bioihbjkbjnl/mcl2 huggingface dataset:
Changes in Autonomic Nervous Activity and Blood Pressure After Anesthesia Induction: Remimazolam Versus Propofol
Condition: General Anesthetics
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this clinical trial is to compare the effects of changes in autonomic nervous
      activity on changes in blood pressure after anesthesia induction between propofol and
      remimazolam in patients undergoing low-risk surgery. The main questions it aims to answer
      are:

        -  Does remimazolam shift sympathovagal balance toward parasympathetic predominance less
           than propofol?

        -  Does the less shift in sympathovagal balance toward parasympathetic predominance
           attenuate the reduction in blood pressure? Participants will be administered either
           propofol or remimazolam for anesthesia induction, after which the autonomic nervous
           activity and blood pressure will be measured.

      Researchers will compare the propofol and remimazolam groups to see if remimazolam causes
      less shift in sympathovagal balance toward parasympathetic predominance and subsequently
      attenuates the reduction in blood pressure.
    


Intervention name(s): Anesthesia induction with propofol; Anesthesia induction with remimazolam
Intervention type(s): Drug; Drug
Intervention description(s): After a 10-minute-long acclimation, general anesthesia is induced with 2% propofol at the effect-site concentration of 4 μg/ml based on the Marsh Pharmacokinetic model. The effect-site concentration was maintained at 4 μg/ml until the trachea was intubated. Five minutes after the anesthesia induction, remifentanil was administered at the effect-site concentration of 4 ng/ml based on the Minto pharmacokinetic model until the trachea was intubated. With the initiation of remifentanil infusion, 1 mg/kg of rocuronium was administered following the calibration of the neuromuscular monitoring device. With the train-of-four count of 0, the trachea was intubated. Then, the effect-site concentrations of propofol and remifentanil were decreased to 3 μg/ml and 0 ng/ml, respectively, until the surgical incision was made.; After a 10-minute-long acclimation, general anesthesia is induced with a 2-minute-long infusion of remimazolam at a rate of 12 mg/kg/hr, after which the infusion rate was reduced to 1 mg/kg/hr and was maintained until the surgical incision was made. Five minutes after the anesthesia induction, remifentanil was administered at the effect-site concentration of 4 ng/ml based on the Minto pharmacokinetic model until the trachea was intubated. With the initiation of remifentanil infusion, 1 mg/kg of rocuronium was administered following the calibration of the neuromuscular monitoring device. With the train-of-four count of 0, the trachea was intubated. Then, the effect-site concentration of remifentanil was decreased to 0 ng/ml until the surgical incision was made.
Intervention MeSH terms: Anesthetics; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TB001 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      It was a randomized, double-blind, placebo-controlled combined single ascending dose (SAD)
      and multiple ascending dose (MAD) study, evaluating the safety, tolerability and
      pharmacokinetics of TB001 after single and multiple subcutaneous injections in healthy
      subjects.
    


Intervention name(s): TB001; TB001; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): once-daily subcutaneous injection, on Day 1 in SAD stage; once-daily subcutaneous injection, on Days 1-7 in MAD stage; once-daily subcutaneous injection, on Day 1 in SAD stage; once-daily subcutaneous injection, on Days 1-7 in MAD stage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Impact of a Non-Drug Choice on Cocaine Reinforcement
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Cocaine-use disorders continue to be a significant public health concern, yet no effective
      medications have been identified. The goal of this study is to establish a research platform
      for the development of medications for treatment of cocaine abuse and dependence. This study
      will incorporate self-administration procedures and a non-drug alternative reinforcer, which
      is hypothesized to reduce the reinforcing effects of cocaine.
    


Intervention name(s): Cocaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Three active doses of cocaine will be made available for self-administration during experimental sessions.; Placebo cocaine will be made available for self-administration during experimental sessions.
Intervention MeSH terms: Cocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation
Condition: Cardiac Surgery
Study type: Interventional

Summary: 
      All patients undergoing cardiac surgery require intraoperative anesthesia and short-term
      postoperative sedation with anesthetic agents after the procedure when patient is in the
      intensive care unit (ICU). The clinical data obtained so far are concentrating on
      intraoperative use volatile agents (preconditioning) resulting in better postoperative
      cardiac function and less release of biochemical markers of myocardial damage. There are no
      studies investigating whether postoperative use of volatile agents (post conditioning) in
      cardiac surgical population is improving outcomes. The aim of the present study is to compare
      total intravenous anesthesia and postoperative sedation versus total volatile anesthesia and
      postoperative sedation in cardiac surgical population.
    


Intervention name(s): Isoflurane/sevoflurane; Propofol
Intervention type(s): Drug; Other
Intervention description(s): Volatile for sedation in the CVICU while intubated; Propofol for sedation in the CVICU
Other intervention name(s): 2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane; 2,2,2-trifluoro-1-[trifluoromethyl]ethyl fluoromethyl ether; Diprivan
Intervention MeSH terms: Propofol; Sevoflurane; Isoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cardiac Surgery; Sedation; Intensive care; Volatile anesthesia; Intravenous anesthesia; Pre and post conditioning after cardiac surgery
Optimizing Smoking Cessation for People With HIV/AIDS Who Smoke
Condition: Smoking; HIV
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The single greatest health behavior change that could improve cardiovascular morbidity and
      associated mortality is to assist people living with HIV/AIDS who smoke to quit. The
      investigators will use a factorial design to evaluate the most promising behavioral and
      pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among
      people living with HIV/AIDS who smoke. Results of this study will provide crucial, real world
      evidence of the best way for healthcare providers to help smokers living with HIV/AIDS quit
      smoking.
    

Detailed description: 
      The study used a factorial design to randomize participants into 4 conditions: (1)
      Varenicline (12 weeks) + Positively Smoke Free (PSF) (8 weeks); (2) Varenicline (12 weeks) +
      Standard of Care (brief advice to quit); (3) Placebo (12 weeks) + Positively Smoke Free (8
      weeks); and (4) Placebo (12 weeks) + Standard of Care. The primary outcome was the 7-day
      point prevalence abstinence (PPA) (<10mm) at 36 weeks.

      The specific aims of our proposal are:

      Primary Aim 1: Compare varenicline to placebo on rates of 7-day point prevalence abstinence
      (PPA) at 36 weeks in smokers with HIV/AIDS. We hypothesize that rates of smoking abstinence
      at week 36 will be higher in those treated with varenicline compared to placebo.

      Primary Aim 2: Compare Positively Smoke Free to low intensity, brief counseling on rates of
      7-day PPA at 36 weeks in smokers with HIV/AIDS. We hypothesize that rates of smoking
      abstinence at week 36 will be higher in those treated with Positively Smoke Free compared to
      brief counseling.

      Primary Aim 3: Compare Positively Smoke Free + varenicline to the other two study conditions
      outlined above on rates of 7-day PPA in smokers with HIV/AIDS at 36 weeks. We hypothesize the
      effect of PSF with varenicline is greater than the effect of PSF or varenicline alone.

      Exporatory Aim: Explore the effect of successful cessation/smoking abstinence on levels of
      cardiac specific biomarkers, nicotine biomarkers, generalized markers of inflammation,
      lipids, coagulation and monocyte/macrophage activation.
    

Intervention name(s): Varenicline; Positively Smoke Free; Placebo; Standard of Care
Intervention type(s): Drug; Behavioral; Drug; Behavioral
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of V/Q Mismatch as Predictor of Pulmonary Postoperative Complications in Patients Undergoing Major Surgery
Condition: Anesthesia; Postoperative Complications; Mechanical Ventilation Complication
MeSH terms: Postoperative Complications
Study type: Observational

Summary: 
      Pulmonary postoperative complications (PPC) are among the main causes of surgical
      complications affecting both postoperative morbidity and mortality. Little is known about the
      effect of intraoperative VQ mismatch on the occurrence of PPC. In this trial the
      investigators will evaluate if intraoperative VQ mismatch may predict PPC in a population of
      patients undergoing major surgery.
    

Detailed description: 
      Pulmonary postoperative complications (PPC) are among the main causes of surgical
      complications affecting both postoperative morbidity and mortality. Little is known about the
      effect of intraoperative VQ mismatch on the occurrence of PPC.

      PPC are classically considered associated to the occurrence of intraoperative atelectasis,
      and therefore to the development of a certain amount of shunt, but this concept have been
      recently questioned.

      Recent studies showed indeed that, despite age is one of the main determinants of PPCs,
      increasing age is not associated to the increase of intraoperative shunt. Shunt therefore may
      not be the main determinant of PPC.

      In this trial the investigators will evaluate if other causes of intraoperative VQ mismatch
      (e.g. low V/Q, high V/Q, dead space) may predict PPC in a population of patients undergoing
      major surgery.
    

Intervention name(s): Measure of ventilation/perfusion (V/Q) mismatch using Beacon ALPE (Automatic Lung Paramether Estimator)
Intervention type(s): Device
Intervention description(s): Evaluation of intraoperative V/Q mismatch using the Beacon ALPE during anesthesia.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing general anesthesia for elective major surgery (non-thoracic).
      
Keywords: Anesthesia; Pulmonary postoperative complications; ALPE; Ventilation/perfusion mismatch
The Impact of the MUSE Meditation Device on Student Registered Nurse Anesthetists
Condition: Stress; Anxiety; Affect; Burnout, Professional
MeSH terms: Burnout, Professional; Burnout, Psychological
Study type: Interventional

Summary: 
      The question this study is designed to answer is whether or not the use of a MUSE Meditation
      Device lowers student registered nurse anesthetist's perception of stress, anxiety, and
      burnout within the Mayo Clinic Doctorate of Nurse Anesthesia Practice Program.
    


Intervention name(s): MUSE Meditation Device
Intervention type(s): Device
Intervention description(s): The MUSE Meditation Device guides users in mindful meditation using real-time feedback on brain wave activity.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Complex Care for Kids Ontario (CCKO)
Condition: Children With Medical Complexity
Study type: Interventional

Summary: 
      There are ~6,200 children in Ontario with special and complex healthcare needs requiring
      multiple services from many different doctors and other healthcare providers. These children
      are at a high risk of missed, duplicated or inappropriate care, and extraordinary financial
      burden and stress on families. While small in number (<1% of Ontario kids), these children
      use 1/3 of all child healthcare resources, and are known to desperately need coordinated care
      to optimize their health. Complex Care Kids Ontario (CCKO) brings together researchers,
      children and families, and healthcare providers from across Ontario to develop, implement and
      evaluate an evidence-based and coordinated model of care for every child with medical
      complexity in Ontario.
    


Intervention name(s): Complex care clinic as part of the CCKO initiative
Intervention type(s): Other
Intervention description(s): The CCKO intervention involves intensive care coordination, defined as: "deliberate organization of patient care activities between two or more participants (including the patient) involved in a patient's care to facilitate the appropriate delivery of health care services. Organizing care involves marshaling of personnel and other resources needed to carry out all required patient care activities and is often managed by the exchange of information among participants responsible for different aspects of care". Within CCKO, intensive care coordination will specifically include: 1) the tailored, family/health care provider co-creation and regular updating of care coordination plans for each child which will be 2) facilitated and accounted for by key workers partnering with families.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Care coordination; Complex care kids Ontario; Technology-dependent; Quality of life
Effectiveness of Continuous Negative External Pressure in Preventing Upper Airway Impairment During Routine Colonoscopy
Condition: Airway Obstruction; Apnea; Hypopnea
MeSH terms: Airway Obstruction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary goal of this study is to determine the effectiveness and safety of delivering
      continuous negative external pressure (cNEP) to the upper airway as a means of preventing
      episodes of respiratory impairment (RI) such as hypoxemia, apnea and hypoventilation
      associated with the use of intravenous sedation in elective colonoscopy in adult patients.
    


Intervention name(s): Airway Management System (AMS)
Intervention type(s): Device
Intervention description(s): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.
The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: colonoscopy; oxygen desaturation
Postoperative Hyperthyroidism
Condition: Hyperthyroidism
MeSH terms: Hyperthyroidism
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the frequency and the clinical course of
      postoperative hyperthyroidism following surgery of tertiary hyperparathyroidism (THP) and to
      determine the diagnostic value of thyroglobulin in this setting.
    


Intervention name(s): No intervention performed
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with tertiary hyperparathyroidism undergoing surgery for this reason
      
Keywords: hyperthyroidism; tertiary hyperparathyroidism; palpation thyroiditis; parathyroidectomy; thyroglobulin; rate of postoperative hyperthyroidism
Enhancing Diabetes and Hypertension Self-Management Rural Appalachian Patients In Patient-Centered Medical Homes
Condition: Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The goal of this R34 planning project is to test the feasibility and acceptability of a
      12-week modified diabetes and hypertension self-management program using trained Health
      Coaches.
    

Detailed description: 
      West Virginians have one of the highest prevalence of comorbid diabetes and hypertension in
      the nation that pose an enormous disease and economic burden in this medically underserved
      state. Self-management of these two commonly found chronic conditions are an essential
      component of comprehensive disease management. The goal of this R34 planning project is to
      test the feasibility and acceptability of a 12-week culturally-tailored, multimodal, diabetes
      and hypertension self-management program with a core (diet and physical activity) versus core
      plus (diet, physical activity and medication adherence) to an enhanced usual care (EUC)
      control group. Seventy-five eligible adults with comorbid diabetes and hypertension will be
      randomized with a 1:1:1 ratio, based on allocation sequence generated by the bio-statistician
      investigator in the team. The study will examine the extent to which key components (diet,
      physical activity, and medication adherence) contribute to the differences in clinical
      outcomes (HbA1c and blood pressure) between three groups using quantitative and qualitative
      focus groups and the RE-AIM evaluation framework. The longer term effects of the intervention
      will be evaluated in a subsequent R01 clinical trial.
    

Intervention name(s): Physical Activity; Medication Adherence; Dietary Modification
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Respondents will complete activity logs (step count, using pedometer) and surveys (two items from the Summary of Diabetes Self-care activities measure) for physical activity.; Respondents will provide information on their medication adherence using a survey (questionnaire - MMAS-8).; Respondents will complete food logs and surveys (three items from the Summary of Diabetes Self-care activities measure) for dietary intake.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: None (Open Label)
Primary purpose: Other
Keywords: diabetes; hypertension; self-management
The Effect of Myopic Optical Defocus on the Humphrey Matrix 30-2 Test
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      The purpose of this study is to examine the effect of the myopic optical defocus on the
      Humphrey Matrix 30-2 test.
    

Detailed description: 
      The Humphery Matrix (Zeiss, Dublin, California, USA; in cooperation with Welch Allyn,
      Skaneateles, New York, USA), which is a recently developed version of FDT perimetry, showed
      more improved technology to detect early glaucomatous damage. The user's guide for the
      Humphrey Matrix (Humphrey® matrix visual field instrument user's guide. Zeiss, Dublin,
      California, USA; in cooperation with Welch Allyn, Skaneateles, New York, USA; 2003) suggests
      that myopic refractive errors more than -3.0 D need to be corrected before the 30-2 test.
      However, the proper correction of the optical defocus is not always easy because of a lack of
      trial frame.

      The purpose of the present study is twofold. At first, the influence of the low-grade myopia
      on the Humphery Matrix 30-2 test will be evaluated and compared to the effect of
      moderate-grade myopia. Secondly, the influence of myopic optical defocus and the glaucomatous
      visual field damage on the pattern deviation plot change according to the severity of
      glaucomatous visual field damage will be estimated.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        tertiary care clinic
      
Keywords: myopia; Humphery Matrix 30-2 test
Characterizing Emmer Seeds and Flours, and Determining the Glycemic Effects of Emmer Breads
Condition: Potential Abnormality of Glucose Tolerance; Appetitive Behavior
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      This study characterized emmer seeds, flours, and breads, and investigated the effects of
      emmer breads on the glycemic response
    

Detailed description: 
      This study aimed to 1. describe the technological characteristics of emmer seeds, flours, and
      breads, 2. determine the glycemic index and glycemic load of two emmer breads, and 3. to
      investigate the effects of these breads on postprandial glycemic response in healthy subjects
    

Intervention name(s): Glucose as reference food; Emmer bread from Greek emmer; Emmer bread from Italian emmer; Whole wheat commercial bread
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g glucose diluted in 300ml water, tested three times, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.; Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from Greek emmer bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.; Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from Italian emmer bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.; Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from whole wheat commercial bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: blood glucose; emmer bread; glycemic index; glycemic load; blood pressure