Kornimate/medical-research-clean huggingface dataset:
pediatric intensive care ulcer prophylaxis pilot trial

Conditions: Gastrointestinal Hemorrhage

Summary: this study tests the feasibility of a large study of stress ulcer prophylaxis in critically ill children. children admitted to the pediatric intensive care unit who are expected to require mechanical ventilation for more than 48 hours will be randomized to intravenous pantoprazole 1 mg/kg or matching placebo once daily until they no longer need mechanical ventilation.

despite sparse pediatric data on the effectiveness of stress ulcer prophylaxis to prevent gastrointestinal (gi) bleeding, 60% of critically ill children receive these medications. this may have unintended consequences - increasing the risk of nosocomial infections - which may be more serious and common than bleeding these drugs are prescribed to prevent. a large randomized trial (rct) is needed to assess the balance of these risks and benefits, to determine if a strategy of withholding stress ulcer prophylaxis in critically ill children is not inferior to a strategy of routine stress ulcer prophylaxis. rcts in pediatric critical care are exceptionally challenging to complete; thus, a rigorous pilot rct is crucial. the pilot may prevent pursuit of a trial that is ultimately not feasible - which is ethically and financially responsible. it is more likely that this carefully designed pilot trial will ensure that the larger trial we undertake is successful.

Eligibility criteria:
inclusion criteria: 1. less than 18 years of age 2. \>4 months of age 3. requires respiratory support in the form of invasive mechanical ventilation, non-invasive mechanical ventilation, or high-flow oxygen 4. the attending physician expects the child to require respiratory support for at least 2 more days exclusion criteria: 1. histamine-2 receptor antagonist (h2ra) or proton pump inhibitor (ppi) use for \>1 week in the past month 2. active gi bleeding blood in the nasogastric (ng) tube or coffee-ground emesis suspected by the attending physician to be from the oropharynx is not an exclusion criterion. 3. documented severe reflux, active h. pylori infection, severe esophagitis, zollinger ellison syndrome, barrett's esophagus, peptic ulcer bleeding within 8 weeks 4. are receiving methylprednisolone 15 mg/kg/day or more (or equivalent) equivalent doses: methylprednisolone, prednisone or prednisolone 15 mg/kg/day; dexamethasone 3 mg/kg/day; hydrocortisone 60 mg/kg/day 5. are receiving mycophenolate (enteral), methotrexate, nelfinavir, atazanavir, saquinavir, posaconazole 6. chronic ventilation on usual pressure settings and rate 7. nocturnal or intermittent non-invasive ventilation only 8. are eating, nursing, or if chronically fed via feeding tube, receiving usual feeds 9. received more than 1 daily-dose equivalent of acid suppressive medication in the picu 10. were previously enrolled in this trial 11. are currently enrolled in a potentially confounding trial 12. are known to be pregnant or breastfeeding 13. are known to be allergic to pantoprazole or any other ingredient in the product 14. are not expected to survive this picu admission because of palliative care or limited life support
enteral nutrition product in mild acute pancreatitis

Conditions: Acute Pancreatitis; Enteral Nutrition

Summary: the aim of the study is to evaluate the beneficial effects of the administration of enteral nutrition product with milk proteins, monounsaturated fatty acids and low dextrose equivalent maltodextrin and enriched in eicosapentaenoic acid (epa), docosahexaenoic acid (dha) and medium chain triglycerides (mct) in patients with mild acute pancreatitis. all this against other specific product. the main objectives of this project are: * comparing the tolerance of both preparations. * comparing the evolution of nutritional status in both groups. * comparing the evolution of inflammatory parameters in both groups

oral administration of an oligomeric formula with milk proteins, mainly whey protein partially hydrolysate, monounsaturated fatty acids (agm) and low dextrose equivalent maltodextrin and enriched in polyunsaturated fatty acids (pufa) of omega-3 series, epa and dha, and mct designed for nutritional support of patients with compromised intestinal function, to maintain or improve nutritional status and reduce the inflammatory response in undernourished patients with mild acute pancreatitis, compared with oligomeric enteral nutrition product, low in fat and rich in glutamine.

Eligibility criteria:
inclusion criteria: * patients over 18 with mild acute pancreatitis. exclusion criteria: * patients with several acute pancreatitis * patients with life expectancy less than 48 hours. * renal (creatinin \> 2,5 mg/dl) or kidney failure (got/gpt\>2 from laboratory normal value) * patients with diabetes mellitus prior to acute pancreatitis. * to take part in another study. * pregnant patients * informed consent absence.

Keywords: acute pancreatitis enteral nutrition nutritional status pancreas t-diet plus atémpero
vitamin d supplementation and tb

Conditions: Tuberculosis; Vitamin D; Immunity

Summary: the goal of this study is to understand the effects of vitamin d supplementation on immunological outcomes among patients with tuberculosis.

in this randomized trial, the investigators will enroll 200 adults with active pulmonary tuberculosis (tb; among whom 40 have hiv co-infections) at the time of tb diagnosis in s india. the intervention will include daily vitamin d supplementation in 3 treatment arms (600, 2000, and 4000 iu vitamin d), compared to placebo, for 12 months. the investigators' primary objectives are to assess how vitamin d supplementation affects immunity (immunological markers, immune competence) and serum vitamin d levels. secondary outcomes include tb treatment outcomes (successful sputum smear conversion, relapse) in all patients, and human immunodeficiency virus (hiv) disease progression among a subset of patients with hiv co-infection.

Eligibility criteria:
inclusion criteria: * active tb diagnosis by genexpert * hiv infection status (according to amc hiv clinic medical records of enzyme-linked immunosorbent assay \[elisa\] results) exclusion criteria: * children (\<18 years of age) * 60 years of age * pregnant at baseline * other severe complications or illnesses requiring hospitalization * received tb treatment for greater than 4 weeks in the past 5 years * refused to participate * residing in a geographic location \> 1 hour from amc (by public transit)

Keywords: tuberculosis vitamin d immunity
computerized cognitive training in young adults with depression

Conditions: Depressive Symptoms

Summary: the purpose of the study is to examine the benefits and mechanism of action of computerized cognitive training (cct) on mood, neuropsychological deficits, everyday functioning, and brain activity among young adults with a range of depressive symptoms.


Eligibility criteria:
inclusion criteria: 1. age 18-29. 2. current diagnosis of mdd/persistent depressive disorder or hdrs greater than or equal to 12. 3. daily access to smartphone or tablet with internet connection for the study duration. 4. willing and able to complete mri, mood, and neuropsychological testing. 5. iq \> 85. exclusion criteria: 1. lacks english-speaking ability as determined by self-report and clinical evaluation. 2. evidence of schizophrenia, schizoaffective disorder, psychosis, bipolar i and ii disorder. 3. active suicidal ideation, intent, or plan, or past attempt within 1 year. 4. severe depression (hdrs \> 30). 5. neurological disorder (epilepsy, multiple sclerosis, traumatic brain injury, clinical stroke). 6. use of medications known to have negative impact on cognition (benzodiazepines and lorazepam equivalents \> 1mg daily, narcotics, anticholinergics). 7. history of alcohol or drug abuse or dependence within past year. 8. acute, severe, unstable medical illness. for cancer, acutely ill patients (including those with metastases) are excluded, but past history of successfully treated cancer does not result in exclusion. 9. regular online brain training or regular player of non-fluency verbal games, defined as doing these procedures at a frequency of twice weekly or greater during the year prior to screening.
biomarkers for the detection of heavy alcohol use in patients with and without liver disease

Conditions: Alcohol Abuse; Liver Disease

Summary: the investigators will test the validity of biomarkers for the detection of heavy alcohol use in patients with and without liver disease.

the investigators will test the validity of biomarkers for the detection of heavy alcohol use in patients with and without liver disease. the investigators will test the validity of carbohydrate deficient transferrin (cdt)(using capillary zone electrophoresis) in blood and ethyl glucuronide (etg)(using liquid chromatography-ms-ms) in hair in patients with heavy alcohol use, moderate alcohol use and patients who do not drink alcohol.

Eligibility criteria:
inclusion criteria: * patients who do not drink alcohol, moderate drinkers (between 0 and 60 g a day) and patients who drink 60 or more grams alcohol a day exclusion criteria * refusal for inclusion
p2 study of postoperative interferon/fluorouracil vs cisplatin/fluorouracil for hepatocellular carcinoma.

Conditions: Hepatocellular Carcinoma

Summary: to evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy, interferon/fluorouracil versus low-dose cisplatin/fluorouracil, in patients with hepatocellular carcinoma with portal vein tumor thrombus.

no standard treatment has been established for highly advanced hepatocellular carcinoma (hcc) invading the major branches of the portal vein except for sorafenib. some reports suggested that hepatic arterial infusion chemotherapy improved survival of these patients. other reports indicated surgical intervention improved that survival. however, there is no standard adjuvant therapy after liver resection for the patients with hcc with portal vein tumor thrombus in the main or first branch of the portal vein. our preliminary results showed that combined interferon-alpha and intra-arterial 5-fluorouracil (5-fu) as a postoperative therapy prolonged disease-free and overall survival after liver resection. hepatic arterial infusion chemotherapy using low-dose 5-fu and cisplatin is also promising regimen for advanced hcc. herein, the investigators planed the study to evaluate efficacy (two year survival as primary outcome, and overall-survival as secondary outcome) and safety ( as secondary outcome) in hepatic arterial infusion chemotherapy with continuous infusion of 5-fluorouracil and systemic administration of interferon-alpha or low-dose 5-fu and cisplatin, and to compare the efficacy as randomized control trial.

Eligibility criteria:
inclusion criteria: 1. hepatocellular carcinoma with histological or evidence or typical findings by ct or mri. 2. surgically resectable tumors with tumor thrombus in first branch or main trunk of portal vein. 3. 20 years old or more. 4. eastern cooperative oncology group performance status of 0 or 1. 5. life expectancy of at least 6 months at the pre-treatment evaluation. 6. child-pugh class a or b. 7. adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements. white blood cell count \>= 2000/microliter, neutrophil \>= 1000/microliter, hemoglobin \>= 9.0 g/dl, platelet count \>= 75000/microliter, total bilirubin \ = 60 ml/min - exclusion criteria: 1. histological diagnosed combined hepatocellular and cholangiocellular carcinoma. 2. extrahepatic tumor spread which affects patient's prognosis. 3. hepatic encephalopathy 4. active infections except for hepatitis b virus(hbv) and hepatitis c virus(hcv). 5. sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on) 6. active double cancer 7. pregnancy 8-10) medication or treatment that may affect to the absorption of drug or pharmacokinetics. 11) others, in the investigator's judgment. -
pilot study for automated deep brain stimulation programming

Conditions: Parkinson's Disease; Tremor; Bradykinesia

Summary: the clinical utility of deep brain stimulation (dbs) for the treatment of movement disorders such as parkinson's disease has been well established; however, there is a great disparity in outcomes among dbs recipients due to varied postoperative management, particularly concerning the choosing of an optimal set of programming parameters from the thousands of possible combinations. this study will evaluate the use of motion sensor based assessments to develop a functional map and algorithms to automatically determine a set of programming parameters that maximize symptomatic benefits while minimizing side effects and battery consumption.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of idiopathic parkinson's disease * implanted deep brain stimulation system awaiting initial programming session exclusion criteria: * subjects with significant psychiatric illness or dementia * significant cognitive impairment

Keywords: parkinson's disease tremor bradykinesia deep brain stimulation kinesia
clinical variability in marfan syndrome

Conditions: Marfan Syndrome

Summary: marfan syndrome is an autosomal dominant connective tissue disorder caused by mutations in the fibrillin-1 gene (fbn1). penetrance of fbn1 mutations is complete but intra and inter familial clinical expressivity is extremely variable. the underlying mechanisms for variability are not understood. an interesting mechanism is that the expression level of the wild type and/or mutated allele may play a role in the determination of variability. principal objective: to evaluate in marfan patients, if fbn1 expression level (non-mutated or mutated allele) modulates the clinical expression of the disease. judgment criteria : correlation allelic expression level-phenotype perspectives : to search the predictive factors of severity in order to ameliorate precocity of taking care.

marfan syndrome is an autosomal dominant connective tissue disorder caused by mutations in the fibrillin-1 gene (fbn1). penetrance of fbn1 mutations is complete but intra and inter familial clinical expressivity is extremely variable. the underlying mechanisms for variability are not understood. an interesting mechanism is that the expression level of the wild type and/or mutated allele may play a role in the determination of variability. principal objective : to evaluate in marfan patients, if fbn1 expression level (non-mutated or mutated allele) modulates the clinical expression of the disease in individuals from families with clinical variability (intrafamilial) and in independant probands (interfamilial). judgment criteria : correlation allelic expression level-phenotype method : in marfan patients with a fbn1 nul allele, fbn1 rna will be extracted from a fibroblast culture. allelic fbn1 expression level will be performed by quantitative rt-pcr and then compared with clinical evaluation. number of subjects : 160 subjects, 45 marfan patients in 15 independent families, 5 patients with the same mutation, 30 with a private mutation leading to a nul allele and 80 non marfan subjects. perspectives : to search the predictive factors of severity in order to ameliorate precocity of taking care.

Eligibility criteria:
inclusion criteria: * man or woman \> 18 years old * with a mutation in fbn1 gene * has signed an informed consent form exclusion criteria: -no affiliated to a healthcare system.

Keywords: marfan syndrome variability fibrillin 1 clinical expression
safety and efficacy study of a new formulation of acetylcysteine injection

Conditions: Acetaminophen Overdose

Summary: the primary purpose of this study is determine if a new formulation of acetadote is at least as effective as the current formulation in the prevention and treatment of acetaminophen overdose related liver injury.

the primary objective of this study is to demonstrate non-inferiority of efficacy determined by the proportion of subjects who develop hepatotoxicity when treated with a new formulation of acetadote and the proposed new dosing regimen compared to the rate of hepatotoxicity with the current formulation of acetadote and the current dosing regimen.

Eligibility criteria:
inclusion criteria: 1) any subject requiring treatment with acetylcysteine for acute acetaminophen toxicity exclusion criteria: 1. history of allergy or hypersensitivity to acetylcysteine or any component of acetadote. 2. exposed to investigational drugs within 30 days before clinical trial material (ctm) administration. 3. pregnant or nursing. 4. less than 12 years of age. 5. have a baseline alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>1000 u/l. 6. have a baseline international normalized. ratio (inr) \> 2.0 7. be on dialysis or having existing renal injury such that the volume of the study drug administration would render the patient unsuitable for the study, in the opinion of the investigator. 8. have congestive heart failure such that the volume of the study drug administration would render the patient unsuitable for the study, in the opinion of the investigator. 9. inability to understand the requirements of the study. subjects must be willing to provide written informed consent or consent of parent/legal guardian (as evidenced by signature on an informed consent document approved by an institutional review board \[irb\]), and agree to abide by the study restrictions. (if the subject is incapacitated, informed consent will be sought from a legally acceptable representative). 10. refusal to provide written authorization for use and disclosure of protected health information. 11. be otherwise unsuitable for the study, in the opinion of the investigator.

Keywords: acetaminophen overdose; induced hepatotoxicity, liver injury
usefulness of acupuncture in cancer pain and quality of life

Conditions: Cancer; Pain

Summary: the purpose of this study is to assess the effects of acupuncture on aspects of health including pain, energy level, sleep quality, activities of daily living and appetite.

after receiving permission from the attending physician each study participant who meets the inclusion criteria will then undergo a physical examination and fill out several questionnaires. each participant will undergo one to three treatments per week for a period of eight weeks. there will be one follow-up visit on the twelfth week. participation in this study is free of charge, including all exams, treatment and informational material.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cancer by an md/oncologist * age of 18 or older * baseline pain score of 3 or above on 0-10 rating scale * in the evaluation of the treating physician or medically-qualified investigator, the patient's pain syndrome is the result of underlying cancer or cancer treatment * being ambulatory * permission from the treating physician (md/oncologist) * platelet count of 50,000 or greater exclusion criteria: * acupuncture treatment in past four weeks * neutropenia defined as anc (absolute neutrophil count) \< 1000/ml * inability to obtain permission from the treating physician * unwillingness to sign informed consent form * involvement in litigation * simultaneous infection with hiv or hepatitis c virus * unable to present for follow up

Keywords: cancer acupuncture cancer pain quality of life
new diagnosed type 2 diabetes - online education

Conditions: Type 2 Diabetes

Summary: to determine the effect of online education given to individuals with newly diagnosed type 2 diabetes on metabolic control, self-care and health literacy. a randomized controlled trial. this study was conducted with 95 new diagnosed diabetes patients in the endocrine polyclinic of a university hospital. personal information form, diabetes self-care activities scale and health literacy scale were used to evaluate the data. spss 21 program was used in the analysis of the data and a p\<0.05 level was considered significant.

participants were randomized into both groups (intervention and control). the consolidated standard of reporting trials-consort 2010-guidelines were used to conduct a randomized controlled trial. sample size was estimated using the g\*power software tool, based on 80% power and 95% confidence interval. a minimum of 45 individuals in each group were needed to determine the difference in the mean of the measurements (10% more calculated for the probability of sample loss). between the data collection dates, 248 patients were reached and invited to participate in this study. 78 patients did not meet the inclusion criteria and 70 patients refused to participate. a total of 100 eligible patients were randomized; 50 were assigned to the intervention group and 50 to the control group. after reaching the targeted number, data collection forms were filled in. the participants were then randomly randomized into control and intervention groups in the computer program. until the randomization was made, it was not known in which groups the individuals were. randomization was performed after the target number was reached. the first diabetes self-management training was given to all patients by diabetes education nurses face-to-face in the outpatient clinic. after the study objectives were stated and informed consent was obtained from the study participants, face-to-face interviews by trained interviewers were used to complete the questionnaires. the interviews lasted 20-25 minutes.

Eligibility criteria:
inclusion criteria: * having a diagnosis of type 2 diabetes mellitus for at most one year * be between the ages of 18-65 * being on oral antidiabetic and/or insulin therapy * have a smart phone * volunteer to participate in the study * hearing that interferes with communication * sensory loss such as speech * psychiatric problem exclusion criteria: * illiterate * have a physical, cognitive or mental disability to answer questions * individuals with type 2 dm who did not volunteer to participate in the study