Kornimate/medical-research-clean huggingface dataset:
late evening and early morning protein supplement to reduce readmissions for hepatic encephalopathy

Conditions: Hepatic Encephalopathy

Summary: readmission rates for patients with hepatic encephalopathy due to end stage liver disease are high. hyperammonemia contributes significantly to encephalopathy and occurs because of impaired hepatic ureagenesis and increased skeletal muscle proteolysis. we propose a randomized, 6-month nutritional intervention in cirrhotic patients who have had at least 1 admission for hepatic encephalopathy within the last 6 months. we hypothesize that a combination of late evening and early morning protein supplement (ensure enlive) will decrease recurrent hepatic encephalopathy and consequent readmission rates by lowering skeletal muscle proteolysis and improved lean body mass.


Eligibility criteria:
inclusion criteria: * \> 18 years of age * cirrhosis diagnosed by clinical history and liver biopsy and/or clinical, biochemical and imaging evidence of cirrhosis * at least 1 hospitalization for documented he within the last 12 months. * abdominal ct scan anytime in the past exclusion criteria: * patients with meld score \> 35 * end stage organ failure (major dysfunction requiring organ support) * kidney injury defined by a creatinine \> 2 mg/dl or rise in creatinine by 0.5 gm/dl from baseline that is unresponsive to withholding diuretics and intravenous albumin administration (1 gm/kg up to 100 gm/day) * active malignancy * uncontrolled diabetes mellitus with a1c\>9.5 (to avoid altered muscle protein metabolism * medications (anabolic steroids, corticosteroids) that affect skeletal muscle mass * recent gastrointestinal surgery within past 12 months * ongoing infection (positive blood or other body fluid cultures) * active gastrointestinal bleeding.
food advertisements, satiety and food intake in children

Conditions: Obesity Prevention

Summary: we hypothesized that fa in a tv program watched during a meal, would block satiety responses to pre-meal energy consumption and delay satiation in ow/ob but not in nw boys and girls. food intake was measured at 30 min following a glucose (1 g of glucose/kg body weight) or sweetened noncaloric beverage with or without the presence of food advertisements. subjective appetite will be measured as well.


Eligibility criteria:
inclusion criteria: * born at full-term and of normal birth weight with no emotional, behavioral or learning problems exclusion criteria: * emotional, behavioral or learning problems dieting

Keywords: children food advertisement obesity television viewing food intake
duration of behavioral counseling treatment needed to optimize smoking abstinence

Conditions: Tobacco Addiction

Summary: the purpose of this study is to determine if extending the behavioral smoking-cessation treatment period to one year will significantly improve cessation outcomes among those planning a quit attempt.


Eligibility criteria:
inclusion criteria: * daily cigarette smokers exclusion criteria: * smokers with active atherosclerotic heart disease, severe cardiac arrhythmias, uncontrolled hypertension, severe peripheral vascular disease, pre-controlled diabetes mellitus, pregnancy, lactation or likely to become pregnant during the study period, and chronic dermatologic disease. * smokers who meet dsm-iv lifetime criteria for conditions such as schizo-affective disorder and schizophrenia, bi-polar disorder, or who have had alcohol or drug dependence issues within the past year.
high blood pressure strategy (hbps)

Conditions: Hypertension

Summary: this program developed by the hsfo aims at helping people of ontario and their primary healthcare providers better diagnose, manage and control high blood pressure. the high blood pressure strategy brings together healthcare providers and patients to improve the way in which family doctors, nurse practitioners and pharmacists work together and with patients towards improved control of high blood pressure through the use of evidence-informed tools combined with local systems change.

approximately 5,000 patients will participate in the study at 11 family practice sites throughout ontario. each of the 11 clinic sites will be randomised to either intervention or delayed intervention 9 months later. the intervention is a systems change involving interprofessional education and management tools to bring together physicians, nurses and pharmacists with the patient. patients will be monitored by their family doctor or nurse practitioner at scheduled follow-up visits during a period of 36 months for an effect of the intervention over time on the patient's blood pressure.

Eligibility criteria:
inclusion criteria: * adults aged 18 years or older * history of elevated bp reading or primary hypertension diagnosis exclusion criteria: * major mental health illness of cognitive impairment * language barrier (unable to speak or read english) * lives in a long-term care home * secondary hypertension

Keywords: hypertension blood pressure
traditional chinese medicine five elements music therapy improving quality of life in patients with advanced cancer

Conditions: Cancer

Summary: the study objective is to evaluate the effectiveness of traditional chinese medicine (tcm) five elements music therapy improving quality of life for patients with advanced cancer, as well as establishing the standard operating procedures (sop) for it.

design: as randomized controlled trial (rct) with un-blinded design will be done.

Eligibility criteria:
inclusion criteria: * eligible participation will be enrolled based on diagnostic criteria. * advanced cancer patient with more than 50 scores of karnofsky performance score (kps). * diagnosis of advanced cancer * patients who are willing to be subject with taking part in this research voluntarily. * no prior experience with tcm music therapy. * newly admitted to tcm oncology department for 3 weeks treatment course. exclusion criteria: * complicated diagnose or one who don't consistent with inclusion criteria. * patients suffering from psychosis or diagnosis, or psychiatric diagnoses (e.g., schizophrenia). * suffering from acute organ prostration or other condition of demanding to rescue，inability for accepting music therapy. * one don't read or fill in diary owing to some causes, such as state of the art or acuity of vision * one suffering from hearing disturbance * accepted tcm five elements music therapy in the past.

Keywords: advanced cancer tcm five elements music therapy quality of life (qol)
imaging biomarkers for tms treatment of depression

Conditions: Depression

Summary: the purpose of this research is to learn more about how rtms works to reduce the symptoms of depression. this information can be used to improve the effectiveness of the treatment. the study will use functional magnetic resonance imaging (fmri) to examine changes in brain function after treatment with rtms. fmri is a safe and painless technique that allows investigators to observe the brain "at work." the investigators will use fmri to see what regions of the brain become active when you perform a concentration task and how that activation is changed after rtms.


Eligibility criteria:
inclusion criteria: * primary diagnosis of major depressive disorder * male and female subjects, ages 22-65 * have failed at least 1 antidepressant medication at adequate dose and duration * on stable antidepressant medication regimen for at least 4 weeks prior to tms therapy exclusion criteria: * diagnosed with a psychotic, bipolar, obsessive-compulsive or post-traumatic stress disorder * active substance abuse, including alcohol * medical and/or neurological condition that could affect your brain function or risk of seizure, including a stroke, epilepsy, or a closed head injury; * no presence of an implanted device like a pacemaker/neurostimulator or metal in the head or body; * pregnant or trying to get pregnant * failed to respond to an adequate course of electroconvulsive therapy (ect) * previous treatment with tms * current depressive episode longer than 5 years

Keywords: major depression major depressive disorder tms rtms
combination with intranasal dexmedetomidine and oral midazolam for premedication in pediatric patients

Conditions: Anxiety

Summary: children tend to anxiety and even fear before survey. and this kind of anxiety will not result in the forced induction of anesthesia, but also may increase the incidence of postoperative agitation in children, even lead to postoperative behavior changes.currently,oral midazolam or intranasal dexmedetomidine alone is commonly used as a preoperative regimen, but the clinical effects of each single-use are not satisfactory. in the investigators' study，the researchers conducted the current study to investigate whether dexmedetomidine combined with midazolam can increase the rate of satisfactory anesthesia induction in pediatric patients and achieve better sedative effect.

a trained member of the research team obtained a baseline the modified yale preoperative anxiety scale(mypas) after obtaining consent. and corresponding study medication is administered about 30-40 minutes before the anesthesia induction.vital signs were measured every 5 min after study medication administration.the sedation scores of the children were recorded with university of michigan sedation scale (umss) every 10 minutes.the onset time of satisfactory sedation and parental separation anxiety scale was noted.then recorded the degree of cooperation during inhalation anesthesia induction and recovery times.moreover, recorded the pediatric anesthesia emergence delirium scale (paed) during the recovery period.

Eligibility criteria:
inclusion criteria: 1. with american society of anesthesiologists (asa) physical status i or ii； 2. aged 2-6 years； 3. children with weight for age within the normal range 4. were scheduled lower abdominal and perineal surgery with an expected operation time shorter than 30 minutes. exclusion criteria: 1. children who had gastrointestinal,cardiovascular or endocrine dysfunction; 2. contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to either dexmedetomidine or midazolam; 3. with any nasal pathology,organ dysfunction; 4. recently respiratory infection, mental disorder; 5. other reasons that researchers hold it is not appropriate to participate in this trial.
a phase 1 study of amg 211 in participants with advanced gastrointestinal cancer

Conditions: GI Adenocarcinoma

Summary: the purpose of this phase 1 study is to determine if amg 211 given as a continous intravenous (iv) infusion is safe and tolerable in adult participants that have advanced gastrointestinal adenocarcinoma. the study will be conducted in multiple sites and test increasing doses of amg 211. the safety of participants will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests. efficacy will be assessed by the usual imaging procedures and their interpretation.


Eligibility criteria:
inclusion criteria: * informed consent provided * 18 years or older * advanced relapsed/refracted gastrointestinal adenocarcinoma * at least 1 measurable tumor lesion * tumor tissue available or is willing to undergo biopsy of a tumor lesion before the start of treatment * adequate hematological, renal, and liver function * body weight ≥ 45 kg * other inclusion criteria may apply exclusion criteria: * malignancy other than gastrointestinal (gi) adenocarcinoma requiring current therapy * evidence of uncontrolled systemic disease, active infection, hepatitis b and/or c, human immunodeficiency virus (hiv), history of cardiac disease, history of significant central nervous system (cns) disease, history of chronic autoimmune disease (with the exception of stable type 1 diabetes) * major surgery within 28 days of study day 1 * currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment in another investigational device or drug study. other investigational procedures while participating in this study are excluded. exception to this criterion is the participation in the optional imaging study and all procedures related to this study. * treatment with any chemotherapy, radiotherapy, immunotherapy, biologic, or hormonal therapy for cancer within 14 days prior to study entry and not recovered from treatment * unresolved toxicities from prior anti-tumor therapy * males or females of reproductive potential, and unwilling to practice an acceptable method of effective birth control while on study through 30 days after receiving the last dose of study drug * females who are pregnant, planning to become pregnant, lactating/breastfeeding or who plan to breastfeed while on study through 30 days after receiving the last dose of study drug * other exclusion criteria may apply

Keywords: amgen phase 1 clinical trial oncology gi adenocarcinoma immunotherapy
a registry study on genetics and biomarkers of thoracic aortic aneurysm/dissection

Conditions: Aortic Aneurysm, Thoracic; Aneurysm, Dissecting

Summary: this is a national registry study to determine genetic risk factor and serial biomarkers of thoracic aortic aneurysm/dissection


Eligibility criteria:
case inclusion criteria: 1. subject who was diagnosed as thoracic aortic aneurysm/dissection by ct angiography, interventional angiography or vascular ultrasound; 2. age is less than 80 years old; 3. male and non pregnancy female; 4. subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures. case exclusion criteria: subject has one of the following: 1. pseudoaneurysm; 2. previous infection or trauma in the damaged part of aorta; 3. pregnancy female; 4. participate in other clinical trials in the last 1 months. control inclusion criteria: 1. age and gender are matched with cases; 2. no aortic disease was detected by outpatient ultrasound; 3. no family history of cardiovascular disease; 4. normal biochemical indicators; criteria for culling, shedding and suspension testing: 1. culling: unqualified cases and controls. data of culled subjects can not be used for statistical analysis; 2. shedding: subject that self withdrawal, loss to follow-up, or quitted by doctors; reasons for shedding should be indicated for each shed subject. 3. suspension: a) the researchers found significant safety problems or wrong study design; b) researchers cannot continue clinical research due to funding or management reasons; c) director ends the study. when suspension happens, all the crf table should be reserved for future reference.
mechanism-based choice of therapy for neuropathic pain

Conditions: Pain

Summary: mechanism-based choice of therapy for neuropathic pain: can treatments success in neuropathic post-operative pain be coupled to psychophysical pain modulation profile?

neuropathic or idiopathic pain patients will be assessed with the variety of pain tests including the conditioned pain modulation (cpm) and temporal summation (ts). then, they will be offered on the double-blind design a several weeks treatment with either pregabalin or duloxetine. patients will be followed-up weekly by phone for their pain relief and will be re-assessed in the lab toward the end of the treatment. the investigators suggest that patients with less-efficient cpm (deficient pain inhibition) will "earn" more pain relief from the treatment with duloxetine, while the patients with the enhanced pain summation will response better to pregabalin.

Eligibility criteria:
inclusion criteria: * patients planned for thoracotomy exclusion criteria: * age below 18 and above 75 years * patients with psychiatric or cognitive dysfunction precluding use of psychophysics * those who cannot communicate in hebrew * patients with existing thoracic or other current chronic pain
oral immunotherapy in food allergy in finland

Conditions: Food Hypersensitivity; Immune System Diseases; Anaphylaxis

Summary: the outcomes of oral immunotherapy (oit) in food allergy study will provide more knowledge of oral immunotherapy. so far the oit has showed in clinical experiments to be a interesting way to increase the unresponsiveness in severe food allergies. however little is known about it´s long-term outcomes, immunological mechanisms and there are no previous studies about cost-utility of oit.

the purpose of the present study is to examine the outcomes of the food oral immunotherapy on patients with severe food allergy in the three different subprojects: study 1: long-term follow up after milk oral immunotherapy. the measured outcomes are long-term effectiveness (e.g. health-related quality of life), safety of desensitization and immunological changes. study 2: measure health-related quality of life with disease-specific and generic questionnaire. the aim of this study is to define the suitability of the faqlq and the 15-d questionnaires for the finnish food allergic patients. another purpose of this study is to examine the relationship between faqlq and 15-d questionnaires. study 3: qalys. this is called the cost-utility analyses and qalys and its purpose is to calculate the cost of oit and to define the cost-effectiveness of oit by measuring qalys. to our knowledge this will be the first pilot study to define the qalys in food oral immunotherapy. the aim is to have 50-100 patients. the literature in other areas of medicine 50-100 patients in qaly-publishing is quite plain.

Eligibility criteria:
inclusion criteria: * study 1: all the children have been eligible to participate milk oit during the years 2005-2015. * study 2 + 3: patients will start oit treatment (to milk / egg / peanut). exclusion criteria: * not willing to participate * active asthma, low lung function, pregnancy, cardiovascular or other disease that might worsen during the oit.

Keywords: food allergy health-related quality of life (hrql) quality-adjusted life-years (qalys) oral immunotherapy (oit) cow´s milk allergy (cma) milk oral immunotherapy (moit)
choice of anesthesia in microelectrode recording guided deep brain stimulation for parkinson's disease

Conditions: PD - Parkinson's Disease; Dexmedetomidine; Desflurane; Deep Brain Stimulation

Summary: subthalamic nucleus (stn)-deep brain stimulation (dbs) under general anesthesia has been applied to pd patients who cannot tolerate awake surgery, but general anesthesia will affect the electrical signal in microelectrode recording (mer) to some degree. this study is a prospective randomized controlled, noninferiority study, open label, endpoint outcome evaluator blinded, two-arm study. parkinson's disease patients undergoing stn-dbs are randomly divided into a conscious sedation group (dexmedetomidine) and a general anesthesia group (desflurane). normalized root mean square (nrms) is used to compare the difference of neuronal activity between the two groups. the primary outcome is the percentage of high nrms recorded by the mer signal (with the average nrms recorded by mer after entering the stn greater than 2.0). the secondary outcomes are the nrms, length of the stn, number of mer tracks, and differences in clinical outcomes 6 months after the operation.

stn-dbs under general anesthesia has been applied to pd patients who cannot tolerate awake surgery, but general anesthesia will affect the electrical signal in microelectrode recording (mer) to some degree. at present, there are some studies on the effects of desflurane on neuronal signal amplitude and discharge characteristics during stn-dbs in pd patients but there is no definite conclusion. this study compares the influence of mer mapping during stn-dbs and the differences in postoperative clinical outcomes between desflurane general anesthesia and conscious sedation anesthesia to explore alternative anesthesia for dbs in pd patients who cannot tolerate local anesthesia or conscious sedation and to provide feasible anesthesia techniques for the application of mer during dbs under general anesthesia. this study is a prospective randomized controlled, noninferiority study, open label, endpoint outcome evaluator blinded, two-arm study. parkinson's disease patients undergoing stn-dbs are randomly divided into a conscious sedation group (dexmedetomidine) and a general anesthesia group (desflurane). the primary outcome is the percentage of high nrms recorded by the mer signal (with the average nrms recorded by mer after entering the stn greater than 2.0), which is used to compare the differences in neuronal electrical activities between conscious sedation and general anesthesia via desflurane groups. the secondary outcomes are the nrms, length of the subthalamic nucleus, number of mer tracks, and differences in clinical outcomes 6 months after the operation.

Eligibility criteria:
inclusion criteria: 1.50-80 years old, asa grade ii-iii; 2.bilateral stn-dbs of patients with parkinson's disease; 3.signed informed consent. exclusion criteria: 1. obstructive sleep apnea; 2. bmi \> 30kg/m2; 3. estimated difficult airway; 4. severe preoperative anxiety; 5. serious dysfunction of important organs (i.e. heart failure, renal or liver dysfunction) 6. a history of allergy to the anaesthetics.
clinical evaluation of a specific enteral diet for diabetics

Conditions: Hyperglycemia; Diabetics; Metabolic Syndrome

Summary: the hypothesis of the proposed trials is that the regular intake of a specific diet designed for enteral nutrition of type 2 diabetic patients results into a better nutritional status. thus, the aim of the study is to scientifically evaluate the healthy effects of the administration of an enteral complete diet for diabetic patients (t-diet plus diabet).

this new complete diet has been carefully formulated, and incorporates functional ingredients based on: 1. a good gastrointestinal and metabolic tolerance of the product. 2. beneficial outcomes in the nutritional status. 3. a good control of the glycaemic response and the lipidic profile, allowing an improvement of metabolic syndrome and insulin resistance indicators and hunger-satiety regulation. the experimental enteral product is a complete diet that includes, as carbohydrates, high-molecular maltodextrin, resistant maltodextrin, fructooligosaccharides and cellulose, and does not contain added fructose. indeed, this product contains eicosapentaenoic acid (epa) and docosahexaenoic acid (dha).

Eligibility criteria:
inclusion criteria: * diabetic subjects older than 55 years. * male or female * requirement of total enteral nutrition (ten) during at least 3 months. * under medical supervision. * voluntary informed consent for participation. exclusion criteria: * unstable clinical situation * fatal illness * patients treated with lipidic drugs * refusal to participate in the study or being enrolled in other clinical trials. * social or humanitarian reason

Keywords: t-diet plus diabet np diabetic enteral nutrition glycaemic response metabolic syndrome insulin resistance lipidic profile