Kornimate/medical-research-clean huggingface dataset:
a cpg-methylation-based assay for stratifying stage iii clear cell renal cell carcinoma of receiving adjuvant treatment

Conditions: Renal Neoplasms; Targeted Molecular Therapy

Summary: whether patients with stage iii clear cell renal cell carcinoma(ccrcc) should receive adjuvant targeted therapy or not is still on debate. the investigators invented a assay consisting of 5 cpgs: cg00396667（pitx1）, cg18815943 （foxe3）, cg03890877（twf2）, cg07611000 （ehbp1l1）and cg14391855（rin1）that was successfully categorise patients with stage iii clear cell renal cell carcinoma into high-risk and low-risk groups with harzard ratio(hr) of 4.93. here the investigators randomly assign assay-defined high risk patients of locally advanced ccrcc into adjuvant targeted therapy group and observation group.disease free survival and overall survival are the end points of observation.

the investigators' cpg-methylation-based assay contains 5 cpgs: cg00396667（pitx1）, cg18815943 （foxe3）, cg03890877（twf2）, cg07611000 （ehbp1l1）and cg14391855（rin1）. the investigators evaluate the cpg methylation status of surgical specimens using pyrosequencing and calculate their risk score\[risk score=(0.0066×pitx1)+(0.0034×foxe3)-(0.027×twf2) -(0.018×ehbp1l1)-(0.03×rin1)\], risk score ≥-0.1 as assay-defined high risk status and risk score\<-0.1 as assay-defined low risk status. the investigators randomly assign assay-defined high risk patients of stage iii ccrcc into intervention group and control group. the intervention group should receive adjuvant targeted therapy while the control group deserve observation. primary endpoint is the disease free survival and overall survival.

Eligibility criteria:
inclusion criteria: * the informed consent has been obtained from the patient. * with confirmed diagnosis of stage iii clear cell renal cell carcinoma * with moderate/good ecog health rating (ps): 0-1 score. * the patient receive no anti-cancer treatment before primary surgery. * the patient receive radical operation for renal cancer with negative margin. exclusion criteria: * with severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction. * with bad compliance or contraindication to enrollment. * pregnant woman or lactating woman. * with contraindication to receive adjuvant targeted therapy.
feasibility of endoscopic ultrasound based biliary stone removal without fluoroscopy

Conditions: Common Bile Duct Gall Stones

Summary: to assess the feasibility and success of endoscopic ultrasound (eus) directed biliary stone removal without use of fluoroscopy. success for this study will be defined as the successful removal of all stones from the bile duct without the use of fluoroscopy. fluoroscopy will only be used at the end of a presumed successful procedure to confirm that all stones are removed.


Eligibility criteria:
inclusion criteria: * patients able to give informed consent * patients referred to ies for the endoscopic evaluation and treatment of suspected bile duct stones exclusion criteria: * patients with \>3 bile duct stones or with any stone \>12mm on eus * patients with no bile duct stones on eus * patients with altered biliary anatomy (periampullary diverticulum, anomalous pancreatibiliary junction, altered surgical anatomy) * patients who are pregnant or breast-feeding
pivotal study of ecoin for overactive bladder with urgency urinary incontinence

Conditions: Overactive Bladder; Urge Incontinence; Incontinence, Urinary; Urinary Urge Incontinence

Summary: this trial is a prospective, multicenter, single-arm study of the safety and effectiveness of ecointm tibial nerve stimulation in subjects having overactive bladder (oab) with urgency urinary incontinence (uui). the study will evaluate changes from baseline in oab symptoms as measured by voiding diaries and patient reported-outcomes through 48 weeks of ecointm therapy or 52 weeks of implantation.


Eligibility criteria:
primary inclusion criteria: 1. women and men between 18 and 80 years old. 2. diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component (selfreported), for at least 6 months. 3. individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists). 4. individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxina, or percutaneous tibial nerve stimulation. primary exclusion criteria: 1. predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes. 2. clinically significant bladder outlet obstruction. 3. clinically significant pelvic organ prolapse beyond the hymenal ring. 4. inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.
study to evaluate patients with acromegaly treated with lanreotide autogel (somatuline atg)

Conditions: Acromegaly

Summary: the purpose of the protocol is to evaluate the correlation between plasma lanreotide levels and growth hormone (gh)/insulin like growth factor 1 (igf-1) dynamics and clinical improvement in patients with acromegaly treated with lanreotide autogel (somatuline atg)


Eligibility criteria:
inclusion criteria: * patient on treatment with octreotide lar 20 mg administered every 28 days for at least 3 months prior to visit 1. * patient must have serum gh level ≤ 2.5 ng/ml and serum igf-1 ≤ 1.3 uln, 28 days after their last injection of octreotide lar 20 mg at visit 1. * patients must have serum gh level \> 2.5 ng/ml and serum igf-1 level \> 1.3 uln, 6 or 8 weeks after their last injection of octreotide lar 20 mg. exclusion criteria: * the patient has received pituitary radiation therapy of any kind at any time prior to visit 1. * the patient has received pituitary surgery within 3 months prior to visit 1. * the patient's serum creatinine is higher than 150 µmol/l.
bariatric surgery and pharmacokinetics of amlodipine

Conditions: Obesity, Morbid

Summary: changes to gastric ph, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. these factors are potentially influenced by bariatric surgery. little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. in this study we investigate the pharmacokinetic effects of bariatric surgery on amlodipine.


Eligibility criteria:
inclusion criteria: * preparing to undergo gastric bypass or sleeve gastrectomy in central norway * being a norwegian citizen exclusion criteria: * having previously undergone resections in the gi-tract

Keywords: bariatric surgery gastrointestinal tract biological availability pharmacokinetics amlodipine
erg protein expression in prostatic adenocarcinoma and its clinicopathological features

Conditions: Prostate Adenocarcinoma

Summary: evaluation the erg expression in prostatic acinar adenocarcinoma and its association with clinicopathological features.

prostatic cancer is one of the most common malignancies in males and is the second leading cause of cancer-related deaths in males worldwide. the burden is expected to grow 1.7 million new cases and 499,000 new deaths by 2030. although the diagnosis of prostatic carcinoma can usually be made on histological features, nowadays many immunohistochemical (ihc) markers are used to distinguish it from benign mimickers as well as in predicting prognosis and treatment. out of these markers, ets-related gene (erg product) is a proto-oncogene which participates in chromosomal translocations and is frequently over expressed in prostatic carcinoma which harbors erg-transmembrane protease, serine 2 fusion. erg is a transcription factor belonging to the erythroblast transformation-specific (ets) family. it is involved in many important cellular processes including differentiation, cell proliferation, angiogenesis, cell migration, hematopoiesis, and apoptosis. this proto-oncogene is expressed in the urogenital tract and hematopoietic cells. gene fusions involving sequences of transmembrane protease serine 2 (promoter of tmprss2) and protein coding sequences of erg result in over expression of erg in prostatic tumors. this tmprss2-erg fusion has been shown to occur in 50-70% cases of prostatic acinar adenocarcinoma in different studies. genetic rearrangements were not identified in epithelial carcinomas until tomlins et al. demonstrated erg gene fusions in prostatic carcinoma.the presence of this fusion is now believed to be a critical event in the development of prostatic carcinoma. tmprss2-erg fusion results in constitutive expression of erg oncoprotein resulting in enhanced proliferation and invasive potential of prostatic cancer cells. moreover, tmprss2-erg fusion gene product can be an important therapeutic target in prostatic cancer. immunohistochemical (ihc) expression of erg oncoprotein may serve as a surrogate biomarker of tmprss2-erg fusion gene. therefore in the present study we aimed to evaluate the erg expression in prostatic acinar adenocarcinoma and its association with clinicopathological features.

Eligibility criteria:
inclusion criteria: * all cases diagnosed as prostatic acinar adenocarcinoma exclusion criteria: * other types of prostatic cancer.
audio-visual stimulation for sleep promotion in older adults with osteoarthritis pain

Conditions: Insomnia Chronic; Osteoarthritis; Pain, Chronic

Summary: background and purpose: the purpose of the study is to test the efficacy of an audio-visual stimulation program for sleep promotion in adults with chronic pain. the hypothesis is that hyper-arousal plays an important role in insomnia. brainwave entrainment from 8 to 1 hz reduces arousal, and thereby improves sleep. improved sleep may change how people perceive pain. methods: using a double-blind, randomized controlled trial design, we plan to enroll 30 adults (21-65 years old) experiencing both nonmalignant pain and insomnia. exclusion criteria include: seizure disorder, sleep disorder, and night shift workers. after a one-week baseline measure, participants will be randomized to intervention or placebo group. participants in both groups will be asked to self-administer the audio-visual stimulation program every night at bedtime for one month. upon completion, post intervention measures will be collected.

background: the purpose of this pilot study was to test the efficacy of an open-looped audio-visual stimulation program (avs) for sleep promotion in older adults with osteoarthritis pain. in this study, the avs program was tested in a randomized controlled design. specifically, this pilot study examined a 30-minute audio-visual stimulation program that gradually ramped from 10 hz down to 2 hz, to be used at bedtime for delta brainwave induction, in a randomized controlled design. the placebo control avs program consisted of 30-minutes of constant dim light that slowly changed in color, and a steady monotone at ultra-low (\<1 hz) frequency (outside of the entrainment range). method: a total of 30 older adults (mean age 68 ± 5.1, 90% women) with comorbid insomnia and osteoarthritis pain participated in this 2-week study. participants were randomly assigned to either avs active program or avs placebo control program. after the baseline assessment (which included questionnaires \[sleep, pain, depression\], and quantitative electroencephalogram (qeeg) during avs induction), participants were asked to self-administer their group specific avs program nightly at bedtime for two weeks. post-treatment questionnaires (sleep, pain, depression) were then collected.

Eligibility criteria:
inclusion criteria: * 60 years or older * having difficulty sleeping over the past three months (insomnia severity index ≥ 8) * having osteoarthritis pain (brief pain inventory worst pain ≥ 4) exclusion criteria: * working night shift * previously diagnosed with a primary sleep disorder (sleep apnea or restless leg syndrome). * seizure disorder * photosensitivity * dementia * diagnosis or other significant chronic illness beyond oa that would impact sleep * severe psychiatric disorder including a history of or current diagnosis of psychosis
a stratified sickle event randomized trial (assert)

Conditions: Sickle Cell Disease

Summary: the purpose of this study is to compare the effects of ica-17043 to placebo with or without hydroxyurea (an oral drug used for treatment of sickle cell disease) in patients with sickle cell disease who have had 2 or more acute sickle-related painful crises requiring a visit to a medical facility within the past 12 months.


Eligibility criteria:
inclusion criteria: * 16 to 65 years of age (inclusive) * male or female (not capable of becoming pregnant or using appropriate birth control) * medical history of sickle cell disease * have a history of at least two or more acute sickle-related painful crises requiring a visit to a medical facility within the preceding 12 months exclusion criteria: * hemoglobin \ 11 g/dl * on a chronic transfusion program * has significant active and poorly controlled (unstable) cardiovascular, neurologic, endocrine, hepatic, or renal disorders clearly unrelated to sickle cell disease

Keywords: sickle cell anemia
ingenol mebutate (picato®) with methyl aminolevulinate photodynamic therapy for the treatment of actinic keratosis

Conditions: Actinic Keratosis

Summary: the objective of this study is to determine the efficacy, safety, and patient satisfaction of pretreatment with picato® gel 4 days prior to methyl aminolevulinate photodynamic therapy (mal pdt). patients diagnosed with actinic keratosis who are eligible to receive topical treatment with ingenol mebutate (picato®) and photodynamic therapy will act both as the test group and the control group. each patient will have four distinct treatment areas of 25cm2 on the scalp, and/or scalp and face. three of the treatment areas will receive picato® 0.015% gel, mal pdt, or picato® 0.015% and mal pdt combined. one area will serve as a control and will receive none of the treatments.

study objective the objective of this study is to determine the efficacy, safety and patient satisfaction of pretreatment with picato® gel 4 days prior to methyl aminolevulinate photodynamic therapy (mal pdt). this test area will be compared to picato® treatment alone or mal pdt alone treatment areas as well as a control field (no treatment). rationale this study focuses on the topical treatment of actinic keratosis. patients diagnosed with actinic keratosis who are eligible to receive topical treatment with ingenol mebutate (picato®) and photodynamic therapy will act both as the test group and the control group. patients will be followed through appointments with the study nurse and dermatologist. patient treatment eligibility and regimen for prescribed medication are at dr. rivers (and patient's) discretion. patients will be followed in the study for the duration of one complete treatment plus 2 months. study duration: the inclusion period is 6 months, depending on the speed of patient recruitment. the study duration for each individual patient will end eight weeks after treatment completion.

Eligibility criteria:
inclusion criteria: 1. age \> 40 yrs 2. patients eligible to receive topical treatment with ingenol mebutate gel and photodynamic therapy for treatment of actinic keratosis at the discretion of the dermatologist. 3. fitzpatrick skin type i \& ii. 4. patient must give informed consent. exclusion criteria: 1. diagnosis of basal cell carcinoma(bcc), squamous cell carcinoma(scc) or melanoma in the treatment area. 2. currently experiencing adverse reactions and/or local skin reactions from previous actinic keratosis(ak) treatment in the treatment field. 3. females who are pregnant, nursing or planning a pregnancy during their participation in the study. 4. female subjects of childbearing potential (including subjects using surgical sterilization, ie, bilateral tubal ligation or implanted device methods of contraception) with a positive urine pregnancy test at day 1 prior to study treatment; a female is considered not to be of childbearing potential if she is post-menopausal with at least 12 consecutive months of amenorrhea, has undergone bilateral oophorectomy, or has no uterus.
effects of ashwagandha extract on stress levels

Conditions: Stress

Summary: the purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on stress levels, with secondary outcomes of cognition, energy, and sleep, as compared to a placebo.

participants will take one of two extracts or a placebo every day for 60 days; outcomes of stress, sleep, energy, and cognition will provide information on effectiveness.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study * self reported high stress * baseline score of above-average stress levels on the nri-ss * biological sex of woman; gender identification of female * aged 30 to 59, inclusive * good general health as evidenced by medical history and screening * for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study * agreement to adhere to lifestyle considerations throughout study duration exclusion criteria: * pregnancy, trying to conceive, or breastfeeding * currently smokes or vapes (i.e., tobacco, flavored items, marijuana, etc.) or has in the past year * consumes \> 8 alcoholic beverages in an average week * is a primary caretaker for a child younger than 18 months of age * currently consumes an ashwagandha supplement or has consumed one regularly (defined as 1x week or more often) within the past 24 months * consumes any stress aid, medication, diet, or supplement intended to improve stress in any way * current or recent (within 60 days) history of taking thyroid medications, hypertensive drugs, cns depressants, diabetic medications, benzodiazepines, or immunosuppressants * any liver or kidney disorder * known allergic reactions to any components of the intervention * positive covid-19 test within 30 days of the study period * recent dramatic weight changes (10% change in body weight in the last 6 months) * introducing a new investigational drug or other intervention within 60 days before the start of the study * introducing a new lifestyle stress-reduction aid (i.e. physical activity, yoga, etc) within 60 days before the start of the study

Keywords: energy fatigue cognition nutraceuticals ashwagandha
eras® guidelines validation of crs with or without hipec

Conditions: Peritoneal Diseases

Summary: enhanced recovery after surgery (eras®) pathways have been shown to considerably reduce complications, length of stay and costs after most of surgical procedures by standardised application of best evidence-based perioperative care. recently an international panel of expert have succeeded to elaborate dedicated recommendations for cytoreductive surgery (crs) ± hyperthermic intraperitoneal chemotherapy (hipec) in a two-part series of guidelines based on expert consensus (hübner et al., ejso, 2020). the aim of this prospective validation study was therefore to study acceptance, feasibility and clinical results of these guidelines in clinical practice. hypothesis of the study: introduction of eras® guidelines is feasible and safe. increasing compliance with eras® guidelines (after implementation) will improve recovery and early clinical outcomes of patients undergoing crs/hipec.

the study includes two succesive phases interrupted by a stage to implement eras® guidelines.

Eligibility criteria:
inclusion criteria: * adults female and male patients (\> 18 year-old) * peritoneal cancer from colorectal, ovarian, gastric, appendix origin and primitive peritoneal cancer (peritoneal mesothelioma) * multidisciplinary team meeting validation for crs/hipec * informed and signed surgical consent exclusion criteria: * patients without peritoneal cancer * patients with peritoneal cancer and extended extraperitoneal metastases contraindicating for crs with or without hipec * no informed consent signed

Keywords: crs hipec eras® guidelines peritoneal metastasis colorectal gastric ovarian peritoneal mesothelioma pseudomyxoma peritonei
the study of how long participants stay in the hospital after receiving apixaban for a blood clot in the lung

Conditions: Pulmonary Embolism (PE); Pulmonary Thromboembolism

Summary: a study based on a chart review of participants that presented with a sudden blood clot in the lung


Eligibility criteria:
inclusion criteria: * adults participants at date of admission * primary presentation consistent with pe followed by objectively-confirmed acute pe * received anti-coagulation upon diagnosis of pe during study period and in receipt of anti-coagulation at discharge exclusion criteria: * pe diagnosed during a hospital admission for a reason other than pe during the study period * patients receiving anticoagulation at the time of presentation * patients presenting outside the defined study period other protocol defined inclusion/exclusion criteria could apply
remote ischemic preconditioning and risk of contrast-induced acute kidney injury in patients undergoing coronary stent implantation

Conditions: Acute Kidney Injury

Summary: this single-center, randomized controlled trial is to investigate the impact of remote ischemic preconditioning (ripc) on the risk contrast-induced acute kidney injury and its long-term impact on renal function for patients with diabetes undergoing percutaneous coronary intervention.

patients with diabetes undergoing elective percutaneous coronary intervention in beijing anzhen hospital were enrolled, and all the eligible participants were randomized to either remote ischemic preconditioning (ripc) group or control group. those randomized to ripc group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at \< 2 hours before the pci procedure. the pneumatic medical cuff was inflated to a pressure of 200 mm hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. this procedure was repeated for 3 times. control participants did not experience this procedure of transient upper-limb ischemia.

Eligibility criteria:
inclusion criteria: * patients with diabetes undergoing percutaneous coronary intervention were included. exclusion criteria: 1. emergency pci, 2. baseline troponin value \> 0.04 ng/ml, 3. nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively), 4. patient on dialysis, 5. patients who had some inability to cooperate with the trial, 6. those who could not give informed consent, and (7) second procedure of staged elective pci in this hospitalization.

Keywords: acute kidney injury percutaneous coronary intervention remote ischemic preconditioning