Kornimate/medical-research-clean huggingface dataset:
accuracy of fna versus cnb of abnormal axillary lymph nodes in setting of invasive breast cancer

Conditions: Breast Cancer

Summary: to compare accuracy of ultrasound guided fine needle aspiration (fna) to core needle biopsy (cnb) of ultrasound detected abnormal axillary lymph nodes in patients with newly diagnosed invasive breast cancer or suspected invasive breast cancer. hypothesis: fna and cnb have equivalent diagnostic accuracies in order to prove our hypothesis, we will perform fna and cnb on the same lymph node in each consented patient. the two samples will be evaluated separately by different pathologists blinded to the material in the other sample. the results of the biopsies will be compared to the gold standard (lymph node excision).


Eligibility criteria:
inclusion criteria: * recent or suspected diagnosis of invasive breast cancer with abnormal ipsilateral axillary lymph node * able to provide informed consent exclusion criteria: * lymph node not amenable to core biopsy * patient is unlikely to undergo lymph node excision (i.e. elderly patient with co-morbidities)
study of qiliqiangxin capsule to treat dilated cardiomyopathy

Conditions: Dilated Cardiomyopathy; Heart Failure

Summary: the pathogenesis of dilated cardiomyopathy (dcm) leading to heart failure is closely associated with autoimmunity dysfunction. a few studies represented that qiliqiangxin capsule, a chinese medicine, could enhance heart function in chronic heart failure and regulate the balance of tnf-a and il-10 in myocardial infarction. in this study, to explore the effects of qiliqiangxin capsule on the improving heart function and immunoregulation in patients with dcm, patients were recruited, anti-heart autoantibodies and some representative cytokines were assayed by enzyme-linked immuno sorbent assay (elisa), and the efficacy of heart function improvement was compared between qiliqiangxin capsule and placebo under the standard treatment of dcm.


Eligibility criteria:
inclusion criteria: * dilated cardiomyopathy (lvef ≤ 45%) exclusion criteria: * secondary dilated cardiomyopathy (such as ischemic cardiomyopathy, valvular cardiomyopathy, hyperthyroid cardiomyopathy, diabetic cardiomyopathy, anemia cardiomyopathy, and etc.) * coronary heart disease * rheumatic heart disease * pulmonary heart disease * continuous dysarteriotony: hypertension(systolic blood pressure \[sbp\] ≥ 60mmhg/diastolic blood pressure \[dbp\] ≥ 100mmhg); hypotension(sbp \< 90mmhg/dbp \< 60mmhg) * resting heart rate ≤ 50bpm * atrioventricular block patients without permanent pacemaker

Keywords: immunomodulation
clinical study to investigate the effects of a food supplement santa herba extract on weight loss in overweight women

Conditions: Weight Loss

Summary: aim of the study is to investigate the effect of a 12-week supplementation of santa herba extract on body weight in overweight and obese subjects. additionally appetite related marker as well as marker of white adipose tissue browning will be evaluated.


Eligibility criteria:
inclusion criteria: * subject is able and willing to follow the study protocol procedures to sign the informed consent form prior to screening evaluations * overweight and obese women with bmi 25 - 35 kg/m2 (limits included) * age: 25 - 60 years * subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology exclusion criteria: * relevant history or presence of any medical disorder potentially interfering with this study (heavy depression, diabetes, active cancer, severe liver disease, heavy cardiovascular diseases (e.g. stroke, heart attack)) * chronic intake of medication/dietary supplements with impact on body weight or body composition or lipid modifying products (e.g. protein shakes, statins, omega-3 fatty acids, etc.) 2 months prior to screening or during the study; stable doses of e.g. hypertensive therapy and thyroid gland hormones are acceptable. * change in hormonal contraceptive during or at least 3 months before the study * consumption of any dietary supplement / fortified food (with exception of vitamin d and mineral supplements e.g. ca, mg) * low body fat mass measured at screening with bia ( bioelectrical impedance analysis ) (cut off-value: \<36% body fat). * weight loss intervention or recent body weight change \> 4.5 kg during last 3 months * diet high in vegetables and fruits ≥ 5 portions per day * vegan lifestyle * smoker \> 10 cigarettes / day * gastrointestinal diseases/conditions (colitis ulcerosa, crohn's disease, peptic ulcers, celiac disease)

Keywords: lipid profile 12,13-dihome
establishing a repository of blood and dna samples from people with sickle cell disease (comprehensive sickle cell centers collaborative genotype-phenotype database and sample repository)

Conditions: Anemia, Sickle Cell

Summary: sickle cell disease (scd), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. the purpose of this study is to collect, test, and archive blood and dna samples from children and adults with scd to study the role that genes play in scd. blood and dna samples will be stored for use in future scd studies.

scd is an inherited blood disorder that is caused by an abnormal type of hemoglobin. symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." the comprehensive sickle cell centers (cscc) is a network of 10 centers that conduct research to improve health care and treatment options for people with scd. the collaborative data project (c-data) is a cscc study that is establishing a comprehensive database of children and adults with scd who are receiving medical care at participating cscc research centers. this study will initiate the development of a centralized laboratory that will collect, test, and archive blood and dna samples from participants in the c-data project for use in future scd studies. the collection of blood and dna samples will provide researchers with an important resource to better define the genetic diversity of scd. in the future, genotype-phenotype correlation studies, population studies, and various other genetic studies may be conducted. this study will enroll participants taking part in the c-data project. for this study, participants will undergo a blood collection. the blood sample will then be sent to a lab to characterize the red blood cells and hemoglobin. dna will be analyzed to identify genes that influence the severity of scd. blood and dna will be stored for future genetic research in scd and closely related disorders.

Eligibility criteria:
inclusion criteria: * participating in the c-data project exclusion criteria: * unable to undergo blood collection

Keywords: sickle cell disease sickle cell anemia dna
lyrica dose response study with restless legs syndrome (rls) patients

Conditions: Restless Legs Syndrome

Summary: to test the effectiveness and tolerability of lyrica at various dose levels in rls patients


Eligibility criteria:
inclusion criteria: * moderate to severe idiopathic rls * symptoms occur predominantly in the evening * symptoms interfere with sleep onset or maintenance exclusion criteria: * any secondary rls * require treatment for daytime rls symptoms * symptomatic neuropathies

Keywords: pregabalin, rls, efficacy, safety
bmn 110 us expanded access program

Conditions: Mucopolysaccharidosis IVA; Morquio A Syndrome; MPS IVA

Summary: the expanded access program (eap) is an open-label, multicenter program to: 1. provide patients who have been diagnosed with mucopolysaccharidosis iva (mps iva) access to bmn 110 until commercial product is available 2. collect additional information on the safety and tolerability of bmn 110 administration in patients with mps iva patients enrolled in the eap will receive 2.0 mg/kg intravenous infusions of bmn 110 every week during the program.


Eligibility criteria:
inclusion criteria: * diagnosed with mps iva as confirmed by either n-acetylgalactosamine-6-sulfatase (galns) enzymatic test (galns activity in affected range, beta-galactosidase and a second lysosomal sulfatase activity within normal range) or molecular diagnostic test (two mutations in galns identified that have previously been associated with an enzyme defect). * willing and able to provide written, signed informed consent, or in the case of patients under the age of 18, provide written assent (as required by the irb) and written informed consent by a legally authorized representative after the nature of the program has been explained, and prior to any program assessments or evaluations. * sexually active patients must be willing to use an acceptable method of contraception while participating in the program. * females of childbearing potential must have a negative pregnancy test at baseline and be willing to have additional pregnancy tests during the program. * willing and able to comply with all program procedures. exclusion criteria: * pregnant or breastfeeding at baseline or planning to become pregnant (self or partner) at any time during the program. patients who become pregnant during the program will be discontinued from the program. * currently enrolled in an ongoing clinical study of bmn 110. * discontinued from a bmn 110 clinical study secondary to a safety-related event. * use of any investigational product (other than bmn 110 in a clinical study) or investigational medical device within 30 days prior to baseline, or requirement for any investigational agent prior to completion of all scheduled program assessments. * not a current us resident or expecting to have travel plans outside the us during the planned period of participation in the expanded access program (eap) that may interfere with dosing regimen, scheduled program visits and safety monitoring. * any condition that, in the view of the investigator or sponsor, places the patient at high risk of poor treatment compliance or of not completing the eap.

Keywords: mucopolysaccharidosis iva type a mps iva type a mucopolysaccharidosis iva mps iva morquio a syndrome lysosomal storage disorder lsd n-acetylgalactosamine-6-sulfatase n-acetylgalactosamine-6-sulfate
advanced mr techniques in detection of tumor infiltration and grading in gliomas

Conditions: Gliomas

Summary: in this study, we evaluate the role of diffusion kurtosis imaging (dki) and mr spectroscopy (mrs), two advanced imaging techniques in magnetic resonance (mr) in grading and detection of microscopic infiltrating tumour in gliomas. these parameters are of utmost importance in optimal choice and planning of treatment. patients treated with gliomatous brain tumours are included voluntarily. they undergo one imaging session on a 3t mr scanner prior to treatment. dki data are quantitively analyzed in order to estimate specific parameters in normal appearing white matter, grey matter, tumor and peritumoral edema. mrs data are analyzed quantitatively and qualitatively with peak integration, ratio calculation and classification algorithms. histological confirmation is obtained at subsequent surgery. information from this study can be of significant importance in avoiding brain biopsies. furthermore, information on microscopic tumour spread can be used during neurosurgery or in radiotherapy planning. an important advantage of these advanced mr techniques is the non-invasivity and the lack of ionizing radiation, two important issues in this relatively young patient population.


Eligibility criteria:
inclusion criteria: * diagnosis of gliomatous brain tumour exclusion criteria: * younger than 18 years of age * prior treatment * history of neurological or neurosurgical treatment

Keywords: gliomas magnetic resonance diffusion kurtosis imaging mr spectroscopy grading
safety and effectiveness of cardiac resynchronization therapy with defibrillation

Conditions: Heart Failure, Congestive; Ventricular Fibrillation; Tachycardia, Ventricular

Summary: the purpose of this study was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure.

patients enrolled received a device with cardiac resynchronization therapy (crt) and defibrillation. patients were randomized to crt on or off for up to six months and evaluated for mortality, hospitalization, and functional outcomes including exercise capacity, quality of life, symptomatic status, and echocardiographic analysis.

Eligibility criteria:
inclusion criteria: * symptomatic heart failure * left ventricular ejection fraction \<= 35% * qrs width \>= 120 ms * indicated for an implantable cardioverter defibrillator exclusion criteria: * indicated for a pacemaker * atrial tachyarrhythmias
wearable movement sensors for assessing motor impairments and dyskinesias in parkinson disease

Conditions: Parkinson Disease

Summary: the purpose of this study is to measure motor fluctuations and dyskinesias in patients with parkinson's disease using movement sensors (accelerometers and gyroscopes) to determine if this is a feasible measure to use in addition to self report, and eventually the goal will be to replace self report with a more reliable measure such as movement sensors.

patients with parkinson disease and motor fluctuations will wear movement sensors during their regular clinic visit with the principal investigator. the visit will be videotaped and medication status (on without dyskinesia, on with dyskinesia, or off) will be independently rated from review of the video.

Eligibility criteria:
inclusion criteria: * participants who will be included in the study have probable or definite idiopathic pd (capsit criteria (23)), hoehn \& yahr stage 2-4; * one or more of the following pd-associated motor impairments experienced in the week prior to enrollment (based on history and/or examination): motor fluctuations (end of dose wearing off with hypokinesia and/or levodopa-induced choreiform dyskinesias), tremor, freezing of gait, or frequent falls (≥ 1 per week). exclusion criteria: * neurological disorders (other than pd) or orthopedic deficits that, in the investigator's judgement, contribute substantially to impaired movement (e.g. stroke with motor sequelae; * essential tremor; * severe osteoarthritis); * cognitive impairment sufficiently severe to interfere with informed consent.
a safety and tolerability study of argx-113 in patients with myasthenia gravis who have generalized muscle weakness.

Conditions: Generalized Myasthenia Gravis

Summary: this is a long-term, single-arm, open-label, multicenter phase 3 follow-on trial of the argx-113-1704 study to evaluate the safety and tolerability of argx-113 in patients with gmg. patients who have completed at least 1 cycle of treatment and at least 1 year of trial argx-113-1705 and have started part b are eligible to enroll in the open-label trial argx-113-2002 to receive efgartigimod by sc administration.


Eligibility criteria:
inclusion criteria: 1. patients with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures. 2. patients who participated in trial argx-113-1704 and are eligible for roll over, as specified in the protocol. other more specific inclusion criteria are further defined in the protocol. exclusion criteria: 1. patients who discontinued early from trial argx-113-1704 or patients who discontinued early from randomized treatment for pregnancy or rescue reasons or an (s)ae that might jeopardize the safety of the patient in that trial. 2. pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing. women or childbearing potential should have a negative urine pregnancy test at seb. 3. male patients who are sexually active and do not intend to use effective methods of contraception during the trial or within 90 days after the last dosing or male patients who plan to donate sperm during the trial or within 90 days after the last dosing. 4. patients with known hepatitis b virus (hbv), hepatitis c virus (hcv) or human immunodeficiency virus (hiv) seropositivity. other, more specific exclusion criteria are further defined in the protocol.
asymptomatic leishmania infection in hiv patients

Conditions: Visceral Leishmaniasis

Summary: to collect pilot data on the prevalence and incidence of asymptomatic leishmania donovani infection in hiv infected individuals in a visceral leishmaniasis (vl)-hiv endemic region to inform the feasibility of a larger study exploring a screen and treat strategy for vl in hiv co-infected individuals in east-africa (ethiopia).


Eligibility criteria:
inclusion criteria: * hiv infection * without a history of vl in the last 5 years * stable residents of a vl-endemic area * willing to participate and giving free informed consent exclusion criteria: * younger than 18 years

Keywords: visceral leishmaniasis hiv co-infection asymptomatic
impact of a corrie cardiac rehabilitation program

Conditions: Coronary Artery Disease; Myocardial Infarction; Myocardial Ischemia; Coronary Artery Occlusion; Coronary Artery Stenosis Stent; Bypass Graft Occlusion; Valve Heart Disease

Summary: in this randomized clinical trial, the researchers are investigating whether a multi-component virtual/hybrid cardiac rehabilitation program will improve functional status, cholesterol level, overall cardiovascular health, individual risk factors, quality of life and mental health for patients who have recently been diagnosed with myocardial infarction, received a coronary stent, underwent heart surgery or catheter-based valve replacement, as compared to traditional, center-based cardiac rehabilitation.


Eligibility criteria:
inclusion criteria: * 18 years or older * individuals admitted to the hospital for the following conditions or interventions during the index admission: acute myocardial infarction (stemi or nstemi type 1), coronary artery bypass grafting (cabg), and coronary artery angioplasty/stenting (pci), heart valve surgery, catheter-based aortic valve replacement (tavr). exclusion criteria * non-english speaking * symptomatic severe aortic stenosis or other severe valvular disease * physical disability that would preclude safe and adequate exercise performance * hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of \>25 mmhg * known aortic dissection * severe resting arterial hypertension (systolic blood pressure \>200 mmhg or diastolic bp \>110mmhg) at baseline assessment * mental impairment leading to inability to cooperate with study procedures * untreated high degree atrioventricular block * atrial fibrillation with uncontrolled ventricular rate (heart rate \>110 at rest) at baseline assessment * history of cardiac arrest or sudden death * myocardial infarction or cardiac surgery complications with cardiogenic shock and/or congestive heart failure and/or signs/symptoms of post-procedure ischemia * left ventricular ejection fraction \<40% * history of clinically significant depression * visual or hearing impairment which precludes the use of the intervention * presence of cardiac defibrillator * incomplete revascularization procedure * history of one or more episodes of falls in the last year * pregnancy * if patients are deemed clinically unstable and unable to participate at the time of initial screening, the research team member may return at a later date to determine whether this status has changed.

Keywords: digital health smartphone app self-management guideline adherence behavior modification community engagement
using non-fluoroscopic imaging devices to decrease radiation exposure during ablation of supraventricular tachycardia

Conditions: Supraventricular Tachycardia

Summary: the purpose of this study is to determine whether the additional use of non-fluoroscopic imaging modalities can decrease the use of radiation exposure during standard ablation procedures for supraventricular tachycardia (svt) in children.

the standard of care for children undergoing svt ablation is radiation (fluoroscopy) to see the heart. non fluoroscopic imaging tools have been utilized for adult atrial fibrillation procedures. these tools utilize magnetic fields to visualize the heart without using radiation. the purpose of this study was to determine if these 3d mapping tools could reduce radiation exposure during svt ablation procedures could be performed using these 3d tools.

Eligibility criteria:
inclusion criteria: * age \>/=8 * weight \>/=25kg * structurally normal heart (no major cardiac defects) * history of svt * no prior history of cardiac surgery or ablation exclusion criteria: * congenital heart disease * prior history of cardiac surgery or ablation

Keywords: pediatric electrophysiology ablation radiation devices svt
appetite regulation in older-aged obese individuals

Conditions: Obesity; Aging

Summary: this study plans to learn more about how age and weight impact appetite and food intake. specifically, this study is being done to see whether age and obesity impact appetite and the brain's response to food. in this study the investigators will be evaluating how participants brains respond to food images as well as your food-related behaviors and hormones. the investigators will be comparing older individuals aged 65 to 85 years who are normal weight compared to those who are obese. the investigators will then compare older aged individuals to younger adults aged 21 to 45 years.

in a cross sectional design participants will be studied on one occasion after a 3-day diet run-in. on the study day they will present in the fasting state, have an intravenous catheter placed for blood draws and have baseline blood samples taken and appetite measures performed. participants will then undergo functional magnetic resonance imaging (fmri). this will be followed by a breakfast meal. blood and appetite measures will be performed every half hour for 3 hours. repeat fmri will be performed 30 minutes after the meal. after three hours participants will be offered a buffet style lunch and then will be done with the study visit.

Eligibility criteria:
inclusion criteria: * older aged adults (o): 65-85 * younger adults (y): 21-45 * obese (ob): body mass index (bmi) 30-40 * normal weight (nw): bmi 18-25 exclusion criteria: * pregnancy; * advanced organ failure; * active cancer diagnosis; * uncontrolled hypertension or metabolic disorder; * cognitive impairment or psychiatric disease limiting ability to comply; * presently in an exercise or diet program; * recent weight loss of \>5 lbs in past 6 mo.; * bariatric surgery; * use of any weight loss drugs; * use of any medication known to significantly affect appetite (anti-depressants are allowable); * present tobacco use; * use/abuse of substances of abuse including any marijuana use by history; * any contraindication to mri; * claustrophobia; * body weight \>300 lbs; and * inability to fit in mri scanner.