Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of e.coli nissle 1917 in patients with mild (stage 1-2) or minimal hepatic encephalopathy

Conditions: Hepatic Encephalopathy; Liver Cirrhosis; End Stage Liver DIsease

Summary: the purpose of study to assess the short-term efficacy and safety of probiotic e.coli nissle 1917 strain comparing to lactulose and rifaximin in patients with mild (stage 1-2) or minimal hepatic encephalopathy


Eligibility criteria:
inclusion criteria: * cirrhosis diagnosed on the basis of liver biopsy, liver stiffness measurement or radiological study; * presence of minimal or mild (grade 1-2) he as defined by west haven criteria; * two or more documented episodes of he in the last 6 months, in addition to at least one episode in the last 3 months; * subject is capable and willing to comply with all study procedures; * signed inform consent. exclusion criteria: * history of taking l-ornithine- l -aspartate, zinc, metronidazole, or neomycin, antibiotics, probiotics and yogurt consumption within 6 weeks; * subject has a history of allergy or intolerance to lactulose and/or rifaximin; * alcohol intake during the past 6 month or during follow up; * recent (6 weeks) gastro-intestinal bleed; * hepato-cellular carcinoma or liver transplantation; * renal insufficiency; * significant comorbid illness such as heart or respiratory failure; * concurrent infection such as spontaneous bacterial peritonitis, pneumonia or urinary tract infection; * any neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies; * subject has any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments.

Keywords: hepatic encephalopathy liver cirrhosis end stage liver disease e.coli nissle 1917 probiotic lactulose rifaximin
efficiency of donepezil in elderly patients for prevention of pocd dysfunction

Conditions: Total Knee Arthroplasty; Fracture of Head of Femur Articular Displaced; Protrusion of Intervertebral Disc

Summary: postoperative cognitive dysfunction (pocd) occurs mainly in aged patients. pocd may increase the mortality and morbidity. however, the mechanism of pocd is not clear yet and no effective therapy method was proved. according to our previous study, the central cholinergic system impaired by the anesthesia and surgery play a very important role in the pocd and donepezil an acetylcholinesterase inhibitor can prevent the pocd after isoflurane anesthesia in aged mice. donepezil is a commercial medicine used for the alzheimer disease, which is tolerable and has minimal adverse events. in present study a multi-center randomized case control study was conducted and we hypothesized that donepezil attenuate the pocd.


Eligibility criteria:
inclusion criteria: 1. elder than 60 years old 2. speak chinese mandarin 3. scheduled to undergo hip or knee replacement surgery and lumbar spine surgery 4. the operation time is more than 2 hours. 5. signed the informed consent 6. american society of anesthesiologists (asa) classification i-ii exclusion criteria: 1. existing cerebral disease, or have a history of neurological and psychiatric diseases including alzheimer disease, stroke, epilepsy and psychosis 2. existing cognitive impairment as evidenced by mini-mental state examination scores below 24 3. several audition or vision disorder 4. patients with tumors or infections 5. unwillingness to comply with the protocol or procedures 6. can not communicate normally in mandarin chinese 7. existing bradycardiac arrhythmia (heart rate \<60 bpm for any reasons) 8. existing gastrointestinal ulcer 9. existing urinary incontinence 10. existing asthma or chronic obstructive pulmonary disease 11. postoperative admission to icu 12. allergic to donepezil
talar avascular necrosis: surgical angiogenesis vs. core decompression

Conditions: Avascular Necrosis of Bone

Summary: the purpose of this study is to determine if surgical angiogenesis performed in talar avascular necrosis by free microvascular bone grafts from the medial femoral condyle is a superior technique compared to core decompression and nonvascularized osseous autografts.

the aim of this prospective randomized clinical trial is the comparison of two surgical treatment options for talar avascular necrosis (analogical to ficat and arlet stage ii and iii). the randomized study design allows direct comparability of the outcome after either core decompression and nonvascularized osseous autografting from the iliac crest or core decompression and osseous autografting with a free microvascular medial femoral condyle. talar avascular necrosis is caused by osseous malperfusion leading to malnutrition and destruction of the talar bone. the extend of this malperfusion is variable and can be categorized in 4 stages. the osseous defects can remain without consequences (stage i) or lead to irreversible talar destruction. the current treatment option for stage ii and iii is the core decompression followed by osseous auto grafting from the iliac crest. reducing the intraosseal pressure and filling the drill holes with the nonvascularized bone graft can lead to reperfusion of the talus. a new technique is to fill the drill hole with a vascularized bone graft from the medial femoral condyle, using microvascular anastomosis. this procedure has already been approved for the treatment of avascular necrosis and malperfusion of the carpus (lunate and scaphoid) as well as the femoral head. patients are examined preoperative as well as 3, 6 and 12 month after operation, documenting the active range of motion and pain sensation while resting and on activity. well established scores like the aofas ankle-hindfoot score and the lower extremity functional scale are used to get subjective and objective informations about patients' daily life and postoperative satisfaction. x-rays are taken at the same stages. mris of the ankle joint with contrast agent are performed before as well as 6 and 12 months after surgery. statistical analysis is performed using the statistical package for the social sciences (spss). the study protocol has been approved by the ethics commission of rheinland-pfalz. interventions are done according to the declaration of helsinki.

Eligibility criteria:
inclusion criteria: * patients with talar avascular necrosis without response to non-surgical treatment (immobilization) and with need for surgical intervention (ficat and arlet stage ii and iii; berndt and harty stage ii and iii) exclusion criteria: * talar avascular necrosis stage i (without need for surgical intervention) * surgical revascularization in the past * participation in a different study * pregnancy * peripheral artery occlusive disease * drug associated talar avascular necrosis * ongoing steroid therapy or chemo therapy

Keywords: talar avascular necrosis osteochondrosis dissecans femoral condyle
less bleeding by omitting aspirin in non-st-segment elevation acute coronary syndrome patients

Conditions: Non ST Segment Elevation Acute Coronary Syndrome

Summary: rationale: dual antiplatelet therapy, consisting of aspirin and a p2y12-inhibitor, reduces the risk of stent thrombosis, myocardial infarction and stroke after coronary stent implantation. inevitably, it is also associated with a higher risk of (major) bleeding. given the advances in stent properties, stenting implantation technique and pharmacology, it may be possible to treat patients with a single antiplatelet strategy by completely omitting aspirin. objective: this study will assess whether omitting aspirin reduces the rate of major or minor bleeding while remaining non-inferior to the current standard of care with regards to ischemic events in patients with non-st segment elevation acute coronary syndrome. study design: open-label, multicentre randomized controlled trial. study population: adult patients presenting with non-st segment elevation acute coronary syndrome undergoing percutaneous coronary intervention. intervention: in the intervention group aspirin will be completely omitted from the antiplatelet regimen in the 12 months following pci. main study endpoints: the primary bleeding endpoint is major or minor bleeding defined as bleeding academic research consortium type 2, 3 or 5 bleeding at 12 months. the primary ischemic endpoint is ischemic events defined as the composite of all-cause death, myocardial infarction and stroke at 12 months.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of nste-acs (i.e. nstemi or unstable angina) * successful pci (according to the treating physician) exclusion criteria: * known allergy or contraindication for aspirin or all commercially available p2y12-inhibitors (i.e. ticagrelor, prasugrel and clopidogrel) * concurrent use of oral anticoagulants (e.g. because of atrial fibrillation) * ongoing indication for dapt at admission (e.g. due to recent pci or acs) * planned surgical intervention within 12 months of pci * pregnant or breastfeeding women at time of enrolment * participation in another trial with an investigational drug or device
pharmacotoxicology of trichloroethylene metabolites

Conditions: Congenital Lactic Acidosis

Summary: to establish the relationship between human maai haplotype and dca and tyrosine metabolism. this aim test the postulates that maai haplotype determines, and thus can predict,1) dose-dependent dca kinetics and biotransformation.

the arms of the study involves determining the haplotype of individuals enrolled. then participants were divided into two groups based on their genotype. the groups include a genotype with an egt alle and a group of genotype without an egt alle. all subjects first took a low dose of dca 2.5ug/kg for 5 days then wait 30 days and take a therapeutic dose of dca 25mg/kg for 5 days on the first day and on the 5th day of taking dca kinetics were be done. a total of 16 blood samples were obtained through an intravenous catheter. urine collection will also occur. population pharmacogenetic analysis of mai allelic frequencies and the gc or lc-ms/ms techniques for blood or urinary metabolites were used in this investigation. pharmacokinetic data was used to determine metabolism rate of dca for each allele

Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * pregnancy * other medications * psychiatric illness on meds * abnormal labs

Keywords: dca dichloroacetate trichloroacetate
evaluating abx-egf extended therapy in subjects with metastaticcolorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is to examine the safety of abx-egf administered as monotherapy in subjects with metastatic colorectal cancer who were previously randomized to best supportive care (bsc) in protocol 20020408 and subsequently determined to have progressive disease.


Eligibility criteria:
inclusion criteria: - subject previously randomized to bsc in protocol 20020408 and subsequently determined to have progressive disease - ecog performance status of 0, 1 or 2 - adequate hematologic, renal and hepatic function exclusion criteria: - myocardial infarction in time interval between completing 20020408 and enrollment in study - history or evidence of interstitial pneumonitis or pulmonary fibrosis - prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics during the time interval between completing 20020408 protocol and enrollment in this study - use of systemic chemotherapy or radiotherapy during the time interval between completing 20020408 protocol and enrollment in this study

Keywords: metastatic colorectal cancer, colon colorectal, rectal cancer, egfr metastatic, cancer, abx-egf panitumumab, clinical trial immunex, abgenix, amgen
computed tomography coronary angiography for the prevention of myocardial infarction (the scot-heart 2 trial)

Conditions: Cardiovascular Diseases

Summary: it is hypothesised that, in individuals being considered for cardiovascular preventative therapy, computed tomography coronary angiography guided management will reduce the future risk of coronary heart disease death or non-fatal myocardial infarction compared to management guided by the current standard of care, a cardiovascular risk score.

prevention of cardiovascular disease is currently guided by probabilistic risk scores that both over and under treat individuals, commit most middle-aged people to pharmacotherapy, and have little evidence base. it has been demonstrated that use of computed tomography coronary angiography (ctca) is associated with changes in the diagnosis and treatment of patients presenting with stable chest pain, and that this leads to a marked reduction in the future risk of myocardial infarction. importantly, the proportionate reduction in coronary events was most marked in those with non-anginal chest pain irrespective of their cardiovascular risk score which again demonstrated poor discrimination. the research team propose a randomised controlled trial of at least 6,000 middle-aged individuals at risk of cardiovascular disease that will compare these two strategies of targeting preventative therapies: a probabilistic cardiovascular risk score, and screening with ctca. this trial will determine if ctca guided management will be associated with better targeted intervention, prevent over medicating the general population, and result in fewer future coronary heart disease events than the current standard of care using a cardiovascular risk score.

Eligibility criteria:
inclusion criteria * ≥40 and ≤70 years of age * resident in scotland and have a community health index (chi) number * one or more of the following risk factors: * \>60 years of age * current or recent (within 12 months) smoker * clinical diagnosis of hypertension * known hypercholesterolaemia or total cholesterol \>6.0 mmol/l or receiving statin therapy * diabetes mellitus * rheumatoid arthritis * systemic lupus erythematosus (sle) * family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease below 60 years) * chronic kidney disease stage 3 (estimate glomerular filtration rate 30-59 ml/min/1.73 m2). exclusion criteria * inability to undergo ctca * known coronary heart disease or other major atherosclerotic cardiovascular disease * prior invasive or non-invasive coronary angiography within the last 5 years * chronic kidney disease stage ≥4 (estimate glomerular filtration rate \<30 ml/min/1.73 m2) * known homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapy * intolerance of all statins * statin therapy for \>2 years. * previous coronary artery imaging completed specifically for cardiovascular risk assessment with a result of \>10 au.

Keywords: cardiology computed tomography coronary angiography
a study of pf-05280014 [trastuzumab-pfizer] or herceptin® [trastuzumab-eu] plus paclitaxel in her2 positive first line metastatic breast cancer treatment (reflections b327-02)

Conditions: Metastatic Breast Cancer

Summary: the current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of pf-05280014 in combination with paclitaxel versus trastuzumab sourced from the european union (trastuzumab-eu) with paclitaxel in female patients with her2-positive, metastatic breast cancer in the first-line treatment setting. the hypothesis to be tested in this study is that the efficacy (orr) of pf-05280014 is similar to trastuzumab-eu.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of breast cancer. * presence of metastatic disease. * documentation of her2 gene amplification or overexpression. * available tumor tissue for central review of her2 status. * at least 1 measurable lesion as defined by recist 1.1. * eastern cooperative oncology group status of 0 to 2. * left ventricular ejection fraction within institutional range of normal, measured by either two dimensional echocardiogram or multigated acquisition scan. exclusion criteria: * relapse within 1 year of last dose of previous adjuvant (including neoadjuvant) treatment (except endocrine therapy) and within 1 year before randomization. * prior systemic therapy for metastatic disease (except endocrine therapy). * prior cumulative dose of doxorubicin of \>400 mg/m2, epirubicin dose \>800 mg/m\^2, or the equivalent dose for other anthracyclines or derivatives (eg, 72 mg/m\^2 of mitoxantrone). if the patient has received more than one anthracycline, then the cumulative dose must not exceed the equivalent of 400 mg/m\^2 of doxorubicin. * inflammatory breast cancer. * active uncontrolled or symptomatic central nervous system metastases.

Keywords: phase 3 trastuzumab breast neoplasms
effectiveness of neuromuscular taping on painful hemiplegic shoulder

Conditions: Hemiplegia

Summary: painful shoulder syndrome is a frequent complication after stroke occurring in between 5% and 84% of patients, often having a strong impact on their well-being and resulting in delays achieving rehabilitative objectives. the aim of the study is to demonstrate the effectiveness of neuromuscular taping in a population of post-stroke hemiplegic patients suffering from painful shoulder syndrome with respect to pain, spasticity and range of motion.

the study will use two groups according to the methodology of randomized controlled trials. both components of the two groups were treated by four rehabilitation sessions defined as "standard". this involves joint health and passive mobility for the glenohumeral and scapulothoracic joints for a period of about 45 minutes each. the patients of the sample group underwent the application of the neuromuscular taping (nmt) before each rehabilitative session. the control group was addressed exclusively to the "standard" treatment. the sessions were spaced apart about five days to ensure the optimum adhesion of nmt. the results were evaluated by administering rating scales for pain (vas) and spasticity (modified ashworth scale). the rom was evaluated using the manual goniometer. the outcomes (pain, spasticity, rom) were assessed at base line, before and after each treatment session and at 1 month follow up.

Eligibility criteria:
inclusion criteria: * right or left hemiplegia resulting from an ischemic or hemorrhagic stroke * painful shoulder syndrome, with pain at rest and during functional movement of the shoulder girdle * spasticity with an ashworth score greater than or equal to 1. exclusion criteria: * flaccidity * thermoalgesic sensitivity deficits * previous surgery to the shoulder * cognitive impairment * taking anti-inflammatory drugs and/or muscle relaxants during the course of the trial

Keywords: stroke hemiplegia painful shoulder syndrome neuromuscolar taping
chemotherapy in treating patients with non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to compare the combination of pemetrexed and carboplatin with the combination of docetaxel and carboplatin in terms of survival without grade 3 or 4 toxicity in previously untreated patients with locally advanced or metastatic non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * patient with locally advanced or metastatic (stage iiib/iv) ncslc with no prior chemotherapy for advanced disease or molecular target treatment * easter cooperative oncology group (ecog) performance status 0 to 2 * estimated life expectancy of at least 8 weeks exclusion criteria: * known or suspected brain metastases * concurrent administration of any other tumor therapy * serious concomitant disorders * pregnancy or breast feeding * inability or unwillingness to take folic acid or vitamin b12 supplementation
influence of parents and friends on children and adolescents

Conditions: Healthy

Summary: the objective of this study is to directly compare the effects of parents and friends on overweight and non-overweight children and adolescents' food intake and food selection using a cross-sectional design. overweight and non-overweight children (5-6 year-old) and adolescents (13-14 year-old) will share a meal with a friend and with a parent on separate occasions. participants' food selection and the amount of food they consumed will be compared across conditions. hypothesis 1: the investigators hypothesize that overweight children and adolescents will select more unhealthy food items and eat more in the presence of an overweight friend than when eating with a lean friend; whereas lean participants eating with an overweight friend will eat a similar amount of food than lean youth eating with a lean friend. hypothesis 2: the investigators predict that overweight children and adolescents (but not lean children and teens) will consume more food in the presence of their mother than in the presence of a friend. hypothesis 3: the investigators also predict that overweight youth's energy intake will be related to parental prompts. hypothesis 4: the investigators expect greater similarities in terms of food selection and food intake between adolescents and their friend than between adolescents and their parent.


Eligibility criteria:
inclusion criteria: * boys and girls ages 5-6 yrs and 12-14 yrs and their mothers * children must have a bmi greater than or equal to 15th percentile for their age * children and their mothers must have at least a moderate liking of the study foods used exclusion criteria: * participants should not have any food allergies * participants should have no dietary restraints * participants should have no psychopathology that can limit food choice and alter eating * participants should have no developmental disabilities that can limit food choice and alter eating * participants cannot have a cold or upper respiratory distress that could influence taste, appetite or olfactory sensory responsiveness * participants cannot be on any medications that could influence taste, appetite or olfactory sensory responsiveness

Keywords: social influences meals obesity amount of food consumed
long-term investigation of resveratrol on fat metabolism in obese men with nonalcoholic fatty liver disease

Conditions: Obesity; Nonalcoholic Fatty Liver Disease

Summary: the purpose of this study is to investigate potential metabolic effects of resveratrol in obese healthy men with non-alcoholic fatty liver disease. the investigators hypothesize that resveratrol will: * decrease hepatic very-low-density-lipoprotein-triglyceride (vldl-tg) secretion * decrease liver fat content * increase insulin sensitivity the investigators will look at changes in: * lipid turnover (vldl-tg kinetics, palmitate kinetics, indirect calorimetry) * liver fat content (mr liver spectroscopy) * insulin sensitivity (glucose kinetics during hyperinsulinaemic euglycaemic clamp) * body composition (dxa and mri) * lipase activity and fat cell size (fat biopsy from abdominal and femoral adipose tissue)


Eligibility criteria:
inclusion criteria: * male * 25-65 years * obesity (bmi \> 28 kg/m2, waist/hip ratio \> 0,95) * have nonalcoholic fatty liver disease (nafld)(intervention group) or do not have nafld (control group) * may have hypertension and/or hypercholesterolemia * written informed consent exclusion criteria: * any other disease than nafld (e.g. diabetes, thyroid or parathyroid disease, heart, liver or kidney disease) * present and previous malignancy * alcohol dependency (more than 21 units of alcohol per week) * history of smoking * participation in studies with radioactive isotopes within the last six months * hemoglobin under normal range regarding to sex (under 8.3 mmol/l for men)

Keywords: obesity resveratrol nonalcoholic fatty liver disease insulin sensitivity lipid turnover liver fat content