Kornimate/medical-research-clean huggingface dataset:
clinical pharmacokinetic study of ceftazidime and cefazolin

Conditions: CAPD-related Peritonitis

Summary: peritoneal dialysis-related peritonitis is a common complication of peritoneal dialysis, which is the main cause of transfer from peritoneal dialysis to hemodialysis. guidelines for international society for peritoneal dialysis（ispd）published in 2016 recommend that timely and adequate use of antibiotics is the most important part of treatment. empiric treatment should be initiated as soon as possible after obtaining microbiological specimens，then adjust the antibiotics according to culture results and drug sensitivity of bacteria. intraperitoneal antibiotic can ensure antibiotic concentrations at the local sites of the infection are maximized，however, in patients with renal failure, the investigators should pay attention to the nephrotoxicity caused by the reduction of renal excretion，being guided by pharmacokinetic/ pharmacodynamic principle on antibiotic can develop dosing recommendations to optimize antibiotic efficacy and minimize toxicity. in this study, the investigators aim to detect the concentration of ceftazidime and cefazolin in capd patients，so as to analyze the pharmacokinetics parameters and evaluate the rationality of the treatment.

the dose of cefazolin and ceftazidime co-administered were 20 mg /kg，they were given intraperitoneal twice daily in the first bag and the fourth bag for 5 days，and given 1g once daily in the fourth bag for 9 days. total treatment duration was 2 weeks. at least 1-ml serum and 5-ml dialysate samples were collected at 1, 2, 4, 6, 10, 14 days after complete instillation of the first dialysis bag containing antibiotic into the peritoneal cavity. the samples were then centrifuged at 3,000 rpm, all study samples were stored frozen (-80℃) within 1 hour after collection.

Eligibility criteria:
inclusion criteria: maintained on continuous ambulatory pd (capd) for at least 1 month,all patients received 4 exchanges per day with dialysate volumes of 2 l per exchange. 1. the diagnostic criteria for capd-related peritonitis are as follows: the dialysate fluid appears cloudy and accord with the following peritonitis diagnostic criteria: (with the following two can be diagnosed) a. clinical manifestations of peritoneics, such as abdominal pain and/or turbid flow of fluid from peritoneal dialysis; b. perital dialysis discharge of liquid pathogen culture positive. c. the white blood cell count of perital dialysis outflow liquid were more than 0. 1 x 10 x 9/l, and the percentage of polymorphic nucleocells is more than 50% (peritoneal dialysis fluid remains in the abdominal cavity for at least 2 hours for more than 2 hours); 2. no urine (less than 100ml per 24h). 3. age range form 15 years old to 70 years old, gender is not limited; 4. understand and agree to this clinical trial study. exclusion criteria: 1. with a clear history of cephalosporine drug allergy or hypersensitivity; 2. received antibiotic treatment within 1 week prior to entering the study; 3. pregnant and lactating women; 4. sepsis; 5. patients with celiac malignancy; 6. the patient is unable to cooperate or unwilling to accept the test.
gestational diabetes and offspring's cardiovascular health: mysweetheart cohort

Conditions: Cardiovascular Diseases; Gestational Diabetes Mellitus

Summary: mysweetheart cohort is an observational study to assess the effect of gestational diabetes mellitus (gdm) on early life offspring's cardiovascular health. the primary objective is to assess the effect of gdm on the surrogate markers of cardiovascular disease (cvd) at birth (left ventricular mass index and subclinical atherosclerosis). the secondary objective is to assess the effect of gdm on the cardiovascular structure and function during the fetal period and neonatal adverse cardiovascular risk factors. the main hypothesis is that offspring of women with gdm have a larger lvmi and a larger cimt at birth (primary outcomes) compared with offspring of women without gdm. further, other hypotheses are that offspring of women with gdm have more foetal cardiovascular alterations and adverse neonatal cardio-metabolic risk factors (secondary outcomes) compared with offspring of women without gdm. my sweetheart cohort is linked to mysweetheart trial, a randomized controlled trial assessing the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve the cardio-metabolic and mental health of women with gdm and their offspring. the principal investigators of this trial are prof jardena puder and dr antje horsch from lausanne university hospital.


Eligibility criteria:
inclusion criteria: women aged 18 yrs or older, with or without gdm at 24-32 weeks of gestation, and understanding french or english. exclusion criteria: women on strict bed-rest, with pre-existing diabetes or known severe mental disorder

Keywords: cardiovascular diseases gestational diabetes mellitus pediatrics fetal programming cohort study
probiotic and antibiotic therapies in women with unexplained infertility

Conditions: Unexplained Infertility; Endometriosis

Summary: the study is designed as a proof of concept pilot study with 3 study arms to evaluate the safety and feasibility of the use of oral probiotics and/or antibiotics in women with unexplained infertility/endometriosis. our secondary outcomes will assess in vitro fertilization outcomes, and changes in the uterine microbiota (bacteria), intestinal barrier integrity, and urinary metabolites in response to study interventions.

previous research has demonstrated that the uterine microbiota can impact fertility and embryo implantation. this information leads to the hypothesis that prophylactic antibiotic and/or probiotic treatment may improve reproductive outcomes in women with unexplained infertility/endometriosis who are seeking in vitro fertilization (ivf). no therapeutic protocols to improve these outcomes currently exist. however, there are safe and easily accessible medications and supplements that may be able to optimally modify the uterine microbiota. herein we are proposing a proof of concept pilot study of the feasibility, safety and tolerability of administering oral probiotics, or oral probiotics in combination with antibiotics, to women seeking ivf.

Eligibility criteria:
inclusion criteria: 1. female aged 18-40 at the time of egg retrieval 2. generally in good health (at physician's discretion) 3. diagnosed with unexplained infertility 4. diagnosed with or suspected of having endometriosis (at one fertility physician's discretion) 5. normal uterine cavity as assessed by prior sonohysterogram 6. planning to undergo frozen embryo transfer with ≥1 frozen blastocyst ≥3bb (grade gardner) to transfer 7. able to understand, comply and consent to protocol requirements and instructions 8. able to attend scheduled study visits and complete required investigations exclusion criteria: 1. any known endometrial pathologies other than endometriosis 2. polycystic ovary syndrome 3. ovulatory dysfunction 4. male factor infertility (total motile sperm count \<5m/ml) 5. poorly controlled auto-immune disease and/or diabetes (at physician's discretion) 6. is immune-compromised 7. cockayne syndrome 8. allergy to metronidazole 9. allergy to rice (bran and hull), pomegranate, acacia gum, hypromellose, fermented gellan gum, chlorophyllin, or sunflower oil 10. known intolerance of lactobacillus and/or bifidobacterium-containing probiotics 11. antibiotic use in the past month 12. use of any of the following: 1. oral probiotics 2. alcohol 3. anticoagulant therapies (warfarin type) 4. drugs containing alcohol 5. busulfan 6. cyclosporin 7. disulfiram 8. 5-fluoruracil 9. lithium 10. phenytoin or phenobarbital 11. vecuronium 12. proton pump inhibitors 13. histamine h2-receptor antagonists 13. currently experiencing nausea, fever, vomiting, bloody diarrhea or severe abdominal pain

Keywords: uterine microbiota endometrial microbiota
digital assessment of mandibular flexure in full arch fixed restorations

Conditions: Mandibular Flexure; Full Arch Fixed Prosthesis

Summary: nine patients (five males and four females) were included in this study who had long-term (10-15 years) of long-span rigid mandibular fixed prostheses that may have led to radiographic changes around the supporting teeth. the treatment plans included the removal of the long-span fixed rigid prostheses followed by restoring the patients with segmented implant-supported prostheses. in order to digitally measure the mandibular flexure, reference markers were adhered to the prostheses, and intraoral scans were obtained before and after splitting the preexisting prostheses at the minimum and maximum mouth opening. the distances between the markers were measured, and mandibular flexure was calculated by subtracting the distance between the markers during the maximum mouth opening from the minimum mouth opening. an independent sample t-test was used to compare mandibular flexure before and after splitting the long-span fixed prostheses.


Eligibility criteria:
inclusion criteria: * full-arch mandibular single fixed prostheses that served for many years (average 12 years) opposed by natural dentition. * patients were free from any systemic or debilitating diseases such as bone diseases, diabetes melilites, or blood dyscrasias. exclusion criteria: * patients with healthy fixed full-arch prosthesis * patients with segmented prosthesis * patients with systematic debilitating diseases. * patients with temporomandibular joint dysfunction, maxillofacial surgeries, or mandibular trauma.

Keywords: mandibular flexure prosthesis failure full arch restorations
massive implants the next generation

Conditions: Bone Cancer; Bone Diseases

Summary: the study will review the use of massive segmental replacements in the femur, which have a porous collar with and without ha, and autologous stem cell augment. this is a randomised controlled trial.

the current surgical treatment of bone cancer patients and revision limb salvage requires usage of massive endoprosthetic bone implants. the incidence of aseptic loosening is a major cause of prosthesis failure in these patients, exploring ways to reduce such failures would allow extending longevity of massive implants in a relatively young population. current published literature stipulates that osteointegration could improve longevity of massive implants. evidence suggests that usage of osteointegrated hydroxyapatite (ha) coated collar would reduce the incidence of aseptic loosening around the cemented intramedullary stem in distal femoral bone prosthesis

Eligibility criteria:
inclusion criteria: * bone cancer patients requiring primary or revision femoral segmental replacements and non-cancer patients requiring revision femoral segment replacement for aseptic loosening * male or female, aged 18 years or above * able to provide consent exclusion criteria: * unable/unwilling to consent * revisions surgery due to infection * bone cancer patients excluded from stem cell arm * bone cancer patients with pathological fractures

Keywords: revision surgery
remission evaluation of metabolic interventions in type 2 diabetes (remit pilot trial)

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this pilot trial is to determine whether an intensive treatment with insulin glargine, metformin, acarbose and lifestyle can normalize blood glucose levels in patients with recently diagnosed type 2 diabetes mellitus when compared to standard diabetes care.

this is a pilot trial of 125 patients allocated to either usual care (1/3), 2 months or 4 months of intensive lifestyle and pharmacotherapy followed by cessation of all drug therapy.

Eligibility criteria:
inclusion criteria: 1. men and women 30-80 years of age inclusive 2. type 2 diabetes mellitus diagnosed by a physician within 3 years prior to patient enrollment 3. anti-diabetic drug regimen (either drug or dose of drug) unchanged during 8 weeks prior to screening and randomization 4. hba1c ≤ 8.5% on no oral hypoglycemic agents or hba1c ≤ 7.5% on 1 agent or on half-maximal doses of 2 agents 5. body mass index ≥ 23 kg/m2 6. a negative pregnancy test and an agreement to use a reliable method of birth control for the duration of the trial in all females with childbearing potential 7. ability and willingness to perform self-monitoring of capillary blood glucose (smbg) 8. ability and willingness to self-inject insulin 9. provision of informed consent. exclusion criteria: 1. current use of insulin therapy 2. history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance 3. renal dysfunction as evidenced by serum creatinine (cr) ≥ 124 μmol/l 4. history of lactic acidosis or diabetic ketoacidosis 5. active liver disease or elevated alanine transferase (alt) levels ≥ 2.5 times upper limit of normal at the time of enrollment 6. history of inflammatory bowel disease, colonic ulcers, recent or significant bowel surgery, or predisposition to bowel obstruction 7. cardiovascular disease including any of: * systolic blood pressure \>180 mmhg or diastolic blood pressure \>105 mmhg * peripheral vascular disease * left bundle branch block or third degree av block * tachyarrhythmias or bradyarrhythmias with uncontrolled ventricular rate * stenotic valvular heart disease * cardiomyopathy * history of heart failure * history of aortic dissection * documented history of angina or coronary artery disease * history of stroke or transient ischemic attack 8. pulmonary disease with dependence on oxygen 9. history of any disease requiring intermittent or continuous systemic glucocorticoid treatment 10. history of any major illness with a life expectancy of \<3 years 11. history of injury or any other condition that significantly limits participant's ability to achieve moderate levels of physical activity 12. any history of excessive alcohol intake, acute or chronic 13. known hypersensitivity to metformin, acarbose, or insulin glargine.

Keywords: diabetes insulin glargine metformin acarbose diet exercise lifestyle
effects of genotypes on interferon signaling in chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: the objective of this pilot project is to investigate the prognostic criteria for sensitivity of chronic hepatitis c (chc) genotype 1, patients to ifna treatment. signal transduction in peripheral blood mononuclear cell (pbmc) of control groups will be compared with that of chc patients. for this study, 20 patients with hepatitis c virus (hcv) infection who are to undergo standard antiviral therapy and 10 healthy donors (significant others of the hcv subject) will be enrolled. signal transduction will be studied in peripheral blood of chc subjects before the treatment, after 1 and 3 months of treatment, and 4-6 months following the completion of treatment.

in addition, the mechanism of non-responsiveness of hcv patients to ifna will be studied. for this purpose, formation of complexes between stat1 and its negative regulator, pias1 (immunoprecipitation, western blot) will be examined. in comparing subjects on standard therapy vs the addition of betaine, (under separate studies) we will assess whether the formation of stat1-pias1 complexes is due to impaired methylation on stat1 on arginine residues which may be over come by the addition of betaine.

Eligibility criteria:
inclusion criteria * 19 years of age or older, of either gender * history of chronic hepatitis c documented by hcvrna or healthy family member/significant other * documented genotype 1 for hepatitis participants or no hepatitis infection for healthy control * subject prescribed antiviral therapy for hepatitis participants or none for healthy control * able to give informed consent exclusion criteria * under 19 years of age * unable to give informed consent

Keywords: chronic hepatitis c genotype 1
mindfulness meditation and insomnia in alzheimer disease caregivers

Conditions: Insomnia Chronic

Summary: treatment of insomnia in caregivers is needed given that 60% of alzheimer disease caregivers report sleep complaints, and insomnia may add to the burden of ad caregiving and contribute to morbidity and mortality risk. this is the first intervention trial in ad caregivers to target insomnia and also evaluate two mechanisms of chronic disease risk, inflammation and cellular aging

this randomized controlled trial aims to evaluate the non-inferiority of mindful awareness practices for insomnia (map-i ) vs. cognitive behavioral therapy for insomnia (cbt-i) on outcomes of insomnia, cellular and genomic markers of inflammation, and cellular aging in older adult ad spousal caregivers with insomnia (n=150) over one-year follow-up. the specific aims of this project are: primary aim 1: determine the effects of map-i vs. cbt-i on subjective and objective dimensions of insomnia. secondary aim 1: evaluate the effects of map-i vs. cbt-i on cellular and genomic markers of inflammation. secondary aim 2: evaluate the effects of map-i vs. cbt-i on markers of cellular aging. exploratory aim 1: explore moderating effects of caregiver stress (stress and adversity inventory, strain, number \& experienced intensity of stress exposure) on insomnia outcomes, and effects of map-i vs. cbt-i on caregiver stress, health functioning, chronic medical morbidity and related medication use at follow-up.

Eligibility criteria:
inclusion criteria: * alzheimer or other dementia caregivers * older than 45 years of age * self-identified as the principal person taking care of the patient with alzheimer or other dementia * diagnostic and statistical manual criteria - 5 for insomnia exclusion criteria: * psychiatric disorders including current major depressive disorder or other current dsm-5 psychiatric disorder (e.g. substance dependence) with the exception of anxiety disorder; * psychotic symptoms; * acute suicidal or violent behavior or history of suicide attempt within the last year * other sleep disorders including current or lifetime history of sleep apnea, nocturnal myoclonus, phase-shift disorder as identified by scid-5 and duke structured interview for sleep disorders (dsisd) * medical conditions such as acute or uncontrolled medical illness (e.g., major surgery, metastatic cancer, class iii heart failure, inflammatory disorder) * chronic infections * obesity with body mass index (bmi) \>35 * use of hormone containing medications including steroids or immune modifying drugs * daily use of analgesics such as opioids; * daily us of sedative hypnotic medications * cognitive impairment as evidenced by dsm-5 interview and/or mini-mental status exam (mmse \< 26) * actively practicing a mind body intervention.
effect of weight loss and lifestyle changes on vascular inflammatory markers in obese women

Conditions: Obesity

Summary: obesity is an independent risk factor for cardiovascular disease, which may be mediated by increased secretion of proinflammatory cytokines by adipose tissue. to determine the effect of a program of changes in lifestyle designed to obtain a sustained reduction of body weight on markers of systemic vascular inflammation and insulin resistance. randomized single-blind trial conducted from february 1999 to february 2002 at a university hospital in italy. one hundred twenty premenopausal obese women (body mass index 30) aged 20 to 46 years without diabetes, hypertension, or hyperlipidemia. the 60 women randomly assigned to the intervention group received detailed advice about how to achieve a reduction of weight of 10% or more through a low-energy mediterranean-style diet and increased physical activity. the control group (n = 60) was given general information about healthy food choices and exercise.


Eligibility criteria:
inclusion criteria: * obese premenopausal women, * aged 20 to 46 years * sedentary (\<1 h/wk of physical activity) * with no evidence of participation in diet reduction programs within the last 6 months. exclusion criteria: * type 2 diabetes mellitus or impaired glucose tolerance (plasma glucose levels of 140-200 mg/dl \[7.8-11.1 mmol/l\] 2 hours after a 75-g oral glucose load) * hypertension (blood pressure \>140/90 mm hg) * cardiovascular disease, psychiatric problems * history of alcohol abuse (intake of 500 g/wk in the last year) * current smoking * any medication use.

Keywords: obesity, lifestyle, vascular inflammation
impact of sarpogrelate in the function of endothelial progenitor cells

Conditions: Atherosclerosis

Summary: the purpose of this study is to evaluate the effects of sarpogrelate in endothelial progenitor cells of patients with atherosclerosis.

endothelial progenitor cells play an important role in vasculogenesis and vascular repair. sarpogrelate, a inhibitor of ht2a, is used an an anti-platelet drug, however, a direct effect in vascular cells is supposed.

Eligibility criteria:
inclusion criteria: * patients with atherosclerosis exclusion criteria: * patients with high risk of bleeding * patients with pregnancy * patients with allergic reaction of salpogrelate

Keywords: endothelial progenitor cells
impact of high protein and low carbohydrate smoothie drinks in type-2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: we compared between a regular high protein or a high protein and low carbohydrate smoothie drinks with conventional diabetic enteral drinks (glucerna) on glucose homeostasis, insulin and lipid metabolism in type 2 diabetic and obese individuals.

we aimed to determine the effect of high protein and low carbohydrate smoothie drinks on glucose homeostasis, insulin and lipid metabolism in type 2 diabetic and obese individuals. we compared between a regular high protein or a high protein and low carbohydrate smoothie drinks with conventional diabetic enteral drinks (glucerna). a crossover design study was done in 60 diabetic participants. participants consumed 300 kilocalories of each drink at a time with one week wash out period between drinks and glucose response curves at baseline, 30, 60, 90, 120, 180 and 240 minutes were monitored and compared. the products were formulated to supply 1 kilocalorie/milliliter (kcal/ml). dietary compositions in regular formulas (smoothie, sm) were 30-40% carbohydrate, 20-30% protein and 30-50% fat. while in smoothie with low carbohydrate formulas (smls), they were 25-35% carbohydrate, 25-30% protein and 35-55% fat vs. a control formula (glucerna).

Eligibility criteria:
inclusion criteria: 1. people with type 2 diabetes mellitus or use blood glucose-lowering drugs more than 3 months 2. bmi \> 25 kg/m\^2 3. hba1c 6.5 - 8.5 4. use stable level of blood glucose-lowering drugs and blood lipid-lowering drugs more than 3 months exclusion criteria: 1. pregnancy or breastfeeding 2. people with chronic diseases or tube feeding or dysphagia i.e. pneumonia 3. people with insulin injection or use glp-1 analogues drugs or dpp-4 inhibitors drugs 4. people with history of bariatric surgery, gastroparesis, malabsorption 5. people with history of diseases that affect blood glucose/lipid control i.e. hyperthyroidism, endocrinology and kidney disorders 6. use long-term immunosuppressants 7. cancer patient

Keywords: clinical nutrition smoothie drink meal replacement medical food diabetes obesity