Kornimate/medical-research-clean huggingface dataset:
evaluation of "dose-dense therapy" by s-ham in comparison to conventionally timed double induction in patients with acute myeloid leukemia (aml)

Conditions: Acute Myeloid Leukemia

Summary: evaluation weather early chemotherapy attempts for remission induction can improve the results of patients with acute myeloid leukemia (aml), as compared to the standard group.


Eligibility criteria:
inclusion criteria: * patients with newly diagnosed aml (except acute promyelocytic leukemia) according to the who classification including patients with secondary aml and aml after preceding hematologic disorders * age 18 years or older * informed consent. before any study specific procedure including randomisation is done or before study medication is administered, the subject, or legally acceptable representative, must have given written informed consent for participation in the study. exclusion criteria: * acute promyelocytic leukemia (apl) * previous or concurrent malignancies other than aml * previous treatment with colony-stimulating factors, interleukins or interferons * known hypersensitivity to escherichia coli derived products (e.g. filgrastim, humulin® insulin, l-asparaginase, humatrope® growth hormone, intron a®) * antibody-based or cell-based immunotherapies * respiratory insufficiency with po2 \<60 mmhg * heart failure nyha iii° or iv° * elevated creatinine \>2.0 mg/dl * elevated bilirubin \>2.0 mg/dl * pregnancy or lactation * females without adequate contraception * known hiv and/or hepatitis c infection * severe neurologic or psychiatric disease * psychiatric, addictive, or any disorder, which compromises ability to give truly informed consent for participation in this study * concerns for subject's compliance with the protocol procedures * lack of willingness to record and circulate personal disease-related informations defined in the study protocol
introduction of the adapt system in an orthopedic department

Conditions: Pertrochanteric Fracture

Summary: the adapt system by stryker is introduced in the orthopedic department (at aarhus university hospital). following the introduction of the adapt system all pertrochanteric fractures operated with a gamma3 nail by stryker are operated with the use of the adapt system. following surgery the operating surgeon fill out a questionaire on the use of adapt.

at the ortopedic department, aarhus university hospital pertrochanteric fractures are mostly operated with the gamma3 system by stryker. the adapt system is software based instrumentation designed for use in gamma3 surgery. the software assists the surgeon with implant alignment, lag screw length determination, lag screw positioning and distal targeting. adapt is the only augmented reality instrumentation of its kind. from march 1, 2021 it becomes mandatory for all orthopedic surgeons at the department to use the adapt system when operating pertrochanteric fractures with a gamma3 nail. following surgery the operating surgeon will fill out the system usability scale questionaire and an additional 3 questions.

Eligibility criteria:
inclusion criteria: * surgeons who operated patients with pertrochanteric fractures with the use of a gamma3 nail exclusion criteria: * none
effect of glp-1 on angiogenesis

Conditions: Type 2 Diabetes

Summary: glp-1 receptor agonists are introduced in the treatment of type 2 diabetes (t2d) and their efficacy is documented. however, safety aspects are also important to evaluate with respect to micro and macrovascular complications associated with t2d. few studies have properly addressed the role of glp-1-based therapies in regulating vascular integrity and angiogenesis. the study evaluate the impact of one-month treatment liraglutide on both angpt2 and anglpt4 levels and endothelial circulating progenitor cells, angiogenesis biomarkers in type 2 diabetic patients.

glp-1 receptor agonists are introduced in the treatment of type 2 diabetes (t2d) and their efficacy is documented. beside their therapeutic benefits, direct cardiovascular effects have also been reported. however, safety aspects are also important to evaluate with respect to micro and macrovascular complications associated with t2d. t2d patients treated with glp-1 analogs may suffer from microvascular complications such as macular oedema and proliferative retinopathy, characterized by excessive retinal angiogenesis. few studies have properly addressed the role of glp-1-based therapies in regulating vascular integrity and angiogenesis. the role of glp-1 on endothelial cell (ec) growth, ec integrity and angiogenesis thus needs to be characterized. our aim is to provide the proof of concept that agonists of glp-1 regulate angiogenesis in humans and identify the underlying mechanisms. the present project is the translational part of the anr angiosafe-t2d, regarding clinical safety aspects of glp-1 receptor agonists (namely liraglutide) on angiogenesis. the study evaluate the impact of one-month treatment liraglutide on both angpt2 and anglpt4 levels and endothelial circulating progenitor cells, angiogenesis biomarkers in type 2 diabetic patients.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients (ada criteria) * age \> 18 years * obesity (bmi \>= 25 kg/m2) * hba1c \> 6.5 % * treatment with metformin and/or secretagogues * effective contraception (women) exclusion criteria: * treatment with exenatide, liraglutide or other incretinergic regimen (\<1 month before recruitment) * type 1 diabetes * acute disease or infection * chronic renal failure (mdrd egfr≤50 ml/min) * recent cardiovascular event or surgery (\<3 months) * pancreatitis history * anti-vegf treatment * untreated cancer * immunological disorders * pregnancy and lactation * vulnerable people : deprivation of liberty safeguards * hypersensitivity to the active substance or to any of the excipients of the investigational drug * diabetic ketoacidosis * heart failure stage 3 or 4 (nyha iii-iv) * hepatic insufficiency * inflammatory bowel disease and gastroparesis * no affiliation to the social security

Keywords: type 2 diabetes angiogenesis liraglutide glucagon like peptide 1 receptor agonist
parental perception of child's weight and childhood obesity

Conditions: Childhood Obesity; Diet Habit

Summary: the increasing prevalence of metabolic diseases requires new strategies in the treatment and prevention of obesity. children exposed to a poor diet and a sedentary lifestyle are especially vulnerable and may therefore be at risk of obesity at a very early stage in their lives. recent studies have indicated a notable misperception of children's weight by parents. the main objective of this project is to study the association between parental perception of child's body weight and 1) feeding practices (permissive, restrictive or model); and 2) child's degree of overweight.


Eligibility criteria:
inclusion criteria: * willing to participate exclusion criteria: -
assessing safety & efficacy of meditate temporary implant in subjects with benign prostate hyperplasia

Conditions: Bladder Neck Obstruction; Benign Prostate Hyperplasia

Summary: the purpose of this study is to assess the safety and efficacy of meditate temporary implantable nitinol device (tind) used to alleviate symptoms of bladder outlet obstruction (boo) secondary to benign prostate hyperplasia (bph).the tind is inserted in the bladder neck and prostatic urethra under local anesthesia for few days and taken out some 5 days later in the doctors office.


Eligibility criteria:
inclusion criteria: main ic: * subject signed informed consent prior to the performance of any study procedures. * male with bph, who are at least 50 years of age and that were diagnosed with boo. * ipss symptom severity score ≥ 10. * peak urinary flow of \< 12 ml/sec * no pathology found with kidney us * prostatic urethra length \< 30 mm * prostate volume \< 35 cc * normal urinalysis and urine culture. exclusion criteria: main ec: * any prior prostate treatment * suspected or proved carcinoma of prostate * urethral stricture * urinary bladder stones * serum prostate specific antigen level \> 4 ng/ml (unless proved to be carcinoma free by biopsy). * active urinary tract infection as determined by positive culture, bacterial prostatitis within the past year documented by positive culture. * median prostatic lobe enlargement or a prominent obstructing "ball valve" prostatic lobe. * subject has an interest in future fertility and is not willing to undergo fertility treatments whatsoever. * any serious medical condition likely to impede successful completion of the study intraoperative ec: * irregular findings by the implanting physician during the implantation procedure by the cystoscopy that to the best of the implanting physician are exerting non compliance with the exclusion or inclusion criteria and that were not noticed previously during screening

Keywords: bph bladder neck obstruction bladder neck obstruction secondary to bph
assessment of novel sound changing principles in hearing instruments to determine their application - 2018_12

Conditions: Hearing Loss

Summary: a methodical evaluation of novel sound changing principles in ce-labelled sonova brand hearing instruments (e.g. phonak hearing instruments) is intended to be conducted on hearing impaired participants. these sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. the aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (phase of development). both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. this will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at sonova ag headquarter based in stäfa


Eligibility criteria:
inclusion criteria: * healthy outer ear (without previous surgical procedures) * ability to fill in a questionnaire conscientiously * informed consent as documented by signature exclusion criteria: * contraindications to the md in this study, e.g. known hypersensitivity or allergy to the investigational product * limited mobility and not in the position to attend weekly appointments * limited ability to describe listening impressions/experiences and the use of the hearing aid * inability to produce a reliable hearing test result * massively limited dexterity * known psychological problems * known central hearing disorders * colour blinded
pharmacogenetics of acenocoumarol

Conditions: Thromboembolic Diseases

Summary: the use of oral anticoagulation is marked by an elevated risk of adverse drug events (ade) due to a narrow therapeutic window leading to important medical and economical consequences. the risk of ade is increased partly by drug interactions and recently identified genetic factors influencing the metabolism of coumarins (polymorphism of the cytochrome p450 cyp2c9) as well as the target enzyme of the coumarins (polymorphism of the vitamin k epoxide reductase complex subunit 1 (vkorc1). the objective is to determine the impact of several genotypes on acenocoumarol treatment and on vulnerability to drug-drug interactions.


Eligibility criteria:
inclusion criteria: * every patients with requiring acenocoumarol therapy for at least 4 weeks and a target inr in the low intensity range (inr range 2-3) * age ≥ 18 years * signed informed consent exclusion criteria: * severe cognitive impairment * previous or current treatment with any coumarin
helping employees lose pounds

Conditions: Weight Loss

Summary: this study will evaluate the effectiveness of financial incentives and messaging tailored to individual goals and aspirations to promote and sustain weight loss. this is a 2-arm randomized controlled trial that will recruit eligible employees at a large university to participate in a 3-month weight loss program, followed by a 3-month follow-up period. the primary outcome will be change in autonomous motivation for weight loss. the study hypothesis is that intervention group participants will have a greater increase in autonomous motivation for weight loss than participants in the control group at 12 weeks.


Eligibility criteria:
inclusion criteria: * interested in losing weight * body mass index between 30 and 40 kg/m2 * have wireless internet at home * have android or ios smart device * willing to record themselves weighing in on a scale or let a family member record them weighing in on a scale exclusion criteria: * pregnant or lactating, or intending to become pregnant in the next 6 months * taking medication (other than metformin) for diabetes to control blood sugar * having a serious psychiatric diagnosis, unstable medical conditions or experienced a heart attack or stroke in the past 6 months * having a history of drug or alcohol abuse or addiction to prescription medications
the effects of ultrasound-guided serratus plane block during video-assisted thoracoscopic lobectomy

Conditions: Anesthesia, Conduction; Pain Management

Summary: this study evaluates the effects of serratus plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery.

thoracotomy is known as one of the most painful surgery. thus, there is a development to reduce surgical stress in terms of operation technique, which is video-assisted thoracoscopic surgery. although it has reduced postoperative pain and complications compared with thoracotomy, vats is still quite painful operation. serratus plane block is a novel technique which provide analgesic effect for lateral chest wall by blocking lateral branch of intercostal nerve. it has been reported to be used for pain management including rib fracture, herpes zoster, and postoperative pain. it has become a popular analgesic modality because it is easy to perform and relatively safe. however, the effect of serratus plane block during intraoperative period has not yet been studied. in this study, therefore, the investigators decided to assess the effect of serratus plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status classification i-iii for three port video-assisted thoracic surgery lobectomy under general anesthesia exclusion criteria: * history of allergic reaction to local anesthetics, coagulopathy, local infection at the injection site, and systemic infection.
preventing the return of depression in elderly patients

Conditions: Depression

Summary: the purpose of this study is to compare the effectiveness of two doses of nortriptyline in elderly patients whose depression returned after stopping treatment. nortriptyline is an antidepressant. this study enrolls patients who were treated for depression in an earlier research study and whose depression has returned since stopping treatment. patients are treated for 4 months to bring the depression under control. patients are then assigned randomly (like tossing a coin) to receive either the full dose of nortriptyline or half the usual dose of nortriptyline. patients continue taking nortriptyline for 2 years or until a major depression returns. throughout the study, patients are monitored for symptoms of depression and other side effects.

to determine whether elderly (60-80 years old) depressed patients who cannot sustain a remission without medication must be maintained at full acute-treatment dose. to compare the efficacy of full-dose vs half-dose nortriptyline (nt) in preventing recurrences of major depression in the elderly. to determine whether those patients who experience a recurrence while in a maintenance placebo condition (study i) require 100 percent of their acute-treatment dose of nt to prevent subsequent recurrences or can be successfully maintained on 50 percent of their acute-treatment dose (study ii). investigators expect a pool of 60 patients from study i to become eligible for study ii (the full-dose/half-dose maintenance trial). after treatment of the recurrence and following 16 weeks of stabilization therapy, patients are randomized to 1 of 2 maintenance therapy cells: full-dose nt or half-dose nt. maintenance lasts 2 years or until recurrence of major depression. the following are assessed: differences in recurrence rates and time to recurrence under full-dose vs half-dose conditions; differences in symptomatic ratings of depression, suicidal ideation, social adjustment, and side effects; and differences in compliance rates as determined by variability in level-to-dose (l/d) ratios. exploratory data analyses are used to generate a hypothetical profile of elderly patients who can remain well on half-dose maintenance nortriptyline. for information on related studies, please follow these links: http://clinicaltrials.gov/show/nct00178100 http://clinicaltrials.gov/show/nct00177671

Eligibility criteria:
inclusion criteria: - patients must have: recurrence of major depression while in a maintenance placebo condition in the currently funded maintenance therapy protocol (study i).

Keywords: aged antidepressive agents depression dose-response relationship, drug female human male middle age nortriptyline placebos recurrence aged, 80 and over antidepressive agents -- *therapeutic use antidepressive agents -- administration & dosage depression -- *drug therapy nortriptyline -- *therapeutic use nortriptyline -- administration & dosage
comparison of tab.labetalol and tab.nifedipine for management of postpartum hypertension

Conditions: Postnatal Hypertension

Summary: to compare effectiveness of oral labetalol and oral nifedipine for management of postpartum hypertension.

a comparison of oral labetalol and oral nifedipine for management of postpartum hypertension. which drug is more effective in lowering blood pressures in patient with postpartum hypertension.

Eligibility criteria:
inclusion criteria: * all women with postpartum hypertension as a continuation of pregnancy induced hypertension,eclampsia, pre-eclampsia or new onset de-novo postpartum hypertension,of any parity. * age group between 18-48. * after informed consent. exclusion criteria: * all women with chronic hypertension, uncontrolled and un treated medical disorders will be excluded. * conditions in which drugs labetalol and nifedipine is contraindicated.

Keywords: postpartum hypertension labetalol in postpartum hypertension nifedipine in postpartum hypertension
safety and dose finding study of new vehicle formulations containing ingenol mebutate to treat actinic keratosis on the forearm

Conditions: Actinic Keratosis

Summary: the purpose of this study is to determine if the new vehicle formulations containing ingenol mebutate are as safe and effective as picato® gel 0.05% (it's current vehicle formulation) when applied to ak lesions on the forearm for two consecutive days.

this study will be run in 2 parts. the first part involves applying escalating concentrations of the new vehicle formulations containing ingenol mebutate to aks on the forearms. reactions and safety will be compared to picato® (a registered and marketed ingenol mebutate gel) to ascertain if the new vehicle formulations are at least as safe and effective as picato® . the purpose of part 2 is to select the concentration in the "new formulation" that produces this same, if not better response, as picato® and with a similar or better safety profile.

Eligibility criteria:
inclusion criteria: * must be male or female and at least 18 years of age. * female patients must be of non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception. * ability to provide informed consent. exclusion criteria: * location of the selected treatment area within 5cm of an incompletely healed wound or within 5cm of a suspected basal cell carcinoma or squamous cell carcinoma * undergone cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to the treatment visit * presence of sunburn within the selected treatment areas * use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to the treatment visit * previous enrolment in this clinical trial * prior treatment with ingenol mebutate on the forearms * use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to the treatment visit * treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of the treatment visit * treatment with 5-fu, imiquimod, diclofenac,or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to the treatment visit * use of systemic retinoids * those who are currently participating in any other clinical trial * females who are pregnant or are breastfeeding * those known or suspected or not being able to comply with the requirements of the protocol or provide consent
a human clinical study to collect calibration and performance data for the rba-2 device

Conditions: Coronavirus; COVID

Summary: the current available diagnostic methods used for the detection of covid-19 takes up to 4 hours. in some cases, these diagnostics tests make take up to a couple of days. as it is highly contagious, people who are in close contact with the infected person are at high risk of being infected. covid-19 is transmitted through respiratory droplets produced when an infected person coughs or sneezes. the desire for rapid detection of covid-19 has become an immediate necessity. the purpose of kaligia biosciences' saliva monitoring device (rba-2) is to detect the presence of the covid-19 virus in human saliva. the rba-2 uses raman spectros-copy to detect the coronavirus. once the sample is scanned successfully, the spectra contains the response of the component present in human saliva and provide results in a matter of minutes, rather than hours or days.

the purpose of this study is to calibrate the performance of rba-2 using people by comparing the results against a standard diagnostics test. the objective of this study is to collect non-invasive in vivo saliva from confirmed cases of both infected and non-infected covid-19 patients or site staff at the testing site and compare the test results using the rba-2 against the standard test results used for diagnosis. the comparison of the results obtained from the current testing methods will be used to calibrate machine learning algorithms of the rba-2.

Eligibility criteria:
inclusion criteria: participants can be patients or staff members at the testing site. potential participants may be enrolled if: 1. they are identified as requiring a standard diagnostic test for covid-19 or are being treated after testing positive for covid-19; 2. they are age ≥ 18 years old; 3. they are willing and able to provide verbal informed consent. exclusion criteria: * patients receiving active treatment with antivirals, chloroquine or immune modulators.
neurotox: two dosages of type a botulinic toxin in neurogenic overactive bladder

Conditions: Overactive Bladder

Summary: the purpose of this study is to determine the efficacy and tolerance of 2 dosages (750 versus 500 units) of the dysport type a botulinic toxin for patient suffering from neurogenic urinary incontinence by an overactive bladder and the failure of anticholinergic drugs.


Eligibility criteria:
inclusion criteria: * neurogenic urinary incontinence with urodynamic overactivity resistant to anticholinergic exclusion criteria: * pregnancy * bladder cancer * symptomatic urinary infection

Keywords: overactive neurogenic bladder