Kornimate/medical-research-clean huggingface dataset:
ed50 and ed95 of remifentanil for intubation without nol variation

Conditions: Intubation; Difficult or Failed

Summary: our aim, in this study, is to elucidate the optimal dosing range (ed50 and ed95) of bolus remifentanil in order to counter the painful stimuli resulting from direct laryngoscopy and tracheal intubation by using the nol index. in order to maximize the clinical relevance of our findings, induction of general anesthesia will be done with standard medications and doses and laryngoscopy will be done with the macintosh laryngoscope, the most common tool used for intubation in the operating room

background: there are no study so far that determined the ed50 and ed95 of remifentanil to perform tracheal intubation by using the nol index as the criterion measured to determine the failure (painful intubation) or the success (pain free intubation) of the assessed procedure. objectives: to determine the ed50 and ed95 of remifentanil bolus to perform tracheal intubation without nol index variating over threshold for nociceptive response (determined as a nol index going over 20 - peak value of maximum 20) using the macintosh blade when obtaining good conditions of intubation in anesthetized patients. good conditions of intubation will be determined as obtaining a cormack-lehane grade i and ii.

Eligibility criteria:
inclusion criteria: * asa status i or ii * mallampati class i or ii * patients \> 18 years old and \<65 years (defining elderly patients) * elective general, gynecological, orthopedic, plastic or urological surgery under general anesthesia * type of surgery that usually necessitate endotracheal intubation and controlled ventilation exclusion criteria: * patient refusal * history of psychiatric diseases or psychological problems (including mental retardation); inability to give consent; language barrier. * anticipated difficult airway (mallampati class iii and iv, thyromental distance \< 6 cm, mouth opening \< 3 cm, neck extension \<80° and neck flexion \<35°, inability to prognath, meaning bringing lower mandibular before the upper maxilla) * patient with history of neck rigidity or instability * bmi \> 30 kg/m2 * anticipated difficult ventilation (patients with beard, obesity with bmi more than 30 kg/m2) * patient with history of oropharyngeal or tracheal surgery (excluding adenoidectomy, tonsillectomy and teeth removal) * severe coronary artery disease * serious cardiac arrhythmias (including atrial fibrillation) * use of β-blockers (all types) * history of opioid or illicit drug substance abuse * chronic use of psychotropic and/or opioid drugs * allergy to remifentanil or propofol * pregnancy * contraindications to mask ventilation (gastrointestinal tract obstruction, pregnancy, active not-treated gastroesophageal reflux disease, non-fasting patients) * unexpected difficult airway requesting excessive, possibly painful airway manipulations * requiring hemodynamic support with vasopressors or inotropes 2 min before laryngoscopy to 5 min after insertion of endotracheal tube

Keywords: tracheal intubation remifentanil pain nol index anesthesia analgesia
telemedical assistance in automatic titration of oxygen for intensive care patients

Conditions: Obesity Hypoventilation Syndrome (OHS); Chronic Obstructive Lung Disease; Interstitial Lung Disease; Pneumonia

Summary: the goal of this clinical trial is to clinically validate a system for the monitoring of patients' respiratory function and automated oxygen treatment proposal using non-invasive ventilation devices in the treatment of intensive care patients with acute or chronic lung diseases exacerbations. participants clinical parameters will be monitored and samples will be sent to a clinical laboratory for analysis (arterial blood pressure, heart rate, and respiratory rate will be continuously recorded, and feo2 and co2 will be measured with the help of an additional sensor).

this prospective experimental study is conducted in pauls stradins clinical university hospital (pscuh) and sleep disease center in riga, latvia. the study includes patients with respiratory failure and hypoxemia to whom niv is indicated. participants clinical parameters are monitored and samples will be sent to a clinical laboratory for analysis. initial ventilation parameters will be defined by the clinician who performs the experiment. during the validation phase, the investigators will obtain clinicians' final decision on the changes of the ventilation system parameters and compare it to our module proposal. that way it would be possible to estimate if the system is ready for the next step - fully automated closed-loop ventilation system development.

Eligibility criteria:
inclusion criteria: * signed informed consent to participate in the study; * aged over 18 years; * patients hospitalized with acute respiratory failure (indication to niv therapy) with restrictive or obstructive lung disease exclusion criteria: * refusal to participate further in the study; * age under 18 years; * pregnancy; * the patient is contraindicated for non-invasive lung ventilation * during the study, the patients condition worsens in such a way that an active one is required medical intervention or continuation of the study may worsen the patients condition; * complications related to niv therapy or claustrophobia; * chronic obstructive pulmonary disease and obstructive sleep apnea without documented hypoxemia (sp02 and sa02 \> 94%).

Keywords: telemedicine smart assistant
evaluation of the impact of a connected application on the follow-up of patients treated for glial lesions operated

Conditions: Quality of Life; Phone Use, Cell; Glial Scar

Summary: this study is to evaluate the efficacy of a mobile app for monitoring the quality of life of patients but also on detection delay of side effects and/or complications linked to the therapeutic management. this allow to adapt their care more quickly, through a prospective randomized study. the impact of this connected monitoring of patients' anxiety will also be evaluated in this study as well as the time taken by the medical team to manage alerts generated by this application.


Eligibility criteria:
inclusion criteria: * male or female over 18 years old without upper age limit. * subject operated for a non-recurrent glioma (grade ii or iii or iv glioma / glioblastoma) according to the who classification 2016; * subject with a connected support (smartphone,...) to download the connected tracking application. * unprotected adult within the meaning of the law * subject affiliated to a health insurance scheme * subject having signed an informed written consent exclusion criteria: * minor subject, pregnant or breastfeeding woman; * subject under a measure of legal protection, guardianship or deprived of liberty by judicial or administrative decision; * antipsychotic treatment (neuroleptic or lithium) * subjects with documented cognitive disorders (alzheimer, other dementia) * subject with a personal medical history of psychiatry * subject unable to complete a questionnaire on his own (inability to read french language , severe cognitive disorders) * medical contraindication to performing an mri (pace-maker) or scanner; * subject refusing to sign informed consent.
prospective survey of menstrual migraine & prevention with eletriptan

Conditions: Migraine

Summary: women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.

women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.

Eligibility criteria:
inclusion criteria: * age 18-45 healthy menstruating female exclusion criteria: * cardiac or other conditions precluding use of eletriptan
preview rapid strep a test method comparison study

Conditions: Strep Throat

Summary: this study is designed to determine the accuracy of the preview rapid strep a test compared to a laboratory reference method for group a streptococcal infection and to determine the precision of the preview rapid strep a test.


Eligibility criteria:
inclusion criteria: * any patient presenting with symptoms of pharyngitis * fever * sore throat * swollen lymph nodes in neck * redness of throat/tonsils * white/yellow patches on tonsils * not currently on antibiotics * ≥3 years or older * ability to read, understand and sign a consent form, in english, or for parent(s) to sign an assent form providing permission to include children under the age of 18. exclusion criteria: * currently taking antibiotics * previously enrolled in this study
immunogenicity and safety of gsk biologicals' infanrix hexa in infants

Conditions: Hepatitis B; Tetanus; Poliomyelitis; Diphtheria; Haemophilus Influenzae Type b; Acellular Pertussis

Summary: this study will evaluate gsk biologicals' dtpa-hbv-ipv/hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in canada.

this protocol posting has been updated following protocol amendment 1 (19-may-2010).

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * born after a gestation period of 36 to 42 weeks inclusive. * healthy subjects as established by medical history before entering into the study. * written informed consent obtained from the parent or guardian of the subject. exclusion criteria: * use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs from birth until first primary vaccination dose.. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * major congenital defects or serious chronic illness. * evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis b and/or hib vaccination or disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * the following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met: * current febrile illness or axillary temperature of ≥ 37.5 ºc or other moderate to severe illness within 24 hours of study vaccine administration.

Keywords: infant first nation aboriginal canada
evaluation of safety of low level laser device treatment in chronic wounds

Conditions: Diabetic Foot Ulcer

Summary: this is a randomized, double blind, placebo-controlled study to evaluate the safety of the low level laser mc-8xl device treatment in subjects with an unsuccessfully treated diabetic foot ulcer (dfu) that has been present for at least 3 months. eligible subjects will be randomized to either treatment group or control group, following which, treatment of each subject will be provided by a qualified nurse at the clinic or in the home setting, everyday for up to 16 weeks. study assessments and adverse events monitoring will be also performed throughout the study.


Eligibility criteria:
inclusion criteria: * provide signed and dated informed consent form * willing to comply with all study procedures and be available for the duration of the study * male or female, aged 18 to 90 * having a dfu of at least 3 months duration that had not improved after prior standard wound treatments * hba1c of \<11.0 * size of wounds: 1-10 cm2 * having dfu of grades 2 or 3 according to wagner's classification exclusion criteria: * immeasurable wounds or wounds that are unsuited to this laser treatment (usually due to the wound's location, e.g. in the area between the toes). * uncontrolled diabetes defined as an hba1c of \> 11.0 * arterial insufficiency, doppler vascular assessment (if needed- ankle brachial index (abi) \< 0.6) * osteomyelitis in the bone. * photosensitivity * pregnancy * presence of any suspicious pre-cancerous or cancerous lesions, or having cancer. * being on medications that are immunosuppressive, may affect peripheral blood flow or may affect normal wound healing. * being on medications that might cause photosensitivity. * participation in any other clinical trial testing a device or drug.
efficacy of the tony robbins rapid planning method (rpm)

Conditions: Anxiety; Stress; Mood; Motivation; Well-Being, Psychological; Self Esteem

Summary: this study will consist of an experimental group and a control group. approximately 150 adult males and females from the ages of 19+ will take part in this study. subjects will be divided into a control and experimental group. subjects for the control and experimental group will be recruited from our internal database of subjects who have previously shown interest in studies and from userinterviews. subjects in the experimental group (rpm group) will be admitted to the tony robbins rapid planning method (rpm) virtually at no cost, while the subjects assigned to the control group, will not attend the event, but instead be required to regularly complete journaling involving a to-do-list of their weekly work tasks. psychological assessment surveys will be taken before the event, and at 1 week (day 8-13), and 4 weeks (day 29-34) post intervention. the control group will take the psychological assessment before beginning journaling, and at 1 week (day 8-13), and 4 weeks (day 29-34) post intervention.

for the journaling control group, subjects will be asked to write a weekly to-do-list at least once weekly at the beginning of the week. and at least read, or refer to their journal on a daily basis as direction for the work activities of the day. the 3-day rpm (rapid planning method) event by tony robbins involves online seminar based training sessions designed to enhance participants' productivity, goal-setting abilities, and time management skills. on the first day, subjects engage in virtual workshops focused on establishing clear, specific, and achievable goals through the rpm framework, which emphasizes purpose-driven planning. day two consists of interactive virtual sessions where participants develop personalized action plans, incorporating robbins' strategies for prioritizing and organizing tasks. throughout the event, participants partake in motivational exercises aimed at increasing engagement, self-efficacy, and clarity of vision. the final day includes collaborative virtual activities where subjects practice rpm techniques in real-world scenarios, receive feedback, and refine their plans. psychological assessment surveys will be taken before the event, and at 1 week (day 8-13), and 4 weeks (day 29-34) post intervention. the control group will take the psychological assessment before beginning journaling, and at 1 week (day 8-13), and 4 weeks (day 29-34) post intervention.

Eligibility criteria:
inclusion criteria: * ages 19+ * male and female * english literate * willing to sign the study informed consent form * experimental group: must participant in tony robbins rapid planning method (rpm) * control group: must be willing to journal regularly exclusion criteria: * excluded from the experimental group if you do not participate in rpm * excluded from the control group if you do participate in rpm, or any other tony robbins sponsored event during the study intervention

Keywords: seminar life coach
couples-based yoga program in improving quality of life in patients with high-grade glioma undergoing radiation therapy and their partners

Conditions: Caregiver; Glioma

Summary: this randomized clinical trial studies couples-based yoga program in improving quality of life in patients with high-grade glioma undergoing radiation therapy and their partners. a couple-based hatha yoga program may improve fatigue, distress, sleep quality, and overall quality of life in patients with glioma and their partners.

primary objectives: i. examine the feasibility of a couple-based and a caregiver yoga program in glioma patients undergoing radiotherapy (rt) and their partners. secondary objectives: i. establish the initial efficacy of the yoga program in patients and their partners regarding quality of life (qol) outcomes (i.e., fatigue, sleep disturbance, depressive symptoms, and overall qol and health care utilization). exploratory objectives: i. explore potential moderation (e.g., baseline psychological distress, patients' tumor grade, performance status and class attendance) of the intervention effects. outline: the first five couples are assigned to arm i. all subsequent couples are randomized to 1 of 2 arms. arm i: patients and their partners attend up to 15, 45-60 minute sessions of hatha yoga over the course of radiation therapy 5 times a week for 5-6 weeks. the program comprises four main components: joint loosening with breath synchronization; postures with deep relaxation techniques; breath energization with sound resonance; and meditation. at the fifth session, patients and their partners receive a digital video disc (dvd) and are encouraged to practice on their own (individually and/or together) on the days when they do not meet with the instructor. arm ii: patients receive standard of care provided by the health care team and complete questionnaires before and after radiation therapy.

Eligibility criteria:
inclusion criteria: * able to read and speak english * able to provide informed consent * patients only: diagnosed with a primary glioma and going to receive at least 4 weeks of radiotherapy with at least 20 fractions * patients only: karnofsky performance status (kps) of 80 or above * patients only: having an informal caregiver (spouse, romantic partner, adult child, sibling, or friend) who is willing to participate; for phase 1 only, if patients do not have one consistent primary caregiver for the duration of the study, they may be accompanied to the yoga sessions by an alternate caregiver who meets eligibility criteria exclusion criteria: * patients only: for phase 1 only, regularly (self-defined) participated in a yoga practice in the year prior to diagnosis * patients only: for phase 1 only, physician-rated life expectancy of less than 6 months * patients only: for phase 1 and 2, cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
strategies for implementing a postpartum lifestyle intervention in wic clinics

Conditions: Obesity; Gestational Diabetes; Lifestyle, Healthy; Glucose Intolerance During Pregnancy; PreDiabetes; Hyperglycemia

Summary: the primary objective of the strive study is to compare two implementation strategies for diabetes prevention program delivery: an in-person health coach strategy (standard 24 in-person sessions at wic clinics) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions at wic clinics supplemented by technology support) on implementation and health-related outcomes in postpartum women.

the overall objective of this project is to study the implementation, effectiveness, and sustainability of implementing the diabetes prevention program (dpp) in postpartum women who receive services from wic. in this effectiveness-implementation type iii cluster-randomized trial, we will compare two implementation strategies for dpp delivery: an in-person health coach-led implementation strategy (standard 24 in-person sessions) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions supplemented by technology tools). eighteen clinics will be randomized to the multifaceted technology-assisted health coach strategy and 18 to the in-person health coach-led strategy. a total of 900 postpartum participants (25 per clinic) will be recruited into the study and followed for 12 months for implementation and effectiveness outcomes. a post-intervention study visit will take place 6 months after the end of the 12-month intervention to evaluate the sustainability of the implementation strategies.

Eligibility criteria:
inclusion criteria for clinics: * serve a large number of wic postpartum participants * willing and able to provide space for the study inclusion criteria for participants: * age 18 or older * gave birth in the past 6 weeks to 12 months * obesity or history of gestational diabetes mellitus (current bmi ≥30 kg/m², or medical-record documented history of gestational diabetes mellitus and bmi ≥25 kg/m²) * no self-reported diabetes (other than gestational diabetes) * hemoglobin a1c \<6.5% * not currently pregnant or planning to become pregnant in the next 6 months * no plans to move outside of the study region in the next 12 months * access to a smartphone * willing and able to participate in the intervention and provide consent * not an immediate family member of the staff at the wic clinic * other concerns regarding ability to meet trial requirements, at the discretion of the principal investigator or study coordinator

Keywords: diabetes prevention program
a study to assess clinical effectiveness and safety of vedolizumab intravenous in real world clinical practice in ulcerative colitis (uc) korean participants

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to assess the clinical effectiveness by the clinical response at 6 weeks and the safety of vedolizumab intravenous in uc korean participants.

this is a post-marketing, non-interventional study of participants with moderate to severe uc. the study will review medical records of participants who have initiated medical treatment with vedolizumab intravenous during the defined eligibility period under routine clinical practice to provide the real world data on the effectiveness and safety of vedolizumab intravenous. the study will enroll approximately 100 participants. all participants will be enrolled in one observational group: vedolizumab both retrospective and prospective data will be collected in the index period, with prospective data collected for treatment baseline visit and follow up visits. the multi-center trial will be conducted in republic of korea. the overall duration of study will be approximately 15 months.

Eligibility criteria:
inclusion criteria: 1. moderately to severely active uc and having failed tnf-alpha antagonist therapy. exclusion criteria: 1. was treated with vedolizumab intravenous outside of the locally approved label in south korea. 2. was enrolled in an interventional intestinal bowel disease clinical trial at time of using vedolizumab intravenous.

Keywords: drug therapy