Kornimate/medical-research-clean huggingface dataset:
neurovascular determinants of cognitive function in adults with sickle cell disease

Conditions: Sickle Cell Disease

Summary: cognitive impairment is a poorly understood, serious, and emerging complication for adult patients with sickle cell disease. because there is extensive microvascular damage from oxidative damage in sickle cell disease, the investigators hypothesize that this is also present in the cerebral microvasculature to cause cognitive impairment. the investigators plan to test this by correlating markers of inflammation and oxidative damage with cognitive performance and 7 tesla brain mri microvascular findings in these patients, with the long term goal of understanding the mechanisms and risk factors of cognitive impairment in sickle cell disease.

the neurovascular determinants of cognitive function in adults with sickle cell disease is a study for adults 18 and older who have been diagnosed with sickle cell disease (scd). many adult patients with scd suffer from cognitive impairment (ci), a serious complication responsible for severe functional limitations, and whose pathogenesis, risk factors, and natural history are unknown. this research project will look at cognitive performance and 7 tesla brain mri findings along with markers of inflammation and oxidation to better understand the mechanism and risk factors. the investigators will complete a baseline assessment. scd participants will be seen for follow-up at 3 and 5 years. non-scd participants will be seen for follow-up at 3 years. all assessments are completed at no cost and there is compensation for participation.

Eligibility criteria:
inclusion criteria: 1. age 18 and above 2. able to provide informed consent for non-scd : 1. between age 18 and 55 2. able to provide informed consent 3. are age, race, and gender matched to a sickle cell disease study subject. exclusion criteria: 1. age less than 18 years 2. current pregnancy or lactation 3. any medical condition that may result in neurocognitive or brain dysfunction that is not secondary to scd including: 1. diabetes mellitus 2. coronary artery disease 3. peripheral vascular disease 4. other causes of cerebral vasculitis such as systemic lupus erythematosus (sle) 4. any contraindication to mri scanning including: 1. history of claustrophobia 2. presence of metallic implants such as cardiac pacemaker or implantable defibrillator, surgical aneurysm clips, or any implanted device (e.g. insulin pump, drug infusion device) 3. any known metal fragments embedded in the body (eg: ear implant) 4. neural stimulator (e.g. transcutaneous electrical nerve stimulation unit) 5. metal in the eye (e.g. from machining) 6. any metallic foreign body, shrapnel, or bullet 7. inability to lie still for 30 minutes or more 5. inability to provide direct consent 6. in a current medical or pain crisis as diagnosed by attending physician -
management of elevated cholesterol in the primary prevention group of adult japanese(mega study)

Conditions: Hyperlipidemia

Summary: to evaluate the primary preventive effect of low-dose pravastatin against coronary heart disease (chd) in japanese hypercholesterolemic patients.

mega study is the first prospective, randomized, controlled trial conducted in japan to evaluate the primary preventive effect of pravastatin against chd in daily clinical practice. because the dose of pravastatin used in the mega study was 10-20 mg/day, which is consistent with the approved doses in japan and lower than the doses used in previous large-scale clinical trials.

Eligibility criteria:
inclusion criteria: * tc:220～270mg/dl * male: 40-70 years old/ female: postmenopausal-70 years old * \<40kg in weight exclusion criteria: * fh * history of chd(angina, mi, post-ptca/cabg, etc.) * history of cva(stroke, tia, etc.) * underlying malignant tumor

Keywords: hyperlipidemia coronary heart disease prevention stroke pravastatin
codepad (collaborative outcomes of depression and pain associated with delivery)

Conditions: Depression, Postpartum; Analgesia, Obstetrical; Anesthesia, Obstetrical

Summary: postnatal depression affects about 10-15% of women after childbirth. approximately 3-5% of women experience a moderate-to-severe depression that requires medical attention. this study aims to investigate the implication of pain relief choice in reducing the postnatal depression of women who deliver their babies.

if the patients have not decided on which pain relief method to be used, and would like to take part in this study, they will be assigned to either epidural or non-epidural pain relief for labour based on the study randomization result. blood samples will be drawn to study the presence of known functional polymorphisms in candidate genes associated with depression, pain, stress and anxiety. patients will be followed up with study questionnaires related to pain and postnatal depression screening during the study. for some of the patients, a discrete choice experiment (dce) on pain relief choice will be conducted, and their preferences on epidural analgesia will be asked. during any time of the labour period, the patient is allowed to switch the pain relief option upon request.

Eligibility criteria:
inclusion criteria: * healthy adult (american society of anesthesiologists physical status 1 and 2) parturients at term (36 weeks gestation or more) (nulliparous and multiparous); * with a singleton fetus. exclusion criteria: * multiple pregnancies; * non-cephalic fetal presentation; * obstetric complications (e.g. pre-eclampsia, uncontrolled hypertension, uncontrolled diabetes); * elective and urgent caesarean section (not from delivery suite).

Keywords: anesthesia, obstetrical epidural anesthesia postnatal depression persistent pain
the effects of frailty on chronic kidney disease

Conditions: Sarcopenia; Chronic Kidney Disease

Summary: frailty is a syndrome characterized by decreased reserve and diminished resistance to stressors. the proposed research will evaluate the association of frailty with chronic kidney disease (ckd). the prevalence of frailty increases with age and with ckd, but studies are needed to determine whether frailty is associated with worsening of ckd and whether intervention to treat frailty can improve physical functioning and health-related quality of life (hrqol) as well as slow progression of ckd.

the intervention is a 6-month prospective interventional pilot study targeted to each domain of frailty. subjects will be screened into the study by testing each domain; only those who meet criteria for frailty will be included in the study. the clinical intervention, which all subjects will receive, will begin immediately upon enrollment and completion of baseline measurements. upon enrollment the 3 most recent previous outpatient serum creatinine measurements (up to 1 year) will be used to determine baseline slope of estimated glomerular filtration rate (egfr). the main objectives of the pilot study will be to gain knowledge in the successful implementation and completion of an intervention targeted toward frailty. ultimately information ascertained from this pilot will serve as a springboard for planning of a randomized trial aimed at addressing all the domains of frailty, which is key given that previous studies have only implemented interventions aimed at a single domain or in pairs, but no studies have evaluated the extent to which frailty can be reversed through a cohesive intervention addressing all domains together. the intervention outlined in this proposal is comprehensive and focused while maintaining feasibility.

Eligibility criteria:
inclusion criteria: * chronic kidney disease stage iii to iv * receiving care at the san francisco veterans affairs medical center * able to consent in english exclusion criteria: * early chronic kidney disease * individuals with acute kidney injury * non-ambulatory
a safety study of ly2886721 single doses in healthy subjects

Conditions: Alzheimer's Disease

Summary: this is a phase 1 study in healthy subjects to evaluate the safety and tolerability of ly2886721 single doses, how the body handles the drug, and the drug's effect on the body.

this is a phase 1 study with 2 parts, both in healthy subjects. part 1 is a subject- and investigator-blind, placebo-controlled, randomized, 3-period, crossover study. part 1 will assess the safety and tolerability of ly2886721 single doses, how the body handles the drug, and the drug's effect on the body. part 2 is a subject- and investigator-blind, placebo-controlled, randomized study to assess the safety and tolerability of an ly2886721 single dose, how the body handles the drug, and the drug's effect on the body including in cerebrospinal fluid.

Eligibility criteria:
inclusion criteria: * healthy men and nonchild-bearing potential women * 20 years or older * body mass index between 18-32 kilograms per square meter (kg/m\^2) exclusion criteria: * taking over-the-counter or prescription medication with the exception of vitamins or minerals or stable doses of thyroid or estrogen hormone replacement * smoke more than 10 cigarettes per day
open label sumanirole study of safety, tolerability, and therapeutic response in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: the primary objective is to assess the long term safety and tolerability of sumanirole as measured by safety labs, ecg monitoring, vital signs, and adverse event reports in subjects with parkinson's disease who participated in previous sumanirole studies.


Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease * modified hoehn and yahr scale stages 1-4 * age over 30 years * previous participation in prior sumanirole studies exclusion criteria: * use of dopamine agonist medications and other medications in defined timeframe * unstable dose of cns active therapies (eg, hypnotics, antidepressants, anxiolytics) within the last 30 days * atypical parkinson's syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases * dementia * history of active epilepsy within the past year * significant liver disease with defined laboratory criteria * significant renal disease with defined laboratory criteria * certain cardiac conditions * electroconvulsive therapy in the previous 90 days * subjects participating in other drug studies or receiving other investigational drugs within previous 30 days * positive pregnancy test at screen * unwillingness to use adequate contraceptive methods * lactating women * history of stereotaxic brain surgery * malignant melanoma or history of treated melanoma
vivid - valvular and ventricular improvement via icoapsys delivery - feasibility study

Conditions: Mitral Valve Regurgitation; Left Ventricular Dysfunction; Heart Failure; Mitral Insufficiency; Mitral Incompetence; Ischemic Heart Disease

Summary: the purpose of this prospective, non-randomized, single-arm feasibility study is to evaluate safety and feasibility of the icoapsys system in patients with functional mitral valve insufficiency caused by annular dilation and/or papillary muscle displacement.

functional mr is a frequent outcome of ischemic heart disease or dilated cardiomyopathy. patients with functional mr generally have normal valvular structures complicated by left ventricular dysfunction. left ventricular dysfunction will often create geometric distortions that prevent complete leaflet coaptation, rendering the valve incompetent. changes that will induce functional mr may include (i) dyskinetic or akinetic wall segments, (ii) dilation of the valve annulus or (iii) dilation of the left ventricle leading to tethering of the chordae tendinae. the icoapsys device is intended to treat patients with functional mr. the device is not indicated for patients with diseased or damaged valvular structures caused by rheumatic fever, degenerative diseases, endocarditis, infiltrative diseases or congenital disorders.

Eligibility criteria:
key inclusion criteria: * grade 3 or 4 functional mitral valve regurgitation per 2d echocardiography. * nyha class ii and lvef greater than or equal to 25% or nyha class iii and lvef greater than or equal to 30% key exclusion criteria: * history of pericarditis. * creatinine \> 2.2 at the time of the procedure * inr \> 1.8 at the time of the procedure * prior pericardial intervention (including cabg, pericardiotomy or pericardiocentesis). * any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure (e.g., stent placement). * any planned therapeutic interventional or surgical procedure planned within 30 days following the index procedure * open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis). * structural abnormality of the mitral valve * valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring intervention. * pericardial effusion \>5 mm via echocardiography. * posterior wall end-diastolic dimension \>1.3 cm. * left ventricular end diastolic diameter \> 7.0 cm.

Keywords: functional mitral regurgitation (fmr) ischemic mitral regurgitation less invasive repair percutaneous mv repair mitral valve repair heart failure left ventricular dysfunction
intra-articular injections of platelet-rich plasma, hyaluronic acid, or corticosteroids for knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: to assess if there are any differences among platelet-rich plasma, hyaluronic acid, and corticosteroid knee intra-articular injection regarding function and pain.


Eligibility criteria:
inclusion criteria: * patient aged 35-65 years old * patient with knee pain that had been continuing for at least 12 months with no relief using anti-inﬂammatory medications and that deteriorated with weight-bearing * knee osteoarthritis that classified as mild-moderate or moderate-severe (kellgren-lawrence grade 2, 3, or 4) exclusion criteria: * age \> 65 years * the recent history of knee trauma * autoimmune rheumatic diseases * accompanying severe hip oa * thrombocytopenia or other blood diseases * immunosuppressive or anticoagulant treatment * the invasive procedure applied to the knee * intra-articular steroid injection to the knee within the previous 12 months * previous joint infection * uncontrolled systemic diseases such as diabetes or hypertension, and cancer * excessive varus/valgus knee deformity
clinical safety and preliminary efficacy of aav-dc-ctl treatment in stage iv gastric cancer

Conditions: Stage IV Gastric Cancer

Summary: the purpose of this study is to evaluate the clinical safety and preliminary efficacy of antigen-specific cytotoxic t lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with cea gene in the treatment of stage iv gastric cancer patients.


Eligibility criteria:
inclusion criteria: * sex: male or female * age: from 18 to 80 years * histology: gastric cancer * clinical stage: stage iv * karnofsky performance status: more than 50% * expected survival: more than 2 months * sex: male or female * laboratory tests results 7 days before the start of treatment: * white blood cells: more than 3.0 × 109/l * platelets: more than 100 × 109/l * neutrophils: more than 1.5 × 109/l * hemoglobin: more than 80g/l * serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (uln) * serum glutamic-oxal (o) acetic transaminase: less than 2.5 × uln * serum bilirubin: less than 1.25 × uln * serum creatinine: less than 1.25 × uln * pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment * contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study * informed consent: subject must have the ability to understand and voluntarily sign a written informed consent exclusion criteria: * history of neoplasms: other neoplasms * medical history: mental disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy * metastasis: clinical symptoms of brain metastasis * other clinical trial: the subject received other clinical trial before this study * laboratory tests: the serum test of human immunodeficiency virus, or hepatitis b virus, or hepatitis c virus was positive * woman: pregnant or lactating women * compliance: poor compliance
spectral diagnosis of cutaneous malignancy

Conditions: Skin Cancer

Summary: the goal of this clinical research study is to evaluate the use of an imaging technology called spectral diagnosis. researchers want to find out if a special spectral-diagnosis probe can be used to detect skin cancers.

the spectral-diagnosis probe being used in this study uses dim pulses of light to identify features of tissue that may be related to the status of skin cancer. the probe is shaped like a catheter, and it has a camera on the end, which takes pictures of the skin. if you agree to take part in this study, you will be asked questions about your age, race, smoking status, and the status of any diseases you may have (such as diabetes, connective tissue disease, and infectious disease). it should take about 5 minutes to answer these questions. the study doctor will then decide which of your lesions are suitable for imaging by the probe. if necessary, any hair on or around the lesion(s) will be shaved or trimmed. the area(s) of skin being imaged will be cleaned with rubbing alcohol. as part of your exam, the study doctor will use the probe to measure the selected areas of tissue. to perform the spectral-diagnosis measurement, the probe will be gently placed on the surface of your skin. each selected area of your skin will take about a few seconds to image. the probe will shine different types of light onto the skin, and it will collect the light that reflects from the skin surface. the light signals will be stored so that researchers can look at them. preparing the lesion, imaging it, and collecting the light signals should take about 10-15 minutes per lesion. after all of the imaging is over, you will have biopsies performed on the lesions that your study doctor has decided are in need of such treatment as part of your standard care. after this clinic visit, your participation in the study will be over. this is an investigational study. the imaging probe is not commercially available or fda approved. at this time, it is being used in research only. up to 150 patients will take part in this study. all will be enrolled at m. d. anderson.

Eligibility criteria:
inclusion criteria: 1. male or female and over 18 years of age. 2. patients undergoing an examination of their skin 3. patients with a lesion(s) in one of the five categories: basal cell carcinoma, squamous cell carcinoma, pre-cancer lesions, pigmented lesions, and benign lesions 4. patients whose lesion also warrants a biopsy. 5. signed informed consent document. exclusion criteria: 1. patients with absence of skin lesion(s) in one of the five categories. 2. patients whose identified lesion did not need a biopsy. 3. patients who did not sign the informed consent and agree to participate.

Keywords: basal cell carcinoma squamous cell carcinoma pre-cancer lesions pigmented lesions benign lesions skin cancer spectral diagnosis optical spectroscopy
diabetes treatment with glucobay in combination with sulfonylurea

Conditions: Type 2 Diabetes Mellitus

Summary: in this prospective, non interventional, observational post marketing survelliance study data are obtained on the efficacy, safety and tolerability of glucobay treatment on top of sulfonylurea under daily life treatment conditions.specifically investigated is the influence of glucobay on post prandial blood glucose and hba1c as well as on pateint's weight when added to an already existing sulfonylurea therapy.the study is planned to carried out in 25000 - 30000 patients from 200 trial sites in india.the post marketing survelliance study will be performed with commercially available medication prescribed within regular practice of the physician. no other examination will be performed than would be done without post marketing survelliance study.


Eligibility criteria:
inclusion criteria: * all patient with type 2 diabetes with one of the following treatment ongoing : 1) sulfonylurea 2) sulfonylurea + oha. in such patients, if investigator feels that addition of acarbose would be benficial for the patients exclusion criteria: * according to local product information

Keywords: diabetes mellitus type-2 acarbose drug therapy combination
sustained effect of urticaria remission with relatively high dose vitamin d supplementation after omalizumab discontinuation

Conditions: Urticaria

Summary: the proposed research is intended to determine if supplementation of relatively high dose vitamin d in chronic urticaria patients receiving omalizumab will result in continued symptomatic control of hives after the discontinuation of omalizumab.


Eligibility criteria:
inclusion criteria: * physician diagnosed chronic urticaria * currently be receiving omalizumab therapy for the treatment of chronic idiopathic urticaria and be well controlled with a uss \<25 exclusion criteria: * not capable of informed consent. * not capable of answering the questionnaire. * subjects with a pure physical urticaria. * pregnant or lactating women. * subjects with hypercalcemia (calcium \> 10.3 mg/dl) or renal insufficiency (gfr \<50 ml/min). * subjects with prior anaphylaxis to omalizumab. * currently taking high dose vitamin d supplementation. * prior high dose vitamin d supplementation for urticaria with failure. * baseline 25(oh)d \>80 ng/ml * subjects with sarcoidosis, hyperparathyroidism, histoplasmosis, lymphoma or tuberculosis

Keywords: hives
safety study of abt-263 in combination with paclitaxel in subjects with solid tumors

Conditions: Solid Tumors

Summary: safety study of abt-263 in combination with paclitaxel in subjects with solid tumors.

a phase 1 safety and pharmacokinetic study of abt-263 in combination with paclitaxel in the treatment of subjects with solid tumors.

Eligibility criteria:
inclusion criteria 1. subject must be greater than or equal to 18 years of age. 2. subject must have a histologically and/or cytologically documented cancer for which paclitaxel has been determined an appropriate therapy, per the investigator. 3. subjects with brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of cns disease progression as determined by ct or mri within 28 days prior to the first dose of study drug. 4. subject has an eastern cooperative oncology group (ecog) score of less than or equal to 1. 5. subject must have adequate bone marrow, renal and hepatic function per protocol defined local laboratory testing parameters. exclusion criteria 1. the subject has an underlying, predisposing condition of bleeding or currently exhibits signs of bleeding. the subject has a recent history of thrombocytopenia associated with bleeding within 1 year prior to first dose of study drug. 2. subject is currently receiving or requires anticoagulation therapy (e.g., warfarin at any dose) or any drugs or herbal supplements that affect platelet function, with the exception of low-dose anticoagulation medications such as heparin that are used to maintain the patency of a central intravenous catheter. 3. the subject has active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis. 4. the subject has active immune thrombocytopenic purpura (itp), autoimmune hemolytic anemia (aiha), or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug). 5. the subject has a significant history of cardiovascular (e.g., mi, thrombotic or thromboembolic event in the last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.

Keywords: paclitaxel solid tumors