Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of bi 10773 in combination with insulin in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of the current study is to investigate the efficacy, safety and tolerability of bi 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.


Eligibility criteria:
inclusion criteria: 1. signed and dated written informed consent by date of visit 1 in accordance with good clinical practice (gcp) and local legislation 2. male and female patients with a diagnosis of type 2 diabetes mellitus treated with a stable dose of basal insulin with or without concomitant metformin and / or sulfonylurea. 3. glycosylated hemoglobin a1c (type a, subtype 1c) of \>7.0% and \< or = 10% at visit 1 (screening) 4. suitability for trial participation according to investigator's judgment (evaluating all alternative treatment options and in consideration of the patient completing the study) 5. age \> or =18 years at visit 1 (screening) 6. bmi \< or = 45 kg/m2 (body mass index) at visit 1 (screening) exclusion criteria: 1. patients with poorly controlled hyperglycemia 2. frequent (at the discretion of the investigator) episodes of hypoglycemic events on basal insulin therapy 3. mi, stroke, or tia within 3 months prior to obtaining informed consent 4. impaired hepatic or renal function; gastric surgery; cancer within the last 5 years; blood dyscrasias 6. treatment with other anti-diabetics, anti-obesity medications, steroids or thyroid hormones, participation in another trial with an investigational drug 7. pre-menopausal women on insufficient birth control 8. alcohol or drug abuse
evaluation of 3d-printed space maintainers versus conventional space maintainer : a randomized clinical trial

Conditions: Tooth Loss

Summary: this study aims to compare the clinical evaluation and patients' satisfaction of space maintainers produced by digital workflow using the 3d-printing method (3d-sms) versus conventional band and loop space maintainers (c-sms) produced by traditional methods.


Eligibility criteria:
inclusion criteria: * lower first permanent molar in active state of eruption * patient and parent showing cooperation and compliance. * medically free children. * according to space analysis available space is less than or equal to needed space * primary molar loss in the last 1 week due to caries, infection, and resorption (to eliminate possible space loss) * caries free, non-restored buccal surfaces of the mandibular second primary molars and deciduous canines. exclusion criteria: * children with previous allergies to stainless steel. * there was less than one year left for the permanent tooth to erupt (to prevent possible abutment toot loss) * the patient's oral hygiene is not sufficient and has periodontal problems (to accurately assess the periodontal effects)
diabetes and partnership: evaluation of a diabetes education module

Conditions: Diabetes Mellitus

Summary: this study is a multi-center, randomized prospective trial with a 6-month follow up. a newly developed treatment and education module will be tested compared to a waiting-list control group. the module covers the topic "diabetes and partnership". primary outcome variable is diabetes-specific empowerment regarding diabetes and partnership. secondary outcome variables are: diabetes-related distress, health-related quality of life, depressive symptoms, self-care behavior, and glycemic control.

the module consists of one lesson (duration: 90 minutes). the module is derived from the empowerment approach and is based on the previously evaluated education and treatment program for type 1 diabetes: primas (nct01220557). the module is designed as a group session held by a trained diabetes educator. patients are randomized either to the immediate participation in the module or to the control group. control group is a waiting-list control group. patients in this waiting-list control group get the education after the completion of the 6-month follow-up.

Eligibility criteria:
inclusion criteria: * intensive insulin treatment * specific interest in "diabetes and partnership" * wish to participate in group education * informed consent * fluent in reading and speaking german language exclusion criteria: * diabetes duration \< 4 week * severe organic disease (e.g. terminal renal disease, cancer with poor prognosis) * current treatment of a mental disease * cognitive impairment * dementia * pregnancy

Keywords: diabetes education randomized prospective
effect of probe placement in delivery room on temperature at the admission of premature infants?

Conditions: Body Temperature Changes

Summary: the aim of the study is to compare the effect of 3 different skin temperature placement probe in the case room on the admission temperature to the nicu in preterm infants. the authors aim to evaluate which placement results in more preterm in the acceptable range (36.5-37 °c).

it's a prospective randomized trial conducted at maisonneuve rosemont hospital, neonatal tertiary center located in montreal with over 2600 annual deliveries. all pregnant women who are expecting to deliver a preterm infant with gestational between 28 and 35 6/7 weeks will be eligible to be enrolled into the study and informed consent is obtained. simple randomization is accomplished by opening a sealed pre-set envelope with group assignment before delivery. group 1: the probe is placed lateral from the spine, 1 cm above the intergluteal cleft, and in side position to the flank between the hips and the ribs. group 2: the probe is placed on the chest, 1 cm above the left nipple. group 3: the probe is placed deep in the left axilla at birth, all the preterm are immediately placed under a radiant warmer and resuscitated as per neonatal resuscitation program (nrp) guidelines. application of a skin temperature probe set at 36.5°c, for servo-controlled thermoregulation by 2 minutes of life. probes will be fixed with an insulated reﬂective water-soluble gel probe. no changes are made to the routine delivery room management and resuscitation for this study. after initial delivery room management, babies are transported in a heated radiant warmer (panda) to the nicu. in the delivery room, when the baby has a skin temperature servo-controlled stable at 36.5° c, the baby is ready to be transferred to nicu. all babies admitted to the nicu are routinely cared for by the attending neonatologist. data collection: the temperature displaced on the servo controlled table is collected when the baby is the nicu just before transfer from the radiant table to the incubator. the right axillary temperature will be taken by a thermometer.

Eligibility criteria:
inclusion criteria: * preterm infant with gestational age between 28 and 35 6/7 weeks exclusion criteria: * infant with severe congenital malformation and those who had sever asphyxia or died in the delivery room and infant born before arrival of nicu team.

Keywords: temperature-probe placement-preterm infant-case room
cardiac changes in early parkinson's disease: a follow up study

Conditions: REM Sleep Behavior Disorder; Pre-motor Parkinson Disease; Symptomatic Parkinson Disease

Summary: the purpose of this study is to investigate the long-term effects of treatment with the adrenergic blocker carvedilol on serial datscan, a dopamine transporter (dat) single photon emission computerized tomography (spect) imaging technique in a population of subjects with defined pre-motor parkinson's disease risks (i.e., rem sleep behavior disorder (rbd) and at least one among hyposmia, constipation, depression and color vision abnormality) and abnormal 123i-metaiodobenzylguanidine (mibg) scintigraphy.

primary procedures in this study are mibg scan, dat scan, neuromelanin magnetic resonance imaging (nm-mri), and carvedilol treatment. subjects will return for research visits and imaging tests every six months for three years. we hypothesize that the rate of decline in dat scan123i-ioflupane uptake will be slower in subjects who have received the adrenergic blocker carvedilol, resulting in a decreased clinical phenoconversion rate to parkinsonism. if this is true, it might create a considerable window of opportunity for treatment with adrenergic blockers - or similar compounds able to reduce sympathetic nervous system (sns) hyperactivity - which may result in long-term benefits such as delaying the neurodegenerative process and the onset of neurological symptoms.

Eligibility criteria:
inclusion criteria: * enrolled in the study "the effect of adrenergic blocker therapy on cardiac and striatal transporter uptake in pre-motor and symptomatic parkinson's disease" (pro#00053136) * capacity to give informed consent exclusion criteria: * secondary parkinsonism, including tardive * concurrent dementia defined by a score lower than 22 on the moca * concurrent severe depression defined by a bdi fast screen score greater than 13 * comorbidities related to sns hyperactivity * heart failure (lvef \<45%) * recent myocardial revascularization (\<12 weeks) * hypertension (sbp\>150mmhg or dbp\>100mmhg) * chronic atrial fibrillation * concurrent use of beta-adrenergic antagonist * diabetes mellitus * copd * untreated sever sleep apnea; apnea-hypopnea index (ahi) \> 30/h. * severely reduced kidney function (glomerular filtration rate\<30ml/min) * contraindications to the use of carvedilol * asthma or bronchospasm * recent myocardial infarction (\<48 h) * ongoing unstable angina * cardiogenic shock or prolonged hypotension * second or third-degree av block * significant valvular aortic stenosis * obstructive cardiomyopathy, or constrictive pericarditis * resting heart rate (rhr)\< 45 or bradycardia (hr\<60) with at least one of the following symptoms; lightheadedness, dizziness, weakness, altered mental status, shortness of breath, pre-syncope, syncope, sick sinus syndrome, stroke within the past 1 month, severe hepatic dysfunction * allergy/hypersensitivity to iodine or study medication
omics sequencing of exosomes in body fluids of patients with acute lung injury

Conditions: Acute Lung Injury

Summary: the exosomes in the experimental group and the control group were sequenced to find the difference of the two groups, providing a basis for subsequent basic research.

this study is an observational study, mainly collected by infection, trauma, burns and other non cardiac causes without any related comprehensive character drug treatment of acute respiratory distress (ards) in patients with blood, urine or alveolar lavage fluid specimens, used to extract exosomes for omics sequencing, relevant histomorphic variations in exosomes of this disease were obtained, in addition, functional verification of genes or proteins with different changes will be carried out to provide clinical basis for subsequent basic research.

Eligibility criteria:
inclusion criteria: inclusion criteria of experimental group: * signed informed consent voluntarily; * age: \>18 years old, gender: no restrictions ; * patients with known clinical manifestations of respiratory impairment or new/aggravated respiratory symptoms diagnosed within one week of onset according to the berlin definition guidelines. control group inclusion criteria: * age ≥18 years old (including 18 years old), male and female; * male weight ≥50 kg, female weight ≥45kg, and body mass index (bmi) between 19 and 26(inclusive), bmi= weight (kg)/ height (㎡); * no smoking, alcohol addiction, no history of drug abuse; * no diabetes, asthma, copd, chronic renal insufficiency and other basic diseases; no history of major diseases or infectious diseases (including hepatitis b, hepatitis c, hiv, syphilis); * those who have not taken drugs recently. exclusion criteria: exclusion criteria of experimental group: * patients with diabetes, chronic renal insufficiency, malignant tumors and other basic diseases; * severe malnutrition; * pregnant or lactating women; * the researcher judged that he was not suitable to participate in this study. exclusion criteria for the control group: * pregnant or lactation women; * severe malnutrition; * the researcher judged that he was not suitable to participate in this study.
evaluating a bidirectional priming intervention for goals-of-care communication in oncology

Conditions: Lung Cancers; Gastrointestinal Cancers

Summary: this pilot study will evaluate whether an intervention aimed at hospitalized patients with advanced lung and gastrointestinal cancers can help facilitate goals-of-care (goc) communication with their oncologists after discharge. while goc communication is a recommended component of routine oncology care, many patients with solid cancers do not have the opportunity to talk with their oncologist about their goals and end-of-life preferences. prior research has shown that a systematic method of prompting goc communication with at-risk patients would address a key barrier to timely goc communication and ensure that patients receive care that is in line with their personal preferences. this trial will enroll 80 participants, who will be randomized 1:1 to either an intervention or a control group. participants in the intervention group will complete a short survey regarding their goals, preferences, and disease understanding. survey responses will be shared with each participant's outpatient oncology team. oncologists will subsequently receive a nudge in the electronic medical record reminding them of key survey responses and encouraging them to discuss them at the patient's first clinic visit after hospital discharge. the primary feasibility outcome is intervention completion rate and the primary clinical outcome is goc documentation within 30 days of discharge in the intervention group compared to the control group.


Eligibility criteria:
inclusion criteria: 1. unplanned admission to the hup solid oncology service; 2. underlying diagnosis of advanced lung or gi cancer, defined as metastatic or locally advanced disease; 3. anticipated discharge within the next 72h; and 4. primary oncologist is based at hup; or 5. family member/caregiver of a patient meeting the above 4 criteria. exclusion criteria: 1. unable to complete survey in english.

Keywords: communication
diabetes in the elderly: retrospective study

Conditions: Diabetes

Summary: diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75 years and 40% of adults \>80years of age. management of hyperglycemia is challenging in the geriatric population in long-term facilities. numerous factors place hospitalized patients at increased risk for hyperglycemia including aging, sedentary life, stress of medical and surgical comorbidities, and changes in antidiabetic regimen. in addition, elderly patients often experience changes in their nutritional intake and organ dysfunction which increase the risk of hypoglycemic events. there are only a few retrospective studies in elderly patients analyzing quality of diabetes care and glycemic control adjusted for medications and presence of co-morbidities in long-term care facilities. in addition, no randomized controlled trials have demonstrated benefits of glycemic control on clinical outcome, quality of life, and rate of acute metabolic complications (hyperglycemia and hypoglycemic events) in long-term care facilities.

the investigators will conduct a retrospective study to determine the prevalence of diabetes, comprehensively describe the management of diabetes, and to evaluate the impact of quality of care and glycemic control on clinical outcome in elderly subjects admitted to two large long-term care facilities: grady health system (ghs) and veterans administration medical center (vamc) in atlanta, georgia between 1/01/08 to 12/31/08.

Eligibility criteria:
inclusion criteria: * ages 65+ * diagnosis of diabetes

Keywords: diabetes elderly nursing home resident
a study of hydroxypropyl guar galactomannan 0.25% (hpgg) versus vehicle in dry eye patients

Conditions: Dry Eye

Summary: the purpose of this study is to demonstrate efficacy of hydroxypropyl guar galactomannan 0.25% (hpgg) ophthalmic gel compared to vehicle for the treatment of dry eye.

a 7-day vehicle pre-randomization (run-in) phase during which all patients will receive 1 drop of vehicle in each eye twice daily will precede the 21-day treatment phase, for an overall study duration of 28 days.

Eligibility criteria:
inclusion criteria: * must read, sign, and date an informed consent document and hipaa privacy document. * diagnosis of dry eye at visit 1 (day 0). * able and willing to follow study instructions. * best corrected visual acuity (bcva) of 0.6 logmar or better in each eye as assessed using an etdrs chart at visit 1. * other protocol-defined inclusion criteria may apply. exclusion criteria: * diagnosis of sjogren's syndrome (or suspected to have sjogren's syndrome). * history or evidence of ocular or intraocular surgery in either eye within the previous year. * history or evidence of serious ocular trauma in either eye within the previous 6 months. * history or evidence of corneal transplant or transplant variant procedures. * history of intolerance or hypersensitivity to any component of the study medications. * history of glaucoma or current ocular hypertension in either eye, or treatment for either condition within 6 months prior to visit 1. * history or evidence of corneal conditions, other than dry eye, that may affect the corneal structure. * use of any concomitant topical ocular medications including artificial tears during the study period. * females of childbearing potential if breastfeeding, unwilling to undergo urine pregnancy test at screening and upon exiting the study, have a positive urine pregnancy test at screening, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study. * use of restasis® 0.05% or an ocular steroid within 30 days of visit 1. * use of systemic medications that have not been stable for 30 days prior to visit 1. * any ocular condition that may preclude the safe administration of the test article. * unwilling to discontinue contact lens wear at least 4 weeks prior to visit 1, and during the study period. * use of punctal plugs or punctal cautery. * use of lid scrubs/warm compresses within 14 days of visit 1. * other protocol-defined exclusion criteria may apply.

Keywords: osdi corneal staining dry eye dry eye signs and symptoms in dry eye patients
risk analysis for diabetic cardiovascular autonomic neuropathy

Conditions: Diabetic Cardiovascular Autonomic Neuropathy

Summary: a large-scale, community-based, cross-sectional study was conducted to explore the extent to which risk factors associated with diabetic cardiovascular autonomic neuropathy (dcan) in general chinese population. a total of more than 2000 diabetic participants were recruited by using multiple stages sampling (first cluster sampling and then simply sampling). data involved in demographic information, clinical biomarkers such as glucose and lipids profiles, medical and therapy history were collected. every participants was complete dna extracted and genotyped. diabetic cardiovascular autonomic functions were measured by using short-term heart rate variability (hrv) to evaluate the outcome of dcan. univariate and multiple variables analysis have been performed to examine potential environmental and genetic risk factors of can. in addition, clinical risk model, simply screening model and nonlinear system model such as artificial neural network was created, respectively.

little is known about the risk factors and risk models for diabetic cardiovascular autonomic neuropathy in chinese population. a large-scale, community-based, cross-sectional study was conducted to explore the extent to which risk factors associated with diabetic cardiovascular autonomic neuropathy (dcan) in general chinese population. a total of more than 2000 diabetic participants were recruited by using multiple stages sampling (first cluster sampling and then simply sampling). data involved in demographic information, clinical biomarkers such as glucose and lipids profiles, medical and therapy history were collected. every participants was complete dna extracted and genotyped. diabetic cardiovascular autonomic functions were measured by using short-term heart rate variability (hrv) to evaluate the outcome of dcan. univariate and multiple variables analysis have been performed to examine potential environmental and genetic risk factors of can. in addition, clinical risk model, simply screening model and nonlinear system model such as artificial neural network was created, respectively.

Eligibility criteria:
inclusion criteria: * survey chinese participants with undiagnosed dcan aged 30-90 years, were included in this study. exclusion criteria: * some diabetic patients were excluded from the study to eliminate potential confounding factors that may have influenced their ca function. briefly, the exclusion criteria were as follows: 1. history or findings of arrhythmia and hyperthyroidism or hypothyroidism 2. pregnancy or lactation 3. serious hepatic or renal dysfunctions (gfr \< 30 ml/min/1.73m2).

Keywords: risk factors risk analysis diabetic cardiovascular autonomic neuropathy general chinese population