Kornimate/medical-research-clean huggingface dataset:
safety of tg100-115 for heart attack treated with angioplasty

Conditions: Myocardial Infarction

Summary: tg100-115 is able to reduce the size of heart attacks in pre-clinical models. the hypothesis of this study is that tg100-115 can be given safely to patients who suffer a heart attack and undergo angioplasty to restore blood flow. we will also evaluate whether tg100-115 reduces heart muscle damage.


Eligibility criteria:
inclusion criteria: * age 18-80 yrs * ecg patterns consistent with an acute anterior myocardial infarction with st segment elevation of 2mm in two contiguous ecg leads among leads v1-v4. * have prolonged, continuous (lasting at least 20 mins) signs and symptoms of myocardial ischemia not eliminated with nitrates. * intent to proceed to primary pci within 6 hours of chest pain onset * sign an informed consent form and be willing to attend follow-up visits for safety and other study assessments. exclusion criteria: * female of childbearing potential. * history of previous myocardial infarction. * history of congestive heart failure. * requirement for a cardiac pacemaker or defibrillator. * cardiogenic shock. * patients previously treated with thrombolytic therapy. * myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease.

Keywords: myocardial infarction infarct size angioplasty percutaneous coronary intervention acute myocardial infarction
a confirmatory study of hepabulin iv in hbsag positive liver transplantation recipients

Conditions: Hepatitis B

Summary: the purpose of this study is to evaluate the efficacy and safety of hepabulin iv (hbig, a study drug) after liver transplantation.

a 52-week, multi-center, open label, single arm, phase 3 study to evaluate the efficacy and safety of hepabulin iv in hbsag positive liver transplantation recipients

Eligibility criteria:
inclusion criteria: * hbsag positive candidate for hbv-related liver transplant * primary, single organ recipients * written informed consent exclusion criteria: * acute renal failure, serum creatinin \>1.5\*uln * severe cardiac disease or other significant disease * hav, hcv or hiv positive * immunoglobulin a deficiency. * history of hypersensitivity to human immunoglobulin. * history of cancer within 5 years. (without hcc) * history of alcohol or/and drug abuse. * history organ transplantation. * within 30 days, participation in another clinical trial and use of an investigational product. * subject suffer from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that, may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of study result.

Keywords: liver transplantation hbv hbv recurrence hbsag positive
efficacity and safety of metformin xr in ckd stage 1 to 3

Conditions: Renal Insufficiency, Chronic

Summary: there is limited data availability on effect of metformin xr on 24-h plasma glucose, and there is no available data in chronic kidney disease (ckd). the planned study aims to provide data on glucose plasma level in relation to metformin plasma level in diabetes type ii patients.


Eligibility criteria:
inclusion criteria: * type 2 diabetes patients aged between 18 and 80 years requiring metformin (and any other antidiabetic treatment) exclusion criteria: * pregnancy and lactation * hyperlactatemia (\> 2.5 mmol/l) * no creatinine levels available since 3 months * severe hepatic insufficiency * no liver function parameters available * need of investigation with iodized contrast media * hypersensitivity to metformin

Keywords: diabetes type 2 metformin chronic kidney disease ckd
transcystic versus transanastomotic tube drainage in right lobe ldlt

Conditions: Living Donor Liver Transplantation

Summary: to evaluate the safety and effectiveness of the use of transcystic biliary drainage tube (not transanastomotic) in comparison to the usual transanastomotic biliary drainage tube.

a biliary drainage tube is usually inserted into the biliary passage after choledocho-choledochostomy (bile duct to bile duct joining). a 4f or 5f biliary catheter (marquat genie biomedical, france) is used in all cases. the study is to compare the effectiveness and safety of 2 different placement techniques: 1. the usual trans-anastomotic position (the tube is placed across the anastomosis line with the tip inside the intrahepatic biliary branches) through an opening in the wall of the recipient's common bile duct 2. a transcystic non-anastomotic position (the tube is placed through the cystic duct opening into the distal common bile duct not passing through anastomosis)

Eligibility criteria:
inclusion criteria: * living donor liver transplantation * single bile duct in the graft exclusion criteria: * multiple bile ducts

Keywords: biliary fistula biliary stricture biliary drainage tube
contact allergies to dental metal as a possible risk factor for oral cancer

Conditions: Head and Neck Cancer

Summary: rationale: gathering information about allergies to metals may help doctors learn whether having an allergy to metal used in dental work increases the risk of developing oral cancer. purpose: this clinical trial is studying contact allergies to dental metal as a possible risk factor for oral cancer.

objectives: * identify the relationship between intraoral metal contact allergy and epithelial carcinogenesis in patients with newly or previously diagnosed intraoral squamous cell carcinoma. * compare the prevalence of metal contact allergy in these patients with control data from other existing study populations. outline: this is a multicenter study. * participants undergo metal patch testing using 27 metals\* commonly used in dental repairs that are part of the mayo metal series. metal patches are applied to the patient's back for 3 days and the back is read on days 3 and 5. relevant patient data obtained from their medical and dental history, physical exam, laboratory values and treatment are documented. note: \*healthy volunteers (control) undergo metal patch testing using 8 metals most commonly positive for contact allergens.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * newly or previously diagnosed oral squamous cell carcinoma * recruited from the otorhinolaryngology departments of mayo clinic rochester and mayo clinic arizona * healthy volunteer (control) * no history of intraoral squamous cell carcinoma * employed at mayo clinic rochester or mayo clinic arizona patient characteristics: * no immunosuppression * no other conditions that interfere with patch testing prior concurrent therapy: * not specified

Keywords: lip and oral cavity squamous cell carcinoma oropharyngeal squamous cell carcinoma
assessment of the implementation of the resqgard® impedance threshold device by the san antonio fire department

Conditions: Acute Hypotension

Summary: this study is attached to a comprehensive quality assurance/quality improvement (qa/qi) program conducted by the office of the medical director, and is designed to contribute to generalizable knowledge to determine effectiveness and tolerability of an fda approved impedance threshold device (itd) device in a large urban emergency medical service (ems) system. the cohort will comprise a convenience sample of patients that are being treated by ems for a hypotensive emergency.


Eligibility criteria:
inclusion criteria: * adults between the ages of 18-120 years * presenting to ems with or development of hypotension during ems interaction * treated by ems with the itd exclusion criteria: * pediatric patients * patients that do not present with or develop hypotension * patients who the itd will not form a secure seal due to anatomical abnormalities
investigational study of the ekso for high-dosage use by individuals with sci in a non-clinical environment

Conditions: Spinal Cord Injuries

Summary: the purpose of the study is to study the safety and health effects of using the ekso bionics powered exoskeleton device in a home setting over an extended period, ranging from 12-42 months.

this is a 36 month exploratory investigational study compliant with the nsf human subjects regulations (45 cfr 690) trialing a new device for the sci populations to aid in ambulatory function in a home setting. ekso bionics will enable up to twelve (12) subjects with sci to use an ekso device in their home for a 12-month period. qualified subjects will help ekso bionics determine the practical use of the device in the home environment and will enable ekso bionics to gather data to develop a device for use in a home environment. the study will require a trained spotter to be present at all times that the device is being used. the study will also evaluate the effectiveness of a non-medically licensed spotter to assist the subject.

Eligibility criteria:
inclusion criteria: * be an experienced user of the ekso device with a minimum of 20 hours and no more than 50 hours of device use and require no greater than minimal assist (support of up to 25% body weight) for safe and consistent walking. * no more than 2 episodes of balance loss per 1 hour training session that require no more than moderate assistance (support of 26% to 50% of body weight) * participants with more than 50 hours of device experience must agree to a 1 month period of non-use prior to acquisition of baseline measures * be between 18-65 years of age. * be able to physically fit into the exoskeleton device. * be able to tolerate upright standing for up to 60 minutes. * have sufficient joint range of motion to fit safely within ekso: hip flexion contracture ≤ 15o; knee flexion contracture ≤ 10o; ankle dorsiflexion to neutral with no more than 10o of knee flexion. * have sufficient upper body strength to balance themselves with two arms * be fluent in english exclusion criteria: * height below 60 inches or above 76 inches or with physical characteristics incompatible with device and testing procedure. * weight above 220 lbs. * lower extremity joint contractures that exceed device capacity for safe use. * any medical issue that precludes full weight bearing and ambulation (e.g. osteoporosis that prevents safe standing, orthopedic injuries, pain, severe spasticity) * skin integrity issues that would prevent wearing the device. * cognitive and/or communicative disability inappropriate for testing as determined by ekso bionics clinician. subjects must be able to follow directions well and demonstrate learning capability. * pregnancy (self-reported) * colostomy * medical or environmental conditions arising after the start of the study that are deemed unsafe per ekso bionics discretion.
prevention of adverse drug events (ades) in hospitalised older patients

Conditions: Adverse Drug Reaction

Summary: the next four decades will see a marked expansion of the elderly population in ireland, in particular people aged over 80 yrs. persons aged over 80 are the highest consumers of prescription medicines in ireland and have the highest prevalence rates of major polypharmacy. polypharmacy is intimately linked with serious adverse drug events (ades) and consequent major morbidity and mortality. epidemiological data from the united states indicate that ades is the fifth most common cause of death nationally. experts suggest that effective evidence based interventions can be applied to this major public health problem. recent research data indicate a cause-and-effect relationship between inappropriate prescription medicines and serious ades in older people in hospital. to date, beers' criteria have been the dominant set of criteria for defining potentially inappropriate medicines (pims) in late life. research data collected by this group show that the recently validated stopp/start criteria (screening tool of older persons' prescriptions and screening tool to alert doctors to right treatment) identify ades that are causal or contributory to acute hospital admission in older people 2.7 times more frequently than beers' criteria. based on these findings, our hypothesis is that stopp/start criteria have the potential to be used as a regular intervention for the purpose of ade prevention in older people. a recent single centre randomised control trial (rct) undertaken at cork university hospital showed that prospective application of stopp/start criteria led to a highly significant improvement in medication appropriateness in older hospitalised patients compared with standard inpatient pharmaceutical care. significantly, the improvement in medication appropriateness was maintained to the end of the study follow-up i.e. 6 months post-discharge. however, the ability of stopp/start criteria to significantly reduce ades in a prospective rct has yet to be demonstrated.


Eligibility criteria:
inclusion criteria: all patients aged 65 years and over presenting to cuh accident and emergency departments with acute illness for admission under a medical or surgical team. exclusion criteria: 1. age less than 65 years. 2. patient to be admitted under the care of a geriatrician psychiatrist of old age or clinical pharmacologist, or having been admitted under these services or attended their outpatient clinics in the previous 12 months. (these doctor groups are likely to minimise inappropriate medications in this population). 3. terminally ill patient attended by palliative care team. 4. critically ill patient e.g. admitted to intensive care unit. 5. patients who do not wish to participate in the study. 6. patients whose hospital physician does not wish to participate in the study.

Keywords: adverse drug event adverse drug reaction inappropriate prescribing elderly hospital-acquired
t1-mapping by cardiovascular magnetic resonance imaging to assess non-alcoholic fatty liver disease

Conditions: NAFLD; Heart Failure; Valvular Disease; Coronary Disease

Summary: on clinically indicated cardiovascular magnetic resonance studies, native t1-times and extracellular volume of the liver will be assessed and findings correlated with established risk calculators for non-alcoholic fatty liver disease.


Eligibility criteria:
inclusion criteria: * referred for cardiovascular magnetic resonance imaging exclusion criteria: * non-compatible devices
attentional capacity and working memory in coronary artery disease patients: impact of the presence of a sleep apnea syndrome and chronic effects of treatment with cpap

Conditions: Obstructive Sleep Apnea; Acute Coronary Syndrome

Summary: the presence of obstructive sleep apnea syndrome (osas) has a high frequency in patients victims of a coronary artery disease (cad) (myocardial infarction, revascularization). unlike patients seen in a sleep laboratory with an impact on daytime functioning, cad apneic patients do not complain in their daytime functioning. the objective of this study is to explore whether the objective cognitive assessment measures may be a good marker of the efficacy of cpap treatment given to non-sleepy apneic cad patients. coronary patients with an ahi between 15 and 40 / h will be treated (or not) after randomization with cpap treatment. the expected results are: cpap apneic coronary patients should have a positive impact on cognitive performance, particularly on attention span and working memory measured by improvement in the paced auditory serial addition test score (pasat score).


Eligibility criteria:
inclusion criteria: * patient admitted to the clinical physiology department of exercise of the saint etienne university hospital (myocardial infarction, coronary stenting or coronary artery bypass) and referred for care in cardiac rehabilitation * a native french speaker * no daytime sleepiness (ess \<or = 10) * signature of informed consent by the patient exclusion criteria: * patients with a previous diagnosis of sleep apnea syndrome * patients with severe heart failure (stage iii and iv of the nyha) * patients with a neurodegenerative disease or other known cognitive disorders * presence of progressive disease other than coronary artery disease (cancer for example) * patients participating in other research that can change their cognitive function or drowsiness

Keywords: obstructive sleep apnea acute coronary event cognitive functions continuous positive airway pressure night
folic acid in preventing colorectal polyps in patients with previous colorectal polyps

Conditions: Adenoma of Large Intestine

Summary: rationale: chemoprevention is the use of certain substances to keep cancer from forming. the use of folic acid may prevent colorectal cancer. purpose: this randomized clinical trial is studying how well folic acid works compared with a placebo in preventing colorectal polyps in patients who have had previous colorectal polyps.

objectives: primary * determine if folic acid supplementation lowers the adenoma recurrence rate. secondary * determine the number of adenomas per patient and the size and histology of the adenoma. * assess the interaction between folic acid and alcohol, methionine, and aspirin intake. * assess the interaction between folic acid and pretrial and midtrial folate levels. * assess other complementary biomarkers such as dna methylation and blood folate level as risk factors for polyp recurrence. outline: patients are randomized to 1 of 2 treatment arms. * arm i: patients receive oral folic acid once daily. * arm ii: patients receive oral placebo once daily. at least 1 year after beginning treatment, patients are sent a blood collection kit in order to measure plasma vitamin b12 levels, to measure folate to assess compliance.

Eligibility criteria:
disease characteristics: inclusion criteria: * participated in the nurses' health study (nhs i) or the health professionals follow-up study (hpfs) and have had a previous confirmed diagnosis of adenomatous polyp of the colon or rectum * plan on having an endoscopy within 4 years after initiation of the trial * must release medical records regarding past and any future endoscopies patient characteristics: inclusion criteria: * plasma vitamin b12 concentration of ≥ 300 pg/ml or have a vitamin b12 concentration between 200 and 299 pg/ml and a methylmalonic acid (mma) level ≤ 32 µg/l exclusion criteria: * diagnosis of cancer other than non-melanoma skin cancer, or early stage breast or prostate cancer * diagnosis of homocystinemia * diagnosis of pernicious anemia * any gastrointestinal disorder that could lead to a vitamin b12 deficiency * diagnosis of cirrhosis or pancreatitis * diagnosis of epilepsy, alzheimer's disease, parkinsonism, and psychiatric disorders that may interfere with normal functioning prior concurrent therapy: exclusion criteria: * no prior gastrectomy, total colectomy, or pancreatectomy * other concurrent multivitamins or supplements that contain folic acid (they may take specific supplements, such as a, c, e, calcium, and iron, or antioxidant formula vitamins) * no concurrent methotrexate or anticonvulsant

Keywords: folic acid adenoma of large intestine
treatment of pulmonary hypertension in high-risk cardiac surgery patients using inhalational and intravenous agents

Conditions: Hypertension, Pulmonary; Cardiac Failure; Pulmonary Vascular Resistance Abnormality

Summary: the aim of this study is to examine and compare the effect of levosimendan and milrinone administered intravenously and via inhalation respectively in cardiac surgery patients with pulmonary hypertension and right ventricular dysfunction.

pulmonary hypertension (ph) is a pathophysiological disorder hemodynamically characterized by increased pulmonary vascular resistance and pressure. this can lead to right ventricle pressure overload and failure, which is worsened by cardiopulmonary bypass (cpb) and extracorporeal circulation and is accompanied by high rates of morbidity and mortality in cardiac surgery patients. pharmacological agents used to decrease pulmonary vascular resistance and right ventricle afterload are prostaglandins, iloprost, milrinone, nitric oxide (no) and recently levosimendan. these agents can be administered intravenously or via inhalation. in this study, the intravenous administration of levosimendan will be compared with the inhalational use of milrinone in patients with pulmonary hypertension undergoing cardiac surgery. in this setting, 40 patients with ph caused by left sided heart disease, will be assigned into two groups: group a: intravenous administration of levosimendan in dosage 6mcg/kg after induction of anesthesia. group b: inhalational administration of milrinone in dosage 50mcg/kg after induction of anesthesia. before and after the administration of the drug, heart function will be evaluated by hemodynamic measurements obtained by the swan-ganz catheter. these parameters will be heart rate (hr), blood pressure (bp), mean pulmonary arterial pressure (mpap), central venous pressure (cvp), cardiac output (co), pulmonary capillary wedge pressure (pcwp), cardiac index (ci), systemic vascular resistance (svr), pulmonary vascular resistance (pvr). transthoracic echocardiography (tte) and transoesophageal echocardiography (toe) will also be used. this study will lead to conclusions regarding the effectiveness of intravenous administration of levosimendan and inhalational use of milrinone in the treatment of right heart failure and ph in cardiac surgery patients.

Eligibility criteria:
inclusion criteria: * patients with pulmonary hypertension due to left ventricular dysfunction based on echocardiographic diagnosis preoperatively * elective cardiac surgery exclusion criteria: * primary pulmonary hypertension * thromboembolic disease * chronic obstructive pulmonary disease * emergency surgery * redo surgery * inability to consent to the study

Keywords: pulmonary vascular resistance pulmonary hypertension vasodilators milrinone levosimendan cardiopulmonary bypass
safety, tolerability and efficacy of micardis® in patients with essential hypertension

Conditions: Hypertension

Summary: this post-marketing surveillance study was designed to supplement under conditions of normal clinical practice the data on the safety, tolerability and efficacy of micardis® collected during the clinical studies.


Eligibility criteria:
inclusion criteria: * patients of both sexes with essential hypertension and a minimum age of 18 years exclusion criteria: (not applicable)