Kornimate/medical-research-clean huggingface dataset:
aprepitant for prevention of postoperative nausea and vomiting in elective hysterectomy

Conditions: Postoperative Nausea and Vomiting

Summary: the purpose of the study is to determine whether 40 mg aprepitant administered before surgery is effective for preventing vomiting in the first 24 hours after surgery in women undergoing elective hysterectomy.

postoperative nausea and vomiting (ponv) is the most frequent side effect after anesthesia, occurring in approximately 30% of unselected patients, and can be increased up to 70% in certain populations and procedures. despite screening for patients at high risk for ponv, current prophylactic interventions fail to completely eliminate ponv for a substantial number of patients, leading to dehydration, electrolyte imbalance, prolonged hospitalizations, multiple doses of rescue therapy, and readmissions to the hospital (2). aprepitant (emend) is the first neurokin-1-receptor antagonist in a new class of antiemetics, which has already demonstrated powerful additive effects when combined with dexamethasone and a 5-ht3 to prevent both acute and delayed chemotherapy-induced nausea and vomiting (cinv). early studies have also suggested it may useful in the prevention of postoperative nausea and vomiting (ponv). patients undergoing elective inpatient or outpatient hysterectomy will be offered enrollment in this prospective, randomized, double blinded, placebo controlled trial. subjects will receive aprepitant vs. placebo prior to induction of standardized anesthesia. postoperative nausea (assessed with a vrs), vomiting, and use of rescue antiemetic therapy will be documented over a 48h period. additionally, hospitalization days and readmissions for ponv will be compared. adverse events will be reported to the irb and manufacturer. by reducing ponv in a group of high risk patients, we anticipate a demonstrated decrease in rescue antiemetic costs and hospitalization days for ponv related issues.

Eligibility criteria:
inclusion criteria: * scheduled for elective hysterectomy at mayo clinic in arizona * asa i, ii, or iii exclusion criteria: * pregnancy * concomitant bowel surgery other than appendectomy * hypersensitivity to study drug or rescue medication * preoperative score for nausea greater than 4 out of 10 points * severe hepatic insufficiency (child-pugh score \> 9) * any condition which impairs the patient's ability to complete study assessments * intraoperative hemodynamic instability * icu admission * prolonged postoperative intubation * rifampin, carbamazepine, phenytoin, or other drugs which strongly induce cyp3a4 activity * other antiemetic within 12 hours prior to surgery * participation in a clinical trial using an investigational product

Keywords: elective hysterectomy
effects of dietary interventions on the aging brain

Conditions: Healthy

Summary: the researchers will investigate whether caloric restriction or dietary supplementation could provide positive effects on general brain functions in healthy elderly people.

the age-related degradation of cognitive functions even to the point of neurodegenerative disorders such as alzheimer's disease are a growing public-health concern with devastating effects. referring to animal data, empirical studies, and pilot human trials, a healthy diet rich in unsaturated fatty acids and low in calories should improve cognitive functions such as learning and memory. to test this hypothesis, the researchers study general brain functions in healthy elderly subjects (50-80 years old) during a short term diet.

Eligibility criteria:
inclusion criteria: * healthy subjects * 50-80 years old * moderate to heavy weight (bmi 25-30) * must be able to change diet/take supplements at home exclusion criteria: * diabetes * younger than 50 years * bmi \< 25 * psychiatric medication * severe disease * mmse \< 26 * eating disorders

Keywords: diet elderly cognition prevention cognitive decline lifestyle
the effect of electromyogram (emg) activity on anesthetic depth monitoring

Conditions: General Anesthetic Drug Overdose

Summary: currently, a lot of equipments based on bispectral index (bis) is used clinically in order to measure the depth of anesthesia. although bis is used for the measurement of the presence of consciousness or degree of sedation during general anesthesia, it could be influenced by factors that affect or interfere with the activity of eeg because it is a numerical value which is measured by analyzing eeg. the bis electrode for eeg analysis should be attached to the patient's forehead and the eeg signal is 0.5 - 30 hz, the emg signal is 30 - 300 hz, and the bis analyzes the 0 - 47 hz signal. therefore, 30 -47 hz emg signal may influence the bis value and the bis value may differ from the actual. in patients with complete muscle relaxation, the change in bis varies in proportion to the concentration of anesthetic, but in a state with less muscle relaxation or arousal period of anesthesia when recovery of muscle relaxation occurs, bis value may not accurately reflects the change in the depth of anesthesia. although there is a study on the influence of the degree of muscle relaxation on bis value, there is no study on whether phase lag entropy (ple) measuring anesthesia depth based on different mechanism from bis is affected by status of muscle relaxation. after measuring bis and ple at the same time, i will compare both of them and investigate the reliability of the measurement of the depth of anesthesia of ple and how electromyogram activity affects ple.

intravenous administration of 2% propofol and remifentanil would be done for total intravenous anesthesia. after intravenous injection of rocuronium 0.6 mg/ kg for muscle relaxation, endotracheal intubation would be performed. then, anesthesiologist attaches the sensors of bis and plem 100 on the forehead of the patient, and adheres the neuromuscular monitoring device on the medial side of the wrist and the ipsilateral thumb to continuously monitor the state of consciousness and muscle relaxation before, during and after surgery. before the end of surgery, the degree of neuromuscular relaxation should be within deep block (tof count \<2) and the concentration of 2% propofol should be adjusted for maintaining bis between 50 and 60. reversal of muscle relaxant could be performed by intravenous injection of sugammadex 4 mg/ kg in the case of deep neuromuscular relaxation, and 2 mg / kg in the case of shallow muscle relaxation degree under neuromuscular monitoring. after then, monitor and record the values of bis, phase lag entropy monitor (plem) 100, and neuromuscular monitoring in 1 minute increments for 5 minutes.

Eligibility criteria:
inclusion criteria: * the patient who is scheduled for operation requiring general anesthesia and whose american society of anesthesiologists (asa) status is i or ii. exclusion criteria: * who has neuromuscular disease * who takes medicines related neurologic system

Keywords: emg, bis, phase lag entropy
an observational study of tarceva (erlotinib) in elderly patients with advanced non-small cell lung cancer

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this prospective observational study will evaluate the efficacy and safety of tarceva (erlotinib) in elderly patients with advanced non-small cell lung cancer (nsclc) after failure of at least one prior chemotherapy regimen. data of patients treated with tarceva in routine clinical practice will be collected for 1 year.


Eligibility criteria:
inclusion criteria: * adult patients, \> 65 years of age * locally advanced or metastatic non-small cell lung cancer (stage iiib or iv) * failure of at least one prior standard platinum-based chemotherapy exclusion criteria: * age \< 65 years
prognostic value of exhaled isoprene levels for morbidity and functional outcome in cardiosurgical patients

Conditions: Frailty; Muscle Weakness; Volatile Organic Compounds; Isoprene

Summary: the perioperative preservation of functionality and quality of life plays an increasingly important role in older physically limited and frail patients undergoing cardiac surgery. hereby, impairments of the skeletal muscle system integrity often contributes to a reduced physical performance. early identification of these high-risk patients could help to initiate appropriate preventive and therapeutic measures. volatile organic compounds (voc) represent a non-invasive and real-time measurable approach for recording physiological and pathophysiological processes. isoprene (2-methyl-1,3-butadiene) is one of the most abundantly exhaled vocs and has recently been shown to originate from skeletal muscle metabolism. however, the prognostic value of isoprene as a volatile biomarker for skeletal muscle integrity, physical performance and functional outcome in patients undergoing cardiac surgery has not been evaluated before.

this is a single center prospective observational study evaluating exhaled isoprene as a perioperative volatile biomarker of skeletal muscle integrity, physical performance and functional outcome in cardiosurgical patients. all study participants will be assessed by comprehensive clinical examinations, laboratory testing, breath analysis and skeletal muscle ultrasound before, during as well as five and thirty days after surgery. clinical assessments will be performed using established clinical scores and scales (e.g. the short physical performance battery and the fried frailty index). laboratory testing comprises a broad panel of blood-based biomarkers of skeletal muscle integrity and metabolism. the investigators hypothesize that: * perioperative exhaled isoprene levels correlate with postoperative measures of physical performance, functional outcome and morbidity * perioperative exhaled isoprene levels differ between patients with and without physical frailty * perioperative exhaled isoprene levels correlate with sonographic and laboratory parameters of skeletal muscle integrity

Eligibility criteria:
inclusion criteria: * age \>= 65 years * planned cardiac surgery * operation duration \>60 min exclusion criteria: * refusal of study participation * emergency / urgent surgery * acute myocardial infarction * acute or chronic infection * pre-existing illness with permanent restriction of mobility * pre-existing neuromuscular disease * current malignant disease * terminal renal insufficiency * severe liver cirrhosis * severe obstructive pulmonary disease
diffusion-weighted imaging study in cancer of the ovary

Conditions: Ovarian Cancer; Peritoneal Metastases

Summary: this project seeks to develop a quantitative imaging biomarker for evaluating and monitoring treatment response in ovarian cancer metastases and assess its potential in monitoring treatment response. this will involve standardising dw-mri for the abdomen and pelvis across multiple centres and platforms, assessing reproducibility of the measurement in patients planned for neoadjuvant chemotherapy and assessing its utility as an early response biomarker in patients with platinum-sensitive relapse due to receive therapy with carboplatin. scanning measurements will be correlated with histopathological markers in tumour samples in order to link the biomarker with response mechanisms.


Eligibility criteria:
inclusion criteria: * histologically confirmed ovarian, primary peritoneal or fallopian tube cancer stage iii or iv * scheduled to receive neoadjuvant chemotherapy (carboplatin/cisplatin)with planned debulking surgery. exclusion criteria: * life expectancy of less than 6 months * mri contraindications * low grade or heavily calcified disease
nutritional intervention in migraine

Conditions: Migraine

Summary: migraine is a common medical condition. several studies suggest that obesity and/or weight gain are risk factors for aggravating migraine course, especially increase the frequency of headache episodes. the aim of the current study was to evaluate whether nutritional intervention would be able to improve clinical parameters (as assessed by midas and hit) of patients with migraine.

women with the diagnosis of migraine according to the international headache society (ihs-2) criteria received individualized diet meal plan and nutritional orientation for 12 weeks according to their nutritional diagnosis. patients were evaluated three times with an interval of 30 days between each visit. clinical, anthropometric measurements (weight, height, waist circumference and body composition assessed by bioelectrical impedance analysis) and food evaluations were performed. nutritional orientations were strengthened in each visit. the diet prescription did not change during intervention period. the diet quality of the patients was assessed through the brazilian healthy eating index - revised (bhei-r) version. migraine severity was assessed with the headache impact test (hit) and the migraine disability assessment scale (midas). depressive symptoms were also evaluated with the beck depression inventory (bdi).

Eligibility criteria:
inclusion criteria: * women; * older than 18 years; * migraine diagnosis; * agree to sign the informed consent. exclusion criteria: * patients with headaches not characterized as migraine; * pregnant or lactating women.

Keywords: migraine diet quality nutritional intervention severity of disease depressive symptoms
early diagnosis and intervention for fetal malposition in active labor and its impact on mode of delivery

Conditions: Cesarean Delivery Affecting Fetus; Labor Dystocia; Labor Complication

Summary: the goal of this randomized trial is to test if changing a person's position in labor can increase the chances of delivering their baby vaginally. specifically, it aims to answer the questions: * in fetuses who are facing upwards (occiput posterior, op) or sideways (occiput transverse, ot) during labor, does changing the patient's position during active labor to a side-lying posture with a peanut ball increase the chances of them having a successful, spontaneous vaginal delivery? * does changing the patient's position in active labor affect the position of the baby at the time of delivery? * do intentional position changes in labor impact patient-perceived autonomy during their labor and delivery experience? participants will: * receive an ultrasound during labor to determine the position of their baby * be asked to adopt a specific position in labor (side-lying with peanut ball) if they are randomized to the study group * receive additional ultrasounds during labor to assess their baby's position * fill out a questionnaire about their labor experience following the delivery of their baby

in this randomized trial, the investigators aim to evaluate the effects of early ultrasound diagnosis and active management of fetal malposition during the first stage of labor. specifically, the investigators will compare the modified sims (side-lying) position ipsilateral to fetal spine with the addition of a peanut ball versus free maternal position choice in occiput posterior (op) or occiput transverse (ot) fetuses diagnosed by ultrasound during active labor, defined as greater than 6cm cervical dilation. the primary outcome will be operative delivery rates, defined as either cesarean delivery or instrumental vaginal delivery with vacuum or forceps. the investigators will also assess rates of spontaneous rotation to occiput anterior (oa) position at complete dilation and at delivery, as well as the impact of the position changes on the patient's labor experience and their perceived autonomy.

Eligibility criteria:
inclusion criteria: * maternal age \>18 * term gestation (\>37 weeks) * singleton pregnancy * spontaneous or induced active labor (cervical dilation 6-9cm) * epidural anesthesia * cephalic fetal presentation, op/ot position diagnosed by bedside ultrasound * continuous external fetal monitoring * ability to consent exclusion criteria: * multiple gestations * unanesthetized labor * known fetal anomalies * known intrauterine fetal demise * inability to consent

Keywords: fetal malposition occiput posterior occiput transverse
prospective cohort study evaluating 18fdg pet-ct for the early prediction of the efficacy of immunotherapy associated or not with chemotherapy in patients with locally advanced or metastatic non-small cell broncho-pulmonary carcinoma

Conditions: Carcinoma, Non-Small-Cell Lung (NSCLC)

Summary: the hypothesis of this prospective observational pilot study of diagnostic diagnostic performance is that, for patients with nsclc treated with immunotherapy associated or not with chemotherapy, certain metabolic biomarkers on 18fdg pet scans allow early identification of treatment response (or lack of response to treatment) and optimize prediction of tumor response compared with current standards.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years, * patients with histologically proven, metastatic or locally advanced nsclc, with indication for immunotherapy (nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab), in combination or not with chemotherapy molecules (carboplatin, cisplatin, pemetrexed, paclitaxel or nab-paclitaxel), validated by a multidisciplinary team and prescribed within the scope of their marketed authorization, whatever the line of treatment treatment line, * ecog 0 to 3, * the patient's understanding of the protocol and the note of non-opposition, with oral agreement, * patient has not objected to the use of his or her data for medical research. research, * patient has social security coverage. exclusion criteria: * age under 18, * contraindication to 18fdg pet-ct examinations: severe claustrophobia, unbalanced diabetes at the time of the first pet-ct scan (fasting capillary glucose ≥ 11 mmol), * hemoglobin less than 7 g/dl at inclusion. if the patient has a respiratory or or cardiovascular pathology, hemoglobin must not be less than 9.0 g/dl, * any participation in other biomedical studies involving the drug, medical devices or medical devices or imaging techniques is prohibited, with the exception of biomedical studies, * refusal to participate in the present study, * contraindication (e.g. hypersensitivity to the active substance or to one of the excipients of immunotherapy or chemotherapy treatments...). * vulnerable persons are defined in article l1121-5 to -8: * pregnant women, parturients and nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons hospitalized without consent under articles l. 3212-1 and l. 3213-1 who are not covered by the provisions of the provisions of article l. 1121-8, * and persons admitted to a health or social establishment for purposes other than research purposes, * adults who are the subject of a legal protection measure, or who are unable to exercise their non opposition
prescribed sternal precautions vs. self-guided restrictive care (peeerc)

Conditions: Surgery; Heart Diseases; Heart Failure; Cardiac Valve Disease

Summary: our study aims to compare postoperative outcomes, postoperative pain and postoperative quality of lives in patients who receive the standard sternal precautions to those in patients who received self-managed sternal precautions following sternotomy for cardiac surgeries. the purpose of the study is to see if self-managed sternal precautions following sternotomy for cardiac surgeries lead to better quality of lives while maintaining same postoperative pain and rate of postoperative adverse events than standard sternal precautions. postoperative pain and postoperative quality of lives will be assessed by phone call surveys. postoperative outcomes will be measured by following the patients for up to a year using electronic medical record.

patients who are recruited in this study will be randomized (1:1) into one of two groups/arms. the ?rst arm (arm 1) will receive instruction to use pain and discomfort as the safe limits for their upper limb use during daily activities at post operative discharge. the second arm (arm 2) will receive the standard sternal precautions at time of post operative discharge. standard sternal precautions in study arm (2) include: don't reach both arms overhead don't reach both arms out to the side don't reach behind your back don't lift more than 5 to 8 pounds don't push with your arms don't pull with your arms don't drive each arm will receive weekly phone calls for 8 weeks. information including pain, quality of life, and adherence to the sternal precaution protocol will be collected. please refer to supporting documents (pain scale, quality of life questionnaire, and sternal precaution checklist) for the specific questions that will be asked at the patients. we will also investigate any adverse events related to the medical care.

Eligibility criteria:
inclusion criteria: * undergoing a sternotomy, english speaking, 18-70 years old, able to ambulate independently exclusion criteria: * sternotomy due to vad implantation or cardiac transplantation, discharge over 1.5 weeks after surgery, prior sternotomy
rf ablation of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this is an early feasibility trial designed to demonstrate whether a new ablation device can be used safely and effectively in treating atrial fibrillation. this study is a prospective, nonrandomized, single-arm, multi-center trial to be conducted at a single study site

this study is intended to evaluate the safety and preliminary effectiveness of the rfmesh bas for electrophysiological mapping and radiofrequency ablation in the region of the ostium of a targeted pulmonary vein in the treatment of drug refractory paroxysmal atrial fibrillation.

Eligibility criteria:
inclusion criteria: 1. patients who are between 18 \& 85 years of age. 2. patients with a minimum of 2 episodes of symptomatic paf within the last 6 months prior to baseline evaluation. at least one of these episodes must have been documented. documentation may include electrocardiogram (ecg), trans telephonic monitoring (ttm), holter monitoring (hm), or telemetry strip. additional paf episodes (i.e., verbal accounts from the patient) will be documented in the patient's study record. 3. patients who have failed at least 1 class i or class iii anti-arrhythmic medication regimen. 4. patients with the ability to understand the requirements of the study, who have provided written informed consent and agreed to the study restrictions and to return for the required follow-up assessments. exclusion criteria: 1. any previous ablation of the left atrium (surgical or catheter based). 2. permanent or persistent atrial fibrillation. 3. recent myocardial infarction within 2 months 4. currently unstable angina. 5. any cardiac surgery during the previous 3 months. 6. currently documented intracardiac thrombus by transesophageal echocardiography (tee). 7. a left atrium \> 50mm in major dimension. 8. a common ostium larger than 25 mm in major axis or any individual pulmonary vein larger than 25 mm in major axis. 9. permanent leads in or through the right atrium. 10. clinically significant valvular heart disease or a replacement heart valve. 11. congestive heart failure (nyha classification iii or iv). 12. an ejection fraction \<35%. 13. a contraindication to warfarin. 14. a contraindication to transseptal procedure. 15. any cerebral ischemic event, including any transient ischemic attack (tia), in the preceding 6 months. 16. any known bleeding disorder. 17. women who are known to be pregnant or nursing. 18. uncontrolled hyperthyroidism. 19. patients currently enrolled in any other clinical investigation. 20. any other significant uncontrolled or unstable medical condition. 21. a life expectancy of less than one year. 22. currently taking amiodarone or have taken amiodarone within 4 months prior to baseline evaluation.

Keywords: atrial fibrillation