Kornimate/medical-research-clean huggingface dataset:
a phase ii study of clofarabine in patients with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: to determine the overall response rate (cr+pr) of patients with relapsed or refractory multiple myeloma treated with clofarabine.

to determine the time to response, duration of response, and time to progression of patients treated with clofarabine. to determine the safety and tolerability of clofarabine in these patients.

Eligibility criteria:
inclusion criteria: 1. multiple myeloma diagnosed by standard criteria. 2. measurable levels of monoclonal protein in serum (\>= 0.5 g/dl) or urine (\>= 0.2 g/24 hr). 3. at least 1 prior therapies for multiple myeloma with documented evidence of progression on the most recent treatment. 4. age 18 years or older. 5. ecog performance status \<= 2. 6. acceptable organ and marrow function as defined below: * hemoglobin \>= 8 gm/dl * absolute neutrophil count \>= 1,000/mm3 * platelets \>= 50,000/mm3 * total bilirubin \<= 2.5 x institutional upper limit of normal * ast, alt \<= 2.5 x institutional upper limit of normal * creatinine 1.5 x institutional upper limit of normal * normal cardiac function as determined by standard institutional methods 7. women of child bearing potential must agree to use adequate contraception prior to study entry and for the duration of study. 8. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. receiving any other investigational agents. 2. receiving concurrent steroids with a dose equivalent of prednisone of \>= 150 mg/month. 3. pregnant or nursing. 4. active systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment. 5. severe concurrent disease, including severe insulin-dependent diabetes, uncontrolled hypertension, transient ischemic attacks, uncontrolled symptomatic coronary artery disease, or symptomatic cns involvement or psychiatric illness/social situations that would limit compliance with study requirements. 6. history of other malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast unless the subject has been off treatment and free from disease for \>= 3 years.

Keywords: multiple myeloma
developing models for fatigue monitoring in obstetrics and gyne- cology residents using wearables

Conditions: Fatigue

Summary: this study is set out to observe heart-rate and related bio-metric indicators in obstetrics and gynecology residents during their duty hours, together with self-reporting of fatigue and tasks performances, in order to model possible relationships between the two.

there are vast evidences of the harmful consequences of fatigue in medical residents, consequently, leading to poor task performances and in some cases may cause injury to the patients. medically, fatigue is a non-specific symptom, which means that it has many possible causes and accompanies many different conditions. elevated fatigue is an indication that a person may not be fit-to-task (i.e., task efficacy).the investigators main goal is to use readily available body-worn sensors, such as an activity wrist-band, to continuously monitor for fatigue as a possible antecedent to predictions of task-efficacy in the area of obstetrics and gynecology. this study is anchored in prior research which established basic models that correlate between heart-rate variability (hrv) and fatigue. specific to this study, the investigators would like to further establish the validity of such models at the individual level, also with the perspective of fatigue as an early predictor of task performance related to practices in obstetrics and gynecology. the investigators aim is to extend hrv based models with additional personal measures (e.g., age, weight, activity level), possibly with the extraction of additional data-driven features, to improve model accuracy at the individual level. the investigators will also try to find relationships between such measurements and task effectiveness via the gathering of self-reports regarding on-the-job task performances.

Eligibility criteria:
inclusion criteria: * participants will be chosen from the obstetrics and gynecology department in the hillel yaffe medical center. exclusion criteria: * chronic fatigue syndrome * pregnancy
anaesthetic management of women with heart disease for labor and delivery

Conditions: Heart Diseases; Pregnancy

Summary: heart disease among pregnant women is increasing in incidence. the cardiovascular changes associated with pregnancy may be particularly hazardous for both mother and fetus in a subset of these patients. the period of greatest risk is peripartum while these patients are under the care of the obstetrician and anesthesiologist. we will evaluate the anesthetic management of all women with heart disease whose pregnancies were followed at the university health network and/or mount sinai hospital between 1986 and 2001.

heart disease among pregnant women is increasing in incidence. the cardiovascular changes associated with pregnancy may be particularly hazardous for both mother and fetus in a subset of these patients. the period of greatest risk is peripartum while these patients are under the care of the obstetrician and anesthesiologist. exposing a compromised patient to general anesthesia is further complicated by the cardiovascular stress response to intubation and surgery, the cardiorespiratory implications of mechanical ventilation, the cardiac depression and vasodilation from general anesthetics, residual post-operative respiratory depression from general anesthetics and narcotics and the stress of weaning from mechanical ventilation and post-operative pain. in the adult congenital heart program, obstetric patients are followed the by a specialized team of cardiologists, obstetricians and anesthesiologists who also follow all pregnant women referred with acquired cardiac disease. from this referral practice approximately 100 patients per year are now followed during their pregnancy and delivery. in conjunction with the ongoing system we intend to identify all parturients who delivered at the university health network (toronto general hospital) or mount sinai hospital between the years 1986 and 2001. we will evaluate the anesthetic management of all women with heart disease whose pregnancies were followed at the university health network and/or mount sinai hospital between 1986 and 2001.

Eligibility criteria:
inclusion criteria: * pregnant women with congenital or acquired heart disease * pregnant women with arrhythmias are also included providing they had had symptomatic tachyarrhythmias or bradyarrhythmias requiring treatment exclusion criteria: * women with isolated mitral valve prolapse including those with mild to moderated mitral regurgitation * women referred for termination of pregnancy

Keywords: anaesthesia pregnency heart disease
essential amino acid supplementation in older adult covid-19 patients

Conditions: Covid19

Summary: a 4-week treatment of essential amino acids or placebo to participants with: 1) negative covid-19 test with exposure, or 2) positive covid-19 test and no or mild symptoms. the study team will measure change in symptoms. participants will complete symptom surveys for 4 weeks and once at 8 and 12 weeks as well as pre- and post-assessments.

in people who have been exposed to covid-19 and have been tested (positive or negative) with no to mild symptoms, the study team will administer a treatment of essential amino acids (eaa). the study team will examine if this treatment compared to placebo will reduce the development, length and the severity of symptoms. participants will consume the treatment or placebo for 4 weeks, and will complete symptom surveys, as well as pre- and post-assessments. individuals who receive a covid vaccination will continue to complete symptom surveys for 1 week and take the essential amino acid supplementation for 2 weeks following a vaccination.

Eligibility criteria:
inclusion criteria: * exposure to covid-19 in the last 60 days with no symptoms, with a covid negative test close contact: within 6 feet of a covid-19 positive person for more than a few minutes without wearing ppe, or having direct contact with infectious secretions without ppe * positive covid-19 test with or without symptoms exclusion criteria: * covid-19 positive hospitalized patient * patients who have symptoms of covid but have not been tested. * unable to tolerate oral intake * in hospice or palliative care * unstable medical or psychiatric condition * other criteria deemed acceptable by principle investigator

Keywords: amino acid supplement dietary supplement
dexmedetomidine in off pump coronary artery bypass grafting

Conditions: Coronary Artery Disease

Summary: the study will assess the impact of intraoperative dexmedetomidine infusion on myocardial performance by investigating the left ventricular (lv) systolic and diastolic function and right ventricular (rv) fraction area change (which reflect rv systolic function) using two-dimensional trans-esophageal echocardiography (tee) in patients undergoing elective first-time isolated off-pump coronary artery bypass (opcab) grafting. lv systolic function will be measured by the tee via the fractional area change, fraction shortening, and ejection fraction.

off pump coronary revascularization is an old technique performed first in st petersburg in 1964, off pump coronary artery surgery has been developed following two different approaches. minimally invasive direct-access coronary artery bypass (midcab) that consists of anastomosing the left internal mammary artery to the left anterior descending coronary artery through small anterior left thoracotomy, the second approach is multi-vessel grafting without cpb performed through standard median sternotomy. dexmedetomidine (dex), a highly selective α2-adrenergic receptor agonist, is widely used for sedation and analgesia in the icu or as an anesthetic adjuvant. this study will be a prospective comparative controlled randomized double blinded clinical trial on 36 patients divided into control ,and dexmedetomidine group.

Eligibility criteria:
inclusion criteria: * patients undergoing elective first-time off-pump isolated coronary artery bypass graft (opcab) surgery * patients with good ventricular functions. * patients with normal levels of cardiac troponin i and myocardial enzymes * patients of body mass index (bmi) more than 20 and less than 34. exclusion criteria: * severe functional liver or kidney disease. * diagnosed hf (nyha class \>3). * arrhythmia or received treatment with anti-arrhythmic drugs. * severe bradycardia (hr \< 45 bpm) and av block. * pathologic esophageal lesion (esophageal stricture or varix ) * pregnancy.
addition of transcranial direct current stimulation and transcutaneous electrical nerve stimulation to an education and exercise program in subjects with chronic pain due to knee osteoarthritis

Conditions: Osteo Arthritis Knee; Chronic Pain

Summary: knee osteoarthritis has a very high prevalence in the population over 50 years of age. patients with osteoarthritis often suffer from chronic pain that becomes disabling, affecting both quality of life and mental and physical health. this pathology has also been linked to maladaptive plasticity in the brain, which can contribute to chronic pain. therapies with neuromodulatory approaches, such as transcranial direct current stimulation (tdcs) and peripheral electrical stimulation (tens), have been used therapeutically to counteract the maladaptive plasticity of the brain. transcranial therapy and tens can be a possible effective treatment in the rehabilitation services of the health system for the improvement of chronic pain and quality of life in different pathologies, such as chronic low back pain, fibromyalgia or knee and hip osteoarthritis.


Eligibility criteria:
inclusion criteria: * adults over fifty years of age with a diagnosis of knee osteoarthritis by radiography. * chronic pain of more than six months, compliance with the diagnostic criteria for knee osteoarthritis according to the osteoarthritis research society international (oarsi) guideline: * pain in analog visual scale more than 4/10 * matutinal less than 30 minutes * absence of hyperthermia upon palpation in the joint * alteration of the bone image * crepitus exclusion criteria: * patients who can provide low-quality or biased information discriminated by the mini-mental state examination (score less than 24). * severe hearing, visual or sensory impairment or comorbidities that prevent the correct completion of the questionnaires and mobility activities. * patients who have undergone knee replacement surgery on the contralateral knee. * patients who have received intervention (infiltration, blockages, etc...) in the last 6 weeks. * pain due to tendinopathy, knee fracture, low back pain radiating to the knee, or fibromyalgia. * patients who decline to participate out of fear or denial of therapy. * severe heart disease that prevent exercise. * body mass index above 45. * patients with neuropsychiatric disorders (schizophrenia, epilepsy or bipolar disorders) or taking medication for these conditions (antiepileptic drugs). * patients with metallic implants in the area (skull or knee).

Keywords: tdcs transcranial direct current stimulation knee osteoarthritis tens chronic knee pain
evaluate sln360 in participants with elevated lipoprotein(a) at high risk of atherosclerotic cardiovascular disease events

Conditions: Cardiovascular Diseases; Atherosclerosis; Lipoprotein(a)

Summary: phase 2 study to evaluate the efficacy, safety and tolerability of sln360 administered subcutaneously (sc) compared with placebo in adult participants with elevated lipoprotein(a) at high risk of atherosclerotic cardiovascular disease events


Eligibility criteria:
inclusion criteria: * lipoprotein(a) at screening equal to or greater than 125 nmol/l * at high risk of ascvd events * a body mass index at screening in the range of 18.0 to 32.0 kg/m2, inclusive exclusion criteria: * renal dysfunction with estimated glomerular filtration rate less than 30 ml/min/1.73 m2 at screening * history or clinical evidence of hepatic dysfunction * malignancy within the 5 years before screening * fasting triglycerides \>400 mg/dl (4.5 mmol/l) at screening * currently receiving or \ 200 mg/day niacin or niacin derivative drugs * treatment with lipid/lipoprotein apheresis within the 12 weeks before screening * any previous use of approved or experimental small interfering rna (sirna) therapy (e.g. inclisiran). nb: use of messenger rna (mrna) based vaccines for infectious diseases is permitted

Keywords: cardiovascular diseases atherosclerosis lipoprotein(a)
study on the no.253 lymph node metastasis patterns in left-sided colon and rectal cancer

Conditions: Colorectal Cancer; Lymph Node Metastasis

Summary: the goal of this observational study is to learn about the the pattern of metastasis of the no.253 lymph node in colorectal cancer. the main questions it aims to answer are: 1. what are the risk factors for metastasis to the no.253 lymph node? 2.what is the prognosis for patients with metastasis to the no.253 lymph node? patients with descending colon cancer, sigmoid colon cancer, and rectal cancer who undergo curative surgery with dissection of the no.253 lymph node are included in this study

the no. 253 lymph node (also named as apical lymph node of inferior mesenteric artery), as the third station in the inferior mesenteric artery lymphatic system, plays a vital role in the lymphatic circulation of the descending colon, sigmoid colon, and rectum. they serve as the last barrier for tumor metastasis from regional to distant sites. the definition of the range of the no.253 lymph node primarily follows the japanese colorectal cancer treatment guidelines: the medial boundary is the segment from the root of the inferior mesenteric artery to the origin of the left colic artery, the caudal boundary is from the origin of the left colic artery to the intersection with the inferior mesenteric vein, the lateral boundary is the outer margin of the inferior mesenteric vein, and the cranial boundary is from the horizontal section of the duodenum to the beginning of the jejunum. however, the pattern of metastasis of the no.253 lymph node in colorectal cancer remains unclear, with most studies being retrospective and showing significant differences in results. therefore, the investigator plans to be the first internationally to carry out this retrospective, registry-based study to determine the metastasis pattern to the no. 253 lymph node in colorectal cancer. this will provide definitive clinical evidence for d3 lymph node dissection in colorectal surgery.

Eligibility criteria:
inclusion criteria: 1. age: 18-75 years; 2. underwent laparoscopic left hemicolectomy, sigmoid colectomy, or rectal cancer radical surgery. 3. postoperative pathology confirmed as adenocarcinoma. 4. no evidence of distant metastasis. exclusion criteria: 1. previous history of malignant colorectal tumors. 2. patients who have undergone multiple abdominal-pelvic surgeries. 3. patients undergoing emergency surgery due to complications such as intestinal obstruction, intestinal perforation, or intestinal bleeding. 4. surgery did not achieve r0 resection. 5. patients with concurrent other malignant tumors or multiple primary colorectal cancers. 6. patients unwilling to sign an informed consent or follow the study protocol for follow-up.

Keywords: left-sided colorectal cancer lymph node dissection no.253 lymph node
clinical performance study of safety test abo device

Conditions: Transfusion Reaction

Summary: the study aims to confirm the performance equivalence of the in vitro diagnostic device safety test abo with the abtest card device.

according to the regulatory text "common specifications for certain class d in vitro diagnostic medical devices in accordance with regulation (eu) 2017/746 of the european parliament and of the council" \[2\], 90% of the results will be derived from the performance study carried out at the diagast laboratory on tube left over and blood bag, and 10% of the results will be derived from the use of the device in a real situation ("at the bedside"). regulation 2017/746 (ivdr) on ivdmd has been effective since may 2022 with transitional periods. the ivdr replaces the current eu directive (98/79/ec) to ensure a higher level of health and safety for the making available and putting into service of medical devices on the eu market. as the safety test abo and abtest card® are already ce marked under directive 98/79/ec as list iia product, this study is part of the device's post-marketing performance monitoring.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old for the category marked with \*. * undergo capillary blood sampling; * belong to one of the clinical category: * patient in need of blood transfusion without any pathology known to have an impact on transfusion act\*; * patient in need of blood transfusion suffering from congenital erythrocyte pathology (sickle cell anaemia, beta thalassemia)\* * patient in need of blood transfusion suffering from haematology disease (eg. cancer), or undergoing haemodialysis\*; * patient with cold agglutinin\*; * premature patient with gestational age \< 37 weeks of newborn ≤27 days old in need of blood transfusion; * newborn eligible for guthrie test; * newborn eligible for glycemic test. * have health care insurance; * have given his/her written consent (or legal representative in case of newborn); exclusion criteria: * pregnant woman; * person deprived of liberty; * unconscious person; * person under guardianship or trusteeship; * for neonatal clinical category: age ≥28 days and \<18 years old.
dialysis clinical outcomes revisited (dcor) trial

Conditions: Chronic Kidney Disease

Summary: this is a randomized, open-label, parallel-design study to be conducted at 75 centers within the united states. the study will be described to hemodialysis patients. informed consent will be obtained and the inclusion/exclusion criteria reviewed. eligible patients will be randomized to receive either renagel or a calcium-based binder. starting from the randomization date, mortality data including survival, death date and cause of death (vital status information) and morbidity data including hospitalization date will be recorded for all patients. these data will be collected until the end of the study (december 31, 2004, ± 2 weeks). patients completing or terminating from the study will return to the phosphate binder prescribed by their usual healthcare provider.


Eligibility criteria:
inclusion criteria: * patients must be 18 years of age or older, * on dialysis for more than 3 months, * require phosphate binder therapy, * have medicare as their primary insurance. exclusion criteria: * dysphagia, * swallowing disorders, * severe gastrointestinal motility disorders, * bowel obstruction.
myocardial stress perfusion imaging with dual source ct

Conditions: Coronary Artery Disease

Summary: the investigators propose a novel technique using dual source multidetector computed tomography (dsct) where information on both coronary anatomy and myocardial perfusion is obtained in a single scan. the investigators hypothesize that a coronary cta protocol can be devised to obtain resting myocardial perfusion, myocardial perfusion after stress, and coronary anatomy. hence, one diagnostic test will be able to detect the presence of coronary plaque as well as assess the functional significance of a stenosis.


Eligibility criteria:
inclusion criteria: * a prior adenosine or exercise stress spect exam with high likelihood of being referred to the cardiac catheterization laboratory for invasive angiogram * age \> 40 years old * able to comprehend and sign the consent form. exclusion criteria: * acute coronary syndromes (unstable angina, non-st elevation myocardial infarction, st elevation myocardial infarction) * unstable clinical conditions (i.e. hemodynamic instability, arrhythmias) * premenopausal women who have a positive pregnancy test. * serum creatinine level ≥1.5 mg/dl as an indicator of renal insufficiency. * known allergy to iodinated contrast agents * atrial fibrillation * asthma * critical aortic stenosis * systolic blood pressure \< 90 mmhg * advanced heart block

Keywords: coronary artery disease multidetector computed tomography myocardial perfusion imaging
hip prosthesis components position

Conditions: Hip Arthrosis

Summary: the purpose of the study is


Eligibility criteria:
inclusion criteria: * indication for hip replacement surgery exclusion criteria: * pregnancy * abnormal anatomy (hip dysplasia, fracture) * previous srgery

Keywords: hip prosthesis center of rotation offset
the female health dietary intervention study

Conditions: Polycystic Ovary Syndrome; Morbid Obesity

Summary: this study has two phases: 1. in phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of pcos, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared. 2. in phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.

weight loss is an important and effective treatment of morbidly obese women with pcos. effective weight reduction will improve manifestations of pcos and risk factors for developing type 2 diabetes and coronary heart diseases. we compare the effect of two isocaloric low calorie diets (lcd), - one powder-based shake-diet and a fiber rich diet on the above mentioned parameters. in addition we want to compare the weight-maintenance effect the next 44 weeks of two different follow-up programs: a usual care- and a lifestyle-program.

Eligibility criteria:
inclusion criteria: * woman (european caucasian) * pcos * bmi = or \> 35 exclusion criteria: * cushing syndrome * adrenal hyperplasia * androgen-producing tumors * anovulation caused by hyperprolactinemia * pregnancy, breast feeding * use of oral contraceptives/hormone treatment/insulin-sensitizing agents

Keywords: polycystic ovary syndrome morbid obesity type 2 dm coronary heart disease