Kornimate/medical-research-clean huggingface dataset:
a pilot study of personalized medicine for pediatric asthma

Conditions: Asthma

Summary: a pilot study to test the feasibility of a personalized asthma care intervention.

there are two arms in this study. the control arm of the trial will involve the current standard primary care asthma management, and the intervention arm will involve personalized asthma management. inclusion criteria include: 1) child age 6-17 years, 2) doctor diagnosed asthma, 3) at least one asthma exacerbation in the previous year. children with other coexistent pulmonary diseases such as chronic lung disease and cystic fibrosis will be excluded. the period of participation will be three months for each participant. after screening, each participant will have an initial clinic visit. during this baseline visit, the investigators will collect dna by taking a saliva sample, the investigators will conduct spirometry, and the investigators will survey the families regarding household level environmental exposures, demographics, and other key variables. the participant will be randomly assigned to a study arm at the end of the baseline visit. the data gathered at the baseline visit will be used to develop a management plan. the investigators will mail a plan to the participant and the primary care provider within a couple weeks of the baseline visit. the investigators will then discuss the plan with the participant via phone. both groups will receive a plan which may be used to guide asthma care. sample letters follow the protocol. the intervention group will receive basic information on the skin testing, genetic testing, and spirometry. the control group will not receive the genetic information. the control arm will receive the genetic information at the end of the study follow up. after the baseline visit, the participants will receive a monthly phone call for two months to conduct a survey to assess our study outcomes and covariates. at the 3rd month participants will return to the gcrc for a final clinic visit. during the final visit the investigators will conduct our survey and spirometry and request permission for medical record release.

Eligibility criteria:
inclusion criteria: * age 6-17 years * doctor diagnosed asthma -at least one asthma exacerbation in the previous year. - exclusion criteria: -children with other coexistent pulmonary diseases such as chronic lung disease and cystic fibrosis will be excluded.

Keywords: asthma child pediatric
ventricular shunt and drain infections - timing of reimplantation

Conditions: Ventricular Shunt Infection

Summary: the retrospective study will help determine whether or not placement of new devices prior to the recommended time was associated with a high risk of relapse or treatment failure.

the following information will be collected from the medical record retrospectively: demographic data (age, gender, ethnicity, height, weight), past medical history, laboratory results, microbiologic data, data on the patients' devices (type of device, data that it was placed, exchanged or removed), treatment and clinical and microbiological outcomes. this will all be collected retrospectively.

Eligibility criteria:
inclusion criteria: * patients that were cared for by the pi for the purpose of treating an infected ventricular shunt or drainage device for the central nervous system. exclusion criteria: * those patients records that do not meet entry criteria

Keywords: ventricular shunt
kidney function in diabetics during cpb (cardio pulmonary bypass)

Conditions: Diabetes Mellitus, Kidney, CPB

Summary: filtration of urine in the kidney requires sufficient oxygen supply. the filtration of urine is greater in patents with diabetes. our theory is that the diabetic kidney has a higher oxygen demand than the non diabetic kidney thereby making the diabetic kidney more sensitive to decreased oxygen delivery following reduced blood flow. with a catheter inserted into the kidney vein we will monitor the blood flow and oxygen saturation before and during cpb, in patient with diabetes.


Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus * serum creatinine \< 150 micromol/l preoperative * heart surgery requiring cpb * lv (left ventricle) ef \>40 % * normal hemoglobin exclusion criteria: -
effects of yangxinshi pills on the exercise tolerance of the patients with coronary heart disease

Conditions: Coronary Heart Disease

Summary: compared with conventional treatment of the coronary heart disease,the aim of the research is to find out if the addition of yangxinshi pills on the basis of conventional treatment can improve exercise tolerance of patients with coronary heart disease, improve quality of life or restore social function and mental health

90 outpatients with clear diagnosis of coronary heart diseases will be recruited in the trial and randomized into two group. one group are treated with yangxinshi pills (provided by qingdao growtful pharmaceutical co., ltd.) plus conventional medicine, the other group are treated with placebo plus conventional medicine. the primary end point is vo2max measured by cardiopulmonary exercise test after 3 months of treatment. the secondary endpoint is: 1. mets, anaerobic threshold（at）measured by cardiopulmonary exercise test； 2. changes of other composite indicators of treadmill exercise test or cardiopulmonary exercise test； 3. the maximum walking distance of 6-minute walk test; 4. changes of seattle angina questionnaire; 5. hamilton depression scale/ hamilton anxiety scale. the safety evaluation criteria is: 1. adverse event and serious adverse event; 2. vital signs; 3. resting 12 lead ecg; 4. blood routine examination , urine routine examination、liver and renal function examination(ast、alt、bun、cr).

Eligibility criteria:
inclusion criteria: * age 40 \~ 75, gender is not limited * have a clear history or ecg of hospital myocardial infarction , diagnosed as coronary heart disease by imaging diagnosis * sign the informed consent voluntarily exclusion criteria: * history of hospitalization for acute coronary syndrome in past 3 months * uncontrolled grade 3 hypertension（≥180/100mmhg）or hypotension（\<90/60mmhg） * history of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown type) or lower extremity arterial disease in the past 6 months * in past 6 months, have medical history of: pregnancy, prepare or suspected of pregnancy, abortion, breastfeeding or after childbirth * combined episode bronchial asthma or chronic obstructive pulmonary disease, bradycardia (resting heart rate \<60bpm) or atrioventricular block * severely allergic constitution, known or likely to be allergic to the test drug or its components * known bleeding tendency or hemorrhagic disease * patients with severe liver and kidney dysfunction (creatinine clearance ≤ 40ml / min or in the active stage of kidney disease, serum aminotransferase ≥ 2 × upper limit of clinical reference), other life-threatening serious primary or psychiatric diseases and malignant tumors * any other situations that researchers believe may affect the clinical research
antigenic and antibody detection of candida

Conditions: To Evaluate the Diagnostic Value of Candida Antigen Antibody Detection for Candida Infection

Summary: in this study, a multicenter, prospective, synchronous blind, and controlled study was adopted to set the cut-off values of candida specific igg, igm, and mn with the blood culture results as the gold standard, so as to evaluate the diagnostic value of candida specific igg, igm, and mn levels in candida infection. 1. the cut-off values of serum specific igg, igm and mn of candida sinensis infected population in china were established by comparing the positive results of blood culture of 300 healthy people and 100 patients with positive candida sinensis blood culture as the gold standard and using roc curve (roc curve). 2. 100 patients with positive tracheal aspiration culture and 100 patients with positive urine culture were enrolled. serum levels of candida specific igg, igm and mn were detected, and sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratio of candida specific igg, igm and mn in tracheal aspiration and urine were evaluated. 3. 200 high risk patients with candida infection were enrolled, and the aseptic fluid culture and the simultaneous detection of serum specific igg, igm and mn were adopted to explore the diagnostic value of the detection method. 4. positive candida culture in sputum and positive candida culture in tracheal aspirate were taken as the control group to compare the levels of igg, igm and mn in serum of the two groups, and to explore the diagnostic value of different sampling methods for candida pulmonary infection.


Eligibility criteria:
inclusion criteria:age: (1) 18-85 years old; (2) candida positive in aseptic humoral culture - exclusion criteria:(1) no informed consent has been signed; (2) patients with severe immune deficiency -
spray vs emla cream on pain during intra-articular injection

Conditions: Adhesive Capsulitis of the Shoulder

Summary: all participants are randomly allocated to the spray group, emla group and placebo group. in spray group, participants receive an application of placebo cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. after 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed from a distance of 30 cm for 5 seconds or until the skin was blanched, then intra-articular injection of shoulder is performed. immediately after injection, participants are asked to fill out the visual analog scale for injectional pain, five point likert scale for satisfaction about the topical anesthesia. in emla group, participants receive an emla cream and placebo spray. in placebo group, participants receive a placebo cream and placebo spray.

all participants are randomly allocated to the spray group, emla group and placebo group. in spray group, participants receive an application of placebo cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. after 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed using ethyl chloride spray (walter ritter gmbh and co., hamburg, germany) from a distance of 30 cm for 5 seconds or until the skin was blanched, then intra-articular injection of shoulder is performed. immediately after injection, participants are asked to fill out the visual analog scale for injectional pain, five point likert scale for satisfaction about the topical anesthesia. in emla group, participants receive an application of emla cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. after 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed using placebo spray (evain eau minerale naturelle, a pure water spray with hydrocarbon propellant), then intra-articular injection of shoulder is performed. immediately after injection, participants are asked to fill out the same scales. in placebo group, participants receive a placebo cream and placebo spray.

Eligibility criteria:
inclusion criteria: * who had a normative schedule of intra-articular injection of shoulder exclusion criteria: * those who refused to participate, those who were unable to understand a visual analog scale or a likert scale, those with a history of an allergic reaction to vapocoolant spray or lidocaine, those with a history of cold intolerance (eg, raynaud syndrome), those who took pain medications or had used topical anesthetics within the previous 24 hours, those with prior history of intra-articular injection of shoulder, those who exhibited an abnormal shoulder sensation on neurologic examination
fluorine f 18 fluorodopa-labeled pet scan in planning surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade malignant glioma

Conditions: Adult Anaplastic Astrocytoma; Adult Anaplastic Ependymoma; Adult Anaplastic Oligodendroglioma; Adult Brain Stem Glioma; Adult Diffuse Astrocytoma; Adult Ependymoma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Mixed Glioma; Adult Myxopapillary Ependymoma; Adult Oligodendroglioma; Adult Pilocytic Astrocytoma; Adult Pineal Gland Astrocytoma; Adult Subependymal Giant Cell Astrocytoma; Adult Subependymoma

Summary: rationale: new imaging procedures, such as fluorine f 18 fluorodopa-labeled pet scan, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment. purpose: this clinical trial studies fluorine f 18 fluorodopa-labeled pet scan in planning surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade malignant glioma

primary objectives: i. to determine correlation between 18f-fdopa pet activity, mri contrast enhancement, and high- or low-grade glioma biopsies. ii. to compare radiotherapy target volume delineation with and without 18f- fdopa-pet metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning. secondary objectives: i. to determine correlation between concordance of 18f-fdopa pet activity, mri contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival. outline: beginning at no more than 1 week before biopsy and resection, patients undergo fluorine f 18 fluorodopa-labeled pet/ct scan and pre-operative mri. patients then undergo stereotactic craniotomy. some patients may also undergo radiation therapy. after completion of study treatment, patients are followed up every year for 5 years.

Eligibility criteria:
inclusion criteria: * age ≥18 years. * mri findings compatible with newly diagnosed high- or low-grade malignant glioma * planned craniotomy and resection or biopsy * willing to sign release of information for any radiation and/or follow-up records * negative pregnancy test done =\< 48 hours of injection of study drug, for women of childbearing potential only * provide informed written consent * patients with egfr \< 60 mg/min/1.72m2 are eligible for the study; please note: the patient is not eligible to receive the contrast for the pmri at the study dose. exclusion criteria: * unable to undergo mri scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure) * unable to undergo an 18f-fdopa pet scan (e.g. parkinson's disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists) * pregnant women; nursing women; men or women of childbearing potential who are unwilling to employ adequate contraception
conventional versus rendezvous technique of intraoperative endoscopic retrograde cholangiopancreatography

Conditions: Common Bile Duct Gallstones

Summary: one of the new methods for management of common bile duct stones is intraoperative endoscopic sphincterotomy. it can be performed by many techniques. in the study the investigators compare two methods to find out the best technique for intraoperative endoscopic sphincterotomy.


Eligibility criteria:
inclusion criteria: * patients with mrcp evidence of common bile duct stones exclusion criteria: * cholangitis pancreatitis asa grade iii, iv unfit for laparoscopy unfit for ercp

Keywords: common bile duct stones
safety and pharmacokinetic study of lumacaftor/ivacaftor in subjects aged 2 through 5 years with cystic fibrosis, homozygous for f508del

Conditions: Cystic Fibrosis

Summary: this is a phase 3, 2-part (part a and part b), open-label, multicenter study evaluating the pharmacokinetics (pk), safety, tolerability, and pharmacodynamics (pd) of multiple doses of lumacaftor/ivacaftor (lum/iva) in subjects 2 through 5 years of age (inclusive) with cystic fibrosis (cf), homozygous for f508del. subjects who participate in part a may participate in part b, if they meet the eligibility criteria.


Eligibility criteria:
inclusion criteria: * subjects who weigh ≥8 kilogram (kg) without shoes and wearing light clothing at the screening visit * subjects with confirmed diagnosis of cf at the screening visit * subjects who are homozygous for the f508del-cystic fibrosis transmembrane conductance regulator (cftr) mutation exclusion criteria: * any clinically significant laboratory abnormalities at the screening visit that would interfere with the study assessments or pose an undue risk for the subject * an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before day 1 * a standard 12-lead ecg demonstrating qtc \>450 millisecond (msec) at the screening visit. * history of solid organ or hematological transplantation. * ongoing or prior participation in an investigational drug study (including studies investigating lum and/or iva) within 30 days of the screening visit. * history of cataract/lens opacity or evidence of cataract/lens opacity determined to be clinically significant by a licensed ophthalmologist during the ophthalmologic examination at the screening visit

Keywords: cf
a study to assess the relative bioavailability three new formulations of telaprevir in healthy subjects

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the incivek 375-mg tablets.


Eligibility criteria:
inclusion criteria: * healthy subjects (male and female of non-childbearing potential) between the ages of 18 and 55 years * non-childbearing potential female subjects * male subjects and female partners must agree to use at least 2 methods of contraception * subjects with a body mass index (bmi) of 18 to 30 kg/m2 and weigh \>50 kg at the screening visit. exclusion criteria: * subjects with a positive test result for hepatitis b, hepatitis c, or hiv * subjects with a significant history of any illness, as deemed important by the investigator or any condition possibly affecting drug absorption * subjects with a positive urine screen for drugs of abuse * subjects with a history of regular alcohol consumption * subjects treated with an investigational drug within 30 days * for part a only: subjects with 12-lead ecg qtcf \>450 msec (males) or qtcf \>470 msec (females) at the screening visit * subjects who use prescription and/or nonprescription medications or vitamins and/or dietary supplements * subjects who have made a blood donation of approximately 1 pint (500 ml) within 56 days prior to the first dose of study drug * subjects who have a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug * subjects on hormone replacement therapy (hrt) must discontinue such therapy 28 days prior to the first dose of study drug * subjects who have a habit of using tobacco or nicotine containing products within 6 months before the screening visit

Keywords: relative bioavailability telaprevir formulations
the study of cm326 in moderate-to-severe atopic dermatitis

Conditions: Moderate-to-severe Atopic Dermatitis

Summary: this is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, tolerance, pharmacokinetics, pharmacodynamics, and immunogenicity of cm326 in moderate-severe atopic dermatitis subjects.

the study consists of 3 periods, a up-to-4-week screening period, a 52-week treatment period and a 8-week safety follow-up period.

Eligibility criteria:
inclusion criteria: * with confirmed atopic dermatitis (ad) at the screening. * age ≥ 18 years and ≤ 75 years, male or female. * have the ability to understand the nature of the study and voluntarily sign the informed consent. * be able to communicate well with investigators and follow up protocol requirements. exclusion criteria: * not enough washing-out period for previous therapy. * received allergen specific immunotherapy (desensitization) within 6 months prior to baseline. * major surgery is planned during the study period. * women who are pregnant or breastfeeding, or who plan to become pregnant during the study.
hepatobiliary tumors tissue samples acquisition

Conditions: Hepatocellular Carcinoma; Cholangiocarcinoma; Gallbladder Cancer; Biliary Tract Cancer; Liver Cancer; Precancerous Condition; Benign Hepatobiliary Disease; Healthy, no Evidence of Disease

Summary: hepatobiliary tumors have a poor prognosis and high individual heterogeneity, so it is of great significance to find important prognostic markers and then screen out specific subgroups of people; meanwhile, chronic hepatitis, cirrhosis, and healthy control participants also need to show the evolution of tumors and discover specific diagnostic markers as a control group. moreover, targeted therapy and immunotherapy make cancer treatment enter a new field, but only part of patients achieve response rates and reach clinical benefit. however, these drugs are expensive and can cause treatment-related adverse events. therefore, reliable biomarkers identification is needed to help predict the response to these treatment options in order to screen patients with better responsiveness and avoid wasting money. multi-omics research can reveal the characteristics of hepatobiliary tumors more deeply and find meaningful therapeutic targets. therefore, 450 patients at least 18 years of age with hepatobiliary tumors were included in this study.

objectives: 1. observe the biomarkers of resectable hepatobiliary tumor recurrence (dfs) and survival (os); 2. observe the evolution of tumors and discover specific diagnostic markers as a control group. 3. observe the response (orr), progression (pfs) and survival (os) biomarkers of targeted immunotherapy for advanced hepatobiliary tumors; 4. to elaborate on the multi-omics study of hepatobiliary tumors, to further subtype and find therapeutic targets

Eligibility criteria:
inclusion criteria: 1. be older than 18 years old; 2. ecog 0-2 points; 3. may have received treatment; 4. clinical consideration or diagnosis of benign and malignant hepatobiliary tumors; or chronic hepatitis, cirrhosis, or healthy control participants; 5. patients may have received or are about to undergo surgery, chemotherapy, radiotherapy, targeted therapy, local therapy, immunotherapy, etc.; 6. patients understand and are willing to sign written informed consent documents. exclusion criteria: 1. the doctor thinks it is not suitable to enter the group (mental disorder or poor compliance, etc.) 2. pregnant women; 3. active or uncontrollable infections (fungi, bacteria, etc.); 4. estimated survival time \<12 weeks; 5. if the patient is receiving chronic anticoagulant therapy, the anticoagulant withdrawal should not be shorter than 3 days; 6. in the evaluation of the doctor, there is a risk of uncontrolled complications in the biopsy.