Kornimate/medical-research-clean huggingface dataset:
study to evaluate three times per week (tiw) oral dosing of vadadustat for anemia in subjects with dialysis-dependent chronic kidney disease (dd-ckd)

Conditions: Anemia; Dialysis-Dependent Chronic Kidney Disease

Summary: this is a phase 3 study to evaluate three times per week (tiw) oral dosing of vadadustat for anemia in subjects with dialysis-dependent chronic kidney disease (dd-ckd)


Eligibility criteria:
inclusion criteria: * male and female subjects ≥18 years of age * receiving chronic maintenance in-center hemodialysis (3 times per week) for end-stage kidney disease * currently maintained on esa therapy * mean screening hb between 8.0 and 11.0 g/dl (inclusive) exclusion criteria: * anemia due to a cause other than ckd or presence of active bleeding or recent blood loss * sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia * red blood cell transfusion within 4 weeks prior to or during screening * anticipated to recover adequate kidney function to no longer require hemodialysis during study participation

Keywords: anemia hemoglobin darbepoetin alfa tiw hypoxia-inducible factor prolyl-hydroxylase inhibitor hif-phi akb-6548 vadadustat renal hypoxia-inducible factor hif dialysis-dependent chronic kidney disease ckd dd-ckd kidney erythropoiesis stimulating agent esa
the effect of a structured personalised ergonomic intervention for hospital nurses with musculoskeletal complains

Conditions: Musculoskeletal Diseases

Summary: the purpose of this study is to examine the effect of a structured personalised ergonomic intervention program for hospital nurses with musculoskeletal complains.

in a randomised controlled trial 31 nurses with musculoskeletal complains were observed at work, and an intervention program was completed in 14 nurses with the other 17 acting as controls. the intervention included four meetings during three months. outcome measures were collected before the intervention and post-tests were gathered three months after the determination of the program.

Eligibility criteria:
inclusion criteria: * a minimum of half-time work for at least one year * musculoskeletal pain complaints * agreement to participate in the interventional study. exclusion criteria: * male nurses * nurses with previously defined job restrictions and * pregnancy

Keywords: nurses, workload, musculoskeletal system, intervention
binge eating disorder treatment study

Conditions: Binge Eating Disorder

Summary: the main objective of the proposed study is to determine whether the effectiveness of a group therapy treatment for binge eating disorder (bed) is improved and attrition reduced by optimally matching women with bed who have high attachment anxiety to group psychodynamic interpersonal psychotherapy (gpip). this study represents the next phase in a program of research stemming from a previously conducted randomized controlled trial (rct).


Eligibility criteria:
inclusion criteria: •overweight women 18 years of age or older who binge eat at least twice per week for the past month. exclusion criteria: * unable speak english * history of an eating disorder other than binge eating disorder * concurrent diagnostic and statistical manual-iv (dsm-iv) diagnosis of bipolar disorder, psychosis, drug or alcohol problem * pregnant or planning on becoming pregnant within the next year * are currently or plan to become enrolled in a weight loss program within the next year
behavioral economic analysis of demand for marijuana

Conditions: Marijuana Smoking

Summary: this laboratory study will employ a multi-session experimental design to examine the behavioral economic demand for marijuana, by studying effect of marijuana administration (high thc) on demand for marijuana, and marijuana smoking topography. the study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly.

this laboratory study will employ a multi-session experimental design to examine craving for marijuana, the effect of marijuana administration (high thc) on behavioral economic demand for marijuana, and marijuana smoking topography. the study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly. the relationship between hypothetical and actual demand for marijuana will be examined. we will also investigate relationship between demand for marijuana and indices of marijuana smoking topography. the study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly to obtain a final sample of 85 with complete data (15% of attrition). participants will be tested at a baseline session and during two experimental sessions (an ad libitum marijuana smoking session and a marijuana smoking topography session). this study will confirm the utility of the hypothetical marijuana purchase task as a reliable and valid tool for assessing behavioral economic marijuana demand.

Eligibility criteria:
inclusion criteria: * marijuana use at least 8 times in the past month on average and at least monthly for the past 6 months * english-speaking * negative urine toxicology screen for drugs other than marijuana * non-treatment seeking * purchase of marijuana at least twice in the past 6 months to confirm familiarity with the construct to be measured exclusion criteria: * positive pregnancy test * nursing * inability to use contraception during the study * poor physical health * positive breath alcohol concentration * diagnosis of a current affective disorder, psychosis, and panic disorder * self-report of past serious adverse reaction to marijuana * current psychotropic drug use * smoking more than 20 tobacco cigarettes per day * inability to abstain from marijuana for 15 hours * body mass index outside 18.5-30 kg/m2 range
enoxaparin bioequivalence study in acute coronary syndrome patients

Conditions: Acute Coronary Syndrome

Summary: because of their anti-xa and ease of administration activity, the low molecular weight heparin represent an attractive alternative to the unfractionated heparin. several clinical trials have demonstrated that low molecular weight heparin was more effective than unfractionated heparin without increasing bleeding complications. enoxaparin has been the most studied. its use is recommended. demonstrate that enoxa® is comparable to that of lovenox® in the anti-xa activity action.

single-center randomized controlled trial, single-blind, including patient with an acute coronary syndrome confirmed, to measure the anti-xa activity between h0 and h4.the study was done on two groups ; enoxa® group : in this case the patient is given an injection of enoxaparin ( enoxa® ; unimed laboratories) intravenously. curative dose (100 iu/10 kg). control group ( lovenox ® ): in this case the patient receives lovenox intravenous injection curative dose of 100 kg iu/10 .

Eligibility criteria:
inclusion criteria: * age over 18 year old * with an acute coronary syndrome confirmed exclusion criteria: * age less than 18 years * persistent st segment elevation * contre indication of enoxaparin and heparin in general. * patient participating in another study, * pregnant or nursing women * patients taking an anticoagulant in the last three months, * patients with coagulopathy

Keywords: enoxaparin lovenox ani-xa acute coronary syndrome enoxa
a study to determine the efficacy of lenalidomide versus investigator's choice in patients with relapsed or refractory mantle cell lymphoma (mcl)

Conditions: Mantle Cell Lymphoma; Lymphoma, Mantle-Cell

Summary: to evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory mantle cell lymphoma.

this research study is for patients who have relapsed or refractory mantle cell lymphoma following treatment such as radiotherapy, immunotherapy, chemotherapy, or radioimmunotherapy. chemotherapy agents such as gemcitabine, cytarabine, chlorambucil, fludarabine, or the immunotherapeutic agent, rituximab, may be proposed. thus, the aim is to search for new treatments that may improve the prognosis of patients with relapsed mantle cell lymphoma. the present clinical study aims at determining if lenalidomide is safe and active in patients with mantle cell lymphoma who are refractory to their treatment or have relapsed once, twice or three times. enrollment goal was met on march 7th 2013 and thus enrollment was stopped.

Eligibility criteria:
inclusion criteria: * biopsy proven mantle cell lymphoma * patients who are refractory to their regimen or have relapsed once, twice or up to three times and who have documented progressive disease * eastern cooperative oncology group (ecog) performance score 0,1, or 2 * willing to follow pregnancy precaution exclusion criteria: * any of the following laboratory abnormalities * absolute neutrophil count (anc) \< 1,500 cells/mm\^3 (1.5 x 10\^9/l) * platelet count \< 60,000/mm\^3 (60 x 10\^9/l) * serum aspartate transaminase/serum glutamic oxaloacetic transaminase(ast/sgot) or alanine transaminase/serum glutamic pyruvic transaminase (alt/sgpt) \>3.0 x upper limit or normal (uln), except patients with documented liver involvement by lymphoma * serum total bilirubin \> 1.5 x uln, except in case of gilbert's syndrome and documented liver involvement by lymphoma. * calculated creatinine clearance (cockcroft-gault formula) of \< 30 ml/min * history of active central nervous system (cns) lymphoma within the previous 3 months * subjects not willing to take deep venous thrombosis (dvt) prophylaxis * known seropositive for or active viral infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv) or hepatitis c virus (hcv). patients who are sero-positive because of hepatitis b virus vaccine are eligible

Keywords: mantle cell lymphoma relapsed mantle cell lymphoma refractory mantle cell lymphoma lymphoma mcl
longitudinal multimodal profiling of balance and gait in stroke

Conditions: Stroke

Summary: balance and gait recovery is a critical aspect of post-stroke motor rehabilitation. researchers have effectively utilized eeg to investigate different aspects of lower limb motor control, however there are several technical challenges in the existing brain computer interface (bci) motor profiling. the study aims to test the eeg-bci system to see if it's effective in understanding the balance and walking patterns of post-stroke populations.

brain computer interface represent a groundbreaking field at the crossroads of neuroscience and engineering, serving as a direct communication link between the human brain and computer system. despite advancements in bci technology, the electrocortical oscillations during human walking remain relatively unexplored, providing an opportunity for pioneering investigations. the research highlights the feasibility of using eeg to decode neural patterns associated with various functions and aims to contribute to existing knowledge by using advanced eeg-based techniques to predict balance and gait patterns with the ultimate goal of tailoring rehabilitation approaches to individual patient needs.

Eligibility criteria:
inclusion criteria: * first-ever clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors brain imaging * age 21 to 85 years * at least ≥ 30 days post-stroke * gait impairments related to stroke * functional ambulation category -6 levels (mehrholz et al, 2007): fac ≥ 4, i.e. able to ambulate independently on level surface but requires supervision to negotiate (e.g. stairs, inclines, non-level surfaces). * montreal cognitive assessment (moca) score \> 21 (nasreddine et al., 2005) * able to understand study instructions and requirements exclusion criteria: * non-stroke related causes of gait impairment * medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, severe /untreated depression, agitation, end stage renal/liver/heart/lung failure, dialysis, unresolved cancers e.g.,), active seizures within 3 months * anticipated life expectancy of \< 6 months * on subcutaneous or oral anti-coagulation * local factors potentially worsened by gait training: joint and muscle pains * lower limb pain vas \>4/10, active lower limb fractures or arthritis, fixed leg contractures, severe peripheral vascular disease, organomegaly or aortic aneurysms * active unhealed skin wounds or inflammatory skin conditions over trunk and lower limbs, * severe visual impairment or visual neglect affecting navigation * known allergy to eeg gel (recoverix) * presence of craniectomy skull defect * resident of nursing home or overseas country which may compromise attendance at research site * pregnant or lactating females

Keywords: electroencephalographic (eeg) brain computer interfaces
chronic liver disease in urea cycle disorders

Conditions: Urea Cycle Disorder

Summary: this is a pilot, cross-sectional study to assess liver stiffness and markers of hepatic injury, function, and fibrosis in patients with urea cycle disorders. this study will be conducted at 3 ucdc sites: baylor college of medicine in houston, texas, university of california san francisco (ucsf), san francisco, california and seattle children's hospital, seattle,washington

urea cycle disorders (ucds) are among the most common inborn errors of liver metabolism.with early diagnosis and improved treatments, the survival of individuals with ucds has improved, and this improved survival has led to unmasking of some long-term complications such as hepatic dysfunction and progressive fibrosis in a subset of patients. hepatic complications in ucds are quite variable and dependent upon the specific metabolic defect. currently, there are no guidelines for monitoring hepatic complications or extent of liver disease in ucds. the purpose of this study is: 1) to determine whether liver stiffness is higher in individuals with ass1d, asld, and arg1d as compared to females with otcd, and to assess liver stiffness in other ucds (citrin deficiency, nagsd, cps1d, and males with otcd), 2) to test whether markers of hepatocellular injury and function and novel serum biomarker panels for hepatic fibrosis provide evidence of chronic liver disease in individuals with ass1d, asld, and arg1d as compared to otcd and to assess these sample markers of hepatocellular injury and function and novel serum biomarker panels for hepatic fibrosis in other ucds (citrin deficiency, nagsd, cps1d, and males with otcd).

Eligibility criteria:
inclusion criteria: 1. age \> 5 years and \< 60 years 2. weight ≥ 11 kg 3. males or females with a diagnosis of otcd based on molecular or enzymatic testing. males or females with a diagnosis of cps1d, citrin deficiency, nagsd, ass1d, asld or arg1d based on biochemical or molecular, or enzymatic testing exclusion criteria: 1. history of hyperammonemia (blood ammonia greater than 100 micromoles/l) documented in the medical record or reported by the patient in the 30 days preceding enrollment visit 2. history of liver transplantation 3. current pregnancy 4. confirmed diagnosis of chronic viral hepatitis, autoimmune liver disease, or alcohol liver disease
ferumoxytol-enhanced imaging and mapping in neuroaids

Conditions: AIDS Dementia Complex

Summary: this project will investigate the ability of a novel mri contrast agent to identify and quantitate ongoing monocyte/macrophage (m/mφ)-mediated inflammation in the brains of hiv-infected individuals.

hiv-associated neurocognitive disorders (hand) continue to be prevalent despite effective combination antiretroviral therapy (cart) and have a significant impact on morbidity and quality of life. monocytes/macrophages (m/mφ) are believed to play a critical role in the pathogenesis of hand. neuroimaging hiv research has not focused on assessing m/mφ-mediated inflammation in the brain. currently, no neuroimaging modality exists that can define the extent of active inflammation due to m/mφ in hand either as a clinical diagnostic tool or to assist in defining objective improvement in clinical trials addressing hand. ferumoxytol is an ultra-small iron oxide mri contrast agent avidly taken up by circulating m/mφ. the investigators hypothesize that ferumoxytol-based imaging can identify ongoing inflammation due to perivascular m/mφ which is believed to represent a key pathologic correlate of hand.

Eligibility criteria:
inclusion criteria: * age 40-65 years * plasma hiv rna \< 48 copies/ml (hiv+ subjects only) * on stable cart \>= 1 year (hiv+ subjects only) * global neuropsychological (np) score \<-0.5 in at least one cognitive domain known to be affected by hiv (neurocognitively impaired subjects only) * documentation of negative hiv infection by an fda approved test (hiv- subjects only) exclusion criteria: * active substance use * history of myocardial infarct or stroke * diabetes * chronic hepatitis c virus (hcv) infection * uncontrolled major affective disorder, active psychosis, central nervous system disease that affects the brain structure, or other uncontrolled chronic medical condition that in the opinion of the investigator may impact np testing or the study outcome * psychoactive or other medications which may impact np testing * factors that preclude mri * known hypersensitivity to ferumoxytol * history of laboratory measurements consistent with an iron overload syndrome * medical conditions that require frequent blood transfusions * taking oral iron supplements * elevated iron levels * any condition, which in the opinion of the investigator, would compromise the subject's ability to participate * multiple drug allergies that may pose a greater risk of anaphylaxis associated with ferumoxytol * pregnant, unwillingness to practice birth control, or breastfeeding * unable to give informed consent

Keywords: hiv dementia neuroimaging
effects of a single-bout of moderate-intensity aerobic exercise on mood and mental health biomarkers in adults with depressive and/or anxiety symptoms

Conditions: Healthy; Depression Symptoms; Anxiety Symptoms

Summary: this study investigates whether a single session of aerobic exercise (like running) can improve the participants' mood and whether such benefits can be explained by changes in the blood factors (like hormones) and brain activity. the main questions this study aims to answer are: * can a single session of aerobic exercise improve mood? * which changes in the blood and brain could explain the effects of exercise on mood? researchers will compare the participants' mood states before and after exercise to see whether exercise can improve mood. the participants will: * answer questionnaires, collect blood, and undergo magnetic resonance imaging (mri) before exercise. * perform 30 minutes of running on a treadmill. * answer the same questionnaires, collect blood, and undergo magnetic resonance imaging (mri) after exercise. the entire assessment will last for about 2h45min and will be performed on a single day.


Eligibility criteria:
inclusion criteria: * healthy subjects within the stipulated age range exclusion criteria: * acute injury or illness that impairs the ability to safely exercise and/or inability to exercise with a moderate intensity; * metabolic and/or neurologic disorders; * iron implants; * people who cannot stay still, are intolerant of noise or fearful of enclosed spaces (due to the small space inside the scanner).
irbesartan for the prevention of atrial arrhythmias and cardiac electrical remodeling in patients with hypertension and permanent pacemakers

Conditions: Atrial Fibrillation; Hypertension

Summary: the purpose of this study is to determine whether irbesartan will reduce the rate of recurrent atrial high rate episodes and the development of clinical sustained atrial fibrillation in patients with hypertension and permanent pacemaker.

patients with permanent pacemakers have a high risk of atrial fibrillation (af), particularly those with hypertension, sinus node dysfunction, and those with short episodes of atrial arrhythmias, known as atrial high-rate episodes (ahre). ahre are felt to be a precursor to af, and may be both the result and a cause of changs in the atrial electrophysiology, and structure (known as cardiac remodeling)that are associated with the development of af. evaluating this process in human af has been limited by the cumbersome nature of performing serial, invasive electrophysiologic studies. however, modern pacemakers now permit rapid, non-invasive electrophysiologic testing and can also accurately document ahre, which allows the convenient study of therapy aimed at preventing the progression from ahre to overt af. in addition, this group of patients also affords the ability to evaluate the recurrence of ahre on the progression of structural and electrical remodeling. comparison: irbesartan compared to placebo.

Eligibility criteria:
inclusion criteria: * sinus node dysfunction (with or without av conduction disturbance) * permanent, atrial or dual-chamber pacemaker implanted \> 2 months before enrollment and with ability to record and store atrial high-rate episodes, frequency of mode switches and to perform non-invasive electrophysiologic testing * history of at least 6 ahre in the last 6 months (rate \> 220/min, duration of \> 2 minutes * history of prior diagnosis of hypertension and/or treated for hypertension or two documented bp \> 130/85 (measurements done at least one week apart) exclusion criteria: * permanent or persistent af or more than 6 episodes of symptomatic paroxysmal af in the previous 6 months * documented cr \>200 umol/l and k+ \>5.2 mmol/l in the previous 3 months * current treatment with a potassium sparing diuretic, unless serum potassium known to be in the normal range * lv ejection fraction known to be \< 40 % * moderate or severe mitral regurgitation (3+, 4 +) * mitral stenosis of more than mild severity * aortic stenosis with mean gradient of \> 25 mmhg * angina at rest in the last 2 months, or current ccs class 3 or 4 angina * unipolar atrial lead * previous av node ablation * p-wave amplitude less than 1.5 mv * current therapy with an ace inhibitor, arb or aldosterone antagonist * current or planned (within 6 months) with an anti-arrhythmic medication (amiodarone, sotalol, flecainide, propafenone, quinidine, dofetilide

Keywords: atrial fibrillation arrhythmia pacemaker, artificial atrial high rate episodes electrophysiology renin-angiotensin system hypertension cardiac remodeling