Kornimate/medical-research-clean huggingface dataset:
improved factor viii inhibitor evaluation

Conditions: Hemophilia; Hemophilia A

Summary: commercial one and two-stage factor viii assays may not detect some clinically significant inhibitor antibodies. the purpose of the proposed study is to standardize and validate a platelet-based factor viii activity assay with greater sensitivity to clinically important inhibitory antibodies. investigators will evaluate the platelet-dependent inhibitory activity vs. conventional inhibitory activity in stored patient plasmas and correlate to bleeding histories

factor viii activity assays are used to diagnose hemophilia a, to monitor treatment of these patients, to determine when inhibitory antibodies against factor viii have developed, and to evaluate the activity of engineered pharmaceutical factor viii products. factor viii activity has been measured with one and two-stage assays for more than fifty years. however, all existing assays have major shortcomings that are recognized by the fda, the international society for thrombosis and haemostasis, and pharmaceutical companies. the major deficiencies that have been identified are: 1) factor viii activity levels do not predict the risk of bleeding in patients with inhibitory antibodies. the degree of inhibition in these assays is less than required to explain patient bleeding. 2) the assays are only accurate over a range of 1 - 100% of normal factor viii activity, while values of 0.1 - 1% are also clinically important. 3) the different approved assays give discrepant values for recombinant pharmaceutical factor viii products, with a range of 2-fold difference between assays. this can lead to clinically important differences in dosing of factor viii products from one region to another with corresponding risk of thrombosis or bleeding. the preliminary data identify an additional deficiency of commercial assays that has not been anticipated. commercial one and two-stage assays may not detect some clinically significant inhibitor antibodies. thus, the purpose of the proposed studies is to standardize and validate a platelet-based factor viii activity assay with greater sensitivity to clinically important inhibitory antibodies.

Eligibility criteria:
inclusion criteria: * hemophilia a * presence of inhibitory antibodies exclusion criteria: * none

Keywords: factor viii inhibitor assay
muscle insulin resistance in aging (mirage)

Conditions: Insulin Resistance; Sarcopenia

Summary: the purpose of this study is to provide information regarding potential factors underlying metabolic dysfunction, insulin resistance, and loss of muscle mass in aging muscle.

study objectives: 1. to determine the effects of diet-induced weight loss with and without the addition of exercise on mitochondrial biogenesis and energetic capacity, cellular redox state and insulin resistance. 2. to determine the effects of diet-induced weight loss with and without the addition of exercise on intramyocellular lipid profiles. 3. to determine the effects of diet-induced weight loss with and without exercise on skeletal muscle proteins mediating a program of autophagy and either loss or maintenance of muscle mass.

Eligibility criteria:
inclusion criteria: * 65-80 years of age * stable weight (no gain/loss of \>10 lbs in 6 months) * sedentary (≤ 1 continuous exercise/week) * non-smoker * bmi ≥ 30 kg/m2 * resting blood pressure ≤ 150 millimeters of mercury systolic and ≤ 95 millimeters of mercury diastolic * note from primary care physician/cardiologist for exercise clearance if positive stress test symptoms were observed from exercise test * must be willing to washout for 14 days from all diabetes medication and independent in self blood glucose monitoring during the washout periods (those with diabetes only) exclusion criteria: * clinically significant cardiovascular disease including history of myocardial infarction, within the past year * peripheral vascular disease * hepatic, renal, muscular/neuromuscular, or active hematologic/oncologic disease * clinically diminished pulse * presence of bruits in lower extremities * previous history of pulmonary emboli * peripheral neuropathy

Keywords: insulin resistance muscle health education exercise
pre-esrd syndrome in high risk african americans

Conditions: Blood Pressure

Summary: evaluation of the dipping status of blood pressure (wether blood pressure decreases at night) and renal functional reserve and wether non-dippers (those whose blood pressure does not decrease at night) can be modulated to dippers with potassium treatment.

evaluation of the dipping status of blood pressure (wether blood pressure decreases at night) and renal functional reserve and wether non-dippers (those whose blood pressure does not decrease at night) can be modulated to dippers with potassium treatment.

Eligibility criteria:
inclusion criteria: 18-35, healthy volunteers, african american exclusion criteria: active medical conditions, prescription drug therapy other than birth control
evaluation of pathwork tissue of origin (too) test for human malignancies

Conditions: Neoplasm Metastasis

Summary: the pathworks tissue of origin test is a microarray-based test with the goal of identifying the tissue of origin in patients with metastatic tumors of unknown primary site.


Eligibility criteria:
inclusion criteria:1 subjects must be at least 18 years old. the too test is designed to determine the tissue of origin of common adult malignancies. there are no gender/ethnic restrictions. 2 patients with a diagnosis of malignancy established by pathologic review of h\&e staining of tumor biopsy or tumor resection without definitive determination of tissue of origin as assessed by the pi. samples must have been obtained within three months of enrollment, or the patient must still be under active evaluation for tissue of origin at the time of enrollment. there are no limitations on prior therapy and time from last prior therapy. 3 ability to understand and the willingness to sign a written informed consent document. exclusion criteria:1 patients under the age of 18 are excluded. there are no exclusions based on gender/ethnicity. 2 there are no exclusion requirements due to co-morbid disease or incurrent illness, as needed. 3 pregnancy or nursing participants will not be excluded from the study. 4 patients with a diagnosis of leukemia including acute myelogenous leukemia, acute lymphocytic leukemia, hairy cell leukemia, chronic myelogenous leukemia and chronic lymphocytic leukemia are excluded from enrollment on this study. the too test does not cover these diagnoses.
acceptability and user perceptions of artificial intelligence-based mobile applications adoption for weight management: a sequential explanatory study

Conditions: Weight Management

Summary: to understand the user perceptions of ai and non-ai-based mobile apps for weight management in people with overweight and obesity.


Eligibility criteria:
inclusion criteria: * participants will be recruited if they are above 21 years old, have a bmi ≥23kg/m2 and understand english language. exclusion criteria: * there will be no exclusion criteria to maximize representation of the general population of singaporean who are overweight and obese.
impact of ramadan on achieving joint national committee (jnc) 7 treatment goals in cv risk patients

Conditions: Hypertension

Summary: this is an out-patient based prospective, multi-centre, observational post-marketing surveillance study amongst internists and cardiologists. in this study, patients with essential hypertension and at least one additional risk factor will be included. patients may take any antihypertensive treatment which is approved for cardiovascular protection including micardis 80 mg / micardis plus. patients will be followed over one year in four visits from baseline to endpoint with an additional visit before and after the month of ramadan.

purpose:

Eligibility criteria:
inclusion criteria: 1. male or female of age 18 years or older; 2. newly diagnosed and untreated or previously treated and uncontrolled patients with essential hypertension; 3. seated blood pressure of \>140/90 mmhg or \>130/80 mmhg in patients with diabetes mellitus or chronic kidney disease; 4. patients with at least one cardiovascular (cv) risk factor; 5. ability to provide written informed consent. exclusion criteria: 1. patients with contraindications to the prescribed antihypertensive medications; 2. pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception; 3. patients who are participating in any other study protocol.
an assessment of 4 different bearing types in hip replacement types to analsye the lowest wear rates of polyethylene

Conditions: Arthroplasty Complications; Hip Arthritis

Summary: the aim of the study is to assess the ideal bearing surfaces in hip replacement by comparing 4 different combinations. in a hip replacement this means what the head and the socket liner are made of.

in hip replacements, arguably the most important thing for survivorship is what rubs against what. traditionally surgeons used metal (cobalt-chrome) against a conventional polyethylene (plastic). more recently (around 15 years ago) a newer more dense type of polyethylene (called xlpe) had been developed and a new type of head called oxidized zirconium was also developed. in this trial, adults who were undergoing hip replacements were randomized assigned into one of the four groups: group 1: old plastic vs metal head group 2: old plastic against oxidized zirconium group 3: new plastic versus metal head group 4 new plastic vs oxidized zirconium all patients were followed up for a minimum of 10 years to assess which group wore the most amount of polyethylene and which group had the best survival rate.

Eligibility criteria:
inclusion criteria: * all adults with no history of cancer, infection of the hip and with the capacity to make informed consent for the trial exclusion criteria: * those under the age of 18 and over 65. those with a history of cancer and infection. those without the capacity to make an informed consent.

Keywords: hip arthroplasty tribology wear
depression and art adherence in hiv+ latinos

Conditions: Depressive Symptoms; HIV Infections

Summary: the current hiv treatment adherence project was designed to adapt culturally and then pilot test an empirically supported cognitive-behavioral therapy program for adherence and symptoms of depression (cbt-ad)with hiv+ latinos living on the u.s.-mexico border.

additionally, the investigators will assess the feasibility and efficacy of a novel medication monitoring and reminder system (medsignals®) in the form of an electronic pillbox with monitoring and reminding functions that is available in a spanish-language version. our hypotheses are grounded in a conceptual model proposing that the cbt-ad intervention will improve problem-solving ability and decrease depressive symptomatology, which will directly improve biomedical outcomes of hiv-1 rna viral load and cd4 as well as indirectly improve biomedical outcomes through increased motivation, improved memory, and better medication adherence. evaluating and implementing generalizable and sustainable mental health and adherence interventions such as the ones proposed are urgently needed in the region to improve hiv treatment outcomes and thwart the development and transmission of drug resistant virus.

Eligibility criteria:
inclusion criteria: * hiv+ participants (a) currently receiving hiv care at la fe care center (study site); * 18 years of age or older; * latino (i.e., self-identified as being of mexican heritage); * english- or spanish-speaking * capable of giving informed consent; * currently on a prescribed antiretroviral regimen; * suboptimally adherent (i.e., demonstrated either by a vl load taken in the last 12 months that is above the undetectable threshold of 50 ml copies or self-reporting a missed dose in the last two weeks); * exhibiting some depressive symptomatology (i.e., scoring on the beck depression inventory-1a 10 or above), and (i) male or female (including transgender female-to-male and male-to-female. exclusion criteria: * actively psychotic or so cognitively impaired that they cannot participate, * so physically ill as to be unable to come to the clinic to participate in the intervention, or * report the use of crack, cocaine, heroin, or methamphetamines to any extent in the past 40 days. * those who are planning on being away from the area for any extended period during the study (as in the case of seasonal workers) or whom * have household members already enrolled in the study will also be excluded. we did choose to restrict study eligibility to individuals of mexican descent.

Keywords: depression latinos adherence cognitive-behavioral therapy hiv/aids
effect of glycemic variability on autonomic tone in hospitalized patients with type 2 diabetes

Conditions: Type 2 Diabetes; Inpatient

Summary: glycemic variability has been associated with mortality in hospitalized patients with hyperglycemia. however, it is unknown how modulation of glycemic variability would impact outcomes. one possibility is that glycemic variability could impact autonomic tone. in particular, heart rate variability (hrv) measurement is a sensitive marker for measuring autonomic tone, and aberrations in hrv have been associated with mortality. the current randomized pilot study will compare the effects of continuous intravenous (iv) insulin and subcutaneous basal bolus insulin on glycemic variability and autonomic tone in hospitalized non-critically ill patients with diabetes. non-critically ill patients who are hyperglycemic or are requiring at least 20 units of insulin per day will be included. patients with conditions that preclude accurate hrv readings (such as atrial fibrillation or paced rhythms) will be excluded. patients randomized to intravenous insulin will receive the therapy for 24 hours according to our standard hospital guideline. patients randomized to subcutaneous (sq) insulin will receive basal bolus therapy using insulin analogues. all therapies will begin between 8 and 10 am. patients will undergo repeated heart rate variability recordings during the 24 hour period. blood draws will be collected at baseline and at 24 hours for measurement of catecholamines, insulin, and c-peptide. glycemic variability will be measured using a continuous subcutaneous glucose monitor and reported as coefficient of variation. the primary outcome measure is low frequency-to-high frequency power spectrum ratio of heart rate variability. 1. glycemic variability is associated with unfavorable changes in autonomic tone, as assessed by low frequency (lf)/high frequency (hf) hrv ratio, independent of changes in overall glycemia. 2. short-term increases in glycemic variability, followed by more prolonged glycemic stability are observed in generalized hospitalized patients treated with intravenous insulin compared to standardized basal bolus therapy. lf/hf hrv differs among subjects receiving intravenous compared to subcutaneous insulin. 3. glycemic variability differs among subjects receiving intravenous compared to subcutaneous insulin


Eligibility criteria:
inclusion criteria: * age 18 and above * admitted to a general medicine or medicine subspecialty service * insulin use (\>20 units/day) or hyperglycemia. hyperglycemia is defined as glucose greater than 180 mg/dl on at least 2 occasions separated by at least 4 hours apart. exclusion criteria: * type 1 diabetes * hospital stay expected less than 48 hours * inability to consent * pregnancy * prisoners * previous participation * autonomic neuropathy * conditions that preclude accurate heart rate variability monitoring: atrial fibrillation, frequent ectopy, congestive heart failure, paced heart rhythms * conditions which require lower dose insulin algorithms: end stage renal or liver disease

Keywords: hospital diabetes glycemic variability autonomic tone
efficacy and safety study of iron sucrose and oral iron acetyl-transferrin hydroglycerin

Conditions: Iron Deficiency Anemia

Summary: multi-center, prospective, randomized, open-labeled, active-drug-controlled, two-parallel-group-comparison(venoferrun group vs bolgre group)study


Eligibility criteria:
inclusion criteria: * 30\~32nd weeks pregnant women aged over 18 years * women who have hb level of more than 10.0g/dl a week before study initiation * patients who agree to participate in this study in writing exclusion criteria: * patients who have participated in another clinical study in recent 3 months * patients who are prone to acute hemorrhage during pregnancy * patients who have shown intolerance to iron therapy * hemolytic anemia, hemoglobinopathies (thalassemia, sickle cell) * bleeding tendency, hypersplenism * chronic heart failure, class ii-iv heart disease, uncontrolled arterial hypertension (dbp ≥ 115mmhg), deep vein thrombosis, thrombocytosis, chronic renal disease * severe renal failure patients (2.5 times or more higher plasma creatinine level than high limit of normal state) * patients with severe liver dysfunction (2.5 times or more higher ast or alt than high limit of normal state) * patients with doubled or more ck level than high limit of normal state * patients who are regarded as ineligible for this study by investigator

Keywords: iron deficiency anemia pregnant women with iron deficiency anemia
neuroprotective role of erythropoietin in perinatal asphyxia

Conditions: Perinatal Asphyxia

Summary: whether erythropoietin improves the neurological outcomes of neonates with perinatal asphyxia.

will be a randomized trial

Eligibility criteria:
inclusion criteria: * babies with severe perinatal asphyxia with moderate to severe hie in the immediate neonatal period exclusion criteria: * babies with congenital malformations * small for gestational age babies * babies with chromosomal anomalies

Keywords: perinatal asphyxia erythropoietin
a study comparing gb241 and rituximab in patients with b-cell non-hodgkin's lymphoma

Conditions: B-Cell Lymphoma

Summary: the purpose of this study is the area under the curve (auc) for gb241 and rituximab concentrations.


Eligibility criteria:
inclusion criteria: * having histologically confirmed nhl expressing cd20 antigen * having obtained cr (complete remission) or cru (uncertain complete remission) after the prior therapy * signed an informed consent form which was approved by the institutional review board of the respective medical center * aged from 18 to 75 years * ecog performance status of 0 to 1 * expected survival of at least ≥ 3 months exclusion criteria: * had received rituximab or other anti-cd20(+) monoclonal antibody treatment within 1 year before enrollment * having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or have not recovered from significant toxicities of prior therapy * participating in other clinical trial within 30 days before enrolment * with serious hematologic dysfunction (white blood cell count of \ 1.5×uln; aspartate amino transferase (ast) and alanine amino transferase (alt) levels of \>2.5 × uln; renal dysfunction (serum creatinine level of \> 1.5×uln ); and international normalized ratio (inr) and partial thromboplastin time or activated partial thromboplastin time (aptt) \> 1.5 × uln (unless on therapeutic coagulation) * had received live vaccine within 4 weeks prior to study entry * with other malignancies ; or central nervous system (cns) lymphoma, aids-related lymphoma; or active opportunistic infection, a serious nonmalignant disease * seropositive for hcv antibody, or hiv antibody, or hepatitis b virus surface antigen (hbsag). hbc antibody seropositive, but hbv dna and hbsag negative patients may participle following consultation with a hepatitis expert regarding monitoring and use of hbv antiviral therapy, and provided they agree to receive treatment as indicated * recent major surgery (within 28 days prior to study entry ) * with a history of allergic reaction or protein product allergy including murine proteins * pregnant or lactating or not accepted birth control methods including male patients * patients considered unsuitable by pi * previous malignant tumor except cured cervical cancer,basal cell carcinoma and squamous cell skin cancer * active opportunistic infections and other serious non neoplastic diseases

Keywords: gb241 rituximab b-cell lymphoma
bone ultrasonic scanner (buss): validation study

Conditions: Osteoporosis; Osteopenia

Summary: the aim of clinical study is to assess effectiveness of bone ultrasonic scanner (buss) versus densitometry (dxa) in osteoporosis detection.

study will conduct measurements in a group of postmenopausal women and use their dxa examination data as a control. buss data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by dxa measurements.

Eligibility criteria:
inclusion criteria: * postmenopausal * age 50-90 years * any race or ethnicity * dxa spine and hip exam within one year exclusion criteria: * open wounds or rashes on the testing area * active skin infection * recent tibia surgery * abnormal tibia anatomy * body mass index \> 34.9 kg/m2 * current or previous tibial fracture on side of testing * stroke or with total or partial paralysis with residual disability lasting more than 3 months current or recent (within past 6 months) use of bone-active drugs: * bisphosphonates * calcitonin * estrogens or selective estrogen receptor modulator (serm) * therapeutic doses of fluoride (\> 2mg/day) * teriparatide used currently or within past 3 months * drugs under research protocols, and * unstudied or unapproved drugs * presence of metabolic bone disease

Keywords: osteoporosis ultrasound sonometer dxa
pharmacokinetics and safety/tolerability after oral administration of ckd-387 and d635 under fed condition

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of the clinical trail is to evaluate the pharmacokinetics and safety/tolerability after oral administration of ckd-387 and d635 under fed condition in healthy adults.


Eligibility criteria:
inclusion criteria: 1. healthy adults aged 19 to 55 years 2. females must be menopause or surgical infertility 3. signed informed consent form 4. other inclusion criteria, as defined in the protocol exclusion criteria: 1. history of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder 2. clinical laboratory test values are outside the accepted normal range at screening * aspartate aminotransferase(ast), alanine aminotransferase(alt) \> 1.25 times the upper limit of the normal range * total bilirubin \> 1.5 times the upper limit of the normal range * creatine phosphokinase(cpk) \> 1.5 times the upper limit of the normal range * estimated glomerular filtration rate(egfr, mdrd\* formula) \< 60 ml/min/1.73m2 (\*mdrd: modification of diet in renal disease) * positive reaction on following tests: hepatitis b, hepatitis c, human immunodeficiency virus(hiv) and syphilis * systolic blood pressure(sbp) ≥ 150 mmhg or \ 100 mmhg or \< 50 mmhg 3. subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization 4. participated in a clinical trial within 90 days prior to 1st ip dosing 5. not eligible to participate for the study at the discretion of investigator 6. other exclusive inclusion criteria, as defined in the protocol