Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of yangxin shengmai granules for the treatment of stable angina pectoris

Conditions: Coronary Heart Disease; Stable Angina

Summary: this study is a randomized, double-blind, placebo-controlled, parallel clinical trial in chinese population with stable angina pectoris. the purpose is to determine the efficacy and safety of yangxin shengmai granules in the treatment of stable angina pectoris.

yangxin shengmai granules is a chinese patent medicine composed of ginseng, ophiopogon japonicus, salvia miltiorrhiza, schisandra chinensis, etc. it is used for the treatment of chest pain caused by qi-yin deficiency and blood stasis in traditional chinese medicine. the symptoms include chest tightness, chest pain, palpitation, shortness of breath, fatigue, dry mouth and dry throat. clinical applications suggested that yangxin shengmai granules were safe and effective in the treatment of coronary heart disease. however, high-quality clinical trials are still needed to further confirm, so as to provide theoretical basis for the treatment of stable angina pectoris with traditional chinese medicine. the study is designed to determine the efficacy and safety of yangxin shengmai granules in the treatment of stable angina pectoris.

Eligibility criteria:
inclusion criteria: * participants are aged between 40 and 75 years. * meet the diagnostic criteria of stable angina pectoris. * meet chinese medicine syndrome differentiation of qi-yin deficiency and blood stasis syndrome. * voluntarily participate and sign informed consent. exclusion criteria: * patients were diagnosed as acute myocardial infarction, unstable angina, stable exertion angina and other heart diseases. * patients with poor control of hypertension and diabetes, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), with a history of heart pacemaker or cerebrovascular disease within one year. * any of the following disease history or evidence was found in the screening period: severe cardiovascular or cerebrovascular diseases; active, recurrent peptic ulcer or other bleeding risk diseases; other serious diseases of digestive system; combined with malignant tumor, blood system disease, serious or progressive diseases of the other system; combined with mental diseases. * before screening, any laboratory inspection index meets the following standards: the results showed that glutamic aspartate transaminase (ast) or alanine aminotransferase (alt) were more than 1.5 times of the upper limit of normal value and serum creatinine (cr) was more than 1.2 times of the upper limit of normal value. * with a history of alcohol and drug abuse. * pregnant or lactating women. * patients who have participated in clinical trials of other drugs within 3 months before enrollment.

Keywords: yangxinshengmai granules stable angina pectoris coronary heart disease randomized controlled trial
mri based biomarkers in pediatric autoimmune liver disease

Conditions: Autoimmune Liver Disease; Primary Sclerosing Cholangitis; Autoimmune Hepatitis

Summary: autoimmune liver diseases (aild), which include primary sclerosing cholangitis (psc) and autoimmune hepatitis (aih) are a common etiological factors for chronic liver disease among adolescents. in all these conditions, autoimmune lymphocyte responses are thought to orchestrate inflammatory injury against hepatocytes (primarily in aih) or cholangiocytes (in psc). in this proposal we aim to evaluate the magnetic resonance imaging (mri) modalities; mr cholangiopancreatography (mrcp) and mr elastography (mrel), as non-invasive biomarkers to assess two primary pathophysiological processes of aild: bile duct damage and liver fibrosis. in this cross-sectional study mri based findings of bile duct injury and liver fibrosis will be correlated with both liver histology and circulating biomarkers of these disease processes.


Eligibility criteria:
inclusion criteria: 1. age 6-23 years old. 2. established or suspected clinical diagnosis of aih or psc. exclusion criteria: 1. history of liver transplantation. 2. chronic hepatitis b or untreated hepatitis c virus infection. 3. pregnancy. 4. absolute contraindication for mri (e.g. pacemaker, metallic implants, claustrophobia). 5. diagnosis of cystic fibrosis or biliary atresia 6. diagnosis of cardiac hepatopathy. 7. diagnosis of wilson's disease, alpha-1 antitrypsin deficiency, or glycogen storage disease. 8. skin conditions which could be aggravated by mrel (i.e. epidermolysis bullosa).
performance of currently available transcatheter aortic valve platforms in inoperable patients with pure aortic regurgitation of a native valve. the pantheon international project.

Conditions: Aortic Regurgitation

Summary: * to investigate the performance of currently available thvs in terms of safety and efficacy * to evaluate potential predictors of thv embolization or migration (tvem) * to assess the impact of tvem on prognosis


Eligibility criteria:
inclusion criteria: * severe aortic regurgitation * prohibitive surgical risk exclusion criteria: * surgical candidates
buprenorphine and naloxone for the treatment of opiate dependence - 1

Conditions: Heroin Dependence; Substance-Related Disorders

Summary: the purpose of this study is the use of buprenorphine/naloxone in treatment of opioid dependence.

the objective of this study is to determine the safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment.

Eligibility criteria:
inclusion criteria: dsm-iv diagnosis of current opiate dependence males and non-pregnant, non-nursing female 18-59 yrs of age exclusion criteria: any significant medical condition ast or alt levels greater than 3x's the upper limit of normal level current axis i diagnosis other than opiate, caffeine or nicotine dependence

Keywords: opioid dependence
study of the effectiveness of vestibular stimulation as a coadjuvant treatment in major depression

Conditions: Depression; Major Depression; Vestibular Disorders

Summary: major depression is characterized by vestibular anomalies. the investigators hypothesized that vestibular stimulation will improve depression symptoms in major depression patients.


Eligibility criteria:
inclusion criteria: * major depression patients, * actual hamilton score \> 14 exclusion criteria: * pregnant, * neurological disorders, * epilepsy, * bipolar disorder, * schizophrenia, * anorexia, * bulimia.

Keywords: depression vestibular
next generation sequencing in intrahepatic cholangiocarcinoma

Conditions: Intrahepatic Cholangiocarcinoma

Summary: the aim of the present study is to perform a comprehensive molecular characterization of intrahepatic cholangiocarcinoma (icc) in patients exposed to well-known or putative risk factors (such as asbestos) for this malignancy, in order to identify possible "molecular signatures" associated to such different risk factors.

exposure to distinct risk factors of the enrolled icc patients will be assessed by modified renam questionnaire. molecular characterization of icc tissue samples will be carried out by rnaseq. briefly, after surgical resection tissue samples will be immediately suspended in rnalater. rnaseq analysis will be performed on the illumina hiscansq platform. any possible mutations identified by rnaseq will be validated by sanger sequencing. putative identified fusion transcripts will be confirmed by rt-pcr, using specific primers pairs located on the sequences from the exons of the two putative fusion genes. variations in gene expression will be validated by the real-time pcr. the bioinformatic analysis will be made by using centos5 server. for evaluation of asbestos fibers in tumor tissues, samples embedded in paraffin will be incinerated and then analyzed in a scanning electron microscope and by eds spectroscopy.

Eligibility criteria:
inclusion criteria: * patients having a confirmed diagnosis of icc resected; * patients who have signed the informed consent; * patients (males or females) who are at least 18 years old. exclusion criteria: * patients who have been treated with any medical treatment (chemotherapy or experimental standard) or with radiotherapy during the last 5 years.

Keywords: intrahepatic cholangiocarcinoma rnaseq risk factors asbestos
electrocardiograph changes and holter abnormalities in children with predialytic chronic kidney disease

Conditions: Predialytic Chronic Kidney Disease

Summary: ckd is a strong risk factor for cardiovascular disease and mortality , as in adults, cardiovascular disease occurs in some children with ckd before they reach esrd as well as after

this work aims to study the electrophysiological changes in cardiovascular system in children with predialytic ckd. ecg is important in detection of cardiac rhythm abnormalities, cardiac conduction defects and detection of myocardial ischemia

Eligibility criteria:
inclusion criteria: age 1 to 15 year children with predialytic chronic kidney disease gfr.\>15 ml\\min per 1.73m2 , stages 1, 2, 3, 4 according to (kdoqi stages). exclusion criteria: * age \>15 year on regular dialysis gfr\<15 ml\\min per 1.73m2, stage 5 according to (kdoqi stages). children with known cardiovascular disease or known arrhythmia patients on the potential medication affecting ecg result as b-blocker, antipsychotics , antidepressant

Keywords: chronic kidney disease
influence of vasculary inflammation on development of diabetes

Conditions: Coronary Artery Disease(CAD)

Summary: the purpose of this study is to investigate if patients with coronary heart disease have higher risk to develop diabetes mellitus among the following two years. the examination of biomarkers taken from blood and fat issue shall provide which factors could be responsible for development of diabetes mellitus.


Eligibility criteria:
inclusion criteria: * all patients with mi * signed informed consent * older than 18 years * ability to give informed consent exclusion criteria: * absence of legal competence
safety of overnight corneal reshaping lenses

Conditions: Keratitis; Myopia

Summary: this retrospective chart review study compares the incidence of corneal inflammation due to infection in children vs. adult patients wearing overnight corneal reshaping lenses.


Eligibility criteria:
inclusion criteria: * patients completing at least 3 months of wearing corneal reshaping lenses exclusion criteria: * less than 3 months of wearing corneal reshaping lenses

Keywords: contact lens infection cornea
mindfulness-based stress reduction for urban youth

Conditions: Stress, Psychological

Summary: our uncontrolled study of mindfulness-based stress reduction (mbsr) for urban youth suggests benefits in mental health and quality of life outcomes. to evaluate further the specific effects of mbsr, we are conducting a small randomized controlled trial of the mbsr program compared with a health education program.

a randomized controlled trial will be conducted at two urban clinic sites. hiv-positive youth between the ages of 14 and 22 will be recruited and randomized into either an eight-week (with one retreat session) mindfulness-based stress reduction (mbsr) course (intervention) or an eight-week (with one retreat session) healthy topics (ht) course (active control). measures of psychological functioning, coping, and life satisfaction will take place at baseline, immediately post-program, and 3-months post program. medical data, including cluster of differentiation 4 (cd4) and viral load counts, will also be collected at the three data collection time points.

Eligibility criteria:
inclusion criteria: * 14-22 year old youth who receive primary care at the harriet lane clinic or children's hospital of philadelphia. exclusion criteria: * significant developmental, behavioral, substance abuse, or psychiatric disorders

Keywords: mindfulness meditation urban youth stress reduction adolescent stress reduction for urban youth
utility of induced sputum using hypertonic saline to evaluate infection and inflammation in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the objective of the study is to evaluate the clinical utility and the feasibility, in an outpatient setting, of sputum induction using hypertonic saline. this study will also study pilot techniques on a sub using a sub-sample to assess the lower airway inflammatory cells and markers in relation to new emerging organisms in cystic fibrosis (cf) and antibiotic therapy in cf.

chronic airway infection, mainly by staphylococcus aureus (sa) and pseudomonas aeruginosa (pa), is a major cause of morbidity and mortality in patients with cystic fibrosis (cf). isolation of organisms from the respiratory tract is important to optimize treatment. the current recommended methods for bacterial evaluation are bronchoalveolar lavage (bal) and expectorated sputum (es) analysis. however, a significant proportion of young cf patients cannot produce sputum spontaneously. the method used most frequently therefore is to isolate respiratory organisms is to perform throat swabs (ts) which have poor sensitivity and specificity in the evaluation of respiratory pathogens in cf patients. induced sputum (is) using hypertonic saline has been used in a limited number of studies to evaluate respiratory organisms in cf patients. these studies have reported that is may be a useful non-invasive diagnostic test to increase the yield of detection of respiratory pathogens. beside its use as a diagnostic test to identify bacterial pathogens induced sputum has been used to assess lower airway inflammation in cf. while numerous studies have clarified the role of s. aureus and p. aeruginosa in cf lung disease, the role of other emerging bacteria such as stenotrophomonas maltophilia (sm) and achromobacter xylosoxidans (ax) species remains largely unclear. is offers the potential to possibly differentiate between colonisation and infection for the emerging pathogens and to help clarify their role in cf lung disease.

Eligibility criteria:
inclusion criteria: 1. children diagnosed with cf (by sweat chloride ≥60 and/or genetic testing) 2. children ages between 6-18 years 3. ability to perform pulmonary function tests 4. fev1 ≥ 30% predicted18. additional inclusion criteria for sub-sample undergoing antibiotic therapy: 1. above criteria 2. admitted to hospital for i.v. antibiotic therapy exclusion criteria: 1. acute respiratory distress or hypoxia (oxygen saturation \<92% at room air) 2. new onset of wheezing 3. previous history of intolerance of inhalation of hs

Keywords: pediatrics cystic fibrosis hypertonic saline induced sputum expectorated sputum
lymph node identification using magtrace and magseed before chemotherapy

Conditions: Breast Cancer

Summary: magnetic tracer injected before preoperative chemotherapy in breast cancer patients for sentinel lymph node detection. also, magnetic tracer in combination with magnetic clip for index node identification.

this is an interventional single arm study. the aim is to see if sentinel lymph nodes marked with a magnetic tracer injected before preoperative chemotherapy can be detected at surgery three to six moths later. the investigators also want to see if they can find the same nodes with a tracer injected before chemotherapy as with a tracer injected after chemotherapy. the hypothesis is that the chemotherapy might affect the lymph drainage and the nodes marked before the chemotherapy are the true sentinel lymph nodes. furthermore, in patients with known lymph node metastases before chemotherapy one metastasis is marked with a magnetic clip before the chemotherapy. this is a well known method but it has not been done in combination with the magnetic tracer. we will show that this is feasible. all patients included in the study will receive their treatments according to the current standard national guidelines as both the magnetic tracer and the routinely used radioactive tracer are used in parallel. the magnetic clip is also used at several sites in sweden today.

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older. * patients with breast cancer planned to undergo nact with * planned sentinel lymph node dissection (slnd), or * targeted axillary lymph node dissection (tad), in conjunction with the * breast surgery after nact. exclusion criteria: * intolerance / hypersensitivity to iron or dextran compounds or spio. * patients who are required to undergo mri to evaluate tumour response. * pregnancy or breast feedin.g * patients with an iron overload disease. * patient deprived of liberty or under guardianship. * inability to understand given information and give informed consent or undergo study procedure

Keywords: sentinel lymph node detection neoadjuvant chemotherapy
biomarker study for sunitinib and docetaxel in prostate cancer

Conditions: Hormone Refractory Prostate Cancer

Summary: docetaxel and sunitinib will be compared to docetaxel for their effect on cec/cep spikes induced by docetaxel in hrpc patients

docetaxel (75mg/m2 q21d) is standard of care for patients with hormone refractory prostate cancer (hrpc). recent data indicate, that chemotherapeutics given at mtd induce, besides their cytotoxic effects, mobilization of circulating endothelial cells (cec) and - progenitors (cep) in drug-free breaks of each cycle. in preclinical models, mobilized cec/cep result in tumor vasculogenesis and progression of disease. we hypothesize that treatment with sunitinib, an anti-angiogenic tyrosine kinase inhibitor, in between 3 weekly docetaxel disrupts cec/cep spikes following docetaxel leading to chemosensitization and reduced tumor re-growth in hrpc patients responding to docetaxel.

Eligibility criteria:
inclusion criteria: * who performance status of 0-2. * histologically proven prostate adenocarcinoma. * all patients must have prostate adenocarcinoma that is unresponsive or refractory to androgen ablation with biochemical progression * measurable and/or evaluable progressive disease, which is defined by one of the following three criteria: * 25% increase in bidimensionally measurable soft tissue metastases * appearance of new metastatic lesions (proven by ct scan, x-ray or bone scan) * psa level of at least 10ng/ml, with increases on at least 2 successive occasions at least 2 weeks apart * if the patient has been treated with antiandrogens, treatment must have been stopped at least 6 weeks prior to study randomization exclusion criteria: - prior chemotherapy for prostate cancer
assessment of age-related hearing loss in hiv-1 patients

Conditions: HIV Seropositivity

Summary: the ageing process is known to be accelerated in hiv-infected patients, compared to the general population. normal age-related hearing loss (presbyacusia) is a frequent phenomenon, affecting more than 70% of people above 65 years. it is believed to be mostly the consequence of a mitochondrial damage caused by oxidative stress. risk factors for accelerated age-related hearing loss are present in many hiv-infected patients : chronic inflammation, smoking, diabetes, etc. the global aim is to measure the prevalence of presbyacusia in a well controlled hiv positive population in france, and to compare it to hiv negative controls matched for age and sex. 90 hiv positive patients and 90 age- and sex- matched hiv negative controls will undergo a screening for presbyacusia (pure-tone, speech and evoked-response audiometry). we expect to find an increased prevalence of presbyacusia in hiv-infected patients, as compared to controls matched for age and sex.


Eligibility criteria:
inclusion criteria: * age 40 years and more * hiv-1 infection known since 10 years and more * undetectable plasmatic hiv-1 viral load thanks to antiretroviral therapy (any regimen) for at least 5 years * cd4 lymphocytes count above 350 * condition of cerebral small vessel disease detected recently with mri exclusion criteria: * personal history of otologic pathology or otologic surgery * family history of hearing impairment * personal history of bacterial meningitis * personal history of neurological disease * personal history of treatment with ototoxic drugs * personal history of treatment with chemotherapy * use of illegal drugs (except cannabis or poppers) * alcoholism * diabetes complicated by retinopathy and/or by glomerular filtration rate \ 300 mg) * uncontrolled high blood pressure (who criteria) * mri contraindication * known pregnancy or breastfeeding woman * no medical insurance coverage

Keywords: hiv seropositivity audiometry hearing loss
evaluation of the fluidvision accommodating intraocular lens (aiol) with an improved injector system

Conditions: Aphakia

Summary: the purpose of this study is to evaluate the clinical outcomes of an investigational iol in patients undergoing cataract extraction and intraocular lens implantation using an improved injector system.


Eligibility criteria:
key inclusion criteria: * eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction; * best corrected distance visual acuity worse than 20/40 either with or without a glare source present (e.g. brightness acuity tester); * less than or equal to 1.0 diopter (d) of preoperative keratometric astigmatism; * willing and able to comply with schedule for follow-up visits for 36 months after surgery. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * systemic disease that could increase the operative risk or confound the outcome (e.g. autoimmune disease, diabetes); * taking systemic medications that may confound the outcome or increase the risk to the subject; * ocular conditions that may predispose for future complications; * previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject; * pregnant, lactating during the course of the investigation, or with another condition associated with fluctuation of hormones that could lead to refractive changes; * diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future best corrected visual acuity loss worse than 20/40. * other protocol-defined exclusion criteria may apply.

Keywords: cataract
ocular imaging study using advanced oct

Conditions: Retinal Vascular Disorder; Macular Degeneration

Summary: the purpose of this study is to evaluate this angioscan angiography software on patients with various retinal vascular disorders. the advanced oct instrument is an fda approved clinically used camera, but the angioscan angiography software is not fda approved. investigators would like to know if this imaging device and software can improve the quality of images and visualization of imaged tissues and whether they are useful in the diagnosis and treatment of eye diseases. images collected in this study may be compared to other images collected as part of standard of care on the same patient (oct, fa, af, fundus).


Eligibility criteria:
inclusion criteria: • any patient with abnormal retinal findings as determined by investigators. exclusion criteria: * those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging. * participants who are unable to maintain retinal fixation on a specified target. * participants unable to achieve sufficient pupil dilation and alignment stability for imaging to take place. * patients with media opacity which preclude high quality imaging.