Kornimate/medical-research-clean huggingface dataset:
influence of vitamin d treatment on multi-systemic functions in young men with vitamin d deficiency due to work conditions

Conditions: Vitamin D Deficiency

Summary: vitamin d has multiple systemic effects: bone and calcium metabolism, muscle function, insulin responsiveness, body-composition regulation, cell differentiation, and the immune system. proper status of vitamin d is found to be related to risk reduction in hypertension, cardiac and vascular diseases, autoimmune diseases, and others. furthermore, vitamin d supplementation resulted in improved endothelial function. limited sun exposure may lead to vitamin d deficiency, and it may be assumed that modern life styles lead to a lack of sun exposure. long work-days may be the primary risk factor for vitamin d deficiency. the purpose of this research is to study the effect of vitamin d treatment on multi systemic functions in young healthy men with vitamin d deficiency due to working conditions.

the study has 2 stages: first stage would be survey of 400 employees, who will fill out a questionnaire to identify occupational and demographic risk factors, a nutritional questionnaire, and data from periodic checkups will be collected. participants will sign a consent form for vitamin d level determinations, and for freezing blood samples. from this survey, the participants that have vitamin d deficiency (25(oh)d levels \< 20 ng/ml) will continue to the second stage of the study - administration of vitamin d or placebo. participants in the interventional study will sign an additional consent form. length of follow-up: one year. all parameters will be tested at 0, 6, and 12 months.

Eligibility criteria:
inclusion criteria: * healthy men between 20-65 years old * for stage 2: baseline 25(oh)d levels \< 20 ng/ml exclusion criteria: * liver dysfunction * kidney dysfunction * patients with unbalanced chronic diseases * regular use of medications that lower serum vitamin d levels, or which interfere with intestinal vitamin d absorption

Keywords: quality of life
keto-/amino acid supplemented low protein diet in patients with chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: keto-/amino acid supplemented low protein diet can reduce uremic symptoms, improve nutritional status, delay dialysis therapy and enhance health-related quality of life in our patients with stage v ckd in comparison to non-supplemented low protein diet.

fifty patients will be included into the study. the study comprises 9 visits. the treatment period covers 6 months, preceded by a 2-week screening period and a 1 month run-in period. patients are required to visit the investigator two times before the start of active treatment. all patients who are qualified for this study will then be randomised by receiving their medication/introduction of dietary management using the standard simple randomization method.group i patients will receive keto-/amino acid (ketosteril) supplemented low protein diet during the active treatment period while group ii patients will receive non-supplemented low protein diet during the same period. the daily dose of keto-/amino acid for each group i patient is one tablet every 5 kg body weight. the total daily dose will be divided into three times a day.

Eligibility criteria:
inclusion criteria: * 1. serum creatinine ≧6 mg/dl at visit 12. creatinine clearance \< 15 ml/min at visit 13. urine output ≧ 1,000 ml/day4. primary renal disease: chronic glomerulonephritis or non-diabetic stage ⅴ chronic kidney disease (confirmed by biopsy or clinical presentations/symptoms)5. bilaterally reduced renal size shown by sonography6. male or female patients aged 20 - 657. ability of the patient to understand the basic implications of the study and to follow instructions8. willingness to participate as indicated by a signed written informed consent exclusion criteria: * 1. severe arterial hypertension not responsive to medical therapy, maximum blood pressure values allowed: 180/100 mm hg 2. inadequate caloric intake due to extremely severe uremia (vomiting, anorexia, etc) 3. malnutrition status with serum albumin level less than 3.5 g/dl in recent one month 4. lack of adherence to dietary prescription 5. water and sodium retention not responsive to diuretics 6. clinical relevant severe cardiac disease, hepatic disorders (total bilirubin \> 1.5 times the upper limit of normal), malabsorption disorders, diseases requiring steroids or non-steroid anti-inflammatory drugs 7. severe sodium wasting syndrome that may affect renal function markedly and independently of dietary therapy 8. concurrent use of nephrotoxic drugs 9. severe infection with catabolic situation 10. signs of uremic pericarditis 11. symptoms of uremic polyneuropathy 12. disorder of amino acid metabolism 13. pregnant or nursing women 14. participation in a clinical trial within the last 2 months 15. former participation in the present study

Keywords: chronic kidney disease
olmesartan comparison to losartan in hypertensive subjects

Conditions: Hypertension

Summary: this study will evaluate the efficacy and safety of the fda approved blood pressure medication olmesartan medoxomil compared to the fda approved medication losartan potassium.


Eligibility criteria:
inclusion criteria: * males or females aged \> 18 years who are not institutionalized and have signed informed consent. * mean cuff seated diastolic blood pressure (bp) must be \> 95 mmhg and \< 115 mmhg and a mean cuff seated systolic bp must be \< 180 mmhg when measured at two consecutive qualification study visits during the placebo run-in phase. * the difference in mean cuff seated diastolic bp must be \< 7 mmhg between two consecutive qualification study visits during the placebo run-in phase. exclusion criteria: * subjects with type 2 diabetes mellitus with an hba1c ≥ 9.5% at screening. * subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of olmesartan medoxomil and losartan potassium, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic (with the exception of non-insulin, dependent type 2 diabetes mellitus with hba1c \< 9.5% at screening), hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases. * subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or heart failure within the last 12 months. * subjects with any history of new york heart association class iii or iv congestive heart failure (chf). a history of new york heart association class i or ii chf may be exclusionary at the discretion of the investigator. * subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year. * subjects with clinically significant cardiac conduction defects, including second or third degree atrioventricular (av) block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.
study of nivolumab (bms-936558) vs. everolimus in pre-treated advanced or metastatic clear-cell renal cell carcinoma (checkmate 025)

Conditions: Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma

Summary: the purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of nivolumab vs. everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy


Eligibility criteria:
inclusion criteria: * men \& women ≥18 years of age * histologic confirmation of renal cell carcinoma (rcc) with clear-cell component * advanced/metastatic rcc * measurable disease per response evaluation criteria in solid tumors (recist) 1.1 criteria * received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting * no more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment * karnofsky performance score ≥70% exclusion criteria: * any central nervous system (cns) metastases or history of cns metastases * prior therapy with an mammalian target of rapamycin (mtor) inhibitor * any active known or suspected autoimmune disease * uncontrolled adrenal insufficiency * active chronic liver disease * prior malignancy active within past 3 years, except for locally curable cancers other protocol-defined inclusion/exclusion criteria apply
evaluation of remin pro forte versus remin pro on treatment of white spot lesions post orthodontic treatment

Conditions: White Spot Lesion

Summary: randomized clinical trial to evaluate caries regression, the change in colour and mineral content of the demineralized enamel after treatment with remin pro forte paste (fluoride, hydroxyapatite, xylitol, ginger, and curcuma) and remin pro cream which contains (fluoride, hydroxyapatite, xylitol) remineralizing agents with the null hypothesis that remin pro forte will have the same clinical performance as remin pro in remineralizing white spot lesions post-orthodontic treatment.

recently, a remineralizing water based cream containing hydroxyapatite, fluoride and xylitol (remin pro) has been introduced. it has been claimed that hydroxyapatite fills eroded enamel, fluoride seals dentinal tubules and xylitol acts as an antibacterial agents. this product has been assumed to be suitable for management of dentinal hypersensitivity, prevention of enamel demineralization and promoting remineralization of enamel subsurface lesions. there are few studies regarding the effect of calcium phosphate and hydroxyapatite-based agents on remineralization and optical appearance of white spot lesions following orthodontic therapy. recently a new formulation of remin pro has been introduced called (remin pro forte) with the same components of fluoride, hydroxyapatite, xylitol in addition to two natural products (ginger, curcuma) with the rationale based behind that they have antibacterial effect against streptococcus mutans in addition to anti-cariogenic effect which is being confirmed in the scientific literature. follow up period is selected to be 3 months, which is enough for evaluation of the outcomes (caries regression, color change, mineral content) assessed in this study.

Eligibility criteria:
inclusion criteria: 1. no systemic disease. 2. has completed fixed orthodontic treatment, brackets debonded. 3. has at least two teeth with white spot lesion. 4. has received conventional periodontal therapy after orthodontic treatment. 5. between the ages of 12 and 25 years of age. exclusion criteria: 1. presence of enamel hypoplasia or dental fluorosis. 2. presence of tetracycline pigmentation. 3. periodontal pocketing of 3mm or greater. 4. taking antibiotics. 5. presence of carious cavities. 6. allergy to fluoride gel / varnish being used in study. 7. subjects who had evidence of reduced salivary flow or significant tooth wear

Keywords: remineralization caries regression color improvement
the eshre study into the evaluation of oocyte euploidy by microarray analysis

Conditions: Aneuploid Oocytes

Summary: a pragmatic, multicentre, randomized double-blind controlled trial with an intention-to-treat analysis, of the use of preimplantation genetic screening (pgs) for aneuploidy by means of microarray comparative genomic hybridization (cgh) for the chromosomal analysis of the polar bodies (pb) of oocytes collected after ovarian stimulation for in vitro fertilization (ivf), and with the intention to assess the genetic competence of oocytes of advanced biological age, and the effect of this technique on reproductive outcome.


Eligibility criteria:
inclusion criteria: * infertility as an indication for ivf or icsi; * patients between their 36th and 41st birthdays (at time of signing icf i.e. max 40years and 364days at the day of signing the informed consent); * bmi range 18 to 30 kgs per m2; * patients prepared to accept transfer of up to two embryos; * absence of any type of genetic abnormality in the patient's personal and family history; * normal karyotype (optional) exclusion criteria: * treatment involving donor oocytes (donor sperm is allowed subject to local practice and regulations and provided karyotype of the sperm donor is available and normal); * menstrual irregularity (\ 35 days); * three or more previous failed ivf or icsi cycles, with the present partner. (definition of a failed cycle: 'absence of a clinical pregnancy relating to a treatment with embryo transfer resulting from oocyte retrieval for the current intended pregnancy and with the current partner; the transfers include transfers of fresh and frozen within this treatment; clinical pregnancy is defined as the presence of a gestational sac at the earliest ultrasound and includes early clinical miscarriage, late miscarriage and clinically confirmed extrauterine pregnancy, and excludes preclinical miscarriage (biochemical pregnancy); - * three or more clinical miscarriages; * poor response in any previous cycle; * low ovarian reserve (at least one of the following two features must be present: (1) a previous poor ovarian response (≤ 3 oocytes with a conventional stimulation 119 protocol); (2) an abnormal ovarian reserve test (i.e. afc \< 5 follicles or amh \< 0,5 ng/ml)\* (adapted from ferraretti et al., 2011); * cycles requiring surgical sperm recovery procedures; * total asthenozoospermia and/or globozoospermia. * any type of genetic abnormality or family history of genetic abnormality in subject or partner

Keywords: aneuploid oocytes icsi ivf polar body biopsy
the effect of music on pain, anxiety and satisfaction during mammography

Conditions: Breast Cancer; Pain; Anxiety

Summary: this study was planned to determine the effect of music listened to during mammography screening on pain, anxiety and satisfaction.

the randomized controlled and experimental study will be conducted with 70 women who apply to the cancer early diagnosis, screening and training center for mammography screening. women in the experimental group (n=35) will listen to music before, during and after mammography screening, and women in the control group (n=35) will undergo routine mammography screening. information form containing sociodemographic information and situational anxiety inventory will be used to collect data.

Eligibility criteria:
inclusion criteria: * knowing how to read and write, * not having had a mammogram before, * being between the ages of 40-69, * no hearing-related problems, * not having used analgesic or anesthetic medication within 24 hours before or during the procedure, * voluntarily participating in the study, exclusion criteria: - the woman has a cognitive and auditory problem

Keywords: mammography pain music therapy
the role of fatty acids in vaccine efficacy

Conditions: Rabies Vaccination Reaction

Summary: this study intends to use a randomized controlled trial design to vaccinate all participants against rabies and perform ara interventions during vaccination to test the efficacy, safety, and intestinal flora of each group after immunization.

rabies is an acute zoonotic infectious disease caused by central nervous system invasion by rabies virus. at present, there is still a lack of effective treatment, and once clinical symptoms appear, it is almost 100% fatal. rabies vaccination within 24 hours of exposure may reduce the incidence of rabies. pre-exposure prophylaxis is also effective, and the current recommended pre-exposure vaccination program in china is 0 days, 7th day, 21st days. the health of the human body is inseparable from various nutrients. there are studies suggesting that arachidonic acid(ara) has an immunomodulatory effect, but there is limited evidence for its effect on vaccines. therefore, this study will explore the effects of nutritional supplements on the effectiveness of rabies vaccination.

Eligibility criteria:
inclusion criteria: * 1）18-45 years old; * 2）bmi 18.5-24.9 kg/m2; * 3）have not received rabies vaccination. exclusion criteria: * 1) those who have severe disorders of abnormal lipid metabolism; * 2) those who have used lipid-lowering drugs, weight loss drugs, and insulin drugs in the past three months; * 3) those who have received other vaccines in the past three months; * 4) those who have used probiotics or prebiotics in the past three months; * 5) those who have used steroids and immunosuppressants, other hormonal drugs in the past year; * 6) those with immunodeficiency diseases; * 7) those with a history of severe vaccine allergies; * 8) those who have disorders of liver and kidney metabolism; * 9) those who have had fever, cold, severe diarrhea and other diseases in the past month. * 10) smokers in the last year.

Keywords: rabies vaccination arachidonic acid efficacy
prognostic value of plasma biomarkers among patients with hypertension

Conditions: Hypertension

Summary: hypertension is the most important risk factor for cardiovascular and cerebrovascular diseases，and also a substantial public health problem. the purpose of the study is to investigate the association between plasma biomarkers and adverse outcomes in patients with hypertension.


Eligibility criteria:
inclusion criteria: * \>18 years old * in accordance with the diagnosis of hypertension (bp≥140/90mmhg) exclusion criteria: * the exclusion criteria for the study program were as follows: pregnancy, history of heart failure or left ventricular ejection fraction less than 40%, myocardial infarction within one month, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting, cerebrovascular disease, severe liver disease, severe chronic renal failure (egfr less than 30 ml/min/1.73 m2) in the past three months.
an extension of protocol pro 140_cd01 ts study

Conditions: HIV; Human Immunodeficiency Virus

Summary: this study is a phase 2b, multi-center, extension study designed to evaluate the long-term efficacy, safety, and tolerability of pro 140 monotherapy for the maintenance of viral suppression in patients who were stable on combination antiretroviral therapy and completed 12 weeks of treatment under pro140_cd01 treatment substitution study without experiencing virologic failure. consenting patients will continue to receive pro 140 monotherapy for 160 additional weeks. total treatment duration with pro 140 will be up to 161 weeks with one week overlap of existing retroviral regimen and pro 140 at the end of the treatment extension phase in subjects who do not experience virologic failure.


Eligibility criteria:
inclusion criteria: 1. subjects who have completed 12 weeks of treatment in pro 140_cd01 study without experiencing virologic failure. 2. both male and female patients and their partners of childbearing potential must agree to use appropriate birth control methods (birth control pills, barriers, or abstinence) throughout the study duration (excluding women who are not of childbearing potential and men who have been sterilized). females of childbearing potential must have a negative urine pregnancy test prior to receiving the first dose of study drug. 3. willing and able to participate in all aspects of the study, including use of sc medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent. exclusion criteria: 1. not currently enrolled in pro140_cd01 treatment substitution study 2. any acquired immune deficiency syndrome (aids)-defining illness according to the 1993 centers for disease control and prevention (cdc) aids surveillance definition 3. laboratory test values ≥ grade 4 daids laboratory abnormality. 4. females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study 5. unexplained temperature \>38.5c (101.3f) for seven consecutive days within 14 days prior to the first study dose 6. diagnosed with either substance dependence or substance abuse or any history of a concomitant condition (e.g., medical, psychologic, or psychiatric) that in the opinion of the primary care provider and/or site investigator would interfere with the subject's successful completion of the study requirements 7. any other clinical condition that, in the investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy
impact of covid-19 in congenital heart disease

Conditions: Congenital Heart Disease; Covid-19

Summary: the ongoing coronavirus (covid-19) pandemic has recently generated the first epidemiological data on populations at risk. currently, the risk factors, recognized for severe forms of covid-19 infection, are elderly patients (\> 70 years), obese patients, patients with chronic renal or respiratory diseases, cardiovascular history (stroke or coronary artery disease), high blood pressure, diabetes, and cancer. the population of congenital heart disease (chd) might also be at risk, however, no data is available in this group of patients. chd is the leading cause of birth defects, and as a result of recent medical advances, currently the number of adults with chd exceeds the number of children, with an increasing prevalence of complex chd. approximately 200,000 children and 250,000 adults are living with a chd in france today. the french society of cardiology, coordinator of this study, issued recommendations on march 14, 2020 for the french chd population on the basis of expert opinions based essentially on the data published in the general population. nevertheless, there is a need to provide scientific data on the impact of covid-19 in the pediatric and adult chd population. this study aims to assess the morbidity, the mortality and the risk factors associated with covid-19 in patients with chd in france


Eligibility criteria:
inclusion criteria: * patient with chd as defined in the international classification acc-chd * covid-19 infection over the study period exclusion criteria: - patient with genetic heart disease (cardiomyopathy, hereditary rhythmic disease).

Keywords: congenital heart disease covid-19 adults peadiarics
effect of gnrh agonist vs gnrh antagonist on oocyte morphology in polycystic ovary syndrome patients during ivf/icsi

Conditions: In Vitro Fertilization; Infertility; Intracytoplasmic Sperm Injection; Polycystic Ovary Syndrome

Summary: selection of developmentally competent oocytes enhances ivf efficiency. usually, oocyte quality is determined based on its nuclear maturation and the presence of specific cytoplasmic and extracytoplasmic morphologic features. gonadotropin-releasing hormone agonists (gnrh agonists) and gonadotropin-releasing hormone antagonists (gnrh antagonists) are used during controlled ovarian stimulation (cos) protocols in order to prevent premature luteinizing hormone (lh) surge and premature ovulation. however, gnrh receptors are also expressed in extra-pituitary tissues such as ovary, but it is still unknown whether the type of gnrh analogues used during cos could affect the oocyte morphology in polycystic ovary syndrome (pcos) patients. the aim of this prospective, non-randomised, open-label, clinical trial is to compare the effects of two pituitary suppression regimens; gnrh agonist-long protocol and gnrh antagonist-flexible protocol on oocyte morphology in pcos patients during ivf/icsi.


Eligibility criteria:
inclusion criteria: * pcos women undergoing ivf/icsi. * age: 18-39 years. * both ovaries present. exclusion criteria: * age ≥ 40 years. * history of three or more previous ivf failures. * patients with hormonal disorders like hyperprolactinemia, thyroid disorders. * patients who previously undergo unilateral oophorectomy. * patients with chronic diseases: diabetes mellitus, cardiovascular diseases, liver diseases, kidney diseases. * patients with diseases may affect ivf outcomes: endometriosis, uterine fibroids, hydrosalpinx, adenomyosis, autoimmune diseases, * cancer.

Keywords: gnrh agonist gnrh antagonist oocyte morphology assisted reproduction technique in vitro fertilization intracytoplasmic sperm injection polycystic ovary syndrome