Kornimate/medical-research-clean huggingface dataset:
study to evaluate daptomycin given during dialysis and after dialysis

Conditions: End-stage Renal Disease; Renal Failure Chronic Requiring Hemodialysis

Summary: the purpose of this study is to determine whether daptomycin at a higher dose given during the last 30 minutes of a dialysis session is equal to a lower dose of daptomycin given after a dialysis session.


Eligibility criteria:
inclusion criteria: * written informed consent prior to any study-related procedure not part of normal medical care; * male or female ≥ 18 years of age; * if female of childbearing potential; willing to practice reliable birth control measures during study treatment and for at least 28 days after study completion, not lactating or pregnant, and has a documented negative pregnancy test result within 24 hours prior to study medication administration; * end-stage renal disease on stable (for at least 2 weeks) hemodialysis regimen, three times weekly using high-flux membranes; * functioning hemodialysis access (for example, graft or fistula); * considered to be in appropriate health for study entry by the investigator (for example, no acute, debilitating medical problems) and appropriate candidate for completing study treatment; * if taking concomitant medications, subject must be on a relatively stable dose for at least two weeks prior to study drug administration. exclusion criteria: * received an investigational drug (including experimental biologic agents) within 30 days of study drug administration; * has received any dose of daptomycin within 7 days prior to study drug administration; * known to be allergic or intolerant to daptomycin; * evidence of active ongoing infection; * known human immunodeficiency virus (hiv) infection with cd4 count ≤ 200 cells/mm3; * active illicit drug use or alcohol abuse; * myocardial infarction within last 6 months; * subject with a history of muscular disease (for example, polymyositis, muscular dystrophy); * subject with a history of neurological disease (for example, guillain barré, multiple sclerosis), except stroke \> 6 months prior to study entry; * intramuscular injection within 7 days of study drug administration; * body mass index (bmi) ≤ 18.5 or ≥ 40 kg/m2 (bmi = weight \[kg\]/height \[m2\]); * wbc ≥ 12, 000 cells/mm3 or ≤ 2500 cells/ mm3; * neutropenic subject with absolute neutrophil count ≤ 500 cells/mm3; * baseline cpk values ≥ 3x uln (upper limit of normal); * alanine aminotransferase (alt) \> 5xuln; * aspartate aminotransferase (ast) \> 5xuln; * hemoglobin ≤ 9 gm/dl; * is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations; * history of rhabdomyolysis.

Keywords: end-stage renal disease hemodialysis chronic renal failure
evaluation of a digiphysical screening method to identify and diagnose familial hypercholesterolemia

Conditions: Familial Hypercholesterolemia; Hypercholesterolemia

Summary: longitudinal and observational registry-based cohort study of individuals participating in the national digiphysical screening program for familial hypercholesterolemia. the information collected in the screening process will be combined in pseudo-anonymous form with data from the national board of health and welfare (registries: cause of death, diagnoses according to international classification of diseases (icd) and prescribed drugs) and statistic sweden (longitudinal integrated database for health insurance and labour market studies). primary analysis: association between familial hypercholesterolemia and cardiovascular disease. secondary analysis: efficacy and health economic aspects of digiphysical screening for familial hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * swedish personal identification number exclusion criteria: * decline informed consent

Keywords: familial hypercholesterolemia cardiovascular disease coronary artery disease ischemic stroke peripheral artery disease hypercholesterolemia
osa risk level in dental patients and correlation with complications after general anesthesia

Conditions: Obstructive Sleep Apnea Risk Management; Postoperative Complications; Dental Caries Under General Anesthesia; Obstructive Sleep Apnea of Adult

Summary: obstructive sleep apnea (osa) is a sleep-related respiratory dysfunction. the prevalence of osa is increasing with the increasing rates of obesity and elderly population worldwide. perioperative anesthesia management should be adjusted to improve patient safety in patients with osa. in osa patients, positive pressure ventilation support may be required in the preoperative period, various ventilation strategies may be required in the intraoperative period, different pharmacologic agents may need to be avoided, and intensive care unit follow-up or noninvasive ventilation support may be required in the postoperative period. however, it is reported that a significant percentage of osa patients remain undiagnosed. asa (american society of anesthesiologists) has reported the criteria that should be questioned in order to determine the risk of patients in terms of osa and to initiate the diagnostic process in risky patients and to make appropriate anesthesiologic arrangements in the perioperative period. in addition, the stop-bang assessment scale, which is widely used all over the world in osa risk assessment, is also used in osa risk assessment. it is thought that dental caries and extraction needs may be higher in osa patients, especially since open-mouth sleeping accompanies the situation. in this respect, it is also important for patients to be diagnosed with osa as it may prevent dental damage due to open-mouth sleeping in the future. identifying patients at risk for osa and directing them to the diagnostic process is very important for patient safety. within the scope of the study, the criteria recommended by asa and stop-bang score will be evaluated and recorded. risk stratification in terms of stop-bang questionnaire and asa criteria will be done separately for each patient and for each classification method. patients at high risk will be consulted to the relevant medical department in the preoperative period for further investigation and treatment. in addition, it is aimed to correlate the risk levels determined in the study with postoperative respiratory complications and recovery time.


Eligibility criteria:
inclusion criteria: * patients between 18-80 years of age who apply to the anesthesia clinic for dental procedures planned to be performed under general anesthesia * patients without a previous diagnosis of osa exclusion criteria: * individuals who do not want to participate in the study * patients previously diagnosed with osa * necessity of emergency surgery
evaluation of the anti-aging efficacy of one face care cosmetic product

Conditions: Skin Aging

Summary: the purpose of this study is to evaluate the anti-wrinkle efficacy and effect on skin epigenetic and on mitochondrial morphology of a facial cosmetic product compared to a placebo


Eligibility criteria:
inclusion criteria: * written informed consent to participate in the study * willingness to actively participate in the study and to come to the scheduled visits * female and approximately 10% male (at least 4 male subjects) * from 50 to 75 years of age * healthy skin in the test areas * visible wrinkles in the face (grade 3 to 6 according to sgs proderm scale) for biopsy subpanel: -vaccination of tetanus within the last 10 years exclusion criteria: * female subjects: pregnancy or lactation * drug addicts, alcoholics * aids, hiv-positive or infectious hepatitis * conditions which exclude a participation or might influence the test reaction/evaluation * participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area * active skin disease at the test area * documented allergies to face/eye care products * diabetes mellitus * cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years * one of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension (if not adjusted with medication), cardiovascular diseases * epilepsy * wounds, moles, tattoos, scars, irritated skin, excessive hair growth, freckles, etc. at the test area that could influence the investigation * regular use of tanning beds * any topical medication at the test area within the last 3 days prior to the start of the study * systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) and/or within the last 7 days prior to the start of the study * therapy with antibiotics within the last 2 weeks prior to the start of the study * past cosmetic surgery procedure in the test area (e.g. laser, facelift) * cosmetic surgery procedure in the test area, e.g. ipl (intensed pulsed light), botox, chemical peel, dermabrasion within the last 2 years prior to the start of the study and/or throughout the entire course of the study * medical treatment for wrinkle reduction (e.g. peeling with vitamin a or fruit acids) on the face within the last 2 weeks prior to the start of the study for biopsy subpanel: * regular medication with anti-coagulating drugs like aspirin®, macumar®, etc. (e.g. for thrombosis prophylaxis) within up to 15 days prior to the taking of the biopsies * history of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar) * known intolerance to local anaesthetics * known sensitivity to any dressing systems

Keywords: mitochondria urolithin a mitopure aging
magnesium replacement and hyperglycemia after kidney transplantation

Conditions: Hypomagnesemia; Kidney Transplantation

Summary: the insulin receptor is dependent on magnesium and hypomagnesemia is associated with increased insulin resistance and decreased insulin secretion and action. recent data suggest that hypomagnesemia may play a role in development of type 2 diabetes. kidney transplantation patients have low plasma magnesium levels, partly due to treatment with calcineurin inhibitors. however, the role of magnesium in the development of post-transplant diabetes mellitus (ptdm) is unclear. the present study addresses, whether hypomagnesemia is feasible to reverse by oral administration of magnesium. the investigators wish to investigate whether oral magnesium supplementation is sufficient to increase magnesium levels in kidney transplant recipients, and if supplementation improves glycemic parameters as measured by an oral glucose tolerance test (ogtt).


Eligibility criteria:
inclusion criteria: * kidney transplant recipients more than one year after transplantation * hypomagnesemia (\< 0.7 mmol/l) * age ≥ 18 years and able to give written informed consent exclusion criteria: * current treatment with magnesium containing medication or supplements * current medical treatment for diabetes * conditions impairing magnesium absorption from the gastrointestinal tract (e.g. short bowel syndrome, chronic pancreatitis) * subjects with primary non-graft function and subjects with need of dialysis therapy \>2 months or graftectomy at any time point after transplantation

Keywords: oral glucose tolerance test magnesium hydroxide hyperglycemia
a first-in-human study of eos301984 as monotherapy or combination therapy in adult participants with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: apt-008 is an open-label, phase i/ib, dose escalation and expansion cohort study to evaluate the safety, tolerability, pharmacokinetic (pk), pharmacodynamic (pd), and preliminary efficacy of eos301984 as monotherapy and in combination with other anticancer therapies in participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria * provide a signed written informed consent before any study-specific evaluation. * be at least 18 years old on the day of signing informed consent. * have a histologically confirmed advanced solid tumor for which no standard approved treatment is available, or are ineligible for, or did not tolerate standard approved treatment. * have at least one tumor lesion measurable per response evaluation criteria in solid tumors (recist) v1.1. * have an eastern cooperative oncology group (ecog) performance status of 0 or 1. * have adequate organ and marrow function. * agree to use adequate highly effective method of contraception during the study is mandatory, if women of childbearing potential (wocbp) or male. exclusion criteria * have received prior systemic anticancer treatment including investigational agents within 4 weeks before the first dose of study treatment. * have major surgery planned or have had a major surgery within 5 weeks before the first dose of the study treatment. * have received prior radiotherapy within 2 weeks before the first dose of study treatment. * have allergy to study treatment(s) or any of its components. * have a history or current evidence of uncontrolled or significant cardiovascular disease. unable to comply with the requirements of the study or who, in the opinion of the investigator, should not participate in the study. * pregnant or breastfeeding women.

Keywords: advanced solid tumors neoplasm cancer phase i immunotherapy anticancer
postprandial response after intake of meals with different fatty acid composition

Conditions: Healthy; Familial Hypercholesterolemia

Summary: the aim of the study is to understand more about how different fatty acids modulate postprandial lipid metabolism and inflammatory response.


Eligibility criteria:
inclusion criteria: * 18 - 30 years of age * healthy or diagnosed with familial hypercholesterolemia (fh) (mutation in gene coding for ldl-receptor). fh subjects can be included if they are: 1. untreated 2. treated with low dose statin (\<20 mg atorvastatin, \<10-20 mg simvastatin or \<5-10 mg rosuvastatin) 3. treated with high dose statin and willing to use low dose statin during the last 4 weeks prior to both study visits (total 8 week period) 4. treated with high dose statins and willing to discontinue statin treatment during the last 4 weeks prior to both study visits (total 8 week period) * bmi 18.5 - 30 kg/m2 * stabile weight the last three months prior to the first study visit (weight change less than ± 5 % of body weight) exclusion criteria: * crp \>10 mg/l * tg \>4 mmol/l * comorbidities including diabetes type i and ii, coronary heart disease, haemophilia, anaemia, gastro intestinal disease, renal failure and hyperthyroidism * pregnant or lactating * allergic or intolerant to gluten or egg * not willing to stop using n-3 fatty acid supplements during the last 4 weeks prior to both study visits * using medications affecting lipid metabolism or inflammation, except statins for fh subjects * hormone treatment (except contraception and thyroxin (stabile dose last 3 months)) * donating blood 2 months within or during study period * tobacco smoking * large alcohol consumption (\>40g daily)
the effect of stress ball and 4-7-8 breathing technique on fear, anxiety and physiological parameters

Conditions: Endoscopy; Breathing Exercises; Cognitive Therapy; Stress; Anxiety; Physiological Parameters

Summary: the study aimed to examine the effects of two different applications (stress ball and 4-7-8 breathing technique) before upper gi endoscopy on patients' fear, anxiety and physiological parameters before the procedure. the study as a single-blind, pre-test and post-test experimental study.

due to the procedures involved, endoscopy patients experience high levels of fear and anxiety. fear and anxiety may activate the patient's autonomic nervous system, causing increased sweating, heart rate, blood pressure and respiratory rate, and complications related to the procedure. reducing fear and anxiety and making the patient feel relaxed not only prevents possible harm to the patient due to the procedure, but also facilitates the work of the healthcare team performing the procedure and ensures accurate results. in this context, this study aimed to examine the effects of stress ball exercise and 4-7-8 breathing technique on the fear, anxiety and vital signs of patients who will undergo upper gastrointestinal (gi) endoscopy.

Eligibility criteria:
inclusion criteria: 1. upper gi endoscopy will be performed for the first time, 2. american society of anesthesiologists (asa) status i-ii 3. those over 18 years of age 4. participates in the research voluntarily and is willing to cooperate. 5. no visual impairment, hearing impairment or communication problem, 6. not having a psychiatric diagnosis and not using anxiolytic, hypnotic or sedative drugs exclusion criteria: 1. those diagnosed with severe respiratory failure 2. those who have health problems in the hand, wrist or arm area that prevent squeezing the stress ball. 3. using psychiatric medication (antipsychotic, antidepressant, anxiolytic, sedative, etc. 4. anyone who wishes to leave the research at any stage of the research, with his or her own initiative.
efficacy and satisfaction with remifentanil analgesia in parturients during the childbirth

Conditions: Complication of Labor and/or Delivery

Summary: retrospective observational study to determine the efficacy of remifentanil during the delivery. authors will search the data in period between 2010 and 2014 in cohort of 100 parturients and obtain data of analgesic efficacy (vas score after remifentanil analgesia induction) and parturients satisfaction with the method.

in retrospective observational study will authors search the documentation of parturients. the cohort size is estimated to 100 subjects, in period between 2010-2014. excluded will be all patients who did not signed the informed consent for processing with their medical data.the main aim is to evaluate the efficacy of the remifentanil analgesia in parturients in the first phase of delivery. the analgesic efficacy will be evaluated by the change in vas (visual analogue scale) score after induction of remifentanil analgesia satisfaction will be evaluated by the questionary.

Eligibility criteria:
inclusion criteria: * parturients during the delivery * administered remifentanil analgesia * signed informed consent exclusion criteria: * informed consent not signed * missing data about the analgetic method a analgetic efficacy

Keywords: remifentanil, delivery, childbirth, analgesia, parturition, confinement
the effect of simvastatin on uterine leiomyoma development and growth in infertile women

Conditions: Infertility

Summary: uterine leiomyomas with an estimated incidence of 50%-80% are the most common tumors of female reproductive system. statins as a hmg-coa reductase inhibitors inhibit the mevalonate pathway of cholesterol synthesis, thus have been known as a group of drugs used for treatment of hypercholesterolemia. statins inhibit proliferation of several cell types including vascular smooth muscle, hepatocytes and other cell types. leiomyomas are benign uterine tumors characterized by smooth muscle proliferation and excessive deposition of extracellular matrix. in the present study we aim to evaluate the effect of simvastatin on uterine leiomyoma development and growth.

the proposal of the present study approved by our institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. all patients will be randomly divided into three groups and will be randomized to receive simvastatin 40 mg orally + vaginal placebo, simvastatin 40 mg vaginally + oral placebo and vaginal placebo + oral placebo for 3 months. cbc, lipid profile, kidney \& liver function tests, fbs \& hormonal evaluation will be performed before and after the treatment. ultrasound examination will be performed before and after the treatment for determining of the number, size, and site of the myoma and also size of the uterus.

Eligibility criteria:
inclusion criteria: * age between 20-40 years * intramural fibroids confirmed by ultrasound * presence of at least one fibroid with size \>4 cm or two fibroids with size \>3 cm detected by pelvic ultrasound. * presence of at least 3 fibroids with size \<3 cm and a history of 2 ivf failures. * number of fibroids ≤ 5 * bmi\>25 kg/m2 exclusion criteria: * pregnancy * hormonal contraception or any hormonal therapy received in the last 3 months * alcohol consumption * allergic to simvastatin * suspicion or diagnosis of cancer * signs or symptoms of mental illness, hepatic dysfunction, myopathic syndromes, diabetes mellitus, renal disease, cardiovascular disease, hypothyroidism, hypotension, neuropathy, lupus and cataract * hb ≤ 7 * taking antifungal medications, lipid-lowering medications (gemfibrozil, clofibrate), warfarin, danazol and erythromycin in the last one month. * severe male factor * severe endometriosis * diminished ovarian reserve

Keywords: leiomyoma simvastatin infertility
study of changes and characteristics of genes in patients with pancreatic cancer for better treatment selection

Conditions: Carcinoma, Pancreatic Ductal

Summary: researchers are looking for better ways of understanding and treating pancreatic cancer. the purpose of this study is to see how useful it is to look for changes and characteristics in your genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour. these characteristics may be useful in choosing treatments for patients in the future. changes (mutations) in genes have been shown to be an important characteristic in cancers. looking at differences in genes in patients with advanced pancreatic ductal adenocarcinomas and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.


Eligibility criteria:
inclusion criteria: * patients must have a histological or radiological diagnosis of locally advanced or metastatic pancreatic ductal adenocarcinoma. patients with borderline resectable disease are not eligible. * patient must have a tumor lesion that is amenable to a core needle biopsy. * patients must have a measurable lesion by recist 1.1 in addition to the lesion that is going to be biopsied. * patients must be fit enough to safely undergo a tumor biopsy. * age 18 years or older. * eastern cooperative group (ecog) performance status of 1 or less. * life expectancy of greater than 90 days. * patients must have normal organ and marrow function * patients must undergo systemic treatment with m-folfirinox or nab-paclitaxel as a first line standard systemic palliative treatment or combination treatment with m-folfirinox or nab-paclitaxel with or without other investigational agents within a clinical trial as a first line palliative treatment. * ability to understand and willing to sign a written informed consent document. exclusion criteria: * patients with one or more contraindications to tumor biopsy. * patients who have prior systemic treatment (chemotherapy or any other anti-cancer agent) in advanced setting. * patients who are currently on anti-cancer treatment including chemotherapy. * patients with known brain metastases. * patients with advanced pdac who are going to be treated with gemcitabine monotherapy in advanced setting. * uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.