Kornimate/medical-research-clean huggingface dataset:
a comparison of two initial dosing formulas

Conditions: Diabetes Mellitus, Type 2

Summary: this study will evaluate two methods of starting basal insulin to see which method may achieve a faster-to-goal titration.

the current recommended starting dose of basal insulin in type 2 diabetes is either a fixed dose, e.g. 10 u, or a weight-based formulas, 0.1-0.2 u/kg. the estimate of eventual titration dose to attempt to reach a fasting glucose goal is 0.49 u/kg. those many weeks of dosage upward titration are required. the investigators propose to compare the current recommended weight based, 0.1 u/kg to a correction factor derived formula. starting with an insulin tolerance test estimation of basal dose, one would arrive at the eventual titrated basal insulin dose in significantly less days than starting at a starting dose estimate of 0.1 u/kg. further, there would be no significant increase in overall reported hypoglycemia.

Eligibility criteria:
inclusion criteria: 1. type 2 diabetes 2. age 18 years and above 3. concurrently on ± sulfonylureas ± thiazolidinedione ± ddp iv inhibitors ± metformin ± glinides 4. a1c ≥ 7.0% but ≤ 10% 5. capable of self monitoring glucose ≥4/day 6. previously compliant with clinical recommendations 7. fasting blood glucose ≥ 150 mg/dl 8. bmi ≤ 45 kg/m2 exclusion criteria: 1. urinary ketosis 2. currently or expected alteration in insulin sensitivity such as major surgery, infection, renal failure (creatinine \>1.5 mg/dl), glucocorticoid treatment, recent (within 2 weeks) serious hypoglycaemic episode (requires assistant of another) 3. currently participating in another clinical trial 4. known or suspected allergy to insulin determir 5. using insulin 6. pregnancy or nursing or the intention of becoming pregnant or not using adequate 7. significant liver or heart failure.

Keywords: basal insulin hypoglycemia diabetes mellitus type two
ascending dose pharmacokinetic (pk) and absolute bioavailability (ba)

Conditions: Bacterial Infections

Summary: the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single rising and multiple rising iv doses of tr-701 fa and to determine the absolute bioavailability of oral tr-701 fa following single oral and iv dose administrations in healthy adult subjects.

sad/part a. * all subjects in the pilot cohort will receive a single infusion of 50 mg tr-701 fa for injection in 250 cc of saline over 180 minutes. * subjects in cohort 1 will be randomized to receive a single infusion of placebo or 100 mg of tr-701 fa for injection in 250 or 500 cc of saline over 60 or 120 minutes. * subjects in cohort 2 will be randomized to receive a single infusion of placebo or 200 mg of tr-701 fa for injection in 250 or 500 cc of saline over 60 or 120 minutes. * subjects in cohort 3 will be randomized to receive a single infusion of placebo or 400 mg of tr-701 fa for injection in 250 or 500 cc of saline over 60 or 120 minutes. mad/part b * subjects in cohort 4 will be randomized to receive once daily infusions of placebo or 200 mg of tr-701 fa for injection in 250 cc of saline over 60 minutes for 7 days. * subjects in cohort 5 will be randomized to receive once daily infusions of placebo or 300 mg of tr-701 fa for injection in 250 cc of saline over 60 minutes for 7 days. ba/part c * subjects in cohort 6 will receive a single 60 minute infusion of 200 mg tr-701 fa for injection in 250 cc of saline and a singe oral dose of 200 mg tr-701 fa tablet in an open-label crossover design. venous tolerability/part d - subjects in cohort 8 will receive once daily 60 minute infusions of 200 mg tr-701 fa for injection in 250 cc of saline for 3 days and once daily placebo infusions for 3 daysin a blinded crossover design.

Eligibility criteria:
inclusion criteria: * in good health * body mass index of 20 to 29.9 kg/m2 * female subjects must be post menopausal for at least 1 year, surgically sterile, abstinent or agree to use an effective method of birth control exclusion criteria: * history or clinical manifestation of any clinically significant disorder * history of hypersensitivity to any drug compound * history of stomach or intestinal surgery or resection * history of infections of unexplained frequency or severity * history of alcoholism or drug addiction within 1 year * use of any tobacco- or nicotine-containing products within 6 months * use of alcohol-, grapefruit-, caffeine-, or high tyramine-containing foods or beverages * use of any other medications * pregnancy, lactation, or breastfeeding
the effect of dexmedetomidine to cognition of geriatrics in prolonged surgery

Conditions: Cognitive Ability, General; Brain Injury

Summary: the incidence of postoperative cognitive dysfunction (pocd) is high and pocd affect the life quality and the prognosis of patients. geriatrics is the independent risk factor of pocd, and pocd is also correlated with many other factors such as type of surgery, the duration of anesthesia and the anesthesia drugs used et al. so, the prevention and treatment of pocd in geriatrics is important. dexmedetomidine is found to have the effect of neuro-protection, but it is controversy whether dexmedetomidine has the effect of neuro-protection in geriatrics, especially the prolonged surgery. the purpose of this study is to explore the effect of dexmedetomidine to the cognitive function at prolonged surgery in geriatrics in geriatrics.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. scheduled for elective abdominal surgery 3. age≥65 yrs 4. weight is within the range of ±20% of standard weight \[standard weight=height(cm)-80)×70﹪ for male and(height(cm)-70)×60﹪\] for female 5. american society of anesthesia classification i\~iii 6. expected time of surgery is more than 4 hours - exclusion criteria: 1. systolic blood pressure≥180 mm hg or \<90 mm hg，diastolic blood pressure≥110 mm hg or \< 60 mm hg； 2. serious cardiac,liver,kidney,lung, endocrine disease or sepsis. 3. allergy to trial drug or other contraindication； 4. difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation 5. history of mental illness and cerebral vascular disease 6. history of unstable angina or myocardial infarction 7. education level\<7 yrs 8. factors existed that affect cognition assessment such as language, visual sense,auditory sense disorders. 9. abuse of narcotic analgesia or suspected; 10. neuromuscular diseases; 11. mentally unstable or has a mental illness; 12. pregnant or breast-feeding women; 13. attended other trial past 30 days; -
study of n-homocysteinylation of key proteins in alzheimer's disease (ho-ma)

Conditions: Alzheimer Disease

Summary: alzheimer's disease (ad) is the leading cause of dementia in france. it is a multifactorial pathology, combining genetic and environmental risk factors. homocysteine, a sulfur-containing amino acid belonging to the methionine-monocarbon cycle, has frequently been found at high levels in neurodegenerative diseases, and in ad in particular. it has been shown on human brain sections that the interaction of homocysteine with tau and map1, two key ad proteins, was significantly higher in ad patients than in controls, and corresponded to an n-homocysteinylation type interaction. this is a prospective study, the main objective of which is to compare map1 n-homocysteinylation levels in fibroblasts from individuals with ad versus disease-free cell lines.


Eligibility criteria:
inclusion criteria: * age \> 18 years * age of onset of ad \< 75 years * person with ad with positive csf biomarkers * person who has previously benefited from an analysis of ad genetic characteristics (app, psen1, psen2, trem2, abca7, sorl1 genes and apoe status) and an analysis of monocarbon metabolism genes in the case of biochemical abnormalities by clinical exome, targeted panel or complete exome, and for whom the data set is already available. exclusion criteria: * pregnant, parturient or breast-feeding women * minor (not emancipated) * person of legal age (subject to a legal protection measure) * adult unable to give consent

Keywords: alzheimer disease genetic n-homocysteinylation
tolerup enteral feeding protocol

Conditions: Gastrointestinal Tolerance

Summary: this prospective, observational, multi-center study will follow children with cerebral palsy who decided to switch to an enteral product that contains partially hydrolyzed protein and medium chain triglycerides as a result of clinical symptoms/diagnosis of gastrointestinal intolerance.


Eligibility criteria:
inclusion criteria: * diagnosis of cerebral palsy * fed with an enteral product that does not contain partially hydrolyzed protein and medium chain triglycerides and decided to be switched to an enteral product contains partially hydrolyzed protein and medium chain triglycerides as a result of clinical symptoms/diagnosis of gastrointestinal intolerance * fed by tube, using enteral tube feeding as sole source of nutrition * a signed and dated informed consent by subject's legally acceptable representative exclusion criteria: * chronic diseases other than cerebral palsy (e.g. diabetes mellitus, renal, liver, endocrine diseases, malignancy) * intestinal obstruction * dialysis treatment * requirement of artificial ventilation * requirement of parenteral nutrition * normal nutrition in addition to enteral tube feeding * allergy or intolerance to any ingredient of the study product * currently participating in another clinical or non-clinical study
a study to evaluate the safety, tolerability, and pharmacokinetics of a single dose of srp-5051 (vesleteplirsen) in patients with duchenne muscular dystrophy (dmd)

Conditions: Muscular Dystrophy, Duchenne

Summary: the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (pk) of 5 escalating doses of srp-5051 (vesleteplirsen) administered as a single dose to patients with dmd amenable to exon 51 skipping treatment.


Eligibility criteria:
inclusion criteria: * has a genetic diagnosis of dmd and an out-of-frame deletion mutation of the dmd gene amenable to exon 51 skipping treatment * has been on a stable dose of oral corticosteroids for at least 12 weeks prior to study drug administration with continued dosing of oral corticosteroids while participating in the study\*, or has not received corticosteroids for at least 12 weeks prior to study drug administration and will not initiate dosing of oral corticosteroids while participating in the study exclusion criteria: * has a left ventricular ejection fraction (lvef) less than (\<) 40 percent (%) based on an echocardiogram (echo) performed within 3 months prior to screening or at the screening visit * has a qt interval corrected with fridericia's method (qtcf) \>= 450 millisecond (msec) on the screening electrocardiogram (ecg) * initiation or change of dosing (except for modifications to accommodate changes in weight) within 12 weeks prior to screening and while participating in the study for any of the following: angiotensin-converting enzyme (ace) inhibitors, angiotensin-receptor blocking agents (arbs), beta-blockers, or potassium * requires antiarrhythmic and/or diuretic therapy for heart failure * forced vital capacity (fvc) \<40% of predicted value within 3 months of screening or at the screening visit * known kidney disease or had an acute kidney injury within 6 months prior to screening * treatment with eteplirsen or drisapersen within 6 months prior to screening, or any experimental gene therapy for the treatment of dmd at any time * use of any herbal medication/supplement containing aristolochic acid other inclusion/exclusion criteria apply. \*the dose of steroids must remain constant except for modifications to accommodate changes in weight.

Keywords: duchenne muscular dystrophy exon skipping dmd exon 51 ambulatory pediatric nonambulatory peptide-conjugated phosphorodiamidate morpholino oligomer (ppmo) duchenne
memory inhibition and delayed onset post-traumatic stress disorder in older subjects

Conditions: Post-Traumatic Stress Disorder in Old Age

Summary: in the elderly, we can see a post-traumatic syndrome associated with an event that occurred before old age that had not previously manifested or not fully manifested. this little-known pathology and notable psychiatric co-morbidities (depression, anxiety) can take in elderly subjects different masks that interfere with diagnosis and treatment. the data in the literature suggest that this post-traumatic stress disorder with delayed expression (tspt-r) may be related to a deficiency of the executive functions of inhibition, and more particularly a deficit of mental memory inhibition and therefore the removal of unwanted memories.


Eligibility criteria:
inclusion criteria: - regarding the constitution of the group patient (tspt-r): * subjects 65 years of age or older * clinical diagnosis of delayed-onset ptsd according to dsm-5 criteria after 65 years * the traumatic event must have taken place at the latest before 65 years * affiliated person or beneficiary of a social security scheme. * written consent before any examination required by research) regarding the constitution of the control group: * subjects 65 years of age or older * no diagnosis of ptsd (delayed or not) or history of ptsd (delayed or not) * affiliated person or beneficiary of a social security scheme. * written consent before any examination required by the research). exclusion criteria: * for both groups: * acute or chronic cognitive impairment known * greco mmse pathological score less than or equal to the pathological threshold weighted according to level of education and age, namely: * 22 if no diploma * 23 if certificate of study * 25 if patent * 26 if bin or more * remove one point at each threshold if age\> 80 years * sensory or motor disorder preventing the passing of different tests * psychotic disorder * mood disorder in decompensation (for depression, had-d score equal to or greater than 11) * disorder of the use of a moderate or severe substance (except tobacco). * patients under guardianship or curatorship.
influence of injection technique of premixed insulin on glucose excursion in type 2 diabetes mellitus

Conditions: Type2 Diabetes Mellitus

Summary: to compare patients and nurses using insulin pen injector to inject premixed insulin respectively, using continuous glucose monitoring system to evaluate the glucose excursion in the two sets, study the relationship between glucose excursion and inject technique in type 2 diabetes mellitus.

a total of 60 patients with type 2 diabetes who used premixed insulin will enrolled in this study.measure their blood pressure，height and weight, bmi, liver and kidney function, blood lipids, glycosylated hemoglobin, fasting glucose, 2 hour postprandial glucose，fasting c peptide, 2 hour postprandial c peptide, fasting glucagon, 2 hour postprandial glucagon,fasting serum insulin，2 hour postprandial serum insulin，urinary albumin and insulin antibodies.the first and second days，the patients inject premixed insulin themselves，the specialist nurse graded the patient's injection technique score.the third and the fourth days the nurse change a new insulin with the same types maintain the same injection dosage.the patient need perform continuous glucose monitoring system(cgms) for 96-hours.

Eligibility criteria:
inclusion criteria: 1. type 2 diabetes patients 2. aged 20-80 years 3. had been on premixed insulin and used an insulin pen for at least 3 months 4. fasting glucose between 6.1-16 mmoll, postprandial(or random) glucose below 22.2mmol/l. 5. no acute complications such as diabetic ketoacidosis, diabetic hypertosmolar syndrome. 6. subjects were able and willing to ues cgms and eat regularly. 7. patients who were able to inject insulin themselves or actual injections can be accompanied. exclusion criteria: 1. insulin allergy. 2. there has been a history of drug abuse and alcohol dependence in the past five years, or systemic hormone therapy within 3 months. 3. patients with poor compliance and irregular eating and exercise. 4. infection or stress within four weeks. 5. patients unable to tolerate cgms. 6. patients with pregnancy, breast-feeding, planning to have a baby 7. patients with coagulopathy, serious complication,such as cardiovascular disease, end stage renal disease; and patients with severe retinopathy or other eye problems that impair their visual function, or cognitive dysfunction

Keywords: glucose excursions insulin technique insulin antibodies premixed insulin
prevalence of early childhood caries in egyptian children with serum vitamin d deficiency.

Conditions: Vitamin D Deficiency

Summary: to detect the effect of vitamin d deficiency in the development of early childhood caries (ecc) among egyptian children.

justification for undertaking the trial: american academy of pediatric dentistry (2012), defined early childhood caries (ecc) as the presence of one or more decayed, missing teeth (resulting from caries), or filled surfaces in the primary tooth of child 6 years old or younger. early childhood caries is a chronic childhood disease, that decreasing quality of life, this include pain, disturbed sleep, poor aesthetics, difficulty in eating and speaking and behavioral changes that affect the child's self-esteem. (guay, 2004). due to the rising incidence of dental carries in early childhood, contributory factors need to be investigated in order to facilitate treatment of such a large population of children in desperate need of dental care (guay, 2004).these multiple risk factors include the lack of a dental home, poor oral hygiene, diet, and nutrition ( najeeb et al., 2016). enamel is the most mineralized substance in the human body; it is mainly made of calcium and phosphate. vitamin d plays an important role in increasing the absorption of calcium and phosphate from food. which calcium and phosphate improve the strength of the teeth as make them able to fight the demineralization from bacteria (youssef et al., 2011). therefore, it is responsible of promoting the calcification of teeth, having a topical fluoride like effect, and in the forming of enamel, dentin, and bone. (mellanby \& pattison, 1928). vitamin d receptors are present on the cells of immune system and on the teeth. it binds to these receptors and increases the amount of good antimicrobial proteins as cathelicidin and other special defense in saliva (youssef et al., 2011). these antimicrobial peptides have antibacterial neutralizing activity against periodonto pathogens as gram negative and gram positive bacteria and candida albicans, its effective in vitro against oral microorganisms such as streptococcus mutants, prophyromonas gingivalis and actinobacillus, so it prevents dental caries.( potturu et al., 2014). east, (1939) study concluded that children who consumed a high vitamin d diet, vitamin d played an indispensable role in 1) preventing the initiation of new caries, 2) inhibiting the spread of existing caries, and 3) arresting the caries. likewise, an examination of children found a decreased caries prevalence in areas of increased vitamin d exposure.

Eligibility criteria:
inclusion criteria: 1. children ages from two to five years 2. both sexes. 3. parent and children cooperation. 4. healthy children. 5. children with serum vitamin d deficiency. exclusion criteria: 1. children age more than 5 years. 2. children had a complex metabolic or medical disorder. 3. parents that will not sign the consent.
malignant pleural effusions: evaluating the psychosocial impact of indwelling pleural catheters on patients

Conditions: Malignant Pleural Effusion; Indwelling Pleural Catheter

Summary: the purpose of this study is to better understand the impact that indwelling pleural catheters have on patients with malignant pleural effusions from a psychosocial point of view.

after being informed about the study, all patients giving written informed consent will undergo a baseline assessment including disease and social characteristics on the day of their indwelling pleural catheter (ipc) insertion. at 2 weeks and 6-8 weeks post insertion, they will be contacted via telephone for a semi-structured interview focusing on the psychosocial impact that the ipc has had on their lives. data surrounding the medical care of the ipc will also be collected.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study * aged 18 years or above * diagnosis of malignant pleural effusion * will be undergoing ipc insertion for management of their malignant pleural effusion * have the means to be contacted and be able to conduct an interview in english via telephone within the study timeframe exclusion criteria: * inability to consent * estimated life expectancy of \<4 weeks

Keywords: malignant pleural effusion indwelling pleural catheter psychosocial
clinical trial of chinese formula amp-1915 on metabolic syndrome

Conditions: Metabolic Syndrome X

Summary: the purpose of this study is to determine whether the chinese formula amp-1915 has effect on metabolic syndrome (ms) in ms patients. half of patients received amp-1915, while the other half received placebo.

in china, the herbal formulas have been used in the treatment of diabetes for centuries. huangqisan, investigators named it amp-1915, is one of traditional chinese herbal formula used to relieve diabetes which was recorded in shengji zonglu (general medical collection of royal benevolence) published in 1117 a.d. amp-1915 consists of three herbs: radix astragali (roots of astragalus membranaceus (fisch.) bge. var. mongholicus (bge.) hsiao, a), mori cortex radices (root barks of morus alba l., m) and puerariae lobatae radix (roots of pueraria lobata (willd.) ohwi., p). recent studies have shown that these three herbs and their constituents have therapeutic effects on the metabolic disorders. this randomized, double-blind, placebo-controlled trial was conducted in a community hospital of shanghai, china. 60 adult participants were metabolic disorder patients according with at least two impaired metabolic profiles (obesity, hyperglycemia, hyperlipidemia or others). during 3-month treatment, participants were randomly divided in to two groups assigned to take amp-1915 or placebo. amp-1915 or placebo was mixed into instant noodles as daily meals with same color, shape, size and packaging. bmi, fasting blood glucose (fbg), triglyceride (tg), total cholesterol (tch), high-density lipoprotein cholesterol (hdl-c), low-density lipoprotein cholesterol (ldl-c), insulin, hba1c were measured before and after treatment.

Eligibility criteria:
inclusion criteria: * overweight (bmi \>= 20) or * hyperglycemia (fbg\>=6.7 mmol/l) or * hyperlipidemia (tg \>=1.7 mmol/l or tch\>=5.72 mmol/l or hdl-c \ =3.12 mmol/l) exclusion criteria: -

Keywords: obesity hyperlipidemia hyperglycemia
a study in people with mild hypertension

Conditions: Mild Hypertension

Summary: the primary objective of this study is to test the hypothesis that ly518674, administered for 6 weeks to patients with mild hypertension, reduces systolic blood pressure, compared with placebo.


Eligibility criteria:
inclusion criteria: 1. are men and women between 18 and 70 years of age, inclusive 2. have given signed informed consent to participate in this study 3. are diagnosed with mild essential hypertension at screening (currently untreated or treated with monotherapy) exclusion criteria: 1. secondary or malignant hypertension 2. have or have had a history of hyperlipidemia within 3 months of screening requiring treatment 3. any previous cardiovascular disease other than hypertension 4. type 1 or 2 diabetes