therapy in boys with duchenne muscular dystrophy (dmd). it is a single-arm, non-randomized, open-label study

the study will assess the safety and tolerability of fordadistrogene movaparvovec gene therapy. approximately 10 participants will be enrolled in the study and receive a single iv infusion of pf-06939926; there is no placebo arm. the study includes boys who are at least 2 years old and less than 4 years old (including 3 year olds up until their 4th birthday). all boys will need to be negative for neutralizing antibodies against aav9, as measured by the test done for the study as part of screening. the primary analysis will occur when all participants have completed visits through week 52 (or withdrawn from the study prior to week 52). all participants will be followed in the study for 5 years after treatment with gene therapy.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of dmd by prior genetic testing. exclusion criteria: * any of the following genetic abnormalities in the dystrophin gene: a. any mutation (exon deletion, exon duplication, insertion, or point mutation) affecting any exon between exon 9 and exon 13, inclusive; or b. a deletion that affects both exon 29 and exon 30; or c. a deletion that affects any exons between 56-71, inclusive. * positive test performed by pfizer for neutralizing antibodies to aav9. * any prior treatment with gene therapy. * any treatment designed to increase dystrophin expression within 6 months prior to screening (including, but not limited to, exon-skipping and nonsense read through). * previous or current treatment with oral glucocorticoids or other immunosuppressive agents for the indication of dmd. * abnormality in specified laboratory tests, including blood counts, liver and kidney function.

Keywords: early stage duchenne muscular dystrophy dmd gene therapy fordadistrogene movaparvovec
study of nivolumab (bms-936558) compared with dacarbazine in untreated, unresectable, or metastatic melanoma

Conditions: Melanoma

Summary: the purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * men and women ≥18 years of age * eastern cooperative oncology group performance status of 0 or 1 * untreated and histologically confirmed unresectable stage iii or stage iv melanoma, as per the staging system of the american joint committee on cancer * measurable disease as per response evaluation criteria in solid tumors 1.1 * tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses * known braf wild-type, as per regionally acceptable v600 mutational status testing. braf mutant patients and those with indeterminate or unknown braf status are not permitted to randomize exclusion criteria: * active brain metastases or leptomeningeal metastases * ocular melanoma * any active, known, or suspected autoimmune disease
digital health promotion for children with congenital heart disease and their guardians

Conditions: Congenital Heart Disease; Pediatric ALL

Summary: congenital heart disease (chd) affects approximately 1% of live births, and children with chd often fail to meet who physical activity guidelines. digital interventions to promote physical activity in chd patients are limited. this study will develop and test a 12-week digital lifestyle intervention for children (ages 8-13) and their guardians, using a garmin vivofit jr. 2 wearable to continuously monitor physical activity (pa). we will assess its impact on children's moderate to vigorous intensity physical activity (mvpa), daily activity (steps per day), quality of life, nutrition, and health literacy, as well as the quality of life and health literacy of their parents.


Eligibility criteria:
inclusion criteria: * ages 8-14 years * presence of a congenital heart defect (must be moderate or complex according to acc criteria) * nyha class i or ii * presence of written informed consent exclusion criteria: * cognitive impairments that inhibit patients from understanding the tasks * no sports clearance by paediatric cardiologists

Keywords: congenital heart disease congenital heart defect child physical activity exercise mvpa digital health telemedicine health literacy quality of life
tele-coaching in patients with covid-19

Conditions: Covid19; Rehabilitation

Summary: respiratory exercise training and aerobic exercise training will be given to patients who have been hospitalized in intensive care due to covid 19 and underwent imv, who were hospitalized in the service and underwent nimv or high-flow oxygen inhalation, and whose respiratory symptoms persist after discharge. the patients in the study group will be called by phone once a week and a motivating conversation will be made. no control will be made to the control group. before and after the training, 6-minute walking test, mrc dyspnea scale, sgrq quality of life questionnaire and hospital anxiety depression scale will be applied.

some of the patients with covid 19 pneumonia still have respiratory symptoms despite being treated. it has been reported that pulmonary rehabilitation programs applied in various models and in a small number to relieve or reduce these symptoms reduce dyspnea, increase exercise capacity and improve quality of life. there is no study reporting the results of a pulmonary rehabilitation program applied to covid 19 patients in our country. the main purpose of this study is to determine the efficacy of pulmonary rehabilitation applied by telecoach to patients with severe covid 19 pneumonia or persistent respiratory symptoms. secondly, it is aimed to present the data of turkish society to the literature. in accordance with this purpose investigators planed a randomised control clinical study. in our study respiratory exercise training and aerobic exercise training will be given to patients who have been hospitalized in intensive care due to covid 19 and underwent imv, who were hospitalized in the service and underwent nimv or high-flow oxygen inhalation, and whose respiratory symptoms persist after discharge. the patients in the study group will be called by phone once a week and a motivating conversation will be made. no control will be made to the control group. before and after the training, 6-minute walking test, mrc dyspnea scale, sgrq quality of life questionnaire and hospital anxiety depression scale will be applied.

Eligibility criteria:
inclusion criteria: * being treated in intensive care unit due to covid-19 pneumonia, * receiving imv, nimv, or high-flow oxygen therapy * patients whose respiratory symptoms persist despite discharge exclusion criteria: * patients with pcr test + * patients without any complaints. * patients who are hospitalized and discharged within 10 days * patients with orthopedic, neurological, cognitive problems

Keywords: covid19 rehabilitation telecoaching