Kornimate/medical-research-clean huggingface dataset:
effects of aprotinin during cardiac surgery/long term death rates

Conditions: Cardiac Surgery

Summary: the dept. of anesthesiology currently has a database of subjects whom had surgery and received either aprotinin or amicar in the or. the current viewpoint is that aprotinin is more harmful than amicard. in an effort to see what the long term outcomes were for subjects whom had surgery here at upstate, it was decided to look at long term death rates to see if any differences. a student t-test will be used to determine statistical significance where a p value of \<0.05 will be deemed significant. using data from 462 subjects that had undergone cardiac surgery at suny upstate medical university, cabg only and the long term mortality rate from the mangano, et.al. publications, the unadjusted mortality for the two drugs are aprotinin 5.4% and amicar 1.2%. a power analysis was performed using the hospital mortality rates of 5.4% and 1.2% with the sample size in the propensity data and a p-value of 0.05. the result was a power of 81.7%.

charts for 462 subjects will be reviewed from 2002-2005 based on the surgery performed. from each chart, the subject name, date of birth,and social security number will be recorded along with the state of residence and year of surgery. this information will be transferred to a cd that is encrypted and password protected. the cd will be sent via fedex overnight to the center for disease control(cdc), national death registry. the cdc will use the information on the cd to extract death outcomes for each subject's information provided. once all information is complete, the cdc will transfer on to a cd that is encrypted and password protected and return to our office via fexex overnight. the information on the cd will then be used to determine what the long term death rates were for subjects here at suny upstate medical university and stored in an anonymous database. once the information is verified as accurate, the cd will be destroyed and no identifying information will be kept. the cdc will also destroy the information after 60 days, with no links to the identifying information.

Eligibility criteria:
inclusion criteria: * subjects must be 18 years of age or older * subjects must have received either aprotinin or amicar during cardiac surgery exclusion criteria: * cardiac surgery and did not receive aprotinin or amicar
levosimendan versus combination with magnesium sulphate on spine protection by nirs in infants undergoing coarctectomy

Conditions: Aortic Coarctation

Summary: in pediatric patients ,undergoing elective surgical correction of aortic coarcatation one of our main concern is spinal cord protection .our aim to study the protective effect of levosimendan versus its combination with magnesium sulphate .

effect of levosimendan and its combination with magnesium sulphate infusion as spinal cord protection using nirs values before aortic cross clamp and 10,20 min after cross clamp till the end of surgery .

Eligibility criteria:
inclusion criteria: age group ranging from 0 to 12 months of both sexes. aortic coarcatation eligible for correction exclusion criteria: parents or guardian refusal. age more than12 months. significant left ventricular dysfunction patient with heart block patient with pre-existing cns disorder eg seizure patient with renal or hepatic dysfunction
examination of the safety and tolerability of nnc 0070-0002-0349 in overweight/obese volunteers

Conditions: Metabolism and Nutrition Disorder; Obesity

Summary: this trial will be conducted in the united states of america (usa). the aim of this clinical trial is to investigate whether nnc 0070-0002-0349 is safe and well tolerated. groups of eight subjects will be administered subcutaneous injections of nnc 0070-0002-0349 or placebo on day 1 beginning with a low dose; after which laboratory and vital sign data as well as subject reported adverse events will be evaluated. if safe to proceed, the next group of subjects will be given a higher dose and the safety evaluation performed again before proceeding. in total, 5 dose levels will be evaluated. subjects will be administered a dose and remain in the clinic until the morning of day 8 after dosing and vital signs and safety labs as well as blood drawn for pharmacokinetic samples taken. subjects will return to the clinic on days 10, 12, 14, 16, 18 and 22 for repeat blood draws and safety labs. day 22 is the final study visit.


Eligibility criteria:
inclusion criteria: * bmi greater than 27.0 and less than 35.0 kg/m2 exclusion criteria: * systolic blood pressure greater than 140 mm hg or diastolic greater than 90 mm hg * depression or suicidal thoughts (scoring on patient health questionnaire-9-item) * eating disorders * unusual diets or eating habits * dieting, use of diet drugs or obesity surgery * diabetes history or abnormal fasting glucose
attain stability™ quad clinical study

Conditions: Heart Failure

Summary: the purpose of this clinical study is to evaluate the safety and efficacy of the attain stability quadripolar mri surescan left ventricular (lv) lead (model 4798).

the attain stability quad clinical study is a prospective, non-randomized, multi-site, global, investigational device exemption (ide), interventional clinical study. the purpose of this clinical study is to evaluate the safety and efficacy of the attain stability™ quad mri surescan lv lead (model 4798). this will be assessed through a primary safety and primary efficacy endpoints. all subjects included in the study will be implanted with a medtronic market released de novo crt-p or crt-d device, compatible market released medtronic ra and medtronic rv leads and an attain stability quad mri surescan lv lead (model 4798). up to 471 subjects will be enrolled into the study and up to 471 attain stability quad mri surescan lv lead (model 4798) implanted, to ensure a minimum effective sample size of 400 model 4798 leads implanted with 6 months post implant follow up visits (assuming 15% attrition) at up to 56 sites worldwide.

Eligibility criteria:
inclusion criteria: * patient meets crt implant criteria as determined by local regulatory and/or hospital policy (i.e. us subjects should meet crt device indications per the hrs/acc/aha guidelines) * patient (or legally authorized representative) has signed and dated the study-specific informed consent form * patient is 18 years of age or older, or is of legal age to give informed consent per local and national law * patient is expected to remain available for follow-up visits exclusion criteria: * patient has had a previous unsuccessful lv lead implant attempt * patient has a previous crt system or lv lead implanted (for example, transvenous or epicardial) * patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or safety alert) ra and/or rv lead * patient has known coronary venous vasculature that is inadequate for lead placement * patient has unstable angina pectoris or has had an acute myocardial infarction (mi) within the past 30 days * patient has had a coronary artery bypass graft (cabg) or percutaneous transluminal coronary angioplasty (ptca) within the past 90 days * patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve) * patient has had a heart transplant (patients waiting for heart transplants are allowed in the study) * patient has known renal insufficiency that would prevent them from receiving an occlusive venogram during the implant procedure * patient is contraindicated for \<1mg dexamethasone acetate * patient is enrolled in any concurrent drug and/or device study that may confound the results of this study * patient has a terminal illness and is not expected to survive more than six months * patient meets exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.) * patient is unable to tolerate an urgent thoracotomy

Keywords: heart failure cardiac pacing cardiac resynchronization therapy left ventricular lead
buccal acupuncture for delirium treatment in older patients recovering from orthopedic surgery

Conditions: Older Patients; Orthopedic Surgery; Postoperative Delirium; Acupuncture; Treatment

Summary: this study is designed to test the hypothesis that, for older orthopedic patients who developed postoperative delirium, combining buccal acupuncture with routine care will shorten delirium duration and relieve delirium severity.

delirium is an acute, transient central nervous system dysfunction characterized by fluctuating disturbances of attention, consciousness, and cognitive function. delirium is common in older patients following surgery. the incidence of postoperative delirium ranges from 12.0% to 23.8% in older patients; the incidence of delirium is about 10.7-17.6% in older patients after joint replacement surgery. the occurrence of delirium is associated with worse outcomes, including increased early postoperative complications, prolonged hospital-stay, and increased in-hospital mortality, as well as long-term decline in cognitive function, quality of life, and survival duration. clinical use of acupuncture has a long history in china. buccal acupuncture therapy is a microneedle technique and provides treatment for systemic diseases by acupuncturing specific acupoints in the cheek. acupuncture is also used for delirium treatment. studies of older patients who developed delirium in internal medicine wards found that, compared with routine care alone, combining routine care with acupuncture relieved delirious symptoms and severity more efficaciously. however, evidence in this aspect is limited. we suppose that, for older orthopedic patients who developed postoperative delirium, combining buccal acupuncture with routine care will shorten delirium duration and relieve delirium severity.

Eligibility criteria:
inclusion criteria: * aged ≥65 years, but \<90 years. * after knee or hip replacement surgery. * diagnosed with delirium in the morning of enrollment. exclusion criteria: * refuse to participate in the study. * presence of any contraindications to acupuncture, such as puncture site infections or platelet count ≤20×10\^9/l. * preoperative history of schizophrenia, epilepsy, parkinson's disease, or myasthenia gravis. * inability to communicate due to coma, profound dementia, or language barrier, or inability to cooperate with treatment due to agitation. * american society of anesthesiologists physical status grade ≥v, or estimated survival ≤24 h.

Keywords: older patients orthopedic surgery postoperative delirium buccal acupuncture treatment effects
studies of immune responses in patients with chronic hepatitis b

Conditions: Hepatitis B

Summary: taiwan is a hyperendemic area of hepatitis b virus (hbv) infection. previous studies demonstrated vigorous t cell responses to hbv-encoded antigens developed in patients with self-limited acute hepatitis b. in contrast, weak or no t cell responses could be detected in chronic hepatitis b (ch-b) patients. however, these immune responses are still not well known in patients with acute exacerbation (ae) of ch-b and in patients with advanced liver diseases, such as liver cirrhosis (lc) and hepatocellular carcinoma (hcc). the cd4+cd25+ regulatory t cells might suppress immune responses against foreign antigens and pathogens. the roles of cd4+cd25+ regulatory t cells in patients chronically infected with hbv remain to be clarified. the high percentage of hbv carriers in taiwan are related to the vertical transmissions. high maternal hbv viral load may make the newborns tolerant to the hbv. however, the hbv-specific cd8+ t cells responses in the cord bloods of newborns are still unknown. thus, we want to resolve these issues in this study. we will enroll the hbsag (+) patients from ntuh. blood samples will be collected. we will then analyze the hbv-specific cd8+ t cell responses and the clarify the roles of regulatory t cells.

the hbsag (+) patients from national taiwan university hospital will be included. screening for hla haplotype will be performed by amplification refractory mutation system / pcr method. the hla-a2 or hla-a11 will be enrolled to the study group because these two haplotypes are the most ones in taiwan. the other hla haplotype hbv carriers will be enrolled as hla-mismatch control. the disease spectra include inactive hbv carrier, ch-b, ch-b with ae (defined as alt \>= 5 x unl), hbv-related lc, hbv-related hccs. hbsag, anti-hbs, igm anti-hbc, hbeag, anti-hbe, anti-hcv, anti-hdv, anti-hiv will be determined by commercial enzyme immunoassay kits. the serum levels of hbv dna and genotypes will be done by quantitative real-time pcr. patients who are also infected with hdv or hcv or hiv will be excluded. pbmcs will be isolated from heparinized blood samples by density gradient centrifugation on ficoll-hypaque. the pbmc will be washed with phosphate-buffered saline (pbs) and resuspended in t cell medium. analysis of hbv-specific cd8+ t cell responses will be done by flow cytometry using pentamer staining. to analyze hbv-specific cd8+ t cells responses in patients with chronic hbv infection (prospective study). this part of the study is to clarify the role of hbv-specific t cell responses during the course of acute exacerbation of ch-b. blood will be collected at four important time points.

Eligibility criteria:
inclusion criteria: * patients chronically infected with hepatitis b virus exclusion criteria: * coinfected with hcv or hiv
curative proton beam therapy for patients with lung metastasis of colorectal cancer

Conditions: Colorectal Cancer

Summary: proton alone therapy is performed -\> 5 times a week, 7200 cgy / 15 fractions for 3 weeks total

this clinical trial is a prospective, single-organ, phase ii clinical trial to evaluate the efficacy of curative proton therapy for pulmonary metastasis of colon cancer diagnosed histologically as adenocarcinoma. patients who meet the selection criteria should be selected, signed for consent, and treated 5 times a week for 7200 cgy / 15 fractions alone for 3 weeks.

Eligibility criteria:
inclusion criteria: 1. histologically diagnosed colon adenocarcinoma in primary or metastatic lesions.. 2. if there is no other remote metastasis other than lung, or if there is, control is possible 3. if there are less than 2 lung metastatic lesions 4. if they refuse lung surgery or surgery is inappropriate (medically unsuitable for surgery due to surgery refusal, diabetes mellitus, high blood pressure, pulmonary disease, heart disease, etc., repeated surgery, poor systematic function, short disease-free period, etc.) exclusion criteria: 1. other histologic cancer other than adenocarcinoma of the colorectal 2. colorectal cancer without primary lesion resection 3. if there is another remote metastasis and is not completely resected or regulated 4. if the patient has experience of other invasive cancer diagnosis within 5 years of colorectal cancer diagnosis 5. pregnancy and women under lactation

Keywords: lung metastasis, curative proton beam therapy
stem cell therapy: a compassionate use program in perianal fistula

Conditions: Perianal Fistula

Summary: this observational study aims at assessing the safety and efficacy profiles of mesenchymal stem cell, in different formats (svf, autologous, allogenic), to treat complex perianal fistula according to the spanish national compassionate-use law .

under controlled circumstances, and approved by european and spanish laws, a compassionate-use program allows the use of stem-cell therapy for patients with non-healing diseases, mostly complex fistula-in-ano, who do not meet criteria to be included in a clinical trial. candidates had previously undergone multiple surgical interventions that had failed. the intervention consisted of surgery (with closure of the internal opening or a surgical flap performance), followed by stem cells injection. three types of cells were used for implant: stromal vascular fraction, autologous expanded adipose-derived or allogenic adipose derived stem cells. healing was evaluated at 6th month follow-up. outcome was classified as partial response or healing. relapse was evaluated 1 year later. maximum follow up period was 48 months.

Eligibility criteria:
inclusion criteria: * patients with complex perianal fistula * patients who didn't meet criteria of the clinical trial (ct) in development * foreign patients, who were not allowed to be included in the ct * patients included in some ct control arms * failure treatment in patients included in a ct treatment arm as a retreatment exclusion criteria: * not signature informed consent

Keywords: perianal fistula compassionate use mesenchymal stem cells
laparoscopic adjustable gastric banding versus laparoscopic sleeve gastrectomy

Conditions: Morbid Obesity

Summary: * the investigators aim to determine the clinical and metabolic outcomes of two available bariatric restrictive procedures: laparoscopic adjustable gastric banding (lap-band) and laparoscopic sleeve gastrectomy for the treatment of morbid obesity (bmi \> 35 with comorbidities or bmi \> 40) in veterans. * the investigators hypothesize that the short and long term outcomes between laparoscopic adjustable gastric banding (lap-band) and sleeve gastrectomy are similar in veterans.

this is a bariatric surgery phase 3 prospective trial.

Eligibility criteria:
inclusion criteria: * morbidly obese veterans only (bmi\>35 with comorbidities or bmi \> 40) * age \> 18 y/o exclusion criteria: * pregnancy * severe uncontrolled medical or psychiatric conditions * previous bariatric surgery * multiple previous abdominal surgeries

Keywords: morbid obesity bariatric surgery obesity surgery gastric banding sleeve gastrectomy
safety and effectiveness of mesenchymal stem cells in blood purification for the treatment of liver failure

Conditions: Liver Failure

Summary: the goal of this clinical trial is to learn if mesenchymal stem cells in blood purification works to treat liver failure in adults. it will also learn about the safety and effectiveness of mesenchymal stem cells in blood purification. the main questions it aims to answer are:1.does mesenchymal stem cells in blood purification improve the condition of patients with liver failure? 2.what medical problems do participants have when taking mesenchymal stem cells in blood purification? participants will receive routine medical treatment and blood purification treatment with mesenchymal stem cells.these cells work outside the body and do not enter the body. we will: 1.collect samples from participants such as blood, urine and feces. 2.record post-treatment outcomes such as survival rate at 4 weeks after treatment, conversion rate to liver transplantation, inflammatory, survival rate at 7days, 14days, 8 weeks and 12 weeks after treatment, and liver disease indicators(prothrombin time activity percentage, lactic aicd, blood ammonia, α-fetoprotein, ferritin).


Eligibility criteria:
inclusion criteria: 1. age range from 18 to 65 years old; 2. patients with acute liver failure in the early and intermediate stages caused by various reasons; 3. total bilirubin (tbil) ≥ 171μmol/l or an increase of ≥ 17.1μmol/l per day; 4. prothrombin activity (pta) between 20% and 40% (or inr between 1.5 and 2.6); 5. no hepatic encephalopathy or encephalopathy below grade ii (including grade ii); 6. elevated inflammatory markers (il-6 / tnf-α / crp, etc.); 7. the subjects are able to communicate well with the researchers and can complete the study in accordance with the study regulations; 8. the subjects must be informed of this study and voluntarily sign a written informed consent form before the experiment. exclusion criteria: 1. patients with severe active bleeding or diffuse intravascular coagulation; 2. patients with a high degree of allergy to blood products or drugs used during treatment, such as plasma, heparin, and protamine; 3. patients with circulatory failure; 4. patients with a meld score \> 30; 5. patients with other severe heart diseases, lung diseases, blood diseases, autoimmune diseases, or diabetes; 6. subjects who may be unable to complete this study for other reasons or who the researchers believe should not be included.
computer assisted volumetric analysis of ct-identified metastatic pulmonary or hepatic lesions

Conditions: Metastatic Cancer

Summary: the purpose of this study is to evaluate the ability of a new type of ct computer program(mevis™)to accurately analyze and measure the size and changes in metastatic liver and lung tumors. this study will evaluate the data from current ct evaluation methods using the mevis™ 3-d software.

this is a pilot study that will evaluate if metastatic liver and lung tumor measurements made by the mevis™ software program can provide more accurate information about the size and changes of the tumor compared to the current evaluation method, recist(response evaluation in solid tumors). this study will also collect information about the kind of treatment each subject receives. subjects will receive standard of care surveillance ct examinations(a baseline to document tumor size and interval ct exams as indicated by the oncology department protocols); the tumor will be measured according to the current standard-recist by radiology personnel not involved in the study. the ct data will then be analyzed by investigators using the mevis™ software.

Eligibility criteria:
inclusion criteria: * subjects with cancer metastatic to either the liver or lungs * subjects scheduled for regular ct surveillance examinations * subjects with life expectancy of at least 6 months exclusion criteria: * age \<18 years * no written informed consent

Keywords: ct software mevis™ metastatic pulmonary and hepatic lesion growth
supreme-dm (diabetes mellitis) treatment study

Conditions: Diabetes

Summary: this multisite pragmatic clinical trial was designed to assess the effectiveness of a single scripted telephone call to diabetes patients who (a) were currently above recommended clinical goals for glucose, blood pressure, or lipids, and (b) had recently been prescribed a new medication for that specific clinical domain. the goals of the intervention were to improve primary adherence and persistence to the newly prescribed medication and to improve control of glucose, blood pressure, and lipids.

this randomized trial tested the hypothesis that a telephone contact with a patient recently prescribed a new medication for uncontrolled glycated hemoglobin (a1c), blood pressure, or low-density lipoprotein cholesterol would improve (a) primary medication adherence, (b) medication persistence, (c) medication possession ratio, and (d) a1c, blood pressure or low-density lipoprotein cholesterol control. this study was part of the larger agency for healthcare research and quality funded supreme-dm study. the clinical trial reported here was coordinated and led by healthpartners institute for education and research, while data collection was coordinated through kaiser permanente northwest and analysis was conducted at kaiser permanente colorado. the clinical intervention sites for this study included kaiser permanente northern california, group health cooperative, marshfield clinic, and geisinger clinic.

Eligibility criteria:
inclusion criteria: * at each clinical intervention site, study subjects were selected if they: * were age 18-75 years * met study criteria for diabetes mellitus before study enrollment * received clinical care at a designated clinic or medical center involved in this study for at least 15 months before enrollment * were prescribed a new class of medication (not filled in the past 180 days) for a1c, bp, or ldl that was uncontrolled at the time of medication prescription (a1c\>=8%, systolic bp\>= 140 mm hg, or ldl \>=100 mg/dl). exclusion criteria: * study subjects were excluded if they were younger than 18 years of age * older than 75 years of age * did not have evidence of diabetes mellitus prior to study enrollment * were not receiving care at a clinic site involved in this study for at least 15 months before enrollment * did not have prescribed a new class of medication for uncontrolled a1c, bp or ldl.

Keywords: diabetes type 2 primary care chronic disease care improvement adherence, randomized trial bp control lipid control glucose control natural language processing.