Kornimate/medical-research-clean huggingface dataset:
the longitudinal conquer study of rare neuroimmunologic disorders

Conditions: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder; Transverse Myelitis; Optic Neuritis

Summary: this study seeks to determine the biologic causes of inflammation in patients with transverse myelitis (tm) neuromyelitis optica spectrum disorder (nmosd) and related conditions. while patients will be treated according to decisions with their treating physician, this study will collect data and samples from patients prospectively to gain a better understanding of the disease. we are seeking to understand why some patients respond to medications, while others do not. we also seek to understand what happens biologically, preceding relapses. gathering these data and samples will allow researchers to identify new ways of diagnosing and treating these diseases. data and samples will be shared with researchers around the world to support collaborative efforts to treat these conditions.

this study seeks to determine the biologic causes of inflammation in patients with neuromyelitis optica (nmo), transverse myelitis (tm), optic neuritis (on), related conditions and healthy controls. while patients will be treated according to decisions with their treating physician, this study will collect data and samples from patients prospectively to gain a better understanding of the disease. we are seeking to understand why some patients respond to medications, while others do not. we also seek to understand what happens biologically, preceding relapses. gathering these data and samples will allow researchers to identify new ways of diagnosing and treating these diseases. data and samples will be shared with researchers around the world to support collaborative efforts to treat these conditions. patients will agree to share medical records, complete questionnaires and donate samples on a timed basis.

Eligibility criteria:
inclusion criteria: * age 6 years or greater * male or female * patient or parent (in the case of a minor) able to give informed consent * for patients 10 to 17, patient able to assent * patient diagnosed with nmo, nmosd, tm or on exclusion criteria: * unable to maintain scheduled visits * patient has known hiv or hepatitis c infection

Keywords: neuromyelitis optica neuromyelitis optica spectrum disorder transverse myelitis optic neuritis biorepository
intraabdominal hypertension after kidney transplantation

Conditions: Intraabdominal Hypertension; Kidney Transplantation

Summary: intraabdominal hypertension (iah) is a frequent and severe condition affecting intensive care patients. gold standard for estimation of intraabdominal pressure is intravesical pressure (ivp) measurement. ivp measurement is recommended in patients presenting iah risk factor(s). acute kidney injury is the most frequent and described complication of iah condition. patients undergoing kidney transplantation have several risk factors to develop iah. nevertheless, to our knowledge, iah incidence, associated factors and impact on renal function recovery remains unknown. we aim to study iah incidence, associated factors and impact on renal function recovery in post kidney transplantation period.

intraabdominal hypertension (iah) is a frequent and severe condition affecting 30 to 54% of intensive care patients. gold standard for estimation of intraabdominal pressure is intravesical pressure (ivp) measurement. iah is defined by ivp elevation above 12mmhg. ivp measurement is recommended in patients presenting iah risk factor(s). acute kidney injury (aki)is the most frequent and described complication of iah condition. iah related aki traduces renal hypoperfusion and its severity seems to correlate with ivp levels. patients undergoing kidney transplantation have several risk factors to develop iah : abdominal wall surgery, acidosis and hypervolemic resuscitation. nevertheless, to our knowledge, iah incidence, associated factors and impact on renal function recovery remains unknown. we aim to study iah incidence in post kidney transplantation period. thus, we want to identify associated factors with iah development in this context. we also aim to correlate ivp early evolution with extra-cellular hydration status evolution. finally, impact of iah on renal function recovery will be investigated. presupposing that 50 kidney transplantations per year will take place in university hospital of reims (france), we attend to include about 100 patients in this study. with a prevalence of at least 30% of iah prevalence (as reported in intensive care units cohorts), enrollment of 100 patients will permit to estimate iah prevalence with a 9% precision (with a 95%ic).

Eligibility criteria:
inclusion criteria: * end stage chronic kidney disease ; * hospitalized in intensive care of nephrology unit in university hospital of reims (france) during study period ; * undergoing kidney transplantation ; * accepting to participate. exclusion criteria: * minor ; * protected by the law.

Keywords: intraabdominal hypertension kidney transplantation
phase iii randomized, double-blind, placebo-controlled study of oral topiramate for lennox-gastaut syndrome

Conditions: Lennox-Gastaut Syndrome

Summary: objectives: i. evaluate the safety and efficacy of oral topiramate in patients with lennox-gastaut syndrome.

protocol outline: this is a randomized, double-blind study. following a 28-day baseline period, patients are randomly assigned to oral topiramate or placebo. the dose of study medication is titrated over the first 3 weeks; the maintenance dose is administered for the next 5 weeks. extended topiramate treatment is available to all patients after randomized therapy.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- lennox-gastaut syndrome slow spike and wave pattern on electroencephalogram at least 60 seizures with atypical absence and drop attacks within 1 month seizure types allowed in addition to those above: tonic tonic-clonic myoclonic minor motor absence of progressive lesion confirmed by computerized tomography or magnetic resonance imaging no change documented by physical exam subsequent to imaging no generalized status epilepticus within 3 months while complying with drug therapy no seizures resulting from progressive disease, e.g.: active infection neoplasm metabolic disorder no anoxic episode requiring resuscitation within 1 year --prior/concurrent therapy-- 1 or 2 concurrent maintenance antiepileptics required at least 6 months since corticotropin at least 60 days since acetazolamide or zonisamide at least 60 days since investigational drug or device no ketogenic diet --patient characteristics-- hematopoietic: no hematological abnormality within 2 years hepatic: no hepatic disease within 2 years renal: no nephrolithiasis no other renal disease within 2 years cardiovascular: no clinically significant electrocardiographic abnormality no cardiovascular disease within 2 years pulmonary: no respiratory disease within 2 years other: weight at least 25 lb (11.5 kg) no medical disease within 2 years, e.g.: rheumatic fever gastrointestinal abnormality malignancy no psychiatric or mood disorder inconsistent with lennox-gastaut within 6 months requiring any of the following: electroconvulsive therapy antidepressants anxiolytics antipsychotics lithium carbonate no history of alcohol or drug abuse no history of poor compliance on past antiepileptic therapy able to take medication and maintain seizure calendar (assistance allowed) adequate parental supervision 1 parent/guardian with adequate english fluency if english not patient's primary language the following required of fertile women: negative serum-beta pregnancy test immediately prior to entry normal menstrual flow for 3 months prior to entry medically acceptable form of contraception during study

Keywords: lennox-gastaut syndrome epilepsy neurologic and psychiatric disorders rare disease seizures
a clinical study to evaluate the safety and efficacy of the combination of aliskiren and amlodipine in hypertensive non responders patients

Conditions: Hypertension

Summary: to evaluate the blood pressure lowering effect and safety of aliskiren 150 mg used in combination with amlodipine 5 mg in patients with essential hypertension not adequately responsive to amlodipine 5 mg.


Eligibility criteria:
inclusion criteria * patients with essential hypertension * patients who are eligible and able to participate in the study exclusion criteria * severe hypertension * history or evidence of a secondary form of hypertension * history of hypertensive encephalopathy or cerebrovascular accident. other protocol-defined exclusion criteria may apply.

Keywords: hypertension, aliskiren, blood pressure, amlodipine
clinical, histological and in-depth molecular characterization as well as experimental models of liver metastasis from patients with breast cancer in order to identify new potential treatment avenues.

Conditions: Breast Cancer; Liver Metastases

Summary: the goal of this observational study is to learn about breast cancer liver metastasis in patients who met the following criteria: * female; * be ≥ 18 years of age on the day of signing informed consent; * confirmed diagnosis of breast cancer liver metastases. newly diagnosed patients with de-novo liver metastases are eligible; * be planned for liver surgery. the main questions it aims to answer are: 1. to characterize the tumour cells and their microenvironment in the liver metastases at the transcriptomic and protein single-cell level; 2. to determine the levels and patterns of immune infiltrates in liver metastases from bc patients; 3. to identify biological features associated with the histopathological growth patterns in liver metastases. 4. to create patient-derived xenografts (pdx) and organoids (pdo) from liver metastases isolated from patients with bc; 5. to perform a histopathological and molecular comparison of liver metastases, pdx and pdo isolated from the same patient participants will be willing and able to provide written informed consent for this study and tissue samples for research purposes.


Eligibility criteria:
inclusion criteria: * be willing and able to provide written informed consent for this study; * female; * be ≥ 18 years of age on the day of signing informed consent; * confirmed diagnosis of breast cancer liver metastases. newly diagnosed patients with de-novo liver metastases are eligible; * be planned for liver surgery; * be willing to provide tissue samples for research purposes. exclusion criteria: * unwillingness to provide the samples or clinical information needed for the study; * history of radiofrequency destruction (rf), stereotactic body radiotherapy (sbrt) or intra-arterial treatment such as chemoembolization (tace) or selective internal radiation therapy (sirt) performed on the metastasis to be examined (accepted if performed in other metastasis); * has an active autoimmune disease that has required systemic treatment in the past 2 years prior to the surgery (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; * presence of immunodeficiency or immune dysregulatory diseases and conditions which require active immune modulatory treatment of any kind, or required treatment in the past two years from date of diagnosis of breast cancer; * history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results in the opinion of the treating investigator.
high density lipoprotein subspecies and coronary disease

Conditions: Cardiovascular Diseases; Coronary Disease; Coronary Arteriosclerosis; Heart Diseases

Summary: to investigate the relative contributions of high density lipoprotein-c (hdl-c) subspecies to risk for coronary heart disease (chd) in two distinct existing populations (samples from the va-hit study and the framingham offspring study \[fos\]) as well as the response of these subfractions to gemfibrozil treatment.

background: coronary heart disease (chd) continues to be a leading cause of death and disability in the united states. information about the contribution of different subspecies of hdl-c to increased or decreased risk for premature chd and the extent to which common lipoprotein lipase (lpl) mutations affect hdl-c composition and subspecies could contribute to an increased understanding of the role of hdl-c in determining chd risk. design narrative: the following parameters will be measured in blood samples collected from the va-hit study and the framingham offspring study: apo a-i-containing hdl subspecies (prebeta, alpha, and prealpha) in plasma using two-dimensional gel electrophoresis immunoblot and image analysis, lpa-i and lpa-i/a-ii in plasma using differential electroimmunoassay, and apo c-iii in hdl using immunoturbidometric assay. the study hypotheses are as follow. a) subjects from the placebo arm of va-hit will have significantly lower alpha l hdl subspecies, lpa-i, and apo c-iii in hdl, and higher hdl/alpha l and apo a-i/alpha l ratios than subjects free of coronary heart disease from the framingham offspring study. b) these parameters will also predict prospectively risk of coronary heart disease in both groups. c) in the va-hit study, treatment with gemfibrozil, which has been shown to be associated with a 22 percent reduction in myocardial infarction and coronary heart disease death, will be associated with increases in alpha l hdl subspecies, lpa-i, and apo c-iii in hdl, as well as decreases in hdl/alpha l and apo a-i/alpha l ratios, compared to placebo. d) the hypothesis that subjects with specific mutations in the lipoprotein lipase gene have less beneficial changes in hdl subspecies with gemfibrozil than subjects with no mutations will also be tested.

Eligibility criteria:
va-hit: men, established chd, hdl-c\<40 mg/dl, ldl-c \< 140 mg/dl, tg \< 300 mg/dl fos: men having no evidence of chd
a registry study on shenqifuzheng（a chinese medicine injection）used in hospitals in china

Conditions: Gastric Carcinoma; Carcinoma of the Lungs

Summary: this study was advocated by institute of basic research in clinical medicine, china academy of chinese medical sciences in december 2012. it was funded by china major scientific and technological specialized project for 'significant new formulation of new drugs'. the purpose of this study is to make a cohort event monitoring to see whether and how shenqifuzheng injection in hospital results in adverse events or adverse drug reactions.

it is very common that chinese medicine injection used in hospitals in mainland china. however safety problems rose in recent years. there could be many uncertain factors influence chinese medicine injection in clinical practice. safety surveillance on chinese medicine injection is an important problem that needs to be sorted out through large sample observational study. a registry study for shenqifuzheng injection safety surveillance with 30000 patients will be conducted from jan.2013 to dec.2014. eligibility criteria patients who will use shenqifuzheng injection in selected hospitals

Eligibility criteria:
inclusion criteria: - patients using shenqifuzheng injection from 2013 to 2014 exclusion criteria: * none
dose escalation study of lee011 in combination with buparlisib and letrozole in hr+, her2-negative post-menopausal women with advanced breast cancer.

Conditions: Advanced or Metastatic Breast Cancer

Summary: this is a multi-center, open-label, non-randomized, phase i study


Eligibility criteria:
inclusion criteria: 1. women with advanced (recurrent or metastatic) breast cancer who received no prior therapy for advanced disease. 2. patient is postmenopausal. 3. patient may have received ≤ 2 lines of chemotherapy for metastatic or recurrent breast cancer in the dose-escalation phase. 4. patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory. 5. patient has her2-negative breast cancer defined as a negative in situ hybridization test or an ihc status of 0, 1+ or 2+. if ihc is 2+, a negative in situ hybridization (fish, cish, or sish) test is required by local laboratory testing. 6. patient must have either: * measurable disease, i.e., at least one measurable lesion as per recist 1.1 criteria or at least one predominantly lytic bone lesion exclusion criteria: 1. patient who received any cdk4/6 or pi3k inhibitor. 2. patient has active cardiac disease or a history of cardiac dysfunction including any of the following: * history of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry * history of documented congestive heart failure (new york heart association functional classification iii-iv) * documented cardiomyopathy * patient has a left ventricular ejection fraction (lvef) \< 50% as determined by multiple gated acquisition (muga) scan or echocardiogram (echo) * history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months. * on screening, any of the following cardiac parameters: bradycardia (heart rate \ 90 at rest), pr interval \> 220 msec, qrs interval \>109 msec, or qtcf \>450 msec. systolic blood pressure \>160 or \<90 mmhg 3. patient is currently receiving any of the following medications: * that are known strong inducers or inhibitors of cyp3a4. * that have a known risk to prolong the qt interval or induce torsades de pointes. * that have a narrow therapeutic window and are predominantly metabolized through cyp3a4. 4. certain scores on an anxiety and depression mood questionnaires

Keywords: lee011, buparlisib, letrozole, hr +, her2 - negative, post-menopausal, breast cancer, cdk 4/6, pi3k, mtd
etoposide plus cisplatin in treating patients with recurrent ependymomas

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy in treating patients with recurrent ependymomas following radiation therapy.

objectives: i. assess the efficacy and toxicity of etoposide and cisplatin in patients with recurrent ependymomas. outline: all patients receive cisplatin followed by etoposide on days 1-3. treatment repeats every 4 weeks for a total of 6 courses unless disease progression or unacceptable toxicity intervenes. the etoposide dose may be increased by 10% on subsequent courses if the white blood cell and platelet nadirs on the previous course are at least 3,000 and 100,000, respectively. patients are followed every 2 months for 6 months, then every 3 months for 4.5 years. projected accrual: a total of 35 patients will be entered over approximately 7 years if there are 3-8 responses in the first 13 patients and 7-9 responses in the first 25 patients.

Eligibility criteria:
disease characteristics: histologically confirmed ependymoma that is recurrent after radiotherapy histologic confirmation of recurrence encouraged but not required in patients with pure ependymoma at diagnosis and unequivocal radiologic evidence of recurrence histologic confirmation of recurrence required in patients with mixed histology at diagnosis ependymoma at least 80% of histology no subependymoma measurable or evaluable disease on imaging exam patient characteristics: age: 18 and over performance status: ecog 0-3 hematopoietic: wbc at least 3,500 platelets at least 130,000 hepatic: bilirubin no greater than 0.3 mg/dl above normal renal: creatinine no greater than 0.3 mg/dl above normal cardiovascular: no nyha class iii/iv status other: no uncontrolled infection no pregnant or nursing women negative pregnancy test required of fertile women effective contraception required of fertile patients prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior cisplatin or etoposide at least 4 weeks since chemotherapy (6 weeks since nitrosoureas) endocrine therapy: steroid dose stable for at least 1 week prior to entry if indicator lesion in cns radiotherapy: see disease characteristics at least 4 weeks since radiotherapy surgery: not specified

Keywords: recurrent adult brain tumor adult myxopapillary ependymoma adult anaplastic ependymoma
xelox for metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: both capecitabine and oxaliplatin have single agent activity in breast cancer. the combination has improved activity in other solid tumors. this study seeks to assess the activity of the combination in breast cancer.


Eligibility criteria:
inclusion criteria: * preserved organ function * good performance status * no more than one prior therapy * no active brain metastasis exclusion criteria: * no prior capecitabine or oxaliplatin * no con-current therapy
the pharmacokinetics and pharmacodynamics between hr011408 and novorapid® in healthy subject

Conditions: Diabetes

Summary: the objective of the study is to compare the pharmacokinetics and pharmacodynamics between hr011408 and novorapid® in healthy subject.


Eligibility criteria:
inclusion criteria: 1. informed consent obtained prior to any trial-related activities； 2. male or female subjects aged 18-55 years (both inclusive) at the time of signing informed consent； 3. body weight ≥50.0 kg for men and ≥45.0 kg for women, with body mass index (bmi) between 18.0 and 26.0 kg/m2 (both ends included)； 4. are nonsmokers, have not smoked for at least 6 months before entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or not use smokeless tobacco or nicotine products for the duration of the study. exclusion criteria: 1. have an abnormality in the 12-lead electrocardiogram (ecg) and as deemed to be clinically significant by the investigator; 2. have a significant history of the circulatory system, respiratory system, digestive system, urinary system, hematopoietic system, endocrine and metabolic system, neuropsychiatric system, musculoskeletal system, or existing diseases in the above systems may affect the safety of the subjects and interfere with the study data. 3. in the opinion of the investigator, are unsuitable for inclusion in the study.