Kornimate/medical-research-clean huggingface dataset:
fish oil and diet for the treatment of non-alcoholic steatohepatitis (nash)

Conditions: Nonalcoholic Steatohepatitis (NASH); Hepatic Steatosis

Summary: the current pilot study assesses the use of magnetic resonance imaging (mri) to quantify hepatic steatosis. it will provide preliminary data regarding the use of omega-3 fatty acid supplementation (lovaza) for the treatment of nonalcoholic steatohepatitis (nash).


Eligibility criteria:
inclusion criteria: * males and females at least 18 years of age. * evidence of nonalcoholic steatohepatitis (nash) on a liver biopsy performed within six months of entry to this study. * laboratory parameters indicative of decompensated liver disease including: * bilirubin less than 2 milligrams/decilitre (mg/dl). * stable albumin within normal limits. * prothrombin time less than 3 seconds prolonged. * serum creatinine less than 1.5 times the upper limit of normal. * diabetic patients must be stable on oral medication for diabetes or have had less than a 10 percent change in their insulin dose over the past two months. * thyroid stimulating hormone (tsh) or free thyroxine index (fti) within the normal range. * hepatitis c antibody negative. * hepatitis b surface antigen (hbsag) seronegative. * antinuclear antibody (ana) less than 1:320. * patient provides written informed consent. exclusion criteria: * alcohol use exceeding 10 to 29 grams per day during the past six months. * evidence of a cause of liver disease other than nonalcoholic steatohepatitis (nash) on liver biopsy including: viral hepatitis, alcoholic liver disease, autoimmune hepatitis, hemochromatosis, wilson's disease, alpha-1 antitrypsin deficiency, or recent hepatoxic drug exposure. * patients with cirrhosis. * use of medications commonly associated with nonalcoholic steatohepatitis (nash) including: glucocorticoids, estrogens, tamoxifen, methotrexate, nifedipine, diltiazem, chloroquine, isoniazid, or amiodarone within the past six months. * use of non-steroidal antiinflammatory drugs, fibrates (fenofibrate or gemfibrozil) or warfarin within one month of entering the study. * uncontrolled diabetes, defined as a glycated hemoglobin (a1c) level greater than 8%. * patients with insulin-dependent diabetes. * history of jejunal-ileal bypass or extensive small bowel resection. * substance abuse including, but not limited to, alcohol or intravenous and inhaled drugs within the past six months. * use of chemotherapy within six months of enrollment. * patients taking metformin. * thyroid abnormality in which normal thyroid function cannot be maintained by medication. * pregnancy, females who are breastfeeding. * solid organ transplant recipient. * history of a medical condition, which could interfere with participation in and completion of the protocol. * use of oral supplements of vitamin e within one month of enrollment.

Keywords: non-alcoholic steatohepatitis omega-3 fatty acids mri nash
stop csua: physical activity, mood and sleep in chronic spontaneous urticaria and angioedema

Conditions: Chronic Spontaneous Urticaria

Summary: chronic spontaneous urticaria and angioedema (csua) is a disease of the skin characterised by hives, swellings or both that last longer than 6 weeks. people with this disease commonly describe poor sleep, reduced quality of life and psychological difficulties such as depression and anxiety. this study seeks to understand relationships between physical activity, sleep and symptoms of urticaria. we are asking individuals with urticaria to wear a fitbit tracker which monitors their physical activity and sleep. participants also download an app onto their smartphone called athena cx which is designed by the study team in dcu. the purpose of the app is capture real-time information from participants on mood and any skin symptoms they experience. we will use this information to learn more about possible links between symptoms of urticaria and lifestyle behaviours.

chronic spontaneous urticaria and angioedema (csua) is a disease of the skin characterised by hives, swellings or both that last longer than 6 weeks (1). a quarter of patients with this disease report impaired quality of life (2). furthermore, individuals with csua are more likely to have depression and anxiety (3). in addition, our previous qualitative research findings have noted issues with self-compassion among this cohort (4). fatigue and poor sleep are common (5). we seek to examine possible links between physical activity, sleep, mood and symptoms of urticaria. for participants who give their consent, we will do this by collecting and exploring: * fitbit tracker data * information on mood via the athena cx app * information on symptoms of urticaria via the athena cx app electronic health applications for smartphones are increasingly used in chronic health conditions and have been piloted in chronic spontaneous urticaria for recording of symptoms, medication reminders and patient education. this study will develop a smartphone application designed specifically for this cohort of patients, entitled athena cx focusing specifically upon symptomatology and mood. an observational study collecting biofeedback data in this cohort will inform our understanding of this disease and future research. objectives 1. to delineate the psychological symptoms encountered by this cohort of patients 2. to examine whether there is a link between biofeedback data and symptoms of chronic spontaneous urticaria and angioedema (csua) 3. to collect linked clinical data on participants with csua 4. to inform an rct examining the use of a digital behavioural intervention for patients with csua

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of chronic spontaneous urticaria with or without angioedema 2. urticaria control test score \< 12 indicating poorly controlled urticaria at time of consent 3. preference to participate in the study 4. in possession of a smartphone exclusion criteria: unable or unwilling to provide informed consent
effect of calling the patient's name on recovery from general anesthesia

Conditions: Delayed Emergence From Anesthesia

Summary: the purpose of this study is to find if we can shorten the recovery time by calling the patient's name during anesthesia reversal.


Eligibility criteria:
inclusion criteria: * patient aged between 20-70 * patient receiving breast cancer surgery under general anesthesia with total intravenous anesthesia using remifentanil and propofol, and intubated with lma exclusion criteria: * refusal of consent * patients taking cns stimulants * general anesthesia with other agents than propofol and remifentanil * intubated with other equipments than lma * chronic alcoholic patient * patients with convulsive disorder
effectiveness of a combination of trimetazidine with one hemodynamic agent in patients recently diagnosed with stable angina and still symptomatic despite first line hemodynamic therapy

Conditions: Stable Angina

Summary: the purpose of this study is to assess in recently diagnosed stable angina patients symptomatic despite first line hemodynamic therapy, the effect of a combination of this hemodynamic agent with a metabolic one (trimetazidine). the treatment effect will be measured by the reduction of patients' angina symptoms, physical limitation and an improvement of quality of life using the seattle angina questionnaire-7 items (saq-7) patients will be also proposed to complete a beamer (behavioral and adherence model for improving quality, health outcomes and cost-effectiveness of healthcare) questionnaire which will contribute to a separate research project developed by the innovative medicines initiative (imi). analysis of the beamer questionnaires will be performed outside the study by the imi beamer consortium for beamer purposes only.


Eligibility criteria:
inclusion criteria: * male and female recently diagnosed symptomatic stable angina patients * age ≥18 years old * patient already treated by one first line antianginal haemodynamic agent (ß-blocker or ca-channel blocker) (according to ccs management guidelines 2019) and still symptomatic after initiation of this antianginal treatment. * patient for whom the physician intends to prescribe trimetazidine based on her/his daily medical practice in the management of symptomatic angina pectoris, respecting the smpc in force in the country. such treatment decision must be taken independently from the participation of the patient in the study. * evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: * any contra-indication to trimetazidine according to smpc * patient already treated with trimetazidine before entry into the study. * pregnancy or intention to become pregnant or lactating women during the study.

Keywords: symptomatic stable angina adherence prospective, international, non-interventional study quality of life
study of the human anti-tnf monoclonal antibody in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is to assess the safety (by collecting adverse events and serious adverse events) of adalimumab administered every other week to patients with moderately to severly active rheumatoid arthritis who have failed prior disease-modifying anti-rheumatic drugs (dmards).


Eligibility criteria:
inclusion criteria: * patient has completed (i.e. not dropped out of) the de013 study or fulfills criteria 2-12 * patients 18 years of age or older * female is either not childbearing, defined as post-menopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or if childbearing potential, practicing an acceptable method of birth control * female of childbearing potential must have a negative serum pregnancy test prior to first dose of adalimumab * diagnosis of active ra defined by \>= 5 swollen joints and one of the following: * positive rf * one or more joint erosions present of x-ray * haq score \> 1 exclusion criteria: * patient has failed 2 or more biologics * patient who had previous treatment with cyclophosphamide and chlorambucil * previous treatment with total lymphoid irradiation or anti-cd4 or campath 1h monoclonal antibody resulting in presistent cd4 lymphopenia (cd4 lymphocytes +\< 500/mm3) * history of cancer within the past 10 years unless successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix * history of malignant lymphoma or leukemia regardless of treatment
whether sputum can serve as an alternative source for liquid biopsy in patients with lung cancer

Conditions: NSCLC

Summary: this study intends to use onconscreen plus 520 panel (burning rock, china) to conduct ngs testing in sputum, tissues and blood samples of patients with advanced nsclc. in order to explore the use of sputum as a diagnosis method for nsclc patients, we will collect relevant clinical information and follow-up treatment information. the primary endpoint will reveal the effectiveness, accuracy, and feasibility in sputum, as compared to tissues and blood samples. this study aims to study the feasibility and advantages/disadvantages of using sputum as an noval body fluid biopsy option.

with the advancements in the development of targeted therapy, the detection of actionable genes has become routine practice in diagnosing lung cancer, especially in non-small cell lung cancer (nsclc). due to its non-invasiveness and great accessibility, plasma-based mutation profiling, with a sensitivity of approximately 70% relative to tissue samples, is widely used in clinical settings. profiling using other body fluids such as pleural effusion, ascites, cerebrospinal fluid have been actively explored. circulating cell-free dna has also been shown to be present in other bodily fluids such as sputum and urine, which have potential to serve as liquid biopsy media for comprehensive mutation profiling. in this study, we investigated the potential of sputum obtained from nsclc patients for mutation profiling using matched tissue, plasma and sputum from more than 30 advanced-stage nsclc patients. baseline tissues, plasma and sputum samples from more than 30 newly diagnosed advanced nsclc patients with 520 panel sequencing (tissue 1000x, sputum 1000x, plasma cfdna 10000x), in different methods will be compared. primary endpoints: 1、compare different sample types with concordence rate, sensitivity, and specificity.

Eligibility criteria:
inclusion criteria: 1. patients with stage iiib-iv nsclc in ajcc tnm stage (8th edition) confirmed with histology or cytology; 2. newly diagnosed; 3. there are sufficient samples that meet the requirements for examination; 4. eligible for the next anti-tumor systemic treatment; 5. willing to sign the consent inform, age ≥18 years; 6. patients willing to cooperate with the planned follow-up schedule; 7. permit to collect clinical data needed by the institute. exclusion criteria: 1. diagnosed with other malignant tumors at the same time (except for fully treated cervical carcinoma in situ, basal or squamous cell skin cancer); 2. the patient has other serious diseases that may affect follow-up and short-term survival; 3. any other medical conditions and social/psychological problems that investigator evaluated is not suitable to enroll in this study; 4. absents of contrast-enhanced magnetic resonance imaging (mri) or contrast-enhanced computer tomography (ct) during clinical follow-up.
whole blood bactericidal activity against mycobacterium tuberculosis of pyrazinamide plus allopurinol in healthy volunteers

Conditions: Tuberculosis

Summary: the purpose of this study is to evaluate the bactericidal activity against mycobacterium tuberculosis of pyrazinamide in combination with allopurinol. pharmacokinetics (pk) and whole blood bactericidal activity (wba) will be measured in healthy volunteers following administration of pyrazinamide alone and in combination with allopurinol.

the whole blood bactericidal activity (wba) assay is an ex vivo model for measuring the combined effects of administered drugs, host factors and strain factors on mycobacterial sterilisation. if performed in parallel with pk measurements, the method can be used to evaluate the effect of drugs throughout the dosing cycle. the aim of this trial is to assess the wba activity and pk data of pyrazinamide and its metabolites boosted with allopurinol in healthy volunteers.

Eligibility criteria:
inclusion criteria: 1. aged between 21 and 70 years old 2. male or female willing to comply with the study visits and procedures 3. willing and able to provide written informed consent exclusion criteria: 1. women who are currently pregnant or breastfeeding 2. body weight 50kg or below 3. hla-b\*5801 allele positive 4. clinical evidence (symptoms and/or signs) suggestive of active tb 5. previous hypersensitivity, intolerance or allergy to pyrazinamide or allopurinol 6. current use of any drugs or medication known to have an interaction with pyrazinamide or allopurinol, or known to have anti-tb activity 7. evidence of renal or hepatic dysfunction or any clinically significant deviation from normal during screening including laboratory determinations 8. known hepatic disease (including chronic hepatitis), recent hepatitis (within last 6 months) or alcohol abuse 9. known hyperuricaemia or evidence of hyperuricaemia at screening 10. history or current episode of gout 11. any other significant condition that would, in the opinion of the investigator, compromise the volunteer's safety or outcome in the trial 12. current participation in other clinical intervention trial or research protocol
feelings about exercise

Conditions: Physical Activity; Obesity

Summary: this study seeks to investigate why some individuals exercise more than others by focusing on feelings related to exercise. this two part study first examines whether regular exercisers (n=30) and non-exercisers (n=30) differ in how a 30-minute moderate-intensity exercise bout makes them feel. all participants will walk on a treadmill for 30 minutes on two separate occasions and will be asked to report on how they feel before, during, and after exercise, how they anticipate that exercise will make them feel, and how they remembered feeling during exercise. in addition, after exercise session #2, non-exercisers will be randomized to: 1) a brief intervention focused on providing general information about the physical activity guidelines, or 2) a brief intervention which provides general information about physical activity guidelines, but also focuses on affective responses to physical activity. non-exercisers will complete an identical, third exercise session approximately 1-week following this intervention. further, all participants will receive a 12-week, internet-delivered weight loss program following all exercise visits and physical activity will be assessed before and after the weight loss program.


Eligibility criteria:
inclusion criteria: * age 18-60 years * bmi between 25.0 and \<40.0 kg/m2 * either a 'non-exerciser', defined as reporting exercising at a moderate-intensity for \<30 min/week over the past 6 months and a most recent typical week or an 'exerciser', defined as exercising for ≥150 min/week over the past 6 months and a most recent typical week. exclusion criteria: * presence of any condition that would limit one's ability to exercise (e.g., orthopedic limitations) * history of coronary artery disease (i.e., myocardial infarction or symptoms of angina), stroke, diabetes, or pulmonary disease (e.g., copd or emphysema). * currently taking any medication that would alter heart rate (e.g., beta blocker) * women who are pregnant or nursing * uncontrolled hypertension (resting blood pressure ≥140/90 mmhg) * exercising \>30 min/week but \<150 min/week (i.e., neither 'non-exerciser' nor 'exerciser') * use of medications for weight loss, or current participation in another weight loss program * bariatric surgery

Keywords: exercise physical activity obesity weight loss
endoscopic treatment for isolated, single suture craniosynostosis

Conditions: Craniosynostosis

Summary: this is a prospective study to evaluate outcomes in patients undergoing endoscopic craniectomy for isolated, single-suture craniosynostosis.


Eligibility criteria:
inclusion criteria: * infants 1 to 6 months of age with isolated, single-suture craniosynostosis. exclusion criteria: * multiple suture craniosynostosis and infants older than 6 months of age.

Keywords: endoscopic, craniosynostosis, sagittal, synostosis
fiber formula study among radiation oncology patients

Conditions: Constipation

Summary: during radiation treatment for head and neck cancer a large percentage of patients at mayo clinic rochester develop the need for tube feeding to meet nutrition and hydration needs. these patients are usually taking pain medication along with a stool softener or laxative. currently, when these patients get a feeding tube it is our standard practice to choose a fiber-free enteral tube feeding formula as to not worsen their constipation. currently, there are no guidelines as to which patients are good candidates for fiber containing enteral tube feeding formulas. the investigators hope this study will help determine if fiber containing enteral tube feeding formulas can be used for patients undergoing radiation for head and neck cancer without increasing rates of constipation or increasing use of stool softeners/laxatives. hypothesis: participants enrolled in the study will not have increased rates of constipation on fiber-containing enteral tube feeding formula compared to historical standards on fiber-free formula.


Eligibility criteria:
inclusion criteria: * cancer of: 1) lip/oral cavity 2) pharynx 3) larynx 4) nasal cavity/paranasal sinus 5) salivary gland 6) thyroid according to ajcc cancer staging manual 6th edition 2002 * current radiation therapy or starting radiation therapy in the next 2 weeks * patient must have a gastrostomy tube exclusion criteria: * jejunostomy tube * diagnosis of irritable bowel syndrome (abdominal pain and diarrhea or constipation lasting at least three months in one year) * short bowel (a patient is generally considered to have short bowel syndrome when less than 100 to 150 centimeters of functioning small bowel remains) * body max index (bmi) \<18.5kg/m2 * gastroparesis (when the stomach retains food for longer than normal periods). this must be diagnosed with a gastric emptying study. * use of metoclopramide * receiving 5-fu chemotherapy

Keywords: tube feeding fiber constipation
glycerin-preserved, human-donor, corneoscleral patch grafts for glaucoma drainage devices

Conditions: Glaucoma; Graft Failure; Intraocular Pressure

Summary: this was a retrospective, non-comparative study of 100 eyes of 100 consecutive glaucoma patients who had undergone glaucoma drainage device implantation (baerveldt shunt) during january 2006 to december 2016. glycerin-preserved, human-donor, corneoscleral tissue was used as a patch graft to cover the tube portion of the gdd over the sclera. the patch graft related complication was comparable to the previous reports using conventional sclera or pericardium.

this retrospective, non-comparative study was conducted at the department of ophthalmology, faculty of medicine, siriraj hospital, mahidol university, bangkok, thailand. the medical records of consecutive patients who had undergone glaucoma drainage device implantation employing the fornix-based conjunctival flap technique and using a glycerin-preserved, human-donor, corneoscleral graft. the procedures were carried out by, or under the supervision of, one surgeon (nk) between january 2006 and december 2016 were reviewed. the study protocol was approved by the siriraj institutional review board, faculty of medicine, siriraj hospital, mahidol university.

Eligibility criteria:
inclusion criteria: 1. consecutive patients who had undergone glaucoma drainage device implantations between january 2006 and december 2016 at siriraj hospital by or under supervision of one surgeon (nk). 2. the gdd implantation using glycerin-preserved, human-donor, corneoscleral tissue as a patch graft exclusion criteria: 1.patients who had follow-up period less than 12 months after operation.

Keywords: glaucoma glaucoma surgery patch graft intraocular pressure
clinical study evaluating beta blockers use and fracture risk in patients with primary osteoporosis

Conditions: Beta Blocker Toxicity

Summary: clinical study evaluating selective or nonselective beta blockers use and fracture risk in patients with primary osteoporosis

clinical study evaluating selective or nonselective beta blockers use and if there is fracture risk in patients with primary osteoporosis

Eligibility criteria:
inclusion criteria: * • male \& female osteoporotic patient aged ≥ 50 years * hypertensive \& normotensive patients * bmd t-score ≥ 2.5 or more sd below peak bone mass exclusion criteria: * patients on drugs that may improve osteoporosis disease state such as: * angiotensin converting enzyme inhibitor (acei) or angiotensin receptor blockers (arbs), thiazide diuretic, nitrates, spironolactone, statins. patients on drugs that may worsen osteoporosis disease state such as: • corticosteroids, loop diuretics, anticonvulsants, antidepressants, aromatase inhibitors, thyroid replacement therapy and proton pump inhibitors.
erythropoietin resistance in anemia of chronic kidney disease

Conditions: Anemia; Kidney Failure; Erythropoietin

Summary: our goal of this pilot project is to identify inflammatory biomarkers that correlate with epo-resistance among ckd patients.


Eligibility criteria:
inclusion criteria: * prevalent patients greater than or equal to 18 years old with ckd defined as a glomerular filtration rate \< 60 cc/min exclusion criteria: * active gi bleeding or history of gi bleed in the prior 3 months * uncontrolled hyperparathyroidism (pth\>500) * untreated iron deficiency (transferrin saturation \< 20% and ferritin \< 100 * overt infection * active hemolysis * hemoglobinopathies * known adverse response to erythropoietin * prior kidney transplant * aluminum toxicity