Kornimate/medical-research-clean huggingface dataset:
needle procedures success rate after application of ralydan vs emla in children

Conditions: Procedural Pain Relief

Summary: needle-related procedures are among the most common sources of pain and distress for children in the health care setting. more than 50% of children reported pain during these procedures. the necessity for pain management during these procedures is well established. topical anesthesia has been shown to be effective in managing needle-related pain. eutectic mixture of local anaesthetic (emla) cream is the topical anesthetic most used. the application of this mixture of lidocaine and prilocaine reduce pain during needle procedures in children. to be effective emla cream must be applied for at least 60 minutes before needle procedure. this is the major limitation for its use in emergency settings. ralydan patch is a drug delivery system designed to release local anaesthetics (lidocaine and tetracaine) through the skin. there is evidence of pain relief after 30 minutes from its application. only one randomized controlled trial compared the two topical anaesthetics in children during venipuncture and showed that ralydan patch led to superior analgesia than emla cream, even if in this study the two anaesthetics were applied only for 35 minutes before needle procedure. no differences were found in success rate of the procedure and vein visibility. in adult patients, ralydan and emla were equally effective in pain relief after 60 minutes from application. to the best of the investigators' knowledge there is no published study that compared needle procedure success rate in children and pain relief effectiveness of lidocaine/tetracaine patch and lidocaine/prilocaine cream, at time of their maximum analgesic effect. the aim of this study is to compare ralydan patch and emla cream at time of their maximum analgesic effect (30 minutes vs 60 minutes), regard to needle procedure success rate at the first attempt and pain relief in children.


Eligibility criteria:
inclusion criteria: * age 3 to 10 years * need for peripheral iv line or venipuncture * informed consent signed by parents or legal guardians exclusion criteria: * need for emergency care * known allergy or sensitivity to local anesthetics

Keywords: ralydan emla cream procedural pain phlebotomy child
the technical and operational performance of the quidelortho savanna rvp4 analyzer

Conditions: Respiratory Viral Infection

Summary: the purpose of this study is for the research team to become familiar with and evaluate the technical and operational performance of the quidelortho savanna rvp4 analyzer by testing 120 archived specimens that were previously tested at the wisconsin state laboratory of hygiene (wslh) by rt-pcr and multiplex respiratory pathogen panel within the last year.

to test the technical and operational performance of the quidelortho savanna rvp4 analyzer, the investigator proposes to test samples archived from the oregon child absenteeism due to respiratory disease study (orchards) study (hsc 2013-1357), a study that had the goal to "develop and implement a system for daily school-based monitoring of ili (influenza-like illness) and cli (covid-like illness) student absenteeism in kindergarten (k) through grade 12 schools, and assess the system's usability for early detection of accelerated influenza, sars-cov-2 and other respiratory pathogen transmission in schools and surrounding communities". the deidentified paired (wslh vs. savanna rvp4) results will be used by quidelortho corporation to evaluate the technical and operational performance of the analyzer.

Eligibility criteria:
inclusion criteria: * previously collected specimens from the orchards study. exclusion criteria: * specimens not collected as part of the orchards study.
aromatase inhibitors for treatment of uterine leiomyomas

Conditions: Symptomatic or Large Uterine Fibroids

Summary: fibroids are benign tumors that might results in bleeding. surgery is their definitive treatment. some medical therapies have been tried for women who wish to preserve their uterus. recent reports have demonstrated a role for a new category of drugs called aromatase inhibitor (such as femara) in the treatment of fibroids. this study is conducted to assess the effect of femara (letrozole) on the size of fibroids in women around menopause.

fibroids (leiomyomas) are benign tumors that originate in the musculature of the uterus. they are the most common cause for removal of the uterus in women. surgery is the final definitive treatment of fibroids. however, surgery is relatively risky. hence, a few medical therapies have been tried for women who wish to preserve their uterus. however, most of those therapies have side effects that prohibit their routine use. recent reports have demonstrated a role for a new category of drugs called aromatase inhibitor ( such as femara) in the treatment of fibroids. to the best of our knowledge, this drug has not been studied yet in the management of fibroid of the uterus apart from one case report. the objective of the current study is to assess the effect of aromatase inhibitors, specifically femara (letrozole) on the size of fibroids in women around menopause. we are hoping that by decreasing their size, we could avoid having patients undergo surgery. the data generated is invaluable in that sense.

Eligibility criteria:
inclusion criteria: 1. perimenopausal women (≥ 50 years) with symptomatic uterine leiomyomas (menometrorrhagia, pressure symptoms, urinary retention, pelvic pain) or those with large leiomyomas ≥ 7 cms exclusion criteria: 1. women \<50 years of age 2. postmenopausal women 3. women with impaired renal function 4. oral treatment with any type of estrogen or progesterone more recently than 1 month 5. history of venous thromboembolism 6. any contraindication for magnetic resonance imaging (mri)

Keywords: leiomyoma perimenopause aromatase inhibitor
effect of acute dietary supplementation with grape seed extract on aortic stiffness, arterial pressure, and blood vessel dilation in collegiate obese individuals at rest

Conditions: Obesity

Summary: this study investigated if elevated bp and aortic stiffness characterized in obese individuals are attenuated following acute grape seed extract supplementation. it is hypothesized that acute dietary supplementation with grape seed extract attenuates aortic stiffness, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and total peripheral resistance and these effects are partially due to reductions in peripheral vasoconstriction

twenty men (obese = 10; normal body weight (nbw) = 10) participated in this study. effects of placebo (pl: 600 mg) and gse (600 mg) on systolic blood pressure (sbp), diastolic blood pressure (dbp), mean arterial pressure (map), heart rate (hr), stroke volume (sv), cardiac output (q), total peripheral resistance (tpr), and aos were compared 2 h after ingestion of gse or pl on different days, one week apart. arterial blood pressure was measured using a sphygmomanometer from a brachial artery at the level of the heart on chair. hr and sv were continuously measured using a non-invasive device (physio flow). co was calculated by hr x sv. tpr was calculated by map/co.

Eligibility criteria:
inclusion criteria: * obesity: body mass index (\>30), normal body weight: body mass index (25-29) exclusion criteria: * cardiovascular diseases or consume any antihypertensive medication or supplementation that can affect blood pressure or aortic stiffness
safety and efficacy of empagliflozin (bi 10773) in type 1 diabetes mellitus patients with or without renal hyperfiltration

Conditions: Diabetes Mellitus, Type 1

Summary: this open-label study aims to evaluate the impact of bi 10773 treatment on glomerular filtration rate under controlled conditions of euglycaemia and hyperglycaemia in subjects with type 1 diabetes mellitus with or without renal hyperfiltration and to characterize the safety and efficacy of bi 10773 25 mg qd as add-on therapy to insulin in these subjects.


Eligibility criteria:
inclusion criteria: 1. male or female subjects 18 years of age or older diagnosed with type 1 diabetes mellitus 2. glycated hemoglobin (hba1c) of 6.5% to 11.0% and an estimated glomerular filtration rate (egfr) greater or equal to 60 ml/min/1.73m² at screening 3. subjects must be either experienced insulin pump users or be on multiple daily injections of any type of insulin exclusion criteria: 1. evidence of macroalbuminuria or leukocyte positive urinalysis at screening 2. any concomitant medication known to interfere with renin-angiotensin-aldosterone system (raas) activity or treatment with any other drugs to reduce blood glucose other than insulin 3. history of macrovascular disease or any other disease which would interfere with trial participation or any ongoing clinical condition that would jeopardize subject safety or study compliance based on investigator judgement
improvement and application of new closed drainage device

Conditions: Hydrothorax; Pneumothorax

Summary: according to the problems of traditional closed thoracic drainage in clinical work, this study aims to further improve and improve the new closed thoracic drainage system by changing the material of drainage tube, increasing the regulating valve of external fixator and increasing the gas flow monitoring kit for special patients, so as to expand its clinical application scope and formulate its operation. standardize. at the same time, through a randomized controlled study, the simplicity, effectiveness and safety of the new minimally invasive thoracic closed drainage system developed by the research group were deeply studied.

the traditional closed thoracic drainage method has complex operation and high technical requirements. it has obvious pain during and after operation. operational complications such as tissue organs, intercostal vessels and nerve injury may occur during the operation. accidents may also occur after catheterization, including leakage around thoracic drainage tube, thoracic drainage tube prolapse, subcutaneous emphysema and accumulation. liquid; to solve these problems, we have invented "minimally invasive thoracic closed drainage system" through a number of patent designs, including: thoracic closed drainage tube implantation expansion forceps, double-chamber thoracic drainage device with side balloon, guide wire, puncture needle, various types of dilators, chest tube fixation devices, etc. the system has the characteristics of minimally invasive puncture and implantation of drainage tube, safe, fast operation, no need of suture and fixation, good position of drainage tube after implantation, less pain for patients, and closing incision in the medial part of patients, avoiding leakage and subcutaneous emphysema and hydrops.

Eligibility criteria:
the selection criteria were as follows: * age 18-70 years, gender is not limited; * subjects clearly understand the purpose of the study, are willing and able to comply with the requirements to complete the study and sign the informed consent; * 18 kg/m2 \< bmi \< 25 kg/m2; * patients who need thoracic closed drainage for exhaust and drainage because of pneumothorax volume \> 30%; * subjects did not have serious chest wall deformities. exclusion criteria: * patients at high risk of bleeding, including patients with congenital hemophilia, thrombocytopenia (plt \< 50 \*109/l), platelet dysfunction (such as idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital platelet dysfunction); * cardiopulmonary function is poor, which is not suitable for the participants. * patients with other infectious diseases (inflammation, tuberculosis) or empyema in the thoracic cavity; * infection of skin around puncture and drainage; * participated in other clinical trials within 30 days; * other reasons why the researchers think it is inappropriate to participate in the experiment.
olpasiran trials of cardiovascular events and lipoprotein(a) reduction - dose finding study

Conditions: Cardiovascular Disease

Summary: evaluate the effect of olpasiran administered subcutaneously (sc) compared with placebo, on percent change from baseline in lipoprotein(a) (lp\[a\]).


Eligibility criteria:
inclusion criteria: * age 18 to 80 years * lipoprotein (a) \> 150 nmol/l * evidence of atherosclerotic cardiovascular disease exclusion criteria: * severe renal dysfunction * history or clinical evidence of hepatic dysfunction * malignancy within the last 5 years * currently receiving, or less than 3 months at day 1 since receiving \> 200 mg/day niacin

Keywords: olpasiran amg 890 sirna lipoprotein (a) lp(a) cardiovascular cardiovascular disease atherosclerotic cardiovascular disease cholesterol apolipoprotein (b) hyperlipidemia dyslipidemia
prognosis study of different anterior cruciate ligament surgery methods

Conditions: Anterior Cruciate Ligament Injuries

Summary: from june 1, 2016, to july 1, 2017, a total of 406 patients with acl rupture were randomly assigned to three different acl surgeries: anatomical single-bundle, central axial single-bundle and double-bundle. a prospective randomized cohort study was conducted.


Eligibility criteria:
inclusion criteria: 1. age from 18-45. 2. acl rupture confirmed by both physical examination and mri. 3. surgery done by senior doctor. 4. using stg as autograft. exclusion criteria: 1. with bilateral acl rupture. 2. second injury. 3. previous surgery in extremity. 4. with oa.

Keywords: anterior cruciate ligament (acl) signal of noise (snq) graft bending angle (gba) central axial single-bundle anatomical single-bundle double bundle
therapeutic impact of kt along with bt in patients with chronic low back pain of sacroiliac joint dysfunction

Conditions: Sacroiliac Joint Dysfunction

Summary: this research aimed to determine the impacts of kt and balance exercises in patients with clbp of sij dysfunction.

the study will be based on a two-arm parallel group randomized control design. thirty participants of clbp of sij dysfunction will be recruited from the physiotherapy department, at integral university, india. study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. all the participants will be randomly divided into two groups a and b. experimental group a will receive the hot pack, stretching exercise, and kinesio taping along with balance training (kbt), and group b will receive the hot pack, stretching exercise, and balance training (bt) exercise

Eligibility criteria:
inclusion criteria: * subjects having chronic (\>3 months) non-specific low back pain (nslbp) of sacroiliac joint (sij) origin * age 20-50 years. * presence of pain exacerbated as a result of bending laterally or backward. * positive results on at least 2 of the pain-provocation tests \[faber, posterior shear, and gaenslen pain provocation tests) and one of the motion palpation tests (ie, gillet and forward flexion tests) . exclusion criteria: * past or current history of surgery or major trauma to spine, pelvis, lower limb, chest or abdomen in the past 12 months. * lower extremity musculoskeletal disorders. .localized spinal pathology, congenital anomalies of hip, pelvis or spine that limits mobility -systematic arthropathy, neuropathy or metabolic disorder * presence of other causes of lbp such as lumbar discopathy and spinal stenosis discovered via clinical examination and mri scanning * pregnancy.
daratumumab and revlimid refractory mm

Conditions: Multiple Myeloma

Summary: retrospective and prospective multicenter observational study on patients with relapsed and refractory multiple myeloma after anti-cd38 moab therapy and imids treated with onlabel regimens.


Eligibility criteria:
inclusion criteria: phase i * patients with rrmm after therapy with anti-cd38 moab plus imids started on therapy with pvd scheme * patients aged ≥ 18 years * patients able to understand and voluntarily sign an informed consent and be willing to consent to the review of clinical data phase ii * patients with rrmm after first-line therapy with anti-cd38 moab plus imids started on therapy with on-label schemes * patients aged ≥ 18 years * patients able to understand and voluntarily sign an informed consent and be willing to consent to the review of clinical data exclusion criteria: * patients not willing to consent to review of clinical data
altered drug disposition and biomarkers for diagnosis of chronic inflammatory liver disease

Conditions: Fatty Liver

Summary: one-third of the u.s. population suffers from non-alcoholic fatty liver disease (nafld). nafld is caused by diabetes and obesity, and is becoming more common. although many people have this disease, the change in how the liver handles drugs and compounds in the body has not been studied. the purpose of this study is to investigate how advanced nafld changes the ability of the liver to handle both endogenous and exogenous compounds.


Eligibility criteria:
inclusion criteria: general: * man or woman between 18 and 65 years of age * negative pregnancy test for women of childbearing potential * negative urine drug screen healthy subjects: * normal liver function tests * normal kidney function and lipid panel nonalcoholic steatohepatitis patients: * recent liver biopsy with nonalcoholic fatty liver disease activity score at least 4 exclusion criteria: general: * history of significant alcohol use (\>20 g/day) and/or illicit drug use * inability to abstain from alcohol for 48 prior to study * use of drugs associated with a clinical or histological picture consistent with fatty liver disease or nash for more than 12 consecutive weeks in the year prior to screening; these include amiodarone, tamoxifen, methotrexate, glucocorticoids, anabolic steroids, tetracyclines, estrogens (at doses greater than those used for hormone replacement) or valproate/valproic acid * type 2 diabetes treated with oral agents other than metformin; these include secretagogues, thiazolidinediones, alpha-glucosidase inhibitors, exenatide and pramlintide. * current or recent use of bile acid sequestrants, bile acid derivatives (i.e. ursodiol) or fibric acid derivatives. * current use of antioxidants such as silymarin, vitamin c, glutathione, or non-prescribed complementary alternative medications (including dietary supplements, megadose vitamins, herbal preparations, and special teas) within 30 days prior to screening. * previous liver biopsy that demonstrated presence of cirrhosis. * radiologic imaging consistent with cirrhosis or portal hypertension. * serum creatinine of 2.0 mg/dl or greater, or on dialysis, at screening. * history of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, severe psoriasis, rheumatoid arthritis) that could affect the assessment of biomarkers (bile acids or inflammation). * history of bariatric surgery. * bmi \> 45 kg/m\^2 at screening. * any known hypersensitivity to opiates, opiate antagonists, or ondansetron. healthy subjects: * taking concomitant medications, both prescription and non-prescription (including herbal products and over-the-counter medications), other than oral contraceptives and multivitamins (women stabilized on hormonal methods of birth control will be allowed to participate) * history or other evidence of liver disease in the opinion of the study investigators. * bmi \> 30 kg/m\^2 at screening.

Keywords: bile acids pharmacokinetics
the prognostic value of lactate is different among septic patients

Conditions: Sepsis; Diabetes Mellitus

Summary: sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. early diagnosis of sepsis and identification of more severe sepsis is important to improve the outcomes .therefore, reliable markers are required to early identify the high-risk patients. currently, lactate is widely applied as the marker for evaluating the severity of sepsis and for outcome predicting. dm affects lactate balance and raised baseline lactate. the objective of this study was to compare the different prognostic value of admission lactate for sepsis patients with or without dm.

sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. early diagnosis of sepsis and identification of more severe sepsis is important to improve the outcomes .therefore, reliable markers are required to early identify the high-risk patients. currently, lactate is widely applied as the marker for evaluating the severity of sepsis and for outcome predicting.nevertheless, the value of lactate for predicting sepsis is still controversial.the reasons for the different cutoff value may be due to the fact that sepsis is a heterogeneous disease which has already been defined by a number of clinical, laboratory and radiologic criteria, rather than specific pathologic findings. therefore, we hypothesized that the discrepancy clinical value of lactate may be resulted from the heterogeneous feature of sepsis. dm affects lactate balance and raised baseline lactate. the objective of this study was to compare the different prognostic value of admission lactate for sepsis patients with or without dm.

Eligibility criteria:
inclusion criteria:18 years or older, informed consent signed, admission serum lactate level obtained, and admission to the hospital with sepsis or septic shock diagnosis. - exclusion criteria:congenital metabolic and psychiatric diseases and clinical data deficiency. -

Keywords: hyperlactatemia
the potential of oxytocin to reduce opioid abuse liability and pain among older adults

Conditions: Pain

Summary: some research suggests that administration of oxytocin with oxycodone may reduce its abuse liability and improve its ability to reduce pain. in a 6-session laboratory study, we will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, and decision-making.

the overall project goals are to determine oxytocin effects on oxycodone's subject-rated abuse liability, and experimental pain. generally healthy individuals (determined via medical history review and a screening session) will, after informed consent, self-administer intranasal oxytocin (or placebo, containing the same ingredients but no oxytocin) shortly after oral oxycodone or placebo in a non-residential, double-blind, randomized, placebo-controlled, within-subjects laboratory study. prescreening will assure drug application safety and, using a validated, comprehensive pain history interview, determine previous or existing chronic pain conditions, including current pain medication use.

Eligibility criteria:
inclusion criteria: * individuals fluent in english will participate. * must report some experience with opioids (e.g., oxycodone, defined as use at least once in the subject's lifetime). * be within 20% of their ideal body weight. * are not currently experiencing chronic pain (pain on most days during the past 3 months) * have a systolic blood pressure of \<=140 and diastolic blood pressure of \<= 90, and a heart rate \<= 90 beats per minute. * participants must also have a normal electrocardiogram (ekg) reading and bloodwork indicating no major health contraindications. exclusion criteria: * significant current physical disease or major (uncontrolled) psychiatric disorder. * no self-reported current interest in drug abuse treatment. * women who are pregnant or nursing. * any severe comorbid illicit substance use disorders or current clinically significant withdrawal for any abused drug excluding nicotine and caffeine.

Keywords: pain abuse liability