Kornimate/medical-research-clean huggingface dataset:
a clinical research on disease progression and intervention of chronic hepatitisb

Conditions: Hepatitis B, Chronic

Summary: hbv(hepatitis b virus) with metabolic comorbidities may accelerate liver disease progression and increase the risk of hcc(hepatocellular carcinoma)development. it is reported combination of metabolic diseases and chb is associated with substantially increased rates of liver cirrhosis and secondary liver-related events compared to chb alone. consequently, hepatitis b patients with metabolic comorbidities warrant particular attention in disease surveillance and evaluation of treatment indications.

primary objective: to evaluate the impact of metabolic disease on the progression of chronic hepatitis b * to observe hbsag/hbeag/hbv dna changes /hbsag seroconversion * to determine high rates of liver cirrhosis and hepatocellular carcinoma group 1 : chb with diabetes group 2 : chb with hyperlipemia group 3 : chb without metabolic diseases study duration (in months) 24 months

Eligibility criteria:
inclusion criteria: * chronic hepatitis b (positive hbsag for at least 6 months prior to na therapy start) * patients on-treatment with nas exclusion criteria: * treatment with immunosuppressors (including systemic corticosteroids) or anti-neoplastic treatment (including radiation therapy) \<=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study. * history of depression or uncontrolled psychiatric disorders * subjects protected by law or not in a position to give consent

Keywords: hbv metabolic diseases
vitamin d, insulin sensitivity, and vascular associations in adolescents

Conditions: Insulin Sensitivity; Flow-mediated Dilation; Arterial Stiffness

Summary: the overall objectives of this study are to examine the relationships between circulating vitamin d, insulin sensitivity, and multiple indices of vascular function and to examine whether vitamin d deficiency in aa is responsible for ethnic differences in insulin sensitivity and hypertension in aa and ea, as well as mechanisms underlying the association between insulin resistance and blood pressure. we hypothesize that 1) serum 25(oh)d is associated with insulin sensitivity and vascular functioning, independent of adiposity, 2) lower insulin sensitivity and vascular functioning in aa relative to ea is due to lower circulating 25(oh)d in aa, and 3) the relationship between insulin resistance and vascular dysfunction is mediated by 25(oh)d. acronyms: african american (aa), european american (ea), serum 25-hydroxy vitamin d (25()h)d, body mass index (bmi), alabama (al).


Eligibility criteria:
inclusion criteria: * african american or caucasian ethnicity * ages 14-18 yrs * healthy exclusion criteria: * bmi-for age and -sex higher than 95th centile on the centers for disease control and prevention growth charts * use of medication(s) known to influence body composition, vascular function, or glucose metabolism * pregnancy * diabetes or any chronic diseases

Keywords: insulin sensitivity vascular function flow-mediated dilation arterial stiffness ethnicity adolescents females glucose tolerance diabetes hypertension cardiovascular
diagnosis of oral precancers and cancers using optic coherence tomography

Conditions: Oral Cancers

Summary: diagnosis of oral precancers and cancers using optic coherence tomography

diagnosis of oral precancers and cancers using optic coherence tomography

Eligibility criteria:
inclusion criteria: * oral cancer, oral precancers exclusion criteria: * other diseases

Keywords: optic coherence tomography oral cancer oral precancers
self help intervention to decrease stress

Conditions: Stress, Psychological

Summary: the present study is designed to test the feasibility and efficacy of a stand alone self help program for decreasing stress and anxiety and enhancing quality of life. the intervention will be offered in the form of a self help book and three handouts with no in-person instructor time.

stress is a ubiquitous problem and a mediator of symptoms for a variety of medical conditions. most medical diagnoses, procedures, and physician visits are associated with considerable stress. excessive stress is associated with adverse medical outcomes, unhealthy coping mechanisms, symptoms of anxiety and depression, and overall a poor quality of life. no specific pharmacologic treatment is available for treating stress. further, it is often difficult or sometimes impossible to change the reality of circumstances causing stress in an individual. thus increasing individual coping mechanisms and ability of a person to handle stress, rather than changing the stressors itself might be a more feasible approach towards reducing stress. several interventions are available to decrease stress. majority of these programs entail extensive in-person training which impacts on widespread dissemination of the program. we are interested in applying an innovative approach toward stress management by testing the efficacy of a stand alone self help program offered in the form of a book with no in-person instructor time. participants will receive a copy of the book, "train your brain engage your heart transform your life" along with three handouts summarizing the contents of the book. this book describes the program of attention and interpretation therapy that is designed to help decrease stress and anxiety and has been developed at mayo clinic rochester.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * good general health * provided with, understand, and have signed the informed consent exclusion criteria: * are currently using (at time of enrollment) antipsychotics and/or antidepressants * have a life time history of schizophrenia. * previously participated in attention and interpretation therapy (ait) training.

Keywords: stress anxiety resilience mindfulness quality of life stress management
progressive metabolic adaptations to low intensity exercise training and weight loss

Conditions: Obesity

Summary: the investigators first aim is to determine the effect of low intensity exercise (without weight loss) on insulin sensitivity, muscle lipid metabolism, and factors regulating these processes in skeletal muscle after 1 day, 2 wks, 12 wks of training, and again after 3 days without exercise in obese adults. the investigators second aim is to determine the effect of combining low intensity exercise training with 10% weight loss on insulin sensitivity, muscle lipid metabolism, and factors regulating these processes in skeletal muscle. although a single 40 minute session of exercise at a low exercise intensity will not improve insulin sensitivity, the investigators anticipate adaptations after two weeks of exercise training (6 session/wk; 12 session total) will improve insulin sensitivity and be accompanied by a reduction in fatty acid intermediates and a reduction in markers for pro-inflammatory activation in muscle. the investigators anticipate changes in insulin sensitivity, fatty acid partitioning, and pro-inflammatory markers the day after the last session of a 12 wk training program (without weight-loss) will be similar to that measured after 2 weeks of training. the investigators anticipate insulin sensitivity, accumulation of fatty acid intermediates, and pro-inflammatory activation will be markedly improved after 10% weight loss when measured the day after exercise. the investigators would expect the improvements in insulin sensitivity, accumulation of fatty acid intermediates, and markers of inflammatory stress will be significantly attenuated when measured 3 days after the most recent exercise session, but beneficial effects of 10% weight loss on these metabolic endpoints will persist when compared with before weight loss.


Eligibility criteria:
inclusion criteria: * body mass index \[bmi\]: 30-45 kg/m2; all women must be pre-menopausal; non-exerciser (no regularly planned exercise/physical activity) exclusion criteria: * hematocrit ≤ 34%; fasting plasma glucose concentration ≥ 125 mg/dl; weight instability ≥ ±5 lbs in past month; taking medications known to affect lipid and/or glucose metabolism; evidence and/or history of cardiovascular or frank metabolic diseases; pregnancy or actively breast feeding

Keywords: insulin sensitivity exercise training weight loss fat metabolism
a non-interventional pilot study to explore the role of gut flora in ulcerative colitis

Conditions: Ulcerative Colitis; Ulcerative Colitis Chronic

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding ulcerative colitis

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding ulcerative colitis

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study 2. male or female patients of any age. 3. diagnosis of ulcerative colitis exclusion criteria: 1. refusal to sign informed consent form 2. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. postoperative stoma, ostomy, or ileoanal pouch 4. participation in any experimental drug protocol within the past 12 weeks 5. treatment with total parenteral nutrition 6. any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 7. inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
it´s up to you: update and digitalization of a universal school-based prevention intervention for drug initiation and use

Conditions: Substance Use; Behavior, Addictive; Smoking Behaviors; Alcohol Drinking; Illicit Drug Use

Summary: this non-randomized cluster-controlled trial examines the effectiveness of the digitalized and updated version of the it´s up to you - program, a universal school-based prevention intervention for drug initiation and use targeting youth aged between 12 and 17 years.

the goal of this non-randomized cluster-controlled trial targeting youth aged between 12 and 17 years is to examine whether the updated and digitalized version of the preventive intervention named "it´s up to you" program is effective in preventing drug use initiation and reducing drug use. participants in the experimental group will receive 6 sessions conducted by trained teachers. each session will target a program module about the following topics: (1) what about drugs? (2) a way to start (3) ana has fun (4) what do you connect to (about the use of the internet and social networks)? (5) two versions of the same story, and (6) how do my parents come in? researchers will compare the experimental group receiving the "it´s up to you" program to a control group receiving the usual teaching activities regarding substance use prevention. the main goal is to see if participants in the experimental group report lower substance (alcohol, tobacco, and cannabis) use and initiation after the intervention and at a 3-month follow-up related to the control group.

Eligibility criteria:
inclusion criteria: * schools having secondary education * schools located in spain. * schools willing to participate under the conditions of the study exclusion criteria: * schools applying the original "it´s up to you" prevention program
impact of admission sofa score and 48-hour delta sofa on clinical outcomes in critically ill patients

Conditions: Critically Ill Patients

Summary: organ dysfunctions are associated with high morbidity and mortality. the sofa (sequential organ failure assessment) score developed by vincent et al. sequentially assesses the presence and severity of dysfunctions in six organ systems: respiratory, cardiovascular, coagulation, hepatic, neurological and renal. although the sofa score was created to quantify organ dysfunctions, the obvious relationship between organ dysfunctions and mortality has been widely documented. dynamic measurements of the sofa score assess response to treatment and can be used to search for perpetuating sources of severity and reassess the treatment plan. the primary objective of this study will be to assess the impact of an admission sofa score equal to or greater than 2 and subsequent interventions on outcomes related to the 48-hour delta sofa on icu and hospital mortality, length of stay in the icu, duration of mechanical ventilation, time of vasoactive drug use. patients will be divided into three groups: those who did not trigger the sofa trigger on admission to the icu (group 1), those who triggered the sofa trigger and improved on the third day (group 2) and, finally, those who triggered the sofa trigger and worsened on the third day (group 3).


Eligibility criteria:
inclusion criteria: * included all patients over 18 years old admitted to the icu during the study period exclusion criteria: * excluded were patients who remained in the icu for a period of less than 48 hours and pregnant women

Keywords: sofa score delta sofa critically ill patients outcomes
randomized controlled trial to evaluate the safety and efficacy of acetaminophen in preterm infants used in combination with ibuprofen for closure of the ductus arteriosus

Conditions: Patent Ductus Arteriosus; Preterm Infant; Bronchopulmonary Dysplasia

Summary: the purpose of the present study is to determine whether treatment of hemodynamically significant patent ductus arteriosus with a combined therapy of intravenous ibuprofen and oral acetaminophen has higher success rate in closing the ductus arteriosus than a standard treatment strategy of using intravenous ibuprofen alone among preterm infants.

the primary objectives of the study are to confirm the safety of oral acetaminophen in extremely low birth infants, given concomitantly with intravenous ibuprofen and also to determine its efficacy in significantly increasing the rates of ductal closure when compared to only intravenous ibuprofen therapy. hence primary outcome variable include patent ductus arteriosus closure success rate, based on the 2-d transthoracic echocardiographic evidence. this study is a single center, randomized, double blinded, placebo controlled trial. preterm infants with gestational age of with a gestational age ≤27 6/7 weeks by the best obstetric estimate are eligible for enrollment. for randomization, the study population will be stratified to two subgroups based on gestational age (ga ≤24 weeks and \> 25 weeks). randomization will occur by using computer generated random sequence, using a 4-block design, with 1:1 parallel allocation. allocations include treatment and control arm. treatment arm will receive combination of intravenous ibuprofen and oral acetaminophen, while control arm will receive intravenous ibuprofen and oral placebo.

Eligibility criteria:
inclusion criteria: 1. preterm infant ≤27 6/7 2. written parental consent is obtained 3. infant requires respiratory support 4. diagnosis of a persistent patent ductus arteriosus after 5 days of age, (defined as at least two of the following: 1. ductus size ≥ 1.5 mm 2. maximum flow velocity through the ductus ≤ 2 m/s 3. left atrium to aorta ratio ≥ 1.4 4. wide pulse pressure 5. b-type natriuretic peptide (bnp) 5. attending neonatologist made decision to treat patent ductus arteriosus exclusion criteria: 1. no parental consent 2. infants \> 21days of postnatal age 3. congenital anomalies such as cardiac or multiple anomalies 4. infection (e.g., septicemia, pneumonia) 5. bleeding disorder or platelet count\< 50,000/ml 6. acute kidney injury (aki)defined as oliguria (urine output\ 1.5 mg/dl 7. elevated liver enzymes (\>2 fold from upper normal limits) 8. pulmonary hypertension or right to left shunt through the ductus arteriosus 9. diagnosis of necrotizing enterocolitis 10. unable to tolerate oral medications at the time of enrollment.

Keywords: patent ductus arteriosus acetaminophen ibuprofen bronchopulmonary dysplasia mechanical ventilation
laparoscopic skills and cognitive function are not affected by night shifts in surgeons

Conditions: Effect of Sleep Deprivation

Summary: the aim of the study was to asses the effect of sleep deprivation during nightshift by monitoring 30 surgeons in unit of surgical gastroenterology in 4 consecutive days. the first day was pre call= day 1, second day was on call= day 2, third day was the first post call day = day 3 and fourth day was the second post call= day 4. the surgeons were monitored in order to asses how performance was on call compared to pre call and post call. the hypothesis was that they would perform worse on call than pre call, and again slightly worse post call.

the surgeons wore an actigraph consecutively on all 4 days, and would fill out a sleep diary on all 4 days as well. the surgeons were heart monitored consecutively on day 1 and 2. the surgeons were tested in a laparoscopic simulator at 8 a.m. day 1, 4 a.m. day 2, and again at 8 a.m. day 4. at the same given times they would perform the d2 test of attention and prescribe medicine in the electronic patient medication system in accordance with a case they were given. furthermore they delivered a salivary sample for the determination of salivary cortisol, at the given times. they sampled urine from 9 pm - 9 am all 4 days, in order to measure the production of melatonin in urine. the surgeons would fill out the karolinska sleepiness scale, vas (visual analog scale) fatigue, vas sleep quality and vas general well being at 8 a.m. day 1, 4 a.m. day 2, and again at 8 a.m. day 4. the karolinska sleepiness scale was filled out every second hour on day 2 from 4pm - 8 am on day 3.

Eligibility criteria:
inclusion criteria: * surgeons at surgical unit of gastroenteroloy * men and women between the age of 22-50 years. exclusion criteria: * pregnancy and breastfeeding * endocrine disease, medically treated * autoimmune disease, medically treated * sleep disturbance, medically treated * intake of alcohol within 24 hours before the study and during the entire study

Keywords: sleep deprivation in surgeons during night shifts and the effect on performance.
pharmacokinetic evaluation of exparel in adults undergoing tonsillectomy

Conditions: Pain

Summary: the purpose of this study is to characterize the pharmacokinetic (pk) profile of a single dose of exparel (133 mg/10 ml) administered intraoperatively per normal infiltration for prolonged analgesia in 12 adult subjects undergoing tonsillectomy with or without removal of the adenoids.

blood samples for bupivacaine pk analysis will be obtained from subjects at baseline (within 30 minutes prior to exparel infiltration), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 36, 48, and 72 hours after the beginning of exparel infiltration, and on day 7.

Eligibility criteria:
inclusion criteria: * male or female, ≥18 years of age at the screening visit. * subjects undergoing tonsillectomy with or without removal of the adenoids. * able and willing to comply with all study visits and procedures. * willing and capable of providing written informed consent. exclusion criteria: * history of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics. * received any investigational drug within 30 days prior to exparel administration, and/or has planned administration of another investigational product or procedure while participating in this study. * currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after exparel administration. female subjects must be surgically sterile, at least 2 years postmenopausal, or using an acceptable method of birth control. if of childbearing potential, must have a documented negative pregnancy test within 24 hours before exparel administration. * subjects with significant medical conditions or laboratory results that, in the opinion of the investigator, indicate an increased vulnerability to exparel and/or procedures, or cause inability to comply with the study requirements.
pharmacodynamic-pharmacokinetic trial, of slow release asa, in the platelet functionalism.

Conditions: Cardiovascular Disease

Summary: the purpose of this study is to evaluate the platelet antiaggregant effect that a chronic treatment with asa (150 mg) produces,comparing this effect between two formulations of asa: normal and the one of sustained release, in patients with stable coronary disease.

a large clinical trials have established the efficacy of the antiaggregant products in patients with ischemic cardiopathy, stroke and intermittent claudication. without doubt, the acetylsalicylic acid (asa) is the most used antiaggregant product, nevertheless, and spite of being centenarian, it last some questions pending regarding the most appropriate dose, mechanism of action implicated, the association with other drugs, and the pharmaceutical form in order to improve the efficacy and the safety of the asa. some previous studies indicate that the slow release form of asa has a different behaviour in the platelet effect in comparison with plain formulation. the aim of this study is to demonstrate the best antiaggregant and safety profile of a low dose of a slow release formulation of asa.

Eligibility criteria:
inclusion criteria: * previous episodes of myocardial infarction * previous episodes of instable angina pectoris * previous coronary revascularization * significant arterial coronary disease exclusion criteria: * patients with other pathologies that requires treatment with other antiaggregants * patients in treatment with low molecular weight heparin or oral anticoagulant * patients with antecedents of hypersensibility to asa

Keywords: slow release asa platelet functionalism secondary cardiovascular prevention