Kornimate/medical-research-clean huggingface dataset:
teriparatide use in hip replaced subjects

Conditions: Osteoporosis

Summary: a pilot study on the use of teriparatide in severe osteoporotic women with hip fracture and submitted to hip replacement the primary objective of this study is to obtain preliminary data, in a pilot group of postmenopausal women with established osteoporosis and a recent hip fracture, who underwent hip replacement 3-6 months before screening phase, about the effect of teriparatide on: * bone turnover markers: ctx, pinp and bsap when given at the dose of 20 mcg/day by subcutaneous route for 18 months. the secondary objectives of the study are as follows: * effects of teriparatide on lumbar spine and non-prosthetic femur bone density, as assessed by bmd measurement with dual energy x-ray absorptiometry (dxa) * effects of teriparatide on quality of life and back pain during treatment.


Eligibility criteria:
inclusion criteria: 1. ambulatory postmenopausal women with established osteoporosis, based on the disease diagnostic criteria 2. presence of more than 1 clinical and/or radiological vertebral fractures or more than 1 non-vertebral fracture 3. presence of hip fracture with hip replacement surgical procedure (both uncemented or cemented total hip arthroplastics or endoprosthesis) in the 3-6 months before screening phase 4. age range 55-85 years 5. normal or clinically insignificant abnormal laboratory values (as determined by the investigator) including serum calcium, pth(1 84), and 25 hydroxyvitamin d concentrations, and alkaline phosphatase activity. exclusion criteria: 1. history of diseases which affect bone metabolism, other than primary postmenopausal osteoporosis, such as paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis (included glucocorticoid-induced osteoporosis), hypoparathyroidism, hyperparathyroidism, hyperthyroidism 2. actual cancer disease or history of malignant neoplasms in the 5 years prior to visit 2, with the exception of superficial basal cell or squamous cell carcinomas of the skin that have been definitively treated. subjects with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be enrolled. 3. increased baseline risk of osteosarcoma: paget's disease of the bone or unexplained elevations of alkaline phosphatase; prior radiation therapy involving the skeleton 4. significantly impaired renal function 5. significantly impaired hepatic function
the impact of the covid-19 pandemic on diabetes management

Conditions: Type 2 Diabetes; Type 1 Diabetes Mellitus

Summary: the "codiam study" examines how diabetes management and outcomes are changing during the covid-19 pandemic and whether these changes are influenced by socio-demographic factors, health literacy, self-efficacy and perceived social support.

the covid-19 pandemic created new challenges for patients with diabetes and their treating physicians. in order to protect people from sars-cov-2 infections, social contacts were reduced by restrictions on many areas of social life. as a side effect, these measures could have also led to changes in the self-management of patients with diabetes mellitus, such as lack of physical exercise, less healthy dietary behavior, and a reduced intensity of medical care. these possible changes may be associated with poorer control of blood glucose, cholesterol, and blood pressure. therefore, the codiam study will investigate how management and outcomes of diabetes are changing during the pandemic and identify associated factors. the study is based on data of patients treated in three gp practices specialized on diabetes treatment in hamburg, germany. data collection will include a written patient survey and extraction of clinical data from patient records. the patient's survey includes sociodemographic data and validated instruments to assess diabetes self-management (dsmq), health literacy (hls-eu-q16), self-efficacy (general self-efficacy scale) and perceived social support (f-sozu k14). data will be analyzed by descriptive statistics and multivariable, multilevel linear and logistic regression analyses adjusted for possible confounders and random effects on the practice level.

Eligibility criteria:
inclusion criteria: * being 18 years or older, and * having diabetes type 2 or type 1, and * having consulted the practice at least once in 2019 and at least once in 2020 exclusion criteria: * no capacity to consent (e.g. because of dementia) * insufficient german language skills to understand the questions in the questionnaire * not able to fill out the questionnaire (e.g. because of blindness) * gestational diabetes
effect of pistachio intake on insulin resistance and type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: hypothesis: chronic intake of pistachios improves glucose metabolism and insulin resistance status thus contributing to decrease the risk of type 2 diabetes mellitus and its associated abnormalities.

in free-living overweight or obese adult with impaired fasting glucose or impaired glucose tolerance we will compare the effects of a pistachio-rich diet or a mediterranean diet on: * fasting glucose levels, hemoglobin a1c, insulin, c peptide, homa ir, advanced glycation end products and soluble receptor of advanced glycation-end products. * peripheral haemostatic parameters. * plasma inflammatory markers. * lymphocyte expression of toll-like receptors, c peptide, resistin and interleukin-6 in peripheral leukocytes. * lymphocyte glucose transport and expression of glucose transporter 4 in peripheral blood leukocytes. * platelet function including platelet number, mean platelet volume, platelet factor 4 levels and urinary 11-dehydro-thromboxane b2.

Eligibility criteria:
inclusion criteria: * bmi less than 35 kg/m2. * fasting plasma glucose levels between 100 and 125 mg/dl or * oral glucose tolerance test of 140 to 199 mg/dl. exclusion criteria: * diabetes mellitus. * alcohol, tobacco, or drug abuse. * significant liver, kidney, thyroid, or other endocrine diseases. * frequent consumption of nuts or known history of allergy to them. * use of plant sterol, oral antidiabetic drugs, supplemental use of phyllium, fish oil supplements and multivitamins, vitamin e or other antioxidant supplements. * bad dentures, implying difficulty to chew pistachios. * being pregnant or wishing to become a pregnant 6 months before or during the study, lactating 6wk before or during the study. * following vegetarian or weight loss diets. * other medical or social conditions that difficult the compliance to the intervention.

Keywords: pistachio intake insulin resistance type 2 diabetes mellitus
bay14-2222 prophylaxis and joint function improvement (adults)

Conditions: Hematologic Disease; Hemophilia A

Summary: the purpose of the study is to evaluate the effect of prophylactic treatment on the number of joint bleeds and quality of life in severe hemophilia a subjects compared to on-demand treatment in a one-group two-treatment schedule design. in addition, the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment and health-economic data will be assessed.


Eligibility criteria:
inclusion criteria: * severe hemophilia a (\< 1% fviii) * 30-45 years of age * previously treated subject (\> 100 exposure days to any fviii) * on-demand therapy with any fviii exclusion criteria: * no history of inhibitor * no planned elective orthopedic surgery during the study duration (13 months) * no severe concomitant disease * no history of anaphylactic or other severe reaction to previous fviii treatment

Keywords: coagulation disorders
clinical investigation of corneal incision size after intraocular lens (iol) implantation

Conditions: Cataracts

Summary: the purpose of this study is to compare corneal incision size after iol implantation with the use of one of four iol delivery systems (three preloaded iol delivery systems and one manually loaded iol delivery system).


Eligibility criteria:
inclusion criteria: * able to comprehend and sign a statement of informed consent; * willing and able to complete all required postoperative visits; * cataract; * planned cataract removal by phacoemulsification; * calculated lens power from 18.0 through 27.0 d inclusive; * preoperative astigmatism \<1.0d; * other protocol-specified inclusion criteria may apply. exclusion criteria: * systemic disease that affects the cornea; * any inflammation or edema of the cornea; * previous or planned refractive or corneal surgery during the subject's participation in the study; * previous corneal transplant; * previous retinal detachment; * pregnancy or lactation, current or planned, during the course of the study; * current participation in another investigational drug or device study that may confound the results of this investigation; * any condition observed before or during surgery that in the surgeon's medical opinion may affect the success of the cataract surgery; * other protocol-specified exclusion criteria may apply.

Keywords: intraocular lens
"how do contrast medias in bone cement affect dxa measurements after thr"

Conditions: Primary and Secondary Osteoarthritis in Hip

Summary: joint replacement is a well-documented and cost effective treatment of degenerative diseases in the hip (1,2). there are two different principles of fixation of prosthesis components; cemented and uncemented. the most common mode of fixation in scandinavia has historically been with bone cement. in the recent years a reverse hybrid combination (uncemented stem and cemented cup) is gaining popularity, especially in norway. beside luxation, infection and venous thromboembolism, the problem with aseptic loosening is a known complication. a marker for aseptic loosening is local bone loss around the components. this is measured with a densiometer and the method is dual energy x-ray absorbtiometry (dxa). periprosthetic bone loss is evaluated by series of dxa scans around the components over time. this enables us to follow changes in bone mineral density (bmd) close to the prosthesis. we want to compare cemented and uncemented prostheses with this technique. this is a problem since we don't know how much different contrast medias in bone cement affect dxa scans. this area is poorly investigated. attempts have been made to exclude the cement-mantle from the measurements both digitally and manually, but these have showed poor precision. a kind of consensus of assuming that contrast medias in bone cement give an increase in measured bmd of 20% (4). this is used when comparing cemented and uncemented components. we have preformed laboratory tests of different cements. zirconium oxide (zro2) and barium sulphate (baso4) are used as radiopacifiers. these contrast medias have different properties. our test showed that zirconium give 63% higher bmd when we scanned cement alone. this is supported by a cadaver study showing significant differences between contrast free cement and zro2 /baso4 containing cements. it is our opinion that it is necessary to perform a prospective study to investigate this more thoroughly. the hypothesis of this study is that it is not accurate enough to add 20% in bmd for cemented implants when comparing them with uncemented implants. it is probably necessary to take into account the amount of cement used and kind of contrast medium.


Eligibility criteria:
inclusion criteria: * osteoarthritis exclusion criteria: * more than 80 yrs * systemic disease
peripherel perfusion index to predict sepsis in very low birth weight infants

Conditions: VLBW - Very Low Birth Weight Infant

Summary: to explore the predictive value of peripheral perfusion index in late onset sepsis of very low birth weight infants , obtain the threshold by observing the perfusion index of very low birth-weight infants within one month after birth, this value can be used as a threshold to predict late onset sepsis in very low birth weight infants.

from the day the very low birth weight infant was admitted to hospital, monitoring was recorded once a day, and continuous monitoring was recorded for 1 month. before collection, the infant was confirmed to be in supine position with neutral temperature, and at the same time, the infant was in a quiet state, without the contact and operation of medical personnel. this study will first use lms curve to fit the trend of perfusion index in very low birth weight infants within one month after birth.the perfusion index threshold of the outcome index was determined by roc curve.

Eligibility criteria:
inclusion criteria: * infants weighting \<1500g * infants admitted to children's hospital of fudan university

Keywords: late onset sepsis peripheral perfusion index
trans radial versus transfemoral route for coronary angiography

Conditions: Coronary Artery Disease

Summary: the purpose of this study was to assess and compare the feasibility, success and safety of transradial approach (tra) verses transfemoral approach (tfa) for diagnostic and therapeutic coronary angiography and coronary interventions, in terms of procedural time, access time, fluoroscopy time, procedural failure, , length of hospital stay in terms of days in hospital, complications in terms of thrombophlebitis, hematoma, ecchymosis, infections thrombosis of vessel, mace, stroke and others.

background: pci has been done traditionally through transfemoral route. but now transradial and transbrachial routes are also coming up in practice. we compared transradial versus transfemoral routes for ease of operability, time for procedure, complications, and failure rates through a prospective study. methods: 400 patients admitted in department of cardiology for percutaneous interventions were enrolled in the study. 200 patients were assigned to each group randomly. a single team did all the procedures. pre procedure, intra procedure and post procedure data of all the patients was collected, tabulated and analysed properly. the variables studied include access time ,fluoroscopy time and overall procedure time, post procedure complications( ecchymosis ,thrombophelibites, hematoma, procedure access bleed), failure rates,post procedure myocardial infarction, stroke, acute renal failure and infections.

Eligibility criteria:
inclusion criteria: * diagnostic angiography of coronary vessels, pci exclusion criteria: * patients with impaired renal function tests. * lack of informed consent. * severe infection. * previous contrast allergy. * severe intrinsic/iatrogenic caogulopathy inr\>2. * abnormal modified allen's test.
effect of nutritional products on metabolic parameters in subjects with type 2 diabetics

Conditions: Diabetes Mellitus, Type 2

Summary: to compare the postprandial glycemic and insulinemic response of subjects with type 2 diabetes consuming a typical breakfast meal or no breakfast to 10004rf via a meal tolerance test (mtt).


Eligibility criteria:
inclusion criteria: 1. type 2 diabetes 2. between 21 and 75 years of age 3. male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile 4. bmi is \> 18.5 kg/m2 and \<35 kg/m2 5. if subject is on a chronic medication such as an anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, they have been on constant dosage for at least two months prior to screening visit. exclusion criteria: 1. hemoglobin a1c value at screening of greater than or equal to 9%. 2. uses exogenous insulin or exenatide for glucose control. 3. type 1 diabetes. 4. history of diabetic ketoacidosis. 5. current infection; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit. 6. active malignancy 7. significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure. 8. end-stage organ failure or is status post organ transplant. 9. history of renal disease. 10. current hepatic disease. 11. history of severe gastroparesis. 12. chronic, contagious, infectious disease 13. taking any herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, that could profoundly affect blood glucose. 14. clotting or bleeding disorders 15. allergic or intolerant to any ingredient found in the study products. 16. habitual user of tobacco products (
control:diabetes pilot study i

Conditions: Insulin Treated Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 1

Summary: this is a single arm open label pilot clinical trial that will assess patient-reported blood glucose levels before and after using the control:diabetes mobile app, while collecting user feedback and recommendations for further improvements to the app functionality and user interface. this study will enroll approximately 70 individuals with insulin-treated diabetes mellitus. the study will include two online surveys (baseline and exit), one study initiation phone call, and will also collect data entered by the users into the mobile app.

the objectives of this study are to: * test the hypothesis that patients with diabetes mellitus treated with insulin and elevated blood glucose will achieve better glycemic control after using the control:diabetes mobile app. * test the hypothesis that patients with diabetes mellitus treated with insulin and frequent hypoglycemia will achieve lower frequency of hypoglycemia after using the control:diabetes mobile app.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of type 1 diabetes or type 2 diabetes * treatment with multiple daily insulin injections (mdii) or continuous subcutaneous insulin infusion (csii) * baseline hba1c between 7% and 10.5% (as reported by the participant) and/or self- reported frequency of symptomatic hypoglycemia ≥ 3 times / week * ownership of a smartphone running either android or ios operating system with an active data plan exclusion criteria: * using a closed loop insulin delivery system (medtronic 670g or openaps)

Keywords: diabetes mellitus insulin therapy glycemic control hyperglycemia hypoglycemia health education self-management lifestyle
impact of electronic devices on myopia development and progression

Conditions: Myopia

Summary: the aim of the stuy is to investigate the effects of the adoption of a curriculum with electronic devices for teaching materials and textbooks in hong kong schoolchildren on their changes in refractive error and visual function.

with the blooming of information technology and electronic engineering in recent years, e-books or tablet computers have been introduced at some local primary and secondary schools and have been provided for their students during studying at school and at home. parents and teachers' utmost concern are adverse effects on eye-sight of children, especially the higher progression rate in myopia and the visual discomfort which may be caused by the e-book technology. this is a prospective cohort study to determine if implementation of electronic devices for teaching promotes myopia development and progression and affects visual function in primary schoolchildren. the schools will introduce e-books to their students in some classes. signed informed consent letters from parents will be obtained prior to subject recruitment and data collection. eye examination and data collection will be conducted in primary school campus. the children from two local primary schools in same grade will be assigned into two groups by their schools. one group will use e-books (e-book group) to study course materials assigned by their teachers whereas another group will use ordinary textbooks (control group). their refractive errors, axial length (axl) and binocular functions will be measured and monitored at six-month intervals for a maximum of 2 years.

Eligibility criteria:
inclusion criteria: * chinese * study local primary schools exclusion criteria: * with any ocular diseases and binocular anomalies might affect visual functions or refractive development * with history of eye surgery * have undertaken any kind of myopia control treatment, such as bifocal lenses, orth-k, eyedrops (e.g. atropine)
does metabolic syndrome exist in anorexia nervosa?

Conditions: Anorexia Nervosa; Metabolic Syndrome

Summary: the purpose of this study is to examine whether body fat distribution changes that occur with weight gain in women recovering from anorexia nervosa are transient or persistent, and if they are associated with other features of metabolic syndrome.


Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of anorexia nervosa (except amenorrhea) (restricting or binge eating/purging subtype) * female * age 18-40 * medically stable * participation in inpatient or daypatient treatment sufficient to restore patient to a bmi of at least 19.5kg/m² exclusion criteria: * additional major axis i disorder (including substance abuse or dependence * on daily prescription medication (including oral contraceptives) * history of suicide attempt or other self-injurious behavior within the previous 6 months * significant current or past medical illness,including diabetes mellitus, heart disease * indwelling metallic object (e.g., pacemaker,pump), non-removable metal jewelry or recent metallic ink tattoo

Keywords: eating disorders anorexia nervosa body fat distribution metabolic syndrome visceral adipose tissue
a study of the efficacy of erbium:yag 2940nm in combination with 1064nm laser on facial rejuvenation

Conditions: Facial Rejuvenation

Summary: 1. facial aging is a progressive, multifactor-induced and multidimensional process which is naturally irreversible. the prominent clinical features of skin aging include loss of volume, pigmentation irregularity, low light reflectance, static and dynamic wrinkles, etc. 2. the development of superpulsed co2 and erbium: yag 2940 nm resurfacing lasers was considered as the "gold standard" for the treatment of facial aging \[8,9\]. however, many drawbacks including intraoperative pain, post procedural erythema, edema, high risk of changes of pigmentation and long downtime have drawn concerns to patients and practitioners. therefore, the facial rejuvenation therapies based on combined modalities to target various factors simutaneously have raised more and more interests. 3. the fotona 4d laser platform incorporates the long pulsed 1064 nm and 2940 nm lasers, which provides versatile modalities to target various skin aging problems simultaneously. the 1064 nm laser can penetrate deep into the skin to explode pigment particles, destroy blood vessels and heat the dermal collagen by targeting melanin and haemoglobin. the 2940 nm er:yag laser in fotona 4d system integrates a non-ablative smooth® mode and cold peel superficial™ mode. the half-face treated by a 2940 nm laser alone showed a significant improvement on indexes of skin wrinkles, texture, pores and elasticity as compared to the baseline.


Eligibility criteria:
inclusion criteria: * patients ranged in age from 35 to 60 years old. * patients had dover scale between 2-4 * fitzpatrick wrinkles scale between 1-3 * medium to very severe nasolabial fold depression with morphological scores of 2 - 3 points. exclusion criteria: * pregnancy, * liver or kidney functional abnormality, * skin ulceration * skin cancer * coagulation disorders * patients on drugs of photosensitizing or anticoagulation agents * systemic diseases such as cardiovascular disease, epilepsy, diabetes.

Keywords: facial rejuvenation, erbium: yag laser, 1064 nm laser, skin aging