Kornimate/medical-research-clean huggingface dataset:
the effect of preoperative oral carbohydrate administration on perioperative hypothermia in pediatric patients

Conditions: Perioperative Hypothermia

Summary: hypothermia that may develop in the perioperative period is associated with many adverse clinical outcomes. in particular, pediatric patients were more susceptible to hypothermia and related complications such as respiratory distress, metabolic acidosis, hypoglycemia, hypoxemia, cardiac disorders, coagulopathy, and wound infection than adults. in this study, the effect of preoperative carbohydrate-rich feeding on temperature regulation in pediatric patients was investigated.


Eligibility criteria:
inclusion criteria: 1. patients to be operated on by the department of pediatric surgery 2. being between the ages of 2 and 15 3. not restricting oral intake 4. asa i-ii-iii patients in anesthesia risk score 5. patients operated between 01.03.2019 and 31.07.2019 6. not having any communication problems (mental retardation, not knowing turkish, etc.) 7. not having gastroesophageal reflux 8. not having any muscle disease 9. informed volunteer consent must be obtained 10. patients for whom emergency surgery is not planned 11. no disease related to the central nervous system exclusion criteria: 1. pediatric patients outside the 2-15 age range 2. having limited oral intake 3. asa iv and above in anesthesia risk scoring 4. patients operated before 01.03.2019 or after 31.07.2019 5. patients who may have communication problems with their parents or themselves 6. patients with gastroesophageal reflux 7. patients with muscle disease 8. patients for whom informed voluntary consent has not been obtained 9. patients who will undergo emergency surgery 10. patients with diseases related to the central nervous system
study of ruxolitinib in pancreatic cancer patients

Conditions: Pancreatic Cancer

Summary: the purpose of this study was to determine whether ruxolitinib added to capecitabine is effective in improving the overall survival of patients with metastatic pancreatic cancer.

the study consisted of an open-label, safety run-in period that was composed of 1 patient cohort with 9 patients/cohort. this phase of the study determined the safety of the capecitabine/ruxolitinib combination in this patient population. a randomized, double-blind study with two treatment arms was conducted once the safety run-in results from the first part of the study showed that the capecitabine/ruxolitinib combination was safe and additional patients could be treated. all patients have received capecitabine therapy in addition to the ruxolitinib or placebo (study drug). treatment for all patients consisted of repeating 21-day cycles. capecitabine was self-administered for the first 14 days of each cycle, and the study drug was self-administered during the entire 21-day cycle. treatment cycles continued as long as the regimen was tolerated and the patient did not meet any of the discontinuation criteria. in the event of disease progression, capecitabine therapy was discontinued but the study drug could continue to be administered. subjects who discontinued treatment with the study drug continued to be followed to obtain information regarding subsequent treatment regimens and survival.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * diagnosis of metastatic pancreatic cancer; subjects must have had measurable, or evaluable disease that was histologically confirmed * karnofsky performance status of ≥ 60 * subjects must have failed 1st-line gemcitabine treatment for metastatic pancreatic cancer: o an alternate chemotherapeutic agent was an acceptable substitute as 1st-line therapy in the event that the subject was intolerant to or ineligible to receive gemcitabine * ≥ 2 weeks elapsed from the completion of previous chemotherapy, and subjects must have recovered or been at new stable baseline from any related toxicities exclusion criteria: * more than 1 prior chemotherapy regimen (not including adjuvant therapy) for metastatic disease * evidence of central nervous system (cns) metastases (unless stable for \> 3 months) or history of uncontrolled seizures * ongoing radiation therapy or prior radiation therapy administered as a second-line treatment * other active malignancy except basal or squamous carcinoma of the skin * inability to swallow food or any condition of the upper gi tract that precluded administration of oral medications * inadequate renal, hepatic and bone marrow function demonstrated by clinical observations and/or laboratory assessments

Keywords: metastatic pancreatic cancer
tolerability and pk of submicron budesonide in children 4 to 11 years old with mild-to-moderate stable asthma

Conditions: Asthma

Summary: this phase 2 study was to investigate the tolerability of unit dose budesonide (map0020) at three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery.


Eligibility criteria:
key inclusion criteria: 1. male or female children with a documented diagnosis of mild-to-moderate persistent asthma (according to the 2007 nih \[epr\] criteria) for at least 1 year prior to screening and medically stable for a minimum of 6 months prior to screening. 2. children 4 through 11 years old (up to one day prior to their 12th birthday at randomization). 3. body weight \>=45 lbs, body mass index (bmi) \<=30 kg/m2 4. ics users had to have been taking an ics for \>=3 months and on a stable dose for \>= 1 month before visit 1.ics users had to be stable enough and able to withhold their therapeutic ics for 24 hours prior to study drug administration, 5. subjects already on stable immunotherapy (ie, allergy shots)if not anticipated to change during the study. key exclusion criteria: 1. females of child-bearing potential/menarche. 2. diagnosis of any other significant chronic illness or abnormality. 3. use of corticosteroids

Keywords: asthmatic children
the use of nociception flexion reflex and pupillary dilatation reflex in icu patients.

Conditions: Critical Illness

Summary: the aim of the study was to describe the feasibility of the nociception flexion reflex and the pupillary dilatation reflex as objective pain assessment tools in the intensive care unit (icu). furthermore to describe the relationship between the responses and the standard of care pain evaluation in the critically ill sedated patients. patients were under propofol / remifentanil or propofol / sufentanil sedation protocol during measurements in a stair-case increasing intensity model of standardized stimulations. (stimulation intensity are similar to the stimulations of neuromuscular blocking agents monitoring.)

pupillary dilatation reflex: tetanic stimulations at the nervus medianus were performed starting form 10 milliamperes (ma) up to 60ma. pupillary diameter was measured before, during and after stimulation. nociception flexion reflex: tetanic stimulations at the nervus suralis were performed starting form 0.5ma in increasing steps via an automated riii (nfr) threshold tracking model.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * critically ill with necessity to mechanic ventilation * hospitalized at the icu of our institution * started sedation protocol (propofol/remifentanil or propofol/sufentanil) * approved informed consent by family member or relative. exclusion criteria: * known eye deformity or extented ophthalmologic surgery in history * severe traumatic brain injury of fulminant stroke * known (poly)neuropathy of complicated diabetes * need for continuously curarization * hemodynamic instability

Keywords: analgesia pain measurement nociception electromyography electrical stimulation pupillometry critical care sedation
evaluation of 4th generation bipolar radiofrequency endometrial ablation device

Conditions: Heavy Menstrual Bleeding

Summary: all women presenting to the gynaecology outpatient clinic with heavy menstrual bleeding (hmb) in the absence of recognizable pelvic pathology, as determined by one or all of a normal pelvic ultrasound, hysteroscopy and / or endometrial biopsy, refractory to medical therapy that persists despite treatment with recommended pharmacological agents(1,2), who have no desire to preserve their fertility and are willing to have an endometrial ablation will be invited to participate. eligible women with hmb will undergo radiofrequency g4 endometrial ablation in either an inpatient or outpatient setting according to their preference. outcomes will be assessed by administering postal questionnaires to measure menstrual bleeding symptoms including rates of amenorrhoea, dysmenorrhoea and life quality at baseline and at 6, and 12 months after ablative treatment. after the main study, there will be an additional evaluation of the long-term effects of outpatient ablative treatments of the endometrium by postal survey at 5 years.


Eligibility criteria:
inclusion criteria: 1. women with no desire to preserve their fertility who have heavy menstrual bleeding without organic pathology (dub) of more than six months duration 2. associated functional disability (negative impact on life quality). 3. lack of response to medical treatment. 4. prepared to undergo surgical treatment without general anaesthesia exclusion criteria: 1. women under 25 years 2. suspected genital tract infection 3. uterine pathology including endometrial pathology on endometrial biopsy (e.g. endometrial hyperplasia or carcinoma) and structural lesions (e.g. uterine malformations, adhesions, polyps, submucous fibroids or extracavity fibroids \> 3cm in diameter) as identified on pelvic ultrasound and/or outpatient hysteroscopy. 4. uterine cavity length \>11cm 5. adnexal pathology 6. previous open myomectomy or endometrial ablation / resection and classical caesarian section 7. patients considered vulnerable (e.g. current mental illness, emotionally labile, learning difficulties, immaturity)

Keywords: endometrial ablation, heavy menstrual bleeding, novosure
research on changes in intestinal barrier function and gut microbiome in patients with type 2 diabetes after duodenal mucosal resurfacing (dmr)

Conditions: Type 2 Diabetes Mellitus

Summary: the aim of this study is to demonstrate the effects of duodenal mucosal resurfacing (dmr) on intestinal barrier function and gut microbiota when treating uncontrolled type 2 diabetes. subjects who underwent dmr and those who did not were enrolled, and potential differences were identified by analyzing urine and fecal samples through microbiotic analysis and high performance liquid chromatography (hplc), combined with changes in clinical data.

this study aims to enroll 100 patients diagnosed with type 2 diabetes who have suboptimal control with one or more oral antidiabetic drugs. of these, 50 will receive dmr treatment at the metabolic weight loss center of the china-japan friendship hospital and will be followed up, while the other 50, who have not received dmr treatment, will be matched by age and gender for comparison. each patient or their legal guardian will sign an informed consent form to participate in the study. researchers will be granted access to the patients' medical records and will collect their medical history and treatment data. researchers will also collect urine and fecal samples for microbiome analysis，metagenomics-based studies and hplc, analyzing the changes in intestinal barrier function and gut microbiota before and after dmr treatment, and between dmr-treated and non-dmr-treated patients.

Eligibility criteria:
inclusion criteria: - 1.25-65 years of age. 2.diagnosed with type 2 diabetes. 3.glycated hemoglobin (hba1c) of 7.5 - 10.0% (59-86 mmol/mol). 4.body mass index (bmi) ≥ 24 and ≤ 40 kg/m2. 5.currently taking one or more oral glucose lowering medications, with no changes in dose or medication in the previous 12 weeks prior to study entry. 6.able to comply with study requirements and understand and sign the informed consent. exclusion criteria: 1. clinical diagnosis of type 1 diabetes. 2. current use of glucagon-like peptide-1 (glp-1) analogues. 3. hypoglycemia unawareness or a history of severe hypoglycemia. 4. clinical diagnosis of autoimmune disease. 5. previous gastrointestinal surgery that could affect the ability to treat the duodenum. 6. use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure. 7. clinical diagnosis of anemia. 8. not potential candidates for surgery or general anesthesia. 9. participating in another ongoing clinical trial of an investigational drug or device. 10. any other mental or physical condition which, in the opinion of the investigator, makes the subject a poor candidate for clinical trial participation.

Keywords: type 2 diabetes mellitus duodenal mucosal resurfacing intestinal barrier function gut microbiome
high-flow nasal oxygenation in obese patients during apnea

Conditions: Apneic Oxygenation; High-flow Nasal Cannulae; Bariatric Surgery; Anesthesia Induction

Summary: before going off to sleep patients are given oxygen to saturate blood with oxygen to extend time before a decrease in the level of oxygen in the blood occurs. during this period, obese patients have a faster decrease in the level of oxygen in their blood. this study uses a device called "high-flow nasal cannula" (hfnc), which delivers humidified high-flow oxygen through 2 small plastic tubes placed just inside nostrils. in the intensive care unit settings this device has been used extensively and has become a standard practice. purpose of this study is to determine whether these high-flow nasal cannula increase the time safely when going to sleep during elective surgery.


Eligibility criteria:
inclusion criteria: * age more than18 years old * asa status i-iii * elective surgery performed under general anesthesia requiring endotracheal intubation * bmi more than 40 kg/m2 exclusion criteria: * chronic respiratory disease * spo2 \<98% after supplementing oxygen * previous or anticipated difficult intubation * uncontrolled hypertension * ischemic heart disease * congestive heart failure * increased intracranial pressure * uncontrolled gerd * known allergy or contraindication to anesthesia drugs * nasal blockade contraindicating the use of hfnc
practice patterns among gynecologic oncologists on tumor genetic testing in endometrial cancer

Conditions: Endometrial Cancer

Summary: in order to formulate strategies to improve adherence to best practice guidelines, as well as utilization of novel therapies, investigators must understand current practice patterns surrounding tumor genetic testing in endometrial cancer. the aim is to survey a representative sample of gynecologic oncologists who belong to the society of gynecologic oncology, via an email survey, to better understand current practices surrounding tumor genetic testing as well as determine if there have been any changes to practice since the publication of recent trials on the use of immune-checkpoint inhibitors in endometrial cancer.

primary objective: proportion of physicians reporting the use of different tumor genetic testing strategies among newly diagnosed endometrial cancer patients. secondary objectives: * explore the use of informed consent in tumor genetic testing in endometrial cancer * explore clinician confidence in utilizing tumor genetic testing to guide treatment decisions. * explore the impact of recent publications regarding immunotherapy on the use of tumor genetic testing in endometrial cancer.

Eligibility criteria:
inclusion criteria: * member of the society of gynecologic oncology * gynecologic oncologist or gynecologic oncology fellow-in-training

Keywords: genetic testing
approach to continuous sciatic nerve block for orthopedic procedures in day surgery with two different techniques

Conditions: Regional Anesthesia Morbidity; Postoperative Pain

Summary: we will enroll patients submitted to feet elective orthopaedic surgery that require analgesia through continuous peripheral nerve block (cnpb) of the sciatic nerve. all catheters will be placed by anaesthesiologists experienced in ultrasound in prone positioning. the patients will be randomized in two groups with technique of sealed envelopes. in the tibial -peroneal nerve (tpn) group we will position the catheter within the confluence of peroneal and tibial nerve. in the tibial nerve (tn) group we will proceed , previous local anaesthesia, to insert a catheter medially to tibial branch of the sciatic nerve according to in plane approach. we will analyze a: the difference in consumption of local anesthetic in the two different groups b: the difference of "insensate limb" in the post-operative home as described by ilfeld(inability to perceive the sense of touch throughout the area of distribution of the sciatic nerve) c: rate of foot drop d: numeric rate scale (nrs) for pain assessment, rate of dislodgment of the catheters, patient satisfaction, need for intervention by the anesthesiologist after discharge.


Eligibility criteria:
inclusion criteria: * patients candidates for orthopedic surgery of the lower limb in unilateral day-surgery with surgical incision in the distribution of the sciatic nerve * patients according to american society of anesthesiologists scale (asa) i-ii * age greater than 18 years * informed consent * presence of a "caretaker" for the night and the next day. exclusion criteria: * contraindications to regional anesthesia * patients asa iii-iv * patients receiving therapy for chronic pain * patients with: renal failure, coagulopathy, liver failure, peripheral neuropathy * refusal by the patient
a long-term safety extension study of wa19926 in participants with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this extension study of wa19926 will assess the long-term safety and the efficacy of roactemra/actemra (tocilizumab) treatment in participants with rheumatoid arthritis. participants who have completed the core study wa19926 are eligible to participate. participants will receive roactemra/actemra 8 mg/kg intravenously every 4 weeks. the anticipated time on study drug is 104 weeks.


Eligibility criteria:
inclusion criteria: * adult participants, \>/=18 years of age who have completed the core study wa19926 and according to the investigator may benefit from roactemra/actemra treatment * no current or recent adverse event or laboratory finding preventing the use of the study drug dose at baseline * receiving treatment on an outpatient basis exclusion criteria: * females who are pregnant * participants who have prematurely withdrawn from the core study wa19926 for any reason * treatment with any investigational drug since the last administration of the study drug in the core study wa19926 * treatment with an anti-tumor necrosis (tnf), anti-interleukin 1 agent or t-cell costimulation modulator since the last administration of the study drug in the core study wa19926 * immunization with live/attenuated vaccine since the last administration of the study drug in the core study wa19926 * diagnosis since the last wa19926 visit of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis * abnormal laboratory values
the impact of genicular nerves chemical neurolysis on the quality of life of patients with advanced knee osteoarthritis.

Conditions: Osteo Arthritis Knee; Osteoarthritis

Summary: genicular nerves chemical neurolysis in advanced osteoarthritis of the knee joint.

the study aims to assess the safety and effectiveness of regional pain treatment methods and their impact on the quality of life of patients with advanced osteoarthritis of the knee joint.

Eligibility criteria:
inclusion criteria: * patients of the pain treatment clinic of the transfiguration of jesus clinical hospital of the medical university of poznań will be qualified for the study * patients with gonarthrosis who failed to achieve satisfactory pain control (nrs\>3) despite the use of nsaids, paracetamol, and co-analgesics * age of patients: from 18 to 110 years of age. * caucasian patients can give informed, complete, written consent. exclusion criteria: * suspected or diagnosed opioid dependence syndrome * active cancer * dementia
bridging therapy in patients at high risk for stent thrombosis undergoing surgery

Conditions: Bleeding; Thrombosis

Summary: patients who have undergone placement of coronary stents require dual antiplatelet therapy with plavix and aspirin to prevent the serious complication of in-stent thrombosis. some of these patients will require surgery while on dual antiplatelet therapy. this poses a challenge because being on plavix is associated with higher risks of perioperative bleeding, but stopping plavix puts patients at increased risk for in-stent thrombosis. currently, the acc/aha guidelines recommend discontinuation of plavix five days prior to surgery to prevent bleeding complications. however, there are no universal recommendations for preventing in-stent thrombosis. some experts recommend the use glycoprotein iib/iiia inhibitors (short-acting antiplatelet agents) as "bridging therapy" during the high-risk perioperative period. although these agents should be beneficial based on theory, there is currently no published data on their effectiveness for this purpose. the current study proposes to evaluate the value of aggrastat (a short-acting intravenous platelet glycoprotein iib/iiia inhibitor) in decreasing the risk of in-stent thrombosis without increasing the risk of perioperative bleeding.

a. d/c clopidogrel 5 days prior to surgery b. continue asa (increase dose to 325 mg until prohibitive bleeding risk) c. check baseline iib/iiia and p2y12 via the verify now device prior to initiating tirofiban d. start tirofiban 2 days prior to the procedure (patient must be on a monitored bed) * load tirofiban only if p2y12 (verify now assay) platelet inhibition is \< 20% otherwise initiate only the continuous infusion dose * creatinine clearance \> 30ml/min: tirofiban 0.4 mcg/kg/min for 30 minutes, followed by continuous infusion at 0.1 mcg/kg/min * creatinine clearance \< 30ml/min: tirofiban 0.2 mcg/kg/min for 30 minutes, followed by continuous infusion of 0.05 mcg/kg/min e. check steady state iib/iiia inhibitor verify now assay (\>8 hour after initiation) f. hold tirofiban 12 hours prior to procedure g. check iib/iiia inhibitor verify now assay (10-12 hours after tirofiban is discontinued) h. cbc pre and post op i. reload clopidogrel\> 24 hours post op (300 mg x 1 then 75 mg daily) unless prohibitive bleeding risk j. reduce asa to pre-procedure dose. restart asa, 24 hours port-op if it was d/c prior to procedure k. check p2y12 via the verify now device post-loading dose of clopidogrel (test cannot be performed w/in 48 hours of the d/c of iib/iiia inhibitor (tirofiban)

Eligibility criteria:
inclusion criteria: * patients' with bms/des on plavix prior to surgery who are in need of an elective procedures exclusion criteria: * patients' with bms/des on not plavix prior to surgery who are in need of an elective procedures

Keywords: gpi glycoprotein iib/iiia inhibitor aggrastat tirofiban verify now platelet function testing bridge therapy