Kornimate/medical-research-clean huggingface dataset:
a study of u-500 insulin (ly041001) in participants with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this two-part study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. in part a, each participant will receive two treatments, a single dose and a single dose with continuous infusion of u-500r insulin, both administered just under the skin. participants who complete part a will continue into part b where they will be assigned to 1 of 2 treatments with u-500r insulin, injected either twice or three times daily under the skin for 5-10 days. this study can last from 7-14 weeks including initial screening and follow up.


Eligibility criteria:
inclusion criteria: * males or females with type 2 diabetes mellitus (t2dm) * are current users of u-100, u-200 and/or u-300 insulin/analog as, basal, premixed and/or basal/bolus delivered with any injection device (pens and/or syringe/vial but excluding continuous subcutaneous infusion (csii)/insulin pump use in the preceding 3 months), taking a total daily dose (tdd) of greater than or equal to (≥) 150 units (u) or at least one dose greater than (\>) 100 u as part of a multiple daily injection (mdi) regimen and tdd less than or equal to (≤)3.0 units per kilogram (u/kg) * concomitant antihyperglycemic agent(s) (aha) therapy may include: metformin (met), dipeptidyl peptidase 4 inhibitors, pioglitazone (doses ≤30 milligrams per day (mg/day)), glucagon like peptide (glp)-1 receptor agonists, sodium-glucose co-transporter-2 (sglt2) inhibitors, except in combination with glp-1 receptor agonists * participant's antihyperglycemic agent (aha) therapy must have been stable for ≥3 months (except for weekly glp-1 receptor agonists which must have been stable for ≥4 months) * have hemoglobin a1c (hba1c) 7.5-11.5 percent (%) exclusion criteria: * have type 1 diabetes mellitus (t1dm), or other types of diabetes mellitus apart from t2dm * have known hypersensitivities or allergies to insulin, excipients contained in insulin products, or related compounds * have used u-500r within 3 months prior to screening * have used rosiglitazone, pramlintide, once weekly or twice daily exenatide, or other injectable or oral antihyperglycemic agent(s) not listed in the inclusion criterion; or are taking oral antidiabetic medications at doses exceeding the respective product labels * have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia which may affect reliability of hba1c measurements
video screening for visual impairment of infants

Conditions: Behavioral Dynamics; Visual Impairment

Summary: an individual senses the world and reflects feedbacks via independent behaviors. such precise collaboration of the sensory and behavioral systems is fundamental to survival and evolution. when a sensory modality is altered, the behavioral system has the potential to fit in a substitute modality. however, the specific dynamics of human behaviors in response to sensory loss remain largely unknown due to the paucities of representative situations and large-scale samples. here, the investigators focused on thousands of human infants who suffered varying degrees of visual stimuli deficiency in early stages, while their behavioral systems remained sensitive and thus retained high behavioral plasticity. having access to this unique population provides an unprecedented opportunity to investigate the effect of diverse visual conditions on the behavioral system and develop a domestic apparatus for screening visual impariment of infants.


Eligibility criteria:
inclusion criteria: * younger than 4 years of age exclusion criteria: * any brain and mental illnesses, or other known illnesses that may affect the behavioral patterns
hydroxyethyl starch and renal function after laparoscopic nephrectomy

Conditions: Kidney Cancer

Summary: the purpose of this project is to investigate if hydroxyethyl starch (hes) is potential nephrotoxic and examine the effects on the circulation and kidneys during administration of hes during surgery.

hydroxyethyl starch (hes) is widely used in hospitals to maintain circulation in critically ill patients. in recent years studies have raised suspicion that hes is nephrotoxic. so far acute kidney injury has been diagnosed based on creatinine measurements, but new technology allows for earlier diagnosis using measurements of biomarkers in urine. the purpose of this project is to investigate hes's potential toxicity and effects on the circulation and kidneys using measurements of biomarkers specific for toxicity and for the sodium/water balance in the urine and by measurements of vasoactive hormones in the blood after administration of hes 130/0.4

Eligibility criteria:
inclusion criteria: * age \> 18 years * males and females * indication for laparoscopic nephrectomy exclusion criteria: * blood donation within the last month * lack of wish to participate * egfr\< 15ml/min * pregnancy or breast feeding
hepatic insulin sensitivity and very low density lipoprotein triglyceride (vldl-tg) kinetics

Conditions: Obesity; Dyslipidemia

Summary: obesity is associated with dyslipidemia, which is a major risk factor for coronary heart disease. triglycerides (tg) and cholesterol are transported in the system of lipoproteins, and the metabolism of these lipids in plasma is closely interrelated. evidence suggests that increased concentration of very low-density lipoprotein triglyceride (vldl-tg) is a central pathophysiological feature of the lipid and lipoprotein abnormalities in dyslipidemia. the primary objective of this study is to investigate vldl-tg kinetics and hepatic insulin sensitivity in age-matched obese and lean, healthy men in the postabsorptive state and during acute hyperinsulinemia using vldl-tg and glucose tracers.

extensive description not included.

Eligibility criteria:
inclusion criteria: * healthy * bmi \ 30 kg/m2 * informed consent exclusion criteria: * alcohol misuse * smoking * use of prescription drugs
early diagnosis of therapy-associated cardiotoxicity basing on pet/ct in lymphoma

Conditions: Positron-Emission Tomography

Summary: to explore the value of 18f-fluorodeoxyglucose (fdg) pet/ct imaging in early diagnosis of treatment-related cardiotoxicity (tact) of lymphoma using visual method and semi-quantitative method.

first of all, the cardiac 18f-fdg uptake in patients with lymphoma will be observed by visual method: according to the uptake site, it will be divided into left ventricular uptake and biventricular uptake, and according to the degree of uptake, it will be divided into equal uptake (myocardial uptake is lower than cardiac blood pool uptake), moderate uptake (myocardial uptake is between cardiac blood pool uptake and liver uptake) and high uptake (myocardial uptake is higher than liver uptake). according to the uptake pattern, it can be divided into diffuse and segmental uptake.then,using the region of interest method to mesure the value of myocardial uptake of 18f-fdg.the difference value of heart's suvmax (δ suvmax- heart) and% δ suvmax- heart before and after chemotherapy or immunotherapy will be calculated. and suvmax- heart / suvmax- mediastinum ratio, suvmax- heart / suvmax- liver ratio and suvmax- heart / suvmax- background ratio (left gluteal muscle) after treatment. taking the abnormality of ecg (early tact) as the end point.

Eligibility criteria:
inclusion criteria: 1. no previous history of heart disease. 2. normal echocardiography, ecg and laboratory tests (creatine kinase, myoglobin, troponin, brain natriuretic peptide) before treatment. 3.18f-fdg pet/ct examination before and after treatment - exclusion criteria: 1.receiving radiotherapy and chemotherapy at the same time. 2.previous chest radiotherapy. 3. with severe hepatic or renal dysfunction. -

Keywords: cardiotoxicity early
laparoscopic ovarian drilling versus letrozole in clomiphene citrate resistant polycystic ovary

Conditions: Induction of Ovulation

Summary: the aim of this work is to compare the clinical outcomes of letrozole with laparoscopic ovarian drilling (lod) in patients with clomiphene-citrate-resistant polycystic ovary syndrome (pcos).


Eligibility criteria:
inclusion criteria: 1. patients diagnosed as pcos according to roterdam (2003) criteria 2. patients with clomiphene resistance, i.e. failure to ovulate following 100 mg cc for 5 days for at least three cycles. 3. patent fallopian tubes, confirmed by hysterosalpingography or hysteroscopic diagnosis. 4. normal semen analysis parameters of the patients' spouses according to the modified criteria of the world health organization. 5. normal serum prolactin, thyroid stimulating hormone and 17-oh progesterone. 6. no systemic disease; no gonadotropin or other hormonal drug treatment during the preceding 3 months. exclusion criteria: 1- infertility induced by reasons other than pcos. 2- uterine cavity lesions or ovarian cyst. 3- \>40 years old. 4- body mass index (bmi) \>26 kg/m2. 5- contraindications to general anesthesia. 6- history of pelvic surgery. 7- other endocrine diseases. 8- a history of liver or kidney disease. -

Keywords: letrozol laparoscopic ovarian drilling
an open-label, multi-centre, phase iii study of local tolerability of zomacton 10mg

Conditions: Turner's Syndrome

Summary: children with growth failure due to inadequate secretion of growth hormone or growth retardation due to turner's syndrome are individually dosed and treated for 12 weeks

ferring pharmaceuticals a/s has developed a new zomacton 10 mg formulation. the formulation provides a higher concentration and thereby a smaller volume to be administered. zomajet vision x is a needle-free injection system. it sends a thin jet of zomacton through the skin and into the subcutaneous tissue without the use of a needle. the mode of administration is referred to as "transjection". by use of zomajet vision x, both transjection and reconstitution of zomacton 10 mg can be done without using a needle. the rationale of the study is to describe the local tolerability of the new zomacton 10 mg administered by zomajet vision x.

Eligibility criteria:
subjects between the ages of 3 and 17 years (both inclusive) with growth failure due to inadequate secretion of growth hormone or growth retardation due to turner's syndrome. subjects have for a minimum of 6 months prior to study enrolment been receiving growth hormone therapy
a study of ly3471851 in participants with eczema

Conditions: Dermatitis, Atopic

Summary: the main purpose of this study is to learn more about the safety and side effects of ly3471851 when given by injection just under the skin to participants with eczema. the study will last up to 48 weeks and may include up to 23 visits to the study center.


Eligibility criteria:
inclusion criteria: * have a confirmed diagnosis of atopic dermatitis (ad) for least 12 months * have active ad according to study specific criteria * be willing and able to undergo skin biopsies exclusion criteria: * have received certain topical medications for ad within 14 days prior to baseline * have received certain systemic medications for ad within 4 weeks prior to baseline * have received ly3471851 previously
comparison of static air support devices (repose®) and alternating-pressure devices in the prevention of pressure ulcers

Conditions: Pressure Ulcer; Pressure Injury; Pressure Sore; Bed Sore

Summary: maintaining and improving skin health are major goals in acute and long-term care. patients at the extremes of age, the critically ill, medically compromised and those with immobility are at risk for developing several skin disorders, with pressure ulcers (pus) as one of the most common and mostly preventable ones. prevalence figures of pus vary between 6.4% and 31.4%. pus are described as localised injuries to the skin and/or underlying tissue, usually over a bony prominence, as a result of pressure or pressure combined with shear. prevention of pus is internationally seen to be a key quality indicator of care. to prevent pus, reducing both the amount and the duration of pressure and shear at the pressure points of the body is strongly recommended. one of the interventions to achieving this, is the use of pressure-reducing devices (mattresses, cushions, etc.). studies that compare the (cost-) effectiveness of different pressure-reducing devices are needed. the primary aim of this study is to compare the (cost-) effectiveness of pressure ulcer prevention in high risk patients using static air support devices (repose®) versus alternating-pressure devices. the second aim is to get insight in patients' experiences and perceptions of comfort using static air support devices and alternating-pressure devices. the third aim is to get insight in caretakers' perceptions of barriers and facilitators of the use of static air support devices and alternating-pressure devices and to reveal how these perceptions influence the readiness to use the products in clinical practice. this randomized controlled trial will be performed in ca. 25 nursing homes in a random sample of 306 residents who are at high risk of developing pressure ulcers. residents will be included in the study for a period of 14 days. skin assessment and risk factor registration will be done on a daily basis by the nurses. reliability checks and time measurements will be completed by the researcher.


Eligibility criteria:
inclusion criteria: * high risk of pressure ulcers (braden score \< 12) and/or pressure ulcer category 1 * currently using alternating-pressure devices * bedbound (\> 8 hours in bed) or chair bound (\> 8 hours in chair) * aged \> 65 years exclusion criteria: * pressure ulcer category 2,3,4, deep tissue injury (dti) or unstageable pressure ulcer * expected length of stay \< 2 weeks * end of life care * medical contraindication for use of static air support devices

Keywords: static air support devices alternating-pressure devices high risk population elderly prevention
the effects of therapeutic resources on structure and function of normal and burned skin

Conditions: Burn; Skin Graft

Summary: burning produces changes in the biomechanical properties of the skin causing limitation of movement. the increase in skin suppleness is very important in the rehabilitation process, since its increase makes therapeutic interventions aimed at increasing the range of motion, thus improving functional pattern. will be evaluated 60 volunteers of both sexes aged 20-80 years seen at the burns unit of the clinical hospital of the faculty of medicine of ribeirão preto. there will be a traditional physical therapy evaluation as well as evaluation of the specific characteristics of the burn and scar. the temperature of the region will be assessed by thermography, and biophysical parameters and biomechanical skin evaluated by cutometer and their accessory probes (mexameter, reviscometer, sebometer) before, immediately after and 10, 20 and 30 minutes of application of therapeutic resources. volunteers will undergo continuous application of ultrasound with 3 mhz and intensity of 1 w/cm2 in the region due to scar deep second degree burn or third degree, and the application time of 2 minutes for each effective radiation area of the head (era) in a predetermined region of 9x5 cm a total of 4 minutes of application, therapy paraffin 20 minutes and 4 minutes endermology negative pressure between 100 and 200mmhg, in a continuous mode with glass head (1.5cm in diameter .) applications will be set by random draw (design crusader cross-over) with an interval of 7 days between applications (wash-out). the data will be submitted to analysis of normality by the shapiro-wilk test, and the behavior of the effect between groups and pre-and post-intervention will be evaluated by two-way anova followed by post-hoc (bonferroni) or friedman, p \<0.05


Eligibility criteria:
inclusion criteria: * victims of deep second degree burns and third degree with a length of at least 1% of body surface area burned * postoperative graft skin (4 and 6 months) * anywhere in the body that has area to uninjured contralateral control * good state of physical and mental health * aged between 20 and 80 years * both genders * irrespective of race, class or social group exclusion criteria: * volunteers with illnesses or deformities that may interfere with evaluation and procedures * volunteers which do not accept signing the instrument of consent and do not meet the inclusion criteria

Keywords: burn skin graft elasticity skin physical therapy modalities
evolution of bone histomorphometry and vascular calcification before and after renal transplantation

Conditions: Chronic Kidney Disease

Summary: a study of the natural history of bone and mineral disease (bmd) in patients with end-stage renal disease before and after kidney transplantation

disturbances of mineral and bone diseaeses are frequently observed in ckd patients. renal osteodystrophy is the term to describe the bone abnormalities. epidemiological data showed adynamic bone disease (abd) is the most frequent bone disorder in ckd stage 5d diseases. low pth, diabetes mellitus, malnutrition, metabolic acidosis, hypogonadism and low 1,25(oh)2d vitamin d deficiency are known risk factors for abd. mounting experimental data point towards a role of protein-bound uremic retention molecules (p-cresyl sulfate and indoxyl sulfate) in the pathogenesis and progression of abd. abd is not only recognized as a risk factor for fractures but also for arterial calcification. the aim of the present study is (1) to investigate the role of indoxyl sulfate and p-cresyl sulfate in the pathogenesis and progression of abd and arterial calcification in ckd stage5 and (2) to investigate the influence of renal transplantation on bone and arterial metabolism.

Eligibility criteria:
inclusion criteria: * eligible for renal transplantation and \>18 years exclusion criteria: * use of biphosphonates within the 6 months before the study entry

Keywords: ckd stage 5 bone histomorphometry renal transplantation
a comparison of two brief suicide prevention interventions tailored for youth on the autism spectrum

Conditions: Suicidal Ideation; Suicidal and Self-injurious Behavior; Suicide; Autism Spectrum Disorder

Summary: rates of suicide have increased significantly over the past two decades, particularly among youth. compared to the general population, autistic people are significantly more likely to think about suicide, attempt suicide, and die by suicide. autistic individuals have identified suicide prevention as a top research priority; however, little is known about how to best help autistic youth at risk for suicide. the purpose of this study is to compare the effectiveness, feasibility, and acceptability of two suicide prevention strategies tailored for autistic individuals: the safety planning intervention tailored for autistic individuals (spi-a) and spi-a plus structured follow-up contacts (spi-a+).

this study includes three aims: aim 1: among autistic youth (age 12-24) at risk for suicide, compare the effectiveness of spi-a vs. spi-a+. the primary outcomes of interest are suicidal ideation (si) and suicidal behavior (sb). secondary patient-centered outcomes are mental health treatment initiation and engagement, quality of life, well-being, skills to manage si, access to lethal means, safety plan use, and acute care services for suicidality. aim 2: compare implementation outcomes of acceptability and feasibility for the two interventions from the perspectives of patients, clinicians, and health system administrators. aim 3: explore patient characteristics that may moderate the relationship between intervention and si and sb.

Eligibility criteria:
patient participants inclusion criteria: * 12-24 years old * able and willing to provide informed consent (age ≥18) or assent and parental consent (age \<18) * able to speak english * have received a safety plan tailored for autistic youth during a clinical visit exclusion criteria: * altered mental status that precludes ability to provide informed assent or consent (acute psychosis, intoxication, or mania) clinician participants inclusion criteria: * employment as a provider serving autistic patients at one of the study sites * employment in a role that involves suicide risk intervention with youth patients at a participating clinic * able to read and speak english * able and willing to provide informed consent * 18-99 years old exclusion criteria: * there are no exclusion criteria for the clinician participants health system leader participants inclusion criteria: * health system or clinic leader at one of the study sites * employed in a role that provides administrative oversight to clinicians conducting safety plans with patients * able to read and speak english * able and willing to provide informed consent * 18-99 years old exclusion criteria: * there are no exclusion criteria for the health system leader participants

Keywords: suicide prevention autism spectrum disorder safety planning intervention
comprehensive intervention to evaluate outcomes and cost in hospitalized surgical patients with diabetes mellitus (dm)

Conditions: Diabetes

Summary: this study is being performed to evaluate whether a comprehensive discharge planning and close follow up for one year can improve clinical outcomes and cut costs of care for patients with poorly controlled diabetes. the study takes a high risk approach and is focused on patients admitted to hospital for elective surgery with hba1c \>8%. secondary goals include improving teamwork and communication for clinicians within the team and teaching nurse practitioners and physicians-in-training how to work effectively within interdisciplinary teams. investigators anticipate that the results of this project may lead to the following benefits: 1) improved health outcomes for surgical patients with diabetes, 2) improved strategies for better communication within interdisciplinary health care teams, and 3) decreased health care costs.

all patients who are planned for elective surgery at the hospital are seen in the pre-operative center a few days before admission. the diabetes management team becomes involved in care of patients with hba1c \>8.0% at this time. once the patients are admitted to the hospital, the diabetes management team continues to follow them until they are ready for discharge. at the point of discharge, patients are randomized to one of two arms- the usual care group and the expanded diabetes management service (edms). the edms group is followed closely for 1 year after discharge by the investigators to make sure they receive appropriate care for their diabetes. aims of this study are: 1. to evaluate whether patients that receive the edms have lower re-hospitalization rates at 1 month compared to patients who receive the traditional (current) dms. investigators hypothesize that the edms program will have lower re-hospitalization rates at 1 month. 2. to evaluate whether patients that receive the edms have lower hba1c levels at 1 year compared with patients who receive the traditional dms. investigators hypothesize that patients in the edms program will have lower hba1c levels and improved diabetes-related health outcomes after 1 year in the program.

Eligibility criteria:
inclusion criteria: * elective surgery * hba1c \>=8% within 3 months before surgery * age \> 18 years exclusion criteria: * undergoing same day surgery without post-operative admission * hba1c \< 8% * individuals undergoing bariatric surgery * individuals with metastatic cancer or short life expectancy

Keywords: diabetes mellitus team approach