Kornimate/medical-research-clean huggingface dataset:
a pilot study of dietary chloride supplementation on cardiorenal function in heart failure

Conditions: Heart Failure

Summary: the purpose of this study is to determine if administration of supplemental chloride in the form of lysine chloride to patients with congestive heart failure will affect their neurohormonal profile as well as response to diuretics.

this prospective pilot "pre-post" study was designed to determine if supplementation of sodium free chloride ion as a lysine chloride to patients with heart failure could improve parameters of neurohormonal status and diuretic responsiveness. volunteers will receive lysine chloride 7 grams three times daily for three days. at baseline and then again post lysine chloride patients will undergo sampling of venous blood for determination of neurohormonal parameters in addition to formal diuretic responsiveness testing.

Eligibility criteria:
inclusion criteria: * age ≥18 years * fluency in english * heart failure requiring loop diuretic therapy * loop diuretic dose ≥ 80mg/day furosemide equivalents * stable volume status and diuretic requirement as assessed by treating physician exclusion criteria: * unstable heart failure * renal replacement therapy or an estimated gfr \< 30 ml/min/1.73m2 * significant bladder dysfunction * history of hepatic failure * pregnancy * history of hyperinsulinemia/hyperlysinuria

Keywords: lysine chloride
efficacy and safety of oltipraz in the patients with non-alcoholic fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease

Summary: dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (ampk) activators, prevent insulin resistance through ampk-dependent p70 ribosomal s6 kinase-1 (s6k1) inhibition. and it is well known that the modulation of s6k1 by oltipraz inhibited the development of insulin resistance and hyperglycemia through the ampk-s6k1 pathway.also some research reported that lxrg (a member of the nuclear hormone receptor)-mediated increases in srebp-1c (the sterol regulatory element-binding protein-1c gene) promote the expression of lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits lxrg and srebp-c. therefore, oltipraz inhibits fatty acid synthesis through ampk-s6k1 pathway and lxrg-srebp-1c pathway in liver.


Eligibility criteria:
inclusion criteria: * patients over 18, under 75 years of age * patients with non-alcoholic fatty liver disease exclusion criteria: * over 2 ratio of ast to alt * type 1 diabetes mellitus (insulin-dependent diabetes mellitus) * disorder in liver function with an exception of non-alcoholic fatty liver (e.g. virus infection, biliary atresia, autoimmune hepatitis and etc.) * patients who have been taken drugs induced fatty liver for over 3 month within 1 year of participation in this study; amiodarone, tamoxifen, methotrexate, tetracyclines, glucocorticoids, anabolic steroids, over usual dose of estrogen for hormone replacement therapy and valproate * patients who has been taken any medications that could affect the treatment for non-alcoholic steatohepatitis: insulin, insulin sensitizer(metformin, thiazolidinedione), high dose of vitamin e, high dose of udca, pentoxifylline, sam-e, betaine, types of statin, types of fibrate and orlistat * patients who had a bariatric surgery less than 6 month prior to the participation in the study * patients who are judged by investigator that participation of the study is difficult due to disease as follow; hepatic cirrhosis, wilson's disease, malignant tumor, serious metabolic disease, severe renal disease, severe pulmonary disease, severe cardiovascular disease, severe nervous disease/psychiatric disorder, muscle disease and etc * any history of immune disorder which affect the changes in cytokine: inflammatory bowel disease, autoimmune thrombocytopenic purpura, system lupus erythematosus, autoimmune hemolytic anemia, severe psoriasis, rheumatic arthritis and etc * patients who have received treatment that may affect liver function within 1 month prior to the participation in the study * patient who has been administered other investigational product within 1 month prior to the participation in the study * patient who is not allowed to get mrs test: pacemaker, shunt and etc * pregnant or nursing women * patient who considered ineligible for participation in the study as investigator's judgment
safety and clinical effectiveness of intravitreal bevacizumab (lumiere®) in patients with wet age-related macular degeneration (wet amd)

Conditions: Age-Related Macular Degeneration

Summary: the purpose of this clinical trial is to evaluate the safety and clinical effectiveness of intravitreal bevacizumab (lumiere®) in the single-dose form, for the treatment of patients with wet amd.

age-related macular degeneration is the main cause of severe vision loss in patients over 65 years of age. there is solid evidence of the efficacy and safety of bevacizumab in the treatment of wet amd. however, it has not been registered for such indication yet. in response to the need for a proper adaptation, lumiere® has been developed in a single-dose, sterile dosage containing bevacizumab 5 mg/vial in 0.2 ml injectable solution. this adaptation is intended to assure intravitreal administration avoiding the risk of contamination and potential adverse consequences, such as endophthalmitis and blindness, associated to reutilization or repackaging of bevacizumab vials for oncological use.

Eligibility criteria:
inclusion criteria: * patients over 50 years of age diagnosed with wet age-related macular degeneration having indication of antiangiogenic therapy. * both genders. * subjects able to give informed consent. exclusion criteria: * patients with contraindication to receive bevacizumab: * hypersensitivity to the active ingredient or to some of the formula excipients. * hypersensitivity to products derived from cho cells or to other human recombinant antibodies or humanized antibodies. * patients having received intravitreal antiangiogenic therapy prior to wet amd treatment. * patients receiving previous systemic antiangiogenic therapy. * wet amd in the healing period or disciform scar. * pregnant, breastfeeding or childbearing-aged women. * any person with choroidal neovascularization not associated to wet amd. * history of retinal or intraocular surgery in the affected eye in the last three months. * vitrectomy in the affected eye. * any significant ocular infection, active or suspected, having compromised or able to compromise the eye to be studied. * ocular inflammatory disease. * myopia exceeding -8 diopters. * extensive subfoveal subretinal hemorrhage \> 2 papillary diameter (pd). * coexistence of other severe ocular diseases: uncontrolled ocular hypertension, terminal glaucoma, diabetic retinopathy, retinal vein thrombosis, optic atrophy. * history of stroke or myocardial infarction in the last 6 months. * patients with coagulopathies. * patients physically or mentally disabled to participate in such visual tests.
ctv delineation based solely on geometric expansion from gtv in nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage

Summary: this is a randomized, phase iii, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (npc) patients without distant metastasis. the aim of this study is to evaluate the efficacy and safety of modified imrt, of which ctv delineation was only based on geometric expansion from gtv.

all enrolled patients underwent intensity-modulated radiation therapy (imrt). the imrt technique was selected based on the equipment available at each treatment center and the patients' preferences, including imrt, vmat, or tomotherapy. according to our study design, all enrolled patients will be randomly assigned in a 1:1 ratio before radiation therapy. the target area definitions are based on the international icru reports no. 50 and no. 60. the specific target area definitions and prescribed doses for the two groups are as follows: 1. gtvp (70gy/33fx) experimental group: gross tumor as seen on imaging and nasopharyngoscopy; control group: gross tumor as seen on imaging and nasopharyngoscopy. 2. ctvp1 (60gy/33fx) experimental group: none; control group: gtvp + 5 mm + entire nasopharyngeal mucosa. 3. ctvp2 (54gy/33fx) experimental group: gtvp + 10 mm + entire nasopharyngeal mucosa; control group: gtvp + 10 mm + high-risk anatomical structures. 4. gtvn experimental group: lymph nodes as seen on imaging; control group: lymph nodes as seen on imaging. 5. ctvn experimental group: defined according to caca/cmda guidelines; control group: defined according to caca/cmda guidelines.

Eligibility criteria:
inclusion criteria: 1. pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma; 2. no distant metastatic; 3. patients with baseline mri date of nasopharynx and neck, and completed the first course of treatment in our hospital; 4. eastern cooperative oncology group (ecog) score of 0 or 1; 5. signing informed consent; 6. follow up regularly and comply with test requirements. exclusion criteria: 1. disease progression during imrt; 2. previous malignancy or other concomitant malignant diseases; 3. the evaluation information of tumor efficacy can not be obtained; 4. receive blind treatment in other clinical research; 5. have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer); 6. serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc; 7. active systemic infection; 8. no or limited capacity for civil conduct; 9. the patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study; 10. pregnancy or lactation period;
effectiveness of an intervention for prevention and treatment of burnout in primary care

Conditions: Burnout Syndrome

Summary: background: burnout syndrome is an important health problem that affects many professionals and must be addressed globally, with both organizational measures and personal interventions. burnout of health professionals can be prevented in order to avoid personal, familial, and social consequences, as well as repercussions for patients. methods/design: this work describes a protocol for a controlled, pragmatic, randomized clinical trial in 2 parallel groups: intervention and control. all health professionals from 7 health care centers (hccs) will form the intervention group, and all health professionals from 7 different hccs will form the control group. the intervention group will receive 16 hours of training at their work place. the maslach's burnout inventory (mbi), burnout physician questionnaire (cdpm) or burnout nurse questionnaire (cdpe), and the 28-item goldberg's general health questionnaire (ghq-28), validated for our setting, will be used as measurement tools. change in the average scores from the mbi emotional exhaustion scale will be compared between the intervention and control groups, measured as intention-to-treat, and the intervention will be considered effective if a minimum increase of 20% is achieved. discussion: due to the deleterious consequences of burnout syndrome for people suffering from it and for the organization where they work, it is necessary to evaluate the effectiveness of certain interventions for its prevention. organizational measures are important for preventing burnout syndrome, but so is providing professionals with coping strategies, as this group intervention intends to do.


Eligibility criteria:
inclusion criteria: * all health professionals (family physicians, pediatricians, and nurses) who are part of the health care centers at the moment of the trial. exclusion criteria: * no one.

Keywords: burnout syndrome job stressors primary health care health professional
the cycle study: a study of the effectiveness of cycling exercise in breaking the cycle of pregnancy diabetes

Conditions: Gestational Diabetes Mellitus

Summary: gestational diabetes mellitus (gdm) is one of the most common medical complications of pregnancy and has serious health implications for both the pregnant woman and her child. in particular, offspring of mothers with gdm have an increased prevalence of obesity, diabetes and metabolic syndrome, perpetuating serious health consequences in subsequent generations. although regular exercise offers numerous benefits for both the mother and her child, its effectiveness in preventing gdm remains to be established. it has been recently shown that regular supervised home-based exercise may attenuate the decline in glucose tolerance in obese pregnant women. this study aims to conduct a single-centred, multi-sited, single-blinded randomised controlled trial examining the effect of 14 weeks of supervised home-based exercise (commenced at 14 weeks gestation) on the recurrence and severity of gdm, along with other aspects of maternal and fetal wellbeing. eligible participants (n = 200) will be randomly allocated to an exercise intervention (n = 100) or a control group (n = 100). the exercise intervention will involve three 60-minute home-based, supervised exercise sessions each week. this type of program overcomes many of the barriers to exercise in this population including transportation, child care issues and embarrassment associated with exercising in a public venue. the investigators have already shown this program to be both feasible and warmly accepted by obese pregnant women.


Eligibility criteria:
inclusion criteria: * women at 12-13 weeks gestation, with a history of gestational diabetes in a previous pregnancy. exclusion criteria: * unable to participate in the supervised 14 week home-based exercise program * less than 18 years of age * unable to understand the implications of participation in the trial * women with a multiple pregnancy * women with pre-existing diabetes (type 1 or 2) or cardiac disease * women currently engaged in a structured exercise program
compare the immune response & safety elicited by henogen's adjuvanted hepatitis b vaccine vs aventis pasteur msd's hepatitis b vaccine in pre-dialysis & dialysis patients who did not respond to previous hepatitis b vaccination

Conditions: Hepatitis B

Summary: hepatitis b prevention in non-responders uraemic patients is currently based on both hbsag surveillance and the isolation from hbsag carriers. a more immunogenic vaccine would be a benefit for this population.

study participants will receive either henogen's adjuvanted hepatitis b vaccine or aventis pasteur's hepatitis b vaccine. the study involves a total of 4 visits and blood samples will taken at each of these visits.

Eligibility criteria:
inclusion criteria * a male or female subject greater than or equal to 15 years of age at the time of study entry * written informed consent obtained from the subject/ from the parent or guardian of the subject. * seronegative for anti-hbc antibodies and for hbsag at screening. * pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients * documented evidence of previous hepatitis b vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine. * the last dose should have been administered at least two months before the planned first dose of study vaccine in this study. * documented evidence of non-response to previous hepatitis b vaccination after at least one to maximum three months after the last vaccine dose. exclusion criteria * subject included on hn014/hbv-001 study. history of hepatitis b infection use of immunoglobulins within six months preceding the first study vaccination. * any confirmed or suspected human immunodeficiency virus (hiv) infection. pregnant or lactating female

Keywords: dialysis pre-dialysis hepatitis b vaccine prophylaxis hepatitis b infection
effects of voice records on patient outcomes surgical intensive care unit

Conditions: Intensive Care Unit Patients; Pain Management; Stress Response

Summary: this randomized kontrolled study is aimed to contribute to the literature on recognising, evaluating and reducing stress in the intensive care unit, which is one of the main responsibilities of surgical nurses, and to increase awareness on the subject.

the condition of having surgery, the severity of the disease, being admitted to the intensive care unit in the postoperative period and the presence of many invasive interventions in the body, intense feelings of pain and fear, loss of autonomy, helplessness, and fear of death create a heavy physical, psychological and emotional burden on patients undergoing surgery. all these factors increase the stress level in the patient by causing many metabolic and hormonal changes, and as a result of this stress response, negative conditions such as hyperglycaemia, delay in recovery, and decreased immunity can be seen. nurses have main roles and responsibilities in intensive care settings such as caring for patients, participating in treatment, informing and counselling patients and their relatives. within the scope of these roles and responsibilities, nurses should be aware of the stress experienced by patients, recognise the factors that may cause stress, plan, implement and evaluate basic nursing interventions such as increasing coping strategies and social support in the management and alleviation of stress, informing and counselling, increasing the patients orientation, and enabling the patient to participate in care in order to reduce the level of stress experienced by patients and protect their physical and biopsychosocial integrity. there are no studies in the literature examining the effects of listening to audio recordings, which is an easy, inexpensive and non-pharmacological intervention for stress management of patients in intensive care units.

Eligibility criteria:
inclusion criteria: * to determined as being over 18 years of age, * to staying in the icu for at least two hours, * to being hospitalised in the icu for the first time, * to being able to speak and understand turkish. exclusion criteria: * to determined as being pregnant, * to having a diagnosis of neurological/psychiatric disorder, * to having hearing problems, * to using cortisol-derived drugs, * to having a disease that may affect serum cortisol level, exhibiting agitated behaviour and * to experiencing intense nausea and vomiting.

Keywords: abdominal surgery intensive care unite nursing care voice record
a study to evaluate safety, tolerability and pharmacokinetics of adc3680b in subjects with partly controlled atopic asthma

Conditions: Atopic Asthma

Summary: this study is to examine the safety, tolerability, pharmacokinetics and functional activity of adc3680b administered once daily for 28 days in subjects with partly controlled atopic asthma.


Eligibility criteria:
inclusion criteria: * partially controlled mild-moderate atopic asthma * receiving inhaled corticosteroids * non-smoker or former smoker * males and females aged 18 to 55 years inclusive * if female, must be of non-childbearing potential exclusion criteria: * history of acute severe asthma attacks * history of copd * other serious respiratory or other medical condition which may interfere with the outcome of the study
prospective radiographic and clinical evaluation of surgical treatment for cervical deformity

Conditions: Cervical Deformity; Kyphosis; Scoliosis

Summary: the purpose of this study is to define clinical and demographic features within the population suffering from cervical deformity to assist health professionals to make important treatment decisions.


Eligibility criteria:
inclusion criteria: * adult 18 years of age or greater * cervical deformity (kyphosis c2-7 greater than 10 degrees or scoliosis with coronal cobb greater than 10 degrees) * plans for surgical correction of cervical deformity exclusion criteria: * active tumor or infection * acute trauma * unwillingness to provide consent or complete study forms * prisoner * pregnant or planning to get pregnant during study period
randomized clinical trial of bococizumab (pf-04950615; rn316) in subjects with hyperlipidemia or mixed dyslipidemia at risk of cardiovascular events

Conditions: Hyperlipidemia

Summary: this study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of bococizumab (pf-04950615;rn316) to lower ldl-c.


Eligibility criteria:
inclusion criteria: * treated with a statin. * fasting ldl-c \> 70 mg/dl and triglyceride \<=400 mg/dl. * high or very high risk of incurring a cardiovascular event. exclusion criteria: * pregnant or breastfeeding females. * cardiovascular or cerebrovascular event of procedures during the past 30 days. * congestive heart failure nyha class iv. * poorly controlled hypertension.

Keywords: mixed dyslipidemia high risk of cardiovascular events
efficacy and safety of intravascular high-pressure cutting balloon catheters for pci

Conditions: Atherosclerotic Plaque

Summary: the purpose of this study was to evaluate the safety and efficacy of intravascular high-pressure cut balloon catheter compared to cut balloon catheter during pci, and to support product registration and clinical application.


Eligibility criteria:
inclusion criteria: 1. be between 18 and 80 years of age (including boundary values) and have a life expectancy of more than 12 months； 2. be able to understand the purpose of the study, voluntarily participate in and sign the informed consent, and be able and willing to accept the follow-up established in this study; 3. ischemic cardiomyopathy with single or multiple coronary artery lesions and diagnostic evidence \[e.g., stable angina, unstable angina, or occult ischemia (evidence of myocardial ischemia)； 4. investigator is believed that the target atherosclerotic plaque needs to be incised and that predilation (if necessary) can enable the incised balloon to pass through the lesion； 5. the presence of coronary artery stenosis confirmed by imaging examination, suitable for percutaneous coronary intervention, coronary vessel stenosis ≥70%; or ≥50% (visual) with evidence of ischemia, timi ≥ level 1； 6. the patient had autogenous coronary angiogenesis or restenosis, requiring stent treatment； 7. the reference vessel diameter of target lesion was 2.0mm-4.0mm, and the lesion length was ≤20mm； 8. when there are multiple lesions that need to be treated, only one in situ coronary lesion is selected as the target lesion, and the non-target lesion must be located on different vascular branches； exclusion criteria: 1. patients with bleeding tendencies, contraindications to antiplatelet and anticoagulant therapy, who are unable to undergo anticoagulant therapy； 2. have had any myocardial infarction within a week； 3. people who have an allergic reaction to contrast media or can't take medication 4. there was severe renal failure with or without dialysis, glomerular filtration rate (egfr) \ 2.0 mg/ dl； 5. cardiogenic shock； 6. patients who have received heart transplants； 7. patients who are not eligible for coronary artery bypass surgery； 8. the patient had active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery； 9. the patient had a stroke or transient ischemic attack within 2 months before surgery； 10. patients in the pregnancy or lactation period； 11. participants are currently participating in any other clinical trial within 1 month prior to the trial； 12. patients deemed unsuitable for inclusion by other investigators； 13. severe calcified lesions and twisted lesions or lesion sites \> 45 degrees angled； 14. lesions with significant endometrial tears 15. unprotected left main lesion； 16. the contrast showed a blood clot； 17. scaffold fracture lesion； 18. distal stent lesion after stent implantation；