bioihbjkbjnl/mcl2 huggingface dataset:
Patients Perceptions of Using the "Libre" System Compared With Conventional SMBG in Adolescents With Type 1 Diabetes The Libre Sat Trial
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The Libre- flash glucose monitoring system is an episodic real-time data on demand device.
      This means that patients can measure their glucose level when they choose by scanning the
      device, while at the same time a sensor automatically measures and continuously stores
      glucose readings day and night. Every scan shows the current glucose reading and the last 8
      hours of glucose. There are no alarms and the system does not require calibration.

      In the present study we aim to evaluate treatment satisfaction and comfort using the Libre
      flash glucose monitoring system compared to conventional Self Measurement of Blood Glucose
      (SMBG) in adolescents with type 1 diabetes that discontinued using continuous glucose
      monitoring.

      The second aim of the study is to evaluate the rate of use and the impact of Libre use
      compared to Self-Measurement of Blood Glucose among adolescents who are sub-optimally
      controlled and stopped using Continuous Glucose Monitoring. The study is an investigator
      initiated study, single-center, randomized, parallel study of 12 weeks with an optional
      cross-over 12 weeks extension period .
    


Intervention name(s): Libre Flash CGMS; Self-Measurement Blood Glucose
Intervention type(s): Device; Device
Intervention description(s): Patients will use their personal glucose meter to perform Self-Measurement Blood Glucose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Continuous Glucose Monitoring System
Developing and Testing a Small Private Online Course (SPOC) for Nurse-patient Communication About Sex.
Condition: Nurse-Patient Relations
Study type: Interventional

Summary: 
      This is a three-year research project. The goal is to develop and test "The SPOC-based
      blended teaching and learning platform (Nightingale in Gen-sEx)" that integrates effective
      educational strategies and e-learning methods to meet the Taiwanese nurse's learning needs.
      This project is aimed at resolving sexual education learning problems in nursing continuing
      education due to the time constraints at clinical sites and the shortage of teaching staff.
      Nurse-patient communication attitudes and skills about sex will be enhanced.
    

Detailed description: 
      The research team constructed a course for hospital nurses that followed the commonly used
      ADDIE (Analysis, Design, Development, Implementation, and Evaluation) model. The first year
      research purpose is to: (1) explore the characteristics of nursing-patient communication
      about sex and the core educational needs content for nurses using triangulation methods. (2)
      Construct gender-sensitivity structures characteristics of nursing-patient communication
      about sex and course framework according to the modified Delphi method results and course
      needs assessment. The second year develops the SPOC-based blended teaching and learning
      platform (E-generation Angel of Happiness") and conducts a pilot study to test and correct
      the course content and method. In the third year a pretest-posttest randomized control group
      design will be implemented to investigate the effectiveness of the course "E-generation Angel
      of Happiness" in improving competencies of nurse-patient communication about sex, including
      attitudes, and practices, among nurses.
    

Intervention name(s): Received the Nightingale in Gen-sEx course
Intervention type(s): Behavioral
Intervention description(s): The experimental group (n=75) will participate in the SPOC- based education program, consisting of five online teaching and learning modules over the span of 3 months and two hours of offline classroom.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The course includes five online teaching and learning modules and two hours of offline teaching and learning, using MOOCs/SPOCs online teaching system and constructs on the Chinese Open Education platform. For this prospective, randomized controlled trial, 150 nurses working in a medical center in northern Taiwan were recruited and randomized into 2 groups. The experimental group (n=75) received the Nightingale in Gen-sEx course. The control group (n=75) received without course. Data were collected at baseline, 1month, and 3 months after the course.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: sex education; gender-sensitivity; nurse-patient communication; continuing education; SPOC
Comparison of Immune Responses to Influenza Vaccine In Adults of Different Ages (SLVP015 2007-2017)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study the investigators are trying to understand how immune function declines in the
      elderly using annual influenza vaccinations as a model system. The longitudinal study began
      in 2007 and continued through early 2017.
    

Detailed description: 
      Participants ranging in age from 18 to 100 at time of initial enrollment will be immunized
      annually with the seasonal influenza vaccine, Fluzone, on Day 0. Follow-up visits will be
      conducted on Day 6-8 and Day 28. Unsolicited adverse events are collected from immunization
      until the Day 28 visit, serious adverse events are collected for the entire time of study
      participation. A blood sample is collected pre-immunization and at each follow-up visit.
      Volunteers will be followed for up to 11 years, those too frail to come in for visits
      received annual phone calls to monitor health. Last annual influenza vaccines were given in
      Fall 2015.

      The main basic research effort will be to collect safety data and follow medical history
      events in elderly and younger control subjects. Investigators will also look at immune
      responses to influenza vaccination. In 2008, 2012 and 2014, the cohort added additional
      participants to replace those who had withdrawn.

      Beginning in 2014, those participants 65 years and older were immunized with High Dose
      trivalent Fluzone and younger participants received the quadrivalent formulation of Fluzone.
    

Intervention name(s): Trivalent, inactivated influenza vaccine (TIV); Quadrivalent, inactivated influenza vaccine (IIV4); High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Licensed Seasonal Influenza Vaccine TIV; Licensed Seasonal Influenza Vaccine IIV4; Licensed Seasonal High-Dose Influenza Vaccine TIV
Other intervention name(s): Fluzone (IM); Fluzone (IM); Fluzone High-Dose (IM)
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Inactivated, trivalent influenza vaccine; elderly; immunosenescence; longitudinal study; Inactivated, High-Dose trivalent influenza vaccine; Inactivated, quadrivalent influenza vaccine; young adults
Software Treatment for Actively Reducing Severity of ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of videogame-like digital therapies on
      attentional functioning and symptoms in children diagnosed with ADHD.
    

Detailed description: 
      The study will be a randomized, parallel group, controlled trial of two videogame-like
      (iPad-based) digital therapies. The study will consist of 3 primary phases: Screening,
      Washout/Baseline, and Treatment. During the Screening Phase (Day -28 to Day -7), participants
      will undergo screening to evaluate eligibility for the study. Screening may take place up to
      28 days before the Baseline Visit (Day 0). For those children currently on medication for
      ADHD the Washout period will begin 7 days prior to Baseline where treatment will be
      discontinued. On Day 0, the Baseline visit will occur wherein additional eligibility criteria
      will be established. The Treatment Phase (Day 1 to Day 27) will involve using the digital
      therapy at home for each participant followed by an In-Clinic assessment on Day 28 to assess
      key outcomes. Compliance with treatment/use requirements will be monitored remotely during
      this phase.
    

Intervention name(s): AKL-T01; AKL-T09
Intervention type(s): Device; Device
Intervention description(s): Videogame-like digital therapy; Videogame-like digital therapy
Other intervention name(s): EVO Multi; EVO Words
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Minimum number of subjects = 300, Anticipated number of subjects = 330, Maximum number of subjects = 1,000
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD
Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia
Condition: Fasciculation
MeSH terms: Myalgia; Fasciculation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the effects of different doses of cisatracurium
      pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.
    

Detailed description: 
      Purpose: To investigate the effects of different doses of cisatracurium pretreatment on
      succinylcholine-induced fasciculations and postoperative myalgia.

      Methods: Ninety patients scheduled for laparoscopic cholecystectomies were equally randomized
      into three groups to receive pretreatment of 0.005, 0.01, and 0.02 mg/kg cisatracurium,
      respectively. General anesthesia was induced 3.5 min later, train of four stimulation was
      monitored 4.5 min later, succinylcholine 1.5 mg/kg was injected 5 min later, and endotracheal
      intubation was implemented 6.5 min later. The side effects of cisatracurium, intensity of
      fasciculations, intubating conditions, time and extent to maximal depression of twitch and
      time for its recovery to 20% of control value, severity of myalgia at 24 h postoperatively,
      serum potassium before the induction, at the time of endotracheal intubation, and 5 min after
      intubation were recorded.
    

Intervention name(s): Cisatracurium
Intervention type(s): Drug
Intervention description(s): Different doses of cisatracurium pretreatment
Other intervention name(s): Dose
Intervention MeSH terms: Cisatracurium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cisatracurium; Myalgia; Fasciculation; Succinylcholine
Vitamin C Mesotherapy Versus Diode Laser for the Management of Physiologic Gingival Pigmentation
Condition: Gingival Pigmentation
Study type: Interventional

Summary: 
      Physiologic pigmentation affects the gingival esthetics. Laser ablation has been recently
      used as the most effective and reliable technique for gingival depigmentation. However, the
      high cost of laser technology limits its use in dental practice. Vitamin C/Ascorbic acid
      mesotherapy has been proposed as a minimally invasive, safe, cost-effective new modality of
      treatment.
    


Intervention name(s): Vitamin C mesotherapy; Diode laser
Intervention type(s): Other; Radiation
Intervention description(s): Vitamin C intra-mucosal injection; in which the site of interest will be anesthetized using a topical anesthetic agent (lidocaine gel or xylocaine gel) or infiltration anesthesia, followed by intra-mucosal field injections of 1-1.5 ml Cevarol (L-Ascorbic acid 1000 mg/5 ml; Diode laser ablation: in which the site of interest will be anesthetized using infiltration anesthesia, followed by laser ablation. 980nm Diode laser will be applied using the following setting parameters: continuous mode with 980nm wavelength at 1.5 W output power.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Investigating the Acute Effects of Flavonoids in Blueberries on Cognitive Function.
Condition: Healthy Adults.
Study type: Interventional

Summary: 
      This study was a controlled, cross-over, acute flavonoid intervention trial with younger and
      older adults. Subjects consumed a blueberry beverage during one visit and a control beverage
      on another. Cognitive function pre drink was assessed, blood and urine samples were taken as
      well as blood pressure and a measure of vascular reactivity. These outcome measures were
      taken at 2 and 5 hours post drink.

      It was predicted that the flavonoids in the blueberry drink would lead to improved
      performance on the cognitive tests and vascular reactivity measure compared to following the
      control drink. It was thought this could be due to increased vaso-dilation and improving
      blood flow to the brain which was investigated in an extension to the project where a sample
      of individuals underwent brain imaging in an MRI scanner pre and post a blueberry and a
      control drink.
    

Detailed description: 
      The control drink was matched to the blueberry drink for other bioactive compounds which may
      have affected cognition, specifically sugars and vitamin C. Volunteers were healthy, not on
      any medication, without high blood pressure, high cholesterol, high BMI, diabetes or other
      medical conditions. Older adults were aged 61-75 years and younger adults 18-26 years.

      Blood and urine samples will be analysed for flavonoid levels and Brain Derived Neurotrophic
      Factor, a biomarker of memory and learning, flavonoids may lead to increased BDNF production
      through the ERK-CREB-BDNF pathway.

      Flavonoids may also increase nitric oxide production and improve the flexibility of the blood
      vessels hence the measure of vascular reactivity using the Digital Volume Pulse machine. This
      can lead to increased vaso-dilation and blood flow to the brain, therefore an fMRI study was
      carried out the investigate this using arterial spin labeling following acute blueberry
      supplementation compared to a control drink.
    

Intervention name(s): Flavonoids; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 475g of anthocyanidins in 300ml of blueberry drink.; 29g powder: sugars (glucose, sucrose, fructose), vitamin C and citric acid.
Other intervention name(s): Anthocyanidins, flavanols, flavonols.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Probiotics in Occupational Shift Workers
Condition: Shift-Work Related Sleep Disturbance; Healthy
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      Purpose: To evaluate the influence of probiotic supplementation on body composition and other
      markers of health in occupational shift-workers.

      Participants: Healthy, overweight females (ages 22-55 yrs) who are employed on a
      shift-working schedule.

      Procedures (methods): In a randomized, placebo-controlled intervention, subjects will
      complete 3 different testing sessions (pre-screening, 1 baseline, 1 post-testing session) as
      well as a 6-week intervention period. Prescreening will include written informed consent, a
      health history questionnaire, baseline anthropometric measures, assessment of resting heart
      rate, and exercise protocol familiarization. Baseline testing will involve body composition,
      a fasted blood draw, mood surveys, and an exercise treadmill test. Subjects will be
      randomized to a treatment group (multi-strain probiotic or placebo) for 6 weeks of
      supplementation that includes 2 electronic contacts, followed by post-testing that will occur
      in the same fashion as baseline testing.
    


Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site
Condition: Opiate Addiction
MeSH terms: Opioid-Related Disorders; Behavior, Addictive
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this project is to conduct a multi-site effectiveness study to determine whether
      the addition of a monthly injection of depot naltrexone to treatment as usual (TAU) will
      significantly improve outcome in parolees and probationers with a history of opioid addiction
      compared to TAU alone. Participants will be randomized to either treatment as usual in
      community programs or monthly injections of depot naltrexone for six months with treatment as
      usual in community programs. The effectiveness of depot naltrexone has never been studied in
      opioid dependent parolees. all parolee subjects will be evaluated at baseline, while in
      treatment, and at 6, 12 and 18 month post entry time points. The primary study outcomes are
      retention in treatment, drug use, re-arrests, psychosocial and medical/psychiatric
      functioning, and economic costs and benefit costs of naltrexone.
    

Detailed description: 
      This site serves as the coordinating center for five sites conducting the trial under the
      same IND and same protocol.
    

Intervention name(s): Depot naltrexone; Treatment as Usual (TAU)
Intervention type(s): Drug; Other
Intervention description(s): Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.; Treatment as Usual (TAU) community treatment provided to the participant
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depot naltrexone; Parolees; Opioid addiction prevention; Medication Treatment Alternatives; Prevention of Relapse to Opioid Addiction
Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma; Liver Cancer
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Capecitabine is a chemotherapeutic that has been approved for use in breast and colorectal
      cancers. The advantages of capecitabine are that (1) it is an oral drug; and (2) it is less
      toxic than many other chemotherapeutics. In an off-label hepatocellular carcinoma (HCC)
      clinical study, the response rate with capecitabine was 13%. The botanical drug
      PHY906--currently manufactured pursuant to GMP standards and regulations--has been used in
      China for over 1800 years to treat gastrointestinal-related ailments. Recently, preclinical
      studies demonstrated that PHY906 potentiates the anti-tumor effect of capecitabine. This
      trial will evaluate the safety and efficacy of PHY906 in enhancing the anti-tumor effects of
      capecitabine.
    


Intervention name(s): PHY906; capecitabine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Capecitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; advanced; unresectable; liver cancer; systemic chemotherapy; botanical; herbal; alternative and complementary medicine; capecitabine; PHY906; oral; HCC; traditional chinese medicine; tcm; QOL; quality of life
Evaluation and Comparison of Systemic Exposure to Ibuprofen After Single Oromucosal Versus Oral Administrations
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the systemic exposure to ibuprofen after single
      oromucosal administration of the test product V0498 and single oral administration of a
      reference product.
    


Intervention name(s): V0498 - A mg; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): Single oromucosal administration; Single oral administration
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mass Balance and Biotransformation Study of [14C]DBPR108 in Human
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label phase I clinical study to evaluate the mass balance and
      biotransformation pathways of [14C]DBPR108 in Chinese healthy adult male subjects, to reveal
      the overall pharmacokinetic characteristics of DBPR108 in human body, and to provide a
      reference for the rational administration.
    

Detailed description: 
      This study will evaluate the mass balance and pharmacokinetics of DBPR108 in approximately 6
      healthy male subjects receiving a single oral 100 mg dose of DBPR108 containing approximately
      150 µCi of [14C]- DBPR108. This study consists of a screening period (Day -7 to Day -2), a
      baseline period (Day -1), a treatment period, and a follow-up visit period.
    

Intervention name(s): [14C]DBPR108
Intervention type(s): Drug
Intervention description(s): [14C]DBPR108, single dose of 100 mg (radioactivity of 150 µCi), oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Extubation Readiness and Neuroventilatory Efficiency After Acute Respiratory Failure
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Observational

Summary: 
      The aim of this study was to compare the indices of rapid shallow breathing, neuromechanical
      efficiency (NME), and neuroventilatory efficiency (NVE) between patients being successfully
      extubated and those who failed weaning.
    

Detailed description: 
      Patients, mechanically ventilated for > 24 h, were included when they met criteria for their
      first spontaneous breathing trial (SBT) on continuous positive airway pressure (CPAP) (5-6
      cmH2O) for 30 minutes. Patients who did not fulfill the criteria for successful SBT, or
      required assist, or deceased within 48h post-extubation were considered extubation failure
      (F). Patients who completed the SBT and remained extubated > 48 h were considered
      successfully extubated (S). Before and during the SBT, arterial blood gases, heart, rate,
      blood pressure, and EAdi, flow, Vt, f, and, airway pressure (Paw) were measured. At 0, 5, 10,
      15 and 30 minutes of the SBT, f/Vt, diaphragm electrical activity (EAdi), NME, and NVE were
      calculated. NME was calculated as Paw/EAdi during inspiratory occlusion. NVE was calculated
      as Vt/EAdi during unassisted inspirations.Arterial blood gases, heart rate, and blood
      pressure were measured. The receiver operating characteristic (ROC) curve was calculated to
      evaluate the predictive performance of each index.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who required mechanical ventilation for more than 24 h.
      
Biospecimen description: 
      Parameters of arterial blood gases, haemodynamic and mechanics of breathing
    
Keywords: neuromechanical efficiency; neuroventilatory efficiency; weaning; Respiration, Artificial