Kornimate/medical-research-clean huggingface dataset:
post-surgical pain assessment in children: roles of skin conductance and genomics

Conditions: Pain

Summary: pain assessment in infants and toddlers is quite challenging since children in these populations are nonverbal or preverbal and cannot describe the presence and severity of pain that they perceive. over the last decade, advances in the field have included the development of behavioral scoring systems for the assessment of acute pain . however, although they have been validated, these commonly used methods of pain assessment are largely subjective and rely on a highly trained observer. an objective continuous measure of pain would be an important addition to standard behavioral painscores which require nurses to monitor the child's behavioral responses.

after standard general anesthetic mask induction, 0.5 ml of blood will be drawn for genetic analysis when the intravenous catheter is sited. a member of the research team will manually transport an appropriately-labeled blood collection tube to the department of anesthesiology perioperative genomics laboratory for storage and further preparation for genetic analysis. the samples will be stored until the investigators have enough to process. the results will be stored in a secure database. the surgical procedure, anesthesia technique, intraoperative analgesia treatment and initial postoperative analgesia treatment will be standardized.upon arrival in the post-anesthesia care unit(pacu), the child will be connected to standard monitors as per standard of care. pain scores will be recorded on a scale of 0-10 (flacc, face, legs,activity, cry, consolability scale) scale. a member of the research team will apply the skin conductance (sc) monitor on the child's hand or foot.this will be used to measure sc values that will be saved on a laptop computer and the sc data will be analyzed off-line.

Eligibility criteria:
inclusion criteria: * children 0 - 3 years of age inclusive * presenting for palatal repair (palatoplasty) * american society of anesthesiologists (asa) physical status of 1 or 2 exclusion criteria: * children \> 3 years of age * on chronic pain treatment * pre-operative use of analgesics * allergies to any anesthetics or analgesia products * known obstructive sleep apnea * diagnosis of cystic fibrosis * american society of anesthesiologists (asa) physical status ≥ 3

Keywords: genetic polymorphisms
evaluation of the effect of pectoral nerve block ii on acute and chronic pain in patients undergoing oncological breast surgery

Conditions: Breast Carcinoma; Chronic Pain

Summary: the aim of this observational study is to evaluate the effect of pectoral nerve block ii (pecsii) on the development of pain in the acute and chronic periods in female patients over the age of 18 who underwent oncological breast surgery. the main questions it aims to answer are: is pecsii blockade applied to patients undergoing oncological breast surgery effective on acute pain scores compared to the non-blockade group? is there a difference between the group with block and the group without block in terms of the development of chronic pain in the evaluation made at the 3rd month after surgery? the analgesia method applied to the patients will be recorded in the patient files and acute and chronic pain scores will be evaluated. chronic pain score evaluation will be made by telephone survey.


Eligibility criteria:
inclusion criteria: * patients who will be operated under general anesthesia * asa score i-ii-iii patients * non-pregnant patients * patients who agreed to participate in the study exclusion criteria: * patients with coagulopathy * patients who underwent bilateral mastectomy * patients with chest wall anomalies * patients with neuropathic pain before surgery * patients who did not agree to participate in the study

Keywords: oncological breast surgery, pecs ii block, chronic pain, acute pain
stromal demarcation line: is it predictive for cross-linking efficiency?

Conditions: Progressive Keratoconus

Summary: to assess the association between stromal demarcation line after collagen crosslinking (cxl) for progressive keratoconus and mid-term (6 month) refractive, topographic and clinical outcomes of cxl

all consecutive patients treated with cxl between march 2014 and march 2015 were included. they all underwent the same procedure: accelerated-cxl protocol (10 minutes uva irradiation with 9 mw/cm2 intensity), irradiation device (iroc uv-x™ 2000, medeuronet). one month after the procedure, as-oct examination was performed in all patients (rs-3000, nidek). the visibility of the stromal demarcation line was scored (0: not visible line; 1: visible line, but measurement not clearly defined; 2: clearly visible line) and its depth was measured centrally at anytime it was possible. changes in best corrected visual acuity (bcva), spherical equivalent (se), kmax and thinnest pachymetry, were studied preoperatively and at 6 months

Eligibility criteria:
inclusion criteria: * patients treated with cxl exclusion criteria: -
effect of skipping breakfast on metabolic function

Conditions: Skipping Breakfast; Circadian Rhythms

Summary: the purpose of this study is to test the hypothesis that the disruption of the "normal" (three meals a day) eating pattern and prolonged overnight fasting caused by skipping breakfast: i) alters the expression of specific clock genes and clock gene targets involved in regulating adipose tissue lipolysis (breakdown or destruction); ii) increases basal adipose tissue lipolytic (breakdown) activity and plasma free fatty acid (ffa) concentrations; iii) reduces skeletal muscle insulin sensitivity; and iv) increases daylong plasma glucose, ffa, and insulin concentrations. the investigator will do this by studying healthy, lean persons either randomized to consume either 3 standard meals per day or omit breakfast and consume 2 meals per day without changing daily calorie intake (skipping breakfast group).


Eligibility criteria:
inclusion criteria: * males \& females * 18-55 years old * bmi between 18.5 - 29.9 kg/m² * sleeps \>7 hours/night * normally consume 3 meals/day, including breakfast exclusion criteria: * pregnancy, lactating or breastfeeding * diabetes * sleep disorders * significant organ dysfunction * shift or nighttime workers * smokers * breakfast skippers * people who regularly sleep \<7 hours/night * consume excess amounts of alcohol * medications that could alter the results of this study

Keywords: clock genes metabolism insulin sensitivity
impact of the assisted ventilation mode on diaphragm efficiency in critically ill patients

Conditions: Respiratory Insufficiency

Summary: this study evaluates the impact of the assisted mode of mechanical ventilation on diaphragm efficiency in mechanically ventilated critically ill patients. participants will be randomized to the neurally adjusted ventilatory assist (nava) mode or to the pressure support ventilation (psv) mode.

during mechanical ventilation the ventilator applies positive pressure to the respiratory system. often in the acute phase of critical illness patients are ventilated in the control mode (cmv), where the patient is completely passive. this quickly (within 48 hours) has been shown to induce diaphragm atrophy and dysfunction (levine et al new england journal of medicine, 200; 358:1327-35). to preserve diaphragm function, guidelines suggest to shift as soon as possible to the assisted mode (the ventilator applies positive pressure to assist spontaneous inspiratory effort). the synchrony between patient and ventilator is critical in this context. psv is the classical assisted mode and applies a constant pressure whatever the patient effort. nava is a newer mode based on the diaphragm electrical activity (eadi) measurement. it assist patient effort proportionally to the eadi and hence to patient's effort. the investigator hypothesis is that nava would improve diaphragm efficiency more efficiently than psv.

Eligibility criteria:
inclusion criteria: * older than 18 years * oro-tracheally or naso-tracheally intubate * had been ventilated for acute respiratory failure in control mechanical ventilation for at least 72 hours consecutively * candidate to assisted ventilation * hemodynamically stable without vasopressor or inotropes (excluding a dobutamine and dopamine infusion lower than 5 gamma/kg/min and a 3 gamma /kg/min, respectively * normothermia exclusion criteria: * neurological or neuromuscular pathologies * phrenic nerve dysfunction * contraindications to the insertion of a nasogastric tube (for example recent upper gastrointestinal surgery, esophageal varices).

Keywords: weaning from mechanical ventilation
a study to learn about study medicine alta3263 in adults with advanced solid tumors with kras mutations

Conditions: Cancer; PDAC - Pancreatic Ductal Adenocarcinoma; NSCLC (Non-small Cell Lung Cancer); CRC (Colorectal Cancer); Advanced Solid Tumors

Summary: the purpose of this study is to characterize the safety and tolerability of alta3263 in adults with advanced solid tumors with kras mutations.

this is an open-label, multicenter, phase 1/1b study of alta3263, an orally bioavailable kras isoform-selective inhibitor that inhibits multiple mutant forms of kras, in adults with advanced solid tumor malignancies with kras mutations. this study will evaluate the safety, tolerability, pharmacokinetics (pk), and preliminary clinical activity of alta3263, and aims to find the best dose. the study consists of two parts: part 1 - dose escalation and part 1b - dose expansion.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of a solid tumor malignancy harboring a kras mutation identified through molecular testing (ngs- or pcr-based) with a clinical laboratory improvement amendments-certified (or equivalent) diagnostic test. * unresectable or metastatic disease. * progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage * eastern cooperative oncology group (ecog) performance status of 0 or 1. * adequate organ function exclusion criteria: * prior treatment with a kras inhibitor, certain exceptions are described in the full study protocol * known condition that prohibits the ability to swallow or absorb an oral medication. other inclusion/exclusion criteria may apply.

Keywords: kras mutation nsclc non-small cell lung cancer colorectal cancer pancreatic ductal adenocarcinoma colorectal carcinoma pancreatic cancer pancreatic carcinoma solid tumors kras mutation metastatic advanced unresectable neoplasms neoplasms by site carcinoma non-small cell lung carcinoma non-small cell lung neoplasm pancreatic neoplasm lung neoplasm colorectal neoplasm colon neoplasm mutant kras kras amplification
the effect of mechanical bowel preparation prior to gynaecological laparoscopic surgeries on the surgical conditions

Conditions: Patient Preference; Patient Safety

Summary: this rct aims to investigate the real surgical effects of mbp prior to the gynecological laparoscopic surgeries. those effects include lowest pneumoperitoneum pressure, lowest trendelenburg inclination angle, the ease of the surgical view and the preferences of the patients with objective measures.

mechanical bowel preparation (mbp) has been routinely used prior to minimally invasive gynaecologic procedures (migp) hypothetically to improve intraoperative bowel handling and visualization of the surgical field, and also to reduce faecal contamination in the setting of bowel injury and/or resection. the studies investigating the effect of mbp on migp are limited and most of existing data are extrapolated from the reports of colorectal and urological surgery studies. besides, evaluation of the surgical workspace visualization and intraoperative bowel handling are far from being objective since they were mostly measured by a 4/5/10-point likert scales or rated verbally on scales of excellent to poor by the operating surgeons. in contrary, it is planned to use objective visualize index, and objective surgical conditions to measure whether mbp has any effect or not.

Eligibility criteria:
inclusion criteria: * aged 18 years and older * able to provide informed consent * undergo laparoscopic gynecological surgery for a benign condition exclusion criteria: * history of previous abdominal surgery * clinically significant present or past systemic diseases * inability to perform mechanical bowel preparation * suspicion of malignancy * association with non-gynaecological surgical pathologies * severe endometriosis (stage ≥ iii according to the classification of the american society for reproductive medicine) * psychiatric disorders precluding consent

Keywords: mechanical bowel preparation gynecological surgery minimally invasive gynecological procedures enema trendelenburg angle pneumoperitoneum pressure
a study to evaluate the efficacy and safety of da-8010 in patients with overactive bladder

Conditions: Overactive Bladder

Summary: this study will evaluate the efficacy and safety of da-8010 in patients with overactive bladder for 12 weeks as double-blind, placebo-controlled and active-reference study, and also will evaluate the long-term safety of da-8010 for 52 weeks in patients with overactive bladder as open-label study.


Eligibility criteria:
inclusion criteria: main inclusion at screening (visit 1): * men and women 19 years or older with oab symptoms for ≥ 3 months. * subject who is willing and able to complete the voiding diary correctly. * subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study exclusion criteria: main exclusion at screening (visit 1): * clinically significant stress urinary incontinence or mixed urinary incontinence where stress is the predominant factor * subject who has injury or neurodegenerative disease which is able to effect on lower urinary tract and nerves * subject with diabetes insipidus, urinary stone, urinary tract infection, interstitial cystitis, recurrent urinary tract infection, pelvic organ prolapse or neurogenic bladder * clinically significant benign prostatic hyperplasia at the discretion of the investigator * had bladder or lower urinary tract surgery within 12 months from the screening visit * medical history of malignant tumor in urinary system or pelvic organs * \>150 ml of post-void residual volume in the screening test
supplemental oxygen in colorectal surgery: a quality improvement project

Conditions: 30% Oxygen Concentration During Colorectal Surgery; 80% Oxygen Concentration During Colorectal Surgery

Summary: our primary objective is to develop a clinical pathway for care of patients having colorectal surgery at the clinic. in particular, the investigators would like to determine what intraoperative concentration of oxygen is optimal in our patients.

the investigators therefore propose to test the primary hypothesis that supplemental oxygen (80% versus 30%) reduces the risk of a composite of surgical sites infection and potentially oxygen-related wound complications. secondarily, the investigators will assess the incremental cost benefit of 80% versus 30% oxygen. as a safety measure, enough oxygen will always be given to maintain oxygen saturation (as determined by pulse oximetry) ≥95%.

Eligibility criteria:
inclusion criteria: * adult colorectal surgical patients
effect of a cepham supplement on hot flashes and menopausal symptoms in postmenopausal women

Conditions: D008593

Summary: the goal of this clinical trial is to learn if a daily nutritional supplement can reduce hot flashes and other menopausal symptoms in postmenopausal women. the main questions this study aims to answer are: does the supplement reduce the number and severity of daily hot flashes? does it improve other common menopausal symptoms? researchers will compare the supplement to a placebo (a look-alike capsule with no active ingredients) to see if it helps manage symptoms during menopause. participants will: take either the supplement or a placebo daily for 30 days track their hot flashes each day using a short online survey complete a symptom questionnaire at the beginning and end of the study this study is for women ages 40-60 who have been postmenopausal for at least one year and currently experience bothersome hot flashes.

purpose: to evaluate the effectiveness of a nutritional supplement in reducing hot flash severity/frequency and menopausal symptoms in postmenopausal women. design: randomized, double-blind, placebo-controlled, two-arm, parallel-group trial over 30 days. participants: women aged 40-60 who are postmenopausal (≥1 year without menses) and report bothersome hot flashes (menopause rating scale score ≥14, and hot flash severity of 3 or 4). exclusion criteria: current hormone therapy or medications affecting hot flashes; significant comorbidities. intervention: group 1: placebo group 2: supplement assessments: daily self-reports of hot flash frequency/severity menopausal symptom assessments at baseline (day 0) and post-intervention (day 30) outcomes: primary: hot flash severity and frequency secondary: overall menopausal symptoms

Eligibility criteria:
inclusion criteria: * adult women aged 40-60 years. * menopause rating scale score: (a) ge 14 and (b) score of 3 or 4 (severe to very severe) for hot flashes (blumel et al., 2018). exclusion criteria: * current use of hormone therapy or other medications known to affect hot flashes. * significant comorbidities that may interfere with study participation.

Keywords: menopause hot flashes supplement
a portable thoracic impedance device for detecting pulmonary congestion in heart failure patients

Conditions: Heart Failure

Summary: this study investigates a portable thoracic bioimpedance tomography (tbit) device designed to detect early lung congestion in heart failure patients. the main goal is to evaluate how well the device's measurements match those obtained from lung ultrasound and other imaging techniques. by detecting lung fluid build-up before symptoms worsen, this device could help manage heart failure more effectively outside of hospital settings, potentially improving patient care and reducing hospital admissions. participants in the study are monitored using this device along with standard imaging methods, and data on heart failure symptoms are collected to understand the device\&#39;s accuracy and usability.

the primary objective is to determine the correlation between tbit measurements and b-line scores obtained via portable lung ultrasound, with secondary objectives including correlations with thoracic water content from high-resolution ct scans, heart failure symptoms, and nt-probnp levels adjusted for renal function. conducted as a prospective, cross-sectional diagnostic study, the research involves heart failure patients recruited during hospital admissions or outpatient visits at heart failure and nephrology clinics. data collected include tbit, ultrasound, and ct imaging results, clinical data on heart failure severity, and symptom questionnaires. the study will assess correlations using statistical models such as spearman's correlation coefficient and mixed-effects models, aiming to validate tbit as a non-invasive, cost-effective tool for early detection of pulmonary congestion, potentially improving outpatient management and reducing heart failure-related hospitalizations. ethical considerations include informed consent, confidentiality measures, and ensuring participant safety, with the study procedures being observational and not altering patient treatment based on tbit results.

Eligibility criteria:
inclusion criteria: * adults aged 18 years or older. * diagnosed with heart failure, defined by the following criterion: hospitalization or an emergency visit for decompensated heart failure (pulmonary edema) within the last 12 months. exclusion criteria: * pregnant women at the time of eligibility evaluation. * presence of an implanted electronic device in the thorax, such as a pacemaker or defibrillator. * inability to provide informed consent. * admission to intensive care or the coronary care unit.

Keywords: bioimpedance heart failure diuretic treatment fluid management
dose ranging study of the salmeterol component of fluticasone /salmeterol spiromax compared to fluticasone spiromax and advair diskus in asthma subjects

Conditions: Asthma

Summary: the primary objective of this study is to evaluate the dose response, efficacy, and safety of 4 different doses of salmeterol spiromax (6.25, 12.5, 25, and 50 mcg) each combined with a fixed dose of fluticasone propionate (100 mcg) delivered as fluticasone/salmeterol spiromax® inhalation powder (fs spiromax) when administered as a single dose in subjects 12 years of age and older with persistent asthma.

this was a multicenter, randomized, double-blind and open-label active-controlled, single-dose, 6 period crossover, dose-ranging study conducted in male and female subjects ages 12 years and older with persistent asthma. fluticasone propionate multidose dry powder inhaler (fp mdpi) 50 mcg was provided (to replace the subject's current inhaled corticosteroid (ics)) throughout the 14 day run-in period and each of the washout periods between treatments. subjects were instructed to administer 2 inhalations of fp mdpi 50 mcg (100 mcg total dose) twice daily during the run-in and washout periods. all other medications for the treatment of asthma were discontinued at or prior to the screening visit. a short-acting β2-adrenergic agonist (saba), salbuterol hfa, mdi, was provided (to replace the subject's current rescue medication) for symptomatic relief of asthma symptoms in each the run-in, treatment, and washout periods. treatment period lasted 5 weeks with a 5 to 7 day washout between each of the six single dose treatments: * fluticasone propionate/salmeterol xinafoate multidose dry powder inhaler (fs mdpi) given in doses of 6.25, 12.5, 25, or 50 mcg of salmeterol xinafoate in blinded fashion. * fluticasone propionate multidose dry powder inhaler (fp mdpi) 100 mcg in blinded fashion * advair diskus, 100/50 mcg in open-label fashion

Eligibility criteria:
inclusion criteria: * written informed consent/assent * general good health * diagnosis of asthma as defined by the national institutes of health (nih) * a best fev1 of 40%-85% of the predicted normal value during the screening visit (sv) * subjects need to demonstrate a ≥ 15% reversibility of fev1 within 30 minutes following 4 inhalations of albuterol inhalation aerosol (if required, spacers are permitted for reversibility testing) at the sv. * other inclusion criteria apply exclusion criteria: * history of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation. * culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to the sv. * any asthma exacerbation requiring oral corticosteroids within 3 months of the sv. a subject must not have had any hospitalization for asthma within 6 months prior to the sv. * taking long-acting β-agonists within 2 weeks of the sv * other exclusion criteria apply.

Keywords: asthma dry powder inhaler long-acting beta2-agonist bronchodilation bronchodilator metered dose inhaler inhaled corticosteroid